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
NCT00000371,NCT00000371_EG000,No,All,Adult | Older Adult,Phase 3,60,"Inclusion Criteria:

Diagnosis of Schizophrenia as per DSM IV criteria
Have been treated for at least 6 months with any conventional neuroleptic
Have prominent negative symptoms as defined by a total score of 40 or greater on the scale for the assessment of negative symptoms (SANS)

Exclusion Criteria:

Active alcohol or drug abuse
Unstable Medical Illness, seizure disorder, or other serious neurological disorder
Pregnant or Nursing
Unable to complete a cognitive battery",Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00000392,NCT00000392_EG000,No,All,Adult,Phase 2,106,"Inclusion Criteria:

Patients must have:

Cognitive dysfunction on neuropsychological testing.
HIV antibody positivity.
Expected survival of 6 months.
EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC.
Medically stable EKG and urinalysis.
Given informed, written consent to participate.

Allowed:

Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir.
Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant for relief of peripheral neuropathy that is expected to remain unchanged throughout the first 6 months of the study.
Abstinence or agree to use barrier methods of birth control / contraception during the study
Negative pregnancy test within 30 days of study entry
Bilirubin <= 3
CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related symptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive) HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.)
Creatinine <= 1.5 mg/dl
Granulocytes >= 750
Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.)
Other Lab Values Prothrombin time > 70 percent of control.
Platelet Count >= 75000 /mm3
SGOT(AST) < 5 x ULN (ULN = upper limit of normal).

Exclusion Criteria:

Patients with the following are excluded:

History of mental retardation or learning disability.
Evidence of current DSM-III-R Axis I disorder within 3 months prior to study entry or past history of psychotic disorder or bipolar mania.
History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder).

Patients with the following symptoms or conditions are excluded:

Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study.
Serious underlying medical problems that may complicate interpretation of the treatment results, including unstable diabetes mellitus, severe arteriosclerotic heart disease, uncontrolled hypertension, or hepatic or renal failure.
Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results.
Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration.

Excluded within 4 weeks prior to study entry:

Antiretrovirals except as allowed in the Patient Inclusion Criteria.
Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines)

Excluded within 8 weeks prior to study entry:

Long-acting psychoactive agents (e.g., Prozac).

Active alcohol abuse in the past 3 months, or abuse judged by the investigators as likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine, marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines or other substances within the past 3 months, judged by the investigators as likely to interfere with the analyses of neuropsychologic tests.
Positive pregnancy test within 30 days of study entry
No abstinence or no agreement to use barrier methods of birth control / contraception during the study","Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months

Peptide T",PubChem:129012200 | PubChem:137946971 | PubChem:165363475 | PubChem:467521 | PubChem:60139 | PubChem:73352,Peptide T,CC(N)C(=O)NC(CO)C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C(=O)O)C(C)O)C(C)O)C(C)O)C(C)O,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00030147,NCT00030147_EG002,No,Female,Adult,Phase 4,16,"INCLUSION CRITERIA:

Subjects for this study will meet the following criteria:

Self-report of the onset of depression associated with menstrual cycle irregularity or amenorrhea;
A current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (SCID) severity scale and not meeting DSM-IV criteria symptom 9 (suicide)) as determined by the administration of the minor depression module of the Schedule for Affective Disorders and Schizophrenia - Lifetime Version (SADS-L). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase, as well as a 17 item Hamilton Depression score greater than or equal to 10. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria # 9 (suicide), or anyone requiring immediate treatment after clinical assessment or functional impairment ratings of five or six for more than seven consecutive days on daily ratings;
Evidence of perimenopausal reproductive status;
Age 40 to 60;
No prior hormonal therapy for the treatment of perimenopause-related mood or physical symptoms within the last six months;
No history of psychiatric illness during the two years prior to the reported onset of the current episode of depression;
In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins and calcium supplements).

EXCLUSION CRITERIA:

The following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:

1) Severe major depression with any of the following:

positive (threshold) response to SCID major depression section item # 9, suicidal ideation;
anyone requiring immediate treatment after clinical assessment;
severity ratings greater than moderate on the SCID IV interview;
functional impairment ratings of five or six for more than seven consecutive days on daily ratings.

2) Current treatment with antidepressant medications. Our main concern is to exclude subjects taking medications that would treat or precipitate depression or adversely interact with reproductive hormones, phytoestrogens (e.g., anticoagulants), or SERMs. Thus, we wish to exclude only women receiving psychotropic medications, medications that have been reported to induce a change in mood or behavior, hormone replacement therapy, oral contraceptive agents, or medications that may have a potential adverse interaction with the compounds employed in this study.

3) History of psychiatric illness during the two years before the reported onset of the current episode of depression.

4) History of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, or thrombophlebitis; any subject with risk factors for thrombo-embolic phenomena including cigarette smokers; varicose veins, patients with prolonged periods of immobilization (including prolonged travel), and active heart disease. The literature suggests that although both smoking and hormone replacement/oral contraceptives have associated risks of thromboembolic phenomena and cardiovascular events, these individual risks do not become significantly greater when combined until greater than 10 cigarettes a day are consumed. Thus we wish to exclude only subjects for this study who smoke greater than 10 cigarettes per day.

5) Renal disease, asthma.

6) Hepatic dysfunction.

7) Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.

8) Women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding.

9) Patients with a known hypersensitivity to raloxifene, phytoestrogens (including Rimostil, isoflavones, genistein, daidzein, red clover extract and soy-related compounds), estradiol, Alora, medroxyprogesterone acetate, or the excipients (inactive compounds) contained within these medications including: Rimostil -tocopherols, cellulose, calcium hydrogen phosphate, magnesium stearate, silica-colloidal anhydrous; Provera - calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc; Alora - sorbitan monooleate, acrylic adhesive; Evista - anhydrous lactose, carnauba wax, crospovidone, Federal Food, Drug, and Cosmetic Act (FD& C) blue # 2 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.

10) Pregnant women.

11) Porphyria.

12) Diabetes mellitus.

13) Cholecystitis or pancreatitis.

14) History of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia.

15) Recurrent migraine headaches.

16) Malignant melanoma.

17) History of familial hyperlipoproteinemia.",Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks,ChEMBL:CHEMBL81 | DrugBank:DB00481 | PubChem:5035,Raloxifene,O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12,G03XC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00044005,NCT00044005_EG000,No,All,Adult | Older Adult,Phase 2,32,"Inclusion criteria:

Successful completion of participation in protocol #D1050049

Exclusion criteria:

Substance abuse
Prolactin level of ≥200ng/mL at baseline
Pregnancy",Lurasdione 20 mg oral tablets,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00044005,NCT00044005_EG002,No,All,Adult | Older Adult,Phase 2,3,"Inclusion criteria:

Successful completion of participation in protocol #D1050049

Exclusion criteria:

Substance abuse
Prolactin level of ≥200ng/mL at baseline
Pregnancy",Lurasidone 80mg oral tablets,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00050167,NCT00050167_EG000,No,Female,Child | Adult | Older Adult,Phase 1,297,"Inclusion Criteria:

Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.
Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.
High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.
Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).
Patients with bilateral breast cancers are eligible.
Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.
Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound
Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.
Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.
In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value
Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.
Patients who have overexpression of the her-2/neu oncogene are eligible for the study.

Exclusion Criteria:

Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.
Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.
Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.
Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.
Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.
Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.
Patients who have had an organ allograft are ineligible.
Patients with serious concurrent infections are ineligible.
Sexually active male patients unwilling to practice contraception during the study are ineligible.
Patients with pre-existing peripheral neuropathy > grade 1.",Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00051168,NCT00051168_EG000,No,All,Adult | Older Adult,Phase 3,502,Adult patients of any race and either sex with chronic angle-closure glaucoma.,Travoprost (0.004%),ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00059202,NCT00059202_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,150,"Chronic cholestatic disease of at least six months' duration.
Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.
Retrograde, operative, percutaneous, or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or narrowing consistent with PSC within one year of the study entry.
Liver biopsy in the previous one year which is available for review and compatible with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis, ductopenia with periportal inflammation and biliary fibrosis.",Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses,DrugBank:DB01586,Ursodeoxycholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2,A05AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00067808,NCT00067808_EG001,No,All,Child | Adult | Older Adult,Phase 2,93,"Inclusion Criteria:

MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia
Performance status 0-2 (Eastern Cooperative Oncology Group (ECOG) scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart Association (NYHA) cardiac status III-IV excluded.
Signed informed consent
No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of Hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.

Exclusion Criteria:

Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients with active and uncontrolled infections
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements",20 mg/m2 IV over 1 hour daily for 5 days,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00088634,NCT00088634_EG000,No,All,Adult,Phase 2,90,"Inclusion Criteria:

Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

The patient has used an investigational drug within the past 30 days
The patient has participated in a previous study of this compound",2 40 mg lurasidone tablets taken once/day,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00093847,NCT00093847_EG000,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

Major depressive disorder
Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

Exclusion Criteria:

History of psychosis
Allergy to SAMe
Alcohol or drug abuse in the past 3 months prior to study entry",Participants receiving the oral SAMe tosylate,PubChem:10153079,5'-[[(3S)-3-Amino-3-carboxypropyl]methylsulfonio]-5'-deoxy-Adenosine tosylate,C[S+](CCC(N)C(=O)O)CC1OC(n2cnc3c(N)ncnc32)C(O)C1O.Cc1ccc(S(=O)(=O)[O-])cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00096538,NCT00096538_EG000,No,All,Adult | Older Adult,Not Applicable,6,"DISEASE CHARACTERISTICS:

Histologically confirmed classic Kaposi's sarcoma (KS) involving the skin

Non-HIV-associated disease

HIV negative

Measurable disease

At least 8 KS lesions with ≥ 5 marker lesions measurable in 2 dimensions AND ≥ 3 other lesions measuring ≥ 1 cm in diameter

Two 3 mm punch biopsies of a non-marker lesion entirely composed of KS
Irradiated cutaneous lesions may not be used as indicator lesions
No known active visceral KS or symptomatic KS-related edema that would preclude function or require cytotoxic chemotherapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

At least 12 months

Hematopoietic

Hemoglobin ≥ 8 g/dL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN

Renal

Creatinine clearance ≥ 50 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 months after study participation
No hypersensitivity to valganciclovir or ganciclovir
No other neoplasia requiring cytotoxic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 4 weeks since prior biological therapy for KS
No concurrent immunotherapy

Chemotherapy

More than 4 weeks since prior chemotherapy for KS
No concurrent chemotherapy

Endocrine therapy

No concurrent corticosteroid treatment except for replacement doses (equivalent to 20 mg of hydrocortisone per day)

Radiotherapy

See Disease Characteristics
More than 4 weeks since prior radiotherapy for KS
No concurrent radiotherapy

Surgery

Not specified

Other

More than 14 days since prior acute treatment for infection (other than oral thrush or genital herpes) or other serious medical illness
More than 60 days since prior local therapy for any KS indicator lesion unless the lesion showed documented progression since treatment
More than 4 weeks since prior local therapy for KS
More than 4 weeks since prior investigational agents
More than 4 weeks since other prior antineoplastic therapy for KS
No other concurrent antiviral therapy
No other concurrent investigational agents
No other concurrent systemic therapy for KS",Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.,ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00100828,NCT00100828_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion

Histologically confirmed medullary thyroid cancer
Metastatic or inoperable locoregional disease
Measurable disease by CT scan
18 years and over
ECOG PS 0-1

Adequate lab functions including:

Granulocyte count > 1,000/mm^3
Platelet count > 100,000/mm^3
Bilirubin < 1.5 mg/dL
ALT and AST < 2.5 times upper limit of normal
No unstable or uncompensated hepatic disease
Creatinine clearance > 60 mL/min
No unstable or uncompensated renal disease
Negative pregnancy test
More than 3 months since prior biologic therapy
More than 3 months since prior chemotherapy
No prior radiotherapy to > 25% of bone marrow
More than 3 months since prior radiotherapy
Recovered from prior oncologic or other major surgery
More than 30 days since prior non-approved or investigational drugs

Exclusion:

Patients with elevated calcitonin levels as the only measurement of disease are not eligible
Unstable or uncompensated cardiovascular disease
Unstable or uncompensated respiratory disease
Pregnant or nursing
Diarrhea ≥ grade 2 (antidiarrheals allowed)
Other severe or uncontrolled systemic disease
Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
Illness that would preclude study participation
Significant clinical disorder or laboratory finding that would preclude study participation",irinotecan hydrochloride,PubChem:74990 | PubChem:91654792,Oratecan,CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.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
NCT00113321,NCT00113321_EG000,No,All,Child | Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia. Patients must have failed therapy with azacytidine.
Performance status 0-2 (ECOG scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart Association (NYHA)cardiac status III-IV excluded.
Signed informed consent.
No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m*2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.

Exclusion Criteria:

Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients with active and uncontrolled infections.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.",20 mg/m2 by vein (IV) over 1 hour daily x 5 days.,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00113334,NCT00113334_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Patient has histologically proven squamous cell carcinoma of the head and neck that is not amenable to curative therapy, including radiation or surgery (including surgery following induction chemotherapy or chemo-radiation).
Patient's tumor is biopsy accessible.
Patient has a Karnofsky performance status >/= 70.
Patient has adequate bone marrow function: White blood count (WBC) >/= 3,000 cells/mm3, absolute neutrophil count (ANC) >/= 1,500 cells/mm3, platelet count >/= 100,000 cells/mm3, Hgb >/= 9.0 g/dL.
Patient has adequate liver function: total bilirubin level </= 2.0 mg/dL, albumin >/= 2.5 g/dL.
Transaminases (SGOT and/or SGPT) may be up to 2.5 * upper limit of normal (ULN) if alkaline phosphatase is </= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN. However, patients who have both transaminase elevation > 1.5 * ULN and alkaline phosphatase > 2.5 * ULN are not eligible for this study.
Patient has serum creatinine < 2 mg/dl
Patient has signed a written informed consent.
Patient may have received any number of prior chemotherapeutic regimens for recurrent or metastatic disease.
The subject must not be pregnant or breastfeeding. All subjects (male and female) should practice contraception (e.g., barrier, hormonal, intrauterine device [IUD]) or abstain from sexual intercourse while in the study and for up to two months following completion of therapy.
The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous (SC) injections.
Patient >/= 18 years of age.

Exclusion Criteria:

No biopsy accessible tissue.
Patient has received prior radiation therapy to biopsy site within the past 3 months. (Patient may have received palliative radiation within the past 2 weeks, but not to the biopsy site.)
Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent.
Patient requires total parenteral nutrition with lipids.
Patient has a history of uncontrolled heart disease including congestive heart failure, angina at rest, myocardial infarct in the last 6 months, uncontrolled hypertension with systolic blood pressure (BP) >160 or diastolic BP >90, systolic blood pressure (BP) <90 or symptomatic hypotension, or symptomatic or potentially life-threatening tachycardia, bradycardia or arrhythmia.
Pregnant women and women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
Serious infection or other intercurrent illness requiring immediate therapy.
The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
If subject is receiving therapeutic anticoagulation therapy, low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
The patient has a history of or currently exhibits central nervous system (CNS) metastasis. Brain magnetic resonance imaging (MRI) within 28 days of enrollment is required to confirm the absence of CNS metastases.
Patient has received chemotherapy or biologic therapy within 3 weeks of registration.",Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.,DrugBank:DB05434 | PubChem:6918562,ABT-510,CCC[C@H](NC(=O)[C@@H](NC(=O)[C@H](NC(=O)[C@@H](NC(=O)CNC(=O)CN(C)C(C)=O)C(C)C)[C@@H](C)CC)[C@@H](C)O)C(=O)N[C@H](C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NCC)[C@@H](C)CC,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00114504,NCT00114504_EG000,No,All,Adult | Older Adult,Not Applicable,43,"Inclusion Criteria:

Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.
Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes

Exclusion Criteria:

Active inflammatory diseases
Dyslipidemia under medications
Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases",Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy,ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00116584,NCT00116584_EG000,Accepts Healthy Volunteers,All,Child,Phase 3,72,"Inclusion Criteria:

Any child 2-12 months old seen in the emergency department.
A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.

Exclusion Criteria:

No child will be excluded based on race or gender
Patients under the age of 2 months or greater than 12 months
Patients with cyanotic heart disease
Patients with lobar pneumonia, defined by results of chest radiographs.
The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
Patients with croup.
Patients with foreign body aspiration.
Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
Patients with liver or renal disease.
Patients with sickle cell anemia.
Patients requiring mechanical ventilation.
Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
Patients with tracheomalacia or bronchomalacia.
Patients who had received bronchodilators within 2 hours of initiation of the study.
Patients who had received systemic corticosteroids within 72 hours of enrollment
Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.",heliox-driven nebulizations for children with moderate to severe bronchiolitis,PubChem:123812,Heliox,O=O.[He],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00116584,NCT00116584_EG001,Accepts Healthy Volunteers,All,Child,Phase 3,72,"Inclusion Criteria:

Any child 2-12 months old seen in the emergency department.
A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.

Exclusion Criteria:

No child will be excluded based on race or gender
Patients under the age of 2 months or greater than 12 months
Patients with cyanotic heart disease
Patients with lobar pneumonia, defined by results of chest radiographs.
The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
Patients with croup.
Patients with foreign body aspiration.
Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
Patients with liver or renal disease.
Patients with sickle cell anemia.
Patients requiring mechanical ventilation.
Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
Patients with tracheomalacia or bronchomalacia.
Patients who had received bronchodilators within 2 hours of initiation of the study.
Patients who had received systemic corticosteroids within 72 hours of enrollment
Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.",Oxygen nebulizations for children with moderate to severe bronchiolitis,ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00117312,NCT00117312_EG000,No,Male,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

Exclusion Criteria:

Any patient meeting any of the following exclusion criteria will not be entered into the study:

Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
Requires hormonal therapy for neoadjuvant purposes.
Requires treatment with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.",Degarelix 40 mg (10 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00117312,NCT00117312_EG003,No,Male,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

Exclusion Criteria:

Any patient meeting any of the following exclusion criteria will not be entered into the study:

Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
Requires hormonal therapy for neoadjuvant purposes.
Requires treatment with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.",Degarelix 160 mg (40 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00117949,NCT00117949_EG000,No,Male,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent before any study related activity is performed (A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.)
Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
Is at least 18 years.
Has an ECOG score of 2.
Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
Has a PSA value of 2 ng/mL as measured by the central laboratory.
Has a life expectancy of at least 6 months.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:

Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
Requires hormonal therapy for neoadjuvant purposes.
Is recently (within the last 12 weeks preceding Visit 1) or presently treated with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Has received an investigational drug within the last 12 weeks preceding Visit 1.
Has previously participated in this study.",Degarelix 40 mg (10 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00117949,NCT00117949_EG003,No,Male,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent before any study related activity is performed (A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.)
Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
Is at least 18 years.
Has an ECOG score of 2.
Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
Has a PSA value of 2 ng/mL as measured by the central laboratory.
Has a life expectancy of at least 6 months.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:

Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
Requires hormonal therapy for neoadjuvant purposes.
Is recently (within the last 12 weeks preceding Visit 1) or presently treated with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Has received an investigational drug within the last 12 weeks preceding Visit 1.
Has previously participated in this study.",Degarelix 160 mg (40 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00123162,NCT00123162_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 1 | Phase 2,25,"Inclusion Criteria:

Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of >35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.

Exclusion Criteria:

Secondary dysmenorrhea
Any current medication
Serious medical condition",A single vaginal dose of sildenafil citrate 100 mg.,ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00125528,NCT00125528_EG000,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Must have a history of low back pain for a minimum of 6 months with or without radiation of pain to leg or buttocks.
Must be 18 years of age.
Must have a visual analogue scale (VAS) pain score >50 mm
Must be in generally stable health
Must be willing to abstain from drinking alcohol during the course of the study.
If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue either during the course of the study.
Must be able and willing to read and understand instructions as well as questionnaires
Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion Criteria:

Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
Neurologic disorder, including history of seizures
Major psychiatric disorder during the past 6 months
Moderate or severe depression as determined by the Beck Depression Inventory or any active suicidal ideation
Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
Significant renal disease or severe renal insufficiency
History of, or current, substance abuse/dependence including alcohol
Significantly abnormal laboratory values
Pregnant or lactating at any time during the course of the study
Known sensitivity to D-cycloserine
Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
Any change in medication for back pain in the last 30 days.",D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00133679,NCT00133679_EG000,No,All,Child,Phase 4,9,"Inclusion Criteria:

Congenital diaphragmatic hernia
10-42 days (d) of age
Significant illness severity as demonstrated by:

Receiving assisted ventilation and

FiO2 >= 0.40 at 10-14d of age, or
FiO2 >= 0.40 for >=48hours at 15-27d of age, or
FiO2 >= 0.35 at 28-42d of age
Or, need for extracorporeal support at >=10d of age
Or, estimated pulmonary arterial or right ventricular systolic pressure of >= 2/3 systemic pressure at 14-42d of age

Exclusion Criteria:

Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect [ASD] or non-hemodynamically significant ventricular septal defect [VSD])

Sildenafil contraindicated (until condition resolves):

Unable to absorb oral medication, or
Unstable systemic blood pressure, or
Receiving a drug that may interfere with sildenafil metabolism, or
Renal insufficiency
Hepatic insufficiency Previous use of sildenafil","Sildenafil x 45 days

sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00141115,NCT00141115_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence and a comorbid anxiety disorder, including: panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, no otherwise specified (NOS).
Individuals capable of giving informed consent and capable of complying with study procedures.
Individuals must have clinically significant anxiety.
Individuals must have current average alcohol use over past 28 days with > 4 drinking days per week and >4 standard drinks/drinking day for women and > 5 standard drinks/drinking day for men.
Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy test done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant the study medication will be discontinued.
Individual's breathalyzer reading at the time of signing consent must be < 0.04%.

Exclusion Criteria:

Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-Text Revision (DSM-IV-TR) supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition (SCID-I/P) that in the investigator's judgment might require pharmacological intervention, with the exceptions of alcohol dependence and a comorbid anxiety disorder (panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, NOS). Current diagnoses of post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder are exclusionary.
Individuals with evidence of moderate to severe alcohol withdrawal that would require pharmacologic intervention.
Individuals meeting DSM IV criteria for current cocaine or opioid dependence.
Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension and tachycardia (systolic blood pressure [SBP] > 150 mm Hg, diastolic blood pressure [DBP] > 90 mm Hg, or a sitting quietly heart rate [HR] > 100 bpm), acute hepatitis (patients with chronic mildly elevated transaminase levels ((2-3 x upper limit of normal) are acceptable) or poorly controlled diabetes.
Patients currently taking prescribed psychotropic medications.
Patients with a known sensitivity to levetiracetam.
Individuals who have exhibited suicidal or homicidal behavior within the past two years or have current active suicidal ideation.
Women who are pregnant or nursing.
Individuals physiologically dependent on any other drugs (excluding nicotine, caffeine).
Individuals with a history of a hazardous drinking behavior (e.g., driving while intoxicated convictions, violent crimes committed while intoxicated) will be excluded.",Levitiracetam 1500 mg administered twice daily under open label conditions.,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00145327,NCT00145327_EG000,No,Female,Older Adult,Phase 3,613,"Inclusion Criteria:

Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

Poor kidney, eye, or liver health
Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.","Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00145327,NCT00145327_EG002,No,Female,Older Adult,Phase 3,1221,"Inclusion Criteria:

Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

Poor kidney, eye, or liver health
Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.","Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00145470,NCT00145470_EG001,No,All,Adult | Older Adult,Phase 3,158,"Inclusion Criteria:

Have bipolar I disorder, current episode manic or mixed
Treated with lithium or valproic acid

Exclusion Criteria:

Have an unstable medical condition
Clinically significant laboratory abnormality.
Have a primary diagnosis other than bipolar I disorder.","Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00145496,NCT00145496_EG000,No,All,Adult | Older Adult,Phase 3,244,"Inclusion Criteria:

Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
Caregiver required.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition.
Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.",5-10 mg sublingually twice daily for up to 26 weeks,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00150813,NCT00150813_EG000,No,All,Child | Adult | Older Adult,Phase 3,66,"Inclusion Criteria:

Subjects with a confirmed diagnosis of epilepsy.
Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
Male/female subjects (>= 16 years).

Exclusion Criteria:

- Need for an additional Antiepileptic Drug (AED).",Subjects received open-label Levetiracetam.,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00154063,NCT00154063_EG001,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Patients of any race, 18 to 65 years of age inclusive.
Patients with a history of migraine (with or without aura) according to the Headache Classification Committee of the IHS. Migraine attacks have to have had an onset before age 50 and have to have been present for at least 12 months.
Patients with 4-12 qualified migraine attacks per month over the past three months prior to Screening, as well as during the four weeks of the Baseline Phase will be eligible for entry into this study. The interval between two qualified migraine attacks should be at least 24 hours to be counted as distinct migraine attacks. A qualified migraine attack without aura is defined as a headache that lasts 4-72 hours (if untreated or unsuccessfully treated) or if successfully treated (revised per Amendment 01). This attack has at least two of the following characteristics: unilateral location, pulsating quality, moderate or severe intensity that inhibits or prohibits daily activities or aggravation by routine physical activities such as walking up stairs. In addition, at least one of the following symptoms must be present during the headache: nausea, vomiting, or photophobia and phonophobia (revised per Amendments 01 and 02). A qualified migraine attack with aura must fulfill the same criteria as the headache attack, plus have an associated aura as defined by the Migraine Criteria of the Headache Classification Committee of the International Headache Society. An aura alone that requires acute migraine treatment will also be considered a migraine attack.
Male and female patients will be eligible for enrollment. Females should be either of non-childbearing potential by reason of surgery, radiation, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or IUD) for at least one month before study randomization and for two months after the end of the study, and have a negative serum B-hCG at Screening. Pregnant and/or lactating females are excluded. Those women using hormonal contraceptives must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.
Patients with a Body Mass Index (BMI) between 19 to 40 kg/m2 inclusive at Screening.
Patients who are willing to participate and have provided written informed consent prior to being exposed to any study-related procedures.

Exclusion Criteria:

Patients with chronic daily headaches as defined by more than 14 headache days per month on average during the three months prior to Screening,
Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the IHS 2004),
Patients with a history of being non-responsive to more than two classes of adequately conducted, prophylactic migraine treatments (e.g., beta blockers, calcium channel blockers, tricyclics, MAOIs, valproate (divalproex), topiramate, gabapentin),

Patients who use the following medications as described:

Use of marketed triptans for 10 days or greater per month on average,
Use of ergot-containing medications for ten days or greater per month on average,
Use of NSAIDs, acetaminophen, or isometheptene-containing agents for 15 days or greater per month on average,
Use of opioids for 10 days or greater per month on average,
Use of any two or more of the above medications for 15 days or greater per month on average,
Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting,
Patients with a history of or currently having major psychiatric disorders including schizophrenia, major depressive disorder, or bipolar disorder,
Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV),
Patients with elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >= 1.5 times the upper limit of normal (ULN),
Patients with evidence of significant active hematological disease; white blood cell count cannot be less than or equal to 2500/uL or an absolute neutrophil count less than or equal to 1000/uL,
Patients with clinically significant ECG abnormality, including prolonged QTc (Fridericia correction) defined as >= 450 msec for males and >= 470 msec for females,
Patients with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, and bacterial or viral infections within 30 days prior to Screening or during the Baseline Phase,
Patients with known or suspected history of alcoholism or drug abuse within the previous two years, or a positive finding on urinary drug screening of other than prescribed medications,
Patients who have had severe allergic reactions to multiple drugs,
Patients with any other condition that would make them, in the opinion of the PI, unsuitable for this study,
Patients that have participated in a study involving administration of an investigational compound (including E2007) within one month of Visit 1 (Screening),
Patients with a known or suspected allergy to lactose, excluding lactose intolerance,
Patients who use the following medications for any medical reason during the study: beta-blockers, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, NSAIDs daily, magnesium supplements at high doses (ie, 600 mg/day), riboflavin at high doses (ie, 100 mg/day), corticosteroids, local anesthetics, botuliunum toxin, or herbal preparations such as feverfew or St. John's Wort. Patients who use non-pharmacological prophylactic approaches that were started at least one month prior to Screening may be continued throughout the study.
(revised per Amendment 03)
Patients who fail to complete the migraine diary adequately during the Baseline Phase (ie, patients, who do not have complete diary entries for at least 21 days of the Baseline Phase).

Randomized patients will be both male and female, 18-65 years of age, of any race, with a history of migraine headaches (with or without aura according to the Headache Classification Committee of the International Headache Society (IHS, 2004 guideline) for at least 12 months, with an onset before age 50, experiencing 4-12 migraine attacks per month during both the 3 months prior to Screening and the Baseline Phase. Patients' Body Mass Index (BMI) should be between 19 to 40 kg/m2 inclusive at Screening.","During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00156065,NCT00156065_EG000,No,All,Adult | Older Adult,Phase 3,50,"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.",Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00156065,NCT00156065_EG001,No,All,Adult | Older Adult,Phase 3,92,"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.",Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00159783,NCT00159783_EG001,No,All,Adult | Older Adult,Phase 3,79,"Inclusion Criteria:

Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

Patients with unstable medical conditions or clinically significant laboratory

abnormalities.",Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study),ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00160654,NCT00160654_EG000,No,All,Adult | Older Adult,Phase 4,251,"Inclusion Criteria:

Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.

Exclusion Criteria:

Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
Presence of known pseudoseizures within the last year.
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.",Subjects received open-label Levetiracetam.,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00174265,NCT00174265_EG000,No,All,Adult | Older Adult,Phase 3,85,"Inclusion Criteria:

Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant

medical condition.

Have been judged to be medically noncompliant in the

management of their disease.",5-10 mg sublingually twice daily for 26 weeks,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00199381,NCT00199381_EG000,No,All,Adult | Older Adult,Phase 3,503,"Inclusion Criteria:

Completion of study 6002-INT-001
Not of childbearing potential

Exclusion Criteria:

Cancer within 5 years of enrollment
ALT/AST levels > 2.5 times ULN",Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.,ChEMBL:CHEMBL431770 | DrugBank:DB11757 | PubChem:5311037,Istradefylline,[H]/C(=C(/[H])c1nc2c(c(=O)n(CC)c(=O)n2CC)n1C)c1ccc(OC)c(OC)c1,N04CX01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00203216,NCT00203216_EG000,No,All,Adult | Older Adult,Not Applicable,31,"Inclusion Criteria:

Patient is male or female between the ages of 18 and 65
Patient has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
Patient has experienced between 4 and 10 migraine headaches per month over the past six months, with at least 48 hours separating attacks
Patient is able to differentiate migraine attacks from other headache types, if applicable
Patient is not currently and has not in the 4 weeks preceding screening received prophylactic treatment for the indication of migraine
Patients daily medications have remained at a stable dose for the 4 weeks preceding screening
Patient is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
Patient has negative urine pregnancy test prior to study entry, if female of child-bearing potential
Patient is able to understand and comply with all study requirements
Patient provides written informed consent prior to any screening procedures being conducted

Exclusion Criteria:

Women who are pregnant or lactating
Patients with onset of migraine after 50 years of age
Patients who experience > 15 headache days per month
Patients who have been previously treated or are currently being treated with levitiracetam
Patients who have failed greater than 3 adequate trials of other antiepileptic drugs for the prevention of migraine.
Patients who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
Patients with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
Patients who take medication for acute treatment greater than 10 days per month over the past three months.
Patients who are allergic to or have shown hypersensitivity to compounds similar to levetiracetam
Patients with a history of significant drug or alcohol abuse within the past year
Patients who have had a suicidal ideation in the 3 months prior to screening or has a history of attempted suicide
Patients who currently have or have a history of significantly impaired renal function
Patients who have participated in an investigational drug trial in the 30 days prior to the screening visit
Patients who have a Beck Depression Inventory score of > 18 at screening
Patients who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
Patients who have a defibrillator or pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (e.g. a shrapnel wound).","In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00215657,NCT00215657_EG000,No,Male,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07",Degarelix 120 mg (20 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00215657,NCT00215657_EG006,No,Male,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07",Degarelix 240 mg (60 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00215657,NCT00215657_EG007,No,Male,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07",Degarelix 320 mg (60 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00225251,NCT00225251_EG000,No,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Male and female outpatients 18-65 years of age.
Patients with a Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnosis of dysthymic disorder, early onset.
Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.

Exclusion Criteria:

Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
Patients who are pregnant or nursing women.
Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder
Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia
Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.

Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:

Report of having a specific plan for killing themselves,
A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors), or
A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication).
Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal seizures, and those with other medical conditions in which Wellbutrin XL would be contraindicated, including a history of head trauma.
Use of any psychotropic medication within 1 week of starting study medication
Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14 days prior to the initial dose of study medication.
Use of fluoxetine within 28 days of the initial dose of study medication.
Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of medication.
Patients who have failed to respond to adequate trials (minimum of six consecutive weeks) of two different classes of antidepressant medication (see Table 1 for definitions of an adequate trial.)
Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic or neurologic disease, or any clinically significant laboratory abnormality.
Patients who have begun a course of psychotherapy within 3 months of starting the study, or who plan to terminate an ongoing psychotherapy prior to the end of the study.","Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT00234078,NCT00234078_EG000,No,All,Adult | Older Adult,Phase 2,72,"Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.",0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks,ChEMBL:CHEMBL1697771 | DrugBank:DB11656 | PubChem:5042,Rebamipide,O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1,A02BX14,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00234078,NCT00234078_EG001,No,All,Adult | Older Adult,Phase 2,72,"Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.",1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks,ChEMBL:CHEMBL1697771 | DrugBank:DB11656 | PubChem:5042,Rebamipide,O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1,A02BX14,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00234078,NCT00234078_EG002,No,All,Adult | Older Adult,Phase 2,74,"Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.",2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks,ChEMBL:CHEMBL1697771 | DrugBank:DB11656 | PubChem:5042,Rebamipide,O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1,A02BX14,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00239005,NCT00239005_EG000,No,All,Adult | Older Adult,Phase 4,68,"Inclusion Criteria:

Received kidney transplant
Receiving immunosuppressive regimen that includes MMF
Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
At least 18 years of age
Willing to provide written informed consent
Able to meet all study requirements including completing questionnaires and completing four study visits.

Exclusion Criteria:

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including, but not limited to, visual problems or cognitive impairment.
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Additional protocol-defined inclusion/exclusion criteria may apply.","Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00245466,NCT00245466_EG002,No,Male,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Has completed study treatment in study FE200486 CS02.
Has completed visit 16 in study FE200486 CS02.
Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02","In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00249002,NCT00249002_EG000,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria:

Thrombosed graft within the past 7 days or a patent but dysfunctional polytetrafluoroethylene (PTFE) graft (identified by any means) with a stenosis of greater than 50% at the graft-vein anastomosis or within 8 centimeters of the graft-vein anastomosis which will be referred to as the index lesion. Following angioplasty patients must have residual stenosis of less than 20% post angioplasty for the index lesion and for all other stenoses; also index lesion must be located in the arm. PTFE graft requiring angioplasty must be at least 30 days old.
Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
Patient or guardian has provided a signed written informed consent for the administration of ABI-007 (post-angioplasty or at the time of first dialysis through the new graft) using a form that is approved by the local IRB/ethics committee of the investigative site.
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

Use of a stent at the time of current angioplasty or at any previous time in the index lesion.
No perforation at the time of current angioplasty.
Thrombosed graft for more than 7 days.
Patient has the following blood counts at baseline:
Absolute neutrophil count (ANC) < 2.0*10^9/L;
platelets < 100*10^9/L;
Hemoglobin (Hgb) < 9 g/dL.
Patient has the following blood chemistry levels at baseline:
Aspartate transaminase (AST or SGOT), alanine transaminase (ALT or SGPT) > 2.5x upper limit of normal range (ULN);
total bilirubin ≥ upper limit of normal (ULN);
Unable to give informed consent, or for whom informed consent cannot be obtained from a legal guardian.
Women who are pregnant and women of child bearing potential who do not use adequate contraception.
2 procedures of percutaneous or surgical intervention on the PTFE graft within the previous 90 days.
Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial.
Patient has a life expectancy of less than 6 months.
Intended kidney transplant within 6 months of enrollment in the study
Any significant medical condition which in the investigators opinion may interfere with the patients optimal participation in the study.
Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
Patient has a history of allergy or hypersensitivity to the study drug.
Documented hypercoagulable state requiring anti-coagulation (protein S, protein C, antiphospholipid; anticoagulation on an empiric basis for graft thromboses in not a contradiction).
Patient is human immunodeficiency virus (HIV) positive.
Patient is currently receiving other chemotherapy drug(s).","ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00251303,NCT00251303_EG000,No,All,Child,Phase 2,30,"INCLUSION CRITERIA:

Subjects may be included in the study only if they meet all of the following criteria:

Male or female subjects, 7 to 17 years of age.
Male and female subjects of childbearing potential must be using a medically accepted means of contraception or must remain abstinent.
Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study. Each legal guardian must consent to study protocol.
Subjects must fulfill DSM-IV criteria for (OCD) and have a CY-BOCS score of greater than 20. In the double-blind phase, subjects enrolled in the combined OCD and ASD cohort must also meet DSM-IV criteria for Pervasive Developmental Disorder as well as OCD.
Each subject already taking medicine must be taking usually effective doses of a medicine demonstrated to be effective in childhood OCD, must have been stable on that dose for at least six weeks, and must have no newly recognized or intolerable adverse effects from that medicine. Subjects who are currently not taking such a medication must have had adequate trial in the past of at least one medicine that has been shown to be effective for the symptoms of childhood OCD, and must have failed to see improvement or must have had intolerable adverse effects from the medicine.
Subjects must be able to swallow capsules.

EXCLUSION CRITERIA:

Subjects will be excluded from the study for any of the following reasons:

Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or other serious unstable psychiatric illness. Medically unstable due to binging, purging, or starvation.
Judged clinically to be at risk for suicide (suicidal ideation, severe depression, or other factors). Diagnosis of DSM-IV Major Depressive Disorder is not necessarily an exclusion criterion.
Disabling Tic Disorder requiring contraindicated medicines.
Male or female subjects who are unwilling to use effective contraception, or female subjects who are pregnant or nursing.
Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Renal or hepatic dysfunction that would interfere with excretion or metabolism of riluzole as evidenced by increase above upper limits of normal for BUN/creatinine, or more than two-fold elevation above upper limits of normal of serum transaminases (ALT/SGPT, AST/SGOT), gamma glutamate (GGT), or bilirubin.
Documented history of hypersensitivity or intolerance to riluzole.
DSM-IV Substance Abuse Disorder within the past 90 days or Substance Dependence Disorder within the past 5 years, or any use of tobacco.
Taking contraindicated drugs.
Unable to swallow capsules.
In addition, patients will not receive cognitive-behavior therapy during the period of the study.
Abnormal EEG unless evaluated by a neurologist and approved by that specialist for this protocol.","In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.

Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent.",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00264290,NCT00264290_EG001,No,All,Adult | Older Adult,Phase 4,14,"Inclusion Criteria:

Infection with HIV >1 year in duration.
Age >18
Cytomegalovirus (CMV) antibody positive.
All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3

On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months.

90% adherence to antiretroviral therapy within the preceding 30 days.
Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period.
Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10%

Exclusion Criteria:

Patients intending to modify antiretroviral therapy in the next 16 weeks.
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
Evidence of active symptomatic CMV end-organ disease.
Treatment with valganciclovir or ganciclovir in the past 30 days.
Concurrent treatment with immunomodulatory drugs.
Concurrent treatment with nephrotoxic drugs
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute.
Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis.
Pregnant or breastfeeding women","900mg PO qd

Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00265109,NCT00265109_EG000,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Men and women age 18-65;
Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
Suitable for treatment in an outpatient setting

Exclusion Criteria:

Unstable medical illness, including renal failure or dialysis;
Myocardial infarction within 6 months;
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
Clinically significant suicidality, including a suicide attempt within the past two months;
Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
Current or recent (past 3 months) DSM-IV substance abuse or dependence;
Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
Ongoing cognitive-behavioral therapy from a mental health professional;
Previous treatment with levetiracetam;
Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.","All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00265200,NCT00265200_EG000,No,All,Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

invasive lung cancer (small cell or non-small cell lung cancer)
osteolytic bone metastasis determined by clinical exam, bone scan/XR
age > 18 years

Exclusion Criteria:

concurrent malignancy with a second primary
renal failure (serum creatinine > 3mg/dl)
pregnancy
active rheumatoid arthritis
intolerance to zoledronic acid","3.0-4.0 mg by IV (in the vein), once a month for 6 months",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00274261,NCT00274261_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 3,836,"Inclusion Criteria:

Potential subjects must:

Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception.
Be within the age range of 18 through 40 years inclusive.
Be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection and currently have a single sex partner (minimum 4 months) who is also at low-risk for HIV or STD.
Have a negative urine pregnancy test prior to enrollment.
Have normal cyclic menses with a usual length of 24 to 35 days over the last 2 cycles or at least one spontaneous, normal menstrual cycle (2 menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
Be willing to accept a risk of pregnancy.
Be willing to engage in at least 4 acts of heterosexual vaginal intercourse per month for a period of 6 months.
Be willing to be randomized to either study treatment.
Be willing to only use the study product as the primary method of contraception over the course of the study with the exception of emergency contraception (EC), when indicated.
Be capable of using the study product properly and agree to observe all study directions and requirements.
Be willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data of subject and partner.
Agree not to participate in any other clinical trials during the course of the study.
Be willing to give written informed consent to participate in the trial.

Exclusion Criteria:

Potential subjects must not:

Have a history of allergy or sensitivity to spermicides or products containing N-9.
Have had 3 or more urinary tract infections (UTI) in the past year.
Have UTI by urine culture or symptomatic yeast vaginitis or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.
Have any contraindications to pregnancy (medical condition) or chronic use of category D or X medications.
Have had more than one sexual partner in the last 4 months.
Have shared injection drug needles within the past 12 months.
Have or have been suspected to have HIV infection.
Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within three months prior to screening.
Have 3 or more outbreaks of HSV within the last year.
Have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit (with the exception of Human Papilloma Virus [HPV]).
Be lactating or breastfeeding.
Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
Have any clinically significant abnormal finding on pelvic examination or baseline labs, which in the view of the investigator, precludes her from participating in the trial.
Have clinically significant signs of vaginal or cervical irritation on pelvic examination.
Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
Have used vaginal or systemic antibiotics or antifungals within 14 days prior to screening or randomization.
Have had a Depo-Provera® injection in the 10 months prior to enrollment.
Have an abnormal Pap smear with high grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC) or ASC-H (atypical squamous cells, cannot exclude HSIL) within the last 12 months.
Have an abnormal Pap smear with low-grade squamous intraepithelial lesion (LSIL) or ASCUS-HPV HR positive unless resolved by colposcopy.
Have a Cervical Intraepithelial Neoplasia (CIN) diagnosis by biopsy within the last 12 months.
Have a history or a current diagnosis of cervical cancer.
Consume (on average) greater than three drinks of an alcoholic beverage per day.
Have a past history (within twelve months) or current history of drug abuse [recreational, prescription or over-the-counter (OTC)].
Have taken an investigational drug or used an investigational device within the past 30 days.
Have previously participated in or completed this study or any other phase III study of C31G.
Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.",C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel,DrugBank:DB05398,C31G,CCCCCCCCCCCC[N+](C)(C)CC(=O)[O-].CCCCCCCCCCCC[N+](C)(C)[O-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00283933,NCT00283933_EG000,No,Male,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Males between 18 and 65 years of age (inclusive)
Hemizygous for Fabry disease
Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
Had enhanceable enzyme activity based on in vitro tests
Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency)
Were previously untreated by enzyme replacement therapy (ERT) or substrate depletion for Fabry disease, or if ERT or other specific treatment for Fabry disease was administered, were able to stop ERT for at least 30 weeks.
Were willing to undergo 2 kidney and 3 skin biopsies
Agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following completion of the study
Were willing and able to sign an informed consent form

Exclusion Criteria:

History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease [per the New York Heart Association classification]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have impaired the participant's ability to participate in the study)
History of organ transplant
Serum creatinine >176 millimole per deciliter on Day -2
Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds prior to dosing
Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
Participated in a previous clinical trial in the last 30 days
Any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results",Migalastat 150 mg was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.,ChEMBL:CHEMBL110458 | DrugBank:DB05018 | PubChem:176077 | PubChem:29435,Migalastat,OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O,A16AX14,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00284050,NCT00284050_EG002,No,All,Adult | Older Adult,Phase 2,49,"Inclusion Criteria:

Diabetic macular edema with center involvement in at least one eye
Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion Criteria:

Patients with uncontrolled systemic or ocular diseases
Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.",Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00290290,NCT00290290_EG000,No,All,Adult | Older Adult,Phase 3,440,"Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.

-

Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.

-",Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine,PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00291226,NCT00291226_EG000,No,All,Child | Adult,Phase 2 | Phase 3,4,"Inclusion Criteria:

meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

history of psychosis","Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.

Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or ""sprinkles"" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.

Glycine: Glycine 0.4 g/kg bid",ChEMBL:CHEMBL773 | DrugBank:DB00145 | PubChem:750,Glycine,NCC(=O)O,B05CX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00291655,NCT00291655_EG000,No,All,Child | Adult | Older Adult,Phase 3,130,"Inclusion Criteria:

Male/female adult subjects (≥ 16 or 18 years)
Diagnosis of epilepsy (all types of seizures may be included)
Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy

Other inclusion criteria may apply

Exclusion Criteria:

Subjects withdrawn from N01175 (NCT00175903) trial for any reason
Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
Subject requiring add-on antiepileptic treatment
Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
Sexually active woman with childbearing potential who is not using a medically accepted birth control method","Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00295867,NCT00295867_EG000,No,Female,Adult | Older Adult,Phase 2,45,"Inclusion Criteria

Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.
If adjuvant chemotherapy is recommended, it must be completed before study start.

Bone marrow aspirate positive by IC/FC assay

a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.

ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.

Adequate renal function as defined by:

a. Creatinine must be < upper limit of normal

Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)
Ability to understand and sign informed consent.
Concomitant hormonal therapy is allowed
Concomitant radiation therapy is allowed
Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial

Exclusion Criteria

History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.
History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.
Karnofsky Performance status < 90%.
Any significant medical condition that might interfere with treatment.
Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.
Patients who are pregnant",Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00299416,NCT00299416_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,30,"Inclusion Criteria:

Age 18-80 years
Clinical presentation of acute ischemic stroke
Computed tomography (CT) scan compatible with acute ischemic stroke.
Time to caffeinol treatment < 240 minutes from stroke onset.
Time to hypothermia initiation < 300 minutes from stroke onset.
Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment.
Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

Exclusion Criteria:

Etiology other than ischemic stroke.
Item 1a on NIHSS > 1
Signs/symptoms of subcortical, brainstem or cerebellar stroke.
Symptoms resolving or NIHSS < 8 at time of each treatment.
NIHSS > 20 if right hemisphere or >25 if left hemisphere
Known alcoholic
Clinical or laboratory evidence of alcohol intoxication.
Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
Known hematologic dyscrasias that affect thrombosis.

Comorbid conditions likely to complicate therapy:

End-stage cardiomyopathy
Uncompensated or clinically significant arrhythmia
Myopathy
Liver disease
History of pelvic or abdominal mass likely to compress inferior vena cava.
End-stage AIDS
History of clinically significant gastrointestinal (GI) bleeding
Impaired renal function with creatinine clearance, 50 ml/min
Intracerebral / intraventricular hemorrhage
Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg
Severe coagulopathy
Pregnancy
Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
Known history of epilepsy.",Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.,PubChem:53630515,Caffeinol,Cn1cnc2c1c(=O)n(CO)c(=O)n2C,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT00304512,NCT00304512_EG002,No,Female,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Females between 18 and 65 years of age (inclusive)
Heterozygous for Fabry disease
Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
Had enhanceable enzyme activity based on in vitro tests
Were naïve to enzyme replacement therapy (ERT) and other therapies, except for palliative therapies for the signs and symptoms of Fabry disease, or stopped ERT for at least 18 weeks
Had end organ dysfunction, even minimal, demonstrated by abnormal electrocardiogram (ECG) or evidence of left ventricular hypertrophy documented by echocardiogram or by cardiac biopsy; or renal insufficiency documented by common clinical assessments such as creatinine and glomerular filtration rate or by renal biopsy; or brain tissue dysfunction as documented by evidence of stroke (clinically or imaging); or peripheral nervous tissue dysfunction documented by complaints of intolerance to heat or cold, decreased vibratory sense and proprioception, decreased ability to perspire, or acroparesthesia.
Were willing to undergo 2 renal and 3 skin biopsies
Agreed to be sexually abstinent or practice an effective method of contraception when engaging in sexual activity during the course of the study and for a period of 30 days following their completion of the study for women of childbearing potential.
Were willing and able to provide written informed consent

Exclusion Criteria:

Pregnant or lactating
History of organ transplant
History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease [per the New York Heart Association classification]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have impaired the participant's ability to participate in the study)
Serum creatinine >176 micromoles/liter on Day -2
Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds
Pacemaker or other contraindication for magnetic resonance imaging scanning
Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
Participated in a previous clinical trial in the last 30 days
Any other condition which, in the opinion of the investigator would jeopardize the safety of the participant or impact the validity of the study results.",Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.,ChEMBL:CHEMBL110458 | DrugBank:DB05018 | PubChem:176077 | PubChem:29435,Migalastat,OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O,A16AX14,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00322153,NCT00322153_EG001,No,All,Adult | Older Adult,Phase 3,341,"Inclusion Criteria:

Ambulatory patients aged >/= 50 years
Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
Patients who have taken memantine within one month of Screening (Visit 1)
Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
Patients who are receiving therapy with more than one AChEI.
Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
Patients who had dementia that was complicated by other organic disease
Patients who had dementia complicated by the presence of predominant delusions",28mg once daily oral administration for 24 weeks.,PubChem:181458,Memantine Hydrochloride,CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00323063,NCT00323063_EG000,No,All,Adult | Older Adult,Phase 2,26,"DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Locally advanced or metastatic disease

Disease progression after at least 1 prior chemotherapy regimen for metastatic disease

No more than 2 prior chemotherapy regimens for metastatic disease (prior neoadjuvant or adjuvant treatment will not be included in determining the number of prior chemotherapy regimens)
Measurable disease

No known symptomatic or untreated brain metastases or carcinomatous meningitis

Previously treated and clinically stable brain metastases allowed provided patient has been off steroids for > 7 days
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
ECOG performance status 0-2
Life expectancy ≥ 3 months
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
Able to swallow oral medication
No coexisting medical condition that would preclude study compliance

No uncontrolled illness, including any of the following:

Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia requiring therapy
Myocardial infarction within the past 6 months
Active infection
No New York Heart Association class III-IV cardiac disease
No history of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride and/or imatinib mesylate
No other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
No known HIV infection

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from all prior therapy
More than 2 weeks since prior surgery
At least 2 weeks since prior hormonal therapy
At least 2 weeks since prior trastuzumab (Herceptin®)
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
At least 3 weeks since prior anti-vascular endothelial growth factor therapy
More than 28 days since prior investigational agents

At least 3 weeks since prior radiotherapy

Must have evidence of ≥ 1 measurable target lesion outside the irradiated fields OR radiologically confirmed disease progression within the irradiated fields after completion of radiotherapy
No prior imatinib mesylate for metastatic disease
No prior gemcitabine hydrochloride for metastatic disease
More than 6 months since prior adjuvant gemcitabine hydrochloride
No other concurrent investigational or commercial agents

No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)

Concurrent heparin or low-molecular weight heparin (e.g., Lovenox®) for therapeutic anticoagulation allowed
Concurrent prophylactic warfarin therapy (e.g., mini-dose Coumadin® ≤ 1 mg daily) to maintain catheter patency allowed
No concurrent routine chronic systemic corticosteroids
No concurrent medications that would preclude study compliance","Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.

gemcitabine hydrochloride: Given IV",PubChem:60749,Gemcitabine Hydrochloride,Cl.Nc1ccn(C2OC(CO)C(O)C2(F)F)c(=O)n1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00333814,NCT00333814_EG002,No,All,Adult | Older Adult,Phase 2 | Phase 3,75,"Inclusion Criteria:

18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

Uncontrolled systemic disease
Any active ocular infections",Sham,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00334737,NCT00334737_EG002,No,All,Child,Phase 2,33,"Inclusion Criteria:

500-1250 grams birth weight
less than or equal to 32 weeks gestation
less than 2 days of age

Exclusion Criteria:

severe hemorrhagic disease
severe hemolytic disease
DIC
seizures
hypertension
thromboses
receiving erythropoietin","Sham injection

sham injection: sham injection",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00335972,NCT00335972_EG001,No,All,Adult | Older Adult,Phase 4,142,"Inclusion Criteria:

Consenting adult patients (age >50 years) undergoing carotid endarterectomy with general anesthesia.

Exclusion Criteria:

Receiving another alpha 2-adrenoreceptor agonist;
Contraindication to dexmedetomidine, including allergy;
Current hepatic disease (liver function tests > twice upper limit of normal);
Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;
Mentally impairment, including dementia or delirium;
Heart block ;
Sick sinus syndrome;
Atrial fibrillation with a low ventricular response (< 50 bpm);
Absolute or relative hypovolemia;
Prior stroke;
Severe left-ventricular dysfunction","Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00336232,NCT00336232_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,42,"Inclusion Criteria:

-

Exclusion Criteria:

kidney, GI, or liver disease requiring treatment
prescribed osteoporosis medications in the previous 3 months
use of acid reducers more than twice per week
blood clotting disorder and/or abnormal clotting time
warfarin or anticoagulant use in the previous 12 months
diabetes
smoking
hormone therapy in the previous 3 months
oral contraceptive use in the previous 3 months; pregnancy
strict vegetarian diet","5 day baseline vitamin K

Vitamin K: phylloquinone (vitamin K1) 200 mcg daily

28 day diet low vitamin K

Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days

treatment started day 6, completed day 33

28 day diet high vitamin K

Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month

treatment started day 34, ended day 61",ChEMBL:CHEMBL1550 | DrugBank:DB01022 | PubChem:4812 | PubChem:5280483 | PubChem:5284607,Vitamin K,CC(=CCC1=C(C)C(=O)c2ccccc2C1=O)CCCC(C)CCCC(C)CCCC(C)C,B02BA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00336817,NCT00336817_EG000,No,All,Adult | Older Adult,Not Applicable,30,"Inclusion Criteria:

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.
Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.
Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).
Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).
Patients with tacrolimus- or cyclosporine-induced neurotoxicity.
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period.

Exclusion Criteria:

Multi-organ transplant patients.
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients and nursing mothers.
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment.
Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
Evidence of drug and/or alcohol abuse.
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves","Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00336895,NCT00336895_EG000,No,All,Adult | Older Adult,Not Applicable,29,"Inclusion Criteria:

ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
Patients must be more than 30 days post-transplant to be eligible
Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period

Exclusion Criteria:

Multi-organ transplant patients
HIV positive patients.
Living-related liver transplant recipients
Pregnant patients
Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment
Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)
Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
Evidence of drug and/or alcohol abuse
Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves","All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00345384,NCT00345384_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,19,"Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I, II or III
Undergoing thoracic surgery on an inpatient basis
Age 18 up to 85 years of age

Exclusion Criteria:

Subject is pregnant and/or lactating
Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
Subject for whom alpha-2 agonists are contraindicated
Subject meets any of the following cardiovascular criteria:
Acute unstable angina (defined during current hospital stay)
Suspicion of acute myocardial infarction.
Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.
Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
Subject is unable to undergo any procedures required by the protocol.
Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
Subject has a known, uncontrolled seizure disorder.
Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
Subject is terminally ill with a life duration expectancy of < 60 days.
Subject has a history of Obstructive Sleep Apnea.
Oxygen saturation is < 90% on room air.
Subject is on beta blocker medication.",Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00351299,NCT00351299_EG000,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

Adults admitted to our surgical ICU who do not have any exclusion criteria
Eligibility for treatment- Development of delirium as defined

Exclusion Criteria:

Acute MI (myocardial infarction),
Trauma <24 hours,
Head injury,
Multiple organ failure,
EF (ejection fraction) < 30%,
History of hypersensitivity to alpha2 agonist,
History of seizures, MAP (mean arterial pressure) <60 mm of Hg,
Dysrhythmias a/with bradycardia (HR (heart rate) <50),
Need for vasopressors,
Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)","infusion 0.3-0.7 dexmedetomidine

Dexmedetomidine: dexmedetomidine infusion titrated to effect",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00351377,NCT00351377_EG000,No,All,Adult | Older Adult,Phase 3,111,"Inclusion criteria:

Patients with autoimmune diseases;
receiving immunosuppressive therapy that includes MMF at time of study enrollment;
receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1 month prior to enrollment. Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).

Exclusion criteria:

If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception;
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
Current acute medical intervention or hospitalization;
Presence of a medical condition not related to a GI event at time of visit, which requires immediate medical intervention.

Other protocol-defined inclusion/exclusion criteria may apply",Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.,ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00358527,NCT00358527_EG000,No,All,Adult | Older Adult,Phase 4,267,"Inclusion Criteria:

Must be >=18 years of age and older, of either sex, and of any race.
Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1)
At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8)
At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11)
Must have a 2-year or longer history of SAR occurring during the same season as the current study.
Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit
Must be free of clinically significant disease that would interfere with study evaluations
Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation.
Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit.

Exclusion Criteria:

Women who are pregnant, intend to become pregnant during the study, or are nursing
Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow
Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants
Acute respiratory infection within 2 weeks of the Screening Visit
Diagnosis of clinically relevant sleep problems unassociated with allergies
Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints
Snoring associated with an enlarged uvula or other upper airway pathology
Had episodes of snoring associated with gasping or choking
Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling
Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems
Diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting beta-2 adrenoceptor agonists
Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit and who wish to remain on this schedule during the study are eligible for study inclusion; however, they may not receive hyposensitization treatment within 24 hours prior to any study visit
Smokers or ex-smokers who have smoked within the previous 6 months
Concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders.
Any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Subjects participating in any other clinical study(ies).
Subjects allergic to or with a sensitivity to the study drug or its excipients.
Subjects who are night-shift workers or do not have a standard ""asleep at night/awake during the day"" cycle","Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00359216,NCT00359216_EG000,No,All,Adult,Phase 4,20,"Inclusion Criteria:

Demonstration of willingness to participate in the study and comply with its procedures by signing a written informed consent.
Ages 18 to 60 years, of either sex, and of any race.
A 2-year or longer history of perennial allergic rhinitis (PAR) with or without SAR.
Skin test positive to a relevant prevalent perennial allergen or seasonal allergens if the subject also has SAR done either at the Screening Visit or within the previous 12 months.
At the Screening Visit (Visit 1) subject must have TNSS of >=12 our of a possible 24, nasal congestion score of 4 out of a possible 6 on congestion, an Interference With Sleep average score of (2) moderate over 7 nights prior to the Screening Visit.
At the Baseline Visit (Visit 2) scores, reflective over the previous 12 hours, of 4 or more for nasal congestion using a categorical whole-number symptom severity scale encompassing 7 severity ratings on at least 6 of the 15 recordings of the Run-in period which may include the morning of the Baseline Visit (Visit 2).
At the Baseline Visit (Visit 2) subject must have a TNSS of more than >=12 out of a possible 24 reflective over the past 12 hours on at least 6 or more of the 15 recordings of the Run-in period, which may include the morning of the Baseline Visit.
Current complaint of sleep disturbance while symptomatic with PAR and have a score of at least 2 with the Interference with Sleep scale on at least 4 out of the 8 AM diary recordings during the Run-in period and may include the morning of Visit 2 (Baseline).
The number of AH events per hour will be recorded but should not exceed 30 per hour.
Freedom from any clinically significant disease (other than PAR or SAR) that would interfere with the study evaluations.
Confirmation by subject that he/she is practicing adequate contraception: Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening and while receiving protocol-specified medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation).
Understanding of, and ability to adhere to, the dosing and visit schedules, and agreement to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

Exclusion Criteria:

Pregnant or intention to become pregnant during the study
Breast-feeding or intention to breast-feed during the study or within 30 days after study completion
Currently medication for PAR, or during the 10 days prior to the Screening Visit, treatment for SAR or PAR with an antihistamine or a nasal inhaled corticosteroid.
Current or a history of frequent (2 or more episodes per year for the past 2 years) clinically significant sinusitis or chronic purulent postnasal drip.
Recent nasal septum ulcers, nasal surgery, or nasal trauma; postpone inclusion until healing has occurred.
A diagnosis of rhinitis medicamentosa.
Upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to screening, or a viral upper or lower respiratory infection within 7 days prior to screening.
Nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfere with nasal airflow.
Bronchial asthma that cannot be controlled by short-acting beta 2-agonist adrenergic receptor agonists.
Current desensitization immunotherapy and expectation of receiving an increase in dose during the study. Subject may not receive desensitization treatment within 24 hours prior to a study visit.
Failure to observe the designated washout periods for any of the prohibited medications outlined in section 6.2 of the protocol.
Previous randomization into the study.
Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study, or the subject's ability to complete the diary cards.
Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex.
Compromised ability to provide informed consent.
A history of non-compliance with medications or treatment protocols.
Morbidly obese (BMI >= 40).
Night-shift working schedule with no standard asleep at night/awake during the day cycle.
Any clinically significant deviation from the appropriate reference range in the physical examination that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Participation in any other clinical study(ies).
Subject is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
Subject is allergic to or has sensitivity to the study drug or its excipients.","100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00360308,NCT00360308_EG001,No,All,Adult | Older Adult,Phase 3,234,"Inclusion Criteria:

Male or female patients with idiopathic PD fulfilling the (United Kingdom [UK]) Parkinson's disease Society Brain Bank diagnostic criteria, with a good response to levodopa.
Patients must have been diagnosed with idiopathic PD at ≥ 30 years of age. In addition the onset of symptoms associated with Parkinson's disease must have occurred ≥ 30 years of age.
Patients must have predictable motor fluctuations of the wearing OFF type with the presence of at least 2 hrs of OFF time during the waking day (excluding the morning OFF time) as evidenced by diary cards completed at screening and confirmed by diary data collected in the 3 day diaries completed before randomisation.
Before patients are randomised, they must be able to show that they are able to accurately complete the diary cards. During the diary-training period at Screening Visit 1, there must be diary evidence of at least one transition of OFF to ON or from ON to OFF.
Patients must rate between II IV on the Hoehn &Yahr (8) scale when in an OFF state.
Patients must be taking optimised levodopa (plus dopamine decarboxylase inhibitors [DDI]) therapy (according to the Investigator's opinion) at least 3 times during the waking day (not including bedtime/night time dose) up to a maximum of 8 doses daily (including bedtime/night time dose).
Patients who are treated with DA or MAOB inhibitors or other anti-PD drugs must be on optimised and stable doses for at least 4 weeks prior to the Screening visit and must remain stable throughout the study. Only levodopa dosage can be adjusted downwards in the first 6 weeks of the double blind treatment phase.
In the Investigator's opinion, patients must be able to distinguish their own motor states and the absence or presence of troublesome or non-troublesome dyskinesias.
In the Investigator's opinion, patients are able to complete the study including the completion of the home diary cards and are capable of giving full written informed consent.

Exclusion Criteria:

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum B-human chorionic gonadotrophin (B-HCG) test at the initial screening visit (Visit 1) and a negative urine pregnancy test at the baseline visit (Visit 3). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non child bearing potential as determined by the Investigator.
Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders (4th edition; DSM IV) criteria.
Patients with a past (within 1 year) or present history of psychotic symptoms requiring anti psychotic treatment. Patients may be taking anti-depressant medication; however, the dose must be stable for 4 weeks prior to the Screening visit. Use of anti psychotic medication including clozapine and quetiapine is prohibited.
Patients with a past (within 1 year) or present history of major depression, suicidal ideation or suicide attempts.
Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems that might complicate assessment of the tolerability of the study medication.
Patients who have a past or present history of liver impairment, neuroleptic malignant syndrome, non traumatic rhabdomyolysis or pheochromocytoma.
Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
Patients with current or prior treatment (within 4 weeks prior to the Screening visit) with medication known to induce the enzyme CYP3A4.
Current or prior treatment (within 4 weeks prior to the Screening visit) with pergolide (only applies to patients entering after April 5, 2007), cabergoline (effective as of the date of the IRB/IEC approval of this amendment), tolcapone, methyldopa, budipine, reserpine, quetiapine or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
Current treatment with non selective MAOA/B or combination of selective MAOA and selective MAOB inhibitors.
Patients with a known hypersensitivity to the active substance or to any of the excipients of entacapone.
Patients with previous stereotactic surgery (e.g., pallidotomy) for PD or with planned stereotactic surgery during the study period.
Patients receiving or with planned (next 6 months) deep brain stimulation.
Patients who have received entacapone previously or are currently using entacapone.
Patients who have received an investigational product within 4 weeks prior to the Screening visit or patients who have participated in a previous study with E2007.
Patients with clinically significant cognitive impairment (Mini Mental State Examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to PD).
Patients with conditions affecting the peripheral or central sensory system unless related to PD (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.","Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00361595,NCT00361595_EG000,No,Female,Child | Adult | Older Adult,Not Applicable,35,"Inclusion Criteria:

Postmenopausal women to age 85, inclusive
Finish treatment of 12 months or longer with Forteo
Signed informed consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

Hip and spine DXA T-score >-1.0
Patients with 25-(OH) vitamin D levels less than 15 ng/mL at Visit 1. (Patient can be repleted with vitamin D 50,000 units biweekly for up to 2 months and re-screened anytime during the 2 months while continuing Forteo.)
Baseline renal insufficiency (calculated creatinine clearance less than 40.0 mL/min (MDRD) at Visit 1 and/or Visit 2 or urine dipstick greater than or equal to 2+ protein without evidence of contamination or bacteriuria (may be repeated one time at least a week apart if there is suspicion of contamination). Patients with calculated creatinine clearance equal to or greater than 40.0 mL/min and less than 60.0 mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must be retested between Visit 1 and 2. Patients with calculated creatinine clearance greater than 60.0 mL/min and serum creatinine within normal limits at Visit 1 do not require re-test.
Patients who require re-test of creatinine clearance between Visit 1 and 2 will be excluded if there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1 and Visit 2.
Serum calcium <8.5 or >11.0 mg/dl at Visit 1
AST or ALT greater than twice the upper limit of normal
Serum alkaline phosphatase greater than 1.5 times the upper limit of normal (liver fraction)
No history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM with Hb1 AC > 10%
Hypersensitivity to bisphosphonates
Treatment with biphosphonates while on Forteo
Prior treatment with i.v. biphosphonates
Estrogen, calcitonin, raloxifene use prior to Forteo treatment are not exclusions, but concomitant therapy during with any bone agents during the trial will not be permitted
Any prior use of strontium ranelate or sodium fluoride
Chronic use of systemic corticosteroids (oral or i.v.) within the last year:

NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary.

Prior exposure to anabolic steroids or growth hormone within 6 months prior to randomization
Treatment with any investigational drug(s) and/or devices within 30 days prior to randomization.
History of iritis or uveitis, except when secondary to trauma, and must have resolved for more than 2 years prior to randomization.

Cancer exclusions:

Patients with a new diagnosis or active treatment for any malignancy less than or equal to 12 months prior to Visit 1.
Patients with evidence of any metastases on or prior to randomization, or with a history of metastases
Subjects with evidence of paraneoplastic syndrome, especially those characterized by hypercalcemia during screening or by history
Patients with the following may be included: basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, and Carcinoma in-situ (CIS) of the prostate (Stage I only) that has been surgically removed.
Previous major solid organ or bone marrow transplant recipient or on a transplant waiting list
Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA (L1-L4) e.g., implantable devices, scoliosis, ankylosing spondylitis, DJD. (Less than two lumbar spine vertebral bodies evaluable)
Active primary hyperparathyroidism or hypoparathyroidism
Subject with complete thyroidectomy
Active hyperthyroidism
Hypothyroidism not treated with adequate replacement therapy
History of multiple myeloma or Paget's disease
Patients with severe dental problems or current dental infections, or with recent or impending dental surgery within three months of dosing
Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol",5 mg zoledronic acid in a single 15 minute IV (intervenous),ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00367432,NCT00367432_EG000,No,All,Child | Adult | Older Adult,Phase 3,398,"Inclusion Criteria:

Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]

Exclusion Criteria:

Female patients during pregnancy, delivery and lactation, or suspected of pregnancy","Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00368108,NCT00368108_EG001,No,All,Adult | Older Adult,Phase 3,251,"INCLUSION CRITERIA:

Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.
Patients must have been diagnosed with idiopathic PD at > 30 years of age.
Patients must have predictable motor fluctuations of the wearing ""OFF"" type.
Patients must rate between II-IV on the Hoehn & Yahr scale when in an ""OFF"" state.
Patients must be taking optimized levodopa therapy.

EXCLUSION CRITERIA:

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.
Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.",The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.,ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00371176,NCT00371176_EG000,No,All,Adult | Older Adult,Not Applicable,26,"Inclusion Criteria:

Male or female outpatients 18 years of age or older who served in Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) and who have a primary diagnosis (designated by the patient as the most important source of distress of PTSD.
Willingness and ability to comply with the requirements of the study protocol.

Exclusion Criteria:

A lifetime history of:

bipolar disorder
schizophrenia
psychosis
delusional disorders or obsessive-compulsive disorder
organic brain syndrome
cognitive dysfunction that could interfere with capacity to engage in therapy
a history of substance or alcohol dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate services.
Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
Serious medical illness or instability for which hospitalization may be likely within the next year.
Patients with a current or past history of seizures
Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., intra uterine device, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration specifically targeting PTSD is excluded. General supportive therapy initiated > 3 months prior is acceptable.
Patients with seizures or ongoing severe cognitive impairment that compromised mental status.
Patients receiving Isoniazid.
Patients unable to understand study procedures and participate in the informed consent process.
Patients with a history of renal insufficiency (creatinine clearance less than 50 mL/min).",Brief imaginal exposure therapy plus DCS pill,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00376220,NCT00376220_EG000,No,All,Adult | Older Adult,Phase 2,94,"Inclusion Criteria:

Ages 18-75
Diagnosed with Bipolar I or II disorder and currently depressed
Tried at least one antidepressant during the current episode of depression
Currently taking either lithium, depakote, or tegretol
Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

Current psychotic symptoms
Women who are pregnant or nursing
Any serious, uncontrolled medical illness
History of liver problems
Current or past blood diseases
Current drug or alcohol abuse
Currently receiving Electroconvulsive Shock Therapy (ECT)
Judged to be at serious suicidal risk","Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00377676,NCT00377676_EG000,No,All,Adult | Older Adult,Phase 3,2054,"Inclusion Criteria:

Type 2 diabetes
age 30-80 years
body mass index < 43 kg/m2
HbA1c ≤ 10% for at least 12 weeks prior to screening
stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents (no more than 2), or insulin (with or without no more than 1 oral hypoglycemic agent) for 4 weeks prior to randomization

Exclusion Criteria:

Subject who had taken prescription sympathomimetic drugs within seven (7) days prior to the first screening visit. Prescription sympathomimetic drugs were not allowed for any period greater than ten (10) consecutive days during the course of the study. Other ergot alkaloid derivatives or anti-migraine medications such as zolmitriptan (Zomig) and sumatriptan (Imitrex) were not permitted during the study.
Subject who had a history of alcoholism or drug abuse in the three (3) years prior to the first screening visit.
Subject who had a known hypersensitivity to any of the formulation components of the study drug.
Subject who had received any experimental drug or used an experimental device in the 30 days prior to the first screening visit or would do so during the study.
Subject who was pregnant or lactating women or women planning to become pregnant during the study. Women of childbearing potential had to have a negative pregnancy test at screening. Women who became pregnant were discontinued from the study.
Subject who had given donations of blood during the 30 days prior to the screening visit. Donation of blood also was prohibited during the study and for 30 days after completion of the study.

Subjects with clinically significant major organ system disease, such as

seizure disorder
significant gastroparesis or orthostatic hypotension (autonomic neuropathy)
cerebrovascular accident in the previous 6 months
uncontrolled hypertension (systolic BP >160 or diastolic BP > 100 at screening)
coronary artery bypass graft or coronary angioplasty in the previous 3 months, myocardial infarction in the previous 6 months, or unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the ER or hospital for chest pain) within the previous 3 months
congestive heart failure defined by NYHA as Class III or IV
clinical nephrotic syndrome, or renal impairment with a serum creatinine > 1.4 mg/dl if female receiving treatment with metformin, > 1.5 mg/dl if male receiving treatment with metformin, and > 1.6 mg/dl in not on metformin
impaired liver function, including having AST or ALT greater than three times the upper limit of normal
active infection (e.g., HIV, hepatitis), or a history of severe infection during the 30 days prior to screening
major surgical operation during the 30 days prior to screening
cancer, other than non-melanoma skin or non metastatic prostate cancer within the past 5 years
Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen
Working rotating, varying or night shifts
Patients taking unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc)
Patients who had started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients could not begin treatment with an erectile dysfunction drug during the study period; patients previously taking erectile dysfunction drugs could do so only under medical supervision.
Subjects with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
Clinically significant abnormalities (values outside the normal range) on screening central laboratory evaluation unless discussed with and approved by the study principal investigator or Sponsor medical monitor.","During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.",PubChem:31100,Bromocriptine Mesylate,CC(C)CC1C(=O)N2CCCC2C2(O)OC(NC(=O)C3C=C4c5cccc6[nH]c(Br)c(c56)CC4N(C)C3)(C(C)C)C(=O)N12.CS(=O)(=O)O,,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00381485,NCT00381485_EG002,No,All,Child | Adult | Older Adult,Phase 3,240,"Inclusion Criteria:

A subject must be at least 12 years of age, of either sex, and of any race, with a diagnosis of asthma of at least 12 months duration that is consistent with the following definition:

The diagnosis of asthma is based upon clinical history and examination, pulmonary function parameters, and response to beta2-agonists, according to international guidelines.

A subject must have been using a high dose of inhaled glucocorticosteroid (ICS) either alone or in combination with a long-acting beta2 agonist (LABA) for at least 12 weeks prior to Screening, with no use of oral glucocorticosteroids within 30 days prior to Screening. A subject must have been on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening. High daily doses of ICS are defined as follows:

>1000 mcg beclomethasone chlorofluorocarbon (CFC)
>500 mcg beclomethasone hydrofluoroalkane (HFA)
>1000 mcg budesonide dry powder inhaler (DPI)
>2000 mcg flunisolide
>500 mcg fluticasone
>400 mcg MF
>2000 mcg triamcinolone acetonide
>320 mcg ciclesonide

Note: Dose delivery by method or modality other than those noted above must be equivalent.

A subject must have experienced at least one severe exacerbation requiring a course of oral glucocorticosteroid 2 to 12 months prior to Screening.
If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, then the subject (and parent/guardian, if applicable) must be willing to discontinue his/her prescribed ICS or ICS/LABA prior to initiating MF MDI run-in medication.

To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization, one of the following methods can be used at the Screening Visit, Day-14, or thereafter, but prior to the Baseline Visit:

The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within approximately 15 to 20 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg).
The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percent of the best and lowest morning pre-bronchodilator PEF over at least 1 week.
The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value. Note: If a subject is to qualify using diurnal variation, the subject should be instructed to perform his/her PEF evaluation after using his/her bronchodilator in the evening.
At the Screening Visit, the subject's FEV1 must be >=50% predicted when all restricted medications have been withheld for the appropriate intervals.
At the Baseline Visit, the subject's FEV1 must be >=50% and <=85% predicted when all restricted medications have been withheld for the appropriate intervals.
The subject (and parent/guardian for a subject under the age of legal consent) must be willing to give written informed consent and be able to adhere to dose and visit schedules.

A female subject of childbearing potential must be using a medically acceptable, adequate form of birth control. This includes:

hormonal contraceptive as prescribed by a physician (oral combined, hormonal vaginal ring, hormonal implant or depot-injectable);
medically prescribed intra-uterine device (IUD);
medically prescribed topically-applied transdermal contraceptive patch;
condom in combination with a spermicide (double-barrier method);
monogamous relationship with a male partner who has had a vasectomy. The subject must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with spermicide), and must agree to continue its use for the duration of the study. A female subject of childbearing potential who is not currently sexually active must agree and consent to using a medically acceptable method should she become sexually active during the course of this study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for the open-label MF MDI Run-in Period.

Exclusion Criteria:

A subject who demonstrates a change (increase or decrease) in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit. Pulmonary function tests (PFTs) will be performed in the morning.
A subject who requires the use of >8 inhalations per day of short-acting beta agonists (SABA) MDI or >=2 nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
A subject who experiences a decrease in AM or PM peak expiratory flow (PEF) below the Run-in Period stability limit on any 2 consecutive days prior to randomization.
A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [including oral or other systemic corticosteroids, but allowing SABAs]), at any time from the Screening Visit up to and including the Baseline Visit.
A subject who has been treated in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction, within the last 3 months.
A subject who has ever required ventilator support for respiratory failure secondary to asthma.
A subject who has experienced an upper or lower respiratory tract infection (viral or bacterial) within the previous 2 weeks prior to Screening and Baseline Visits. Visits can be rescheduled 2 weeks after complete resolution of the event to re-assess eligibility.
A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years.
A subject with a clinically significant abnormal vital sign.
A subject with evidence (upon visual inspection, laboratory culture is not required) of clinically significant oropharyngeal candidiasis at Baseline (Visit 3) with or without treatment. If there is evidence of oropharyngeal candidiasis at Screening or Pre-Baseline Visit, the subject may be treated as appropriate and the Baseline Visit can be scheduled upon resolution. If there is evidence of oropharyngeal candidiasis at the Baseline Visit, the subject may be treated as appropriate and the visit can be rescheduled upon resolution.
A subject with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or require treatment that might interfere with the study. Specific examples include (but are not limited to) insulin-dependent diabetes, hypertension being treated with beta blockers, active hepatitis, coronary artery disease, arrhythmia, stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as clinically diagnosed chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, etc. Other conditions that are well-controlled and stable (eg, hypertension not requiring beta blockers) will not prohibit participation if deemed appropriate per the investigator's judgment.
A subject who is known to be allergic to or intolerant of ICS, beta2 agonists, or any of the excipients present in the medications used in this study.
A female subject who is breast-feeding, pregnant, or intends to become pregnant while participating in this study.
A subject who is a known illicit drug user.
A subject who is known to be human immunodeficiency virus (HIV) positive (HIV testing will not be conducted in this study).
A subject who is unable to correctly use an oral MDI inhaler.
A subject who has been taking any of the restricted medications prior to Screening without meeting the required washout timeframes.
A subject who cannot adhere to the permitted concomitant medications and prohibited medications.
A subject participating in this study may not participate in this same study at another investigational site. In addition, a subject cannot participate in a different investigational study at any site, during the same timeframe of this study.
A subject must not be randomized into this study more than once.
No person directly associated with the administration of the study may participate as a study subject. No family member of the investigational study staff may participate in this study.
A subject who previously participated in a trial with MF/F.
Subjects with a history of significant QTC prolongation (ie, QTc>500 msec) are excluded from participation in the study.",Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00383721,NCT00383721_EG002,No,All,Adult | Older Adult,Phase 3,253,"Inclusion Criteria:

Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of <=70%.
At Screening & Baseline, postbronchodilator FEV1 must be >= 60% predicted normal & >=25% predicted normal.
COPD symptoms for >=24 months.
>=2 COPD exacerbations requiring course of oral corticosteroid &/or antibiotics within 2-12 months before screening.
Ex- or current smoker with smoking history >=10 pack years.
Only albuterol/salbutamol for relief for at least 2 weeks prior to randomization.
Withdraw from parenteral & oral steroids, anticholinergics, & antibiotics 4 weeks prior to Screening.
No harm in changing current COPD therapy, willing to discontinue his/her anticholinergics, inhaled corticosteroids (ICS) or ICS/long-acting beta agonists (LABA) at Screening, & transferred to albuterol/salbutamol for relief for 2 weeks prior to Randomization.
Lab tests conducted at Screening must be acceptable to investigator. Electrocardiogram (ECG) performed at Screening or within 30 days prior to Screening must be acceptable to investigator. Chest X-ray or computerized tomography (CT) scan is acceptable within 12 months prior to Screening must be acceptable to investigator.
Female of childbearing potential must use birth control. Includes: hormonal contraceptives, intra-uterine device (IUD), condom in combination with spermicide, monogamous relationship with male partner who had vasectomy. Started birth control at least 3 months prior to Screening (exception condom), & must agree to continue. Female who is not currently sexually active must agree/consent to using a method should she become sexually active. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.

Exclusion Criteria:

Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate & visit can be scheduled upon resolution. If there is evidence at Baseline, may be treated as appropriate & visit can be rescheduled upon resolution.
History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) hypertension treated with beta-blockers), active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB [Fridericia or Bazett corrections, respectively >500 milliseconds (msecs)]) stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled & stable (eg hypertension not requiring beta-blockers) will not prohibit participation if appropriate to investigator.
Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients.
Female who is breast-feeding, pregnant, or intends to become pregnant.
Illicit drug user.
Human immunodeficiency virus (HIV) positive (testing not conducted).
Unable to correctly use oral MDI.
Taking any restricted medications prior to Screening without meeting washout.
Cannot adhere to permitted concomitant & prohibited medications.
May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time.
Not be randomized into study more than once.
No person directly associated with administration of study may participate.
Previously participated in MF/F trial.
Increase in absolute volume of >=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.
Asthma.
Lobectomy, pneumonectomy or lung volume reduction surgery.
Lung cancer.
Requires long-term administration of oxygen (>15 hours/day).
Alpha-1-antitrypsin deficiency.

A history and/or presence of intraocular pressure in either eye >=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening:

nuclear opalescence (NO): >=3.0,
nuclear color (NC): >=3.0,
cortical cataract (C): >=2.0,
posterior subcapsular (P): >=0.5.",Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00383942,NCT00383942_EG000,No,Female,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Singleton pregnancy
Cephalic presentation
36 completed weeks of gestation
Intact membranes
Unfavorable cervix (defined as Bishop score < 5)
Indication for induction of labor
Fetal Station less than or equal to -3

Exclusion Criteria:

Clinically significant vaginal bleeding
Evidence of spontaneous labor (3 contractions in 10 minutes)
Contraindication to induction of labor or to use of prostaglandins
Fetal station higher than -3",Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00394355,NCT00394355_EG000,No,All,Adult,Phase 4,140,"Inclusion Criteria:

Informed consent, adhere to schedules.
Inform usual treating medical doctor (MD) of study participation.
Female 18 to 40, male 18 to 50, any race.
>=3-month asthma history.
Never treated with inhaled corticosteroids (ICS) for asthma or not have taken ICS for ≥3 months prior to Screening.
Prebronchodilator forced expiratory volume (liters) in 1 second (FEV1) >=60% & <=90% predicted at both Screening & Baseline, when all restricted medications withheld.
Prior to randomization, demonstrate increase in absolute FEV1 of >=12%, with absolute volume increase of >=200 mL, after reversibility testing.
Lab tests normal/acceptable to investigator/sponsor. Electrocardiogram (ECG) performed at screening or <30 days of screening normal/acceptable to investigator. Chest x-ray performed at screening or <12 months of screening normal/acceptable to investigator.
25-hydroxy vitamin D level >=15 ng/mL. If <15, re-tested after taking calcium plus vitamin D for 4 weeks.
Free of significant disease (other than asthma) known to affect bone mineral metabolism including renal disease, unstable hyperthyroidism or other endocrinopathies, Paget's disease, osteoporosis, malabsorption, or others that could interfere with study evaluations (eg scoliosis, metal pins, calcification in spine/femur).
Women of childbearing potential must use birth control. Includes: hormonal contraceptive, intra-uterine device (IUD); condom in combination with spermicide; monogamous relationship with male who had vasectomy or is using condom. Started method ≥3 months prior to Screening (exception condom), & agree to continue for duration. Women who are not currently sexually active must agree/consent to using double-barrier method if become active. Females must have negative serum pregnancy test at Screening.
2 valid scans, as confirmed by local dual energy x-ray absorptiometry (DXA) center, for lumbar spine, left total femur, & femoral neck prior to randomization. Valid scans will be 2 scans of same region, performed on same day, that agree within 5% & scans are technically satisfactory (eg correct scan mode, no artifacts present, correct region).

Exclusion Criteria:

>12 inhalations/day of salbutamol on 2 consecutive days between Screening & Baseline.
Increase/decrease in FEV1 of >=20% between Screening & Baseline.
Treated with methotrexate, cyclosporin, gold, or other cytotoxic agents, for asthma or concurrent condition within last 3 months.
Pipe/cigar smoking history.
Smoker/ex-smoker who smoked within previous year or has smoking history ≥10 pack-years.
Upper/lower respiratory tract infection within 2 weeks prior to Screening & Baseline. Can be rescheduled.
>14 days of oral steroids within previous 12 months or required burst of systemic steroids within previous month.
Ever required ventilator support for respiratory failure secondary to asthma.
Treated in emergency room (ER) for asthma exacerbation or admitted to hospital for management of airway obstruction on 1 occasion in last 3 months or on >=2 occasions within last 6 months.
Chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis.
Participated in study within last 30 days.
Allergic to/intolerant of ICS, beta-agonists, or drugs/excipients in study.
Average of 2 lumbar spine (L1-L4) scans at Screening is >2 standard deviations below normal.
Condition that might affect ability to ambulate normally, (ie major surgical procedure). Condition that may interfere with BMD measurement.
History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere (eg calcium urolithiasis or absorptive hypercalcuria, insulin dependent diabetes, cancer within last 10 years (except basal cell carcinoma), active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, human immunodeficiency virus (HIV), or respiratory conditions such as chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis. Others which are well-controlled & stable (eg hypertension, arrhythmia, subjects on stable thyroid hormone replacement for at least 3 months whose thyroid stimulating hormone (TSH) levels are normal) may be allowed.
Treated within last year with drug known to interfere with bone metabolism including: bisphosphonates, estrogens such as depot injectables (estrogens used in oral combined hormonal contraceptives are allowed if dose is stable throughout), high-dose fluoride, & thyroid replacement hormones (if not stabilized).
History &/or presence of intraocular pressure in either eye >=22 mm Hg, glaucoma, &/or posterior subcapsular cataracts. History &/or presence of nuclear cataract or undergone bilateral lens extraction may be eligible.
The subject has undergone incisional or intraocular surgery in which the natural lens is still present in the eye.
The subject has a history of penetrating trauma to both eyes.
The subject has one or more of the following lens opacities classification system version III (LOCS III) grades at screening: nuclear opalescence (NO) >=3.0, nuclear color (NC) >=3.0, cortical (C) >=2.0, posterior (P) >=0.5.
Pregnant, breast-feeding, or postmenopausal women. Amenorrhea >6 months will be excluded (exception hysterectomy). Bilateral oophorectomy excluded.
Relevant abnormal Baseline vital sign.
Body mass index (BMI) >35 kg/m2.
HIV positive (testing not performed).
Alcoholic or illicit drug abuser.
Evidence of oropharyngeal candidiasis at Baseline with or without treatment. If evidence at Screening, may be treated as appropriate & visit can be scheduled upon resolution. If evidence at Baseline Visit, may be treated as appropriate & visit can be rescheduled upon resolution.
Normal sleep/wake cycle is inverted (eg night shift workers).
Taken restricted medications prior to Screening.
Cannot adhere to prohibited & permitted concomitant medications.
No subject may participate in this same study at another site or simultaneously in any other study.
No person directly associated with administration of study may participate.",Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00398983,NCT00398983_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,20,"Inclusion Criteria:

Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
Performance status of 0, 1, or 2
Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal

Exclusion Criteria:

Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
Known to be HIV+
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
No other investigational therapy within the past 14 days",20 mg/m^2 intravenous (IV) daily for 5 days,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00405652,NCT00405652_EG000,No,All,Adult | Older Adult,Phase 3,34,"Inclusion Criteria:

Received liver transplant at least 3 months prior to study enrollment.
Receiving immunosuppressive regimen that includes a calcineurin or mTOR inhibitor, and MMF at time of study enrolment. The patient must be stable on current immunosuppressive regimen. The MMF dose must be stable for at least 1 month prior to enrollment. Steroid use will be according to local practice.
Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).
Patients with a medical condition that necessitates MPA-treatment for probably the next 6- 8 weeks (time of study duration).
Patients with at least mild overall Gastrointestinal (G)I complications as assessed by the GI complications Case Report Form(CRF).
Eligible and willing to convert to Myfortic.
At lease 18 years of age.
Willing to provide written informed consent.
Able to meet all study requirements including completing the questionnaires and completing 2 study visits.
Patients receiving drugs that may cause GI symptoms such as bisphosphonates, minerals, vitamins, antibiotics or proton pump inhibitors (PPIs) have to be on a stable dose of these substances for at least 1 month prior to enrollment. Patients receiving these drugs can only be enrolled into the study, if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).
Females capable of becoming pregnant must have a negative pregnancy test within 7 days prior to or at baseline. Pregnancy test has to be repeated every 4 weeks. Females are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.

Exclusion criteria:

If applicable, GI symptoms assumed or know not to be caused by MPA therapy (e.g. oral bisphosphonates induced, infections diarrhea).
Acute rejection <1 week prior to study enrollment
Patients with Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and or/ bilirubin values >=3 x Upper limit normal (ULN) (values available from the last routine assessment within 3 months are acceptable).
Patients with serum creatinine values >=265 umol/L (values available from the last routine assessment within 3 month are acceptable).
Patients with hemoglobin values <7g/dL and/or an absolute platelet count of <50 x 10^9/L and /or an absolute leukocytes count of <2.0 x10^9/L (values available from the last routine assessment within 3 month are acceptable.)
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating or who is unwilling to use effective means of contraception.
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, could interfere with study requirements.
Undergoing acute medical intervention or hospitalization.
Presence of a medical condition not related to a GI event at the time of visit, which requires immediate medical intervention.
Any other medical condition that, in the opinion of the site investigator based on recall or chart review, interfere with completing the study, including but not limited to, visual problems or cognitive impairment.
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Patients with hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolic mofetil or other components of the formulation (e.g. lactose; see also SmPCs)

Other protocol-defined inclusion/exclusion criteria may apply.","Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00413062,NCT00413062_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 3,554,"Inclusion Criteria:

Sexually active women, at risk for pregnancy and not planning to use condoms;
Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index >=17 and <=35;
Good physical and mental health;
Willing to give informed consent in writing.

Exclusion Criteria:

Contraindications for contraceptive steroids
In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone (conditions that predispose to hyperkalemia):
Renal insufficiency;
Hepatic dysfunction;
Adrenal insufficiency.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
Clinically relevant abnormal laboratory result at screening as judged by the investigator;
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).","Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).",ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00414310,NCT00414310_EG000,No,All,Child | Adult | Older Adult,Phase 2,71,"Inclusion Criteria:

Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, granulocyte colony-stimulating factor (GCSF) are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT < 2.5x institutional upper limit of normal.
Signed informed consent.

Exclusion Criteria:

Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Active and uncontrolled infections.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Known ornithine transcarbamylase disorder.
Patients requiring continuous valproic acid treatment for the control of seizure disorders.",Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00419393,NCT00419393_EG000,No,All,Child | Adult | Older Adult,Phase 3,189,"Inclusion Criteria:

Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
Subjects who were discontinued prior to the end of titration period","1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00420212,NCT00420212_EG001,No,All,Adult,Phase 3,410,"Key Inclusion Criteria:

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.",Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD),ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00420212,NCT00420212_EG002,No,All,Adult,Phase 3,416,"Key Inclusion Criteria:

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.",Participants received two 120 mg BG00012 capsules orally three times daily (TID),ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00424619,NCT00424619_EG000,No,All,Adult | Older Adult,Phase 4,22,"Inclusion Criteria:

Fragility hip fracture patient
Previous Vitamin D supplementation is okay.

Exclusion Criteria:

Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
Cancer in the past 10 years likely to metastasize to bone
Renal insufficiency (creatinine <30 mls/min)
Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
Pre-existing bone abnormality
Renal stones in past 10 years",50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days,ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00424619,NCT00424619_EG001,No,All,Adult | Older Adult,Phase 4,22,"Inclusion Criteria:

Fragility hip fracture patient
Previous Vitamin D supplementation is okay.

Exclusion Criteria:

Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
Cancer in the past 10 years likely to metastasize to bone
Renal insufficiency (creatinine <30 mls/min)
Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
Pre-existing bone abnormality
Renal stones in past 10 years",100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days,ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0
NCT00425607,NCT00425607_EG000,No,All,Child | Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

All patients must have confirmatory mutational analysis showing G608G mutation in the lamin A gene.
Patients with progeroid laminopathies, showing clinical signs of Progeria but with other confirmed mutations in LMNA will be eligible for therapy. This population will be analyzed separately from those with the classical mutations.
Patients must be willing and able to come to Boston for appropriate studies and examinations approximately once every 4 months.
Patients must have a minimum of one year of weight data available, with five data points or more, each separated by one month or more over a one year period and approval by the study team.
APC (ANC + bands + monocytes = APC) > 1,000/ml, Platelets > 75,000/ml (transfusion independent); Hemoglobin >9g/dl.
creatinine less than or equal to 1.5 times normal for age or GFR > 70 ml/min/1.73m2.
bilirubin less than or equal to 1.5 x upper limit of normal for age; SGPT (ALT) < and SGOT (AST) < 5 x normal range for age.
PT/PTT < 120% upper limit of normal OR PI approval.
No overt renal, hepatic, pulmonary disease or immune dysfunction.
Patients taking growth hormone when entering the study must have pretreatment weight measures while on growth hormone which are specified above. In addition, patients must remain on growth hormone treatment for the duration of the present clinical trial. Patients entering the trial not on growth hormone must remain off of growth hormone for the duration of their participation.
Signed informed consent according to institutional guidelines must be obtained and patient must begin therapy within twenty eight (28) days.

Exclusion Criteria:

Patient must not be receiving any other experimental drug therapy.
Patients must not be taking medications that significantly affect the metabolism of lonafarnib.
Subjects who have known or suspected hypersensitivity to any of the excipients included in the formulation should not be treated.
Patients must not be pregnant or breast-feeding. Female patients of childbearing potential must have negative serum or urine pregnancy test. Male and female patients of reproductive potential must agree to use a medically accepted form of birth control while on study and up to 10 weeks after treatment. It is permissible for female patients to take oral contraceptives or other hormonal methods while receiving treatment with lonafarnib.","Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24-29 mo. Patients were monitored for liver, kidney, and hematological toxicity each month for the first 3 mo by their local physicians and every 4 mo in Boston for the duration of the study. Adverse events were monitored and recorded throughout the study.",ChEMBL:CHEMBL298734 | DrugBank:DB06448 | PubChem:148195,Lonafarnib,NC(=O)N1CCC(CC(=O)N2CCC([C@H]3c4ncc(Br)cc4CCc4cc(Cl)cc(Br)c43)CC2)CC1,A16AX20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00426842,NCT00426842_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

This study will be performed on subjects 18 to 65 years old, with chronic SCI (> 1 year), who are neurologically stable and have demonstrated significant hypotension (total time [proportion 50%] spent with hypotension [systolic BP below 110 mmHg for males and 100 mmHg for females] during a 24-hour observation.

Exclusion Criteria:

hypertension
diabetes
vascular disease
cardiac disease
cardiovascular medication
pregnancy",Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.,PubChem:18340,Midodrine Hydrochloride,COc1ccc(OC)c(C(O)CNC(=O)CN)c1.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
NCT00427700,NCT00427700_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 3,42,"Inclusion Criteria:

All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e., oligoovulation defined as < 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey >8) or laboratorial (total Testosterone >=0.81 ng/dL) or polycystic ovary > 10cm3.

Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol

Age >18 years old and <= 38 years old.
No endometriosis on laparoscopy

Exclusion Criteria:

Not willing to participate in the study
use of IUD or contraceptive pill within 2 months before the study.
Hyperprolactinemia (>20ng/mL)
Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).
High 17-OH progesterone (>=4.9ng/mL)
Endometriosis
Known allergy to clomiphene or raloxifene","Use of 100mg of raloxifene during days 5-9 of the menstrual cycle

raloxifene: 100mg PO on days 5-9 of the menstrual cycle

Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild",ChEMBL:CHEMBL81 | DrugBank:DB00481 | PubChem:5035,Raloxifene,O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12,G03XC01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00430040,NCT00430040_EG001,No,All,Adult | Older Adult,Phase 4,14,"Inclusion Criteria:

Is male or female >= 18 and <= 70 years of age
Has a documented history of type 2 diabetes mellitus for a minimum of four months prior to the screening visit
Has a documented history of or current presentation with Stage 1 or Stage 2 hypertension and meets one of the following criteria:
Has controlled hypertension (sSBP <130 mmHg AND sDBP <80 mmHg) on >=2 antihypertensive medications NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications OR
Has uncontrolled hypertension (sSBP >=130 and <=170 mmHg AND/OR sDBP >=80 and <=105 mmHg) on one or two antihypertensive medications OR
Has newly diagnosed or previously untreated hypertension (sSBP >=130 and <=170 mmHg AND/OR sDBP >=80 and <=105 mmHg
At Randomization, sitting systolic blood pressure (sSBP) >= 130 mmHg or sitting diastolic blood pressure (sDBP) >= 80 mmHg and sSBP <= 170 mmHg and sDBP <= 105 mmHg
Has been on a stable dose of a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) for a minimum of four months prior to the screening visit

Exclusion Criteria:

Has any clinically significant abnormality identified in the screening physical examination, laboratory tests or electrocardiogram which, in the judgement of the investigator, would preclude safe completion of the study
Is female of childbearing potential
Has any of these cardiac conditions: uncontrollable or symptomatic arrhythmias, unstable angina, sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker), bradycardia (heart rate <55 bpm), and stroke within three months of study screening, and history of myocardial infarction.
Has Congestive Heart Failure NYHA (New York Heart Association) class II-IV
Has type 1 diabetes mellitus
Has newly diagnosed type 2 diabetes (within 4 months of screening visit)
Has HbA1c > 8.5%
Has the following, as it relates to subject's antidiabetic therapy:Initiated or changed dosage or formulation of thiazolidinediones (TZDs) within 6 months of screening visit.
A history of acute or chronic acidosis, including diabetic ketoacidosis
Has current clinical diagnosis of chronic obstructive pulmonary disease (COPD, e.g., chronic bronchitis) or asthma
Has a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
Has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication:
renal disease defined as estimated Glomerular Filtration Rate (eGFR) <60mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula below: GFR (mL/min/1.73m2) = 186 x [Serum Creatinine (umol/L) x 0.0113]-1.154 x Age(years)-0.203 (x 0.742 if female)
hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment)
Chronic biliary disorders
Has endocrine disorders (e.g., pheochromocytoma, active and untreated hypo or hyperthyroidism)
Has any known contraindication to ACE inhibitors, alpha- or beta-blocker treatment
Has systemic disease, including cancer, with reduced (<12 months) life expectancy
Has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
Has a history of a psychological illness or any condition that would interfere with the subject's ability to understand or complete the requirements of the study","lisinopril

lisinopril: lisinopril",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00433147,NCT00433147_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs",Afegostat tartrate was administered orally during the 4-week treatment period.,PubChem:23581846,Afegostat tartrate,O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O,,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00433147,NCT00433147_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs",Afegostat tartrate was administered orally once per day during the 4-week treatment period.,PubChem:23581846,Afegostat tartrate,O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00433147,NCT00433147_EG003,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Had a confirmed diagnosis of type 1 Gaucher disease with a known documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase alleles
Clinically stable
Male or female participants, 18 to 74 years old inclusive
All participants of childbearing potential used adequate birth control
Provided written informed consent to participate in the study

Exclusion Criteria:

Clinically significant disease, severe complications from Gaucher disease, or serious illness that precluded participation in the study in the opinion of the Investigator that compromised the safety of the participant or precluded the participant from completing the study
During the screening period, any clinically significant findings, as deemed by the Investigator
Partial or total splenectomy (removal of spleen) within the 2 years prior to study entry
History of pulmonary hypertension or Gaucher related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious adverse reaction to iminosugars (for example, N-butyldeoxynojirimycin or miglustat)
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence or symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs",Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.,PubChem:23581846,Afegostat tartrate,O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00434590,NCT00434590_EG000,,All,Adult | Older Adult,Phase 4,5,"Inclusion criteria:

Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
Age > 18 yrs
Adequate and stable renal function
Informed consent.

Exclusion criteria:

Kidney transplant combined with other organs;
Significant proteinuria
Severe ongoing infections;
Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
Relapse of the end-stage renal disease on the transplanted kidney;
Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply","The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00434876,NCT00434876_EG000,No,All,Adult | Older Adult,Phase 3,10,"Inclusion Criteria: subjects between the ages of 18-65 years, with a DSM-IV diagnosis of current alcohol dependence (past year), can speak, understand, and print in English, and is capable of giving written informed consent

Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts [posterior capsular/ nuclear (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.",Quetiapine XR,PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00436917,NCT00436917_EG000,No,Female,Adult | Older Adult,Not Applicable,52,"DISEASE CHARACTERISTICS:

Diagnosis of localized breast cancer

Stage I-IIIA disease

Adequately treated breast cancer

No clinical or radiological evidence of recurrent or metastatic disease
Baseline total lumbar spine or femoral neck bone mineral density T-score < -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible)

Hormone-receptor status:

Estrogen receptor and/or progesterone receptor-positive breast cancer

PATIENT CHARACTERISTICS:

Female

Postmenopausal, defined by 1 of the following criteria:

Age > 55 years with cessation of menses
Age ≤ 55 years with spontaneous cessation of menses for > 1 year
Age ≤ 55 years with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels
Bilateral oophorectomy
ECOG performance status 0-2
Life expectancy ≥ 5 years
WBC ≥ 3,000/mm³ OR granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine < 2.0 mg/dL
Creatinine clearance ≥ 45 mL/min
No hypercalcemia (i.e., calcium level > 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level > 0.5 mg/dL below lower limit of normal) within the past 6 months
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

No other nonmalignant systemic diseases, including any of the following:

Uncontrolled infection
Uncontrolled diabetes mellitus
Uncontrolled thyroid dysfunction
Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta)
Malabsorption syndrome
No uncontrolled seizure disorders associated with falls
No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D

No concurrent active dental problems, including any of the following:

Infection of the teeth or jawbone (maxillary or mandibular)
Dental or fixture trauma
Prior or current diagnosis of osteonecrosis of the jaw
Exposed bone in the mouth
Slow healing after dental procedures

No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following:

History of surgery at the lumbosacral spine, with or without implantable devices
Scoliosis with a Cobb angle > 15 degrees at the lumbar spine
Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan
Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA
No condition that would preclude study follow-up or compliance
No psychiatric illness that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

More than 3 weeks since prior and no other concurrent oral bisphosphonates
No prior intravenous bisphosphonates
No prior aromatase inhibitor therapy
More than 6 months since prior anabolic steroids or growth hormone
More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate)
More than 30 days since prior systemic investigational drug and/or device
More than 7 days since prior topical investigational drug
More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants)
Concurrent short-term corticosteroid therapy allowed
No concurrent sodium fluoride, parathyroid hormone, or tibolone
No other concurrent investigational drug or device",4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years),ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00436969,NCT00436969_EG000,No,All,Adult | Older Adult,Phase 3,87,"Inclusion Criteria:

A candidate for unilateral treatment of osteoarthritis of the shoulder
Have failed conservative treatment

Exclusion Criteria:

Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
No active instability or acute dislocation episodes within the previous 12 months
Known allergy to hyaluronate preparations
Pregnant or breast feeding
Is receiving prescription pain medication for conditions unrelated to the index shoulder condition",Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).,ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00438659,NCT00438659_EG000,No,All,Adult | Older Adult,Phase 3,84,"DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ

Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:

Whole breast (as part of breast-conservation therapy)

Chest wall (as part of post-mastectomy irradiation)

Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed

Must meet the following criteria for planned radiotherapy:

Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
No planned split-course radiotherapy
No partial breast treatment, defined as treatment of < 75% of the breast parenchyma
Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed

Must be entered on study within 7 days prior to beginning radiotherapy

Must start study drug prior to receiving the third radiotherapy fraction
No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
No bilateral breast cancer treatment
No inflammatory carcinoma of the breast
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to complete questionnaires independently or with assistance
No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy to the planned radiotherapy treatment area

No concurrent or planned leukotriene inhibitors, including the following:

Zafirleukast
Monteleukast
Zileuton

No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:

Cortaid®
Cortizone 10®
Tucks®
Preparation H®
No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment",Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00440232,NCT00440232_EG000,No,All,Adult | Older Adult,Not Applicable,35,"Inclusion Criteria:

Male and female subjects between the ages of 18 and 65, inclusive
Subjects diagnosed with episodic migraine, with or without aura according to IHS criteria for at least one-year prior to screening
Subjects who experience between 1 and 6 migraine attacks per month inclusive (during the previous 6 months) with no more than 15 days of headache per month.
Subject reports hunger or fasting as a known trigger for migraine
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
Subjects who are able to understand and comply with all study procedures.
Subject is willing to complete one 20-hour fast, starting between 5:00 and 8:00 P.M., with no food or drink (except water needed to take routine medication)
Subject provides written informed consent prior to any screening procedures being conducted
If subject is taking a preventive migraine medication for migraine or any other reason, that medication must have been a stable dose for at least 4 weeks prior to screening, and must remain stable throughout the duration of the study.

EXCLUSION CRITERIA

Pregnant and/or lactating women
Subjects who have a history of clinically relevant allergy to frovatriptan or like compounds
Subjects who, in the investigators opinion, have a history or have evidence of any other medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Subjects who currently have or have a history of significant cerebrovascular disease including basilar or hemiplegic migraine
Subjects who have a history of non-response to triptans, as determined by investigator
Subjects with uncontrolled hypertension
Subjects with diabetes mellitus who require insulin or oral anti-hyperglycemic agents will be excluded. (Subjects with Type II diabetes who are well controlled with diet and exercise alone may be included.)
Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease",5.0 mg of Frovatriptan given as single dose,ChEMBL:CHEMBL1279 | DrugBank:DB00998 | PubChem:77992,Frovatriptan,CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1,N02CC07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00441363,NCT00441363_EG001,No,All,Adult | Older Adult,Phase 3,34,"Inclusion Criteria:

Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.
18-75 years of age, inclusive.

Male or if female, is either:

postmenopausal or
of childbearing potential and has used appropriate contraceptive methods
Treated with a stable dose of metformin at least 3 months.
Has not been treated with a sulfonylurea, thiazolidinedione, meglitinide, alpha-glucosidase inhibitor, or combination oral anti-diabetic therapy within 3 months prior to screening.
Has not been on a regimen of lipid-lowering agents or if on such a regimen, it has been stable for a minimum of 6 weeks at screening.
HbA1c value between ≥ 7.5% and < 11%, at screening (Visit 1) and Visit 3.
Fasting plasma glucose measurement of ≤260 mg/dL at screening (Visit 1) and Visit 3.
Fasting C-peptide value equal to or greater than the normal accepted minimum value (e.g. < 0.9 NG/ml).
Stable body weight, i.e., not varying by > 10% for at least3 months prior to screening
Body mass index (BMI) at screening of 25 kg/m2 to 42 kg/m2,inclusive.
If treated for hypertension, the individual has been on stable therapy for 1 month prior to screening.

Exclusion Criteria:

Prior exogenous insulin therapy as part of an outpatient diabetes treatment regimen.
Type 1 diabetes mellitus
Clinically significant history of cardiac disease or presence of cardiac disease, including MI, clinically significant arrhythmia, unstable angina pectoris, moderate to severe congestive heart failure, CABG, or angioplasty; or expected to require CABG or angioplasty during the study.

Uncontrolled hypertension, defined as systolic blood pressure > 160 or diastolic blood pressure > 100 mmHg measured in sitting position at screening(Visit 1)

Clinically significant history or presence of:

Hepatic disease (i.e. impaired liver function, including having AST or ALT greater than three times the upper limit of normal)
Renal disease (i.e. renal impairment with a serum creatinine ≥ 1.4 mg/dl)
Central nervous system disease, including epilepsy
CVA within the last 3 years.
Less than 5 years remission from clinically significant malignancy.
Major surgical operation within 3 months of screening.
Organ transplantation.
Evidence of acute or chronic illness including known or suspected HIV,HBV, or HCV infection.
Currently abuses drugs or alcohol, including binge drinking, or history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
Regularly uses medications with addictive potential such as opiates,narcotics, tranquilizers, etc.
Used drugs for weight loss, e.g., Xenical® (orlistat), Meridia® (sibutramine),Acutrim® (phenylpropanolamine), or similar over-the-counter medications within 3 months of screening.
Known hypersensitivity to any components of the study drugs.
Received any experimental drug or used an experimental device within 3 months of screening or will do so during the study.
Has received unstable dose of fibric acid derivatives within 3 months of the screening.
Requires regular use of systemic corticosteroids by oral, intravenous (IV),or intramuscular (IM) route, or regular use of potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption.
Prescription sympathomimetic drugs within 7 days of screening.
Started therapy with an erectile dysfunction drug within 2 weeks prior to screening. The subject may not begin treatment with an erectile dysfunction drug during the study period; subjects previously taking erectile dysfunction drugs should do so only under medical supervision.
Donated blood within 60 days of screening. Donation of blood also is prohibited during the study and for 30 days after completion of the study.
Occupation that requires a rotation of shift work or working over night shifts.",matching placebo,PubChem:31100,Bromocriptine Mesylate,CC(C)CC1C(=O)N2CCCC2C2(O)OC(NC(=O)C3C=C4c5cccc6[nH]c(Br)c(c56)CC4N(C)C3)(C(C)C)C(=O)N12.CS(=O)(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00442117,NCT00442117_EG000,No,All,Child | Adult | Older Adult,Phase 3,91,"Inclusion Criteria:

Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.
Subjects must have had a history of asthma for at least 6 months.
The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.
Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.

If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:

Flunisolide between 1000 to 2000 mcg/day
Budesonide between 400 to 800 mcg/day
Triamcinolone acetonide between 600 to 1600 mcg/day
Beclomethasone Dipropionate between 252 to 840 mcg/day
Fluticasone propionate between 200 to 500 mcg/day
Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
Women of childbearing potential (includes women who are less than 1 year postmenopausal) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation) if they become sexually active.
Subjects must understand and be able to adhere to visit schedules and enter information in a daily diary.

Exclusion Criteria:

Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
Subjects who used Leukotriene modifiers within 2 weeks of screening.
Subjects who took immunosuppressive agents within the previous 3 months.
Subjects who use daily nebulized ß2-adrenergic agonists.
Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months.
Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
Subjects with evidence of clinically significant oropharyngeal candidiasis at Screening or Baseline.
Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (e.g. COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.","Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00442351,NCT00442351_EG000,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Sign informed consent
Be 18-75 years of age, of either sex and any race
Have asthma for >= 12 months
Have mild or moderate persistent asthma
Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period
Be off treatment with leukotriene receptor antagonist (LTRA) for at least 14 days prior to Screening
Have an FEV1 >=65% but <=85% of predicted normal value at Screening and at Baseline when SABAs have been withheld for at least 6 hours
Demonstrate an increase of absolute FEV1 of >= 12% with an absolute volume increase of at least 200mL during Screening. Written documentation of FEV1 reversibility of >= 12% within 2 years prior to Screening was acceptable in lieu of testing. FEV1 reversibility testing should be done after withholding inhaled SABA for at least 6 hours
Have a frequency of asthma score of at least 2 (at least 2 symptoms) and/or frequency of bronchodilator use score of at least 2 at Screening
Have a Total Asthma Severity Score (TASS) of at least 4 on 8 or more of the AM and PM recordings from the last 7 days during the Run-in period prior to Baseline and the AM of the Baseline Visit
At Screening Visit, have sleep disturbance and scores of >=2 on the interference with sleep rating scale (recall over the past 7 nights), and at least 30 on the Medical Outcomes Study Sleep scale (MOS-SS) Sleep Disturbance Sleep Scale (recall over the past 7 days)
At the Baseline Visit, must have sleep disturbance and scores of >= 2 on interference with sleep rating scale (recorded in a diary during the past 7 nights), and at least 30 on the MOS-SS Sleep Problems Index II 9 items(SLP 9)

Exclusion Criteria

Women who are pregnant or intend to become pregnant during the study
Women who are nursing or intend to nurse during the study or within 30 days after completion
Have participated in any clinical trial within the last 30 days or in one involving antibodies for asthma or rhinitis within 3 months prior to Screening
Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month prior to Screening
Have been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Screening
Have used >12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist per day on 2 consecutive days within 4 weeks prior to Screening
Required more than 2 courses of oral/systemic corticosteroids for asthma within 12 months prior to Screening
Have a history of sleep disorders, including narcolepsy, or use of medications that affect alertness or sleep
Have sleep apnea, obstructive sleep apnea-hypopnea, or are being treated with the ventilation devices Continuous Positive Airway Pressure (CPAP) or (Bi-level Positive Airway Pressure (Bi-PAP), or are receiving oxygen by inhalation
Are smokers or ex-smokers who have smoked within 6 months prior to

Screening or have a cumulative smoking history of 10 pack-years or greater

Are allergic to corticosteroids, SABAs, or LABAs
Required ventilator support for respiratory failure secondary to asthma in the last 10 years
Have a Body-Mass-Index greater than 35",Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT00445601,NCT00445601_EG000,No,All,Adult | Older Adult,Phase 3,165,"DISEASE CHARACTERISTICS:

Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting the following criteria:

Ta or T1 primary tumor
Grade 1 or 2 disease

No more than 2 recurrences (except for index tumor) within the 18 months prior to the index tumor's transurethral resection of the bladder tumor (TURBT)

Index tumor post-TURBT must meet the following criteria:

Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade) disease within 2 years prior to index tumor TURBT, or invasion of the muscularis propria (stage ≥ T2)
Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low malignant potential and low-grade bladder cancer)
Not a candidate for a therapy other than TURBT (e.g., a series of instillations of intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or partial cystectomy)

Negative upper tract imaging studies within 1 year (365 days) prior to study entry

Imaging studies may be performed after registration provided it is done prior to TURBT on the day of treatment
No urothelial cancer of the prostate or more distal urethra (or urethra at all in women) as assessed by endoscopy
Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed flora-likely contamination) OR negative urine analysis for infection AND negative nitrates on reagent strip, ≤ 10 white blood cell count (WBC)/high-power field, and no rods or organisms on examination of spun urine sediment OR an automated or visual reagent strip urinalysis that is negative for leukocytes and nitrates within the past 28 days
TURBT planned within the next 28 days and planned treatment within 3 hours after TURBT

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Not pregnant or nursing
Fertile patients must use effective contraception

No other prior malignancy except for any of the following:

Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
Adequately treated stage I or II cancer from which patient is in complete remission
Any other cancer from which patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 145 days since prior intravesical therapy",Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.,PubChem:60749,Gemcitabine Hydrochloride,Cl.Nc1ccn(C2OC(CO)C(O)C2(F)F)c(=O)n1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00446550,NCT00446550_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Confirmed diagnosis of type 1 Gaucher disease with a known genotype and a documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase (GBA) alleles
Clinically stable
Treatment naïve to ERT and SRT or had not received ERT or SRT in the 12 months before screening
Willing to not initiate ERT or SRT treatment during study participation
Male or female participants, 18 to 74 years old, inclusive
At the screening period (Day -21 to Day -1), participants must have met at least 2 of the following criteria: platelet count of ≤150,000 per microliter, hemoglobin ≤12 grams/deciliter (g/dL) for females and ≤13 g/dL for males, liver volume ≥1.25 multiples of normal (MN), and spleen volume ≥2 MN
All participants of reproductive potential were required to practice an acceptable method of contraception
Provided written informed consent to participate in the study

Exclusion Criteria:

A clinically significant disease other than Gaucher disease, severe complications from Gaucher disease, or serious intercurrent illness that precluded participation in the study in the opinion of the investigator
During the screening period, had any clinically significant findings as deemed by the investigator
Partial or total splenectomy
Documentation of moderate or severe pulmonary hypertension, defined as pulmonary arterial pressure >35 millimeters of mercury (mmHg) or significant Gaucher-related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars
Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the last 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence of symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs","For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.",PubChem:23581846,Afegostat tartrate,O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00446550,NCT00446550_EG001,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Confirmed diagnosis of type 1 Gaucher disease with a known genotype and a documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase (GBA) alleles
Clinically stable
Treatment naïve to ERT and SRT or had not received ERT or SRT in the 12 months before screening
Willing to not initiate ERT or SRT treatment during study participation
Male or female participants, 18 to 74 years old, inclusive
At the screening period (Day -21 to Day -1), participants must have met at least 2 of the following criteria: platelet count of ≤150,000 per microliter, hemoglobin ≤12 grams/deciliter (g/dL) for females and ≤13 g/dL for males, liver volume ≥1.25 multiples of normal (MN), and spleen volume ≥2 MN
All participants of reproductive potential were required to practice an acceptable method of contraception
Provided written informed consent to participate in the study

Exclusion Criteria:

A clinically significant disease other than Gaucher disease, severe complications from Gaucher disease, or serious intercurrent illness that precluded participation in the study in the opinion of the investigator
During the screening period, had any clinically significant findings as deemed by the investigator
Partial or total splenectomy
Documentation of moderate or severe pulmonary hypertension, defined as pulmonary arterial pressure >35 millimeters of mercury (mmHg) or significant Gaucher-related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars
Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the last 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence of symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs","Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.",PubChem:23581846,Afegostat tartrate,O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00451451,NCT00451451_EG002,No,All,Adult,Phase 3,344,"Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.",Participants received two 120 mg BG00012 capsules orally three times daily (TID),ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00453063,NCT00453063_EG000,No,All,Child | Adult | Older Adult,Phase 3,426,"Inclusion Criteria:

Must be 12 years of age or older, of either sex and of any race.
Must have at least a 2-year documented history of SAR which exacerbates during the study season.
Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
Must be clinically symptomatic at the Screening Visit.
Must be clinically symptomatic at the Baseline Visit.
Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria:

A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
A subject with rhinitis medicamentosa.
A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.",MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00454142,NCT00454142_EG000,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the following criteria:

World Health Organization (WHO) type II-III disease
Stage IV or recurrent disease
Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent disease
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 70-100%
Life expectancy > 3 months
WBC >= 3,000/mm³
Absolute neutrophil count >= 1,500/mm³
Platelet count >= 100,000/mm³
Bilirubin normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN)
Creatinine normal OR creatinine clearance >= 60 mL/min
Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.2 times ULN

Systolic blood pressure (BP) =< 140 mm Hg and diastolic BP =< 90 mm Hg

Initiation or adjustment of BP medication allowed provided the average of 3 BP readings are < 140/90 mm Hg prior to study entry
No history of allergic reaction attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or to other study agents
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
No cerebrovascular accident within the past 6 months

No history of any of the following diseases within the past 12 weeks:

Myocardial infarction
Cardiac arrhythmia
Admission for unstable angina
Cardiac angioplasty or stenting
Venous thrombosis

No New York Heart Association (NYHA) class III-IV heart failure

Patients with a history of NYHA class II heart failure are eligible provided they are asymptomatic on treatment
No significant electrocardiogram (ECG) abnormalities, including QTc prolongation (i.e., QTc >= 500 msec)
No serious or non-healing wound, ulcer, or bone fracture

No condition that would impair the ability to swallow and retain pazopanib hydrochloride, including any of the following:

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

No concurrent uncontrolled illness including, but not limited to, the following:

Coagulopathy
Ongoing or active infection
Psychiatric illness or social situation that would preclude study compliance
No known allergy to CT contrast agents
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
More than 4 weeks since prior radiotherapy
At least 4 weeks since prior surgery
No prior antiangiogenesis therapy
No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride, as determined by the Principal Investigator
No concurrent medications that have the potential to interact with the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4

No concurrent therapeutic warfarin

Low molecular weight heparin or prophylactic low-dose warfarin allowed
No concurrent antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients","Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

computed tomography : Correlative studies

pharmacological study : Correlative studies

pazopanib hydrochloride : Given PO",PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00455702,NCT00455702_EG000,No,All,Adult | Older Adult,Phase 4,19,"Inclusion Criteria:

Male or female
Age 18-65 years
Diagnosis of schizophrenia or schizoaffective disorder, depressed type
Stable dose of antipsychotic for at least 4 weeks.
Able to provide informed consent
Able to complete a cognitive battery

Exclusion Criteria:

Current treatment with clozapine
Dementia
Seizure disorder
Unstable medical illness
Active substance abuse
Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.",50 mg d-cycloserine,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00455858,NCT00455858_EG000,No,All,Adult | Older Adult,Phase 4,87,"Inclusion Criteria:

Type 2 diabetes (diagnosed more than 12 months ago)
HbA1c greater than 7.0 and less than 12.0% at screening
Currently on any OAD in more than 3 months ago
BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

Previous treatment with insulin in more than 7 days within the last 3 months
Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)",Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00459381,NCT00459381_EG000,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Histologically confirmed glioblastoma multiforme, including gliosarcoma

Recurrent disease

Must have unequivocal radiographic evidence of tumor progression by MRI, as defined by any of the following:

25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline
Clear worsening of any evaluable disease
Appearance of any new lesions or site
Clear clinical worsening
Must have failed prior radiotherapy that was completed ≥ 42 days ago
Patients who received prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease, rather than radiation necrosis, based on positron emission tomography (PET) scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease

Treatment for no more than 2 prior relapses allowed

Relapse is defined as progression following initial therapy (i.e., radiotherapy with or without chemotherapy, if that was used as initial therapy; therefore no more than 3 prior therapies [initial therapy and therapy for 2 relapses] allowed)

If the patient had a surgical resection for relapsed disease and no anticancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered as 1 relapse
For patients who had prior therapy for a low-grade glioma, the surgical diagnosis of a glioblastoma multiforme will be considered the first relapse
Karnofsky performance status 60-100%
Life expectancy > 8 weeks
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 10 g/dL (may be reached by transfusion)
Platelet count ≥ 100,000/mm^3
PT/INR/PTT ≤ 1.2 times upper limit of normal (ULN)
SGOT < 2.5 times ULN
Bilirubin < 2.5 times ULN
Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
Urine protein:creatinine ratio > 1 OR urine protein < 1,000 mg by 24-hour urine collection OR proteinuria < 1+
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-barrier contraception during study therapy OR practice abstinence from sexual intercourse for 14 days prior to, during, and for ≥ 21 days after study therapy

Systolic blood pressure (BP) ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg

Prior initiation or adjustment of BP medication allowed provided the average of 3 BP readings is ≤ 140/90 mm Hg
No uncontrolled significant medical illnesses that would preclude study therapy

No other conditions, including any of the following:

Serious or nonhealing wound, ulcer, or bone fracture
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
Cerebrovascular accident (CVA) within the past 6 months
Myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty, or stenting within the past 84 days
Venous thrombosis within the past 84 days

New York Heart Association (NYHA) class III or IV heart failure

Asymptomatic NYHA class II heart failure while on treatment allowed
No other cancer except for nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off of all therapy for that disease for ≥ 3 years
No disease that would obscure toxicity or dangerously alter drug metabolism
No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents
No QTc prolongation (i.e., QTc interval ≥ 500 msecs) or other significant ECG abnormalities

No condition that impairs the ability to swallow and retain pazopanib hydrochloride, including any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication
Requirement for IV alimentation
Prior surgical procedures affecting absorption
Active peptic ulcer disease
See Disease Characteristics
Recovered from prior therapy

At least 28 days since prior resection of recurrent or progressive tumor and recovered

Residual disease after resection of recurrent glioblastoma is not mandated for eligibility into the study

More than 7 days since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)

Radiosensitizers allowed
More than 14 days since prior investigational agents
More than 14 days since prior vincristine
More than 21 days since prior procarbazine
More than 28 days since prior cytotoxic therapy
More than 42 days since prior nitrosoureas
No prior bevacizumab
No prior sorafenib tosylate or sunitinib malate
No prior pazopanib hydrochloride

No concurrent CYP2C9 substrates, including any of the following:

Anticoagulants (e.g., warfarin [therapeutic doses only])
Oral hypoglycemics (e.g., glipizide, glyburide, tolbutamide, glimepiride, or nateglinide)
Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)
Neuroleptics (e.g., pimozide)
Erectile dysfunction agents (e.g., sildenafil, tadalafil, or vardenafil)
Antiarrhythmics (e.g., bepridil, flecainide, lidocaine, mexilitine, amiodarone, quinidine, or propafenone)
Immune modulators (e.g., cyclosporine, tacrolimus, or sirolimus)
Miscellaneous drugs (e.g., theophylline, quetiapine, risperidone, tacrine, clozapine, or atomoxetine)
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal treatment, or immunotherapy) or investigational drugs

No concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)

Non-EIAEDs allowed","Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

pazopanib hydrochloride: Given orally

laboratory biomarker analysis: Correlative studies",PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00459862,NCT00459862_EG000,No,All,Adult | Older Adult,Phase 2,34,"Inclusion Criteria:

Histologically or cytologically confirmed malignant pleural mesothelioma:

Measurable disease
No progressive disease inside or outside of any prior radiation field

No symptomatic, untreated, or uncontrolled CNS metastases

Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT

Patients may begin study therapy as early as the next day after completion of WBRT
ECOG performance status 0-2
Life expectancy >= 12 weeks
ANC >=1,500/mm^3
Platelet count >= 100,000/mm^3
WBC >= 3,000/mm^3
Bilirubin =< 1.5 times upper limit of normal (ULN)
AST and ALT =< 2.5 times ULN
Alkaline phosphatase =< 2.5 times ULN
Creatinine =< 1.5 times ULN or creatinine clearance >= 50 mL/min
Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart

No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication
Requirement for IV alimentation
Prior surgical procedures affecting absorption
Active peptic ulcer disease
No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
Patients with a history of low-grade (Gleason score =< 6) localized prostate cancer are eligible even if diagnosed within the past 5 years
No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study

None of the following concurrent severe and/or uncontrolled medical conditions:

Serious or nonhealing wound, ulcer, or bone fracture
Abdominal fistula, diverticulosis, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
Poorly controlled diabetes
Interstitial pneumonia
Extensive and symptomatic interstitial fibrosis of the lung

No cardiovascular illness or complication, including any of the following:

Any history of cerebrovascular accident within the past 6 months
History of myocardial infarction (prior electrocardiographic evidence of myocardial injury)
History of cardiac arrhythmia (prior electrocardiographic evidence of abnormal heart rhythm)
Admission for unstable angina
Cardiac angioplasty or stenting within the past 12 months

NYHA class III-IV heart failure

Asymptomatic NYHA class II heart failure allowed
QTc prolongation (defined as a QTc interval ≥ 500 msecs) or other significant electrocardiogram abnormalities
Venous thrombosis within the past 12 weeks
No ancillary therapy considered investigational within the past 4 weeks
No symptomatic, untreated, or uncontrolled seizure disorder
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit study compliance
No significant traumatic injury within the past 4 weeks
No more than 1 prior systemic therapy for malignant pleural mesothelioma

No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks

Insertion of a vascular access device is not considered major or minor surgery

No minor surgery within the past 2 weeks

Insertion of a vascular access device is not considered major or minor surgery

Prior palliative radiotherapy allowed

No prior palliative radiotherapy to the chest except for a maximum of 3 fractions of radiotherapy for superior vena cava syndrome

No concurrent therapeutic warfarin

Low molecular-weight heparin or prophylactic low-dose warfarin allowed
No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy
No concurrent medications that act through the CYP450 system
No concurrent combination antiretroviral therapy for HIV-positive patients
PT/INR/PTT =< 1.2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No uncontrolled infection
No uncontrolled blood pressure (BP) (defined as systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg in spite of adequate anti-hypertensive therapy)
No other severe underlying disease that, in the judgment of the investigator, would limit study compliance",Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.,PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00465972,NCT00465972_EG001,No,All,Adult | Older Adult,Phase 4,23,"Inclusion Criteria:

Insomnia
HIV Seropositive
Stable HIV Disease

Exclusion Criteria:

Other psychiatric illnesses
Unstable HIV disease","1 15 mg pill taken orally, nightly, at bedtime.",ChEMBL:CHEMBL967 | DrugBank:DB00231 | PubChem:5391,Temazepam,CN1C(=O)C(O)N=C(c2ccccc2)c2cc(Cl)ccc21,N05CD07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00468052,NCT00468052_EG001,No,All,Child,Phase 3,61,"Inclusion Criteria:

ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy

Exclusion Criteria:

diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or developmental delays are currently on psychotherapeutic or sedating medication are on chronic pain medication or opiate any known adverse effect to the study drug any known cardiac abnormalities",1 subjects Group D experienced an adverse event.,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00468312,NCT00468312_EG000,No,All,Child | Adult | Older Adult,Phase 3,429,"Inclusion Criteria:

Must be 12 years of age or older, of either sex and of any race.
Must have at least a 2-year documented history of SAR which exacerbates during the study season.
Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
Must be clinically symptomatic at the Screening Visit.
Must be clinically symptomatic at the Baseline Visit.
Must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory test (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.
A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.

Exclusion Criteria:

A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
A subject with rhinitis medicamentosa.
A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
A subject who have had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who have had a viral upper respiratory infection within 7 days before the Screening Visit.
A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Use of any drug in an investigational protocol in the 30 days before the Screening Visit.
A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit.
Pregnant or nursing females.
Family member of the investigation study staff.
Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.
Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
A subject whose ability to provide informed consent is compromised.
A subject with a history of noncompliance with medications or treatment

protocols.",MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00471536,NCT00471536_EG000,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Histologically or cytologically confirmed transitional cell cancer of the urothelium or bladder

Metastatic disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
No known brain metastases
ECOG performance status 0-2
Life expectancy ≥ 12 weeks
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Creatinine normal OR creatinine clearance ≥ 60 mL/min
PT/INR/PTT ≤ 1.2 times ULN
No proteinuria > 1+ on two consecutive dipsticks measured ≥ 1 week apart
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study

No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:

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

No uncontrolled illness that would limit compliance with study therapy including, but not limited to, any of the following:

Ongoing or active infection
Psychiatric illness or social situations
No QTc prolongation (defined as a QTc interval ≥ 480 msecs) or other significant ECG abnormalities (e.g., frequent ventricular ectopy, evidence of ongoing myocardial ischemia)

No other conditions, including any of the following:

Serious or non-healing wound, ulcer, or bone fracture
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
Cerebrovascular accident within the past 6 months
Myocardial infarction, cardiac arrhythmia, or admission for unstable angina within the past 12 weeks
Venous thrombosis within the past 12 weeks

New York Heart Association (NYHA) class III or IV heart failure

Asymptomatic NYHA class II heart failure on treatment allowed

No other active second malignancy other than non-melanoma skin cancer

Patients are not considered to have an active malignancy if they have completed anti-cancer therapy and are considered by their physician to be ≤ 30% risk of relapse
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
At least 4 weeks since prior radiotherapy
Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable and/or evaluable lesion(s) that has not been irradiated
At least 4 weeks since prior surgery
One prior chemotherapy regimen for metastatic urothelial or bladder cancer
More than 12 weeks since prior cardiac angioplasty or stenting
Prior adjuvant or neoadjuvant therapy allowed
No prior experimental treatment for metastatic disease
No other prior or concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients

No concurrent CYP2C9 substrates, including any of the following:

Anticoagulants (e.g., warfarin [therapeutic doses only])

Low molecular weight heparin and prophylactic low-dose warfarin (≤ 2 mg daily) allowed
Oral hypoglycemics (e.g., glipizide, glyburide, tolbutamide, glimepiride, or nateglinide)
Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)
Antipsychotics (e.g., pimozide or clozapine)
Erectile dysfunction agents (e.g., sildenafil, tadalafil, or vardenafil)
Antiarrhythmics (e.g., bepridil, flecainide, lidocaine, mexiletine, amiodarone, quinidine, or propafenone)
Immune modulators (e.g., cyclosporine, tacrolimus, or sirolimus)
Miscellaneous drugs (e.g., theophylline, quetiapine, risperidone, tacrine, or atomoxetine)
No other concurrent anticancer agents or therapies
No concurrent medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes",Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.,PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00479765,NCT00479765_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion Criteria:

At least 18 to less than 70 years of age
Radiological evidence on MRI of progressive recurrent malignant glioma that is unilateral, unifocal, supratentorial and of the minimum tumor volume as required per dose level assignment
Tumor must have a solid contrast enhancing component
Gross total resection >95% of the recurrence must be planned
Must have received prior conventional radiation therapy completed >4 weeks before Study Day 1 (ie, day of craniotomy and OncoGel administration)
Previous cytoreductive surgery or biopsy with pathologic diagnosis of glioblastoma multiforme
Diagnosis of glioma at the time of debulking surgery for recurrence (by frozen section or squash preparation)
Life expectancy > 2 months
KPS greater than or equal to 70
Using appropriate birth control, if female of child-bearing potential;
Able and willing to participate in the study by signing the informed consent document

Exclusion Criteria:

Contrast-enhancing tumor crossing the midline
Multifocal or non-contiguous tumor resulting in multiple resection cavities
Evidence of tumor dissemination (ependymal, leptomeningeal)
Tumors that result in a lobectomy or after resection leave an insufficient residual cavity to receive the expected OncoGel volume
Expected communication between the ventricle and resection cavity that cannot be repaired
Involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve or any other cranial nerve
Significantly increased intracranial pressure
Received any type of stereotactic radiosurgery or brachytherapy with the exception of a stereotactic radiosurgery boost as part of the initial radiation therapy
History of seizures refractory to two or more anticonvulsant medications co-administered at therapeutic levels
Impaired organ function as evidenced by clinically significant laboratory parameters including but not limited to the following: Hepatic Status: Bilirubin >2.0 mg/dL; Aspartate transaminase (AST) >2.5 times the normal limit; Alanine aminotransferase (ALT) >2.5 times the normal limit. Hematopoietic Status: Absolute neutrophil count (ANC) <1500mm3; Platelet count <100,000/mm3; Hemoglobin < 10 g/dL. Hemostatic: Prothrombin Time (PT) or INR above normal range; Partial Thromboplastin Time (PTT) above normal range; Bleeding Time outside normal range (if performed by hospital). Renal Status: Serum creatinine >2 mg/dL.
Contraindication to MRI
Receipt any chemotherapeutic agent within 28 days of Study Day 1 or nitrosourea within 6 weeks of Study Day 1
Received any intracerebral investigational agent
Receipt of another investigational drug or device within 28 days of the planned surgery
Known history of allergy to paclitaxel or any other component of OncoGel
Pregnant or lactating
Concurrent life-threatening disease
Any medical condition or other circumstance that, in the opinion of the Investigator, would make the subject unlikely or unable to successfully complete the study, or would interfere with analysis of study results","OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel

OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00480740,NCT00480740_EG000,No,All,Child | Adult,Phase 3,41,"Inclusion Criteria:

age is birth to 18 years
> or = 6 kg.
American Society of Anesthesiology (ASA) I, II, or III
undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
scheduled for cardiac catheterization

Exclusion Criteria:

subject or family history of malignant hyperthermia
known hepatic disorder determined by history physical exam or laboratory tests
pregnant or lactating female
receiving inotropic agents or has a pacemaker
weighs less than 6 kg.","Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00480740,NCT00480740_EG001,No,All,Child | Adult,Phase 3,41,"Inclusion Criteria:

age is birth to 18 years
> or = 6 kg.
American Society of Anesthesiology (ASA) I, II, or III
undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
scheduled for cardiac catheterization

Exclusion Criteria:

subject or family history of malignant hyperthermia
known hepatic disorder determined by history physical exam or laboratory tests
pregnant or lactating female
receiving inotropic agents or has a pacemaker
weighs less than 6 kg.","Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00480740,NCT00480740_EG002,No,All,Child | Adult,Phase 3,41,"Inclusion Criteria:

age is birth to 18 years
> or = 6 kg.
American Society of Anesthesiology (ASA) I, II, or III
undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
scheduled for cardiac catheterization

Exclusion Criteria:

subject or family history of malignant hyperthermia
known hepatic disorder determined by history physical exam or laboratory tests
pregnant or lactating female
receiving inotropic agents or has a pacemaker
weighs less than 6 kg.","control group

Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00485836,NCT00485836_EG000,No,All,Adult | Older Adult,Phase 3,129,"Inclusion Criteria:

Willingness to provide signed Informed Consent Form
Age ≥ 18 years
For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
Ability and willingness to return for all scheduled visits and assessments

Ocular Inclusion Criterion (Study Eye):

Foveal center-involved macular edema secondary to CRVO
BCVA using ETDRS charts of 20/40 to 20/320 (Snellen equivalent)
Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening [confirmed by the central reading center] and Day 0 [confirmed by the evaluating physician])
Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs

Exclusion Criteria:

History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
History of any anti-vascular endothelial growth factor (VEGF) or treatment in the fellow eye within 3 months prior to Day 0
History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
History of allergy to fluorescein
History of allergy to ranibizumab injection or related molecule
Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion.
Uncontrolled blood pressure
Pregnancy or lactation
Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)
Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry

Ocular Exclusion Criteria (Study Eye):

Prior episode of retinal vein occlusion (RVO)
Brisk afferent pupillary defect
History of radial optic neurotomy or sheathotomy
History or presence of age-related macular degeneration (AMD; dry or wet form)
History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
History of laser photocoagulation for macular edema within 4 months prior to Day 0
History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 4 months following randomization
History of intraocular corticosteroid use within 3 months prior to Day 0
History of pars plana vitrectomy
History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
Previous filtration surgery in the study eye
History of herpetic ocular infection
History of ocular toxoplasmosis
History of rhegmatogenous retinal detachment
History of idiopathic central serous chorioretinopathy
Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity
Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
Aphakia
Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
Improvement of > 10 letters on best corrected visual acuity (BCVA) between screening and Day 0","Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00486018,NCT00486018_EG000,No,All,Adult | Older Adult,Phase 3,131,"Inclusion Criteria:

Willingness to provide signed Informed Consent Form
Age ≥ 18 years
For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
Ability and willingness to return for all scheduled visits and assessments

Ocular Inclusion Criterion (Study Eye):

Foveal center-involved macular edema secondary to BRVO
BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent)
Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening [confirmed by the central reading center] and Day 0 [confirmed by the evaluating physician])
Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs

Exclusion Criteria:

History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
History of any anti-vascular endothelial growth factor (VEGF) treatment in fellow eye within 3 months prior to Day 0
History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
History of allergy to fluorescein
History of allergy to ranibizumab injection or related molecule
Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion
Uncontrolled blood pressure
Pregnancy or lactation
Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)
Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry

Ocular Exclusion Criteria (Study Eye):

Prior episode of retinal vein occlusion (RVO)
Brisk afferent pupillary defect
History of radial optic neurotomy or sheathotomy
History or presence of age-related macular degeneration (AMD; dry or wet form)
History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
History of laser photocoagulation for macular edema within 4 months prior to Day 0
History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 4 months following randomization
History of intraocular corticosteroid use within 3 months prior to Day 0
History of pars plana vitrectomy
History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
Previous filtration surgery in the study eye
History of herpetic ocular infection
History of ocular toxoplasmosis
History of rhegmatogenous retinal detachment
History of idiopathic central serous chorioretinopathy
Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity
Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
Aphakia
Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
Improvement of > 10 letters on best corrected visual acuity (BCVA) between screening and Day 0","Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00486031,NCT00486031_EG000,No,All,Adult | Older Adult,Phase 3,440,"Inclusion Criteria:

Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.
Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug.
Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.
Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.
Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.","balsalazide disodium tablets,3.3 g BID,",PubChem:135413496,Balsalazide Disodium,O=C([O-])CCNC(=O)c1ccc(N=Nc2ccc([O-])c(C(=O)O)c2)cc1.[Na+].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0
NCT00488618,NCT00488618_EG001,No,All,Adult | Older Adult,Phase 2,118,"Inclusion Criteria:

Male or female inpatients 18 to 65 years of age
Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode

Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:

Irritability,
Speech,
Content, and
Disruptive/Aggressive Behavior

Exclusion Criteria:

Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)].
Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2.
Patients experiencing first manic episode.
Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.","Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00491829,NCT00491829_EG001,No,Female,Adult | Older Adult,Phase 3,316,"Inclusion Criteria:

Women who are 18 years of age and older at the Screen Visit.
Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement
A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.
Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as ""0"" or ""1"" at the Screen Visit
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 eDiary on a daily basis (e.g., have access to a working land line or wireless telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately, having missing entries for five or less days during the 28-day Screen period.
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 relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present (i.e., available for sexual activity at some time during a 24 hour day) at least 50% of each month during the 4-week Screen period and 24-week efficacy period of the trial.

Exclusion Criteria:

Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study.
Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy.
Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year
Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.
Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage [i.e., have had hysterectomy (without bilateral oophorectomy), bilateral oophorectomy, endometrial ablation (any type), and chemical induced (e.g., chemotherapy)] according to the STRAW criteria.
Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory© II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation.","100 mg qhs

BIMT 17 BS 100 mg: flibanserin 100mg",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00492531,NCT00492531_EG000,No,All,Child | Adult | Older Adult,Phase 2,37,"• Eligibility based on the following inclusion and exclusion criteria.

INCLUSION CRITERIA:

Screening Phase:

Males or females, greater than or equal to 12 years of age and less than or equal to 70 years of age.
Diagnosis of sickle cell disease (including, but not limited to SS, SC, SD, or S-beta zero thalassemia).
Provision of informed consent and, where applicable, assent.

Observational Follow-up Study:

Satisfaction of screening criteria.
In the opinion of the investigator, ability to maintain follow-up contact.
Failure to satisfy the eligibility requirements of the Main Interventional Trial (MIT) OR discontinuation/completion of the MIT/Open-label Follow-up Phase.
Provision of informed consent and, where applicable, assent.

Main Interventional Trial:

Males or females, 12 years of age or older and less than or equal to 70 years of age.
Female subjects, on a reliable method of birth control or not physically able to bear children.
Electrophoretic documentation of sickle cell disease (including, but not limited to SS, SC, SD, or S-beta zero thalassemia).
At least mild pulmonary hypertension with TRV greater than or equal to 2.7 m/sec by echocardiogram.
Six-minute walk distance of 150-500 m.
In the opinion of the investigator, able to complete the protocol scheduled assessments during the 16-week, double-blind phase.
Provision of informed consent and, where applicable, assent.
Subjects with systemic hypertension must be on a stable antihypertensive regimen for greater than or equal to 90 days and a stable dose for greater than or equal to 30 days.

EXCLUSION CRITERIA:

Current pregnancy or lactation.

Any one of the following medical conditions:

Stroke within the last six weeks.
Diagnosis of pulmonary embolism within the last three months.
History of retinal detachment or retinal hemorrhage in the last 6 months.
Non-arteritic anterior ischemic optic neuropathy (NAION) in one or both eyes.
History of sustained priapism requiring medical or surgical treatment, unless currently impotent or on transfusion program within the last two years.
Any unstable (chronic or acute) condition that in the opinion of the investigator will prevent completion of the study.

Subjects taking nitrate-based vasodilators (including, but not limited to nicorandil [available in the UK only]), prostacyclin (inhaled, subcutaneous or intravenous) or endothelin antagonists. Subjects taking calcium channel blockers will be allowed to participate if they are on a stable dose for greater than or equal to 3 months.

Left ventricular ejection fraction (LVEF) less than 40 percent or clinically significant ischemic, valvular or constrictive heart disease: LVEF less than 40 percent or SF less than 22 percent.

Subjects in other research studies with investigational drugs (with the exception of hydroxyurea) unless the other trial has been approved by the walk-PHaSST Executive Committee for co-participation.

Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication, symptomatic hip osteonecrosis.

Tonsillectomies for sleep apnea within 3 months prior to randomization. Active therapy for pulmonary hypertension, including prostacyclin analog, endothelin-1 antagonist, or PDE-5 inhibitor.

Protease inhibitor therapy for HIV treatment Subjects taking potent CYP3A4 inhibitor therapy (e.g., itraconazole, ritonavir, ketoconazole) Subjects who are anticoagulated and have proliferative retinopathy (unless they have had ophthalmologist recommended intervention (e.g., phototherapy) or have been cleared by the ophthalmologist to participate in the study.

Subjects with systolic blood pressure greater than or equal to 140 mmHg OR diastolic blood pressure greater than or equal to 90 mmHg.","Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00494013,NCT00494013_EG001,No,All,Adult | Older Adult,Phase 3,210,"Inclusion Criteria:

Have type 2 diabetes mellitus for at least 1 year.
Are at least 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.",Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00495521,NCT00495521_EG000,No,All,Child | Adult,Phase 2,1,"Inclusion Criteria:

Age less than 18 years
Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
Harvey Bradshaw Index of at least 7
The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
Written informed consent

Exclusion Criteria:

Concomitant corticosteroids, budesonide
Corticosteroids within 2 months
Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
If the severity of the flare has started to decrease spontaneously
Coexisting diagnosis of primary sclerosing cholangitis
Infectious diarrhea
Signs of intestinal obstruction or perforation
New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
Hypersensitivity to 4-ASA or any components of PASER®
Pregnancy or breast-feeding
Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC < 3,000 during the preceding three months",Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks,ChEMBL:CHEMBL1169 | DrugBank:DB00233 | PubChem:4649,AMINOSALICYLIC ACID,Nc1ccc(C(=O)O)c(O)c1,J04AA01 | J04AA02 | J04AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00505765,NCT00505765_EG000,No,All,Adult,Phase 2,21,"Inclusion Criteria:

DSM IV/DSM IV TR diagnosis of schizophrenia
Capable of providing informed consent
Males and Females
Age: 18 and 60
Caucasian or Non Caucasian
Subjects will be treated with one of the following second generation antipsychotics: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole for the previous two months, with no change in dose in the last month, and/or with injectable depot antipsychotics (fluphenazine or haloperidol decanoate) with no change in last 3 months.

Subjects will meet the following symptom criteria:

Average Brief Psychiatric Rating Scale (BPRS) item score >3 (mild)
Simpson-Angus Scale total score less than or equal to 6
Calgary Depression Scale total score less than or equal to 10

Subjects will meet the following cognitive performance criteria:

Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:

Letter-number span (20);
HVLT total (31); and
CPT d-prime (3.47)
Able to complete the baseline MCCB validly as assessed by Chief Neuropsychologist or NP tester
Raw score of 6 or greater on the WTAR

Exclusion Criteria:

Current treatment with oral conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine.
Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months

Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

Loss of consciousness (LOC) for more than 1 hour
Recurring seizures resulting from the head injury
Clear cognitive sequellae of the injury
Cognitive rehabilitation following the injury
Subjects with a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder (e.g. unstable angina, decompensated congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
Clinically significant renal disease.
Women who are pregnant or of child-bearing potential, either not surgically-sterile nor using appropriate methods of birth control
Women who are breast-feeding
Prior participation in a clinical trial of investigational medication within 60 days.","AL-108, 30 mg/day- 3 sprays in each nostril, twice per day",ChEMBL:CHEMBL2103826 | DrugBank:DB12613 | PubChem:9832404,Davunetide,CC[C@H](C)[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](C)NC(=O)[C@@H](N)CC(N)=O)C(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)O,,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00505765,NCT00505765_EG001,No,All,Adult,Phase 2,20,"Inclusion Criteria:

DSM IV/DSM IV TR diagnosis of schizophrenia
Capable of providing informed consent
Males and Females
Age: 18 and 60
Caucasian or Non Caucasian
Subjects will be treated with one of the following second generation antipsychotics: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole for the previous two months, with no change in dose in the last month, and/or with injectable depot antipsychotics (fluphenazine or haloperidol decanoate) with no change in last 3 months.

Subjects will meet the following symptom criteria:

Average Brief Psychiatric Rating Scale (BPRS) item score >3 (mild)
Simpson-Angus Scale total score less than or equal to 6
Calgary Depression Scale total score less than or equal to 10

Subjects will meet the following cognitive performance criteria:

Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:

Letter-number span (20);
HVLT total (31); and
CPT d-prime (3.47)
Able to complete the baseline MCCB validly as assessed by Chief Neuropsychologist or NP tester
Raw score of 6 or greater on the WTAR

Exclusion Criteria:

Current treatment with oral conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine.
Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months

Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

Loss of consciousness (LOC) for more than 1 hour
Recurring seizures resulting from the head injury
Clear cognitive sequellae of the injury
Cognitive rehabilitation following the injury
Subjects with a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder (e.g. unstable angina, decompensated congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
Clinically significant renal disease.
Women who are pregnant or of child-bearing potential, either not surgically-sterile nor using appropriate methods of birth control
Women who are breast-feeding
Prior participation in a clinical trial of investigational medication within 60 days.","AL-108, 5 mg/day- one spray in each nostril once per day",ChEMBL:CHEMBL2103826 | DrugBank:DB12613 | PubChem:9832404,Davunetide,CC[C@H](C)[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](C)NC(=O)[C@@H](N)CC(N)=O)C(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00506662,NCT00506662_EG000,No,All,Older Adult,Phase 4,38,"Inclusion Criteria:

Type 2 diabetes
Insulin naive
Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
HbA1c between 8% - 10.5%

Exclusion Criteria:

Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
Proliferative retinopathy, maculopathy requiring treatment,
Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
Acute disease with poor prognosis
History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
Participation in another clinical trial less than one month before inclusion in this trial
Illness requiring repeated hospitalisation
Known or suspected allergy to the insulin or any compositional component
Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Terminal illness",Individually adjusted dose of insulin detemir once daily,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00509587,NCT00509587_EG000,No,All,Adult | Older Adult,Phase 2,21,"Criteria:

No prior bevacizumab
Histologically or cytologically confirmed invasive breast carcinoma (recurrent or metastatic disease)
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
Patients who may still benefit from hormonal therapy are ineligible (patients with hormone receptor-positive breast cancer should have received appropriate sequential hormonal therapy for metastatic disease until disease progression)
Patients with HER-2 positive disease who have not yet received trastuzumab (Herceptin®) to maximal benefit are ineligible (patients with disease progression during trastuzumab therapy are eligible)
No known brain metastases
ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
Life expectancy > 12 weeks
Absolute neutrophil count >= 1,500/mm³
Platelets >=100,000/mm³
Total bilirubin normal (exception made for patients with known Gilbert's disease)
AST/ALT =< 2.5 times upper limit of normal (ULN)
No proteinuria > +1 on two consecutive dipsticks taken >= 1 week apart
PT/INR/PTT =< 1.2 times ULN
No allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or other study agents
No QTc prolongation (defined as a QTc interval >= 500 msecs) or other significant ECG abnormalities
No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain study drug
No poorly controlled hypertension (systolic blood pressure [BP] >= 140 mm Hg or diastolic BP >= 90 mm Hg) Initiation or adjustment of BP medication is allowed prior to study entry provided that the average of 3 BP readings prior to study entry is < 140/90 mm Hg
No serious or non-healing wound, ulcer, or bone fracture
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 4 weeks
No cerebrovascular accident within the last 6 months
No myocardial infarction, cardiac arrhythmia, hospital admission for unstable angina within the last 12 weeks
No venous thrombosis within the last 12 weeks
No NYHA class III-IV heart failure Patients with a history of class II heart failure may be considered eligible provided they are asymptomatic on treatment
No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would preclude study compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgery
No cardiac angioplasty or stenting within the last 12 weeks
No more than 1 prior chemotherapy regimen for recurrent disease
No prior surgical procedures affecting absorption
No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

Therapeutic warfarin Low molecular weight heparin or prophylactic low-dose warfarin are allowed

No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

Erectile dysfunction agents: sildenafil, tadalafil, or vardenafil
Antiarrhythmics: bepridil, flecainide, lidocaine, mexilitine, amiodarone, or quinidine
Immune modulators: cyclosporine, tacrolimus, or sirolimus
Miscellaneous: theophylline, quetiapine, or risperidone

No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment, including any of the following:

Oral hypoglycemics: glipizide, glyburide, or tolbutamide
Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or methylergonovine
Neuroleptics: pimozide
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapy
WBC >= 3,000/mm³
No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic disease
Creatinine normal OR creatinine clearance >= 60 mL/min
At least 3 months since prior trastuzumab","Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

pazopanib hydrochloride: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies",PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00510783,NCT00510783_EG001,No,All,Adult | Older Adult,Phase 4,76,"Inclusion Criteria:

age 18 or older
patient presenting to Grady Memorial Hospital's Emergency Department after having a tonic-clonic seizure (primary or secondarily generalized) within the last 4 hours

Cause of seizure for inclusion: reason for seizure is often undetermined at time of presentation to the Emergency Department. The most likely expected causes of a seizure are noncompliance to existing antiepileptic drug regimen, refractory epilepsy with breakthrough seizure, metabolic aberration, alcohol withdrawal, or unknown.

Exclusion Criteria:

non-English speaking
first time seizure
seizures other than tonic-clonic seizure (primary or secondarily generalized)
more than 3 seizures in 24 hours or status epilepticus, pregnant patients by history or by urine pregnancy testing, serious neurologic insult resulting in seizure but where seizure is not the primary reason for admission (e.g. traumatic brain injury with seizure or hemorrhagic stoke would be excluded)
contraindication to IV levetiracetam
received IV phenytoin within 24 hours
known allergy to phenytoin
previously enrolled in the study",Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00514501,NCT00514501_EG000,No,All,Adult | Older Adult,Phase 2,507,"Inclusion Criteria:

Provide written informed consent and are willing to comply with protocol requirements
Are 40 years of age or older.
Are being evaluated for possible ACS.
If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

<40 years of age.
Females who are pregnant or lactating.
History of left ventricular ejection fraction (LVEF)=40%.
History of MI.
Acute ST segment elevation on ECG.
Left bundle branch block on ECG.
Known history of significant allergy to x-ray contrast media or iodine/iodides.
Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
Serum creatinine level >2.0 mg per dL.
Received investigational compound and/or medical device within 30 days of admission into this study.
Q-wave abnormalities consistent with previous MI","A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.",PubChem:636427,Iodofiltic acid (123I),CC(CCCCCCCCCCCCc1ccc(I)cc1)CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00515879,NCT00515879_EG000,No,All,Adult | Older Adult,Phase 3,169,"Inclusion Criteria:

Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
Total score of greater than or equal to 60 on the LSAS
Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities

Exclusion Criteria:

Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
Eating disorder within the 6 months prior to study entry
History of organic brain syndrome, mental retardation, or other cognitive dysfunction
Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
Suicidal thoughts
Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
Significant personality dysfunction
Serious medical illness or instability for which hospitalization may be likely within the next year",Participants will receive D-cycloserine augmented cognitive behavioral therapy,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00518154,NCT00518154_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

HIV-1 infected subjects 18 years of age or older
Receiving HAART for at least two years
At least a viral load determination per year since HAART initiation, all undetectable
Patient's status is Immunological Non Responder (InR), that is, his or her viral load is reduced, but CD4+ cell count has not raised accordingly
Current viral load: undetectable
Patient agrees and signs informed consent

Exclusion Criteria:

Concomitant active infectious or neoplastic disease
History of new AIDS-defining events during HAART
Pregnancy or breast-feeding
Patients who have been subjects of an investigational agent, chemotherapy or radiotherapy within the previous 28 days
Subjects requiring treatment for Tuberculosis
Subjects unable to follow, or comply with the protocol interventions
Subjects receiving immunosuppressive treatment, including corticosteroids","Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment

Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks",ChEMBL:CHEMBL1115 | DrugBank:DB00545 | PubChem:4991,Pyridostigmine,CN(C)C(=O)Oc1ccc[n+](C)c1,N07AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00518284,NCT00518284_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
Normal vessel diameter of the SFA is 4-6 mm
Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
No target vessel thrombosis confirmed angiography post-PTA procedure
No distal embolization within target limb
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

Exclusion Criteria:

Women of child bearing potential who do not use adequate contraception
Patients who have experienced acute onset of claudication
History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
Patients with lesions requiring treatment with atherectomy or primary stenting
Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
Patient is immunosuppressed or is HIV positive
Any individual who may refuse a blood transfusion
Documented major gastrointestinal bleeding within 3 months
The following lab values at baseline are exclusionary:
Serum creatinine greater or equal to 2.5 mg/dl
Platelet count less than 100,000 cells/mm^3
Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
Hemoglobin (Hgb) less than 9 g/dl
Total Bilirubin greater than 1.5 mg/dl
Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
Aspartate transaminase (SGOT) greater than 2.5 x ULN
Alkaline phosphatase greater than 2.5 x ULN
Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
Patient treated with bivalirudin (Angiomax)
Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
Renal failure requiring hemodialysis
Lower extremity or pedal pulse","Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00518284,NCT00518284_EG002,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
Normal vessel diameter of the SFA is 4-6 mm
Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
No target vessel thrombosis confirmed angiography post-PTA procedure
No distal embolization within target limb
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

Exclusion Criteria:

Women of child bearing potential who do not use adequate contraception
Patients who have experienced acute onset of claudication
History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
Patients with lesions requiring treatment with atherectomy or primary stenting
Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
Patient is immunosuppressed or is HIV positive
Any individual who may refuse a blood transfusion
Documented major gastrointestinal bleeding within 3 months
The following lab values at baseline are exclusionary:
Serum creatinine greater or equal to 2.5 mg/dl
Platelet count less than 100,000 cells/mm^3
Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
Hemoglobin (Hgb) less than 9 g/dl
Total Bilirubin greater than 1.5 mg/dl
Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
Aspartate transaminase (SGOT) greater than 2.5 x ULN
Alkaline phosphatase greater than 2.5 x ULN
Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
Patient treated with bivalirudin (Angiomax)
Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
Renal failure requiring hemodialysis
Lower extremity or pedal pulse",Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00518284,NCT00518284_EG003,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
Normal vessel diameter of the SFA is 4-6 mm
Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
No target vessel thrombosis confirmed angiography post-PTA procedure
No distal embolization within target limb
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

Exclusion Criteria:

Women of child bearing potential who do not use adequate contraception
Patients who have experienced acute onset of claudication
History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
Patients with lesions requiring treatment with atherectomy or primary stenting
Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
Patient is immunosuppressed or is HIV positive
Any individual who may refuse a blood transfusion
Documented major gastrointestinal bleeding within 3 months
The following lab values at baseline are exclusionary:
Serum creatinine greater or equal to 2.5 mg/dl
Platelet count less than 100,000 cells/mm^3
Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
Hemoglobin (Hgb) less than 9 g/dl
Total Bilirubin greater than 1.5 mg/dl
Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
Aspartate transaminase (SGOT) greater than 2.5 x ULN
Alkaline phosphatase greater than 2.5 x ULN
Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
Patient treated with bivalirudin (Angiomax)
Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
Renal failure requiring hemodialysis
Lower extremity or pedal pulse",Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00523718,NCT00523718_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of OCD, confirmed by Structured Clinical Interview for DSM-IV (SCID-IV); symptoms of at least 1 year duration
moderate to severe OCD symptoms as measured by a score on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) of 16 or greater
documented failure of an adequate trial of a selective serotonin reuptake inhibitor (SSRI)
agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

primary diagnosis of a psychotic disorder
active substance abuse or dependence
unstable medical condition
prior exposure to riluzole
prior psychosurgery
pregnancy, breastfeeding, or intent to become pregnant during study
liver function tests (LFTs) elevated to more than 2x the upper limit of normal
evidence of active liver disease
seizure disorder
active suicidal ideation","Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment

riluzole: 50 mg PO bid, 12 weeks",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00525044,NCT00525044_EG000,No,All,Child | Adult | Older Adult,Phase 3,249,"1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.

Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.
Counting of white blood cell in blood routine examination exceeds 10?109/L.
Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).
Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.
Previous and/or existing tumour condition.
Pregnancy and/or breast-feeding.
Alcohol, and/or drug abuse.
Simultaneous participation in another clinical trial.","Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day",ChEMBL:CHEMBL153479 | DrugBank:DB06742 | PubChem:2132,Ambroxol,Nc1c(Br)cc(Br)cc1CN[C@H]1CC[C@H](O)CC1,R02AD05 | R03CC63 | R05CB06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00527488,NCT00527488_EG000,No,Male,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).",Two doses of Degarelix 16 mg on Day 0 and Day 14,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00527488,NCT00527488_EG001,No,Male,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).",A single dose of Degarelix 32 mg on Day 0,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00527488,NCT00527488_EG002,No,Male,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).",Two doses of Degarelix 32 mg on Day 0 and Day 14,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00527488,NCT00527488_EG003,No,Male,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).",A single dose of Degarelix 64 mg on Day 0,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00527592,NCT00527592_EG000,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:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00535392,NCT00535392_EG000,No,All,Child,Phase 2,33,"Inclusion Criteria:

Male or female between 4 and 16 years of age, inclusive
The subject suffers from epilepsy (except status epilepticus)
The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

The subject has difficult venous accessibility
History of status epilepticus during the 3 months prior to visit 1.
The subject is taking felbamate at visit 1 or has been taking it in the past.","Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00539526,NCT00539526_EG001,No,All,Adult | Older Adult,Phase 4,33,"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",travoprost 0.004%,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00544544,NCT00544544_EG000,No,All,Adult | Older Adult,Not Applicable,14,"Inclusion Criteria:

Male or female age 18-65
Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
Current score of >/= 18 on the Hamilton Depression Scale

Exclusion Criteria:

Active psychotic/manic symptoms
Lifetime history of schizophrenia or obsessive compulsive disorder
Clinically significant medical disease
Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.",Riluzole 100-200 mg/day,ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00547456,NCT00547456_EG000,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.
Clinical stability defined by absence of treatment change or need for acute care within the last two months.
Weight stable, within 5%, in the previous three months as measured during office visits.
Willingness to participate in a clinical study.

Exclusion Criteria:

Acute illness within the preceding 2 months.
Patients who received systemic glucocorticoid therapy within the past month.
Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.
Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas
Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.
No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.
Primary care or pulmonary physician refusal.
Patient refusal for any reason.
Lack of capacity to participate in the informed consent process.","Patients are their own controls and tested pre and post the addition of night time supplemental oxygen

Oxygen: Oxygen 2-3L Nasal cannula",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00547586,NCT00547586_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.",N-methylnaltrexone bromide (MOA-728): Oral,PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00547586,NCT00547586_EG002,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.",N-methylnaltrexone bromide (MOA-728): Oral,PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00547586,NCT00547586_EG003,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.",N-methylnaltrexone bromide (MOA-728): Oral,PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00547586,NCT00547586_EG004,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.",N-methylnaltrexone bromide (MOA-728): Oral,PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00552032,NCT00552032_EG000,No,All,Child,Phase 3,66,"Inclusion Criteria:

Participants and their parents must demonstrate willingness to participate and comply with study procedures. Parents must sign a written informed consent
Participants and their parents must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, medication times, and concomitant medications accurately and consistently in a daily diary
Children with a history of adenoid hypertrophy for at least 3 months with no response to previous medical treatment
Baseline adenoid tissue size must have been graded by nasopharyngoscopy examination as Grade III or IV on the Adenoid/Choana (A/C) Index (between 50% and 100% obstruction)
Baseline Total Severity Symptoms Score must be ≥ 8 points (AM or PM)
For inclusion in endpoints relating to otitis media with effusion (OME), participant must have persistent middle ear effusion for the past 3 months or more documented by otoscopic examination, middle ear pressure less than -150 mm H2O, Jerger type B flat tympanogram, and mild-moderate conductive hearing loss in audiometry supporting the diagnosis of OME

Exclusion Criteria:

Participants with previous surgery of hypertrophic adenoids with or without tympanostomy tube placement
Participants treated with inhaled or systemic corticosteroids within the past 1 month
Participants with Morbid Obesity (Body Mass Index >95 percentile of charts from the Centers for Disease Control)
Participants who have not accomplished the designated washout periods for any of the prohibited medications
Participants who have used any investigational products within the last 30 days
Participants who have used any antibodies for allergies in the past 90 days
Participants who have any abnormal physical examination results that may affect study evaluations or participant safety in the investigator's judgment
Participants who are allergic or have an idiosyncratic reaction to corticosteroids
Participants with signs and symptoms of acute or chronic bacterial rhinosinusitis
Participants has had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose later than 14 days prior to screening, or who has had a viral upper or lower respiratory infection within 7 days prior to screening
Participants with a documented immunodeficiency condition
Participants with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow
Participants with any clinically significant metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect participant safety","1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00558272,NCT00558272_EG001,No,All,Adult | Older Adult,Phase 2,69,"Inclusion Criteria:

Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression
At least one radiographically confirmed metastatic bone lesion
No change of cancer therapy for at least 8 weeks before randomization

Exclusion Criteria:

Have had any prior exposure to bisphosphonate
Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months
Inadequate renal function or low haemoglobin
Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.",Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00561678,NCT00561678_EG000,No,All,Older Adult,Phase 4,189,"Inclusion Criteria:

68 and older
elective major surgery under general anesthesia(major surgery is defined by a planned 2 day hospitalization)
ASA physical status I-III
capable and willing to consent
MMSE > 20 (to exclude dementia)

Exclusion Criteria:

Cardiac surgery
Intracranial Surgery
Emergency Surgery
Patients with severe visual or auditory disorder/handicaps
Illiteracy
Patients with clinically significant Parkinson's Disease
Patients not expected to be able to complete the 3 and 6 month postoperative tests
Sick sinus syndrome without pacemaker
Hypersensitivity to drug or class
Current 2nd or 3rd degree AV block
History of clinically significant bradycardia
Contraindication to the use of an 2A-agonist
Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
ASA physical status IV or V",Precedex (Dexmedetomidine) 0.5/ug/kg/hr,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00562120,NCT00562120_EG002,No,All,Adult,Phase 2,19,"Inclusion Criteria:

Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
Subjects that respond to a ragweed nasal allergen challenge at screening.

Exclusion Criteria:

History of asthma or FEV1 < 80% predicted.
Significant concomitant disease or medications.
Symptoms of allergic rhinitis within 2 weeks prior to screening.",Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.,PubChem:9831873,Fexofenadine hydrochloride and pseudoephedrine hydrochloride,CC(C)(C(=O)O)c1ccc(C(O)CCCN2CCC(C(O)(c3ccccc3)c3ccccc3)CC2)cc1.CNC(C)C(O)c1ccccc1.Cl.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
NCT00564018,NCT00564018_EG000,No,All,Child | Adult,Not Applicable,33,"Inclusion Criteria:

Newly diagnosed type 1 diabetes within 1 week of diagnosis
Age 6 - 18 years
Care provided at Children's Medical Center, Dallas

Exclusion Criteria:

Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents)
Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids)
Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry)
Expected poor compliance
Pregnancy
Any other condition that by the judgement of the investigator may be potentially harmful to the patients",Subjects randomized to treatment with insulins detemir and aspart,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00566462,NCT00566462_EG000,No,All,Adult | Older Adult,Phase 2,1,"INCLUSION CRITERIA:

Male or female patients with idiopathic PD fulfilling the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) diagnostic criteria, with a good response to levodopa. The requirement in the UKPDSBB Step 2 for prior brain imaging is at the discretion of the investigator.

Clinical diagnosis of idiopathic Parkinson's disease (patients must have at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia)
Hoehn and Yahr Stage II to IV.
Treatment with monotherapy of levodopa plus an aromatic acid decarboxylase inhibitor (carbidopa). The carbidopa/levodopa medication should be taken at least two times daily (excluding the bedtime/night time dose) up to a maximum of eight doses daily (including the bedtime/night time dose).
Intermittent use of either liquid forms of levodopa or subcutaneous apomorphine is permitted.
Age >30 years of age
Women who are incapable of bearing children (e.g., clinically assessed as infertile, including surgically sterile) or who are practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method).

Postmenopausal women may be recruited but must be amenorrheic for at least 1 year to be considered. Women must have a negative serum beta-human chorionic gondotrophin (β-HCG) test at the Screening Visit and a negative urine pregnancy test prior to radiotracer administration on the day of each SPECT scanning session. Women must also be willing to remain on their current form of contraception for the duration of the study.

In the investigator's opinion, patients are able to complete the study and are capable of giving full written informed consent.

EXCLUSION CRITERIA:

Patients with any one of the following will be excluded:

Inability or unwillingness to undergo SPECT or other study procedures
Pregnant or lactating women
Atypical or drug-induced PD
Current treatment with dopamine agonists, MAO or COMT inhibitors, anticholinergics
Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking antidepressant medication, however, the dose must be stable for 4 weeks prior to the Baseline Visit. Use of antipsychotic medication including clozapine and quetiapine is prohibited, even if the indication is for movement disorders.
Current or prior treatment (within 4 weeks prior to Baseline Visit) with pergolide, tolcapone, methyldopa, budipine, reserpine, seroquel, or the herbal dopamine agonist, Mucuna Pruriens
Patients with current or prior treatment (within 4 weeks prior to the Baseline Visit) with medication known to induce the enzyme cytochrome P450 3A4
Use of an investigational product within 4 weeks prior to randomization or patients who have participated in a previous study with perampanel
Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria
Dementia (as defined by a MMSE score of ≤ 24) and/or fulfilling the criteria for dementia due to PD (as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association - 4th Edition)
Clinically significant unstable medical or psychiatric illness
Presence of physical, mental, or social condition that precludes informed consent or interferes with careful follow-up
Past (within 1 year) or present history of suicidal ideation or suicide attempts
Elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN)
Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication
Evidence of significant active hematological disease: white blood cell (WBC) count ≤ 2500/μL; absolute neutrophil count ≤ 1000/μL
Patients with previous stereotactic surgery (eg, pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period
Patients receiving or planning to receive (within 3 months) deep brain stimulation
Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to ""OFF"" periods) that could interfere with the evaluation of any such symptoms caused by the study drug
Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study
Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc > 450 msec)","A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00569530,NCT00569530_EG001,No,All,Child,Phase 3,85,"Inclusion Criteria:

Less than or equal to 1000 gm. birth weight
Less than or equal to 30 weeks gestational age
Day 7-14 of life
Intubated and mechanically ventilated at any time days 7-14 of life

Exclusion Criteria:

Serious congenital malformations
Life expectancy less than 7 days from enrollment
Previous treatment with iNO
Active pulmonary hemorrhage at time of enrollment
Active air leak syndrome at time of enrollment
Bilateral grade IV intracranial hemorrhage prior to enrollment
Less than 48 hours from last clinical dose of early surfactant.","Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Sham Infants will not receive additional doses of Infasurf.",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00572234,NCT00572234_EG000,No,All,Adult | Older Adult,Not Applicable,40,"Inclusion Criteria:

patient in the substance use disorder program at either the Omaha VA Medical Center or at Catholic Charities Campus for Hope
diagnosis of methamphetamine dependence as well as presence or history of psychosis based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria (not to include patients in full sustained remission)
provide names, addresses, and phone numbers of at least two collateral informants who can provide information on their methamphetamine and other drug use during follow-up
must sign an informed consent as approved by the UNMC Internal Review Board (IRB) and Catholic Charities Research Committee.

Exclusion Criteria:

a history of severe injury to their brain
advanced cardiac, pulmonary, renal or liver disease
predisposition to seizures
history of bulimia or anorexia nervosa
current diagnosis of major depressive disorder
diagnosis or past history of panic disorders, schizophrenia, or bipolar affective disorder
family history or childhood history of epilepsy or seizures
history of strokes, brain tumors, or bleeding in the brain.
used any psychoactive drug within one week of study entry (two weeks for MAO (monoamine oxidase) inhibitors or protriptyline, four weeks for fluoxetine)
currently using any theophylline product (e.g. Theodur)
used an investigational drug in any study within the past four weeks
used a therapeutic course of bupropion SR for > 1 week at any time in the past 12 months or have been evaluated in previous studies examining bupropion SR at anytime
If female, the participant must not be pregnant or breast feeding","receiving bupropion SR

bupropion SR: 12 week course of bupropion SR 150 mg, BID",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT00573066,NCT00573066_EG000,No,All,Child,Phase 1,56,"Inclusion Criteria:

Patients must be greater or equal to one month or less than or equal to 24 months of age.
Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
Planned tracheal extubation within 24 hours post-operatively.
Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and >12 months to 24 months creatinine < or= to 1.0mg/dL)
Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to 165 U/L and > 12 months to 24 months < or = to 90 U/L)
Isolated heart surgery
Informed consent

Exclusion Criteria:

Patients who have received another investigational drug within the past 30 days.
Receiving continuous infusions of muscle relaxants in the postoperative setting.
Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Patients who show signs or symptoms of elevated intracranial pressure.
Post-operative hypotension based on age.
Preexisting bradycardia based on age.
Heart block
Weight < 5kg
Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.","Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00574197,NCT00574197_EG000,No,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
Patients who are able to give written informed consent.

Exclusion Criteria:

Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
Known sensitivity to the study drug or class of the study drug.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Use of any other investigational agent in the last 30 days.","Enteric-coated Mycophenolate Sodium (Myfortic)

1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00576381,NCT00576381_EG000,No,All,Child,Phase 1,30,"Inclusion Criteria:

Patients must be less than or equal to 1 month old.
Postconceptual age must be > or equal to 37 weeks on the day of surgery.
Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
Planned tracheal extubation within 24 hrs post-op.
Adequate renal function (serum creatine < or equal to 1.5mg/dL)
Adequate liver function (ALT < or equal to 165 U/L)
Isolated heart surgery
Informed consent

Exclusion Criteria:

Patients who have received another investigational drug since birth.
Patients receiving continuous infusions of muscle relaxants in the post-op setting.
Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
Patients who show signs and symptoms of elevated intracranial pressure.
Post-op hypotension defined by post conceptual age.
Pre-existing bradycardia defined by age
Heart block
Weight < 2kg
Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study","Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.

Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00577642,NCT00577642_EG000,No,All,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Men or women 18 years of age or older
Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
ECOG Performance Status of 0-2

Exclusion Criteria:

MM patients on active anti-MM therapy (maintenance regimens allowed)
Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
Relapsed, refractory or progressive disease
Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
Hypersensitivity or any contraindication to a single dose of zoledronic acid",This was a nonintervention biomarker study after a single dose of Zoledronic acid.,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00581828,NCT00581828_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,19,"Inclusion Criteria:

women at least five years past onset of menopause, defined as date of last menses (ages reported above are the range in ages of the participants recruited to the study)
serum 25(OH)D 16-24 ng/ml by reverse phase HPLC
calcium intake < or = 1,100 mg daily

Exclusion Criteria:

Intake of >1,100 mg of calcium per day through the combination of diet and supplements
Hypercalcemia (baseline serum calcium above the normal reference range)
Nephrolithiasis, documented in the medical record or by patient report
Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics within the past month
Creatinine >2.0 mg/dL
Hypercalciuria (baseline urine calcium: creatinine ratio >0.25)
Current use of medications known to interfere with vitamin D and/or calcium metabolism, including oral steroids or anticonvulsants
Ongoing or recent (past six months) use of bisphosphonates, estrogen compounds, calcitonin or teriparatide, as these compounds may independently affect retention of calcium within bone
Diagnosis of, or evidence for, osteomalacia, manifest by serum 25(OH)D < 16 ng/ml or the presence of at least two of the following blood tests: low calcium, low phosphorus, or elevated alkaline phosphatase (23).
Prior adult clinical fragility fracture or baseline T-score below -3.0 at the lumbar spine or femur","Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00585468,NCT00585468_EG000,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Renal transplant recipients greater than 18 years of age, who have given written consent

Exclusion Criteria:

Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium
Experienced an acute rejection episode prior to the pharmacokinetic profile collection
Serum creatinine >2 mg/dL
Neutropenia (Absolute Neutrophil Count < 1.3x10^3/mL)
Received a previous transplant other than a kidney
Receiving chronic steroids at time of transplant
Known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid or any of its excipients",Mycophenolate sodium taken with a meal,ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00585468,NCT00585468_EG001,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Renal transplant recipients greater than 18 years of age, who have given written consent

Exclusion Criteria:

Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium
Experienced an acute rejection episode prior to the pharmacokinetic profile collection
Serum creatinine >2 mg/dL
Neutropenia (Absolute Neutrophil Count < 1.3x10^3/mL)
Received a previous transplant other than a kidney
Receiving chronic steroids at time of transplant
Known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid or any of its excipients",Mycophenolate sodium taken separately from food by 2 hours,ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00587067,NCT00587067_EG000,No,All,Adult | Older Adult,Phase 2,34,"Inclusion Criteria:

Patients with a liver mass that is radiographically consistent with HCC and a serum alpha fetoprotein (AFP) > 500 ng/dl do not require biopsy confirmation of the diagnosis.
Patients with HCC or ICC undergoing exploration for a possible curative resection but found to have unresectable disease confined to the liver will be eligible, provided that no intraoperative findings would exclude them and prior informed consent has been obtained (see below).
There must be <70% liver involvement by cancer, and the disease must be considered unresectable.
Patients who have failed ablative therapy will be eligible.
Patients must have a KPS > 60% and be considered candidates for general anesthesia and hepatic artery pump placement.
Patients with chronic hepatitis and/or cirrhosis are eligible
Serum albumin must be >2.5 g/dl and total serum bilirubin must be <1.8 mg/dl based on preoperative laboratory values within 14 days of registration.
WBC must be >3500 cells/mm3 and platelet count must be >100,000/mm3 based on preoperative laboratory values within 14 days of registration.
The international normalized ratio (INR) must be less than 1.5 in patients not on coumadin therapy, based on preoperative laboratory values within 14 days of registration.
Age >_ 18 years.
Female patients cannot be pregnant or lactating.
Patients must be able to understand and sign informed consent.

Exclusion Criteria:

Patients who have received prior treatment with FUDR
Patients who have had prior external beam radiation therapy to the liver.
Patients who have a diagnosis of sclerosing cholangitis.
Patients who have a diagnosis of Gilbert's disease.
Patients who have clinical ascites
Patients with hepatic encephalopathy
Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage.
Patients with occlusion of the main portal vein nor of the right and left portal branches Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers). Patient with active infection. Female patients who are pregnant or lactating.","FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate

* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles.",ChEMBL:CHEMBL917 | DrugBank:DB00322 | PubChem:5790,Floxuridine,O=c1[nH]c(=O)n([C@H]2C[C@H](O)[C@@H](CO)O2)cc1F,L01BC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00588159,NCT00588159_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,63,"Inclusion criteria:

Age 45-75 years
Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection)

Exclusion criteria:

Undergoing chest wall resection, gastroesophageal surgery
Enrolled in another post-thoracotomy analgesic research protocol
Pre-existing pain syndrome
Current gabapentin or pregabalin therapy
Inability to understand the study protocol
Coagulopathy
Current use of anticoagulants
Allergy to medications on protocol
Creatinine >1.3
Moderate or severe aortic stenosis
Severe psychological disorders
Bacteremia, osteomyelitis, or infection at site of thoracic epidural placement
History of previous thoracotomy
Patient declines preoperative epidural catheter placement
Prisoners or other institutionalized individuals
Severe hepatic, renal or cardiovascular disorders
Women who can become pregnant",Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.,ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00590317,NCT00590317_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,32,"Inclusion Criteria:

Patients presenting to the ED with at least one of the following
Nausea
Vomiting documented in the ED

Exclusion Criteria:

Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
Patients with missed last menstrual period
Pregnancy
Age < 18 years old
Treatment with antineoplastic agents within 7 days prior to randomization
Irritable bowel syndrome
Gastroparesis
Suspected gastrointestinal bleed
Suspected intestinal obstruction
Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
Traumatic brain injury upon admission to ED
Intracranial hemorrhage upon admission to ED
Patients unable to read, write or communicate in the English language
Patients leaving the ED against medical advice",Patients receiving Prochlorperazine 10mg IV,ChEMBL:CHEMBL728 | DrugBank:DB00433 | PubChem:4917,Prochlorperazine,CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1,N05AB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00591825,NCT00591825_EG001,Accepts Healthy Volunteers,All,Adult,Phase 2,54,"Inclusion Criteria:

Right-handed
Adults between 18 and 55 years of age
Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
Individuals of both genders and all races will be included

Exclusion Criteria:

Women who are breastfeeding or pregnant
Individuals with medical conditions unsuitable for MR scanning
Individuals reporting a history of epilepsy or seizures
Individuals reporting an allergy to cycloserine
Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury *Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
Individuals currently taking any psychotropic medication",Participants without phobia were given one administration 100 mg D-cycloserine (DCS).,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00591825,NCT00591825_EG003,Accepts Healthy Volunteers,All,Adult,Phase 2,54,"Inclusion Criteria:

Right-handed
Adults between 18 and 55 years of age
Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
Individuals of both genders and all races will be included

Exclusion Criteria:

Women who are breastfeeding or pregnant
Individuals with medical conditions unsuitable for MR scanning
Individuals reporting a history of epilepsy or seizures
Individuals reporting an allergy to cycloserine
Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury *Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
Individuals currently taking any psychotropic medication",Participants with phobia were given one administration 100 mg D-cycloserine (DCS).,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00598585,NCT00598585_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,5,"Inclusion Criteria:

Patients meeting the CDC definition of CFS.
All races, ethnicities, socio-economic status (SES), and gender
Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
Age less than 50. Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than 50.
Able to provide informed consent.
Willingness to be off all medicines and supplements for 3 weeks prior to the study.
Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.

Exclusion Criteria:

Disabilities that would prevent them from participating in the study.
Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI > 32 kg/m2),
Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
Current abuse of illicit drugs or heavy ethanol use.
Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
Abnormal EKG
Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.","Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00599027,NCT00599027_EG000,No,All,Adult | Older Adult,Phase 3,51,"Inclusion Criteria:

Outpatients (≥18 and ≤ 75 years of age) of either sex
Willingness to participate and comply with procedures by signing a written informed consent
Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
To qualify at the randomization visit the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 week run-in period
Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL)
All prior medication washout times had been observed
Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication
Negative urine pregnancy test
Free of any clinically relevant disease that would have interfered with study evaluations
Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary

Exclusion Criteria:

Female who was or intended to become pregnant during the study or within 12 weeks after study completion
Nursing, or intended to be nursing during the study or within 12 months after study completion
Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
Rhinitis medicamentosa
Evidence of persistent asthma, or asthma with daytime and nighttime symptoms not controlled by short-acting beta2-adrenoceptor agonists
Asthma requiring chronic use of inhaled or systemic corticosteroids
Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period, or had a viral upper respiratory infection within 7 days prior to screening
Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
Undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit were eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
Diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas)
Concomitant medical problem
Had any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex
Smoked or had smoked within the previous 6 months
Member of the staff, affiliated with, or family member of the staff personnel directly involved with this study
Previously randomized into this study
Any other clinically significant deviation from normal in the physical examination or medical history that could interfere with the study evaluation or affect subject safety
In a situation or condition that could interfere with participation in the study
Used any drug or device in an investigational protocol in the 30 days prior to visit 1
Participating in other clinical studies
Allergic or has sensitivity to the study drug or its excipients
Compromised ability to provide informed consent
History of non-compliance with medication or treatment protocols",Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00600756,NCT00600756_EG000,No,All,Adult | Older Adult,Phase 3,391,"Inclusion Criteria:

Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Exclusion Criteria:

Patients with a baseline SWN-K total score of >75
Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.","Experimental - oral, once daily, tablets of 400 mg to 800 mg",PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00605644,NCT00605644_EG001,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast feeding, or plan to become pregnant.","MOA-728

MOA-728: Oral Capsules",PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00605644,NCT00605644_EG002,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast feeding, or plan to become pregnant.","MOA-728

MOA-728: Oral Capsules",PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00605644,NCT00605644_EG003,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast feeding, or plan to become pregnant.","MOA-728

MOA-728: Oral Capsules",PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00605644,NCT00605644_EG004,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast feeding, or plan to become pregnant.","MOA-728

MOA-728: Oral Capsules",PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00607477,NCT00607477_EG001,No,All,Adult | Older Adult,Not Applicable,2,"Inclusion Criteria:

Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
Stable management of other toxicities from the cancer treatments
Expected to continue current cancer treatments for at least 4 weeks
18 years and older
Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.

Exclusion Criteria:

Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
Current uncontrolled toxicities due to the cancer treatments.
Patients having known contraindications to hydralazine or minoxidil therapy.
Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
Use of either minoxidil or hydralazine in the six (6) months prior to screening.","2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00607724,NCT00607724_EG002,No,All,Adult | Older Adult,Phase 1,4,"DISEASE CHARACTERISTICS:

Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists

Progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit)

Must receive standard second-line therapy if second-line therapy has been shown to provide clinical benefit

Evaluable disease by physical examination, imaging, and/or one of the following:

Two rising prostate-specific antigen (PSA) levels ≥ 2 weeks apart, with one obtained during screening (for patients with prostate cancer)
Two rising CA-125 levels ≥ 2 weeks apart, with one obtained during screening (for patients with ovarian cancer)
No CNS cancer, either primary lesions or metastatic disease, as the current malignancy
No pleural effusions, ascites, or leptomeningeal disease as the only manifestation of the current malignancy

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Granulocyte count ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9 g/dL
Serum bilirubin normal
Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) (≤ 4 times ULN for patients with liver or bone metastases)
AST and ALT ≤ 1.5 times ULN (≤ 5 times the ULN for patients with liver metastases)
Serum creatinine ≤ 1.5 mg/dL
INR < 1.3
aPTT ≤ 1.5 times ULN
Fasting total serum cholesterol ≤ 220 mg/dL (without cholesterol-lowering drugs)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able and willing to swallow pills
No malabsorption syndrome or other condition that would interfere with enteral absorption

No history of significant atherosclerotic disease, including the following:

Coronary artery disease (i.e., myocardial infarction within the past year or unstable angina)
Documented carotid atheromas
No history of congestive heart failure or ventricular arrhythmia requiring medication
No congenital long QT syndrome
No baseline QTc intervals > 0.47 seconds on two of three baseline 12-lead ECGs recorded during the screening period
No active infection requiring intravenous antibiotics
No known HIV infection
No uncontrolled hypocalcemia, hypomagnesemia, or hypokalemia, defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation
No history of clinically important liver disease, including cirrhosis or viral or other hepatitis
No current alcohol abuse
No significant traumatic injury within the past 3 weeks
No 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 study results or renders the patient at high risk from treatment complications

PRIOR CONCURRENT THERAPY:

At least 4 weeks since prior chemotherapy, investigational therapy, radiotherapy, or major surgical procedure and recovered
No concurrent medications with narrow therapeutic indices that are cytochrome P450 substrates (warfarin sodium [Coumadin®])

No concurrent medications known to prolong the QT interval, including any of the following:

Quinidine or other anti-arrhythmic agents
Haloperidol, fluoxetine, paroxetine, or sertraline
Pentamidine, fluoroquinolone, or macrolide antibiotics
No concurrent medications that may interfere with the metabolism of GDC-0449 (e.g., ketoconazole)
No concurrent grapefruit juice","Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00612508,NCT00612508_EG000,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)",oral contraceptive,ChEMBL:CHEMBL1533 | DrugBank:DB00304 | PubChem:40973,Desogestrel,[H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC(=C)[C@@]1([H])[C@@]2([H])CCC2=CCCC[C@@]21[H],G03AA09 | G03AB05 | G03AC09 | G03FB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00613015,NCT00613015_EG002,No,All,Adult | Older Adult,Phase 2,109,"Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.

Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) during the GCRC admission.

Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.

Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.

Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.

Subjects with any liver function test (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams and Dluhy 1987) and may affect drug metabolism.

Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.

Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.

Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in HPA axis function.

Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with HPA axis function within one month of the time of testing.

Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect HPA axis function.Participants taking SSRI's will be included.

Subjects required to take medications that could adversely interact with study medications, including, but not limited to, azole type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine. Any medications that induce or inhibit CYP3A4 pathways are excluded, as modafinil is metabolized through this enzyme system.

Subjects with any acute illness or fever as this may affect HPA axis activity. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.

Subjects who are grossly obese (BMI > 39), as this may interfere with HPA axis function.

Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to the stress task procedure.

Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.","Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00613015,NCT00613015_EG003,No,All,Adult | Older Adult,Phase 2,109,"Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.

Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) during the GCRC admission.

Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.

Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.

Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.

Subjects with any liver function test (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams and Dluhy 1987) and may affect drug metabolism.

Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.

Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.

Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in HPA axis function.

Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with HPA axis function within one month of the time of testing.

Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect HPA axis function.Participants taking SSRI's will be included.

Subjects required to take medications that could adversely interact with study medications, including, but not limited to, azole type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine. Any medications that induce or inhibit CYP3A4 pathways are excluded, as modafinil is metabolized through this enzyme system.

Subjects with any acute illness or fever as this may affect HPA axis activity. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.

Subjects who are grossly obese (BMI > 39), as this may interfere with HPA axis function.

Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to the stress task procedure.

Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.","Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00614445,NCT00614445_EG000,No,Female,Adult | Older Adult,Phase 3,133,"Inclusion Criteria:

The patient has signed a written informed consent to participate in the study and has agreed to follow dosing instructions and complete all required study visits.
The patient is a pregnant female age equal to or greater than 18 years old.
The patient's entry ultrasound indicates a viable pregnancy and confirms gestational age of the fetus is 7-14 weeks at the anticipated time of the first dose of study medication or placebo. If an ultrasound was done within 4 weeks of the admission visit, and results can be obtained, an additional ultrasound is not necessary.
The patient is suffering from NVP and has a Pregnancy Unique Quantification of Emesis (PUQE) score ≥6.
The patient has not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.
The patient agrees, if on a multivitamin, to continue on their current dose of multivitamin for the duration of the trial.
The patient does not plan termination of the pregnancy.

Exclusion Criteria:

The investigator confirms the patient's nausea and vomiting is of etiology other than Nausea and Vomiting of Pregnancy (NVP).
The patient has gestational trophoblastic disease or multifetal gestation.
The patient has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, heart block, etc.).
The patient has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous 48 hours or plans to do so during the study .
The patient is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
The patient is taking multivitamins containing more than 10 mg of vitamin B6, or plans to do so during the study.
The patient is taking supplementary vitamin B6 in addition to any multivitamin preparation, or plans to do so during the study.
The patient is currently drinking any amount of alcohol.
The patient has any condition that might interfere with the conduct of the study.
The patient is likely to be unable to comply with study procedures because of inadequate cognitive skills.
The patient has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study.",Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet,PubChem:163685,Diclegis,CN(C)CCOC(C)(c1ccccc1)c1ccccn1.Cc1ncc(CO)c(CO)c1O.Cl.O=C(O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00615433,NCT00615433_EG001,No,All,Adult | Older Adult,Phase 3,118,"Inclusion Criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months",3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00618332,NCT00618332_EG000,No,All,Adult,Not Applicable,40,"Inclusion Criteria

Males and females between 18 and 60 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin or RAST test to grass, trees and/or ragweed antigen.
Symptomatic at time of entry into study.

Exclusion Criteria

Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
Use of any other investigational agent in the last 30 days.
Absence of nasal symptoms.
Smoking.
URI at the time of screening.","2 weeks of treatment

mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00618436,NCT00618436_EG000,No,All,Adult | Older Adult,Phase 4,52,"Inclusion Criteria:

Subjects with traumatic brain injury
Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
Hemodynamically stable with a systolic BP >90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age at least 18 years
Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
Subjects with subarachnoid hemorrhage (SAH)
SAH documented by CT scan
Hunt-Hess grade 3-5, inclusive
Hemodynamically stable with a systolic BP> 90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age of at least 18 years
Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

No venous access
Spinal cord injury
History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
Hemodynamically unstable
Suspected anoxic events
Other peripheral trauma likely to result in liver failure
Positive pregnancy test in females
Age less than 18 years of age
Known hypersensitivity to any anticonvulsant
An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
Inability to obtain signed informed consent or HIPAA authorization for research.",This group will receive treatment with Levetiracetam.,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00624195,NCT00624195_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,29,"Inclusion Criteria:

HIV infected- confirmed by ELISA or 2 prior viral loads >2000
18 years or older
Under consideration to initiate or change their HAART regimens (based on current consensus treatment guidelines) as directed by their primary care physicians.
Measurable HIV Neurocognitive Impairment (HNCI)
Willing and able to undergo at least 3 lumbar punctures safely during the course of the study.
Potential subjects must have a Karnofsky score of > or = to 60 within 60 days prior to study entry.
Potential subjects must have a CD4 cell count obtained within 60 days prior to study entry.

Exclusion Criteria:

Presence of serious illness, including HIV-related opportunistic infections, requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Presence of neurologic disorders other than HIV judged to be the principal cause of neurocognitive impairment.
Presence of active, severe psychiatric disorders (e.g., major depression, schizophrenia) that would interfere with interpretation of the study evaluations or adherence to the study protocol or that might make their participation in the study problematic or unsafe.
Presence of active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Use of any immunomodulator (interferons, interleukins, cyclosporine), vaccine, or investigational therapy including dexamethasone within 30 days prior to study entry.
Inability to provide informed consent.
Enrollment in other ARV treatment studies, unless the study is: 1) observational; 2) a compassionate use study that predated the current study; 3) one that does not require specific interventions (or one that does not dictate the regimen); or 4) one that does not include NP testing.
A positive serum or urine pregnancy test, if female and of reproductive potential.","CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).",ChEMBL:CHEMBL584 | DrugBank:DB00220 | PubChem:64143,Nelfinavir,[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2,J05AE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00624195,NCT00624195_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,30,"Inclusion Criteria:

HIV infected- confirmed by ELISA or 2 prior viral loads >2000
18 years or older
Under consideration to initiate or change their HAART regimens (based on current consensus treatment guidelines) as directed by their primary care physicians.
Measurable HIV Neurocognitive Impairment (HNCI)
Willing and able to undergo at least 3 lumbar punctures safely during the course of the study.
Potential subjects must have a Karnofsky score of > or = to 60 within 60 days prior to study entry.
Potential subjects must have a CD4 cell count obtained within 60 days prior to study entry.

Exclusion Criteria:

Presence of serious illness, including HIV-related opportunistic infections, requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Presence of neurologic disorders other than HIV judged to be the principal cause of neurocognitive impairment.
Presence of active, severe psychiatric disorders (e.g., major depression, schizophrenia) that would interfere with interpretation of the study evaluations or adherence to the study protocol or that might make their participation in the study problematic or unsafe.
Presence of active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Use of any immunomodulator (interferons, interleukins, cyclosporine), vaccine, or investigational therapy including dexamethasone within 30 days prior to study entry.
Inability to provide informed consent.
Enrollment in other ARV treatment studies, unless the study is: 1) observational; 2) a compassionate use study that predated the current study; 3) one that does not require specific interventions (or one that does not dictate the regimen); or 4) one that does not include NP testing.
A positive serum or urine pregnancy test, if female and of reproductive potential.","Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.",ChEMBL:CHEMBL584 | DrugBank:DB00220 | PubChem:64143,Nelfinavir,[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2,J05AE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00625846,NCT00625846_EG001,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Histologically or cytologically confirmed differentiated, medullary or anaplastic thyroid cancer that is now advanced or metastatic; NOTE: patients with thyroid lymphomas or sarcomas are specifically excluded, as are patients with metastatic disease from other sites of origin to thyroid
Patients with confirmed differentiated thyroid cancer to be enrolled in the expanded/additional differentiated thyroid cancer (DTC) cohort must be thyroglobulin antibody negative
Zero, one or two prior therapeutic regimens (this includes cytotoxic plus non-cytotoxic therapeutic regimens)
Absence of sensitivity to therapeutic radioiodine (differentiated only)
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; NOTE: disease that is measurable by physical examination only is not eligible
Life expectancy > 3 months
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 (Karnofsky >= 60%)
Leukocytes > 3,000/mcL obtained =< 7 days prior to registration
Absolute neutrophil count > 1,500/mcL obtained =< 7 days prior to registration
Platelets > 100,000/mcL obtained =< 7 days prior to registration
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) obtained =< 7 days prior to registration (if there is reason to believe that the patient has Gilbert's syndrome, the bilirubin can be fractionated; if the fractionated bilirubin is consistent with Gilbert's syndrome and there is no other possible explanation for the elevated indirect bilirubin, the patient may be eligible for the study if and only if the direct bilirubin is =< 1.5 X institutional ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 X institutional ULN obtained =< 7 days prior to registration
Creatinine =< 1.5 X ULN obtained =< 7 days prior to registration
Proteinuria =< + on urinalysis (may re-check) obtained =< 7 days prior to registration
International normalized ratio (INR) =< 1.2 X the ULN obtained =< 7 days prior to registration
Blood pressure (BP) < 140 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 < 140/90 mmHg

Objective evidence of tumor progression in the 6 month period prior to GW786034 initiation as assessed by:

Unequivocal progression of objectively measured disease on successive appropriate imaging (e.g. CT scan); in cases of uncertainty of tumor progression, the principal investigator of the study will be available to assist in decisions
Women of child-bearing potential must have a negative serum pregnancy test =< 7 days prior to registration; NOTE: 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 participating in this study, she should inform her treating physician immediately; effective contraception is required for all fertile participants in the trial
Ability to understand and the willingness to sign a written informed consent document
Willingness to comply with the requirement of the study
Willingness to donate blood for correlative marker studies; (only applicable to sites within the United States)

Exclusion Criteria:

Anaplastic, differentiated, medullary: a total of > 2 prior therapeutic regimens (this total includes cytotoxic plus non-cytotoxic regimens); Note: enrollment of anaplastic, differentiated, and medullary patients who have had zero, one or two prior therapeutic regimens (cytotoxic plus non-cytotoxic regimens) is allowed - provided therapy ceased > 21 days prior to registration;

NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon prior therapies
Disease that is measurable by physical examination only

Any of the following:

Radiotherapy =< 4 weeks prior to registration
Major surgery =< 4 weeks prior to registration
Radiotherapy to >= 25% of bone marrow
Concurrent therapy with octreotide unless tumor progression on this therapy has been demonstrated
Any other ongoing investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW786034 (pazopanib) or other agents used in the study
> +1 proteinuria (< 30 mg/dL) on two consecutive dipstick or other urine assessments taken at least 1 week apart; NOTE: (in cases where questions arise related to disparate proteinuria measurements, the study principal investigator [PI] should be consulted for assistance in determining patient study eligibility)
Corrected QT interval (QTc) prolongation (defined as a QTc interval >= 480 msecs) or other significant electrocardiogram (ECG) abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon ECG changes
Receiving cytochrome P450 (CYP) interactive concomitant medications; certain medications that act through the CYP450 system are specifically prohibited in patients receiving GW786034 (pazopanib) because in vitro data indicate that the agent has the potential to interact with the cytochrome P450 isoenzymes cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); certain other agents should be used with caution
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 and retain GSK786034 (pazopanib)

Any of the following conditions:

Serious or non-healing wound, ulcer, or bone fracture
History of abdominal fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess or gastrointestinal tract bleeding =< 28 days of registration
Any history of cerebrovascular accident (CVA) =< 6 months
Current use of therapeutic warfarin; Note: low molecular weight heparin and prophylactic low-dose warfarin (INR < 1.2 X ULN) are permitted; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria
History of myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty or stenting within the last 12 weeks
History of venous thrombosis in last 12 weeks
Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; NOTE: a patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
History of bleeding disorder, including patients afflicted with hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding
Poorly controlled depression or anxiety disorder, or recent (=< 6 months) suicidal ideation
Known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g. corticosteroids); NOTE: (because of the poor prognosis often associated with brain metastases and because of the potential risk of bleeding in active brain metastases associated with multi-targeted tyrosine kinase inhibitor therapy, patients with active and/or untreated brain metastases and/or those with brain metastases requiring ongoing therapy - e.g. corticosteroids - are excluded from trial enrollment; enrollment will, however, be permitted in cases of patients with longstanding treated and inactive brain metastases not requiring ongoing therapy, providing that stability of brain metastases has been demonstrated for a period of 3 months or greater as assessed by intracranial imaging - and providing that there is no indication of increased vascularity of the treated metastases by magnetic resonance imaging (MRI) imaging conducted =< 14 days prior to registration; when questions arise related to these criteria, the PI of the trial, Dr. Keith Bible, should be contacted for assistance on eligibility)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would or might reasonably be expected to limit compliance with study requirements
Pregnant women; NOTE: (breastfeeding should be discontinued if the mother is treated with GW786034/pazopanib)
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy; NOTE: (appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated)
Receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of GW786034 (pazopanib); NOTE: the eligibility of patients will be determined following review of their case by the principal investigator; efforts should be made to switch patients who are taking enzyme-inducing anticonvulsant agents to other medications
Receiving any concomitant medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes; NOTE: these medications should be discontinued or replaced with drugs that do not carry these risks, if possible",Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.,PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00632632,NCT00632632_EG000,No,All,Adult | Older Adult,Not Applicable,25,"Inclusion Criteria:

English-speaking adults
Between the ages of 18 and 70
Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
Diagnosed with PTSD symptoms.

Exclusion Criteria:

Presence of current organic mental disorder
Schizophrenia
Bipolar disorder
Depression with psychotic features
Current substance dependence
Delusional disorder
Active suicidal ideation, intent, or plan
Active homicidal ideation, intent, or plan
Use of pacemaker
Medically unstable
Pregnant or lactating
A history of severe renal disease
History of seizures
Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
History of allergic reaction to cycloserine.",D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times),ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00633256,NCT00633256_EG000,No,All,Adult,Not Applicable,20,"Inclusion Criteria:

female and male smokers, aged 18 to 55 years;
history of smoking daily for the past 12 months, at least 10 cigarettes daily;
CO level > 10ppm;
for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods other than OCP;
Non-treatment seeking nicotine dependent smokers.

Exclusion Criteria:

history of heart disease, renal or hepatic diseases or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
current dependence on alcohol or on drugs other than nicotine;
regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
allergy to cycloserine;
subjects with epilepsy or a history of seizures;
Treatment seeking nicotine dependent smokers.",50 mg cycloserine,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00634842,NCT00634842_EG000,No,All,Adult | Older Adult,Phase 4,121,"Inclusion Criteria:

Type 2 diabetes
1-3 oral treatments
Insulin naive
BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

Pregnancy
Retinopathy
Cardiac disease
Uncontrolled hypertension
Recurrent hypoglycaemia",Aggressive FPG (fasting plasma glucose) titration target range group,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00634842,NCT00634842_EG001,No,All,Adult | Older Adult,Phase 4,122,"Inclusion Criteria:

Type 2 diabetes
1-3 oral treatments
Insulin naive
BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

Pregnancy
Retinopathy
Cardiac disease
Uncontrolled hypertension
Recurrent hypoglycaemia",Conventional FPG (fasting plasma glucose) titration target range group,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00640146,NCT00640146_EG000,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Male and female participants greater than or equal to (>=) 18 years of age.
Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
Participants must be acutely constipated following their orthopedic procedure.
Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
Participants must sign an informed consent form.
Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).

Exclusion Criteria:

Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
Participants who received any investigational new drug (experimental) in the previous 30 days.
Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose.
Participants with constipation not attributed to post procedure opioids.
Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
Female participants who are pregnant or lactating.
Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.","Participants received MNTX 12 mg SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant was enrolled.",PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00646646,NCT00646646_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,65,"Inclusion Criteria:

Healthy, human volunteers, age 19-65.
American Society of Anesthesiology (ASA) class I-II for inclusion criteria

Exclusion Criteria:

Pregnancy
Respiratory disease (severe asthma, emphysema)
Cardiac disease (coronary artery disease, congestive heart failure)
Symptomatic reflux disease
Advanced rheumatic disease involving cervical spine
Propofol or egg allergy
Neurological disease (stroke, intracranial processes)
Severe anemia","sedative

dexmedetomidine : Sedative",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00654329,NCT00654329_EG001,Accepts Healthy Volunteers,All,Child,Phase 4,1,"Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

The subject is 6 months to 6 years of age
The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
The subject is scheduled for elective bilateral myringotomy with tube placement

The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

Subjects will be excluded from study participation if any of the following exclusion criteria exists:

The subject has a history or a family (parent or sibling) history of malignant hyperthermia
The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
The subject has know central nervous system disease or neurological impairment
The subject is an ASA classification of 3 or greater (See Appendix 1)
The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
The subject refuses inhalation induction
The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)",Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00655733,NCT00655733_EG000,No,All,Adult | Older Adult,Phase 2,51,"Inclusion Criteria:

Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen

Exclusion Criteria:

They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication",Subjects who fulfilled all entry criteria and randomized HMPL-004 arm will receive HMPL-004 400 mg 3 times daily 3 times daily for 56 days (8 weeks) with a 28-day (4-week) follow-up.,DrugBank:DB05767 | PubChem:5318517,Andrographolide,[H][C@]12CCC(=C)[C@@H](C/C=C3/C(=O)OC[C@H]3O)[C@]1(C)CC[C@@H](O)[C@@]2(C)CO,,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
NCT00659165,NCT00659165_EG000,No,All,Adult,Not Applicable,10,"Inclusion Criteria:

Type 1 diabetes
Treated with long-acting and meal time insulin therapy for at least 2 years
Ages 18 to 60 years of age
Glycosylated hemoglobin value between 7 - 9 mg/dL
C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.

Exclusion Criteria:

Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
Pregnancy
Alcohol or drug abuse or dependence within three months of study entry
Less than 50 % agreement on 50-item Food Questionnaire with the Food Array ""buffet style"" study meal.
Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.","These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.",ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00671060,NCT00671060_EG000,No,Female,Child | Adult | Older Adult,Phase 3,77,"Inclusion Criteria:

Women presents with spontaneous fetal death
Gestational age of fetus between 14-28 weeks

Exclusion Criteria:

Transmural uterine scar;
Allergies or other contraindications to use of misoprostol;
Placental abruption with active hemorrhage;
Complete placenta previa;
Extreme uterine structural anomalies;
Or other contraindications to vaginal delivery of the fetus;
Presentation in active labor (moderate to severe contractions every 10 minutes); or
Four or more previous deliveries","Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00671060,NCT00671060_EG001,No,Female,Child | Adult | Older Adult,Phase 3,76,"Inclusion Criteria:

Women presents with spontaneous fetal death
Gestational age of fetus between 14-28 weeks

Exclusion Criteria:

Transmural uterine scar;
Allergies or other contraindications to use of misoprostol;
Placental abruption with active hemorrhage;
Complete placenta previa;
Extreme uterine structural anomalies;
Or other contraindications to vaginal delivery of the fetus;
Presentation in active labor (moderate to severe contractions every 10 minutes); or
Four or more previous deliveries","Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00674570,NCT00674570_EG001,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","D-Cycloserine

D-Cycloserine: 50 mg/oral one hour prior to extinction task",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00680407,NCT00680407_EG000,No,All,Adult | Older Adult,Phase 2,26,"Inclusion Criteria:

Age at least 18 years at screening.
Informed consent signature.
AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than 40 IU/L within one year of screening and at least once during the screening period.
The participant must agree to adhere to the alcohol consumption guidelines.
Have a liver biopsy performed within 12 months of randomization demonstrating features consistent with NASH without cirrhosis; NAS score of at least 4. Historical biopsy must include one Trichrome and one H&E slide, otherwise the biopsy must be redone.
No change in diabetic medications or insulin sensitizers (if applicable) between biopsy and screening or during the screening period.
Weight loss/gain of no more than 10% between biopsy and screening, or within 30 days of screening if the biopsy is performed during the screening period.
Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study medication. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on study drug and during follow-up).

Exclusion Criteria:

Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. A multivitamin at standard doses will be allowed.
Use of silymarin or other antioxidants or non-prescribed complementary alternative medications (as above) during the screening period or patient unwilling to refrain from taking these medications through completion of the study.
BMI > 45 kg/m2 between screening and randomization.
Type 2 diabetes treated with oral agents other than the secretagogues or metformin; these include, thiazolidinediones, alpha-glucosidase inhibitors, exenatide, pramlintide between screening and randomization. Januvia (sitagliptin) is allowed.
Evidence of poorly-controlled diabetes (defined as HbA1c > 8% in patients with diabetes) between screening and randomization.
Known allergy/sensitivity to milk thistle or its preparations.
Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the 1 year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens at doses greater than those used for hormone replacement, valproate/valproic acid.
For patients using antihyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose from screening through randomization.
Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) from screening through randomization.
Lactose intolerance defined as patient reported inability to tolerate milk products.
History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s).
Previous liver biopsy that demonstrated presence of cirrhosis.
Radiologic imaging consistent with cirrhosis or portal hypertension.
Clinical or histological evidence of cirrhosis or, in the opinion of the investigator, the inability to safely obtain a liver biopsy due to technical reasons, such as body habitus.
Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dl, total bilirubin > 1.5 mg/dl, or PT/INR (Prothrombin Time/International Normalized Ratio) > 1.3 times normal at screening, or history or presence of ascites or encephalopathy, or bleeding from esophageal varices.
Platelet count < 130,000/mm3 at screening.
Serum creatinine of 2.0 mg/dL or greater or CrCl ≤ 60cc/min, or on dialysis, at screening. The creatinine clearance (CrCl) will be calculated according to Cockcroft-Gault.
Average alcohol consumption of more than one drink or equivalent (>12 grams) per day or more than two (2) drinks on any one day over the 30 days prior to screening. Patients who met either criterion more than 30 days prior to screening must have consumed a monthly average of 12 grams or less per day of alcohol for at least six months prior to screening.
Evidence of drug abuse in the year prior to screening or prior to randomization.
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers of inflammation.
History of solid organ or bone marrow transplantation.
History of thyroid disease poorly controlled on prescribed medications.
Use of oral steroids for more than 14 days within 30 days of screening or prior to randomization.
Primary hepatic malignancy.
Secondary hepatic malignancy (metastatic disease) or extrahepatic malignancy.
Women with ongoing pregnancy or breast feeding, or contemplating pregnancy.
History of bariatric surgery, or undergoing evaluation for bariatric surgery.
Participation in a research drug trial, exclusive of the SyNCH Phase I trial, within 30 days of screening.
History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
Inability or unwillingness to give informed consent or abide by the study protocol.","420 mg Legalon (silymarin) three times daily

Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period",ChEMBL:CHEMBL9509 | DrugBank:DB09298 | PubChem:124304713 | PubChem:1548994 | PubChem:1549163 | PubChem:24832061 | PubChem:3086637 | PubChem:31553 | PubChem:45933924 | PubChem:5213 | PubChem:5748849 | PubChem:6610285,Silibinin,COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O,A05BA03,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00680407,NCT00680407_EG001,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Age at least 18 years at screening.
Informed consent signature.
AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than 40 IU/L within one year of screening and at least once during the screening period.
The participant must agree to adhere to the alcohol consumption guidelines.
Have a liver biopsy performed within 12 months of randomization demonstrating features consistent with NASH without cirrhosis; NAS score of at least 4. Historical biopsy must include one Trichrome and one H&E slide, otherwise the biopsy must be redone.
No change in diabetic medications or insulin sensitizers (if applicable) between biopsy and screening or during the screening period.
Weight loss/gain of no more than 10% between biopsy and screening, or within 30 days of screening if the biopsy is performed during the screening period.
Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study medication. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on study drug and during follow-up).

Exclusion Criteria:

Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. A multivitamin at standard doses will be allowed.
Use of silymarin or other antioxidants or non-prescribed complementary alternative medications (as above) during the screening period or patient unwilling to refrain from taking these medications through completion of the study.
BMI > 45 kg/m2 between screening and randomization.
Type 2 diabetes treated with oral agents other than the secretagogues or metformin; these include, thiazolidinediones, alpha-glucosidase inhibitors, exenatide, pramlintide between screening and randomization. Januvia (sitagliptin) is allowed.
Evidence of poorly-controlled diabetes (defined as HbA1c > 8% in patients with diabetes) between screening and randomization.
Known allergy/sensitivity to milk thistle or its preparations.
Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the 1 year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens at doses greater than those used for hormone replacement, valproate/valproic acid.
For patients using antihyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose from screening through randomization.
Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) from screening through randomization.
Lactose intolerance defined as patient reported inability to tolerate milk products.
History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s).
Previous liver biopsy that demonstrated presence of cirrhosis.
Radiologic imaging consistent with cirrhosis or portal hypertension.
Clinical or histological evidence of cirrhosis or, in the opinion of the investigator, the inability to safely obtain a liver biopsy due to technical reasons, such as body habitus.
Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dl, total bilirubin > 1.5 mg/dl, or PT/INR (Prothrombin Time/International Normalized Ratio) > 1.3 times normal at screening, or history or presence of ascites or encephalopathy, or bleeding from esophageal varices.
Platelet count < 130,000/mm3 at screening.
Serum creatinine of 2.0 mg/dL or greater or CrCl ≤ 60cc/min, or on dialysis, at screening. The creatinine clearance (CrCl) will be calculated according to Cockcroft-Gault.
Average alcohol consumption of more than one drink or equivalent (>12 grams) per day or more than two (2) drinks on any one day over the 30 days prior to screening. Patients who met either criterion more than 30 days prior to screening must have consumed a monthly average of 12 grams or less per day of alcohol for at least six months prior to screening.
Evidence of drug abuse in the year prior to screening or prior to randomization.
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers of inflammation.
History of solid organ or bone marrow transplantation.
History of thyroid disease poorly controlled on prescribed medications.
Use of oral steroids for more than 14 days within 30 days of screening or prior to randomization.
Primary hepatic malignancy.
Secondary hepatic malignancy (metastatic disease) or extrahepatic malignancy.
Women with ongoing pregnancy or breast feeding, or contemplating pregnancy.
History of bariatric surgery, or undergoing evaluation for bariatric surgery.
Participation in a research drug trial, exclusive of the SyNCH Phase I trial, within 30 days of screening.
History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
Inability or unwillingness to give informed consent or abide by the study protocol.","700 mg of Legalon (silymarin) three times daily

Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period",ChEMBL:CHEMBL9509 | DrugBank:DB09298 | PubChem:124304713 | PubChem:1548994 | PubChem:1549163 | PubChem:24832061 | PubChem:3086637 | PubChem:31553 | PubChem:45933924 | PubChem:5213 | PubChem:5748849 | PubChem:6610285,Silibinin,COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O,A05BA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00680706,NCT00680706_EG000,No,All,Adult | Older Adult,Phase 2,131,"Inclusion Criteria:

History of heart failure on a loop diuretic.
Worsening dyspnea over the past 24 hours.
Currently dyspneic sitting or supine, on or off oxygen.
Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
Elevated NT pro-BNP (>450).
Able to communicate in English or Spanish.
Able and willing to provide informed consent.
Age > 18 years.
A primary admitting diagnosis of acute decompensated heart failure.

Exclusion Criteria:

Renal failure on dialysis.
Severe valvular disease.
EKG criteria for acute myocardial infarction (ST segment elevation > 1mm on two contiguous leads).
Initial troponin elevated.
Ventricular arrhythmia (ventricular tachycardia or fibrillation).
Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute.
Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable
Taking a daily fatty acid supplement.
Pregnancy as determined by standard serum or urine b-HCG assay.",Receives thiamine,ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00681265,NCT00681265_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,16,"Inclusion Criteria:

Age > 18 years
symptoms of dry eye
no other history of ophthalmic problems

Exclusion Criteria:

Use of any ocular lubricant or ointment in the past 36 hours
use of contact lenses or excessive eye lid cosmetics on the study day",One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.,ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00687102,NCT00687102_EG001,Accepts Healthy Volunteers,Female,Older Adult,Phase 3,1498,"Inclusion Criteria:

Women enrolled in STAR trial at a site participating in Co-STAR
65 years of age or older
Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year
Have not been diagnosed with dementia
Have signed a separate consent document for the Co-STAR Study
Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion Criteria:

Not enrolled in the STAR Trial
Younger than 65 years of age
Diagnosed with dementia","Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years",ChEMBL:CHEMBL81 | DrugBank:DB00481 | PubChem:5035,Raloxifene,O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12,G03XC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00687531,NCT00687531_EG000,No,All,Child | Adult | Older Adult,Phase 4,385,"Inclusion Criteria:

Willingness to participate and comply with procedures by signing a written informed consent
12 years of age or older of either gender and any race
Women of childbearing potential (includes women who are less than 1 year postmenopausal and currently are or will become sexually active during the study) must be using or agree to use an acceptable method of birth control unless they are surgically sterilized
Must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, PEFR values, medication times, and concomitant medications accurately and consistently in a daily diary.
Diagnosed history of mild-moderate persistent asthma for at least 12 months.
FEV1 must be >60% of predicted normal or personal best FEV1 during the last 12 months.
Using daily inhaled corticosteroids for at least 30 days prior to Screening. In the Screening Visit patients FEV1 should be >= 65% to <= 90% predicted.
Asthma Symptom Total daily (AM+PM) severity score at Screening Visit should be <= 2.
For two weeks prior to Screening, subjects must have been on a stable regimen of one of the following twice daily regimen: fluticasone propionate (FP) >= 100 - <= 500 mcg/day; budesonide (BUD) >= 200 - <= 1000mcg/day; beclomethasone dipropionate (BDP) >= 200 - <= 1000 mcg/day; triamcinolone acetonide (TA) >= 400 - <= 2000 mcg/day
During the inhaled corticosteroid (ICS) Dose Reduction period (max. of 4 weeks; min. of 1 week) of sequential ICS Dose Reduction (approximately 50% reduction in daily dose or discontinue according treatment scheme), subjects must demonstrate a measurable loss of asthma control, with both A) Decreased Lung Function (from the Screening value in absolute FEV1 of >= 10% or >= 220ml OR a decrease in AM PEFR of 25% from the average value for the pre-ICS Dose Reduction period on at least 2 consecutive days out of the last 7 days) AND B) Increased Symptoms (Total AM and PM symptom score of >= 10 out of 24 (using 0-3 scale for each of 4 individual symptoms) on at least 2 days out of the last 7 days OR Increased use of rescue medication from the average value for the pre-ICS Dose Reduction period (one week) of >= 2 puffs on at least 2 days out of the last 7 days)
Once criterion above have been fulfilled, subjects can be initiated if the FEV1 is 60%-80% predicted
Subjects must agree to inform their usual treating physicians of their participation in this study

Exclusion Criteria:

Females who are pregnant or breast-feeding.
Subjects who have not observed the designated washout periods for any of the prohibited medications
Subjects who have used any investigational product within 30 days or any antibodies for asthma or allergic rhinitis in the past 90 days prior to enrollment.
Subjects who have any clinically significant deviation from normal in the physical examination that may interfere with the study evaluations or affect subject safety.
Subjects who have required systemic steroids within the previous month.
Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.
Subjects who have required inpatient hospitalization for asthma control within the previous 3 months, or more than once in the previous 6 months.
Subjects with clinical evidence of chronic obstructive pulmonary disease or lung diseases other than asthma.
Subjects who have experienced an upper or lower respiratory tract infection within the previous 2 weeks prior to the Screening Visit.
Subjects with evidence of clinically significant oropharyngeal candidiasis
Subjects with any clinically significant immunologic, metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which may interfere with the study evaluations or affect subject safety.
Subjects with a history of drug abuse, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study",Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00690235,NCT00690235_EG000,No,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
Volunteers will have a current BMI=>27 but equal to or less than 40.
Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.
Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.
Able and willing to give informed consent.

Exclusion Criteria:

Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study

Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines
Any patient with current diabetes mellitus, even if caused by antipsychotic use .
Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.
Any patients with medical disorders that are not properly controlled by medications.
Pregnant women or women who are breast feeding.
Patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.
Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits.
Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels.
Any patient judged by the principal investigator to be inappropriate for the study.
Known hypersensitivity to study medication or its components

Non-English speaking

The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.","volunteers are given 180mg of pramlintide, twice daily

Pramlintide: 180mg subcutaneous injections, twice daily",ChEMBL:CHEMBL2103758 | DrugBank:DB01278,PRAMLINTIDE,[H]N[C@@H](CCCCN)C(=O)N[C@H]1CSSC[C@@H](C(=O)N[C@@H](C)C(=O)N[C@]([H])(C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](Cc2cnc[nH]2)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)NCC(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(C)C)C(=O)N2CCC[C@H]2C(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@]([H])(C(=O)N[C@@H](Cc2ccc(O)cc2)C(N)=O)[C@@H](C)O)C(C)C)[C@@H](C)O)[C@@H](C)CC)C(C)C)[C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](CC(N)=O)NC1=O,A10BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00690794,NCT00690794_EG000,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:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00691054,NCT00691054_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
Patients have to be 18 years-old or older
Able to give signed Informed consent

Adequate end-organ function with laboratory parameters as follows:

Neutrophils: 1.5 x10^9/L or greater
Plts: 100 x10^9/L or greater
Hemoglobin: ≥ 9.0g/dL
Serum Creatinine: ≤ 1.5mg/dL
Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
Measurable or non-measurable disease by RECIST criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
Life expectancy greater than 3 months
Willing and able to comply with the protocol requirement.
Patients must not have any peripheral neuropathy equal or greater than grade 2

Exclusion Criteria:

Chemotherapy within 3 weeks prior to enrollment
Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
Any major surgery within 4 weeks prior to enrollment
Peripheral neuropathy equal to or greater than grade 2
Clinical AIDS or known positive HIV serology
Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction within 3 months
History of stroke within 3 months
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
Pregnant (positive pregnancy test) or lactating
Inability to comply with study and/or follow-up procedures
Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.","Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00692237,NCT00692237_EG000,No,Male,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Patients with type 2 diabetes mellitus
Patients age 35-75
Metabolic control of diabetes by diet or oral treatment (unmodified in the last 3 months)
Blood pressure <160/100 mmHg, including subjects with controlled hypertension, treated with ACE-inhibitors/sartans, unmodified in the last 3 months

Exclusion Criteria:

Participation in another study with an investigational drug or device
HbA1c >12%
Alterations during ECG stress examination
Current use of nitrate agents
Proliferative retinopathy
Patients with history of cardiovascular and malignant disease
Psychosocial disturbance
Alcohol or drug dependence
Allergy or hypersensitivity to sildenafil or other Phosphodiesterase inhibitors.",Sildenafil citrate 100 mg/day (50+25+25),ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00693485,NCT00693485_EG002,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Primary open-angle glaucoma in one eye
Visual acuity 20/80 or better
Intraocular pressure in the study eye ≤ 24 mm Hg
Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

Known allergy to brimonidine tartrate
Uncontrolled systemic disease or infection of the eye
Recent eye surgery or injections in the eye
Female patients who are pregnant, nursing or planning a pregnancy",Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00694707,NCT00694707_EG001,No,All,Adult,Phase 2,145,"Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.",Participants received cariprazine 1.5 mg orally once a day for 6 weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00694707,NCT00694707_EG002,No,All,Adult,Phase 2,146,"Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.",Participants received cariprazine 3.0 mg orally once a day for 6 weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00694707,NCT00694707_EG003,No,All,Adult,Phase 2,147,"Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.",Participants received cariprazine 4.5 mg orally once a day for 6 weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00705757,NCT00705757_EG002,No,All,Adult | Older Adult,Phase 4,28,"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 Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00708422,NCT00708422_EG000,No,All,Adult | Older Adult,Phase 4,116,"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:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00709202,NCT00709202_EG000,No,All,Adult,Phase 2,19,"Inclusion Criteria:

Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder
Patients will be currently treated with antipsychotics

Patients will qualify for entry if they meet the following weight criteria:

The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.

The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.

.

Exclusion Criteria:

Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.","Subjects assigned to this arm will receive Betahistine.

Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.",DrugBank:DB06698 | PubChem:2366,Betahistine,CNCCc1ccccn1,N07CA01,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00712985,NCT00712985_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 3,18,"Inclusion Criteria:

Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).
Calculated creatinine clearance > 40 ml/min
Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.
Urine NTx > 50 nano moles(nM)based on second morning void.
Signed informed consent.
Ambulatory patients at least 18 years of age.
Eastern Cooperative Oncology Group (ECOG)0-2.
Ability to comply with trial requirements.

Exclusion Criteria:

Bone Metastases.
Any woman of child bearing potential.
Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
Calculated creatinine clearance less than 30 mL/min at screening.
Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL).
Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN).
Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to bisphosphonates.
Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).
History of uveitis or iritis, except when secondary to trauma, and must have resolved > 2 years prior to entry.
A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
Previous major solid organ transplant recipient or on a transplant waiting list.
Treatment with any investigational drug within 30 days prior to randomization.
History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis.
Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months.
Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.
Prior treatment with IV bisphosphonates within the last 2 years.
Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*). *NOTE: If used less than 8 weeks, the washout period is 6 months.
Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
Any treatment with strontium ranelate, samarium, sodium fluoride or parathyroid hormone.
Use of systemic high dose corticosteroids at an average dose of > 7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
Known hypersensitivity to zoledronic acid or other bisphosphonates.
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).",Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00715429,NCT00715429_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,7,"Inclusion Criteria:

One or more prescription for quinine at the Madison VA in the last 5 years, or else be a UWHC (U Wisconsin Health Clinics) patient whose UWHC medication list had quinine listed in the last five years
At least 50 years of age, with women being past menopause. This is defined as the woman reporting no periods in the last 12 consecutive months or longer.
Leg cramps listed in medical record,
Ability & willingness to give informed consent,
Stable estimated Glomerular filtration rate (GFR)>35 ml/min for the prior 6 mos,
No change in diuretic therapy in last 3 months,
Stable pattern of two or more cramps per week for past three months,
Ability to complete daily diary entry,
Post-consent: serum 25-OH of 20-45 ng/mL, albumin- corrected calcium <10.3 mg/dL, and urine calcium/creatinine ratio <0.25.

Exclusion Criteria:

Not receiving primary care at Madison VAMC, or at UWHC
Hyperparathyroidism (1°, 2°, or 3°),
Osteomalacia ,
Paget's disease,
Metastatic cancer,
Taking vitamin D 50,000 units capsules,
Serum Ca++ >10.3 mg/dL in subject chart,
Sarcoidosis or tuberculosis, and
Peripheral vascular disease or other condition confounding assessment of cramps.","Vitamin D arm

vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00718861,NCT00718861_EG000,No,Female,Older Adult,Phase 3,92,"Inclusion Criteria:

Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

Poor kidney, eye, liver health
Use of certain therapies for osteoporosis in study CZOL446H2301E1
Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply",Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00720382,NCT00720382_EG001,No,All,Child | Adult | Older Adult,Phase 3,237,"Inclusion Criteria:

Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
Must be willing and able to provide informed consent and to participate in all study procedures
Must be in generally good health
Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Use of any investigational drug within 30 days of the first visit
Any nasal surgery or sinus surgery within the previous year
Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
Women who are pregnant or nursing
Women who are not using an acceptable method of birth control
Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
Patients with Arrythmia
Patients with know history of alcohol and drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
Use of medications that could affect the study results",Mometasone furoate 200 mcg,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00728416,NCT00728416_EG000,No,All,Child | Adult | Older Adult,Phase 3,333,"Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.",Mometasone furoate nasal spray 200 mcg QD (once per day),ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00730912,NCT00730912_EG000,No,All,Child | Adult,Phase 4,53,"Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration",Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days,ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00730912,NCT00730912_EG001,No,All,Child | Adult,Phase 4,104,"Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration",Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days,ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00730912,NCT00730912_EG002,No,All,Child | Adult,Phase 4,104,"Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration",Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days,ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00732381,NCT00732381_EG000,No,All,Child | Adult | Older Adult,Phase 3,351,"Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.",Mometasone furoate nasal spray 200 mcg QD (once per day),ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00733005,NCT00733005_EG000,No,All,Child | Adult | Older Adult,Phase 3,324,"Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.",Mometasone furoate nasal spray 200 mcg QD (once per day),ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00738049,NCT00738049_EG000,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF.
Subjects must be greater than 18 years of age.
Female subjects must be surgically sterile or documented as post-menopausal for at least 2 years.
Subjects must have documented coronary artery disease as evidenced by previous myocardial infarction, interventional procedure, significant stenosis by cardiac catheterization, or an abnormal perfusion study.
Subjects must have an abnormal PET scan.

Exclusion Criteria:

Subjects with acute heart failure
Subjects with sustained or symptomatic hypotension (SBP 90 mmHg)
Subjects with uncontrolled hypertension (SBP of 170 mmHg or DBP of 100 mmHg) at Screening
Subjects with unstable angina pectoris
Subjects with acute myocardial infarction, stroke, transient ischemic attack, or coronary angioplasty within the last 6 months
Subjects with primary valvular disease
Subjects with significant vascular aneurysm
Subjects with a documented history of renal failure
Subjects with liver disease (total bilirubin 3 mg/dL or serum ALT or AST >2X ULN)
Subjects with active malignancy
Subjects with a fatal non-cardiovascular disease that they are expected to succumb to within 1 year
Female subjects that are pregnant or lactating
Female subjects with the potential for child-bearing
Female subjects being treated with hormone therapies
Subjects with uncontrolled diabetes mellitus
Subjects with diabetes with gastro paresis or severe neuropathy
Subjects with a history of substance abuse within the last 2 years
Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
Subjects with known hypersensitivity or allergy to L-arginine, aminophylline, adenosine, or dipyridamole
Subjects who have a planned surgical procedure during the course of the study
Subjects taking herbal food supplements (L-carnitine, L-arginine or Ginko biloba)
Subjects with known active or dormant type 2 herpes simplex virus infections
Subjects with a contraindication to treatment with an ERA. Contraindications may include, but are not limited to, evidence of elevated liver function tests (e.g., aminotransferases >2X ULN) or an event defined as a serious adverse event attributed to previous treatment with an ERA
Subjects who are judged by the investigator to be ineligible for this study for any other reason","Darusentan 100mg during Phase 1, Placebo during Phase 2",ChEMBL:CHEMBL23261 | DrugBank:DB04883 | PubChem:177236,Darusentan,COc1cc(OC)nc(O[C@H](C(=O)O)C(OC)(c2ccccc2)c2ccccc2)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
NCT00738049,NCT00738049_EG001,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF.
Subjects must be greater than 18 years of age.
Female subjects must be surgically sterile or documented as post-menopausal for at least 2 years.
Subjects must have documented coronary artery disease as evidenced by previous myocardial infarction, interventional procedure, significant stenosis by cardiac catheterization, or an abnormal perfusion study.
Subjects must have an abnormal PET scan.

Exclusion Criteria:

Subjects with acute heart failure
Subjects with sustained or symptomatic hypotension (SBP 90 mmHg)
Subjects with uncontrolled hypertension (SBP of 170 mmHg or DBP of 100 mmHg) at Screening
Subjects with unstable angina pectoris
Subjects with acute myocardial infarction, stroke, transient ischemic attack, or coronary angioplasty within the last 6 months
Subjects with primary valvular disease
Subjects with significant vascular aneurysm
Subjects with a documented history of renal failure
Subjects with liver disease (total bilirubin 3 mg/dL or serum ALT or AST >2X ULN)
Subjects with active malignancy
Subjects with a fatal non-cardiovascular disease that they are expected to succumb to within 1 year
Female subjects that are pregnant or lactating
Female subjects with the potential for child-bearing
Female subjects being treated with hormone therapies
Subjects with uncontrolled diabetes mellitus
Subjects with diabetes with gastro paresis or severe neuropathy
Subjects with a history of substance abuse within the last 2 years
Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
Subjects with known hypersensitivity or allergy to L-arginine, aminophylline, adenosine, or dipyridamole
Subjects who have a planned surgical procedure during the course of the study
Subjects taking herbal food supplements (L-carnitine, L-arginine or Ginko biloba)
Subjects with known active or dormant type 2 herpes simplex virus infections
Subjects with a contraindication to treatment with an ERA. Contraindications may include, but are not limited to, evidence of elevated liver function tests (e.g., aminotransferases >2X ULN) or an event defined as a serious adverse event attributed to previous treatment with an ERA
Subjects who are judged by the investigator to be ineligible for this study for any other reason","Received placebo during Phase 1, Darusentan 100mg during Phase 2",ChEMBL:CHEMBL23261 | DrugBank:DB04883 | PubChem:177236,Darusentan,COc1cc(OC)nc(O[C@H](C(=O)O)C(OC)(c2ccccc2)c2ccccc2)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
NCT00739661,NCT00739661_EG000,No,Female,Adult | Older Adult,Phase 2,52,"Inclusion Criteria:

Histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
Must be in second or third complete remission, have received chemotherapy (platinum-based and/or non-platinum-based) for recurrent disease, and have achieved a complete remission after their most recent chemotherapy regimen. Complete remission is defined as no symptoms suggestive of persistent cancer, computed tomography (CT) scan of the chest/abdomen/pelvis without evidence of ovarian cancer within 4 weeks of randomization, and normal CA-125 (measured within 2 weeks of randomization) following completion of prior chemotherapy. The study investigator should confirm the status of disease remission by CT scan before patient enrollment. If patient has lymphadenopathy by CT scan and the investigator thinks that it is unlikely due to ovarian cancer, this patient is considered eligible. If indicated, a confirmatory biopsy should be performed.
Patients must have completed their most recent cytotoxic chemotherapy regimen (platinum-based or non-platinum based) no less than 3 weeks and no more than 14 weeks prior to randomization.
Archival tissue must be available and requested.
Negative pregnancy test on Day 1 (first day the patient receives vismodegib or placebo).
For women of childbearing potential: Use of two effective methods of contraception, including one barrier method.

Exclusion Criteria:

Pregnancy or lactation.
Patients whose ovarian cancer is in first remission.
Patients must not have experienced more than two prior recurrences of disease.
Concurrent non-protocol-specified anti-tumor therapy, either approved or unapproved (eg, chemotherapy, hormonal therapy, other targeted therapy, radiation therapy, surgery, herbal therapy). Hormonal replacement therapies for treatment of postmenopausal symptoms do not exclude patients from this study.
Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study.
History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma (BCC) or squamous-cell carcinoma of the skin; ductal carcinoma in situ of the breast; or carcinoma in situ of the cervix.
Uncontrolled medical illnesses such as infection requiring intravenous (IV) antibiotics.
Life expectancy < 12 weeks.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications.","Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00740129,NCT00740129_EG000,No,All,Child | Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Written Informed Consent
Participants with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months
Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

Exclusion Criteria:

A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
Bisphosphonate Hypersensitivity
Participants with suspected/proven metastases at re-treatment
Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening
Serum calcium level <2.07 millimole/liter (mmol/L) at screening
Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply.",Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00744380,NCT00744380_EG001,No,All,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

Patients requiring mechanical ventilation in the medical or surgical ICUs.
Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
Anticipated duration of continuous sedation > 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.

Patients qualifying for daily awakenings as determined by all of the following:

fraction of inspired oxygen (FiO2) ≤ 70% or
positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
hemodynamically stable, and
NOT receiving pharmacologic neuromuscular blockade.
Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving intermittent or ""as needed"" administration of lorazepam or midazolam.
Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
Patients receiving epidural administration of medication(s).
Patients with Childs-Pugh class C liver disease.
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
Patients with alcohol abuse within six months of study eligibility.
Pregnant females or females suspected of being pregnant.","Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.

Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00746421,NCT00746421_EG000,No,All,Adult | Older Adult,Phase 4,12,"Inclusion criteria:

Provision of written informed consent
A primary diagnosis of Bipolar disorder type 1 or 2, with a definite history of manic or hypomanic episodes by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV).
Females and/or males aged 18-65 years.
Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
Able to understand and comply with the requirements of the study.
YMDRS score <13.
MADRS score <19.
Currently receiving medication therapy with lithium, valproate, or lamotrigine or any combination thereof. (preference given to lithium and/or valproate).
Clinically stable for 4 weeks prior to study entry, confirmed at week 2.

Exclusion criteria:

Intolerance of quetiapine
Change in mood stabilizer medication or dose in the last 4 weeks, change in antidepressant medication or dose in the last two months.
Current treatment with carbamazepine, stimulants, atomoxetine, or another antipsychotic
Current treatment with norepinephrine reuptake inhibiting antidepressants (Milnacipran, bupropion, paroxetine, duloxetine, venlafaxine, all MAOI's, all TCAs)
Current pregnancy or lactation
Active Anorexia nervosa or Bulimia nervosa in the past six months
History of non-affective psychotic disorders (including schizoaffective disorder)
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
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 inducers in the 14 days preceding enrollment 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
Active Substance/ alcohol abuse or dependence in the past three months before enrollment ( except for caffeine or nicotine dependence), as defined by DSM-IV criteria Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hyperlipidemia, hypertension) as judged by the investigator
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 enrollment 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 randomization. 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 10^9 per liter",Quetiapine XR 200-400 mg/day,PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00759473,NCT00759473_EG000,No,All,Adult | Older Adult,Phase 2,79,"Inclusion Criteria

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance with the exceptions of nicotine and alcohol. Because of the high comorbidity of cocaine with alcohol and nicotine dependence, excluding nicotine and alcohol dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue exposure/extinction session will be controlled. Although individuals who meet criteria for alcohol dependence will be accepted for study participation, anyone who has a measurable blood alcohol level on the day of the sessions will be excluded as acute alcohol intake can increase serum levels of DCS and lower the seizure threshold.
Use of one of the following methods of birth control by female subjects: birth control pills, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Subjects must live within a 50-mile radius of the research facility and have reliable transportation.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) prior to the first session and through the final session.
Subjects must consent to random assignment to the DCS vs. placebo conditions.
For fMRI participants, subjects must be right-handed.

Exclusion Criteria

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including insulin-dependent diabetes, as these conditions may affect heart rate or skin conductance measurement.
Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to and between the cue procedures.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, alcohol or cocaine as appropriate) within the past 60 days.
Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to DCS.
Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
Subjects with a history of epilepsy or seizure disorder.
Subjects with significant liver impairment, as DCS may increase serum transaminases.
For fMRI participants, the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
For fMRI participants, clinically significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.",Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761319,NCT00761319_EG000,No,All,Adult | Older Adult,Phase 3,353,"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:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00762645,NCT00762645_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Age ≥ 18 years
Chronic Angle Closure Glaucoma (CACG)
21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
Peripheral anterior synechiae (PAS)

Exclusion Criteria:

Traumatic damage of the anterior chamber angle
History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
Visual Acuity ≥ 1.0
Contact lenses wearer",Travoprost 0.004% Ophthalmic Solution,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00763061,NCT00763061_EG000,No,All,Adult | Older Adult,Phase 4,111,"Inclusion Criteria:

≥18 years;
IOP=16-30mmHg

OH or OAG with visual filed abnormality:

≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
Glaucoma Hemifield Test outside normal limits,
Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria:

Previous damage of anterior chamber angle;
ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
contact lens wearer;
severe central field loss;
uncontrolled cardiovascular, hepatic or renal disease;
any medication within past 1 month.",Travoprost at 9 AM + Placebo & 9 PM,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00763867,NCT00763867_EG001,No,All,Adult | Older Adult,Phase 3,113,"Inclusion Criteria:

Previous clinical diagnosis of heart failure with current New York Heart Association (NYHA) Class II-IV symptoms

Has experienced at least one of the following in the 12 months before study entry:

Hospitalization for decompensated heart failure
Acute treatment with intravenous loop diuretic or hemofiltration
Mean pulmonary capillary wedge pressure greater than 15 mm Hg or left ventricular end diastolic pressure (LVEDP) greater than 18 mm Hg at catheterization for dyspnea
Long term treatment with a loop diuretic and chronic diastolic dysfunction on echocardiography, as determined by left atrial enlargement
Left ventricular ejection fraction greater than or equal to 50%, as determined by a clinical echocardiogram or ventriculogram in the 12 months before study entry
Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%

Exclusion Criteria:

Has a neuromuscular, orthopedic, or other non-cardiac condition that prevents individual from exercise testing on a bicycle ergometer or from walking in a hallway
Non-cardiac condition that limits life expectancy to less than 1 year at the time of study entry, based on the judgment of the physician
Current or anticipated future need for nitrate therapy
Valve disease (i.e., greater than mild aortic or mitral stenosis; greater than moderate aortic or mitral regurgitation)
Hypertrophic cardiomyopathy
Infiltrative or inflammatory myocardial disease (e.g., amyloid, sarcoid)
Pericardial disease
Primary pulmonary arteriopathy
Has experienced a heart attack or unstable angina, or has undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) in the 60 days before study entry, or requires either PTCA or CABG at the time of study entry
Other clinically important causes of dyspnea, such as morbid obesity or significant lung disease, as defined by clinical judgment or use of steroids or oxygen for lung disease
Systolic blood pressure less than 110 mm Hg or greater than 180 mm Hg
Diastolic blood pressure less than 40 mm Hg or greater than 100 mm Hg
Resting heart rate (HR) greater than 100 bpm
History of reduced ejection fraction (less than 50%)
Implanted metallic device that will interfere with MRI examination (in people without atrial fibrillation)
Severe kidney dysfunction (estimated glomerular filtration rate [GFR] less than 20 ml/min/1.73m2 by modified modification of diet in renal disease [MDRD] equation)
Pregnant or not using an effective form of contraception
Hemoglobin level of less than 10 g/dL
Taking alpha antagonists or cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine, or serum protease inhibitors for HIV)
Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance
Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease)
Severe liver disease (aspartate aminotransferase [AST] level greater than three times the normal limit, alkaline phosphatase or bilirubin greater than two times the normal limit)
In being consistent with American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, people with dyspnea and risk factors for coronary artery disease should have had a stress test and those people with a clinically indicated stress test demonstrating significant ischemia in the 1 year before study entry will be excluded.
Listed for heart transplantation",sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks,ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00764478,NCT00764478_EG000,No,All,Adult | Older Adult,Phase 3,122,"Inclusion Criteria:

Each participant must be at least 18 years of age
Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).","Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00764478,NCT00764478_EG001,No,All,Adult | Older Adult,Phase 3,119,"Inclusion Criteria:

Each participant must be at least 18 years of age
Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).","Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00771056,NCT00771056_EG000,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Flow cytometry confirmed B-CLL
No prior chemotherapy or immunotherapy
Performance status 0-2
Age > 18 years old
If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use
Must have capacity to consent for study and sign consent form
Asymptomatic CLL not requiring treatment at time of study entry

Exclusion Criteria:

Pregnancy
Significant optic nerve pathology as documented by an opthalmologic exam
Hypersensitivity to 4-aminoquinoline compound
Patients taking cardiac glycosides and cyclosporine","Hydroxychloroquine 400 mg po daily for up to one year.

Hydroxychloroquine: 400mg by mouth daily x 1 year",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00780442,NCT00780442_EG000,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance within the past 60 days with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the testing session will be controlled. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.
Use of one of the following methods of birth control by female subjects: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Subjects must live within a 50-mile radius of our research program and have reliable transportation.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine or alcohol) for 24 hours immediately prior to the GCRC admission.
Subjects must consent to random assignment to the DCS vs. placebo conditions.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
Individuals with creatinine clearance of 1.2 or greater as DCS is renally excreted.
Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
Subjects who are unwilling or unable to maintain abstinent from alcohol and other drugs of abuse (except nicotine) for 24 hours days prior to the cue procedure.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or cocaine as appropriate) within the past 60 days.
Subjects currently taking B-blockers, anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to DCS.
Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
Subjects with a history of epilepsy or seizure disorder.
Subjects with significant liver impairment as DCS may increase serum transaminases.",Participants received DCS prior to cocaine cue exposure sessions.,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00784849,NCT00784849_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 2,62,"Inclusion Criteria:

Stage 0,I, II breast cancer
Clinical node status N0, N1
No know allergy to iodine, lymphazurin or methylene blue dyes

Exclusion Criteria:

Patient cannot be pregnant or nursing
Prisoners will not be eligible
Women under the age of 18 will not be eligible
Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes",One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes,DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00786487,NCT00786487_EG001,Accepts Healthy Volunteers,All,Adult,Not Applicable,7,"Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.","glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,",ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00786487,NCT00786487_EG003,Accepts Healthy Volunteers,All,Adult,Not Applicable,6,"Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.","glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,",ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00789854,NCT00789854_EG000,No,All,Adult | Older Adult,Phase 3,228,"Inclusion Criteria:

Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria:

Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months","Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)",PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00790855,NCT00790855_EG000,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,25,"Inclusion Criteria:

Patients will be 16 years of age or older.
Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission (longer than 3 months). Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by World Health Organization (WHO) classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or chronic myelogenous leukemia (CML) in blastic phase.
Continued from #2: Elderly patients with AML who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible. The phase II portion of the study will enroll patients with AML, MDS, and ALL. Patients with CML and CMML will not participate in the phase II portion of the study. Patients who are being considered for stem cell transplant are also eligible for this protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Men and women must maintain effective contraception until 4 weeks after the last dose of drug is administered.
Must be able and willing to give written informed consent.
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. Persistent clinically significant toxicities (any grade 2 or worse toxicities, non-hematologic or hematologic) from prior chemotherapy must not be greater than Grade 1.
Patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1) Serum creatinine </= 2.0 mg/dl; 2) Total bilirubin </= 1.5 times the upper limit of normal unless considered due to Gilbert's syndrome; 3) Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) </= 3 times the upper limit of normal unless considered due to organ leukemic involvement.
Patients with active Central Nervous System (CNS) disease are included and will be treated concurrently with intrathecal therapy.
Phase II Portion: All above criteria apply. After the phase I portion, patients eligibility will be for only 3 disease categories which will accrue in parallel: 1) AML, 2) MDS, and 3) ALL.

Exclusion Criteria:

Uncontrolled intercurrent illness including, but not limited to uncontrolled infection (i.e. persistent fever, clinical deterioration), acute congestive heart failure and exacerbation, cardiac arrhythmia, chronic liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Active heart disease including myocardial infarction within previous 3 months, unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Patients with New York Heart Association (NYHA) class 3 or 4 are excluded.
Patients receiving any other standard or investigational treatment for their hematologic malignancy, except as permitted under Inclusion #9 above.
Pregnant or breast feeding females are excluded because the effects of bendamustine on a fetus or nursing child are unknown.",Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.,ChEMBL:CHEMBL487253 | DrugBank:DB06769 | PubChem:65628,Bendamustine,Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21,L01AA09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00791336,NCT00791336_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0) NSCLC in whom neoadjuvant therapy is recommended.
Must have had a mediastinoscopy to determine nodal status and potential resectability
Must have enough tissue from the biopsy for tissue marker determination for correlative studies
Negative metastatic work up (FDG PET/CT, brain CT or MRI)
No prior thoracic radiotherapy will be permitted
Age 18 years or greater
ECOG performance status 0-1 (Karnofsky at least 70%)
Normal organ and marrow function
No known HIV infection
Not pregnant
Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

Patients requiring a pneumonectomy
Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.
Prior thoracic radiation
Treatment with any other investigational agents.
Known metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV
Patients receiving drugs contraindicated with NFV will be excluded.
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 compliance.
Pregnant or lactating women
HIV-positive patients on combination antiretroviral therapy",Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.,ChEMBL:CHEMBL584 | DrugBank:DB00220 | PubChem:64143,Nelfinavir,[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2,J05AE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00795600,NCT00795600_EG000,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2

Exclusion Criteria:

Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection",Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00798759,NCT00798759_EG000,No,All,Adult | Older Adult,Phase 4,117,"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:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00803595,NCT00803595_EG000,No,All,Adult | Older Adult,Phase 3,337,"Inclusion Criteria:

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction",CS-8958 powder to be inhaled - high-dose arm,ChEMBL:CHEMBL467058 | DrugBank:DB11888 | PubChem:10412535 | PubChem:20751579 | PubChem:9847629,Laninamivir octanoate,CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00803595,NCT00803595_EG001,No,All,Adult | Older Adult,Phase 3,326,"Inclusion Criteria:

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction",CS-8958 powder to be inhaled - low-dose arm,ChEMBL:CHEMBL467058 | DrugBank:DB11888 | PubChem:10412535 | PubChem:20751579 | PubChem:9847629,Laninamivir octanoate,CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=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
NCT00804141,NCT00804141_EG000,No,All,Adult | Older Adult,Phase 3,1034,"Inclusion Criteria:

Men and women 18 years or older.
A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
A history of chronic constipation before initiation of opioid therapy.",Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.,PubChem:146018922 | PubChem:16088037 | PubChem:16089914 | PubChem:53395210 | PubChem:5361917 | PubChem:66577063,Relistor,C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-],A06AH01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00808132,NCT00808132_EG002,No,Female,Adult,Phase 3,230,"Inclusion Criteria:

Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
Intact Uterus

Exclusion Criteria:

Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.",Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.,ChEMBL:CHEMBL46740 | DrugBank:DB06401 | PubChem:154257,Bazedoxifene,Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12,G03CC07 | G03XC02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00808665,NCT00808665_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

American Society of Anesthesiologists (ASA) Classification I - III
Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

Exclusion Criteria:

Allergy to dexmedetomidine
Cardiac disease with reduced ejection fraction < 30%
History of cirrhosis, active hepatitis or attenuated hepatic function
Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins
Current anticoagulant therapy
Patients requiring motor evoked potential (MEP) monitoring
Positive pregnancy test","At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.

Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT00811473,NCT00811473_EG000,No,All,Child,Phase 3,92,"Inclusion Criteria:

Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
Patients must be able to swallow the study medication tablets.

Exclusion Criteria:

The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
Patients who in your doctors judgement pose a current suicidal or homicidal risk.",Quetiapine XR 150 to 300mg once a day,PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00818623,NCT00818623_EG000,No,Male,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Degarelix 120 mg (20 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00818623,NCT00818623_EG004,No,Male,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Degarelix 200 mg (60 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00818623,NCT00818623_EG006,No,Male,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Degarelix 240 mg (60 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00818623,NCT00818623_EG007,No,Male,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Degarelix 320 mg (60 mg/mL),ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00819156,NCT00819156_EG000,No,Male,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Written informed consent prior to any study related procedures
Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
Hypersensitivity towards any component of degarelix or mannitol
Cancer disease within the last 5 years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Known hepatic disease
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier precluding adequate understanding or cooperation
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00819156,NCT00819156_EG003,No,Male,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Written informed consent prior to any study related procedures
Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
Hypersensitivity towards any component of degarelix or mannitol
Cancer disease within the last 5 years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Known hepatic disease
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier precluding adequate understanding or cooperation
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial",Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00819247,NCT00819247_EG000,No,Male,Adult | Older Adult,Phase 2,43,"Inclusion Criteria:

Signed informed consent before any trial related activity
Proven prostate cancer with a need for endocrine treatment
Testosterone level within the normal range for the age

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Candidate for prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial","Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00819247,NCT00819247_EG001,No,Male,Adult | Older Adult,Phase 2,46,"Inclusion Criteria:

Signed informed consent before any trial related activity
Proven prostate cancer with a need for endocrine treatment
Testosterone level within the normal range for the age

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Candidate for prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial","Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00819247,NCT00819247_EG002,No,Male,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Signed informed consent before any trial related activity
Proven prostate cancer with a need for endocrine treatment
Testosterone level within the normal range for the age

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Candidate for prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial","Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00828711,NCT00828711_EG002,No,Female,Adult | Older Adult,Phase 2,131,"Inclusion Criteria:

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacologic induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed fetal abnormalities;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5˚C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.","MVI 200 mcg vaginal insert

Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00830388,NCT00830388_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Male or female patients, aged 19 years and over.
Clinical presentation of tinea versicolor.
Positive KOH using calcofluor.
The ability to provide informed consent (including photography release)

Exclusion Criteria:

Use of topical antifungal to the affected area in the past 30 days
Use of topical steroid to the affected area in the past 14 days
If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)
Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results
Current diagnosis of immunocompromising conditions
Any medical or psychiatric condition that may interfere with treatment or compliance",Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.,ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00833417,NCT00833417_EG000,No,All,Adult | Older Adult,Phase 2,104,"Inclusion Criteria:

Men and women ≥ 18 years of age.
For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI).
For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable.
For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (GDC-0449).
For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or other Hedgehog pathway inhibitors.
Pregnancy or lactation.
Life expectancy of < 12 weeks.
Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement.
Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
Recent, current, or planned participation in an experimental drug study.
History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.","Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00839852,NCT00839852_EG000,No,All,Adult,Phase 2,93,"Inclusion Criteria:

Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
Patients must have a caregiver to ensure treatment compliance.

Exclusion Criteria:

Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).","Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00842075,NCT00842075_EG000,No,All,Child,Not Applicable,10,"Inclusion Criteria:

Between 13 and 17 years of age, inclusive
Diagnosed with type 1 diabetes for > 1 year
Hemoglobin A1c between 7.5 and 10% inclusive
Currently using carbohydrate to insulin ratio
Acceptable form of birth control

Exclusion Criteria:

Use of oral hyperglycemic agents or medications affecting blood sugar levels
Recurrent severe hypoglycemia requiring assistance in past 6 months
History of hypoglycemia unawareness
History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
Previous use of pramlintide",Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin,ChEMBL:CHEMBL2103758 | DrugBank:DB01278,PRAMLINTIDE,[H]N[C@@H](CCCCN)C(=O)N[C@H]1CSSC[C@@H](C(=O)N[C@@H](C)C(=O)N[C@]([H])(C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](Cc2cnc[nH]2)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)NCC(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(C)C)C(=O)N2CCC[C@H]2C(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@]([H])(C(=O)N[C@@H](Cc2ccc(O)cc2)C(N)=O)[C@@H](C)O)C(C)C)[C@@H](C)O)[C@@H](C)CC)C(C)C)[C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](CC(N)=O)NC1=O,A10BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00844298,NCT00844298_EG000,No,All,Child | Adult | Older Adult,Phase 2,91,"DISEASE CHARACTERISTICS:

Newly diagnosed acute lymphoblastic leukemia or acute mixed lineage leukemia

Positive for Bcr-Abl fusion transcript (Philadelphia chromosome-positive disease) by RT-PCR

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Total bilirubin < 2 mg/dL
SGOT < 3 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN (unless considered tumor-related)
Creatinine < 2.0 mg/dL ULN
Serum amylase and lipase ≤ 1.5 times ULN
Potassium, magnesium, and phosphorus normal (supplementation allowed)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No rare hereditary problems with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
No known sensitivity to any of the study drugs
No severe medical condition that, in the opinion of the investigator, would preclude study participation

No impaired cardiac function, including any of the following:

LVEF < 45% or below the lower limit of normal by ECHO
Long QT syndrome or known family history of long QT syndrome
Clinically significant resting bradycardia (< 50 beats per minute)
QTc > 450 msec on baseline ECG (using the QTcF formula)
Myocardial infarction within the past 12 months

Other clinically significant heart disease, including any of the following:

Unstable angina
Congestive heart failure
Uncontrolled hypertension
Uncontrolled arrhythmias
No other primary malignant disease requiring systemic treatment
No acute or chronic liver, pancreatic, or severe renal disease
No other severe and/or life-threatening medical disease
No history of significant congenital or acquired bleeding disorder unrelated to cancer
No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
No history of non-compliance

PRIOR CONCURRENT THERAPY:

More than 30 days since prior investigational agents
No concurrent medications that have the potential to prolong the QTc interval
No concurrent strong CYP3A4 inhibitors
No concurrent therapeutic coumarin derivatives","Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan

Nilotinib+mVPD: 1.Induction:

Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)
Vincristine 2 mg iv push (d1, 8, 15, 22)
Prednisolone 60 mg/m2/day po (d1-28)
Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)
Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)
Vincristine 2 mg iv (d1, 8)
Prednisolone 60 mg/m2/day po (d1-14)

Nilotinib 400mg bid/d

3. Consolidation B (cycles 2&4)

Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)
Etoposide 150 mg/m2/day iv over 3 hours (d1-4)

Nilotinib 400mg bid/d

4.Consolidation C (cycles 3&5)

Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)
Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,

Nilotinib 400mg bid/d

5.Maintenance

Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)

6.Consider alloHCT",ChEMBL:CHEMBL803 | DrugBank:DB00987 | DrugBank:DB02097 | PubChem:114682 | PubChem:596 | PubChem:6175 | PubChem:6253,Cytidine,Nc1ccn(C2OC(CO)C(O)C2O)c(=O)n1,L01BC01 | L01XY01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00844480,NCT00844480_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Men and women
Age 18 years and older
Spinal cord injury within 8 weeks of study entry
ASIA AIS A or B
Medically stable in the opinion of their physiatrist
Able to have dexa performed
Able to return for follow-up at 6 and 12 months

Exclusion Criteria:

Vitamin D deficiency
Hypocalcemia
Renal insufficiency (estimated creatinine clearance <30ml/min)
Abnormal thyroid hormone status
Abnormal mental status
Osteoporosis at the hip or spine by dexa","zoledronic acid: zoledronic acid, 5mg, iv",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00847522,NCT00847522_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,90,"Inclusion Criteria:

Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
Between 18 and 90 years of age.
Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues)

Have a primary melanoma meeting one of the following criteria:

Primary melanoma was ≥ 0.75 mm Breslow thickness and Clark level III or
Primary melanoma was Clark level IV/V or
Primary melanoma was ulcerated or
Primary tumor mitotic >1/mm2 or
Primary melanoma was less than 0.75 mm Breslow thickness with one or more poor prognostic features (regression > 75%, vertical growth phase, mitotic Count > 1/mm2, transected deep biopsy margin) or
Have had a prior excision (non-wide local excision) of a melanocytic lesion with development of a primary melanoma in the excision scar or
Have had a wide locale excision within the past 120 days of a primary melanoma as defined in (a-f) above but not yet undergone a SLNB
Clinically negative lymph nodes.
ECOG performance status 0-1

Exclusion Criteria:

Primary melanoma of the eye, mucous membranes or internal viscera.
Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional or distant metastatic disease.
Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to the lymph node basin.
Allergy to radiocolloid or fluorescein.
Inability to localize 1-2 SLN drainage basins via lymphatic mapping. (e.g., no basin found which emits gamma-radiation after injection with technecium-99m or more than 2 basins are found which emit gamma-radiation.)
Prior completion lymph node dissection or SLNB that may have altered the lymphatic drainage from the primary cutaneous melanoma to a potential lymph node basin.
Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol, or be exacerbated by therapy.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
History of organ transplantation.
Pregnant or lactating women.
Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
Nonmalignant systemic disease (e.g., cardiovascular, renal, hepatic, etc.) that precludes a patient from being subjected to any of the treatment options or that would prevent prolonged follow-up based on the physician's judgment.","Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.",ChEMBL:CHEMBL4297067 | DrugBank:DB00693 | PubChem:16850,Fluorescein,O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21,S01JA01 | S01JA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00855309,NCT00855309_EG000,No,All,Adult | Older Adult,Phase 3,56,"Inclusion Criteria:

Be 18 years of age or older.
Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
Receiving chemotherapy or have received chemotherapy within the past 2 weeks
Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
Creatinine clearance ≥ 50 mL/min
Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

Exclusion Criteria:

Pregnant or nursing
Hypersensitivity to acyclovir sodium
High tumor burden (i.e., WBC > 50,000/mm^3 at admission)
Neutropenic, defined as one of the following:
ANC < 500/mm^3
ANC < 1,000/mm^3 with a predicted decrease to 500/mm^3
Active HSV infection, as evidenced by any of the following:
Positive HSV cultures
Oral lesions
Receiving 5 mg/kg acyclovir sodium every 8 hours",Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.,PubChem:23665721,Acyclovir Sodium,Nc1nc([O-])c2ncn(COCCO)c2n1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00855309,NCT00855309_EG001,No,All,Adult | Older Adult,Phase 3,55,"Inclusion Criteria:

Be 18 years of age or older.
Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
Receiving chemotherapy or have received chemotherapy within the past 2 weeks
Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
Creatinine clearance ≥ 50 mL/min
Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

Exclusion Criteria:

Pregnant or nursing
Hypersensitivity to acyclovir sodium
High tumor burden (i.e., WBC > 50,000/mm^3 at admission)
Neutropenic, defined as one of the following:
ANC < 500/mm^3
ANC < 1,000/mm^3 with a predicted decrease to 500/mm^3
Active HSV infection, as evidenced by any of the following:
Positive HSV cultures
Oral lesions
Receiving 5 mg/kg acyclovir sodium every 8 hours",Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.,PubChem:23665721,Acyclovir Sodium,Nc1nc([O-])c2ncn(COCCO)c2n1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00858858,NCT00858858_EG000,No,All,Adult | Older Adult,Not Applicable,42,"Inclusion Criteria:

Patients who have been scheduled for elective endoscopic examination at the Dallas VA Medical Center for the evaluation of GERD or Barrett's esophagus

Exclusion Criteria:

Patients unwilling or unable to provide informed consent
Patients with esophageal carcinomas
Patients with esophageal varices
Patients taking warfarin or clopidogrel
Coagulopathy that precludes safe biopsy of the esophagus
Comorbidity that precludes safe participation in the study
Allergy to omeprazole or UDCA
Pregnancy","Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.",DrugBank:DB01586,Ursodeoxycholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2,A05AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00862563,NCT00862563_EG001,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.

-","Levetiracetam: Levetiracetam 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 of 2000 mg levetiracetam capsules.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00864123,NCT00864123_EG001,Accepts Healthy Volunteers,All,Child,Phase 2,30,"Inclusion Criteria:

The child must receive a principal diagnosis of OCD at Baseline, based on DSM-IV criteria. This diagnosis will be derived from the Anxiety Disorder Interview Schedule for DSM-IV-Child Interview Schedule - Parent version (ADIS-IV-P), and must reflect a clinical severity rating of 4 or above
CY-BOCS Total Score ≥ 16
Be between the ages of 8 and 17 years
Score ≥ 80 on the Peabody Picture Vocabulary Test-3rd Edition (Dunn & Dunn, 1997)
At least one parent available to accompany the child to all sessions;
English speaking.

Exclusion Criteria:

Psychosis, pervasive developmental disorder, bipolar disorder, or current suicidal intent measured by the ADIS-IV-P and all available clinical information
Principal diagnosis other than OCD
Youth with mental rituals, incompleteness, or hoarding symptoms as E/RP exercises would be more difficult to conduct/monitor than those with overt rituals
Unavailability of at least one caregiver to participate in the treatment
Refusal of parent to accept random assignment to treatment condition
A positive diagnosis in the caregiver of mental retardation, psychosis, clinically significant tics, or other psychiatric disorders or conditions that would limit their ability to understand E/RP (based on clinical interview)
Weight less than 25.0 kg or greater than 80.0kg
Epilepsy, renal insufficiency, and current or past history of alcohol abuse (DCS is contraindicated for such conditions)
Pregnant or having unprotected sex [in females] as the effects of DCS on pregnant youth are unknown
General poor physical health as determined by medical physical and laboratory tests.","Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00865098,NCT00865098_EG000,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

The patient has pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx, or larynx.
The patient has been confirmed Epidermal Growth Factor Receptor expressing in tumor specimen by immunohistochemistry.
The patient has stage III or IV disease (Unio Internationalis Contra Cancrum / International Union against Cancer Tumor-Lymph Nodes-Metastases classification) with an expected survival of ≥ 12 months.
The patient has at least bi-dimensionally measurable disease.
The patient is medically suitable to withstand a course of the definitive radiation therapy.
The patient aged ≥ 20 years old at informed consent
The patient's Karnofsky performance status is ≥ 60
Hemoglobin ≥ 9g/dL
Neutrophil ≥ 1500/mm^3
Platelet ≥ 100,000/mm^3
Total Bilirubin ≤ 1.5 mg/dL
Aspartate Aminotransferase ≤ 2 x the upper limit of normal
Alanine Aminotransferase ≤ 2 x the upper limit of normal
Serum creatinine ≤ 1.5 mg/dL
Serum calcium concentration: within normality
The patient is eligible if disease free from a previously treated malignancy for greater than three years.
The patient agrees to use effective contraception if procreative potential exists.
The patient has given signed informed consent
The patient who is a Japanese with Japanese citizenship

Exclusion Criteria:

The patient has evidence of distant metastatic disease. The patient who has any metastatic disease documented by Magnetic Resonance Imaging for the head and neck, and Computed Tomography for the chest and abdomen should be excluded.
The patient has squamous cell carcinoma arising in the nasopharynx or oral cavity.
The patient has received prior systemic chemotherapy within the last three years.
The patient has undergone previous surgery for the tumor under study other than biopsy.
The patient has received prior radiation therapy to the head and neck.
The patient's radiation therapy is considered to be a part of a postoperative regimen following primary surgical resection.
The patient is pregnant or breast feeding.
The patient has received prior Cetuximab or murine monoclonal antibody (including chimeric antibody) therapy or a history of severe hypersensitivity to any component of Cetuximab solution for Injection.
The patient has a medical or psychological condition that would not permit the patient to complete the study or sign informed consent (including drug abuse).
The patient has uncontrolled diabetes mellitus, malignant hypertension, or liver failure.
The patient has or has suffered from a pulmonary fibrosis, acute pulmonary disorder, or interstitial pneumonia.
The patient has an active infection (infection requiring intravenous anti-bacterial, anti-fungus, or anti-viral agent), or known and declared Human Immunodeficiency Virus infection.
The patient has a clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
The patient has a dental disease which requires incision and drainage.
The patient has active multiple cancers (excluding skin cancer except for melanoma, and carcinoma in situ of the cervix or the digestive tract) in the last 3 years.
The patient has been received some investigational medication within 30 days before study entry.","Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.",PubChem:136170999,FOLFIRI regimen,CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=c1[nH]cc(F)c(=O)[nH]1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00866775,NCT00866775_EG000,No,All,Child | Adult | Older Adult,Phase 3,65,"Inclusion Criteria:

Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE) (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a. Medical history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c. Documented EEG recording (done within 5 years prior to screening) consistent with focal onset epilepsy.
Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable.
≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period.
Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
Subjects must have the ability to comprehend the informed consent form and be willing to provide informed consent. For subjects who are unable to comprehend the written consent, a witness/caregiver who is able to describe and provide an understanding of the informed consent to the subject must sign the consent form on behalf of the subject.
Subjects must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. Subjects of Asian ancestry are required to give written informed consent for genotyping. All subjects must sign a HIPAA Form. All females of child bearing potential must also sign the ""Women of Childbearing Potential"" Addendum.
A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); b. Child-bearing potential (all females ≤65 years of age), has a negative pregnancy test at screening and agrees to satisfy contraception requirements.

Exclusion Criteria:

Subjects with only simple partial seizures without a motor component.
Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome).
History of pseudo-seizures.
Current seizures related to an acute medical illness.
Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.
Status epilepticus within 2 years prior to screening.
Seizures only occurring in a cluster pattern.
Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine.
Subjects taking 2 AEDs with both being in the upper dose range (defined as approximately two-thirds of the defined daily dose).
Subjects taking more than 2 AEDs.
Subjects with progressive structural central nervous system lesion or progressive encephalopathy.
Psychiatric exclusion criteria: subjects with history of suicide attempt in last 2 years; major depressive episode within last 6 months; abuse of alcohol or substance abuse in last 2 years; significant psychiatric disorder or recurrent episodes of severe depression within 2 years prior to screening.
Medical exclusion criteria: known renal insufficiency or subject with estimated creatinine clearance [CrCL] <60 mL/min based on serum creatinine using the Cockcroft-Gault formula.
Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests positive for the presence of the HLA-B*1502 allele.
Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular basis within 3 months prior to screening.
Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative hypnotics including non-benzodiazepines, central opioid agonists/antagonists, monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2 weeks whichever is longer) prior to randomization.
Subjects presently on felbamate or vigabatrin
Female subjects who are currently breastfeeding or intending to breastfeed during study period.","Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00866775,NCT00866775_EG001,No,All,Child | Adult | Older Adult,Phase 3,128,"Inclusion Criteria:

Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE) (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a. Medical history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c. Documented EEG recording (done within 5 years prior to screening) consistent with focal onset epilepsy.
Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable.
≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period.
Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
Subjects must have the ability to comprehend the informed consent form and be willing to provide informed consent. For subjects who are unable to comprehend the written consent, a witness/caregiver who is able to describe and provide an understanding of the informed consent to the subject must sign the consent form on behalf of the subject.
Subjects must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. Subjects of Asian ancestry are required to give written informed consent for genotyping. All subjects must sign a HIPAA Form. All females of child bearing potential must also sign the ""Women of Childbearing Potential"" Addendum.
A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); b. Child-bearing potential (all females ≤65 years of age), has a negative pregnancy test at screening and agrees to satisfy contraception requirements.

Exclusion Criteria:

Subjects with only simple partial seizures without a motor component.
Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome).
History of pseudo-seizures.
Current seizures related to an acute medical illness.
Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.
Status epilepticus within 2 years prior to screening.
Seizures only occurring in a cluster pattern.
Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine.
Subjects taking 2 AEDs with both being in the upper dose range (defined as approximately two-thirds of the defined daily dose).
Subjects taking more than 2 AEDs.
Subjects with progressive structural central nervous system lesion or progressive encephalopathy.
Psychiatric exclusion criteria: subjects with history of suicide attempt in last 2 years; major depressive episode within last 6 months; abuse of alcohol or substance abuse in last 2 years; significant psychiatric disorder or recurrent episodes of severe depression within 2 years prior to screening.
Medical exclusion criteria: known renal insufficiency or subject with estimated creatinine clearance [CrCL] <60 mL/min based on serum creatinine using the Cockcroft-Gault formula.
Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests positive for the presence of the HLA-B*1502 allele.
Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular basis within 3 months prior to screening.
Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative hypnotics including non-benzodiazepines, central opioid agonists/antagonists, monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2 weeks whichever is longer) prior to randomization.
Subjects presently on felbamate or vigabatrin
Female subjects who are currently breastfeeding or intending to breastfeed during study period.",Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.,ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00868452,NCT00868452_EG000,No,All,Adult | Older Adult,Phase 3,183,"Inclusion Criteria:

Subject is diagnosed with bipolar I disorder, most resent episode depressed
Subject must have a lifetime history of at least one bipolar manic or mixed episode
Subject must be taking lithium or divalproex at least 28 days prior to screening

Exclusion Criteria:

History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
Imminent risk of suicide or injury to self, others, or property","lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00868699,NCT00868699_EG001,No,All,Adult | Older Adult,Phase 3,167,"Inclusion Criteria:

Subject is diagnosed with bipolar I disorder, most resent episode depressed
Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
Imminent risk of suicide or injury to self, others, or property","lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00868699,NCT00868699_EG002,No,All,Adult | Older Adult,Phase 3,164,"Inclusion Criteria:

Subject is diagnosed with bipolar I disorder, most resent episode depressed
Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
Imminent risk of suicide or injury to self, others, or property","lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00868959,NCT00868959_EG000,No,All,Adult | Older Adult,Phase 3,813,"Inclusion Criteria:

Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

Exclusion Criteria:

Imminent risk of suicide, injury to self or to others, or damage to property
Subject has evidence of severe movement disorders.
Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).",lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00871260,NCT00871260_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Suspected coronary artery disease
Symptoms of possible coronary artery disease

Exclusion Criteria:

Acute ST-elevation myocardial infarction
Second or third degree AV block
Severe Renal Disease (Glomerular Filtration Rate (GFR) <30cc/min or hemodialysis)
Contra-indications to MRI (i.e. Implantable Cardioverter Defibrillator (ICD), pacemaker, aneurysm clip, etc)
Hemodynamic instability
Inability to provide informed consent
Severe claustrophobia
Pregnancy
Age <18 years","Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00871624,NCT00871624_EG000,No,All,Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Age ≥ 18 years
Acute respiratory failure requiring the initiation of NPPV
Admission to the medical ICU service at Tufts Medical Center or Winchester Hospital

Exclusion Criteria:

Patients with delirium (intensive care delirium screening checklist score ≥ 4) or disorientation (not oriented to person or place)
Receiving NPPV for ≥ 8 hours (includes treatment with NPPV at an outside hospital)
Intubation and mechanical ventilation in the past month based on hospital admission note
Age ≥ 85 years
Inability of the potential subject to give informed consent
Current treatment with antipsychotic agent based on hospital admission note
Heart rate ≤ 50 bpm
Systolic blood pressure ≤ 90 mmHg
History of heart block without pacemaker use or severe ventricular dysfunction (EF ≤25%) based on hospital admission note
Acute alcohol withdrawal based on hospital admission note
History of end stage liver failure (based on presence of ≥ 1 or more of the following: AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5
Irreversible brain disease consistent with severe dementia based on hospital admission note
Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to study enrollment)
Treatment with clonidine or dexmedetomidine in the past 30 days based on hospital admission note
Known allergy or sensitivity to clonidine or dexmedetomidine",Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00874432,NCT00874432_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
History of ACE-I induced angioedema
History of angioedema, hereditary or idiopathic

Persons lacking consent capacity

500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios","ace inhibitor

lisinopril: 1 x 40 mg per day",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00874432,NCT00874432_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
History of ACE-I induced angioedema
History of angioedema, hereditary or idiopathic

Persons lacking consent capacity

500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios","ace-inhibitor

lisinopril: 1 x 40 mg per day",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00875342,NCT00875342_EG000,No,All,Adult | Older Adult,Not Applicable,41,"Inclusion Criteria:

English-speaking adults
Age 18-70
Survivor of a variety of traumas (e.g., motor vehicle and accidents, burns and others injuries, combat, World Trade Center attack, etc.)
Diagnosed with PTSD
In good health. For persons with chronic injuries/conditions related to their accidents, ""good health"" is defined as the injury being in a state of stabilization and able to attend weekly outpatient sessions.

Exclusion Criteria:

Current organic mental disorder
Schizophrenia or symptoms of psychosis/delusions
Bipolar disorder
Current substance abuse or dependence
Active suicidal/homicidal ideation, intent, or plan
Use of pacemaker
Significant health impairment, including renal disease
Taking oral anticoagulant medication, ethionamide (Trecator-SC), isoniazid (INH), or anti-depressant medication
Hypersensitivity to cycloserine
History of seizures
Pregnant or currently trying to conceive, or breastfeeding",DCS: 1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times),ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00876200,NCT00876200_EG000,No,All,Child | Adult,Phase 2,9,"Inclusion Criteria:

proven diagnosis of Williams Beuren syndrome (genetic test)
normotension or hypertension, treated or not
male or female,
6< age <18,
negative pregnancy test for childbearing potential female
effective birth control for sexually active female
signed consent form collected from parents or legal guardian

Exclusion Criteria:

pulmonary hypertension secondary to mitral stenosis
myocardial infarction within 1 month prior randomization
known allergies to minoxidil or any of the components of Lonoten.
asthma
renal failure (creatinine clearance <40ml/min)
no affiliation to a national health insurance program (social security)
intolerance to lactose
current vasodilator anti hypertensive treatment","Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.

Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.

Minoxidil: Normotension: 0.2mg/kg/day for children under 12 and 5mg/day for children aged 12 or more.

Hypertension: 0.2mg/kg/day, increasing up to a maximal dosage of 1 mg/kg) for children under 12. 5mg/day, increasing as needed of 0.1 mg/kg/day (up to a maximal dosage of 40 mg/day) for children aged 12 or more.",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT00879190,NCT00879190_EG000,No,Female,Adult,Phase 2 | Phase 3,43,"Inclusion Criteria:

Pregnant women in labor or undergoing induction of labor
Greater than or equal to 18 years of age
Diagnosed with chorioamnionitis as defined by maternal temperature > or = 38.0 degrees Centigrade plus at least one of the following: maternal tachycardia (heart rate >110), fetal tachycardia (fetal heart rate baseline >160), purulent amniotic fluid, uterine tenderness.

Exclusion Criteria:

Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
Having received antibiotics for the treatment of preterm premature rupture of membranes or other condition within the last 7 days
Acute or chronic renal disease or insufficiency (creatinine >1.0)
Hearing loss
Major fetal congenital anomalies or intrauterine fetal demise
Neutropenia
HIV
Myasthenia gravis or other neuromuscular disorder","Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.",ChEMBL:CHEMBL506110 | DrugBank:DB12127 | PubChem:444022,Sultamicillin,[H][C@]12SC(C)(C)[C@H](C(=O)OCOC(=O)[C@@H]3N4C(=O)C[C@@]4([H])S(=O)(=O)C3(C)C)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1,J01CR04 | J01CR50,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00880568,NCT00880568_EG001,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.",Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle,DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00880568,NCT00880568_EG002,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.",Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle,DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00880568,NCT00880568_EG003,No,All,Adult | Older Adult,Phase 1,1,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.",Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle,DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00880568,NCT00880568_EG004,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.","Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle",DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00880568,NCT00880568_EG005,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.","Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle",DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00880568,NCT00880568_EG006,No,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.","Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle",DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00880568,NCT00880568_EG007,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria

Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participant must have Performance Status 0 or 1.
Participant must have adequate organ function.

Exclusion Criteria

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
Participant has known hypersensitivity to the components of study drug or its analogs.
Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.","Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle",DrugBank:DB12763,MK-1496,C[C@H](N)c1ccc([C@H](O)CNC(C)(C)C)cc1,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00885079,NCT00885079_EG000,No,All,Adult | Older Adult,Phase 3,93,"Inclusion Criteria:

Out patient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes or less
Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
Ocular hypertension patient or glaucoma patient with ophthalmic solution
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
Anticipated use of contact lens during the study
Patient with punctal plug
Any history of ocular surgery within 12 months
Female patients who are pregnant,possibly pregnant or breast feeding
Known hypersensitivity to any component of the study drug or procedural medications
Receipt of any investigational product within 4 months.","Instillation,4 times/day for 4 weeks

OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%",ChEMBL:CHEMBL1697771 | DrugBank:DB11656 | PubChem:5042,Rebamipide,O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1,A02BX14,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00886834,NCT00886834_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,108,"Inclusion Criteria:

18 years old or older
negative pregnancy test
no prior pregnancies beyond 14 6/7 weeks
no PID in last 3 months
no current cervicitis
be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

active cervical infection
current pregnancy
prior pregnancy beyond 14 weeks gestation
known uterine anomaly
fibroid uterus distorting uterine cavity
copper allergy/Wilson's disease (for Paragard)
undiagnosed abnormal uterine bleeding
cervical or uterine cancer.","Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00898560,NCT00898560_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 1,20,"Inclusion Criteria:

Pre-menopausal female subjects
Age 18-40 years, inclusive
Body mass index (BMI) 19-30 kg/m2, inclusive
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Negative urine pregnancy test at screening and admission to each treatment period.
Using one of the following methods of contraception: double barrier or intrauterine device

Exclusion Criteria:

Subjects who have any contra-indication to the use of oral contraceptives
History or presence of clinically relevant diseases, disorders or surgical history
History of alcoholism or drug abuse
Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion","15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.

eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.

Microginon®: single oral dose on day 14 of treatment period",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0
NCT00900237,NCT00900237_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,7,"Inclusion Criteria:

Healthy subjects
Aged 18-55 years
Body mass index (18.5-29 kg/m3)","Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9

Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00902746,NCT00902746_EG000,No,Female,Adult | Older Adult,Phase 3,147,"Inclusion Criteria:

Dysmenorrhea associated with endometriosis

Exclusion Criteria:

Severe hepatopathy
Pregnant woman","Norethisterone, Ethinyl Estradiol

NPC-01: This study consist of the following steps.

Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.

Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):

After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.",PubChem:94141,11beta-Hydroxyandrostenedione,CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00903760,NCT00903760_EG001,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Patients with higher risk MDS (IPSS int-2 or high, or >/= 10% blasts as defined by WHO or FAB). - No prior intensive chemotherapy or high-dose cytarabine (>/= 1 g/m2). - Prior biologic therapies (</= 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed. - Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease. - Hydroxyurea is permitted for control of counts prior to treatment. - Hematopoietic growth factors are allowed. .
Age >/= 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
Have adequate renal function (serum creatinine </= 1.5 mg/dL)
Serum bilirubin </= 1.5 x upper limit of normal (ULN)
Aspartate transaminase (AST) or alanine transaminase (ALT) </= 2.5 x ULN
Alkaline phosphatase </= 2.5 x ULN
Provide signed written informed consent.
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment.
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria:

Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Pregnant or lactating patients.
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Any concurrent malignancy (with the exception of exclusion # 8)
Exceptions to inclusion # 7: a) Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.",Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00906347,NCT00906347_EG000,Accepts Healthy Volunteers,Female,Child | Adult | Older Adult,Phase 4,176,"Inclusion Criteria:

Clinical decision to augment labor
Gestational age > than or equal to 36 weeks
Singleton gestation
Cephalic presentation
Reassuring fetal heart rate tracing
Cervical dilation between 4 and 8 cm
Ruptured membranes with clear amniotic fluid
Intrauterine pressure catheter in place
Less than 200 MVUs in a 10 minute period
5 or fewer contractions in a 10 minute period
English or Spanish speaking patient

Exclusion Criteria:

Non-reassuring fetal heart rate tracing at time of enrollment
Meconium stained amniotic fluid
Previous uterine incision
Maternal fever (defined as greater than 37.9 C)
Known fetal anomalies
Placenta previa or unexplained vaginal bleeding
Estimated fetal weight of 4,500 grams or more
Abnormal maternal bony pelvis
Grandmultiparity","Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00907803,NCT00907803_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,45,"Inclusion Criteria:

18 - 75 yrs
Healthy volunteer
Ability to consent
Available for clinical follow-up for study
Not taking other medications
Adequate venous access
Using adequate birth control; negative pregnancy test
Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria:

Inability to swallow study medication
Pregnant or breast-feeding
Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
History of drug allergy that contraindicates study participation
Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
Clinically abnormal ECG
Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
Cannot or will not do physical exercise 24 hrs before and after PK days
Will not consume grapefruit/grapefruit juice during study
Vaccination within 2 wks of screening, or planned before Day 42 of study
Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
Clinically significant physical exam and lab results <2weeks from 1st study drug dose",400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.,ChEMBL:CHEMBL1257073 | DrugBank:DB12020 | PubChem:16124688,Tecovirimat,O=C(NN1C(=O)[C@@H]2[C@@H]3C=C[C@@H]([C@H]4C[C@@H]34)[C@@H]2C1=O)c1ccc(C(F)(F)F)cc1,J05AX24,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00907803,NCT00907803_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,46,"Inclusion Criteria:

18 - 75 yrs
Healthy volunteer
Ability to consent
Available for clinical follow-up for study
Not taking other medications
Adequate venous access
Using adequate birth control; negative pregnancy test
Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria:

Inability to swallow study medication
Pregnant or breast-feeding
Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
History of drug allergy that contraindicates study participation
Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
Clinically abnormal ECG
Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
Cannot or will not do physical exercise 24 hrs before and after PK days
Will not consume grapefruit/grapefruit juice during study
Vaccination within 2 wks of screening, or planned before Day 42 of study
Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
Clinically significant physical exam and lab results <2weeks from 1st study drug dose",600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.,ChEMBL:CHEMBL1257073 | DrugBank:DB12020 | PubChem:16124688,Tecovirimat,O=C(NN1C(=O)[C@@H]2[C@@H]3C=C[C@@H]([C@H]4C[C@@H]34)[C@@H]2C1=O)c1ccc(C(F)(F)F)cc1,J05AX24,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00909480,NCT00909480_EG000,No,All,Adult | Older Adult,Phase 4,226,"Inclusion Criteria:

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results",Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00910247,NCT00910247_EG000,No,All,Child | Adult | Older Adult,Phase 3,274,"Subject Inclusion/Exclusion Criteria:

Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
Subject must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the ""Women of Childbearing Potential"" Addendum.
Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
Criterion for Continuation into the Post 1 year Part of Study:

For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.","Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00913744,NCT00913744_EG001,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Male or female subjects aged > 50
Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
The total lesion area must be < 12 disc areas
Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
Subjects with visual acuity of 20/32 to 20/200 in the study eye
Written informed consent obtained from the subject prior to inclusion in the study

Exclusion Criteria:

Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
Subjects with high myopia (> 8D) or aphakia in the study eye
Subjects who have had ocular surgery in the study eye in the prior three months
Subjects who have had a vitrectomy in the study eye at any time.",Sham injection,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00915681,NCT00915681_EG000,No,All,Child | Adult | Older Adult,Phase 2,148,"Inclusion Criteria:

Signed Informed Consent(s) for clinical trial participation (due to the potential critical status of the subject upon presentation, consent may need to be obtained from Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP guidance) Signed Informed Consent for Clinical Trial participation
History of eating foraged mushrooms
Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
Liver function tests suggestive of amatoxin poisoning: AST or ALT above the institutions upper limit of normal after mushroom ingestion

Exclusion criteria:

1. Evidence of significant medical illness or any other abnormal laboratory finding that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of the study or could preclude the evaluation of the subject's response.","Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump

Silibinin: 20 mg/kg/day IV",ChEMBL:CHEMBL9509 | DrugBank:DB09298 | PubChem:124304713 | PubChem:1548994 | PubChem:1549163 | PubChem:24832061 | PubChem:3086637 | PubChem:31553 | PubChem:45933924 | PubChem:5213 | PubChem:5748849 | PubChem:6610285,Silibinin,COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O,A05BA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00916149,NCT00916149_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,8,"Inclusion Criteria

18-55 years of age
Normal Intelligence Quotient (IQ ≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR)
Able to give consent
The subject's treating physician is planning to prescribe levetiracetam for focal or lamotrigine for generalized seizure prevention
Either symptomatic or idiopathic seizures.

Exclusion Criteria:

Non-native English speaking and/or multilingual
Frequent seizures, since seizures themselves impair cognitive function and present a confounding variable. Subjects may have no more than one seizure or one cluster of seizures per month, with a cluster of seizures including more than one seizure, but between which the patient returns to baseline. The cluster may occur over no more than two consecutive days in one month.
Seizure(s) must not have occurred within 3 days of enrollment and testing.
Those with focal seizures who have evidence of renal disease (creatinine clearance less than 80) will be excluded from participation, as levetiracetam is cleared by the kidney.
Those with focal seizures who have neutrophil counts <1000/microliter will be excluded from participation, as levetiracetam may lower white blood cell counts.
Those with focal seizures and irritability or mood swings will not be eligible for participation, as levetiracetam may exacerbate these symptoms. This will be determined by self-report, information obtained from the referring physician and medical record.
Those with generalized seizures who have moderate to severe liver dysfunction (Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is cleared by the liver and the proposed dosing may not be tolerable in this population. This will be determined by self-report, information obtained from the referring physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures) and the medical record.
Subjects who are pregnant will not be eligible to take part in the study, as levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may pose risk to the fetus. Women of childbearing potential will have a urine pregnancy test prior to participation in the study. The urine pregnancy test will be repeated at the final study visit. Subjects with epilepsy who are of childbearing potential must use acceptable methods of birth control during the study, to be continued until one month after discontinuation of the study drug. If a subject does become pregnant during this time period, she must notify the investigators.
Women who are breastfeeding may not participate in this study. Levetiracetam and lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the baby.
Hypersensitivity to lamotrigine, levetiracetam or any components of these products","8 individuals with focal-onset epilepsy. These individuals 12will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00936377,NCT00936377_EG000,No,All,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
Patients with alcohol withdrawal not requiring ICU admission.
Patients receiving epidural administration of medication(s).
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
Pregnant females or females suspected of being pregnant","Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days

Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00936377,NCT00936377_EG001,No,All,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
Patients with alcohol withdrawal not requiring ICU admission.
Patients receiving epidural administration of medication(s).
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
Pregnant females or females suspected of being pregnant","Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days

Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00939900,NCT00939900_EG000,No,All,Adult | Older Adult,Phase 3,110,"Inclusion Criteria:

Patient who agree to clinical trial
Patient who are more than 18 years of age
Osteonecrosis of the femoral head
Steinberg stage I, II non traumatic osteonecrosis of femoral head
Necrotic area of > 30% (HJ Kim et al )
JIC (Japanese Investigation Committee): C1 or C2 lateral lesion (by X-ray or MRI)

Exclusion Criteria:

Patients who are pregnant (patients who are of child bearing potential who are not practicing a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception)
Patients who have contraindicated condition to zoledronic acid such as chronic renal failure (calculated creatinine clearance less than 35.0 ml/min), severe heart disease such as atrial fibrillation, sensitive to bisphosphonates and hypocalcemia (serum calcium less than 8 mg/dl or 2.0 mmol/L)
Patients who have collapsed lesion including subchonral fracture
Patients who have multiple lesion of osteonecrosis of femoral head
Patients who received other kinds of bisphophonates or anabolic agents before zoledronic acid use
Patients with any medical or psychiatric condition which, in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial per protocol
Patients who are considered potentially unreliable and patients who may not reliably attend study visits","aclasta group

zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00953199,NCT00953199_EG000,No,All,Adult | Older Adult,Not Applicable,506,"Inclusion Criteria:

Patients included are >18 years old, referred to Endoscopy Clinic for an ERCP for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of Oddi dysfunction

Exclusion Criteria:

Known sensitivity to lidocaine or contrast agent
History of seizure disorder
History of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged QT syndrome)
History of congestive heart failure
Active acute pancreatitis before procedure
Planned biliary stent removal without pancreatogram
Pregnancy
Incarcerated individuals
Less than 18 years of age
Previous sphincterotomy
Inability to give informed consent","Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.",PubChem:6314,Lidocaine Hydrochloride,CCN(CC)CC(=O)Nc1c(C)cccc1C.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
NCT00957229,NCT00957229_EG000,No,All,Adult | Older Adult,Phase 2,15,"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, as documented histologically in physicians' records and/or diagnosed clinically by a Study Investigator at baseline.
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, including prescription and over the counter preparations. Subjects will be encouraged to use sunscreen (SPF 15) at least once daily on all exposed skin sites.
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 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.","placebo pill by mouth once daily

GDC-0449: capsule, 150 mg, one pill daily, 18 months",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00957229,NCT00957229_EG001,No,All,Adult | Older Adult,Phase 2,40,"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, as documented histologically in physicians' records and/or diagnosed clinically by a Study Investigator at baseline.
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, including prescription and over the counter preparations. Subjects will be encouraged to use sunscreen (SPF 15) at least once daily on all exposed skin sites.
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 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.","vismodegib 150MG by mouth once daily

GDC-0449: capsule, 150 mg, one pill daily, 18 months",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00957684,NCT00957684_EG001,No,All,Adult | Older Adult,Phase 3,100,"Inclusion Criteria:

written informed consent signed by patient
aged 18 years or more
documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)

Exclusion Criteria:

only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
primarily generalised epilepsy
known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
seizures of psychogenic origin within the last 2 years
history of schizophrenia or suicide attempt
currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
previous use of ESL or participation in a clinical study with ESL
known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
history of abuse of alcohol, drugs or medications within the last 2 years
uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
second or third-degree atrioventricular blockade not corrected with a pacemaker
relevant clinical laboratory abnormalities",eslicarbazepine acetate : once-daily oral tablet,ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT00957684,NCT00957684_EG002,No,All,Adult | Older Adult,Phase 3,98,"Inclusion Criteria:

written informed consent signed by patient
aged 18 years or more
documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)

Exclusion Criteria:

only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
primarily generalised epilepsy
known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
seizures of psychogenic origin within the last 2 years
history of schizophrenia or suicide attempt
currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
previous use of ESL or participation in a clinical study with ESL
known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
history of abuse of alcohol, drugs or medications within the last 2 years
uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
second or third-degree atrioventricular blockade not corrected with a pacemaker
relevant clinical laboratory abnormalities",eslicarbazepine acetate : once-daily oral tablet,ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT00961896,NCT00961896_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

- Patients with multiple basal cell carcinomas and Gorlin syndrome, or patients with multiple basal cell carcinomas and a mutation in the PTCH1 gene at chromosome 9q22.3

Exclusion Criteria:

Previous treatment of the BCC's that are selected for treatment.
Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.

Other protocol defined Incl./Excl. criteria may apply.",Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.,ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00964548,NCT00964548_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,5,"Inclusion Criteria:

Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
a >50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
any longitudinal mean TCD velocity increase of 80 cm/s or more

Exclusion Criteria:

Inability to obtain consent from patient or health care proxy
Age < 18 years
Pregnancy
Traumatic SAH
Known allergy to dantrolene
Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >165 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
Participants on verapamil",Single dose of Dantrolene 1.25 mg/kg infused over 60 min.,ChEMBL:CHEMBL1201288 | DrugBank:DB01219 | PubChem:2952 | PubChem:5378825 | PubChem:6914273,Dantrolene,O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1,M03CA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00964548,NCT00964548_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,5,"Inclusion Criteria:

Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
a >50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
any longitudinal mean TCD velocity increase of 80 cm/s or more

Exclusion Criteria:

Inability to obtain consent from patient or health care proxy
Age < 18 years
Pregnancy
Traumatic SAH
Known allergy to dantrolene
Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >165 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
Participants on verapamil",Single dose of Dantrolene 2.5 mg/kg infused over 60 min.,ChEMBL:CHEMBL1201288 | DrugBank:DB01219 | PubChem:2952 | PubChem:5378825 | PubChem:6914273,Dantrolene,O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1,M03CA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00976560,NCT00976560_EG001,No,All,Adult,Phase 2,64,"Key Inclusion Criteria:

Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
Males or Females who agree to use protocol specified contraception if of child bearing potential
BMI 18.5-35.0 kg/m2
Normal liver function tests

Key Exclusion Criteria:

History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
Elevated liver function tests on >2 ocassions in the last 7 months
Significant medical illness, autoimmune disease or infectious disease
Pregnant or nursing females
Excessive and regular alcohol consumption
History of substance abuse or dependence in past 6 months or positive urine drug screen
Significant suicidal or homicidal risk
Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
Psychoactive drugs within 1 week or 5 half lives of randomization visit
Treatment resistant subjects","Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.",ChEMBL:CHEMBL1088752 | DrugBank:DB12270 | PubChem:11552706,Losmapimod,Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00980746,NCT00980746_EG000,No,All,Adult | Older Adult,Phase 2,85,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial","Eslicarbazepine acetate 1200 mg once daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00980746,NCT00980746_EG002,No,All,Adult | Older Adult,Phase 2,95,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial","Eslicarbazepine 600 mg twice daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00980746,NCT00980746_EG003,No,All,Adult | Older Adult,Phase 2,100,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial","Eslicarbazepine acetate 800 mg twice daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT00980746,NCT00980746_EG004,No,All,Adult | Older Adult,Phase 2,92,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
Participation in a clinical study within 3 months prior to screening
Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial","ESL 800 mg once-daily

Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00981045,NCT00981045_EG001,No,All,Adult | Older Adult,Phase 3,1285,"Inclusion Criteria:

Male or female subjects > or = to 18 years of age.
Chronically impaired renal function.
Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.",Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg,DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00981227,NCT00981227_EG000,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.","ESL 1200 mg once daily

Eslicarbazepine acetate : Scored tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00981227,NCT00981227_EG001,No,All,Adult | Older Adult,Phase 2,94,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.","ESL 400 mg twice-daily

Eslicarbazepine acetate : Scored tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00981227,NCT00981227_EG002,No,All,Adult | Older Adult,Phase 2,94,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.","ESL 600 mg twice daily

Eslicarbazepine acetate : Scored tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00981227,NCT00981227_EG003,No,All,Adult | Older Adult,Phase 2,94,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.","ESL 800 mg once-daily

Eslicarbazepine acetate : Scored tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00981227,NCT00981227_EG004,No,All,Adult | Older Adult,Phase 2,90,"Inclusion Criteria:

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.","ESL 800 mg twice daily

Eslicarbazepine acetate : Scored tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00982345,NCT00982345_EG000,No,All,Adult,Phase 4,20,"Inclusion Criteria:

Provision of written informed consent
A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
Females or Males aged 18 - 60 years
Female subjects of childbearing potential must be using a reliable method of contraception and have a negative serum human chorionic gonadotropin (HCG) test at enrollment
Able to understand and comply with the requirements of the study
17-item Hamilton Depression Rating Scale (HDRS) score > 15
Hamilton Anxiety Scale (HAM-A) score > 15
Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire

Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:

Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
No danger to self or others.

Exclusion Criteria:

Pregnancy or lactation
Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder
Subjects 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, 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 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 enrollment (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 four weeks prior to enrollment
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (angina pectoris, hypertension) as judged by the investigator
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study.
Participation in another drug trial within four weeks prior enrollment into this study or longer in accordance with local requirements
A subject with Diabetes Mellitus; people who develop hyperglycemia will be removed from the study
An absolute neutrophil count (ANC) of 1.5 x 109 per liter
Use of psychotropics in the past two weeks. If on fluoxetine in the past, then should not have been on this medication for four weeks.
History of lack of response to Quetiapine extended release.
Acutely suicidal or homicidal or requiring inpatient treatment.
Metallic implants.",quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.,PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00991809,NCT00991809_EG001,Accepts Healthy Volunteers,Male,Adult,Not Applicable,22,"Inclusion Criteria:

Age 18-55
No active medical conditions
BMI between 20-30
Able and willing to perform/tolerate pain procedures
Able to communicate in English

Exclusion Criteria:

Lifetime substance use disorder, except for alcohol abuse/dependence in remission
Use of opiates in last 3 months
Ongoing marijuana use
Acute or chronic pain
Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
Current use of prescribed or over the counter pain medications
Previous adverse reaction to opiate medications or diphenhydramine
Use of tobacco or caffeine on study days","Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM",ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01004354,NCT01004354_EG000,No,All,Child | Adult,Not Applicable,12,"Inclusion Criteria:

Males/females between the ages 10 through 18 years,
Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
All subjects will be able to take the prescribed vitamin D by mouth,
All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
All subjects must reside in an in-patient psychiatric facility.

Exclusion Criteria:

Pregnant or lactating women,
Patients with mental retardation (intelligence quotient < 50),
Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
Subjects with known history of parathyroid disorder,
Subjects with acquired or congenital disorders of vitamin D metabolism,
Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
Subjects taking any weight loss medications, such as orlistat, and sibutramine,
Subjects on medications that might affect glucose levels, such as insulin or metformin.",This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.,ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01004510,NCT01004510_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Histologically documented non-small cell lung cancer, Stages 3B, 4 or recurrent
Pleural effusion cytologically proven to be malignant
0 or 1 prior chemotherapy regimens for non-small cell lung cancer (adjuvant chemotherapy post resection, or concurrent chemo-radiation therapy counts as one regimen regardless of number of agents used.)
Planning to start chemotherapy for non-small cell lung cancer (treatment regimen at discretion of treating physician but must include one or more of the following agents:cisplatin,carboplatin,docetaxel,paclitaxel, pemetrexed,gemcitabine,vinorelbine) Patients may receive anti-angiogenesis agents (bevacizumab) in addition to chemotherapy, but patients treated solely with tyrosine kinase inhibitors or growth-factor receptor blockers are not eligible.
Prior radiation therapy is permitted.
Performance status 0,1,2
Serum creatinine less than 2.0 or estimated creatinine clearance over 30cc/min by Calcroft/Gault equation
Estimated life expectancy over 3 months
Signed informed consent
Age greater than 18 years
Patients who have clinical indication for Zometa treatment such as lytic bone metastases or hypercalcemia can be included

Exclusion Criteria:

Pregnant or lactating
Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
Patients who undergo any procedure other than thoracentesis for drainage of effusion.Patients may have had more than one thoracentesis prior to study. Patients who have large bore chest tube placement, permanent transthoracic catheter (Pleurex), medical pleurodesis or thoracoscopy are excluded.
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular);dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks)or planned dental or jaw surgery (e.g.extraction, implants).",Monthly zoledronic acid in addition to chemotherapy,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01006291,NCT01006291_EG000,No,All,Adult | Older Adult,Phase 3,230,"Inclusion Criteria:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)",Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01006291,NCT01006291_EG001,No,All,Adult | Older Adult,Phase 3,226,"Inclusion Criteria:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)",Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01006369,NCT01006369_EG001,No,All,Adult | Older Adult,Phase 2,25,"DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed colorectal carcinoma

Metastatic 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 > 10 mm by spiral CT scan
Brain metastases allowed provided they have been treated and stable for > 4 weeks

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 12 weeks
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
AST/ALT ≤ 3 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 times ULN
PT (INR) ≤ 1.5
Creatinine < 1.5 times ULN
Creatinine clearance ≥ 30 mL/min
Urine protein:creatinine ratio < 1.0 OR < 1 g protein by 24-hour urine collection
Not on dialysis
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment
Prior non-colonic malignancies allowed provided there is no current clinical evidence of persistent or recurrent disease AND the patient is not on active therapy, including hormonal therapy
No uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg, despite antihypertensive medications

No cardiac disease, including any of the following:

NYHA class III-IV congestive heart failure
Unstable angina (anginal symptoms at rest)
New onset angina (began within the past 3 months)
Myocardial infarction within the past 6 months
Uncontrolled arrhythmia
No thrombolic or embolic events (e.g., cerebrovascular accident including transient ischemic attacks) within the past 6 months
No serious non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No neuropathy ≥ grade 2
No evidence of bleeding diathesis or coagulopathy
No condition that would impair the patient's ability to swallow whole pills
No malabsorption problem
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No known G-6PD deficiency
No retinal or visual field changes from prior 4-aminoquinoline compound use
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or hydroxychloroquine
No other concurrent serious systemic disorders (including active infections) that, in the investigator's opinion, would compromise the safety of the patient or compromise the patient's ability to complete the study

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy for metastatic disease, except for adjuvant therapy that was completed ≥ 6 months before the first evidence of metastasis
More than 28 days since prior major surgical procedure or open biopsy

No concurrent anticoagulation with warfarin

Concurrent low molecular weight heparin (or an equivalent drug) allowed
No concurrent hydroxychloroquine for treatment or prophylaxis of malaria
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent St. John wort
No other concurrent investigational or anticancer agents or therapies","bevacizumab: Arm A: FOLFOX6 + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 5 mg/kg in 100 cc Normal Saline every 14 days on day one

Arm B: XELOX + Bevacizumab + Hydroxychloroquine: Bevacizumab will be administered intravenously 7.5 mg/kg in 100 cc Normal Saline every 21 days

XELOX regimen: Capecitabine will be started at a dose of 1,000 mg/m2/day bid po (total daily dose = 2,000 mg/m2) for 14 days (28 doses) of the 21 day cycle. This cycle will be repeated every 21 days. Oxaliplatin will be started at a dose of 130 mg/m2, in 250 ml of D5W over 2 hours given day 1 of each cycle. This cycle will be repeated every 21 days.

hydroxychloroquine: hydroxychloroquine 200 mg po BID daily",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01009060,NCT01009060_EG001,No,All,Adult,Phase 2,25,"Inclusion Criteria:

Clinical diagnosis of Schizophrenia
No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.
Not on any symptomatic treatment for cognition

Exclusion Criteria:

Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.
Co-morbid psychiatric or significant physical illness
Alcohol or drug abuse or dependence.","Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 μg GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.",DrugBank:DB15120 | PubChem:9976892,GSK-239512,O=C1CCCN1c1ccc(Oc2ccc3c(c2)CCN(C2CCC2)CC3)nc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01010568,NCT01010568_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Pathologically confirmed CLL or SLL requiring therapy
Age 18 years of age or older
ECOG performance status 0, 1, or 2
Normal organ and bone marrow function
Resolution of toxic effects from prior therapies
Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria:

Any serious medical, psychiatric illness or laboratory abnormality
Chemotherapy or radiotherapy within 4 weeks of entering the study
Currently receiving other treatment for CLL/SLL or other malignancies
Active other malignancies
History of allergic reactions to bendamustine or ofatumumab
Ongoing corticosteroid use
Pregnant or lactating
HIV positive
Active hepatitis B
Allogeneic transplant within 6 months of entering study or graft-versus-host disease.","Ofatumumab and Bendamustine

Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles",ChEMBL:CHEMBL487253 | DrugBank:DB06769 | PubChem:65628,Bendamustine,Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21,L01AA09,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01015170,NCT01015170_EG000,No,All,Adult | Older Adult,Phase 4,454,"Inclusion Criteria:

Ontario resident
18 years of age or older
Current daily cigarette smoker who smokes 10 or more cigarettes per day and has smoked > 100 cigarettes in their lifetime
Want to quit smoking cigarettes within 30 days of assessment
Willingness and capacity to give written informed consent and to comply with study protocol

Exclusion Criteria:

Enrollment in any of the STOP Study NRT models in the past 6 months
Currently receiving Wellbutrin SR or any medication containing bupropion hydrochloride
Current seizure disorder or history of seizures
Current or prior diagnosis of bulimia or anorexia nervosa
Current diagnosis of bipolar disorder
History of head trauma
Allergy or sensitivity to Zyban, Wellbutrin or bupropion
Undergoing abrupt withdrawal from alcohol, benzodiazepines or other sedatives
Currently taking monoamine oxidase (MAO) inhibitors, or thioridazine
Pregnant or breastfeeding or at risk of becoming pregnant
Central nervous system (CNS) tumor
Severe hepatic impairment","Up to 8 week of bupropion SR (150mg BID) + counseling.

bupropion HCl: 150mg BID for up to 8 weeks + counseling",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT01018056,NCT01018056_EG001,No,All,Child,Phase 4,39,"Inclusion Criteria:

Tourette syndrome (criteria based on the TS Classification Study Group), which includes onset before 18 years, multiple involuntary motor tics, one or more vocal tics, a waxing and waning course, the gradual replacement of old symptoms with new ones, the presence of tics for more than one year, the absence of other medical explanations (effects of a substance (e.g., stimulants) or a general medical condition for tics, and observation of tics by a reliable examiner) or Chronic Motor Tic disorder (criteria similar to Tourette syndrome except for the absence of vocal tics)
Age 8-17 years, either gender
Observable tics, achieving a minimum score of > 22 on the Total Tic score of Yale Global Tic Severity Scale (YGTSS)
Tic symptoms severe enough to warrant therapy (e.g., causing psycho-social or physical difficulty)
Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with Institutional Review Board requirements
Ability and willingness to comply with study protocol requirements
Women of childbearing potential must be using a medically acceptable contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives and estrogen patch, double barrier method (spermicide+diaphragm), or abstinence
Baseline weight of at least 33 kilograms
Tic-suppressing drug naive, or currently not on treatment for TS (off medications for at least three weeks), or if, in the judgment of the PI, they are not adequately managed using current therapy (prescribed for greater than one month) and are willing to maintain a constant dose throughout the protocol.

Exclusion Criteria:

Secondary tics
Significant medical illness (metabolic, endocrine, cardiac, hematological, gastrointestinal, pulmonary, epilepsy)
Current major depression
generalized anxiety disorder
separation anxiety disorder
psychotic symptoms (based on clinical evaluation and the results of the CY-BOCS, CDI-S, and MASC evaluations)
pervasive developmental disorder
autism
mental retardation (I.Q. less than 70)
anorexia/bulimia, or substance abuse
Any other conditions that in the opinion of the Investigators would interfere with the evaluation of the results or constitute a health hazard for the patient
Pregnancy
Hypersensitivity to D-serine or riluzole
Abnormal laboratory values on screening laboratory testing if clinically significant at the Principal Investigator's discretion.

Subjects with co-morbid ADHD, obsessive compulsive disorder (OCD), and conduct disorder will not be excluded as long as these diagnoses are not the subject's primary problem","24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.

Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01021618,NCT01021618_EG001,No,All,Adult | Older Adult,Not Applicable,96,"Inclusion Criteria:

Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
Age >=30 years

Exclusion Criteria:

Extremely limited functional capacity
Age <30 years
Unable or unwilling to provide informed consent
Pregnant or nursing females
Current use of methylxanthines within 12 hours of testing
Current use of dipyridamole or aminophylline within 48 hours of testing
Uncontrolled hypertension (>200 mmHg systolic/>120 mmHg diastolic)
Known hypertrophic cardiomyopathy with obstruction or severe aortic stenosis
Decompensated congestive heart failure
History of sick sinus syndrome or > first degree atrioventricular block in the absence of a functioning pacemaker
Asthma or other bronchospastic reactive airway disease
History of percutaneous coronary intervention or coronary artery bypass grafting, or documented history of acute myocardial infarction or unstable angina within one week of testing
Patients at risk for hypotensive reaction to regadenoson",Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint,ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01022502,NCT01022502_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
Patients were in good general health.
Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion Criteria:

Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
Patients had a history of allergy to indigo naturalis.
Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.","Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.",ChEMBL:CHEMBL253582 | DrugBank:DB02772 | PubChem:5988,Sucrose,OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[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
NCT01024972,NCT01024972_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,16,"Inclusion Criteria:

Documented aneurysmal SAH by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or angiography
Secured aneurysm (coiled or clipped)
Enrollment achievable within 14 days after SAH

Exclusion Criteria:

Pregnancy
Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >120 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
Patients on verapamil
Patients with brain edema and/or elevated intracranial pressure (>25mm Hg)
Patients treated with hypertonic saline or mannitol prior to enrollment
Patients with too severe SAH with low likelihood of survival (Hunt & Hess 5)",Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days,ChEMBL:CHEMBL1201288 | DrugBank:DB01219 | PubChem:2952 | PubChem:5378825 | PubChem:6914273,Dantrolene,O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1,M03CA01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01026012,NCT01026012_EG000,No,All,Adult | Older Adult,Not Applicable,40,"Inclusion Criteria:

Referred for clinically indicated exercise stress Myocardial Perfusion Imaging (MPI) study, Provide written informed consent
Provide written informed consent

Exclusion Criteria:

1. Acute myocardial infarction or unstable angina within three months 2 Any condition judged by the investigator likely to pose a safety risk to the patient 3 Participation in another investigational drug study within one month, Or participation in any previous rate adenosine trial 4 Females who are breast-feeding or pregnant 5 Dipyridamole use within 48 hours 6 Consumption of methyl xanthine's, coffee theophylline, caffeinated soft drinks chocolate within 24 hours of the stress test 7 Has received a heart transplant 8 Has a recent history (less than 30 days) of uncontrolled ventricular arrythmia 9 Active respiratory wheezing, angina, ventricular dysrhythmia, low blood pressure or EKG changes 10 Patients that do not have a functioning artificial pacemaker and have either: 1) second or third degree atrialventicular block 2) sinus node dysfunction",patient's were monitor for approximately 30 minutes following regadenoson infusion,ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01033019,NCT01033019_EG000,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Patients with one histologically confirmed superficial and nodular basal cell carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs)

Exclusion Criteria:

Previous treatment of the sBCC that are selected for treatment.
Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.
Dark-skinned persons whose skin color prevents readily assessment of skin reactions

Other protocol defined Incl./Excl. criteria may apply.",Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.,ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01039584,NCT01039584_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,611,"Inclusion Criteria:

Female subjects, at least 18 years of age
Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
Signed and dated informed consent

Exclusion Criteria:

Were pregnant, nursing, or planning a pregnancy within the study participation period
Had evidence of any bacterial, viral, or protozoal infection
Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study","Butoconazole Nitrate Vaginal Cream

Butoconazole Nitrate Vaginal Cream : vaginal cream",PubChem:47471,Butoconazole Nitrate,Clc1ccc(CCC(Cn2ccnc2)Sc2c(Cl)cccc2Cl)cc1.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
NCT01039584,NCT01039584_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,611,"Inclusion Criteria:

Female subjects, at least 18 years of age
Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
Signed and dated informed consent

Exclusion Criteria:

Were pregnant, nursing, or planning a pregnancy within the study participation period
Had evidence of any bacterial, viral, or protozoal infection
Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study","Gynazole 1 Vaginal Cream

Gynazole 1 vaginal cream : vaginal cream",PubChem:47471,Butoconazole Nitrate,Clc1ccc(CCC(Cn2ccnc2)Sc2c(Cl)cccc2Cl)cc1.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
NCT01044693,NCT01044693_EG003,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Male or female and aged 18 years or over.
Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
Supine hypertension, defined as a systolic blood pressure >150 mm Hg or diastolic blood pressure > 90 mm Hg.
Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

Exclusion Criteria:

Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
Women of childbearing potential who are not using a medically accepted contraception.
Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
Diabetes mellitus or insipidus.
In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
Are not able or willing to comply with the study requirements for the duration of the study.
Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).","Sildenafil 25 mg single oral dose

Sildenafil25 mg: Sildenafil 25 mg single oral dose",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01045122,NCT01045122_EG001,No,All,Adult | Older Adult,Not Applicable,15,"Inclusion Criteria:

Patients with mild or no Sleep disorder breathing
Patients with moderate to severe Sleep disorder breathing

Exclusion Criteria:

No unstable medical conditions
Anatomic pathology of airway
Pregnancy or nursing
Inability to fit an anesthesia facemask
Excessive alcohol or drug abuse
Bleeding abnormalities
Claustrophobia","Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.

Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01046110,NCT01046110_EG000,No,All,Adult | Older Adult,Phase 3,226,"Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)","Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01048944,NCT01048944_EG000,No,All,Adult,Phase 4,32,"Inclusion Criteria:Inclusion Criteria:

Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence
Smokes at least 10 cigarettes per day for the three months prior to enrollment
Currently seeking treatment for nicotine dependence
Medically healthy on the basis of physical examination and medical history, vital signs,
Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment
History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
Currently seeking treatment for nicotine disorders
History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
History of significant recent violent behavior
Blood pressure greater than 150/90
History of eating disorders
History of allergic reaction to any of the study medications
Pregnant","150 mg bid bupropion SR

Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down.",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01053221,NCT01053221_EG000,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Male or female subjects 18-75 years of age.
Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.

Exclusion Criteria:

GFR <40ml/min;
diagnosis of SLE,
Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
multi-organ transplant;
known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
history of documented post transplant non-compliance with medications, transplant clinic or laboratory follow-up;
therapy with an investigational immunosuppressive drug within 6 weeks of study entry;
history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the time of potential randomization,
history of humoral rejection post transplant,
maintenance or for cause treatment with steroids (prednisone) within 3 months of enrollment.","Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy

Mycophenolic Acid: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01054768,NCT01054768_EG001,No,All,Child | Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype
Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.

Exclusion Criteria:

More than 3 packed red blood transfusions in the past 12 months
Coexisting illness that could contribute to inflammation. These include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions.
Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks
Women who are pregnant, attempting to get pregnant, or breast feeding
Active participation in other investigational drug or device studies
Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.","1400 mg placebo tablet twice a day for 6 months.

Placebo: none to report",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01057381,NCT01057381_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,109,"Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.","Intraoperative administration for analgesia.

Dexmedetomidine 0.75 mcg/kg: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01057381,NCT01057381_EG001,Accepts Healthy Volunteers,All,Child,Phase 4,109,"Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.","Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia

Dexmedetomidine 1 mcg/kg: Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01058096,NCT01058096_EG001,No,All,Adult | Older Adult,Phase 3,158,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months","Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01058668,NCT01058668_EG001,No,All,Adult | Older Adult,Phase 3,167,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months","Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01058668,NCT01058668_EG002,No,All,Adult | Older Adult,Phase 3,169,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months","Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01059539,NCT01059539_EG000,No,All,Adult | Older Adult,Phase 3,402,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures.
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.","Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01059799,NCT01059799_EG000,No,All,Adult | Older Adult,Phase 3,284,"Inclusion Criteria:

For Japan only: minimum age is 20 years
Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) no higher than 35.0 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), exenatide or liraglutide
Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)",Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01059994,NCT01059994_EG001,Accepts Healthy Volunteers,Male,Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

1. Age 20-35 yrs, and 60-80 yrs.
2. Ability to sign consent form (score >23 on the 30-item Mini Mental State Examination, MMSE)
3. Stable body weight for at least 3 months

Exclusion Criteria:

1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year)
2. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
3. Pregnancy
4. Significant heart, liver, kidney, blood or respiratory disease
5. Peripheral vascular disease
6. Diabetes mellitus or other untreated endocrine disease
7. Active cancer
8. Use of nitrates
9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
10. Alcohol or drug abuse
11. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS)
12. Cardiac abnormalities such as a cardiac shunt or previously diagnosed pulmonary hypertension.
13. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90.","Sildenafil: oral, 25mg, daily for 1 week",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01059994,NCT01059994_EG003,Accepts Healthy Volunteers,Male,Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

1. Age 20-35 yrs, and 60-80 yrs.
2. Ability to sign consent form (score >23 on the 30-item Mini Mental State Examination, MMSE)
3. Stable body weight for at least 3 months

Exclusion Criteria:

1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year)
2. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
3. Pregnancy
4. Significant heart, liver, kidney, blood or respiratory disease
5. Peripheral vascular disease
6. Diabetes mellitus or other untreated endocrine disease
7. Active cancer
8. Use of nitrates
9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
10. Alcohol or drug abuse
11. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS)
12. Cardiac abnormalities such as a cardiac shunt or previously diagnosed pulmonary hypertension.
13. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90.","Sildenafil: oral, 25mg, daily for 1 week",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01060020,NCT01060020_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Severe aortic stenosis (AVA < 1.0 cm2)
Referred for a clinically ordered right and left heart catheterization
18 years of age and older
Able and willing to comply with all requirements of the study

Exclusion Criteria:

Nitrate use within 24 hours
SBP < 110 mmHg or MAP < 75 mmHg
Severe mitral regurgitation
Severe aortic regurgitation
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours
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 hemodynamic data
Unwilling to provide informed consent","A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.

Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01065844,NCT01065844_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Histological diagnosis of adenoid cystic carcinoma.
Cancer should be staged recurrent or end-stage with/without metastases who have failed all other therapy.
Age ≥ 18 years
ECOG performance status 0-2 (Karnofsky ≥ 50%, see Appendix A).

Patients must have normal organ and marrow function as defined below:

leukocytes ≥ 3,000/mm3
absolute neutrophil count ≥ 1,500/mm3
platelets ≥ 100,000/mm3
total bilirubin < 1.5 mg/dl OR a stable or a decreasing bilirubin in patients who have undergone placement of an intrabiliary stent
AST(SGOT) ≤ 2.5 X institutional upper limit of normal
ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
No known HIV infection. Since NFV is used in HIV patients, we do not want to interfere with the therapy the patient may already be on.
Not pregnant. The effects of NFV on the developing human fetus have been studied in HIV positive women (21). We do not, however, know the risks along with radiation. 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 participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV.
Uncontrolled diabetes.
Hemophilia A & B as increased bleeding during protease inhibitor therapy has been reported (22).
Patients may not be receiving any other investigational agents. concomitant medications counterindicated for use with nelfinavir
Pregnant or lactating women: The effects of NFV on the developing human fetus have been studied in HIV positive women (21). In addition, the chemotherapy will be deleterious to the fetus.
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with NFV.","1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday",ChEMBL:CHEMBL584 | DrugBank:DB00220 | PubChem:64143,Nelfinavir,[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2,J05AE04,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01066039,NCT01066039_EG000,No,All,Adult | Older Adult,Phase 4,200,"Inclusion Criteria:

Age of 20 years or older and less than 80 years
Subjects with T2DM
Subjects who have failed to achieve an appropriate BP level as a result of treatment with any antihypertensive drug other than beta blockers - that is, with BP inadequately controlled to greater than or equal to (>=) 130/80 mmHg. However, those who have used a beta blocker before 12 weeks can be enrolled
Subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to screening
Signed written informed consent

Exclusion Criteria:

Ongoing insulin therapy
Change in two HbA1c levels measured at an interval of 4 weeks or longer for the previous 6 months is at least 1% (the last HbA1c is measured within 4 weeks)
Secondary hypertension
Subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7 milligram per deciliter)
Cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick sinus syndrome, second or third degree atrioventricular (AV) block, bradycardia [less than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral infraction attached within 12 weeks)
Subjects requiring BP control by at least 3 different antihypertensive drugs, or with either systolic blood pressure (SBP) >=180 mmHg or diastolic blood pressure (DBP) >=110 mmHg at baseline
Subjects with type 1 diabetes mellitus (T1DM)
Uncontrolled diabetes with HbA1c >9%
BMI >40 kilogram per square meter (kg/m^2)
Pulmonary disease (chronic obstructive pulmonary disease [COPD], bronchial asthma)
Other patients considered by the investigator to be not eligible for participation in this study for a legal or mental reason
Contraindications for beta-blocker
Pregnant or lactating women
Use of an investigational drug within 30 days of entry to the study","Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01066143,NCT01066143_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,8,"Inclusion Criteria:

Provision of written informed consent
Fluency in English
A diagnosis of GAD
No pregnancy
Right-handedness
Psychotropic medication-free at the start of the study

Exclusion Criteria:

Pregnancy or lactation
Any current DSM-IV-TR Axis I disorder
Any mental retardation or cognitive impairment that precludes informed consent
Known intolerance or lack of response to quetiapine fumarate
Substance or alcohol dependence at enrollment
Participation in another drug trial within 4 weeks prior enrollment
History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
History of prior Seroquel or other antipsychotic agents use
Contraindications to magnetic resonance imaging
Treatment with an effective medication for GAD","Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.",PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01067846,NCT01067846_EG000,No,All,Adult | Older Adult,Not Applicable,29,"Inclusion Criteria:

Eligible subjects must be cocaine-dependent persons between 18 and 65 years

Exclusion Criteria:

Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use
Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications
Positive history of loss of consciousness of greater than 10 min
Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable
History of hospitalization within the previous six months for a medical illness
Deafness, blindness or other significant sensory impairment.
Contraindications for D-cycloserine and magnetic resonance imaging.","Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01068158,NCT01068158_EG000,No,All,Child | Adult | Older Adult,Phase 3,371,"Inclusion Criteria:

Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled.
Household subjects must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free).
Subject is male or female.
Subject is at least 6 months of age at time of enrollment.
Subject is in good general health based on medical history.
Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form.
The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria b (above), they must be willing and able to participate in the study. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation.
Subject and/or their caregiver must be physically able and willing to apply the test article.
Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study.
Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
Subject agrees to not cut or chemically treat their hair while participating in the study.
Subject agrees to follow all study instructions.
Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test.
In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.

Exclusion Criteria:

History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products.
Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations.
Presentation at the treatment site with eczema or atopic dermatitis.
Treatment for head lice (over-the-counter [OTC], home remedy and/or Prescription) in the last 7 days.
Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results.
Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members).
Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, intrauterine device, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization.
Participation in a previous investigational drug study within the past 30 days.
Prior participation in any ivermectin trials.
Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator.
Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).",Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01068665,NCT01068665_EG000,No,All,Adult | Older Adult,Phase 3,228,"Inclusion Criteria:

Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) maximum 45.0 kg/m^2
Type 2 diabetes (diagnosed clinically) for at least 6 months
Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements [for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods]
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)",Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01072643,NCT01072643_EG000,No,All,Child | Adult,Phase 2 | Phase 3,4,"Inclusion Criteria:

Subjects with a diagnosis of pulmonary hypertension
Procedure - Planned cardiac catheterization procedure with spontaneous ventilation and natural airway
Patients who want sedation or general anesthetic for the procedure.
Age: Subjects ≥8 years and < 21 years
Adequate Renal Function defined As:Serum creatinine ≤ 1 mg/dL
Adequate Liver Function defined As:Total bilirubin ≤ 1.5 mg/dL alanine aminotransferase (ALT) ≤ 2 times the upper limit of normal
Informed Consent: All parents or legal guardians must sign a written informed consent.
Signed assent when developmentally appropriate
Negative pregnancy test in menstruating females and all females ≥ 12 yr

Exclusion Criteria:

Refusal of Informed Consent/Assent
Subjects with single ventricle physiology
Pregnant or lactating females
Subjects with syndromes e.g. Trisomy 21 will be excluded due to variability in pharmacodynamic responses and airway instability during sedation
Inappropriate clinical or developmental status to undergo cardiac catheterization under conditions of spontaneous ventilation with a natural airway
Second or third degree heart block
Moderate - severe right ventricular dysfunction/failure
Subjects who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study e.g. behavioral or anxiety disorders, inability to lie supine
Concomitant Medications - Investigational Drugs: Subjects who have received another investigational drug protocol 30 days prior to enrollment in this study
Subjects who in the opinion of the investigator may be non compliant with study schedules or procedures.
Non-English speaking subjects will be excluded due to need for direct communication from clinical and study staff during study procedures and the ability to complete study tools.","To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr

Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01076647,NCT01076647_EG000,No,All,Adult | Older Adult,Phase 3,233,"Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)","Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01093417,NCT01093417_EG001,No,All,Adult | Older Adult,Phase 2,45,"Inclusion Criteria:

HIV infected
HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
25-hydroxyvitamin D level <20
On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

Pregnancy or Breast Feeding
Diabetes
Creatinine Clearance <50
Any active infectious or inflammatory condition
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry",30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks,ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01096342,NCT01096342_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Relapsed or refractory multiple myeloma

Measurable disease as defined by at least ONE of the following:

Serum monoclonal protein >= 1.0 g/dL
> 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
≤ 5 prior therapies; stem cell transplantation and preceding induction therapy will be considered as one therapy; NOTE: Patients must not be candidates for stem cell transplantation or should have had stem cells collected previously
Life expectancy of ≥ 3 months
ECOG performance status of 0, 1 or 2
Absolute neutrophil count >= 1,000/mcL
Platelets >= 75,000/mcL
Hemoglobin >= 8 g/dL
Total serum bilirubin within normal institutional limits
AST (SGOT)/ALT(SGPT) =< 2.5 X institutional ULN
Creatinine < 2.5 mg/dL
Negative serum pregnancy test done ≤7 days prior to registration (for women of childbearing potential only); NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Willingness to provide blood and bone marrow samples for mandatory research component of this study; (US sites only)

Exclusion Criteria:

Any of the following prior therapies:

Myelosuppressive therapy for myeloma ≤ 3 weeks prior to registration or those who have not recovered from acute reversible adverse events due to agents administered > 3 weeks earlier
Non-myelosuppressive agents like thalidomide or high dose corticosteroids ≤ 2 weeks prior to registration
Receiving any other investigational agents

Concomitant high dose corticosteroids

NOTE: Concurrent use of corticosteroids, but patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc.
NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing women; NOTE: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SCH 727965, breastfeeding should be discontinued if the mother is treated with SCH 727965
Currently taking inhibitors/inducers of CYP3A4; (SCH 727965 metabolizes via the CYP3A4 enzyme; there are potential drug interactions with concomitant use of CYP3A4 potent inhibitors/inducers; Principal Investigator should review each case and determine if patients on the CYP3A4 potent inhibitors/inducers are eligible and will make all effort to switch to alternative drugs; patients should not take grapefruit/ grapefruit juice or St. Johns' Wort)
Men or women of childbearing potential who are unwilling to employ adequate contraception","Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.",ChEMBL:CHEMBL2103840 | DrugBank:DB12021 | PubChem:46926350,Dinaciclib,CCc1cnn2c(NCc3ccc[n+]([O-])c3)cc(N3CCCC[C@H]3CCO)nc12,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01098071,NCT01098071_EG000,No,All,Child,Phase 4,34,"Inclusion Criteria:

2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion Criteria:

adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.",One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01098110,NCT01098110_EG000,No,All,Adult,Phase 3,175,"Inclusion Criteria:

current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.
participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.

participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:

at the screening test, the duration of the current episode was no more than 2 months;
current symptoms represented a dramatic and substantial change compared to the participant's symptomatic state prior to the emergence of the current episode;
participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.
participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
responded positively to an antipsychotic medication in a prior episode.
discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.

Exclusion Criteria:

not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening.
not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization.
not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission
not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia
not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder.
not have a 20% or greater decrease in PANSS total score from screening to baseline
not have an imminent risk of self-harm or harm to others, in the investigator's opinion.
not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
not be currently under involuntary in-patient confinement.
not been previously treated with asenapine.",Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01102491,NCT01102491_EG000,No,All,Adult | Older Adult,Phase 4,71,"Inclusion Criteria:

Diagnosis of primary osteoarthritis, knee
Scheduled for elective total knee arthroplasty
Signed written informed consent

Exclusion Criteria:

Refusing participate
Contraindication to regional anesthesia
Severe impairment of bowel motility
administration of other antiemetics within 24hours before surgery
systemic steroid within 24hours before surgery
history of cardiovascular & respiratory disease
renal & hepatic failure",ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery,ChEMBL:CHEMBL1643895 | DrugBank:DB09290 | PubChem:108000,Ramosetron,Cn1cc(C(=O)[C@@H]2CCc3[nH]cnc3C2)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01104558,NCT01104558_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

>18 years of age and <80 years of age
Chronic heart failure subjects with stable clinical condition
New York Heart Association (NYHA) functional classification II-III
Left ventricular ejection fraction (LVEF) ≤45%

Exclusion Criteria:

NYHA functional classification IV
Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
Hypersensitivity to bisoprolol or any of the Concor excipients
Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening
Resting Heart Rate <55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
Woman of childbearing age without effective contraception measures, or who are pregnant or lactating","Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01104779,NCT01104779_EG001,No,All,Adult,Phase 3,167,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months",Oral administration. Once per day.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01104779,NCT01104779_EG002,No,All,Adult,Phase 3,169,"Inclusion Criteria:

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months",Oral administration. Once per day.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01104792,NCT01104792_EG000,No,All,Adult,Phase 3,586,"Inclusion Criteria:

Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures.
Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.","Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01109992,NCT01109992_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,43,"Inclusion Criteria:

Age > 18 years
Clinically indicated N-13 ammonia PET study or ten healthy volunteers
Known coronary artery disease (prior percutaneous coronary intervention, prior coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest likelihood of CAD
Able to exercise on a treadmill
Able and willing to provide informed consent to participate in the study

Exclusion Criteria:

Contraindications to exercise stress testing such as, unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200 mmHg, respectively), or > 1st degree atrioventricular block in the absence of a functioning pacemaker.
Subject requires emergent cardiac medical intervention or catheterization after the clinical study.
Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.
History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.
History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.
History of heart transplantation.
Allergy or intolerance to aminophylline or regadenoson
Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.].
Severe LV dysfunction, with ejection fraction of < 30%
Serious non-cardiac medical illness (e.g., disseminated malignancy, severe neurological dysfunction at time of baseline PET study) or a social situation which will preclude research study participation
History of Seizures.","Regadenoson Rubidium-82 Positron Emission Tomography

Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01110330,NCT01110330_EG000,No,All,Adult | Older Adult,Phase 3,234,"Inclusion Criteria:

Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
other dermatomycosis (fungal skin infection) requiring active treatment
Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
Be HIV-positive (testing will not be performed)
Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment",Ketoconazole 2% cream (formulation F126),ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01110330,NCT01110330_EG001,No,All,Adult | Older Adult,Phase 3,230,"Inclusion Criteria:

Be co-operative, reliable and sufficiently competent to grade and record symptoms as requested
have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy
Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study and have a negative urine pregnancy test at screening (applies to women only)
Sign an informed consent form indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail infection)
other dermatomycosis (fungal skin infection) requiring active treatment
Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication
Have a history of disallowed therapies including oral (by mouth) antifungal treatments within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks, recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet
Be HIV-positive (testing will not be performed)
Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment",Ketoconazole 2% cream (formulation F012) (Nizoral),ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01111149,NCT01111149_EG002,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Male or female subjects, 18-75 years old
Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
Smoking at least 10 cigarettes per day
Weight of at least 100 lbs (45.4 kg)
Motivation to quit smoking
Stabilized psychotic symptoms
Provision of informed consent for testing and treatment

Exclusion Criteria:

Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
Seizure disorder, recent withdrawal from alcohol or anxiolytics
History of bulimia nervosa, anorexia nervosa, or dementia
History of depression, panic, or bipolar disorders
Pregnancy or lactation
Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
Current use of other smoking cessation treatments
Regular use of non-cigarette tobacco products (> than once/week)
Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
Patients with suicidal ideations or plans
Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
History of, or current, alcohol dependence/abuse
Current use of monoamine oxidase inhibitors (MAOI)","Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.

Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT01113385,NCT01113385_EG000,No,All,Child | Adult,Not Applicable,7,"Inclusion Criteria:

2-21 years old
Biopsy proven FSGS or minimal change with steroid resistance
Presence of FSPF (defined as permeability activity >0.5)
Presence of nephrotic range proteinuria (urine protein: creatinine ratio >2) at the time of enrollment.
Persistent nephrotic range proteinuria despite being on stable immunosuppressive medications (cyclosporine, tacrolimus or mycophenolate mofetil) for at least 12 weeks and/or persistent nephrotic range proteinuria despite being on stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for 12 weeks.
Stable serum creatinine (change of less than 0.3 mg/dl) in the prior 3 months.
Schwartz estimated (e) glomerular filtration rate (GFR) >60ml/min/1.73m2

Exclusion Criteria:

Secondary FSGS
Onset of nephrotic syndrome in infancy.
Presence of acute renal failure (as defined by acute kidney injury criteria) at the time of enrollment. These children can be enrolled 1 month after resolution of acute renal failure (ARF).
Decreasing renal function (persistent increase in serum creatinine of greater than 0.3 mg/dl over baseline in the prior 3 months).
Use of another investigational drug
Pregnant or unable to comply with contraceptive measures in females of child bearing age
eGFR < 60 ml/min per 1.73 m2
Children with Galactosemia
Children with type 1 or 2 diabetes","Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.

D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01114204,NCT01114204_EG001,No,All,Adult | Older Adult,Phase 3,199,"Key Inclusion Criteria include:

Males and females ≥18 years of age

Participants with IDA defined as having:

Hemoglobin <10.0 g/deciliter (dL)
Transferrin saturation (TSAT) <20%
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

History of allergy to IV iron
Allergy to two or more classes of drugs
Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2)
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
Hemoglobin ≤7.0 g/dL
Serum ferritin >600 nanogram/mL","Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01114893,NCT01114893_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication",TRAVATAN 0.004% once daily,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01114893,NCT01114893_EG002,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication",Travoprost Group A,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01114893,NCT01114893_EG003,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication",Travoprost Group B,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01114893,NCT01114893_EG004,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication",Travoprost Group C,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01127581,NCT01127581_EG000,No,Female,Adult | Older Adult,Phase 3,678,"Inclusion Criteria:

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacological induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed congenital anomalies, not including polydactyly;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5°C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.","MVI 200 mcg vaginal insert

MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT01128114,NCT01128114_EG000,No,All,Adult | Older Adult,Phase 4,32,"Inclusion Criteria:

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)
Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry

Exclusion Criteria:

Non-response to antipsychotic treatments for manic symptoms in previous episodes
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1. Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%, 2. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter","Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study",PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01129102,NCT01129102_EG000,No,Female,Child | Adult | Older Adult,Phase 3,107,"Inclusion Criteria:

dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman","Norethisterone 1mg, Ethinyl estradiol 0.02mg

NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg",PubChem:94141,11beta-Hydroxyandrostenedione,CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01132547,NCT01132547_EG000,No,All,Child | Adult,Phase 3,9,"INCLUSION CRITERIA:

≥ 2 years and ≤ 21 years of age at the time of study entry
Scheduled to receive chemotherapy for:
Newly diagnosed:
Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
Intermediate or high-risk neuroblastoma
Wilms' tumor (Stage III/IV)
Hepatoblastoma (Stage III/IV)
Germ cell tumors (Stage III/IV)
Brain tumors, including medulloblastoma, PNET and ependymomas
AML
Relapsed/recurrent disease (any patient)
Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)

EXCLUSION CRITERIA:

≥ 29 days after starting chemotherapy
Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
History of anorexia nervosa or bulimia
Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
Children receiving steroids for >7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study
Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction
Allergy to cyproheptadine HCl
Females of childbearing age must not be pregnant.
Female patients who are lactating must agree to stop breast-feeding.","Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally",PubChem:13770,Cyproheptadine Hydrochloride,CN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01135134,NCT01135134_EG000,No,All,Child,Phase 3,220,"Inclusion Criteria:

Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:

Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
Male or female outpatients aged 5 to 15 years at the time of providing informed consent.

Exclusion Criteria:

Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.

Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.","Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:

5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01139801,NCT01139801_EG001,No,Female,Adult | Older Adult,Not Applicable,50,"Inclusion Criteria:

Participant or surrogate is capable of giving informed consent
Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
Participant is undergoing an indicated induction of labor
Participant is found to have cervical Bishop score ≤5 on initial cervical exam
Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
Manufacturer's contraindications to misoprostol or oxytocin","Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01142596,NCT01142596_EG001,No,All,Adult,Phase 3,157,"Inclusion Criteria:

Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.

Exclusion Criteria:

A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
A participant must not be at risk of harming themselves or others, in the investigator's opinion;
A participant must not have been determined to be unsuitable by an investigator.","Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01145625,NCT01145625_EG000,No,Female,Adult | Older Adult,Phase 3,161,"Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the study product, or any ingredients of the study product
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months","2% Minoxidil Topical Solution

2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01145625,NCT01145625_EG001,No,Female,Adult | Older Adult,Phase 3,161,"Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the study product, or any ingredients of the study product
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months","5% Minoxidil Topical Foam

5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01147497,NCT01147497_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,78,"Inclusion Criteria:

18 years
negative pregnancy test
no prior pregnancy beyond 19 6/7 weeks
no pelvic inflammatory disease in last 3 months
no current cervicitis
willing to follow up in 1-2 months

Exclusion Criteria:

active cervical infection
current pregnancy
prior pregnancy beyond 19 6/7 weeks
uterine anomaly
fibroid uterus distorting uterine cavity
copper allergy or wilson's disease for ParaGard
undiagnosed abnormal uterine bleeding
cervical or uterine cancer
sepsis associated with the most recent pregnancy
current breast cancer for levonogestrel IUD
inflammatory bowel disease
allergy to misoprostol",Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01149434,NCT01149434_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

Male or female, ≥18 years of age
For the Pharmacokinetic Drug Interaction Study: Histologically or cytologically confirmed advanced solid tumors that are refractory to all standard of care therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied. For the Pharmacodynamic Study: Histologically or cytologically confirmed metastatic/advanced ovarian carcinoma or metastatic/advanced KRAS mutant colorectal cancer or metastatic/advanced Head and neck squamous cell cancer (HNSCC) that are refractory to all standard therapies therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied.
At least one measurable tumor as defined by RECIST
Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
Eastern Cooperative Oncology Group (ECOG) of 0 to 2
Organ &marrow function as defined in the protocol.
No evidence of preexisting uncontrolled hypertension as documented by two baseline blood pressure readings taken at least 1 hour apart
Clinically euthyroid
Normal range cardiac function
For female patients of child-bearing potential, a negative serum pregnancy test at Screening.
Current use of an acceptable form of double-barrier birth control
Have provided written informed consent

Exclusion Criteria:

Known brain or other central nervous system metastases metastases that are not stable for 3 months or longer
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation.
Major surgery, radiotherapy, chemotherapy, or cytokine therapy within 28 days of Study Day 0;
History of intratumoral bleeding or evidence of bleeding diathesis or coagulopathy
Female patients who are pregnant, planning a pregnancy, or who are breastfeeding
Known allergy or hypersensitivity to JI-101 or everolimus or any component of the investigational products
Use of an investigational drug/device/biologic within 28 days of Study Day 0
Current drug or alcohol abuse or history of drug or alcohol abuse within the past two years
Known history of or serologic positivity for the Hepatitis B Virus (HBV), or the Hepatitis C Virus (HCV), or for the human immunodeficiency virus (HIV)
History of cardiac abnormalities
Gastrointestinal (GI) abnormalities
Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Study Day 0
History of cerebrovascular accident including transient ischemic attack within the past 6 months
History of pulmonary embolism or deep vein thrombosis within the past 6 months
History of significant retinopathy or any progressive eye disease that could lead to severe loss of visual acuity or visual field loss during the study period
Treatment with heparin or heparin analogs
Inability or unwillingness to meet the requirements of the study
Other current active malignancy or history of malignancy within the past five years, except for cervical carcinoma in situ, basal cell carcinoma that has been surgically removed, or prostate cancer that is being managed with watchful waiting.
Any clinically significant abnormal finding at screening that the investigator judges would interfere with study participation","Patients going on the Pharmacodynamic study will receive JI-101 only.

JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.",DrugBank:DB12744 | PubChem:11691242,CGI-1842,COc1ccc(Br)cc1NC(=O)Nc1cccc2c1ccn2Cc1ccnc(N)c1,,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01149538,NCT01149538_EG000,No,All,Child,Phase 1 | Phase 2,31,"Inclusion Criteria:

Available parent or legal guardian capable of participating in informed consent process
Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
Evidence of cognitive deficit in at least one neurocognitive domain

Exclusion Criteria:

History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
History of medical condition known to affect brain function
History of other neurodevelopmental disorder (ex. autism, down syndrome)
History of very low birthweight (<1500 grams)
History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine","Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.",ChEMBL:CHEMBL2105935 | PubChem:10198924 | PubChem:6900,Cholini bitartras,C[N+](C)(C)CCO.O=C([O-])C(O)C(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01152021,NCT01152021_EG000,No,All,Child,Phase 3,8,"Inclusion Criteria:

Patient is 3 - 11 years
Patient is scheduled for MRI at Children's Hospital Boston.
Patient meets criteria to receive either dexmedetomidine or propofol sedation
Patient's guardian provides written consent

Exclusion Criteria:

Patient does not meet established sedation criteria
Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
Patient has current, repaired, or risk for Moya-Moya disease
Patient has had a stroke within the past six months
Patient has uncontrolled hypertension
Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
Known soy, Lecithin, or egg allergy","Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.

Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01157416,NCT01157416_EG000,No,All,Child,Phase 2,17,"Inclusion Criteria:

Certain number of PTSD symptoms plus functional impairment
Must be able to swallow pills

Exclusion Criteria:

Serious kidney or liver disease
Epilepsy
Bipolar
Psychosis","Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01157429,NCT01157429_EG000,No,All,Child | Adult,Phase 2,12,"Inclusion Criteria:

Certain number of PTSD symptoms plus functional impairment
Must be able to swallow pills

Exclusion Criteria:

Serious kidney or liver disease
Epilepsy
Bipolar disorder
Psychosis","Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01160770,NCT01160770_EG000,No,All,Child | Adult,Phase 3,267,"Inclusion Criteria:

The subject or subject's legally authorized representative (LAR) must sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved Informed Consent Form/Health Insurance Portability and Accountability Act (HIPAA) Authorization (if required) prior to study participation.
Previous participation in Lundbeck-sponsored LGS study.
Subject must weigh ≥12.5 kilograms.
Male or female subjects must have been between 2 and 60 years of age at the time of the enrollment in the Phase 3 double-blind study (13110A/OV1012/NCT00518713) or between 2 and 30 years of age at the time of the enrollment in the Phase 2 double-blind study (13108A/OV1002/NCT00162981) study.

If female:

Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with a method of birth control acceptable to the investigator during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study.
Subject is not breastfeeding.
Subjects of childbearing potential must have a negative serum pregnancy test at Study Day 1.
In the investigator's opinion, parent or caregiver must be able to keep an accurate seizure diary.

Exclusion Criteria:

Greater than 14 days have elapsed since the subject received his/her last dose of study medication in the previous Lundbeck-sponsored LGS study.
Subject had a serious or severe adverse event in the previous Lundbeck-sponsored LGS study that in the opinion of the investigator was probably or definitely related to clobazam use and precludes safe use of clobazam.
Subject has had an anoxic episode requiring resuscitation within 6 months of study entry.
Subject has a history of an allergic reaction or significant sensitivity to benzodiazepines or to any of the other ingredients in clobazam tablets.
Subject is taking more than 3 concurrent anti-epileptic drugs (AEDs). NOTE: Vagal Nerve Stimulator (VNS) or ketogenic diet is allowed and will not be counted in the three allowed AEDs.
Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
If the subject is taking felbamate, has been taking it for less than 1 year prior to study entry or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events.
Subject has experienced an idiosyncratic reaction to an AED, e.g., carbamazepine with resulting aplastic anemia or agranulocytosis, topiramate with resulting metabolic acidosis, felbamate with resulting aplastic anemia or hepatic failure, or lamotrigine with resulting skin irritation and/or rash.
Subject has shown any clinically significant history of hyper-sensitivity to central nervous system (CNS) active medications leading to neurobehavioral aberrations (e.g., increased biting, scratching, kicking, or hitting).
Subject has taken or used any investigational drug or device in the 30 days prior to screening, with the exception of clobazam in a Lundbeck-sponsored study.
Subject has a clinically significant unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, or pulmonary disease or ongoing malignancy.
Subject has a diagnosis of sleep apnea.
Subject has a compromised respiratory function or severe respiratory insufficiency.
Subject has a history of severe muscle weakness, including myasthenia gravis.
Subject has a clinically significant abnormal laboratory value or electrocardiogram (ECG) abnormality.
Subject has progressive lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Subject has a history of drug or alcohol abuse.
Subject has a history of poor compliance on past antiepileptic therapy.
Subject has inadequate supervision by parent or guardian.
For any reason, the subject is considered by the investigator to be an unsuitable candidate for the study.",Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily,ChEMBL:CHEMBL70418 | DrugBank:DB00349 | PubChem:2789,Clobazam,CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21,N05BA09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01165424,NCT01165424_EG000,No,All,Child,Phase 3,80,"Inclusion Criteria:

Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion Criteria:

Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects with coexisting fungal infection in nasal/sinus cavity
Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period","Mometasone furoate nasal spray (MFNS) 50 mcg device.

Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.

Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01165996,NCT01165996_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,25,"Inclusion

MDS classified by hematopathology review as WHO categories refractory anemia (RA) or refractory cytopenia with multi-lineage dysplasia (RCMD) or refractory anemia with ring sideroblasts (RARS) or refractory anemia with excess blasts (RAEB1 or RAEB2) or chronic myelo-monocytic leukemia (CMML1 or CMML2)
Symptomatic anemia OR thrombocytopenia with a platelet count of < 100 x 10^9/L OR transfusion dependence for red-cells OR transfusion dependence for platelets OR absolute neutrophil count < 1 x 10^9/L

Exclusion

MDS of the WHO sub-types RA or RCMD with sole 5q- abnormality on cytogenetics unless failed lenalidomide (Revlimid) therapy
Previous treatment with decitabine
Untreated erythropoietin deficiency defined as an erythropoietin level of < 200 IU/L and erythropoietin replacement therapy for < 8 weeks (erythropoietin deficiency until corrected)
Uncontrolled infection
Severe sepsis or septic shock
Current pregnancy or breast feeding
The patient is of childbearing age, and is unwilling to use contraception and has not had a tubal ligation, hysterectomy, or vasectomy , or their partner is also unwilling to use an acceptable method of contraception as determined by the investigator
Not able to give informed consent
Altered mental status or seizure disorder
ALT > 300 IU; or albumin < 2.0 mg/dL
Creatinine > 2.5 mg/dl and creatinine clearance < 60ml/min
B12, folate, or iron deficient, until corrected
NYHA class III/IV status
ECOG performance status > 2
HIV positive or history of seropositivity for HIV
Transformation to acute leukemia ( >= 20% myelo-blasts in marrow aspirate)
Any experimental agents other than the study drug decitabine",INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01166594,NCT01166594_EG001,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Age more than 18 years old
Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
Decision makers fluent in English
Decision makers able to understand and read consent form

Exclusion Criteria:

Patients with active intraocular inflammation/uveitis or neovascular glaucoma
History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
Aphakia in surgical eye
Pregnant and nursing women
Unable to fulfill inclusion criteria
Refusal of consent","Control - BSS

Control: intrableb BSS injection - 29 patients",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01180894,NCT01180894_EG000,No,All,Adult | Older Adult,Not Applicable,75,"Inclusion Criteria:

ICU admission for trauma
Adults (age ≥ 18 years)
Anemia (hemoglobin < 12 g/dL)
≤ 72 hours from ICU admission
Expected ICU length of stay ≥ 7 days

Exclusion Criteria:

Active hemorrhage requiring RBC transfusion
Iron overload (serum ferritin concentration ≥ 1,000 ng/mL) or any condition associated with iron overload (e.g., hemochromatosis, aceruloplasminemia
Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis)
Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, myeloproliferative disease)
Macrocytic anemia (mean corpuscular volume ≥ 100 fL)
Current use of immunosuppressive agents including corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, exclusive of inhaled corticosteroids), calcinurin inhibitors (e.g., cyclosporine, tacrolimus), antimetabolites (e.g., azathioprine), or biologics (e.g., OKT3, thymoglobulin)
Use of recombinant human erythropoietin formulation within the prev 30 days
Pregnancy or lactation
Prohibition of RBC transfusion
Stay of ≥ 48 hours duration in the ICU of a transferring hospital
History of intolerance or hypersensitivity to either enteral or intravenous iron
Moribund state in which death is imminent
Enrollment in any other clinical trial","100 mg IV TIW

Iron sucrose: 100 mg IV TIW",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01186003,NCT01186003_EG001,No,All,Adult | Older Adult,Not Applicable,30,"Inclusion Criteria:

Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
Patients will be of age 19 to 80.

Exclusion Criteria:

Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment",Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy,ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01188551,NCT01188551_EG002,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.",Dexmedetomidine given intranasally in OR without any pre-medication.,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01190254,NCT01190254_EG001,No,All,Child,Phase 3,98,"Inclusion Criteria:

Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
Each participant must be ≥12 years of age and <18 years of age.
Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
Each participant must agree not to begin formal, structured psychotherapy during the trial.

Exclusion Criteria:

A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with ""continuous,"" ""single episode in partial remission,"" or ""single episode in full remission"" course specifiers.
A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).",Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks,ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01190436,NCT01190436_EG000,No,All,Adult | Older Adult,Phase 4,125,"Inclusion Criteria:

Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)
Aged at least 18 years old
Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent

Exclusion Criteria:

Subjects who were already on beta-blocker therapy at the time of recruitment
Subjects with heart rate of at most 60 beats per minute (bpm) at rest
Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
Subjects with coronary conduction disorders (bundle branch block)
Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
Subjects who are pregnant or expect to be pregnant within the 24-week study period
Subjects on oral contraceptives
Subjects with asthma or a history of asthma
Subjects with documented severe renal disease
Subjects on anti-neoplastic drugs","Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01195116,NCT01195116_EG000,No,All,Adult | Older Adult,Phase 4,41,"Inclusion Criteria:

Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
2. Gender of Patients: Male & female,Age of Patients: 18 and older

Exclusion Criteria:

Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.","Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.

Dexmedetomidine: 1 mcg/kg/hour",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01195883,NCT01195883_EG000,No,All,Adult | Older Adult,Not Applicable,534,"Inclusion Criteria:

ASA Physical Status 1-3
Body Mass Index < 35
Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

Exclusion Criteria:

cardiac insufficiency (EF<35%)
coronary disease with angina (NYHA IV)
severe chronic obstructive pulmonary disease
coagulopathies
symptoms of infection or sepsis
renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)
ASA Physical Status > 3.","Lactated Ringers solution will be used for fluid replacement.

Crystalloid: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.",PubChem:6335487,Ringer's lactate,CC(O)C(=O)O.[Ca+2].[Cl-].[Cl-].[Cl-].[Cl-].[K+].[Na+].[Na],,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0
NCT01197300,NCT01197300_EG001,No,All,Child | Adult,Phase 3,15,"Key Inclusion criteria:

Written informed consent before any study-related procedure.

Group 1:

Children and adolescents, male or female, 6-19 years old, who met the inclusion criteria for entry into the Core study and who took at least one dose of study drug and have completed Visit 8 of the CZOL446H2337 Core study.
Patient must be enrolled into the extension at Visit 9 up to 10 months after Visit 5 (month 6) of the Core study.
Patients who followed the regimen of calcium and vitamin D intake as required in the Core study through diet or supplementation.

Group 2:

Children and adolescents, male or female, 5 - 17 years old who met the inclusion criteria for entry into the Core study but were not enrolled because of clinically significant back pain from vertebral fracture and the preexisting clinical care at the Investigator site is to treat this type of patient with a bisphosphonate.
Confirmed diagnosis of non-malignant conditions (including but not limited to rheumatic conditions, inflammatory bowel disease, Duchenne muscular dystrophy, nephrotic syndrome), treated with systemic glucocorticoids (i.v. or oral) within the 12 months preceding enrollment in the study (any duration)
LS-BMD Z-score of -0.5 or worse confirmed by the central imaging vendor
Evidence of at least 1 vertebral compression fracture (at least Genant Grade 1 vertebral compression or radiographic signs of vertebral compression) confirmed by central reading OR At least one lower OR 2 upper extremity long-bone, low-trauma, fracture which occurred sometime within the 2 years or preceding enrollment in the study, confirmed by radiological report. (*Low trauma fracture is defined as falling from standing height or less).

Key Exclusion criteria:

Major protocol violation in the Core Study (Group 1 only).
Prior use of bisphosphonates (Group 2 only) or sodium fluoride (doses for osteoporosis not for dental hygiene).
Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at Visit 8 or 8A.
Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 20 ng/mL or < 50 nmol/L) at Visit 8 (Group 1) or Visit 8A (Group 2).
Renal impairment defined as an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 at screening based on the Schwartz formula at Visit 8 or 8 A; a serum creatinine above the normal range at Visit 9 (Group 1) or an increase between Visit 8A and Visit 9 greater than 0.5 mg/dL (44.2 μmol/L) for Group 2.
Female patients of child bearing potential are eligible only if they are not pregnant/non-lactating. Females of child bearing potential must be practicing a medically acceptable form of birth control for greater than 2 months prior to screening visit and consent to pregnancy tests during the study.",Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0
NCT01200433,NCT01200433_EG001,No,All,Adult | Older Adult,Not Applicable,44,"Inclusion Criteria:

ASA I-III.
Scheduled for DBS.

Exclusion Criteria:

History of dystonia.
Severe heart failure with ejection fraction less than 30%.
History of obstructive sleep apnea.
History of renal failure with creatinine level > 2 mg/dl.
Allergies to α-2 agonists and propofol.
Current use of α-2 agonist medications such as clonidine.","Subjects will be sedated with dexmedetomidine.

dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01201915,NCT01201915_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of 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 might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.",Participants received vismodegib 150 mg orally daily for 12 weeks.,ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01201915,NCT01201915_EG001,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of 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 might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.",Participants received vismodegib 150 mg orally daily for 12 weeks.,ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01201915,NCT01201915_EG002,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
Willingness to consent to biopsy of the lesion.
Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
Adequate hematopoietic capacity.
Adequate hepatic function.
For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.

Exclusion Criteria:

Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
Inability or unwillingness to swallow capsules.
Pregnancy or lactation.
BCC with any clinical and histological pattern other than nodular BCC.
Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
Use of any excluded medication or therapy within 21 days of study entry.
History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
Uncontrolled medical illness.
History of 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 might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
Any medical or psychological illness or condition preventing adequate consent.","Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01204203,NCT01204203_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Males and females > 18 years of age
Life expectancy of at least 2 months
Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
ECOG Performance Status of 0-2

Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:

ANC ≥ 1.5 x 109/L
Platelet Count ≥ 100 x 109/L
Hemoglobin ≥ 9g/dL
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN
ALK-P ≤ 3 x ULN
Serum creatinine ≤ 1.8mg/dL
Calculated Serum Creatinine Clearance 40 - > 60ml/min
Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
Willing and able to provide written informed consent.

Exclusion Criteria:

Known central nervous system (CNS) tumor involvement
Evidence of other active malignancy requiring treatment
Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
Known infection with HIV or hepatitis
Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
Active, serious systemic disease, including active bacterial or fungal infection.
Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.",Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01204918,NCT01204918_EG000,No,All,Adult | Older Adult,Phase 2,25,"Group A inclusion/exclusion

Inclusion Criteria:

Age 18-65
Written informed consent
Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
Inventory of Depressive Symptomatology - Self-Rated (IDS-SR30) score of > 20 at screening, baseline and start of double-blind phase (Phase 2)
May have a history of failure to respond to up to two FDA-approved antidepressants at adequate doses during the current episode for at least 8 weeks, and for inclusion into the Phase 2 subjects must have failed the 8-week prospective citalopram treatment.
Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of Phase 2.

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
Patients who demonstrate > 50% decrease in depressive symptoms as reflected by the IDS-SR total score from screen to baseline
Serious suicide or homicide risk, as assessed by evaluating clinician A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
History of a seizure disorder or clinical evidence of untreated hypothyroidism
Patients requiring excluded medications (see Table 3 for details)
Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
Any investigational psychotropic drug within the last 3 months
Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
Patients with a history of antidepressant-induced hypomania.
Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level >1.5 X ULN at initial screening, or >5 x ULN during Phase 2 treatment.
Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance.
Patients currently being treated for a respiratory disorder (including asthma or COPD)
Any subject who scores a 5 or higher on item #10 of the MADRS

Group B inclusion/exclusion

Inclusion criteria:

Age 18-65
Written informed consent
Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
Inventory of Depressive Symptomatology - Self-Rated (IDS-SR30) score of > 20 at screening and baseline visits, that is at the start of Phase 2
Has a history of failure to respond to 1, 2, or 3 FDA-approved antidepressants at adequate doses during the current episode for at least 8 weeks, as defined by the MGH Antidepressant Treatment Response Questionnaire (MGH-ATRQ), and must be currently on the failed SSRI for at least 8 weeks and on a stable dose for at least 4 weeks.
Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of Phase 2.

Exclusion Criteria

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
Serious suicide or homicide risk, as assessed by evaluating clinician A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
History of a seizure disorder or clinical evidence of untreated hypothyroidism;
Patients requiring excluded medications (see Table 3 for details)
Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
Any investigational psychotropic drug within the last 3 months
Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
Patients with a history of antidepressant-induced hypomania.
Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level >2 X ULN at initial screening, or >5 x ULN during Phase 2 treatment.
Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patients safety or compliance.
Patients currently being treated for a respiratory disorder (including asthma or COPD)
Any subject who scores a 5 or higher on item #10 of the MADRS","Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks

Riluzole: Riluzole 100mg PO",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01209598,NCT01209598_EG001,No,All,Adult | Older Adult,Phase 2,60,"Inclusion Criteria:

A diagnosis of liposarcoma confirmed at MSKCC. Because myxoid / round cell liposarcoma does not have significant CDK4 amplification, patients with this subtype are not eligible.
Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable, with evidence of disease progression, either clinically or radiographically, as determined by the investigator
All patients must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
A minimum of 1 prior systemic regimen for recurrent/metastatic disease. Note: This requirement does not apply to patients enrolled in the Expansion Cohort. The last dose of systemic therapy (include targeted therapies) must have been given at least 2 weeks prior to initiation of therapy. Patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy.
Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.
Age > or = 18 years.
ECOG performance status 0 or 1.
Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):

Absolute neutrophil count ≥ 1.5x109/L Hemoglobin ≥ 9.0 g/dL WBC ≥ 3.0x109/L Platelets ≥ 100x109/L Total bilirubin ≤ 1.5 x ULN except for patients with known Gilbert syndrome AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)QTc interval ≤ 470 msec

Patients must not have current evidence of another malignancy that requires treatment.
The effects of Palbociclib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Women must not breast feed while on study.
Ability to understand and the willingness to sign a written informed consent document.
Ability to swallow intact Palbociclib capsules.
Patients"" tumors must express Rb, as assessed using an historical biopsy sample if available or a newly obtained tumor sample. Samples must demonstrate ≥1+ staining for Rb. Patients' tumors must also have evidence of CDK4 amplification by FISH. Note: This does not apply to patients enrolled in the Expansion Cohort.

Exclusion Criteria:

Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1.
Patients receiving any other investigational agents.
Patients who have received prior treatment with a selective CDK4 inhibitor
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Palbociclib.
Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women and women who are breast-feeding.
Patients with a history of long-QT syndrome or documented family history of long-QT syndrome. Patients who must remain on drugs that prolong the QT interval.
Palbociclib is a substrate of CYP3A. Caution should be exercised when dosing Palbociclib concurrently with CYP3A inducers or inhibitors. Furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk. A list of CYP3A4 substrates, inducers and/or inhibitors is provided in Appendix B. The following medications with strong potential for interaction are not allowed: indinavir nelfinavir ritonavir clarithromycin itraconazole ketoconazole nefazodone saquinavir telithromycin carbamazepine phenobarbital phenytoin pioglitazone rifabutin rifampin St. John's wort Troglitazone","This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

Palbociclib 125mg: Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.",ChEMBL:CHEMBL189963 | DrugBank:DB09073 | PubChem:5330286,Palbociclib,CC(=O)c1c(C)c2cnc(Nc3ccc(N4CCNCC4)cn3)nc2n(C2CCCC2)c1=O,L01EF01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01218126,NCT01218126_EG001,No,All,Adult | Older Adult,Phase 2,149,"Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years","Participants received Losmapimod 2.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.",ChEMBL:CHEMBL1088752 | DrugBank:DB12270 | PubChem:11552706,Losmapimod,Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01218126,NCT01218126_EG002,No,All,Adult | Older Adult,Phase 2,151,"Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years","Participants received Losmapimod 7.5 mg tablet twice daily orally for a period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.",ChEMBL:CHEMBL1088752 | DrugBank:DB12270 | PubChem:11552706,Losmapimod,Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01218126,NCT01218126_EG003,No,All,Adult | Older Adult,Phase 2,149,"Inclusion Criteria:

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking
aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks
treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years","Participants received Losmapimod 7.5 mg tablet twice daily orally for 4 weeks followed by Losmapimod 15 mg for a total period of 24 weeks. During the run-in and treatment periods all participants continued their existing COPD therapy at a constant dose, including long-acting β2-agonists (LABA); long-acting muscarinic antagonists (LAMA); xanthines and/or inhaled corticosteroids (ICS). Participants were followed-up for 1 week after the last dose of the study drug.",ChEMBL:CHEMBL1088752 | DrugBank:DB12270 | PubChem:11552706,Losmapimod,Cc1c(F)cc(C(=O)NC2CC2)cc1-c1ccc(C(=O)NCC(C)(C)C)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01222884,NCT01222884_EG001,No,All,Adult | Older Adult,Phase 3,114,"Inclusion Criteria:

Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be included if they meet all of the following criteria:

Men or women, aged 18 years or greater.
Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness and ability to participate after Informed Consent.
Hb concentrations between 9.5 g/dL and 12.5 g/dL (both values included) both at Screening Visit 1a and at Screening Visit 1b (screening Visit 1a and Visit 1b must be separated by at least 1 week).
Serum ferritin < 800 ng/mL.
Transferrin Saturation < 35%.
Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to screening (with only 1 missed dose to be allowed. Dose to be kept stable during the study period).
Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4 weeks (with only 1 missed dose to be allowed).

Exclusion Criteria:

Anaemia caused primarily by factors other than renal related anaemia.
Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
Patients currently undergoing treatment with immunosuppresives (low dose steroids are allowed during the study conduct for dosages no more than 10 mg prednisolone/day or equivalent. If possible the dosage should be kept constant through the study).
Difference of Hb ≥ 1.0 g/dL between screening (Visits 1a and 1b).
Patients with a history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis [Alanine Aminotransferase (ALT) > 3 times normal] or history of Hepatitis B or C.
Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood Cells (WBC) and C - reactive protein (CRP).
Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy or nursing. [To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches]
Blood transfusion within the previous 12 weeks.
Planned elective surgery in the next 8 weeks.
Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives prior to screening.
Untreated Vitamin B12 or folate deficiency.
Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.","Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01224236,NCT01224236_EG001,No,All,Child,Phase 2 | Phase 3,74,"Inclusion Criteria:

birth weight: < 1500 grams
Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

cyanotic heart disease
bowel resection prior to enrollment",multivitamin solution without iron,ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01226459,NCT01226459_EG001,No,Female,Adult | Older Adult,Phase 3,203,"Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the (study product), or any ingredients of the (study product)
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months","5% Minoxidil Topical Foam

5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01228747,NCT01228747_EG001,No,All,Child | Adult | Older Adult,Phase 3,126,"Inclusion Criteria:

An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria:

Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1","Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks

Levetiracetam: Oral dose tablets, twice daily",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01229735,NCT01229735_EG000,No,All,Child | Adult | Older Adult,Phase 4,177,"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)",250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01232946,NCT01232946_EG001,No,All,Adult,Not Applicable,10,"Inclusion Criteria:

Type 2 diabetic
18-50 years
BMI > 25kg/m2
HbA1c 7.0-10.0%
Treated with up to 2 oral agents

Exclusion Criteria:

Chronic illness or infection (other than diabetes mellitus)
Known coronary artery disease, structural heart disease or abnormal ECG on screen.
Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
Current pregnancy
Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
Known intolerance to GLP-1 agonist
Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
Recognized microvascular complications (neuropathy, nephropathy, retinopathy).","Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.

insulin detemir: 5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months",ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01238471,NCT01238471_EG001,No,All,Child,Phase 1 | Phase 2,10,"Inclusion Criteria:

Evidence for ROP that might progress and that includes any one of the following:

Stage 1 (zone I)
Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is according to International Classification of Retinopathy of Prematurity (ICROP) 2005 (40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is not included since it will always regress spontaneously.

Exclusion Criteria:

The presence of one or more of the following conditions at enrollment in the study:
More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [
Atrio-ventricular (A-V) block [2nd or 3rd degree]
Significant congenital heart anomaly [not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect]
Heart failure
Hypotension (mean blood pressure <45 mmHg)
Hypoglycemia (<50mg/dL)
Platelet count <100000/mm3","Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization

sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks",ChEMBL:CHEMBL253582 | DrugBank:DB02772 | PubChem:5988,Sucrose,OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[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
NCT01239212,NCT01239212_EG000,No,All,Child,Phase 1 | Phase 2,7,"Inclusion Criteria:

Gestational age ≥ 32 weeks
Postnatal age ≤ 30 days
Birth weight ≥ 2000 grams
Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
Clinical or electrographic seizures of any etiology
Seizures or seizure prophylaxis requiring treatment with levetiracetam
Parental consent obtained

Exclusion Criteria:

Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
Infants who have previously received levetiracetam
Parents refuse consent
Attending physician does not wish the infant to be enrolled in the study
Infants who are currently receiving an investigational drug","Single arm, 50 mg/kg of levetiracetam",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01244828,NCT01244828_EG000,No,All,Adult | Older Adult,Phase 3,157,"Inclusion Criteria:

Minimum age of 20 years

Participants who meet at least one of the following:

current diagnosis of schizophrenia of residual subtype
received treatment with 3 or more antipsychotic drugs
treatment-refractory participants with schizophrenia
65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

Uncontrolled, unstable clinically significant medical condition
Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
Seizure disorder beyond childhood (12 years old or younger)
History of neuroleptic malignant syndrome
Allergy or sensitivity to drugs such as psychotropics and antipsychotics
Known history of or currently treated for narrow angle glaucoma
Parkinson's disease
Diagnosis of schizoaffective disorder; schizophreniform disorder
Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
Diagnosis of borderline personality disorder
Diagnosis of mental retardation or organic brain disorder
Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
Positive drug/alcohol tests at the Screening visit
Imminent risk of self-harm or harm to others, in the Investigator's opinion
Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
Currently under involuntary inpatient confinement
Use of a non-approved drug in Japan within 12 weeks prior to informed consent
Previously treated in an asenapine study","All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01246791,NCT01246791_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 3,12,"Inclusion Criteria:

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Exclusion Criteria:

Females who are pregnant
Drug use affecting sex hormone secretion","Single oral administration of NPC-01

NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition",PubChem:94141,11beta-Hydroxyandrostenedione,CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01251146,NCT01251146_EG000,No,All,Adult | Older Adult,Phase 4,86,"Inclusion Criteria:

Subjects aged between 25-65 years
Subjects with essential hypertension (EH)
Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
Subjects with normal sinus rhythm
Subjects with resting heart rate (RHR) greater than 70 bpm
Subjects who give written informed consent

Exclusion Criteria:

Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
Subjects with bradyarrhythmia/hypotension
Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
Subjects with uncontrolled diabetes mellitus (DM)
Subjects with bronchial asthma
Subjects with gastro-intestinal ulcer or skin ulcer
Subjects with liver dysfunction/renal impairment
Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
Subjects with glaucoma
Subjects with known allergic/intolerance to beta-blocker
Pregnant or lactating women
Subjects who had participated in another clinical study within the last 3 months
Subjects who have legal incapacity or limited legal capacity","Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01251354,NCT01251354_EG000,No,Female,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Provision of written informed consent prior to any study related procedures.
postmenopausal or ovariectomised female patient over 18 years of age.
histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
patient has at least one measurable disease site (RECIST criteria version 1.1)

Exclusion Criteria:

patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
patient was treated with any other investigational agent within the 3 weeks before study entry.
patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.","BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops",ChEMBL:CHEMBL286738 | DrugBank:DB02292 | PubChem:5287541,Irosustat,NS(=O)(=O)Oc1ccc2c3c(c(=O)oc2c1)CCCCC3,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01253824,NCT01253824_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 3,7,"Inclusion Criteria:

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Exclusion Criteria:

Females who are pregnant
Drug use affecting sex hormone secretion","1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol",PubChem:94141,11beta-Hydroxyandrostenedione,CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01253902,NCT01253902_EG001,No,All,Adult | Older Adult,Phase 4,53,"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 travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01254292,NCT01254292_EG001,No,Female,Adult,Phase 3,281,"Inclusion Criteria:

Subject has signed and dated the Informed Consent Form (ICF).
The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.

In the opinion of the investigator, the subject is

in good health;
without uterine conditions that would preempt insertion of LCS12;
without conditions/history that would contraindicate the use of oral contraceptives.
Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
Any genital infection (until successfully treated)
Abnormal cervical smear result (see inclusion criteria)
Acute, current or history of recurrent pelvic inflammatory disease
Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.",Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles,ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01257750,NCT01257750_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,20,"Inclusion Criteria:

Ability to provide written informed consent
Ability to comply with study assessments and study requirements (for example, able to open the eye drop foil-wrap packaging and eye drop vials, willing to adhere to the daily dosing schedule) for the full duration of study
Age > 18 years
Patients with superficial or deep corneal neovascularization that extends farther than 1 mm from the limbus
Patients are in stable overall health
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin ≤ 1.5x upper limit of normal (ULN) or isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%
Single QTcF < 450 msec; or QTcF < 480 msec in subjects with Bundle Branch Block
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),

Exclusion Criteria:

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
History of any clotting disorder, including predisposition to hypercoagulation or any previous thromboembolic event
Major surgery within 1 month of screening
Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 60 days of study entry. This includes both approved and investigational treatments.
Has received investigational therapy within 60 days prior to study entry
Concurrent enrollment in another clinical investigational medicinal product or device study
Concurrent use of anti-VEGF agents
Corneal or ocular surface infection within 30 days prior to study entry
Full thickness or lamellar keratoplasty within 90 days prior to study entry
Other ocular surgeries within 60 days prior to study entry
Ocular or periocular malignancy
Soft Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
Persistent epithelial defect (>1mm and ≥14 days duration) within 2 weeks prior to study entry
Intravitreal or periocular steroids within 4 weeks prior to study entry
Change in dose/frequency of topical steroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study entry
Poorly controlled Hypertension: systolic blood pressure (BP) > 150 or diastolic BP > 90
Medical history of uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) >7%

Women 45 years of age or younger that are of child bearing potential as defined by:

No history of a hysterectomy
No history of a bilateral oophorectomy (ovariectomy)
No history of a bilateral tubal ligation
Not post-menopausal
Subjects using hormone replacement therapy (HRT) that have experienced total cessation of menses for ≤ 1 year, OR, in questionable cases, have a follicle stimulating hormone (FSH) value <40 mIU/mL and an estradiol value > 40pg/mL (>140 pmol/L) OR have documented evidence OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT. Signs of current infection, including fever and current treatment with antibiotics
Participation in another simultaneous medical investigation or trial STUDY","This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.

Frequency and Duration: 4 times per day for 3 weeks",PubChem:11525740,Pazopanib Hydrochloride,Cc1ccc(Nc2nccc(N(C)c3ccc4c(C)n(C)nc4c3)n2)cc1S(N)(=O)=O.Cl,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01267279,NCT01267279_EG001,Accepts Healthy Volunteers,All,Child | Adult | Older Adult,Phase 4,27,"Inclusion Criteria:

Patients undergoing primary elective total hip replacement

Exclusion Criteria:

Osteoporosis (BMD ≤-2.5)
Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
Severe renal impairment
Use of any medications affecting BMD
Known sensitivity to bisphosphonates
Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods",Zoledronic acid: Zoledronic acid per protocol,ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01268111,NCT01268111_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,12,"Inclusion Criteria:

1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months

Exclusion Criteria:

1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.

2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.

3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day","ERgocalcifoerol 50,000 units q weekly for 8 weeks",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01269047,NCT01269047_EG000,No,All,Child | Adult,Phase 4,13,"Inclusion Criteria:

Age of 12 to 21 years.
HbA1C less than 9%
Subjects must be on intensive insulin management
Tanner stage greater than or equal to 3
Having Type 1 Diabetes for at least one year
Type 1Diabetes defined by ADA criteria and having at least one of the following antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512) c. Anti-insulin
Willing to give consent.

Exclusion Criteria:

Type 2 diabetes.
Having any other chronic condition except hypothyroidism stable on medications.
On chronic medications that may affect glucose excursions.
Anemia as defined as Hb less than 9 gm/dl.
Abnormal amylase, lipase or creatinine (twice normal).
Abnormal Liver function tests(three times above normal)
Unsupportive family environment as determined by clinicians and/or social workers.
Pregnant or lactating mothers","These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.

Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months",ChEMBL:CHEMBL2103758 | DrugBank:DB01278,PRAMLINTIDE,[H]N[C@@H](CCCCN)C(=O)N[C@H]1CSSC[C@@H](C(=O)N[C@@H](C)C(=O)N[C@]([H])(C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](Cc2cnc[nH]2)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)NCC(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(C)C)C(=O)N2CCC[C@H]2C(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@]([H])(C(=O)N[C@@H](Cc2ccc(O)cc2)C(N)=O)[C@@H](C)O)C(C)C)[C@@H](C)O)[C@@H](C)CC)C(C)C)[C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](CC(N)=O)NC1=O,A10BX05,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01269918,NCT01269918_EG001,No,All,Adult | Older Adult,Not Applicable,142,"Inclusion Criteria:

Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:

Age: Older than 18
Primary and redo cases will be included
Duration of surgery not exceeding 6 hrs.

Exclusion Criteria:

Patient refusal
Emergency craniotomy
Morbid obesity
Uncontrolled hypertension - DBP more than 110
Cardiac conduction defects
Patients with chronic pain.","a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01272934,NCT01272934_EG000,No,All,Adult | Older Adult,Phase 3,102,"Inclusion Criteria:

Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours.

Exclusion Criteria:

Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).","Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,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
NCT01273805,NCT01273805_EG001,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Histologically confirmed unresectable pancreatic adenocarcinoma that is metastatic to distant sites
Measurable disease, defined as at least one lesion that can accurately be measured in at least one dimension
Patients must have been treated with one or two previous lines of chemotherapy for metastatic disease with documented tumor progression or intolerance due to toxicity
Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
18 years of age or older
Life expectancy of greater than 12 weeks
ECOG performance status of 0, 1 or 2
Normal organ and marrow function as outlined in the protocol
Patients must be able to swallow pills
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
More than two previous chemotherapy regimens for the treatment of metastatic pancreatic cancer
Uncontrolled brain or leptomeningeal metastases
History of macular degeneration, visual field changes, retinal disease, or cataracts that would interfere with funduscopic eye examinations
History of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine
Previous treatment with chloroquine or hydroxychloroquine for other indications, such as rheumatoid arthritis, SLE or malaria prophylaxis
Prior treatment with any investigational drug within the preceding 4 weeks
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter absorption of hydroxychloroquine. Patients who have undergone a Whipple procedure for localized pancreatic cancer are not excluded from enrollment
History of non-compliance to medical regimens
Known diagnosis of glucose-6-phosphate deficiency, porphyria or psoriasis
Penicillamine use for Wilson's disease or any other indication
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 or breastfeeding women
Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3-years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past three years: cervical cancer in situ, and basal cell or squamous cell carcinoma
HIV-positive individuals on combination antiretroviral therapy","Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01277211,NCT01277211_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 3,232,"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 drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.",ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01283022,NCT01283022_EG000,No,Female,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacologic induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

Women with hemoglobin level < 10.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed congenital anomalies, not including polydactyly;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5°C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.","MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0
NCT01284517,NCT01284517_EG000,No,All,Adult | Older Adult,Phase 3,177,"Inclusion Criteria:

Provide written informed consent and is 18 to 75 years of age inclusive.
Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Has a lifetime history of at least one bipolar manic or mixed manic episode.
Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than Bipolar I Disorder).
Hospitalization for a manic or mixed episode within the past two months.
Used investigational compound within past 6 months.
Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.",Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01286402,NCT01286402_EG000,No,Female,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Pregnant women ≥ 18 years of age
Gestational age between 14 and 26 weeks confirmed by ultrasound
Currently smoking ≥ 5 cigarettes per day

Exclusion Criteria:

Abnormal liver function tests
History of or current seizure disorder or closed head injury with loss of consciousness
Known hypersensitivity to bupropion
Any psychiatric disorder requiring psychotropic medication
Current anorexia or bulimia
Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks
Major Depressive Disorder or current suicidal risk
Use of any illicit substances since receiving knowledge of pregnancy
Regular use of alcohol (>1 drink/week on average)
Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus
Twins or other multiple gestation
Fetal abnormality on the 14 week ultrasound
Plans to deliver at a hospital other than Memorial Hermann
Inability to communicate with research staff or make study visits due to lack of phone or transportation access
Participation in another clinical study which may affect study outcomes
Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)","Group receiving bupropion SR medication

Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days

- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01290341,NCT01290341_EG000,No,All,Child | Adult | Older Adult,Phase 3,572,"Inclusion Criteria:

Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).

Exclusion Criteria:

Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.
Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
Subjects with a known hypersensitivity to study drugs or their components.
Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
Uncontrolled diabetes mellitus.
Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Current diagnosis of immunocompromising conditions.
Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
Extremely severe tinea pedis (incapacitating).
Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.",Topical; applied once daily for two weeks,PubChem:5281098,Naftifine Hydrochloride,CN(CC=Cc1ccccc1)Cc1cccc2ccccc12.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
NCT01290484,NCT01290484_EG000,No,All,Child,Phase 1 | Phase 2,7,"Inclusion Criteria:

Written informed consent(s) for study participation and (where applicable) the use of the participant's images are obtained according to national regulations from the participant's parent(s) or guardian(s) prior to performing any study procedures.
The participant is 6 months to 10 years of age at inclusion.
The participant weight is at least 8kg.
A diagnosis of LM or mixed venous lymphatic malformation involving the skin and subcutaneous tissue and at least 3cm based on clinical and radiographic criteria.
LMs may benefit from systemic therapy based on clinical criteria.
Females must not be pregnant or breast-feeding.
If participant is a child, parent/guardian must be able to follow instructions and must be willing and able to ensure that the subject is present for all required study visits.
Subject has no contraindication for use of sildenafil.
LMs may involve any part of the body.
Subject will have normal results on screening tests (eye exam, blood tests).
Subject has no contraindication for MRI examinations, such as metal implants, etc.
Subject must not be a smoker.

Exclusion Criteria:

The participant has a medically unstable health status that may interfere with his/her ability to complete the study.
The participant presents with one or more of the following medical conditions: hepatic impairment; severe renal impairment; lymphedema conditions such as Milroy disease, Meige lymphedema, Hennekam syndrome, Njolstad syndrome, Aagenaes syndrome, and Fabry disease; hypotension or at risk for hypotension; seizures or history of seizures; any significant cardiovascular risk factors and any condition which requires participants to use nitric oxide donors or nitrates in any form; underlying anatomic or vascular risk factors for developing non-arteritic anterior ischemic optic neuropathy (NAION) including low ocular cup to disc ratio, age over 10, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. (Participants with Down syndrome, Turner syndrome, and Noonan syndrome will be considered on a case-by-case basis).
The participant has received at least one of the following medications contraindicated in association with sildenafil within 15 days of inclusion: Alprostadil, Azole antifungals, Clarithromycins, Conivaptan, Delavirdine, Erythromycins, Fluvoxamine, Grapefruit, Imatinib, Nefazodone, Nitrates/sodium thiosulfate, Non-selective and selective alpha blockers, Protease inhibitors, Rufinamide, Tadalafil, Telithromycin, Vardenafil, Yohimbe, Yohimbine, Amifostine, Lapatinib, Warfarin
The participant requires concomitant use of potent cytochrome P450 3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin, saquinavir) or concomitant use of ritonavir.
The patient has had extensive prior surgery or sclerotherapy to treat LM such that scarring may interfere with the treatment effect of sildenafil.
The participant has previously been administered treatment for LMs or surgical procedures have been performed to remove the index LMs.
Participant is currently pregnant or considering becoming pregnant in the next 20 weeks.
The participant is known to have an allergy to sildenafil.
Ulcerated or currently infected LMs with pain.
Diagnosis of the soft tissue tumor as LM is not clinically certain.
The participant is participating in another clinical study.
The participant has a history of priapism or is diagnosed with sickle cell anemia or any other disorder which may predispose to priapism.
The investigator may declare any subject ineligible for a valid medical reason.",Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.,ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01292837,NCT01292837_EG000,No,All,Child,Phase 3,13,"Inclusion Criteria:

An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1","Twice daily (morning and evening) orally

Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01295879,NCT01295879_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

History of nephrolithiasis as per medical record
Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
25(OH)D deficiency or insufficiency (defined as a serum level < 30 ng/ml) within 3 months of enrollment

Exclusion Criteria:

Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
Hypercalcemia (serum calcium > 10.4 mg/dL) at baseline
Acute stone event or gross hematuria (blood in the urine) within the past 2 months
Recent stone intervention within the past 1 month
Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)","Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01298921,NCT01298921_EG000,No,All,Adult | Older Adult,Phase 1,4,"Inclusion Criteria:

Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included.

Exclusion Criteria:

Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are excluded.",Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes,ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01298921,NCT01298921_EG001,No,All,Adult | Older Adult,Phase 1,4,"Inclusion Criteria:

Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included.

Exclusion Criteria:

Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are excluded.","Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01305655,NCT01305655_EG000,No,All,Child | Adult,Phase 3,47,"Inclusion Criteria:

Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.

Exclusion Criteria:

Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.","In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.

Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.

No serious effect reported.",PubChem:21195079,CID 21195079,[Zn+2].[Zn+2].[Zn+2].[Zn+2],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01306968,NCT01306968_EG002,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Volunteers must have history of at least one mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria:

Brain injury that occurred more than 4 months prior to enrollment, with the most recent injury occurring no earlier than October 7, 2001.
Most recent traumatic brain injury occurred while serving on active duty, and while deployed to the United States (US) Central Command (USCENTCOM).
Most recent traumatic brain injury was caused by blast exposure or blunt trauma.
Most recent traumatic brain injury resulted in at least one of the following: a period of loss of or a decreased level of consciousness (up to 30 minutes); a loss of memory for events immediately before or after the injury (up to 24 hours); or alteration in mental state at the time of the injury (becoming dazed or confused).

Volunteers must also meet all the following criteria:

18-65 years old at the time of study enrollment.
A TRICARE beneficiary at the time of consent and during study participation.
Has current complaints of brain injury symptoms such as headache, dizziness, or cognitive or affective problems that score at least 3 post-concussive symptoms as assessed by the Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification (ID) Method interview
Has received current local care pharmacologic and non-pharmacologic interventions for TBI and any concomitant posttraumatic stress disorder (PTSD) with no significant change in therapy for at least 1 month
Willing and committed to comply with the research protocol and complete all outcome measures.
Able to self-consent.
Able to speak and read English, as primary language.
Able to participate in all outcome measures.
Able to equalize middle ear pressure.

Exclusion Criteria:

History of brain injury of moderate or severe degree: duration of loss of consciousness at the time of injury greater than 30 minutes, or duration of post-traumatic amnesia greater than 24 hours, or brain injury of a penetrating etiology.
History of brain injury not of traumatic etiology, such as stroke or drug-induced coma.
Prior treatment with HBO2.
Hyperbaric chamber inside attendant, professional (paid)underwater diver (commercial, operational/ military, instructor), or technical diver.
Pregnancy, women who plan to become pregnant during the study period, women who do not agree to practice an acceptable form of birth control during the study period, or women who are breastfeeding;
Those who are unable to participate fully in outcome assessments (Blind in one or both eyes; Deaf in one or both ears; or Ambulation with assistive devices
Pre-existing diagnosis of a psychotic disorder(s): schizophrenia, dissociative disorder, and bipolar disease.
Verifiable degenerative mental disease (e.g., Alzheimer's disease, multiple sclerosis, senile dementia).
Epilepsy or seizure disorder requiring anticonvulsants.
Active malignancy, prior malignancy (except basal cell carcinoma) within the last 5 years.
Presence of chronic debilitating disease (e.g., end-stage renal disease, end-stage liver disease, all types of diabetes with or without sequelae).
Documented clinically significant uncorrected anemia
Documented sickle cell disease.
History of therapeutic ionizing radiation to the head.
Verifiable diagnosis of learning disability.
Positive urine test for an illicit substance(s).
Any condition or use of prescribed medication (lithium, cisplatin, doxorubicin, or bleomycin) in which receipt of HBO2 would impact the safety of the individual.
Anticipated administrative separation, prolonged temporary assigned duty (TAD/TDY) or deployment within 3 months after randomization
Claustrophobia (unwilling or unable to enter hyperbaric chamber).
Inability to protect airway or requires frequent suctioning; presence of tracheostomy
Heart failure with ejection fraction < 50% (due to increased risk for precipitating acute lung edema during exposure to HBO2).
Emphysema, chronic bronchitis, or bullous lung disease (due to risk for pulmonary barotrauma during hyperbaric decompression).
Diabetes (relative contraindication related to risk of hypoglycemia).
Presence of implanted device (e.g., cardiac defibrillator, intrathecal drug delivery device, cochlear implant) that poses increased risk to subject during hyperbaric exposure.","Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (""door-to-door"" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01307111,NCT01307111_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Not Applicable,85,"Inclusion Criteria:

14 years old or older
Negative pregnancy test
No prior pregnancies lasting beyond 19 6/7 weeks
Minimum 2 weeks after spontaneous or medical abortion
Minimum 4 weeks post 2nd trimester or surgical abortion
No previous IUD insertions
No PID in last 3 months
No current cervicitis
Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

Active cervical infection
Current pregnancy
Prior pregnancy beyond 19 6/7 weeks gestation
Known uterine anomaly
Fibroid uterus distorting uterine cavity
Copper allergy/Wilson's Disease (for Paragard)
Undiagnosed abnormal uterine bleeding
Cervical or uterine cancer","Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01315574,NCT01315574_EG001,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 be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01326026,NCT01326026_EG000,No,All,Adult | Older Adult,Phase 3,110,"Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Exclusion Criteria:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])",Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01326026,NCT01326026_EG001,No,All,Adult | Older Adult,Phase 3,111,"Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m^2

Exclusion Criteria:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])","Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01326923,NCT01326923_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis

A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:

Hypopharynx: The tumor must extend across the midline of the posterior pharyngeal wall or be fixed to the cervical spine
Larynx: There must by either direct extension into surrounding muscle or skin or greater than 3 cm of sub-glottic extension
Oral cavity: The lesion must be so extensive that a functional reconstruction is not possible.
Base of Tongue: The tumor must extend into the roof of tongue, or the patient must refuse a recommended total glossectomy
Tonsil: The tumor must extend into the pterygoid region as manifested by clinical trismus or demonstrated across the midline of the pharyngeal wall or directly into soft tissue of the neck
Patients with neck lymph node metastases fixed to the carotid artery, the mastoid, the base of the skull, or the cervical spine are considered un-resectable
Medical unsuitability for resection is not sufficient for patient eligibility
Patient's refusal for surgery except in case of total glossectomy is not considered a reason for unresectibility
Patients must have received no prior treatment for head and neck cancer
ECOG Performance status 0-1

Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)

leukocytes > 3,000/mcL
absolute neutrophil count > 1,500/mcL
platelets > 100,000/mcL
total Bilirubin within normal institutional limits
AST (SGOT)/ALT(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
Ability to give informed consent and willingness to adhere to study protocol
Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment. 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 birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study

Exclusion Criteria:

Patient who have had prior treatment for head and neck cancer
Prior history of radiation to head and neck area
Known malignancy other than the current cancer
Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements
Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
Patient with documented or symptoms of peripheral neuropathy
History of allergic reaction to compounds similar to the ones used in this study
Any condition that would hamper ability to give informed consent or ability to comply with study protocol
HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy","Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

Cetuximab: Single arm phase II study of chemotherapy",PubChem:136170999,FOLFIRI regimen,CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=c1[nH]cc(F)c(=O)[nH]1,,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
NCT01329185,NCT01329185_EG001,No,All,Child | Adult | Older Adult,Phase 2,7,"Inclusion criteria:

Any person approved as a kidney transplant donor with a recipient who has never undergone a previous transplantation
Kidney transplant donor must be 18 years old or older
The kidney transplant donor must be positive for CMV IgG and / or EBV IgG
The donor must be to a recipient that is discordantly seronegative for the virus for which the donor is seropositive (D+ R-)
They must have provided signed informed consent
The potential donors must be willing to contribute samples of blood and oral washings at regular intervals
The potential donor must state willingness to use effective contraception during treatment and 30 days following receiving the study drug/placebo
All females must have a negative pregnancy test
Person must have estimated creatinine clearance (Cockcroft and Gault method) >= 60 ml/min
Person must have Absolute neutrophil count >= 1000 cells/uL
Person must have Platelets >= 100,000/uL
Person must have Hemoglobin >= 9.5 g/dL

Exclusion criteria:

Any potential kidney transplant donor who is seronegative for both CMV & EBV IgG
Any potential kidney transplant donor who is receiving or have received anti-herpes medication in the past week
Any potential kidney transplant donor to a recipient who has received a previous solid organ transplant
Any potential kidney transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications
Any potential kidney transplant donor who is breast feeding during the study
Any potential kidney transplant donor who is on corticosteroids","Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date

Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01334554,NCT01334554_EG000,No,Female,Adult,Phase 1 | Phase 2,23,"Inclusion Criteria:

Race will be self-defined, but only subjects who report both parents of the same race will be included.
Age 18-60 years old.
The investigators will recruit subjects with wide range of BMI 30-45 kg/m2.
Subjects who have metabolic syndrome or who have a fasting insulin >13. The diagnosis include 3 of the following:

Fasting blood glucose of greater than 100 Triglyceride levels of greater than 150 HDL cholesterol of less than 50 in women Blood pressure of at least 130/85, or on blood pressure medicine Waist girth of more than 35 inches in women. Subjects of childbearing potential will be required to have a negative serum/urine pregnancy test. In addition, they will be asked to use a reliable contraceptive method prior to enrollment as determined by the PI (Dr. Cyndya Shibao).

Exclusion Criteria:

Previous allergic reactions to any of the study medication (sildenafil) or inability to take study medications as prescribed during the course of the study.
Type 1 or 2 diabetes mellitus as defined by a fasting glucose of 126 mg/dl or greater.
Use of antidiabetic medication (insulin, metformin, sulfonylurea, troglitazone)
Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy.
Current smokers.
Significant weight change >5% from baseline in the past three months.
Pregnancy or breast-feeding.
History of serious neurological disease such as cerebral hemorrhage stroke, transient ischemic attack.
History or presence of immunological or hematological disorders.
Clinical significant gastrointestinal impairment that could interfere with drug absorption.
Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >1.5X upper limit of normal range).
Impaired renal function (estimated glomerular filtration rate (eGFR) of <60mL/min).
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.
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, inability to return for follow-up visits, and unlikelihood of completing the study.
Patients must not be taking nitratest in any form (e.g., nitroglycerin, isosorbide dinitrate, nitroprusside, and others) during this study
Patients on alpha-blocking drugs (doxazosin, terazosin , or prazosin) will be excluded
Patients on protease inhibitors (ritonavir and others) will be excluded",Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks,ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01336023,NCT01336023_EG000,No,All,Adult | Older Adult,Phase 3,412,"Inclusion Criteria:

Subjects with type 2 diabetes
HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria:

Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Screening calcitonin at least 50 ng/L
Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
History of chronic pancreatitis or idiopathic acute pancreatitis",Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01336296,NCT01336296_EG000,No,All,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Patients capable of understanding the purposes and risks of the study.
Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.
Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.
Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.

Exclusion Criteria:

Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.
Patients who are recipients of A-B-O incompatible transplants, all complement-dependent cytotoxicity (CDC) crossmatch positive transplants.
Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel reactive antibody (PRA) ≥ 25% by a CDC-based assay].
Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.
Patient is receiving chronic steroid therapy at the time of transplant.
Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
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.
Inability to cooperate or communicate with the investigator.","Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01336296,NCT01336296_EG001,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Patients capable of understanding the purposes and risks of the study.
Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.
Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.
Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.

Exclusion Criteria:

Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.
Patients who are recipients of A-B-O incompatible transplants, all complement-dependent cytotoxicity (CDC) crossmatch positive transplants.
Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel reactive antibody (PRA) ≥ 25% by a CDC-based assay].
Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.
Patient is receiving chronic steroid therapy at the time of transplant.
Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
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.
Inability to cooperate or communicate with the investigator.","Myfortic at time of transplant with Thymoglobulin induction

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant",ChEMBL:CHEMBL866 | DrugBank:DB01024 | PubChem:446541,MYCOPHENOLIC ACID,COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2,L04AA06,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG002,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",Extensive metaboliser [EM] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG003,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG006,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG007,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG010,Accepts Healthy Volunteers,Male,Adult,Phase 1,5,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG011,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01343706,NCT01343706_EG012,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion criteria:

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age > 21 and Age < 50 years
Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)",EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01344759,NCT01344759_EG001,No,All,Child | Adult,Phase 4,60,"Inclusion Criteria:

Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
Subjects must be 12 months to 25 years of age (inclusive)
Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
The subject has a tracheostomy or other mechanical airway device
The subject is not scheduled to receive anesthesia-sedation care for the MRI
The subject has a history or a family (parent or sibling) history of malignant hyperthermia.","Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01345058,NCT01345058_EG001,No,All,Adult | Older Adult,Phase 3,36,"Inclusion Criteria:

Adults age 18 or older
Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk
Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)

Exclusion Criteria:

Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
Pregnant, child-bearing age not using contraception, or breast feeding
Medical contraindication to adding lacosamide
History of antiepileptic drug (AED) polytherapy
Presence of a vagus nerve stimulator
Creatinine clearance of less than 50 mL/min
Blood pressure instability: pulse <50 or >100, systolic blood pressure (SBP) <50 or >180, clinically significant electrocardiogram (EKG) abnormality
History of significant drug rash or anaphylactic reaction with antiepileptic drug
Patients with progressive lesions (e.g. brain tumors)",Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01350115,NCT01350115_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Patients with multiple basal cell carcinomas (at least two) and typical presentation of NBCCS.
Female patients must be women of non-childbearing potential (WONCBP).

Exclusion Criteria:

Use of any topical treatment to treat BCCs, including prescription and over the counter in the 4 weeks prior to first dose of study drug.
Use of photodynamic therapy (PDT), radiation or systemic treatment known to affect BCCs or neoplasm in the 12 weeks prior to first dose of study drug.
Patients receiving medications that are recognized to cause rhabdomyolysis or patients with a prior history of rhabdomyolysis.
Patients with a histologically confirmed diagnosis of locally advanced or metastatic BCC.

Other protocol-defined inclusion/exclusion criteria may apply",Participants received 400 mg once daily.,ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01358357,NCT01358357_EG000,No,All,Adult | Older Adult,Phase 3,246,"Inclusion Criteria:

Open-label Phase

18 years of age or older

Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder

•≥ 1 manic, mixed manic, or depressed episode in past 2 years

YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex

Double-blind Phase

Inclusion Criteria:

Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization

Exclusion Criteria:

Open Label Phase

Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
Unstable/inadequately treated medical illness
The subjects answers ""yes"" to ""Suicidal Ideation"" items 4 or 5 on the C-SSRS (at time of evaluation)

Double Blind Phase

Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
Subjects who have not stabilized during the open-label phase (within 20 weeks)
Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study","Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01360996,NCT01360996_EG000,No,Female,Child | Adult,Phase 4,64,"Inclusion Criteria:

•Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception

Actual BMI >18 to <35kg/ m2
Written consent for participation in the study
Patient completed lactation

Exclusion Criteria:

Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)

Uncontrolled hypertension
Cancer or history of hormone-dependent cancer
History of cholestasis
Presence of contradictions for OC administration
Personal history of cardiovascular events.
Use of drugs known to exacerbate glucose tolerance.
No prescription or over-the-counter weight-loss drugs
Diabetes
Use of medications that affect blood pressure or lipid profile
Smoking in past 6 months
Known thrombogenic mutations (e.g. Factor V Leiden)
Current or history of deep venous thrombosis/pulmonary embolism
Major surgery with prolonged immobilization
Injectable hormonal contraceptive use within 6 months
Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements","Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

Normal weight -BMI 18-24.9 kg/ m2

3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only",ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01360996,NCT01360996_EG001,No,Female,Child | Adult,Phase 4,64,"Inclusion Criteria:

•Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception

Actual BMI >18 to <35kg/ m2
Written consent for participation in the study
Patient completed lactation

Exclusion Criteria:

Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)

Uncontrolled hypertension
Cancer or history of hormone-dependent cancer
History of cholestasis
Presence of contradictions for OC administration
Personal history of cardiovascular events.
Use of drugs known to exacerbate glucose tolerance.
No prescription or over-the-counter weight-loss drugs
Diabetes
Use of medications that affect blood pressure or lipid profile
Smoking in past 6 months
Known thrombogenic mutations (e.g. Factor V Leiden)
Current or history of deep venous thrombosis/pulmonary embolism
Major surgery with prolonged immobilization
Injectable hormonal contraceptive use within 6 months
Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements","Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

BMI 25-29.9 kg/ m2

3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only",ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01360996,NCT01360996_EG002,No,Female,Child | Adult,Phase 4,64,"Inclusion Criteria:

•Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception

Actual BMI >18 to <35kg/ m2
Written consent for participation in the study
Patient completed lactation

Exclusion Criteria:

Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)

Uncontrolled hypertension
Cancer or history of hormone-dependent cancer
History of cholestasis
Presence of contradictions for OC administration
Personal history of cardiovascular events.
Use of drugs known to exacerbate glucose tolerance.
No prescription or over-the-counter weight-loss drugs
Diabetes
Use of medications that affect blood pressure or lipid profile
Smoking in past 6 months
Known thrombogenic mutations (e.g. Factor V Leiden)
Current or history of deep venous thrombosis/pulmonary embolism
Major surgery with prolonged immobilization
Injectable hormonal contraceptive use within 6 months
Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements","Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

BMI 30-34.9 kg/ m2

3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only",ChEMBL:CHEMBL1509 | DrugBank:DB01395 | PubChem:68873,Drospirenone,[H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1,G03AA12 | G03AA18 | G03AC10 | G03FA17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01364428,NCT01364428_EG000,No,All,Adult | Older Adult,Phase 3,184,"Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
Body mass index (BMI) below or equal to 45 kg/m^2
Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)","Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT01378520,NCT01378520_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

50 years of age or older;
diagnosis of COPD;
current or former smoker of at least 10 pack-years;
post-bronchodilator FEV1 greater than or equal to 30% predicted and less than or equal to 80% predicted; post-bronchodilator ratio < 70%

Exclusion Criteria:

any concomitant disease that might interfere with study procedures;
use of a drug that may cause a possible drug interaction with ketoconazole",Ketoconazole(600 mg taken orally),ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01378988,NCT01378988_EG000,No,All,Child,Phase 2,2,"Inclusion Criteria:

Subject is 12 months to <24 months of age at screening.
Subject is intubated and mechanically ventilated in an intensive care setting and is anticipated to require a minimum of 6 hours of continuous IV sedation.
Subject has adequate renal function, defined as: Serum creatinine ≤1.0 mg/dL.
The subject's parent(s) or legal guardian(s) must voluntarily sign and date the informed consent document approved by the Institutional Review Board.

Exclusion Criteria:

Pediatric subjects with neurological conditions that prohibit an evaluation of sedation such as:

Diminished consciousness from increased intracranial pressure
Extensive brain surgery (surgery requiring intracranial pressure monitor)
Diminished cognitive function per Principal Investigator (PI) discretion
Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking agents.
Subjects with second degree or third degree heart block unless subject has a permanent pacemaker or pacing wires are in situ.
Subjects who have hepatic impairment as defined by a serum glutamic-pyruvic transaminase/alanine aminotransferase (SGPT/ALT) >90 U/L at the time of screening.
Subjects who have hypotension, based on repeat assessments within 15 minutes preceding the start of study drug, defined as: Systolic blood pressure (SBP) <70 mmHg.
Pre-existing bradycardia based on repeated assessments within 15 minutes preceding the start of study drug, defined as: Heart rate (HR) <70 bpm.
Subject who have acute thermal burns involving more than 15 percent total body surface area.
Subjects who have a known allergy to dexmedetomidine, midazolam or fentanyl.
Subject who has received dexmedetomidine within 15 hours prior to the start of study drug.
Subjects with a life expectancy that is <72 hours.
Subjects that are expected to have hemodialysis (continuous hemofiltration), peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments within 48 hours prior to the start of study drug or during the duration of the study.
Subjects who have been treated with α-2 agonists/antagonists within 2 weeks.
Subjects with a spinal cord injury above T5 (5th Thoracic Vertebra).
Subjects who have received another investigational drug as part of an investigational drug study within the past 30 days.
Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.",Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01378988,NCT01378988_EG001,No,All,Child,Phase 2,3,"Inclusion Criteria:

Subject is 12 months to <24 months of age at screening.
Subject is intubated and mechanically ventilated in an intensive care setting and is anticipated to require a minimum of 6 hours of continuous IV sedation.
Subject has adequate renal function, defined as: Serum creatinine ≤1.0 mg/dL.
The subject's parent(s) or legal guardian(s) must voluntarily sign and date the informed consent document approved by the Institutional Review Board.

Exclusion Criteria:

Pediatric subjects with neurological conditions that prohibit an evaluation of sedation such as:

Diminished consciousness from increased intracranial pressure
Extensive brain surgery (surgery requiring intracranial pressure monitor)
Diminished cognitive function per Principal Investigator (PI) discretion
Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking agents.
Subjects with second degree or third degree heart block unless subject has a permanent pacemaker or pacing wires are in situ.
Subjects who have hepatic impairment as defined by a serum glutamic-pyruvic transaminase/alanine aminotransferase (SGPT/ALT) >90 U/L at the time of screening.
Subjects who have hypotension, based on repeat assessments within 15 minutes preceding the start of study drug, defined as: Systolic blood pressure (SBP) <70 mmHg.
Pre-existing bradycardia based on repeated assessments within 15 minutes preceding the start of study drug, defined as: Heart rate (HR) <70 bpm.
Subject who have acute thermal burns involving more than 15 percent total body surface area.
Subjects who have a known allergy to dexmedetomidine, midazolam or fentanyl.
Subject who has received dexmedetomidine within 15 hours prior to the start of study drug.
Subjects with a life expectancy that is <72 hours.
Subjects that are expected to have hemodialysis (continuous hemofiltration), peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments within 48 hours prior to the start of study drug or during the duration of the study.
Subjects who have been treated with α-2 agonists/antagonists within 2 weeks.
Subjects with a spinal cord injury above T5 (5th Thoracic Vertebra).
Subjects who have received another investigational drug as part of an investigational drug study within the past 30 days.
Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.",Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01379573,NCT01379573_EG000,No,Female,Adult,Phase 2,63,"Inclusion Criteria:

Mothers must have anti-Ro and/or anti-La Ab documented in the NYU immunology laboratory (CLIA-approved), which utilizes an ELISA as well as reactivity on ELISA to at least one of three recombinant antigens (48La, 52Ro, 60Ro, JB laboratory).
Mothers must have a previous child with cardiac NL, defined herein as: the presence of heart block (1st, 2nd, or 3rd degree) documented by electrocardiogram (EKG), echocardiogram, pacemaker, or statement in the medical record, and/or; presence of cardiac injury, which specifically includes autopsy evidence of a mononuclear infiltrate in the endocardium, myocardium, and pericardium and/or EFE on echocardiogram always associated with cardiac dysfunction. In PITCH, we included women with a prior child with rash; however, recent data generated from the RRNL suggest that recurrence of CHB following rash is 11%, not 18% [34]. Thus, inclusion of previous rash could lead to a falsely lowered recurrence rate, and will therefore be excluded.
Intrauterine pregnancy ≤10 weeks.
Mother may be taking ≤20 mg prednisone because, in our experience, CHB has developed in the presence of this dose.
Mother may be asymptomatic, or have a rheumatic disease such as SLE or SS. Maternal health status has not been considered an influence on the development of CHB.
Mother may or may not already be taking HCQ. This latter point was discussed with Dr. Nathalie Costedoat-Chalumeau, who has published extensively on measurement of HCQ. While it might be optimal for the mothers anticipating enrollment in the study to all have been on HCQ prior to conception, this is impractical. Some may never achieve pregnancy and not want to take HCQ unless they conceive (especially those asymptomatic). On the other hand, women with SLE are likely to already be on HCQ and it would limit enrollment to exclude these patients if all must initiate HCQ only at enrollment in the first trimester. Although the accepted dogma is that HCQ requires several months for maximal efficacy in treating rheumatic disease, it is unknown whether this would apply to transplacental passage or fetal levels (which are impossible to measure). Dr. Costedoat-Chalumeau suggests that HCQ is probably a three compartment model which includes the circulation, tissues and cells. In the circulation, the half life is approximately 7 days and in the tissues, it is 40 days. In Dr. Costedoat-Chalumeau's experience, steady state blood levels of HCQ are achieved in 4-6 weeks. Thus, dosing the mother no later than 10 weeks gestation should provide sufficient fetal exposure before the vulnerable period of CHB which is generally accepted to span 18-24 wks. Furthermore, the placenta has to be formed for HCQ to gain access to the fetus and it may be effective quickly for the biology we are considering.

Exclusion Criteria:

Mother does not have Ab to Ro or La.

Identification of any of the following structural lesions considered causal for CHB, i.e., those that could account for block because of fibrous disruption between the atrium and AV node or due to absence of the penetrating bundles of the AV node:

atrioventricular septal defects;
b) single ventricle
c) developmental tricuspid valve disease;
d) L-transposition of the great arteries;
e) heterotaxia.
Mother is taking any glucocorticoids. Although unlikely to be preventative, the use of steroids may confound the interpretation of results. The final point of intense discussion centered around whether another exclusion should be the use of HCQ in the first pregnancy in which CHB occurred. While one could argue that in these mothers HCQ was not effective and perhaps will not be again, this assumption remains speculative and thus prior absence of efficacy of HCQ will not constitute an exclusion criteria.","400 mg/day Hydroxychloroquine

Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01383109,NCT01383109_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Inclusion Criteria:

Male subjects between the ages of 40 and 55 years with a body weight between 60 and 90 kg and a body mass index calculated using Quetelet's Index - weight (kg)/height2 (m2) between 18.5 - 30.0
Signed and dated written informed consent form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the investigator
Strictly normal values of ALT, AST and bilirubin and normal or abnormal and clinically insignificant results (if agreed by the Investigator and the Sponsor on a case by case evaluation) of the other blood and urine laboratory parameters at screening

All sexually active male subjects and their partners are willing to undergo contraception as follows:

All male subjects, including those who are sterilised (i.e., vasectomy), should use a condom. Their female partner must also use at least 1 of the medically acceptable forms of contraceptives listed below. Male subjects must not donate sperm or have unprotected sex during the study and until 87 days after taking the dose of investigational product.

Medically acceptable contraceptives for this study are:

Condoms in addition to:

Intrauterine devices
Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring)
Diaphragms with spermicidal cream or gel
Cervical cap with spermicidal cream or gel
Spermicidal foam
The ability to understand the requirements of the study and willingness to comply with all study procedures

Exclusion Criteria:

Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other clinical abnormality
Known history of hypersensitivity, allergic or adverse reactions to Pyronaridine
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
Seropositive HIV antibody
Previous participation in any clinical study with Pyramax
Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
Known or suspected alcohol abuse or illicit drug use in the last 10 years before the study start or positive findings on urine drug screen
Intake of grapefruit and grapefruit juice alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration
Use of over-the-counter (OTC) medications, including vitamins, analgesics, or antacids, 1 week before the study start
Use of prescription medications 14 days before the study start or required chronic use of any prescription medication
Use of enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, etc.) within 30 days or 5 half lives, whichever the longer, before the study start
Plasma donation 1 month before the study start
Blood donation of 450 mL or more in the last 3 months before the study start
Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested
Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation, isotope studies)","14C-labeled Pyronaridine: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).",DrugBank:DB12975 | PubChem:107771 | PubChem:135617075,Pyronaridine,COc1ccc2nc3cc(Cl)ccc3c(Nc3cc(CN4CCCC4)c(O)c(CN4CCCC4)c3)c2n1,P01BF06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01386879,NCT01386879_EG000,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Exclusion Criteria:

Short duration surgery (anticipated < 2 hours) or emergency (non-elective) surgery
ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
Pregnancy
History of allergic reaction to Methylene Blue medication
Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (< 6 months prior to surgery).
Hypoxemia (hemoglobin oxygen saturation < 90% room air or on O2 at home or in hospital)
History of coagulopathy, IV heparin therapy, or coumadin therapy (INR > 2.5)","Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff

methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01386879,NCT01386879_EG001,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Exclusion Criteria:

Short duration surgery (anticipated < 2 hours) or emergency (non-elective) surgery
ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
Pregnancy
History of allergic reaction to Methylene Blue medication
Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (< 6 months prior to surgery).
Hypoxemia (hemoglobin oxygen saturation < 90% room air or on O2 at home or in hospital)
History of coagulopathy, IV heparin therapy, or coumadin therapy (INR > 2.5)","Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff

methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01386879,NCT01386879_EG002,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Exclusion Criteria:

Short duration surgery (anticipated < 2 hours) or emergency (non-elective) surgery
ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
Pregnancy
History of allergic reaction to Methylene Blue medication
Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (< 6 months prior to surgery).
Hypoxemia (hemoglobin oxygen saturation < 90% room air or on O2 at home or in hospital)
History of coagulopathy, IV heparin therapy, or coumadin therapy (INR > 2.5)","Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)

methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01396226,NCT01396226_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

male or postmenopausal female, aged 20 to 80 years inclusive,
clinical indication for catheter ablation of atrial flutter,
history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study,
sinus rhythm at randomisation,
adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline,

Exclusion Criteria:

cardioversion within 14 days before randomisation,
history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures,
QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,
history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation,
personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia.",AZD2927 solution for infusion,PubChem:57345449,CCR2 antagonist 3,Cc1cc(C(=O)N(C)C(CN2CC(O)C2)C(C)C)ccc1F,,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01396447,NCT01396447_EG001,No,All,Adult | Older Adult,Phase 2,141,"Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.",Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01396447,NCT01396447_EG002,No,All,Adult | Older Adult,Phase 2,146,"Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.","Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01396447,NCT01396447_EG003,No,All,Adult | Older Adult,Phase 2,146,"Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.","Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01397968,NCT01397968_EG000,No,All,Adult | Older Adult,Phase 2,113,"Inclusion Criteria:

Diagnosis of treatment resistant partial epilepsy;
History of epilepsy for at least 2 years;
Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.

Currently treated on a stable dose of :

1 - 3 AED's for at least 12 weeks prior to randomization.
VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
Subject has had status epilepticus within past 1 year.
Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
Subjects taking felbamate with less than 18 months continuous exposure.
Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
Subject meets criteria for current major depressive episode (within 6 months).
Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.","YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day",ChEMBL:CHEMBL3989949 | DrugBank:DB06119 | PubChem:11962412,Cenobamate,NC(=O)O[C@@H](Cn1ncnn1)c1ccccc1Cl,N03AX25,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01398956,NCT01398956_EG000,No,All,Child | Adult | Older Adult,Phase 3,44,"Inclusion Criteria:

The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion Criteria:

Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible",Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01400113,NCT01400113_EG000,No,All,Adult | Older Adult,Phase 4,120,"Inclusion Criteria:

Patients will be between the ages of 18 and 65
Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at least one individual item score of ≧ 4
Patients must have the capacity to provide informed consent, and such consent will be obtained prior to participation

Exclusion Criteria:

Patient is knowingly pregnant
Patient is less than 18 or greater than 65 years old
Patient had a past adverse or allergic response to Asenapine","Asenapine: Asenapine Sublingual Tablet 10mg, single-dose",ChEMBL:CHEMBL3187365 | DrugBank:DB06216 | PubChem:163091 | PubChem:3036780 | PubChem:9903970,Asenapine,CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1,N05AH05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01401049,NCT01401049_EG000,No,All,Adult | Older Adult,Phase 4,116,"Inclusion Criteria:

American Society of Anesthesiologists (ASA) I, II or III.
Age 18 - 65.
Both male and female.
No significant laboratory abnormalities.

Exclusion Criteria:

Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.
Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.
Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.
No emergency patients will be recruited for this study.","To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.

Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.",ChEMBL:CHEMBL1201766 | DrugBank:DB06716 | PubChem:3038498,Fospropofol,CC(C)c1cccc(C(C)C)c1OCOP(=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
NCT01402869,NCT01402869_EG000,Accepts Healthy Volunteers,All,Child,Not Applicable,91,"Inclusion Criteria:

Patient scheduled to undergo comprehensive dental treatment under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry
ASA I or II health status
Age greater than 3 years but less than 6 years
Weigh between 10kg and 25kg

Exclusion Criteria:

Patient not requiring restorative dental treatment
Have a BMI less than the 5th percentile or greater than the 95th percentile for their age and gender",5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment,PubChem:92163,Prilocaine Hydrochloride,CCCNC(C)C(=O)Nc1ccccc1C.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
NCT01411774,NCT01411774_EG001,Accepts Healthy Volunteers,All,Child,Phase 3,142,"Inclusion Criteria:

Outpatient youth with obsessive-compulsive disorder between the ages 7-17 years.
A Children's Yale-Brown Obsessive-Compulsive Scale score ≥ 16
Child has a Full Scale IQ≥85 as assessed on the WASI (within 90% CI).
English speaking

Exclusion Criteria:

Receiving concurrent psychotherapy or a past adequate trial of CBT for OCD. Families will have the option of discontinuing such services to enroll in the study.
New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline.
Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded.
DSM-IV conduct disorder, autism, bipolar, schizophrenia or schizoaffective disorders; or substance abuse in past 6 months using all available information.
Youth with hoarding symptoms that are their primary form of OCD.
Weight less than 25.0 kg.
Epilepsy, renal insufficiency, and current/past history of alcohol abuse.
Pregnant or having unprotected sex [in females] as the effects of d-cycloserine on pregnancy are unknown.
Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
Known d-cycloserine allergy.","This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.

Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.

d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01412060,NCT01412060_EG000,No,All,Adult,Phase 3,765,"Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
Participants in their first episode of psychosis.
Treatment-resistant schizophrenia over the last 2 years.
Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
At imminent risk of injuring self or others or causing significant damage to property.
Suicide risk.","Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01412060,NCT01412060_EG002,No,All,Adult,Phase 3,101,"Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
Participants in their first episode of psychosis.
Treatment-resistant schizophrenia over the last 2 years.
Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
At imminent risk of injuring self or others or causing significant damage to property.
Suicide risk.","Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01415401,NCT01415401_EG000,No,All,Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

Willing to sign an Informed Consent form.
Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable IOP lowering regimen within 30 days of Screening Visit.
IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
Willing to follow instructions and able to attend required study visits.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history of hypersensitivity to any component of the preparations used in this study.
Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.","Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)",PubChem:71306410,Azarga,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01421134,NCT01421134_EG000,No,All,Adult | Older Adult,Phase 3,109,"Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
Subject is 18 to 75 years of age, inclusive.
Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).

Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

Elevated, expansive mood
Inflated self-esteem or grandiosity
More talkative than usual or pressure to keep talking
Flight of ideas or subjective experience that thoughts are racing
Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
Subject answers ""yes"" to ""Suicidal Ideation"" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
Subject has attempted suicide within the past 3 months.
Subject has a lifetime history of any bipolar I manic or mixed manic episode.
Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.","Lurasidone 20, 40 or 60 mg

Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01422226,NCT01422226_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,3,"Inclusion Criteria:

Desires IUD placement
18 years old or older
negative pregnancy test
no prior pregnancies beyond 14 6/7 weeks
no pelvic inflammatory disease (PID) in last 3 months
no current cervicitis
no contraindications to IUD insertion (see exclusion criteria below)
willing to follow-up in 6-8 weeks for a standard IUD follow-up visit
Determined by her clinician to be an appropriate candidate for an IUD.

Exclusion Criteria:

Active cervical infection
current pregnancy
prior pregnancy beyond 15 weeks' gestation
uterine anomaly
fibroid uterus
copper allergy/Wilson's disease (for Paragard)
undiagnosed abnormal uterine bleeding
cervical or uterine cancer
allergy to misoprostol (study drug)",Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01422720,NCT01422720_EG000,No,All,Older Adult,Phase 3,72,"Inclusion Criteria:

Written informed consent form;
Of age 65 years or older;
A documented diagnosis of epilepsy for at least 12 months,
At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
Willing and able to comply with all trial requirements, in the judgment of the investigator;
At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
Satisfactorily complied with the study requirements during the baseline period

Exclusion Criteria:

Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
Primarily generalised seizures;
Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
Occurrence of seizures too close to count accurately;
History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
Seizures of non-epileptic origin;
Major psychiatric disorders;
History of suicide attempt;
Currently treated with oxcarbazepine;
Previous use of ESL or participation in a clinical study with ESL;
Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;
Calculated creatinine values < 30 mL/min at screening;
Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.",Eslicarbazepine Acetate (Esl) tablets (800 mg) QD,ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01423253,NCT01423253_EG000,No,All,Adult | Older Adult,Phase 3,48,"Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject answers ""yes"" to ""Suicidal Ideation"" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.","Lurasidone 20, 40, or 60 mg/day flexibly dosed

Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01426347,NCT01426347_EG001,No,All,Adult | Older Adult,Not Applicable,139,"Inclusion Criteria:

Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
ages 18-75 years

Exclusion Criteria:

Diagnosis of any other autoimmune disease:

such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'

Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke
Severe heart problems
Kidney failure requiring dialysis treatment
Liver failure or cirrhosis of the liver
Poorly controlled hypertension
current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
Pregnancy","Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01431716,NCT01431716_EG000,No,All,Adult | Older Adult,Phase 3,41,"Inclusion Criteria:

Male or female aged 18 years and above
Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins
Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil
Women of childbearing potential must use a reliable method of contraception
Signed informed consent prior to initiation of any study mandated procedure

Exclusion Criteria:

Patients with respiratory and/or cardiovascular distress in need of emergency care
Known or suspicion of pulmonary veno-occlusive disease (PVOD)
Current use of IV inotropic agents
Current use of any prostacyclin or prostacyclin analog other than Flolan®
Tachycardia with heart rate > 120 beats/min at rest
PAH related to any condition other than those specified in the inclusion criteria
Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
History of myocardial infarction

History of left-sided heart disease, including any of the following:

hemodynamically significant aortic or mitral valve disease
restrictive or congestive cardiomyopathy
left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
unstable angina pectoris
life-threatening cardiac arrhythmias
Chronic bleeding disorders
Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
Women who are pregnant or breast-feeding
Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months",EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.,ChEMBL:CHEMBL1139 | DrugBank:DB01240 | PubChem:5280427 | PubChem:5282411,Epoprostenol,CCCCCC(O)C=CC1C(O)CC2OC(=CCCCC(=O)O)CC21,B01AC09,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0
NCT01435928,NCT01435928_EG001,No,All,Adult | Older Adult,Phase 3,144,"Inclusion Criteria:

Open Label:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject is ≥ 18 and ≤ 75 years of age, on the day of signing the informed consent.

Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes as established by clinical interview (using the DSM-IV-TR as a reference and confirmed using the SCID-CT)]. The duration of the subject's illness whether treated or untreated must be ≥ 1 year.

Subject has had at least one prior episode of psychotic exacerbation as judged by the Investigator in the two years preceding screening.

Subject has a PANSS Total score ≥ 80 with a score ≥ 4 on 1 or more of any PANSS Positive subscale items at screening and open-label baseline (Visit 2).

Subject has a CGI-S score of ≥ 4 at screening and open-label baseline (Visit 2).

Subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.

Female subject of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. In the Investigator's judgment, the subject will adhere to this requirement.

Adequate contraception is defined as continuous use of either two barrier methods (e.g., condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive. Acceptable hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) implanted at least 90 days prior to screening; b) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to screening; or c) oral contraception taken as directed for at least 30 days prior to screening.

Subjects who are of non-reproductive potential, i.e., subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception.

Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.

Subject has had a stable living arrangement at the time of screening and agrees to return to a similar living arrangement after discharge, if hospitalized. This criterion is not meant to exclude subjects who have temporarily left a stable living arrangement (e.g., due to psychosis). Such subjects remain eligible to participate in this protocol. Chronically homeless subjects should not be enrolled.

Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.

Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses (i.e., minor adjustments only) for the specified times: 1) antidepressant agents (except fluvoxamine) and/or mood stabilizers (except carbamazepine or oxcarbazepine) must be stable for at least 30 days prior to open-label baseline, 2) oral hypoglycemics must be stable for at least 30 days prior to screening, 3) antihypertensive agents must be stable for at least 30 days prior to screening, and 4) thyroid hormone replacement must be stable for at least 90 days prior to screening. (Note: CYP3A4 inducers and inhibitors will not be allowed).

Subject is willing and able to comply with the protocol assessments and visits, in the opinion of the study nurse/coordinator and the Investigator.

Double-blind -

Subject must achieve and maintain clinical stability for a total of at least 12 weeks in the open label phase, defined as:

a PANSS Total score ≤ 70, a CGI-S score < 4 and a PANSS item score of ≤ 4 (moderate or less) on all PANSS Positive subscale items over at least 12 weeks with the allowance of two excursions (except during the last 4 weeks of the open-label phase) assessed at weekly study visits:

• An excursion is defined as a PANSS total score up to a maximum of 80 and/or a CGI-S score up to a maximum of 4 and/or a PANSS Positive subscale item score up to a maximum of 5.

a PANSS item score of ≤ 4 (moderate or less) on item G8 (uncooperativeness)
taking a stable dose of lurasidone for the last 4 weeks of the open-label phase.

Exclusion Criteria:

Open Label - Subject has a DSM-IV Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.

Subject answers ""yes"" to ""Suicidal Ideation"" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (in the past month) or baseline.

Subject has attempted suicide within 3 months prior to the screening phase. Subject currently has a clinically significant medical condition including the following: neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with human immunodeficiency virus (HIV) seropositivity (or history of seropositivity) will be excluded.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor before being screened.

Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, and active seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subject must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Note: Past history of febrile seizures, drug-induced seizures, or alcohol withdrawal seizures is not exclusionary.

Note: Past history of febrile seizures, drug-induced seizures, or alcohol withdrawal seizures is not exclusionary.

Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.

Note: Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 3 times the upper limit of the reference ranges provided by the central laboratory require retesting. If on retesting, the laboratory value remains ≥ 3 times the upper limit, such subjects will be discussed with the Medical Monitor for enrollment consideration.

Subject has a history of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.

Subject with Type 1 or Type 2 insulin-dependent diabetes.

Subject with newly diagnosed Type 2 diabetes during screening. Subject with Type 2 diabetes is eligible for study inclusion if the following condition is met at screening:

if a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.

Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator. Subjects with a fasting blood glucose at screening ≥ 126 mg/dL (7.0 mmol/L) or HbA1c ≥ 7.0% will be excluded.

Note: Subjects with random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state.

Subject has a prolactin concentration > 100 ng/mL at screening or has a history of pituitary adenoma.

Subject has a history of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.

Subject is judged to be resistant to antipsychotic treatment defined as any one of the following:

failure to respond to > 2 marketed antipsychotic agents, given at an adequate dose and for an adequate duration (within the past 2 years)
history of treatment with clozapine for refractory psychosis Subject is unlikely to achieve a stable condition for ≥ 12 weeks during the open-label lurasidone phase based on the totality of evidence from the psychiatric history and/or the current presentation.

Subject is receiving an antipsychotic medication above the maximum recommended (country-specific) dose at or prior to screening and, in the judgment of the Investigator, is unlikely to respond to standard doses of lurasidone.

Subject has received depot antipsychotics unless the last injection was at least one treatment cycle or at least 30 days (whichever is longer) prior to the screening phase.

Subject has received treatment with MAO inhibitors within 14 days prior to the screening phase.

Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study (see Appendix 3).

Subject has received electroconvulsive therapy treatment within the 3 months prior to screening or is expected to require electroconvulsive therapy (ECT) during the study.

Subject has a history of neuroleptic malignant syndrome. Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity will be determined by the Investigator.

Subject has a history of alcohol or substance abuse (DSM-IV-TR criteria) within 3 months prior to screening or alcohol or substance dependence (DSM-IV-TR criteria) within 12 months prior to screening. The only exceptions include caffeine or nicotine abuse/dependence.

Subject tests positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from using this drug during the study. This information will be discussed with the Medical Monitor prior to study enrollment.

Subject had a history or presence of an abnormal electrocardiogram (ECG), which in the Investigator's opinion is clinically significant (Medical Monitor may be consulted to determine clinical significance).

Subject has poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.

Subject has a history of hypersensitivity to more than 2 distinct chemical classes of drug (e.g., sulfas and penicillins).

Subject was screened or washed out previously more than three times for this study.

Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 3 months prior to signing the informed consent, or has participated in 2 or more studies within 12 months prior to signing the informed consent.

Subject is homeless or did not have a stable residence for the 3 months prior to the screening phase.

Subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator, or was planning to relocate during the study.

Subject requires guardianship under the laws of his/her country.

Double-blind - Subjects who in the Investigator's judgment have not been compliant with study medication during the open-label stabilization phase.",During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily,ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01436266,NCT01436266_EG000,No,Female,Adult,Phase 3,3,"Inclusion Criteria:

English or Spanish speaking
Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment
Ultrasound used for dating purposes must be within the last two weeks.
Women 18-50 years of age undergoing surgical termination of pregnancy

Exclusion Criteria:

Spontaneous fetal demise
Ruptured membranes or intrauterine infection
Fibroids that significantly distort the uterine shape
Uterine abnormality such as unicornuate uterus
Prior transmural myomectomy
Severe oligohydramnios
Morbid obesity with BMI>45
Inability to place osmotic dilators","400 mcg buccally 2 hours prior to procedure

Misoprostol: 400 mcg buccally 2 hours prior to procedure",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01439126,NCT01439126_EG000,No,All,Child,Phase 4,68,"Inclusion Criteria:

Male or female, aged 6 to 17 years inclusive
Subject as well as parent/guardian is able to sign the informed assent or consent form
Subject meets Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), combined subtype, hyperactive/impulsive subtype, or inattentive sub-type based on a detailed psychiatric evaluation using the Shorter version of the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (MINI-Kid) or DSM-IV TR based checklist for ADHD
Subject has a minimum of Attention Deficit Hyperactivity Disorder-Rating Scale-4th edition (clinician version) total score of 28 at baseline (Visit 2)
Subject has a minimum of Clinical Global Impressions-Severity of Illness Scale of 4 at baseline (Visit 2)
Subject is able to swallow intact tablets based upon interview and screening procedures
Subject is functioning at an age-appropriate level intellectually with an estimated intelligence quotient of at least 70 based on interview and history
Subject and parent/guardian understand, are willing, to fully comply with the study requirements, procedures, and restrictions defined in this protocol
Subject has a supine and standing blood pressure measurement within the 95th percentile for age, gender, and height
If a female has experienced menarche, she must have a negative serum beta human chorionic gonadotropin pregnancy test at screening (Visit 1), negative urine pregnancy test at baseline (Visit 2), agree to be abstinent from sexual activity that could result in pregnancy, or use acceptable contraceptives throughout the period of the study drug exposure and for 30 days after the last dose of the study drug

Exclusion Criteria:

Subject has a current comorbid psychiatric condition (except oppositional defiant disorder) that is controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled.
Subject has any condition or illness including clinically significant abnormal screening (Visit 1) laboratory values that, in the opinion of the investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study
Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block), exercise-related cardiac events including syncope and presyncope, or clinically significant bradycardia
Subject is pregnant or nursing (lactating) or deemed by the investigator and staff to be at a significant risk of becoming pregnant.
Subject has orthostatic hypotension or a known history of controlled or uncontrolled hypertension
Subject has clinically significant electrocardiogram (ECG) findings as judged by the investigator with consideration of the central ECG laboratory's interpretation.
Current use of any prohibited medication or other medications including herbal supplements that affect blood pressure, or heart rate, or that have central nervous system effects, or affect cognitive performance such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted); or a history of chronic use of sedating medications (ie, antihistamines) in violation of the protocol specified washout criteria at baseline (Visit 2)
Subject has used an investigational product within 30 days prior to baseline (Visit 2)
Subject is significantly overweight based on body mass Index (BMI) for age-and gender-specific charts compiled by Center for Disease Control and Prevention. Significantly overweight is defined as a BMI of ≥95th percentile
Subject is significantly underweight based on BMI for age-and gender-specific charts compiled by Center for Disease Control and Prevention.
Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to clonidine hydrochloride
Clinically important abnormality on drug and alcohol screening (excluding the subject's current ADHD stimulant if applicable) at screening (Visit 1)
Subject has a history of alcohol, other substance abuse, or dependence as defined by DSM-IV-TR (with the exception of nicotine) within the last 6 months.
Subject is currently considered a suicidal risk in the opinion of the investigator, has previously made a suicide attempt, has a prior history of, or is currently demonstrating active suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS).
Subject has a history of failure to respond to an adequate trial of an alpha 2-agonist with stimulant or non-stimulant drug alone or in combination for the treatment of ADHD.
Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder (including Tourette syndrome)
Subjects who have been treated with an immediate release clonidine and/ KAPVAY™ or guanfacine (INTUNIV™) within the past 30 days","Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period",PubChem:20179,Clonidine Hydrochloride,Cl.Clc1cccc(Cl)c1NC1=NCCN1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01441102,NCT01441102_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,7,"Inclusion Criteria

Participant is 18 years of age or older.
Participant must understand and sign the protocol's informed consent document.
Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative urine pregnancy test within 24 hours prior to initiation of study medication and must be willing to undergo urine pregnancy tests throughout the study.

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 one week after study medication discontinuation. 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 (hysterectomy or tubal ligation).
Participant must agree to notify the study investigator or coordinator if any of his/her doctors initiate a new medication during the course of this study.
Participant must agree not to take medications containing dextromethorphan during the course of this study.
Participant must have normal renal function and liver function, or have mild abnormalities no greater than grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

Participant has a diagnosis of diabetic mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:

Current regular use of insulin for the treatment of diabetes;
Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes;
Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.

Participant has documented hemoglobin A1C 12% or less within one month of baseline.

Participants with elevated hemoglobin A1C but within the 12% or less cutoff will undergo appropriate evaluation, and unstable patients will be excluded according to the investigator's best medical judgment.
Participant agrees to refrain from consuming grapefruit juice, grapefruits and Seville oranges at any time while s/he is enrolled in this study.
Participant has at least one eye that meets the study eye criteria listed below.

Exclusion Criteria

Participant is in another investigational study and actively receiving another study medication for diabetic macular edema (DME).
Participant is unable to comply with study procedures or follow-up visits.
Participant has a known hypersensitivity to sodium fluorescein dye.

Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

• Patients in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled.

Participant has a history of chronic renal failure requiring dialysis or kidney transplant.
Participant has a history of hepatitis or liver failure.
Participant has an allergy or hypersensitivity to dextromethorphan or levorphanol.
Participant is taking or has taken within the last 14 days any medication that could adversely interact with dextromethorphan such as selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs) including but not limited to the following: almotriptan; amitriptyline; amoxapine; bromocriptine; buspirone; cabergoline; citalopram; clomipramine; desipramine; desvenlafaxine; dihydroergotamine; doxepin; duloxetine; eletriptan; ergoloid mesylates; ergotamine; escitalopram; fluoxetine; fluvoxamine; frovatriptan; imipramine; isocarboxazid; linezolid; lithium; maprotiline; meperidine; methylergonovine; milnacipran; mirtazapine; moclobemide; naratriptan; nefazodone; nortriptyline; paroxetine; phenelzine; procarbazine; promethazine; protriptyline; rasagiline; rizatriptan; SAMe (S-adenosylmethionine); selegiline; sertraline; sibutramine; St. Johns wort; sumatriptan; tapentadol; tramadol; tranylcypromine; trazodone; trimipramine; tryptophan; venlafaxine; vilazodone; zolmitriptan.

Participant has a blood pressure of > 180/110 (systolic above 180 OR diastolic above 110).

• If blood pressure is brought below 180/110 by anti-hypertensive treatment, a patient can become eligible.

Participant has a history of treatment with systemic anti-vascular endothelial growth factor (VEGF) agents or steroids within three months prior to study entry.

Study Eye Inclusion Criteria

Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) score of 34 letters or better (i.e., 20/200 or better).
Definite retinal thickening due to diabetic macular edema, based on clinical examination, that is not refractory to further therapy as based on the investigator's clinical judgment.
Retinal thickening due to DME within 3000 μm of the center of the macula, as measured by Spectral optical coherence tomography (OCT).
Media clarity, pupillary dilation and patient cooperation sufficient for adequate fundus photographs.

Study Eye Exclusion Criteria

Macular edema is considered to be due to a cause other than diabetic macular edema.

An eye should not be considered eligible if:

The macular edema is considered to be related to cataract extraction; or
Clinical exam and/or OCT suggest that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition).
An ocular condition is present (other than diabetic retinopathy (DR) 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, Irvine-Gass Syndrome, etc.).
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
History of panretinal scatter photocoagulation (PRP) within four months prior to study entry.
History of prior pars plana vitrectomy within six months prior to study entry.
History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to study entry.
History of Yttrium aluminium garnet (YAG) capsulotomy performed within two months prior to study entry.
History of treatment within three months prior to enrollment with any drug that has not received regulatory approval at the time of study entry, such as intravitreal or periocular steroids or intravitreal anti-VEGF agents.

Choice of Study Eye in Cases of Bilateral Disease

If both eyes of a participant meet the criteria described above, the following will be used to determine the study eye:

If one eye is treatment-naïve and the other is not, the treatment-naïve eye will be chosen as the study eye.
If both eyes are treatment-naïve, the eye with the better visual acuity will be chosen as the study eye.
If both eyes are treatment-naïve and are equivalent, the choice of study eye will be determined at the investigator's discretion after consultation with the participant.
If both eyes have been previously treated, the choice of study eye will be determined at the investigator's discretion after consultation with the participant.",Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.,ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01450306,NCT01450306_EG000,No,All,Adult | Older Adult,Not Applicable,10,"Inclusion Criteria:

Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

History of psychosis, obsessive-compulsive disorder, or mania
Recent substance abuse or suicidality
Previous receipt of study treatments",Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01452529,NCT01452529_EG001,No,All,Adult | Older Adult,Phase 3,296,"Inclusion Criteria include:

Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
Subjects whose low back pain is not adequately treated prior to the screening visit with their stable incoming analgesic regimen;
Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to be appropriate candidates for the protocol specified, around the clock HYD therapeutic regimen;
Female subjects who are premenopausal or postmenopausal less than 1 year and who have not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (eg, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception).

Exclusion Criteria include:

Subjects taking > 100 mg/day oxycodone or equivalent during last 14 days prior to screening visit;
Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain, excluding herbal and nutraceutical medications;
Subjects who cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, botulinum toxin injections for control of chronic low back pain, steroid injections in the lower back or inhalation analgesia). The subject must not have had a nerve/plexus block within 4 weeks of the screening visit, neuroablation within 6 months of the screening visit, a botulinum toxin injection in the low back region within 3 months of the screening visit, steroid injections in the lower back within 6 weeks of the screening visit, or intravenous or intramuscular steroid injections within 4 weeks of the screening visit;
Subjects who have used any investigational medication within 30 days prior to the first dose of study medication;
Subjects with any history of seizures (subjects with history of pediatric febrile seizures may participate in the study) or increase in intracranial pressure;
Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on a stable medication for ≥ 1 month prior to the screening visit to participate in the study);
Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;
Subjects with clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker;
Subjects with unstable respiratory disease that, in the opinion of the investigator, precludes entry into this study;
Subjects with evidence of impaired liver function upon entry into the study (laboratory test values ≥ 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT], or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study;
Subjects with evidence of impaired kidney function upon entry into the study (ie, serum creatinine ≥ 2.5 mg/dL);
Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that, in the opinion of the investigator, is inadequately treated and precludes entry into the study;
Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or scheduled for surgery of the lower back or any other major surgery during the study conduct period;
Subjects with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
Subjects with any condition in which opioids are contraindicated, eg, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;
Subjects who are allergic to hydrocodone or who have a history of allergies to other opioids. This does not include subjects who have experienced common opioid side effects (eg, nausea, constipation);
Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within 2 weeks of the screening visit.

Other protocol-specific inclusion/exclusion criteria may apply.","Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily",PubChem:20831824 | PubChem:5463977,Hydrocodone Bitartrate,COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314.O=C(O)C(O)C(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01453855,NCT01453855_EG000,No,All,Adult | Older Adult,Phase 3,442,"Inclusion Criteria:

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.","Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01453855,NCT01453855_EG001,No,All,Adult | Older Adult,Phase 3,421,"Inclusion Criteria:

Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
Qualifying intraocular pressure at both eligibility visits.
Understand and sign an informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
Any abnormality preventing reliable applanation tonometry.
Hypersensitivity to prostaglandin analogs or to any component of the study medications.
Therapy with another investigational agent within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.","Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01454778,NCT01454778_EG000,No,All,Adult | Older Adult,Not Applicable,50,"Inclusion Criteria:

ability to provide informed consent
age 18-90 years old
Rutherford 1-6
occlusion or stenosis in the infrainguinal vessels

Exclusion Criteria:

inability to pass the guide wire across the lesion
pregnant or lactating women
specific limb has not been previously treated with endovascular intervention","Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3

Paclitaxel Dosage:

Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*

not to exceed 10mg total dose",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01454791,NCT01454791_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or Poser criteria.
Age 18 or more
Ongoing treatment with glatiramer acetate (Copaxone) for three months or more.
No MS exacerbation for 60 days prior to screening.
Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction scale of last 3 days.
Written informed consent.

Exclusion Criteria:

Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (<325 mg daily), between screening and end of study.

Any contraindication to Diclofenac Sodium Topical Gel (DSTG)

allergy to DSTG or any NSAID.
history of asthma, urticaria, or other allergic reaction after taking any NSAID.
Females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures).
Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
Any other serious and/or unstable medical condition.","1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT01456299,NCT01456299_EG000,No,All,Adult,Not Applicable,102,"Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway","The control group, which received an infusion of normal saline

remifentanil 1: The patients received an infusion of remifentanil",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01456936,NCT01456936_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,2006,"Inclusion Criteria:

Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

Subjects with a past or current diagnosis of one of the following disorders:

a. Psychotic Disorders:

Schizophreniform
Delusional Disorder
Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)","Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl,,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
NCT01462279,NCT01462279_EG000,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Adult patients (age > 18 years) admitted to an ICU
Mechanically ventilated

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temp > 100 at time of VO2 measurement
FIO2 > 60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Thiamine supplementation within 24 hours prior to study enrollment","Open label - 200mg IV

Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01469377,NCT01469377_EG001,No,All,Adult | Older Adult,Phase 2,273,"Inclusion Criteria:

Male or female outpatients 18 to 65 years of age, inclusive.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.

History of meeting DSM-IV-TR criteria for:

Depressive episode with psychotic or catatonic features.
Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
Schizophrenia, schizoaffective, or other psychotic disorder.
Obsessive-compulsive disorder.
Bulimia or anorexia nervosa.
Dementia, amnesic, or other cognitive disorder.
Mental retardation.
Participants considered a suicide risk.","Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01469377,NCT01469377_EG002,No,All,Adult | Older Adult,Phase 2,273,"Inclusion Criteria:

Male or female outpatients 18 to 65 years of age, inclusive.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.

History of meeting DSM-IV-TR criteria for:

Depressive episode with psychotic or catatonic features.
Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
Schizophrenia, schizoaffective, or other psychotic disorder.
Obsessive-compulsive disorder.
Bulimia or anorexia nervosa.
Dementia, amnesic, or other cognitive disorder.
Mental retardation.
Participants considered a suicide risk.","Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01484626,NCT01484626_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy
Must have adequate liver and renal function
Zubrod Performance Status (ZPS) of 2 or better
Must have measurable disease

Exclusion Criteria:

Peripheral neuropathy of grade II or higher
Thrombocytopenia (platelets less than 50,000/uL)
Neutropenia (ANC<1000/uL)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.4 X ULN
Total bilirubin >1.5 X upper limit of normal (ULN)
Creatinine clearance of less than 45 milliliters per minute (mL/min)
Patients with HIV
Patients with active hepatitis
Pregnant or lactating women
Individuals of child-bearing potential not using adequate contraception
Individuals unable to provide informed consent",Bendamustine is combined with standard chemotherapy,ChEMBL:CHEMBL487253 | DrugBank:DB06769 | PubChem:65628,Bendamustine,Cn1c(CCCC(=O)O)nc2cc(N(CCCl)CCCl)ccc21,L01AA09,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01484951,NCT01484951_EG000,No,All,Adult | Older Adult,Phase 4,74,"Inclusion Criteria:

Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
Pregnant or lactating.
Participation in any other investigational study within 30 days of screening visit.
Other protocol-defined exclusion criteria may apply.","Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.",PubChem:71306410,Azarga,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01485380,NCT01485380_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,20,"Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I
18 to 35 years of age

Exclusion Criteria:

MRI and/or PET screening criteria not met
Abnormal sleep habits/known or suspected sleep disorder(s)
Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age","Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.

dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01485640,NCT01485640_EG000,No,All,Child | Adult | Older Adult,Phase 3,162,"Inclusion Criteria:

The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required.
The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone

Exclusion Criteria:

The subject is considered by the Investigator, to be at imminent risk for homicidal or suicidal behavior.
The subject resides in a country where lurasidone has been approved for any indication.
The subject is currently enrolled in any other investigational study.
The subject answers ""yes"" to ""Suicidal Ideation"" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).","Lurasidone flexibly dosed

Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491113,NCT01491113_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments","Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491113,NCT01491113_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments","Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491113,NCT01491113_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments","Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491113,NCT01491113_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments","Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491919,NCT01491919_EG001,No,All,Child,Phase 1,8,"Inclusion Criteria:

Kidney transplant recipient
Age 2-17 years, inclusive, at the time of first study dose
Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by <20% change in serum creatinine in the previous 30 days
Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).

Exclusion Criteria:

History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
Blood Potassium value > 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
Previous participation in this study
Physician concern that the participant may not adhere to the study protocol, based on prior behavior
Current plasmapheresis treatment
History of angioedema
Pregnancy",Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day,ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01491919,NCT01491919_EG002,No,All,Child,Phase 1,2,"Inclusion Criteria:

Kidney transplant recipient
Age 2-17 years, inclusive, at the time of first study dose
Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by <20% change in serum creatinine in the previous 30 days
Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).

Exclusion Criteria:

History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
Blood Potassium value > 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
Previous participation in this study
Physician concern that the participant may not adhere to the study protocol, based on prior behavior
Current plasmapheresis treatment
History of angioedema
Pregnancy","Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01493180,NCT01493180_EG000,No,All,Adult | Older Adult,Phase 2,51,"Inclusion Criteria:

Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

Active ocular infection
Vernal keratoconjunctivitis
Recurrent corneal erosion
Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
Anticipated use of contact lens during the study.
Insertion of punctal plug or fall out of punctal plug within 3 months
Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
Receipt of any investigational product within 4 months.",OPC-12759 ophthalmic suspension 2%,ChEMBL:CHEMBL1697771 | DrugBank:DB11656 | PubChem:5042,Rebamipide,O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1,A02BX14,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01493427,NCT01493427_EG000,No,All,Adult | Older Adult,Phase 4,199,"Inclusion Criteria:

Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
Any clinically significant, serious, or severe medical condition.
Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women who are pregnant, lactating.
Women not using reliable means of birth control.
Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
Any clinically significant, serious, or severe medical condition.
Participation in any other investigational study within 30 days of Screening Visit.
Other protocol-defined exclusion criteria may apply.","Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks

Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01493570,NCT01493570_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 1,4,"Inclusion criteria:

Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs after 10 minutes in supine position (blood pressure (BP), pulse rate (PR)), body temperature (BT)), 12-lead electrocardiogram (ECG)), clinical laboratory tests

Age =21 and Age =50 years
Body Mass Index (BMI) =18.5 and BMI =29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and considered by the investigator as clinical relevant
Abnormal values for Prothrombin Time (PT), (Activated Partial Thromboplastin Time (aPTT) and thrombocytes considered by the investigator as clinically relevant
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders)
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker, who consume more than 5 cigarettes per day
Inability to refrain from smoking on trial days
Alcohol abuse (more than 20 g/day): 2 units/day (14 units/week)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval >450 ms)
Inability to understand and to comply with protocol requirements and restrictions and dietary regimen of trial site
of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until three month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female (intra-uterine device with spermicide, hormonal contraceptive since at least two months)",Subjects were orally administered single dose of BI 409306 25 milligram (mg) (5x5 mg) film-coated tablets in the morning.,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,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
NCT01495585,NCT01495585_EG001,No,All,Adult | Older Adult,Phase 2,6,"INCLUSION CRITERIA:

Age 18 years or above, male or female.
Serum alanine or aspartate aminotransferase activities above the upper limit of normal (ALT > 41 or AST > 31 U/L) on an average of three determinations taken during the previous 6 months. The mean of the three determinations will be defined as baseline levels.
Presence of anti-HDV in serum.
Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
Presence of HDV antigen in liver tissue or HDV RNA in serum.
Written informed consent.

EXCLUSION CRITERIA:

Decompensated liver disease, defined by bilirubin > 4mg/dL, albumin < 3.0 gm/dL, prothrombin time > 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (> 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
Pregnancy or inability to practice adequate contraception, in women of childbearing potential or in spouses of such women. Adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of two barrier methods such as condoms and spermicide combination, birth control pills, an intrauterine device, Depo-Provera, or Norplant.
Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR < 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), and active coronary artery disease.
Systemic immunosuppressive therapy within the previous 2 months.
Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Evidence of hepatocellular carcinoma.
Evidence of concurrent hepatitis C infection with positive serum HCV RNA.
Any experimental therapy apart from pegylated interferon within 6 months prior to enrollment.
Diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.
Evidence of HIV co-infection; HIV (Omega) antibody positivity on serum testing.
Concurrent usage of statins as these drugs inhibit mevalonate synthesis which reduces protein prenylation.
Concurrent usage of moderate and strong CYP3A inhibitors and inducers.
Inability to understand or sign informed consent.
Any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.",lonafarnib 100 mg,ChEMBL:CHEMBL298734 | DrugBank:DB06448 | PubChem:148195,Lonafarnib,NC(=O)N1CCC(CC(=O)N2CCC([C@H]3c4ncc(Br)cc4CCc4cc(Cl)cc(Br)c43)CC2)CC1,A16AX20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01495585,NCT01495585_EG002,No,All,Adult | Older Adult,Phase 2,6,"INCLUSION CRITERIA:

Age 18 years or above, male or female.
Serum alanine or aspartate aminotransferase activities above the upper limit of normal (ALT > 41 or AST > 31 U/L) on an average of three determinations taken during the previous 6 months. The mean of the three determinations will be defined as baseline levels.
Presence of anti-HDV in serum.
Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
Presence of HDV antigen in liver tissue or HDV RNA in serum.
Written informed consent.

EXCLUSION CRITERIA:

Decompensated liver disease, defined by bilirubin > 4mg/dL, albumin < 3.0 gm/dL, prothrombin time > 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (> 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
Pregnancy or inability to practice adequate contraception, in women of childbearing potential or in spouses of such women. Adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of two barrier methods such as condoms and spermicide combination, birth control pills, an intrauterine device, Depo-Provera, or Norplant.
Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR < 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), and active coronary artery disease.
Systemic immunosuppressive therapy within the previous 2 months.
Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Evidence of hepatocellular carcinoma.
Evidence of concurrent hepatitis C infection with positive serum HCV RNA.
Any experimental therapy apart from pegylated interferon within 6 months prior to enrollment.
Diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.
Evidence of HIV co-infection; HIV (Omega) antibody positivity on serum testing.
Concurrent usage of statins as these drugs inhibit mevalonate synthesis which reduces protein prenylation.
Concurrent usage of moderate and strong CYP3A inhibitors and inducers.
Inability to understand or sign informed consent.
Any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.",lonafarnib 200 mg,ChEMBL:CHEMBL298734 | DrugBank:DB06448 | PubChem:148195,Lonafarnib,NC(=O)N1CCC(CC(=O)N2CCC([C@H]3c4ncc(Br)cc4CCc4cc(Cl)cc(Br)c43)CC2)CC1,A16AX20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01496157,NCT01496157_EG000,No,Male,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

Newly diagnosed prostate cancer pathologically proven by prostate biopsy
Prostate biopsy histology grade ≥ Gleason 3+3=6.
Patients considered as candidates for and medically fit to undergo prostatectomy
At least 10 days after most recent prostate biopsy
No known problems with peripheral IV or central line access
Able to tolerate urinary straight catheter placement
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

Prior pelvic external beam radiation therapy or brachytherapy
Chemotherapy for prostate cancer
Hormone deprivation therapy
Investigational therapy for prostate cancer
Hemorrhagic cystitis or active prostatitis
Unable to lie flat during or tolerate PET/CT
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2","Patients will be imaged with 18F-DCFBC

18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.",DrugBank:DB14772 | PubChem:25067411,DCFBC F-18,O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)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
NCT01498822,NCT01498822_EG000,No,All,Child | Adult | Older Adult,Phase 4,173,"Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria:

Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
Subject taking any immunosuppressant within 28 days prior to Visit 1
Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
Subject has a history of status epilepticus within last 3-month period prior to Visit 1
Subject has seizures that are uncountable due to clustering (ie, an episode 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) during the 12-week period prior to Visit 1 and/or during the Screening Period
Body weight is lower than 40 kg (< 40 kg)","Levetiracetam twice a day treatment Group

250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01498887,NCT01498887_EG000,No,All,Adult,Phase 4,200,"Inclusion Criteria:

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply",Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.,PubChem:107969,Fingolimod Hydrochloride,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01498887,NCT01498887_EG001,No,All,Adult,Phase 4,147,"Inclusion Criteria:

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply",Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.,PubChem:107969,Fingolimod Hydrochloride,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01500473,NCT01500473_EG000,No,Female,Child | Adult,Phase 2,1,"Inclusion Criteria:

diagnosed congenital central hypoventilation syndrome (CCHS)
female
greater than or equal to 16 years of age

Exclusion Criteria:

less than 16 years of age
male
pregnant
poor adherence to medications
inability to perform pulmonary maneuvers for tests
contraindications to oral contraceptives
pulmonary hypertension","open label studied on drug.

Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel",ChEMBL:CHEMBL1533 | DrugBank:DB00304 | PubChem:40973,Desogestrel,[H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC(=C)[C@@]1([H])[C@@]2([H])CCC2=CCCC[C@@]21[H],G03AA09 | G03AB05 | G03AC09 | G03FB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01504867,NCT01504867_EG001,No,All,Adult | Older Adult,Phase 2,195,"Inclusion Criteria:

Adult patients (age > 18) admitted to the hospital through the emergency department (ED)
At high risk of developing acute lung injury (ALI) Lung Injury Prediction Score (LIPS) greater than or equal to 4

Exclusion Criteria:

Anti-platelet therapy on admission or within 7 days prior to admission
Presented to outside hospital ED > 12 hrs before arrival at site's facility
Inability to obtain consent within 12 hours of hospital presentation
Admitted for elective surgery
Acute lung injury prior to randomization
Receiving mechanical ventilation through a tracheostomy tube prior to current hospital admission (patient who is ventilator dependent)
Presence of bilateral pulmonary infiltrates on admission if he or she has a history of bilateral pulmonary infiltrates (as evidenced by previous x-rays) that can reasonably explain the current degree of pulmonary infiltrates present.
Presentation due to pure heart failure and no other known risk factors for ALI.
Allergy to aspirin or non steroidal anti inflammatory drugs (NSAIDs)
Bleeding disorder
Suspected active bleeding or judged to be at high risk for bleeding
Active peptic ulcer disease (within past 6 months)
Severe chronic liver disease
Inability to administer the study drug
Expected hospital stay < 48 hours
Admitted for comfort or hospice care
Patient, surrogate or physician not committed to full support. (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
Not anticipated to survive > 48 hours
Previously enrolled in this trial
Enrolled in a concomitant intervention trial
Pregnant or breastfeeding",This group received matching lactose powder filled capsules on days 1-7.,ChEMBL:CHEMBL1908365 | DrugBank:DB02061 | DrugBank:DB03323 | PubChem:10991489 | PubChem:11908385 | PubChem:12302673 | PubChem:131632347 | PubChem:16211032 | PubChem:294 | PubChem:439186 | PubChem:439341 | PubChem:440995 | PubChem:45109807 | PubChem:6134 | PubChem:6255,Maltose,OCC1OC(OC2C(CO)OC(O)C(O)C2O)C(O)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
NCT01505933,NCT01505933_EG000,No,All,Child,Phase 2,24,"Inclusion Criteria:

Children undergoing MRI brain
Age 2 - 5 yrs
ASA I - II

Exclusion Criteria:

OSA
Pathology of upper airway
Craniofacial anomalies
Gastroesophageal reflux
Increased intracranial pressure
Body weight of 20% more than ideal
Contraindication to the use of either drug
Failure to maintain a patent airway during the study","Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01506882,NCT01506882_EG000,No,All,Child | Adult | Older Adult,Phase 3,61,"Inclusion Criteria:

Subject is male or female and aged ≥ 16 years at Visit 1
Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

Subject has a history or presence of seizure types other than partial (IA, IB, IC)
Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
Subject has a history or presence of known Pseudo-Seizures
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol","Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01506882,NCT01506882_EG001,No,All,Child | Adult | Older Adult,Phase 3,10,"Inclusion Criteria:

Subject is male or female and aged ≥ 16 years at Visit 1
Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

Subject has a history or presence of seizure types other than partial (IA, IB, IC)
Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
Subject has a history or presence of known Pseudo-Seizures
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol","Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0
NCT01508325,NCT01508325_EG000,No,All,Adult | Older Adult,Phase 4,93,"Inclusion Criteria:

Subjects aged: >=18 years and =<70 years old
EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH subjects who have taken anti-hypertension drug.
Clinic resting Heart Rate >=70 beats per minute (bpm)
Patients who have signed informed consent

Exclusion Criteria:

Subjects with contraindications according to the China Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
Moderate EH patients who have used anti-hypertension drugs
Secondary hypertension
Subjects with history of coronary heart disease
Chronic or acute heart failure
Cerebrovascular events within 6 months before screening
Impaired hepatic or renal function (according to local lab standard)
Other protocol defined exclusion criteria could apply","Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01508676,NCT01508676_EG000,No,All,Adult | Older Adult,Not Applicable,35,"Inclusion Criteria:

Subject will be between 18 and 80 years of age.
Subject has not been on Pennsaid or other topical non-steroid anti-inflammatory drugs for at least one month.
Subject agrees to make no change in his/her current pain medications during the entire study period. This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
Subject has a VAS pain score of 4 or above at the beginning of the study.
Subject has had a neuropathic pain condition such as those listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

Subject has documented severe liver or renal disease that will affect the elimination of Pennsaid or is subject to the adverse effect of Pennsaid on these organs. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
Subject has pending litigation related to the neuropathic pain condition.
Subject has active skin lesion or open wound at the site of Pennsaid application (e.g., active shingles with skin lesions).
Subject is pregnant or lactating.
Subject has scar tissue or sensory deficit at the site of QST.
Subject is allergic to diclofenac or has cross-sensitivity to other non-steroid anti-inflammatory drugs.
Subject has a positive urine (illicit) drug test.
Subjects who experience asthma, urticaria or an allergic type reaction when taking aspirin or NSAIDs.
Subjects undergoing coronary artery bypass surgery.
Subject with a known history of cardiovascular disease, ulcer, gastrointestinal bleed or impaired renal function.
Subjects currently using NSAIDS.",Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).,PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT01509404,NCT01509404_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Male and female patients ≥ 18 years of age.
Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
The patient has given written informed consent to participate in the study.

Exclusion Criteria:

Solid organ transplant recipient is CMV seropositive at the time of transplant.
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
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.
Inability to cooperate or communicate with the investigator.","valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01511939,NCT01511939_EG001,No,All,Adult | Older Adult,Phase 3,5,"Inclusion Criteria:

Male or female adults > than or equal to 55
Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days.
Subjects with bilateral knee OA, the more symptomatic knee is the index knee and PENNSAID can be applied on both knees if both are affected.
Radiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years.
Currently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or clopidogrel) for the past 2 months and expected to remain on current dose for the six week duration of the study.
If currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or acetaminophen for OA knee pain, must be taking it for at least an average of 25 days per month.
Those currently taking oral NSAID must be willing to perform a 7 day washout to be eligible to be enrolled into the study.
A pain score of > than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm scale) at screening and baseline visit.
Able to comply with the study and give informed consent prior to performance of any study procedures.
Able to read, write and understand English.

Exclusion Criteria:

Unwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
Unwilling to abstain from taking < than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial.
Using a handicap assistance device i.e. cane, walker > than or equal to 50% of the time.
Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study.
History or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
Known or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses.
History of abnormal laboratory results > that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study.
Any of the following abnormal laboratory results during screening:
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > than or equal to 2.5 x ULN
Hemoglobin < than 11.5 g/dL (female) or < 13.2 g/dL (male)
White blood cell count (WBC) < than 3500 cells/mm3
Lymphocyte count < than or equal to 1000 cels/mm3
Serum creatinine > than or equal 1.5 x ULN
Platelet count below the central laboratory lower limit of normal (LLN)
Coagulation tests (Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), Platelet Aggregation) requiring an alteration in anticoagulant dosage.
Skin breakdown or rash at knee where topical PENNSAID is to be applied.
Other serious uncontrolled non-malignant, significant, acute or chronic medical or psychiatric illness that, in judgment of investigator, could compromise subject safety, limit subject's ability to complete study and/or compromise the objectives of study.
History of malignancy in the past 5 years with exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
History of drug or alcohol dependence or abuse in the past 3 years.","Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months

Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT01514149,NCT01514149_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening","CJC-1134-PC, 1.5 mg. weekly subcutaneous injection",PubChem:86278325,Albenatide,NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=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
NCT01514149,NCT01514149_EG001,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening","CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection",PubChem:86278325,Albenatide,NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01514149,NCT01514149_EG002,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening","CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection",PubChem:86278325,Albenatide,NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01514149,NCT01514149_EG003,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening","CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection",PubChem:86278325,Albenatide,NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01514734,NCT01514734_EG000,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.","Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks",PubChem:71306410,Azarga,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01518244,NCT01518244_EG000,No,All,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucoma.
History of ocular herpes simplex.
Any abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.","Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks",PubChem:71306410,Azarga,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01519518,NCT01519518_EG000,No,All,Adult | Older Adult,Phase 4,1829,"Inclusion Criteria:

All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial

Exclusion Criteria:

≤ 18 years of age
Known intolerance, hypersensitivity or contraindication to any trial medication
Active bleeding at presentation
Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
Previous enrolment in this trial","70 units/kg body weight intravenous

unfractionated heparin: 70 units/kg body weight intravenous",PubChem:107275093,(2-Bromo-4-imidazol-1-ylphenyl)methanamine,NCc1ccc(-n2ccnc2)cc1Br,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01526538,NCT01526538_EG000,Accepts Healthy Volunteers,All,Adult,Phase 2,52,"Inclusion Criteria:

18-60 years of age (> 60 due to age-related effects on cognitive functioning)
Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
Able to complete all study measures
Currently seeking treatment for cocaine dependence

Exclusion Criteria:

Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
Pregnant, breast feeding, or planning to become pregnant within 3 months
If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
Diagnosis of current major psychiatric disorder besides substance dependence or abuse
Reported use of DCS in the past year
Illiteracy, as will be determined during in-person screening
Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
Positive urine result for opioids at screening interview","active drug condition

d-cycloserine: 50 mg d-cycloserine",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01528891,NCT01528891_EG000,No,All,Child,Phase 3,200,"Inclusion Criteria:

children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
ASA 1,2,3
females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

patients with known dysrhythmias,
not recovering in the ICU
developmental delay,
autism communication disorder
bleeding disorder
PI discretion","Dexmedetomidine

Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01529450,NCT01529450_EG000,No,All,Adult | Older Adult,Not Applicable,3,"Inclusion Criteria:

Age 18 years or older.
Histologically documented diagnosis of basal cell carcinoma deemed to be locally advanced or metastatic who have previously received a non-LDE225 Smo inhibitor.
World Health Organization (WHO) performance status <= 2
At least one measurable site of disease (as defined by Response Evaluation Criteria in Solid Tumors), or other disease specific response assessment criteria, as appropriate. State age restriction and/or gender/race-ethnic restrictions.

Patients with adequate bone marrow, liver and renal function, as specified below:

Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L
Hemoglobin (Hgb) >= 9 g/dL
Platelets >= 80 x 10^9/L
Serum total bilirubin <= 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN or <= 5 x ULN if liver metastases are present
Plasma creatine phosphokinase (CK) < 1.5 x ULN
Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 50ml/min
Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

Patients who have had major surgery within 4 weeks of initiation of study medication.

Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.

State restrictions regarding use of other Investigational Agents.

Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.

State exclusion requirements due to co-morbid disease or incurrent illness, as needed.

Patients who have previously been treated with systemic LDE225.

Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment. If it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution.

b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. Note: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment.

Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with LDE225.
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome (CYP)3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
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 (> 5 mIU/mL).

10 Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include:

Diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.

11 Patients unwilling or unable to comply with the protocol.","Patients previously treated with non-LDE225 Smo inhibitor who were refractory.

LDE225: 800-mg (4 200-mg capsules/day) capsule",ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01529450,NCT01529450_EG001,No,All,Adult | Older Adult,Not Applicable,6,"Inclusion Criteria:

Age 18 years or older.
Histologically documented diagnosis of basal cell carcinoma deemed to be locally advanced or metastatic who have previously received a non-LDE225 Smo inhibitor.
World Health Organization (WHO) performance status <= 2
At least one measurable site of disease (as defined by Response Evaluation Criteria in Solid Tumors), or other disease specific response assessment criteria, as appropriate. State age restriction and/or gender/race-ethnic restrictions.

Patients with adequate bone marrow, liver and renal function, as specified below:

Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L
Hemoglobin (Hgb) >= 9 g/dL
Platelets >= 80 x 10^9/L
Serum total bilirubin <= 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN or <= 5 x ULN if liver metastases are present
Plasma creatine phosphokinase (CK) < 1.5 x ULN
Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 50ml/min
Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

Patients who have had major surgery within 4 weeks of initiation of study medication.

Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.

State restrictions regarding use of other Investigational Agents.

Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.

State exclusion requirements due to co-morbid disease or incurrent illness, as needed.

Patients who have previously been treated with systemic LDE225.

Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment. If it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution.

b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. Note: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment.

Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with LDE225.
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome (CYP)3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
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 (> 5 mIU/mL).

10 Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include:

Diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.

11 Patients unwilling or unable to comply with the protocol.","Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.

LDE225: 800-mg (4 200-mg capsules/day) capsule",ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01534897,NCT01534897_EG000,No,All,Adult | Older Adult,Not Applicable,10,"Inclusion Criteria:

Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation
Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck
Radioiodine-refractory disease
Life expectancy > 6 months
Able to swallow and retain oral medication
Normal organ and marrow function

Exclusion Criteria:

Pregnant or breastfeeding
Previous treatment with a specific BRAF or MEK inhibitor
Receiving any other study agents
Known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine
Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs
History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency
Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias
Taking herbal remedies
Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician
Uncontrolled current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements
History of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence
HIV-positive on combination antiretroviral therapy","Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.

GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)",ChEMBL:CHEMBL2028663 | DrugBank:DB08912 | PubChem:44462760,Dabrafenib,CC(C)(C)c1nc(-c2cccc(NS(=O)(=O)c3c(F)cccc3F)c2F)c(-c2ccnc(N)n2)s1,L01EC02 | L01XE23,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01535235,NCT01535235_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria include:

Stable HAART with maintenance of plasma HIV RNA levels below level of detection (< 40-75 copies/mL) for ≥ 12 months
> 90% adherence to HAART within preceding 30 days

Exclusion Criteria include:

Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg
Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
Pregnant/breastfeeding women.","Active group

Lisinopril: Lisinopril 20mg QD x 24 weeks",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01535287,NCT01535287_EG000,No,All,Child,Phase 4,140,"Inclusion Criteria:

ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)
Between the ages of 1 and 10 years
Undergoing BMT under general anesthesia.

Exclusion Criteria:

ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)
Congenital diseases
Coagulation disorders
Known allergic reaction to dexmedetomidine
Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions
Severe upper airway infection
Predicted difficult airway
Preexisting psychiatric disorders","Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.

Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).

All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01535287,NCT01535287_EG001,No,All,Child,Phase 4,140,"Inclusion Criteria:

ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)
Between the ages of 1 and 10 years
Undergoing BMT under general anesthesia.

Exclusion Criteria:

ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)
Congenital diseases
Coagulation disorders
Known allergic reaction to dexmedetomidine
Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions
Severe upper airway infection
Predicted difficult airway
Preexisting psychiatric disorders","Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.

Dexmedetomidine: Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).

All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01537315,NCT01537315_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Measured stage IV proteinuric chronic kidney disease with an estimated Modification of Diet in Renal Disease (MDRD) GFR (eGFR) of 18 to 35 ml/min.
Current or history of documented proteinuria of more than or equal to 300 mg/dL in 24 hours or a spot urine protein to creatinine ratio of greater than 0.3 ug/mg.
Not on dialysis.
Ages 18 to 80 years, both sexes, all races and ethnicities

Exclusion Criteria:

glucose-6-phosphate dehydrogenase (G6PD) deficiency or known hypersensitivity to 4-aminoquinoline compounds (such as chloroquine or hydroxychloroquine).
Abnormal liver functions; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 2.5 times the normal or international normalized ratio (INR) without being anti-coagulated greater than 1.4.
Known chronic active infections like HIV, Hepatitis B or Hepatitis C positive, chronic osteomyelitis etc.
Recent serious infection including Pneumonia requiring hospitalization, meningitis, septicemia in the 2 months prior to screening.
Active or recently treated (< 1 year in remission) malignancy or systemic inflammatory diseases (Patients with localized squamous cell carcinoma of the skin are eligible).
Pregnancy, breastfeeding or planning to become pregnant during the course of the study.
Use of systemic corticosteroids or other immunosuppression within last 3 months (acute course of steroid for a gouty arthritis or chronic obstructive pulmonary disease (COPD) is eligible if > 1 month ago).
History of prolonged corrected QT interval > 450.
Inability to attend or comply with treatment or follow-up scheduling.
Life expectancy less than 6 months or uncontrolled congestive heart failure (CHF) (defined as more than 2 admissions in prior 6 months).
Any other condition the PI determines may put the research subject in jeopardy during the course of the study.","Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)

Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01539135,NCT01539135_EG000,No,All,Adult | Older Adult,Not Applicable,80,"Inclusion Criteria:

Male or Female of all races
Older than 18 years old
Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
Willing and able to give informed consent for participation in the study
Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
Expected hospital stay of greater than or equal to 23hrs

Exclusion Criteria:

Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
Surgical requirement for naso-tracheal intubation
Patients undergoing surgical procedures directly on the lungs, trachea, or airways
Presence of tracheostomy
History of allergic reaction to methylene blue
Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
Renal insufficiency or failure
Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
Patients younger than 18 years of age
Prone positioning during surgery
Pregnant or lactating women based on standardized preoperative screening protocols
Legally detained prisoner status
Unwilling or unable to give informed consent for participation in the study","Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure

Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01539135,NCT01539135_EG001,No,All,Adult | Older Adult,Not Applicable,80,"Inclusion Criteria:

Male or Female of all races
Older than 18 years old
Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
Willing and able to give informed consent for participation in the study
Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
Expected hospital stay of greater than or equal to 23hrs

Exclusion Criteria:

Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
Surgical requirement for naso-tracheal intubation
Patients undergoing surgical procedures directly on the lungs, trachea, or airways
Presence of tracheostomy
History of allergic reaction to methylene blue
Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
Renal insufficiency or failure
Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
Patients younger than 18 years of age
Prone positioning during surgery
Pregnant or lactating women based on standardized preoperative screening protocols
Legally detained prisoner status
Unwilling or unable to give informed consent for participation in the study","TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure

Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01540071,NCT01540071_EG000,No,Male,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

Histologically or cytologically confirmed prostate cancer
Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
Male, Age > 18 years
ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
Adequate bone marrow, renal and hepatic function
Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter

Exclusion Criteria:

Prior treatment with NRX 194204 or bexarotene (Targretin)
Presence of parenchymal brain metastases
History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
Known HIV or hepatitis B or C infection
Life expectancy < 3 months
Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
Patients with a history of pancreatitis or at significant risk of developing pancreatitis","This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.

NRX 194204: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day",PubChem:9863341,"2,4-Pentadienoic acid, 3-methyl-5-((1S,2S)-2-methyl-2-(5,6,7,8-tetrahydro-5,5,8,8-tetramethyl-2-naphthalenyl)cyclopropyl)-, (2E,4E)-",CC(C=CC1CC1(C)c1ccc2c(c1)C(C)(C)CCC2(C)C)=CC(=O)O,,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01543581,NCT01543581_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Willing and able to give informed consent.
At least 18 years of age.

Have a confirmed BCC at one of listed anatomical sites which must be biopsy-confirmed at the study site and meets this criteria:

non-infected
minimum tumor area of 0.5 cm2 in an anatomic location at risk for significant deformity or functional impairment with surgery.
macroscopically (clinically) consistent with BCC
histologically consistent with BCC
suitable for treatment with Mohs surgical excision
identifiable by subject or reliable subject representative
Free of any significant physical abnormalities (e.g., tattoos) at treatment site.

Willing and able to participate in the study as an outpatient, making frequent visits to clinic during treatment and follow-up periods and comply with study requirements, including:

Consenting to biopsy of the lesion at baseline, if needed, before beginning study drug treatment
Attend all scheduled clinic visits during pre-study, treatment, and follow-up periods
Will delay excision of the target tumor site until time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability
Post-excisional follow-up visits until the area is healed to investigator's satisfaction
Female of reproductive potential must use 2 forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 7 months after completing therapy.
Male patients must use condoms at all times, with spermicide, even after vasectomy, during sexual intercourse with females during treatment and for 2 months after the last dose.
Agrees not to donate blood or blood products during the study and for 7 months after last dose.

Exclusion Criteria:

Prior treatment with GDC-0449 or any HH Pathway Inhibitor
Have evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease. Subjects with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
Have any dermatological disease at treatment site that may be exacerbated by treatment with vismodegib or cause difficulty with examination (e.g., psoriasis, eczema).
Inability or unwillingness to swallow capsules
Pregnancy or lactation
Have a desire to conceive in the future.
Patients with known Gorlin's (basal cell nevus) syndrome or clinical suspicion of Gorlin's Syndrome)
Recent (i.e., within the past 28 days), current, or planned participation in another experimental drug study
Have active chemical dependency or alcoholism..

Have received following treatments for BCC in the treatment area within designated time period before study treatment initiation:

Treatment Time Period:

Prescribed topical retinoids 4 weeks Surgical excision 4 weeks Curettage 4 weeks Cryo destruction or chemo destruction 4 weeks

Received treatment for non-melanoma skin cancer or precancerous condition [squamous cell carcinoma (SCC), or actinic keratosis (AK)] within treatment area within 4 weeks of study treatment initiation, or currently have SCC, malignant melanoma (MM), or any other dermatological condition in treatment area that requires treatment.
Received any cancer chemotherapy within 6 months before study treatment initiation (subject must not currently have any evidence of cancer, other than skin cancer).

Received any of the following treatments within 4 weeks before study treatment initiation:

Interferon or interferon inducers
Immunomodulators or immunosuppressive therapies
Cytotoxic drugs
Investigational drugs
Drugs known to have major organ toxicity
Oral corticosteroids
Inhaled corticosteroids (> 1200 Xg/day for beclomethasone, or > 600 Xg/day for fluticasone)
Topical steroids in treatment area","Oral vismodegib, 150mg per day for 12 weeks.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01552369,NCT01552369_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

Be > / = 18 years of age.
Have negative Cytomegalovirus (CMV) serology (confirmed within 6 months of transplant) and receive a liver from a donor with positive CMV serology (R-/D+).
Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
Have absolute neutrophil count > 1000/µL at randomization.

- If female, and not postmenopausal or surgically sterile, must have negative pregnancy test (serum or urine) within 48 hours prior to randomization and must also agree to use medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence for 100 days after randomization and 3 months after valganciclovir cessation.

-- If male, and has not had a vasectomy, he must agree to practice barrier method of contraception for 100 days after randomization and 3 months after valganciclovir cessation.

Subject or legally authorized representative has provided written informed consent.

Exclusion Criteria:

Currently enrolled in any interventional trial of an investigational therapeutic agent unless co-enrollment has been approved by study Principal Investigators (PIs) and the DMID prior to enrollment.
Have hypersensitivity to acyclovir, ganciclovir or valganciclovir.
Be breast-feeding mother.
Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
Be undergoing multi organ transplant or have undergone prior organ transplant.
Have expected life expectancy of less than 72 hours.",900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction.,ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01552369,NCT01552369_EG001,No,All,Adult | Older Adult,Phase 4,105,"Inclusion Criteria:

Be > / = 18 years of age.
Have negative Cytomegalovirus (CMV) serology (confirmed within 6 months of transplant) and receive a liver from a donor with positive CMV serology (R-/D+).
Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
Have absolute neutrophil count > 1000/µL at randomization.

- If female, and not postmenopausal or surgically sterile, must have negative pregnancy test (serum or urine) within 48 hours prior to randomization and must also agree to use medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence for 100 days after randomization and 3 months after valganciclovir cessation.

-- If male, and has not had a vasectomy, he must agree to practice barrier method of contraception for 100 days after randomization and 3 months after valganciclovir cessation.

Subject or legally authorized representative has provided written informed consent.

Exclusion Criteria:

Currently enrolled in any interventional trial of an investigational therapeutic agent unless co-enrollment has been approved by study Principal Investigators (PIs) and the DMID prior to enrollment.
Have hypersensitivity to acyclovir, ganciclovir or valganciclovir.
Be breast-feeding mother.
Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
Be undergoing multi organ transplant or have undergone prior organ transplant.
Have expected life expectancy of less than 72 hours.",900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction.,ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01555957,NCT01555957_EG000,No,All,Child,Phase 3,20,"Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

Exclusion Criteria:

If does not need TPN by 72 hours;
Direct hyperbilirubinemia within the first 72 hours after birth;
TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
Biliary tract disorders leading to direct hyperbilirubinemia;
Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc",intravenous lipid: intravenous given daily for 6 weeks,ChEMBL:CHEMBL1169 | DrugBank:DB00233 | PubChem:4649,AMINOSALICYLIC ACID,Nc1ccc(C(=O)O)c(O)c1,J04AA01 | J04AA02 | J04AA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01555957,NCT01555957_EG001,No,All,Child,Phase 3,20,"Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

Exclusion Criteria:

If does not need TPN by 72 hours;
Direct hyperbilirubinemia within the first 72 hours after birth;
TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
Biliary tract disorders leading to direct hyperbilirubinemia;
Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc",intravenous lipid: intravenous given daily for 6 weeks,ChEMBL:CHEMBL1169 | DrugBank:DB00233 | PubChem:4649,AMINOSALICYLIC ACID,Nc1ccc(C(=O)O)c(O)c1,J04AA01 | J04AA02 | J04AA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01556009,NCT01556009_EG000,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.","Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01565499,NCT01565499_EG000,No,Female,Adult | Older Adult,Phase 2,81,"Inclusion Criteria:

Female patients with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast ≥ 2cm, or < 2 cm with axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be ≥ 2cm (unless axillary involvement) and is designated as the ""target"" lesion for all subsequent tumor evaluations.
The breast tumors must be ER positive: more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory).
Are clear candidates to receive chemotherapy by the investigator criteria.
Are at least 18 years of age.
Have at least one unidimensionally measurable lesion by RECIST [65] version 1.1, measured by mammogram.
Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2

Have adequate renal and liver function and bone marrow reserve as follows:

Bone marrow: absolute neutrophil count (ANC) > or = 1.500/mm3 (1.5 x 109/L); platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.
Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = 2.5 * ULN and Albumin ≥ 2.5 g/dL.
Renal: serum creatinine < 1.5 x ULN.
Exhibit patient compliance and geographic proximity that allow for adequate follow-up
Entry informed consent form signed by the patient.

Exclusion Criteria:

Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
Synchronous contralateral or multicentric breast cancer.
Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.
Second primary malignancy, except adequately treated carcinoma in situ of the cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was diagnosed and definitively treated more than 5 years ago with no subsequent evidence of recurrence.
Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
Patients with known hypersensitivity to nab-paclitaxel or any of its components.
Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria
Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
Patient is pregnant or breast feeding or planning to become pregnant within the six months after the end of treatment. Women with child-bearing potential must be performed a pregnancy serum or urine testing within 7 days prior to study entry according to institutional standards and should use an adequate non-hormonal contraceptive method (intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterilized) during treatment with study drugs and within the six months after the end of treatment.","The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.

Nab-paclitaxel",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01566162,NCT01566162_EG000,No,All,Adult | Older Adult,Phase 3,191,"Inclusion Criteria:

Subject has agreed to participate by providing written informed consent.
Subject will be eligible to participate if one of the following criteria is met:
Subject has completed the 28-week double-blind phase of study D1050238
Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers ""yes"" to ""Suicidal Ideation"" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer ""yes"" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.","Lurasidone 40 - 80mg flexible dose

Lurasidone: Lurasidone 40-80 mg taken orally taken once daily",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01568255,NCT01568255_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Female gender (refer to section 4)
Age > 18, using an effective form of contraception (refer to section 4)
An indication to be on statin therapy
Moderate to severe myopathic pain while on Simvastatin
Serum CK level < 10 x ULN
Vitamin 25 OH D level < 30 ng/mL (as secondary hyperparathyroidism is triggered below this level)1
English speaking patients only
Myopathic pain that cannot be attributed to other medical conditions
Continue a statin within the CYP3A4 family
Competent to give informed consent

Exclusion Criteria:

Clinical diagnosis of overt vitamin D deficiency: osteomalacia, rickets, hypocalcemia, hypophosphatemia
Already taking Vitamin D supplements > 1000 IU/day
Serum creatinine > 2.2 mg/dL within last 6 months
AST/ALT > 3 x ULN of the local reference range
Serum CK level > 10 x ULN
Systolic blood pressure < 100 mmHg
Albumin adjusted calcium > 2.55 mmol/L or < 2.20 mmol/L
Renal osteodystrophy
Malabsorption syndrome
Metastatic malignancy
Transplant recipients
A co-existent diagnosis of renal calculi within the previous 6 months
A co-existent diagnosis of primary hyperparathyroidism within the previous 6 months
Recent therapy with corticosteroids within the previous 6 months
Currently consuming Digoxin, as usage increases risk of hypercalcemia
Lactating women","Vitamin D Treatment Group

Ergocalciferol: Ergocalciferol therapy at 50,000IU for 8 weeks",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01569841,NCT01569841_EG000,No,All,Adult | Older Adult,Phase 3,23,"Inclusion Criteria:

Type 1 diabetes
HbA1c (glycosylated haemoglobin) below or equal to 8.5%
Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
BMI (body mass index) below 35 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months","The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.

Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.

Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)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
NCT01570309,NCT01570309_EG000,No,All,Adult | Older Adult,Not Applicable,45,"Inclusion Criteria:

Male and nonpregnant females greater than 18 years of age
≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
Serum 25-hydroxyvitamin D < 20 ng/ml

Exclusion Criteria:

confinement to a nursing facility, institution or home
GFR < 60 ml/min (by MDRD equation)
presence of liver disease
hypercalcemia
NYHA class III or IV heart failure
cardiogenic shock at time of presentation
current planned or emergent CABG
prior gastric or small bowel surgery
pancreatitis
malabsorption
inflammatory bowel disease
autoimmune disease
active malignancy
current use of > 800 IU/day of vitamin D
Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy","50,000 units of ergocalciferol once a week for 12 weeks",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01573052,NCT01573052_EG000,No,All,Adult | Older Adult,Phase 4,26,"Inclusion Criteria:

Alcohol dependent at risk for withdrawal symptoms

Exclusion Criteria:

Benzodiazepine dependent","25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01574703,NCT01574703_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,1166,"Inclusion Criteria:

Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.","This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT01575275,NCT01575275_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent GBM or suspected GBM (in patient with pathologically diagnosed prior World Health Organization [WHO] grade II or III tumor) in a patient undergoing a clinically-indicated surgery.
Age >= 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy is not a consideration for protocol entry
Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits; OR
Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
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 participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Prior therapy is not an exclusion criterion
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to aminolevulinic acid (ALA)
Current treatment with hypericin (or an extract) or other photosensitizing agents
Personal or immediate family (parents, siblings, children) history of porphyrias
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; breastfeeding should be discontinued if the mother is treated with ALA","Patients receive aminolevulinic acid PO 2-4 hours before surgery.

aminolevulinic acid: Given PO

therapeutic conventional surgery: Undergo surgery",DrugBank:DB00132,alpha-Linolenic acid,CC/C=C\C/C=C\C/C=C\CCCCCCCC(=O)O,,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01575561,NCT01575561_EG000,No,All,Adult | Older Adult,Phase 3,377,"Inclusion Criteria:

Subject has agreed to participate by providing written informed consent.
Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers ""yes"" to ""Suicidal Ideation"" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).","Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01583218,NCT01583218_EG000,No,All,Adult | Older Adult,Phase 3,3716,"Inclusion Criteria:

men and non-pregnant, non-breastfeeding women
anticipated to be severely immobilized for at least 24 hours after randomization

hospitalized with one of the following

congestive heart failure
acute respiratory failure,
acute infection without septic shock,
acute rheumatic disorders
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

a condition requiring prolonged anticoagulation or anti-platelets
active bleeding or at high risk of bleeding
contraindication to anticoagulant therapy
general conditions in which subjects are not suitable to participate in the study",Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days,ChEMBL:CHEMBL512351 | DrugBank:DB12364 | PubChem:10275777,Betrixaban,COc1ccc(NC(=O)c2ccc(C(=N)N(C)C)cc2)c(C(=O)Nc2ccc(Cl)cn2)c1,B01AF04,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01585298,NCT01585298_EG000,No,All,Adult | Older Adult,Phase 4,6998,"Key Inclusion Criteria:

Subjects with relapsing remitting MS.
Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

- or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

immunocompromised patients
active infections
pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
presence of malignancy (other than localized basal cell carcinoma of the skin).",Fingolimod 0.5 mg by mouth once daily for 7 days.,PubChem:107969,Fingolimod Hydrochloride,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01588951,NCT01588951_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,10,"Inclusion Criteria:

Age greater than or equal to 18 years
Able to give informed consent
New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
Pregnancy: Women of childbearing potential who are β- HCG+","Without LSC, standard cytarabine consolidation

Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.",ChEMBL:CHEMBL4297067 | DrugBank:DB00693 | PubChem:16850,Fluorescein,O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21,S01JA01 | S01JA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01588951,NCT01588951_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,10,"Inclusion Criteria:

Age greater than or equal to 18 years
Able to give informed consent
New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion criteria:

Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
Pregnancy: Women of childbearing potential who are β- HCG+","LSC present, randomized to cytarabine consolidation

Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.",ChEMBL:CHEMBL4297067 | DrugBank:DB00693 | PubChem:16850,Fluorescein,O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21,S01JA01 | S01JA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01589523,NCT01589523_EG000,No,All,Child | Adult | Older Adult,Phase 3,5,"Inclusion Criteria:

Confirmation of a diagnosis of an inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.
Any age
Participant must be willing and able to comply with study assessments and procedures.
The participant and/or parent/legal guardian must have signed the written informed consent document prior to study start.

Exclusion Criteria

1. No confirmed diagnosis of inborn error of bile acid synthesis/conjugation based upon urine analysis by FAB-MS.",15 mg/kg bw/day,DrugBank:DB02691 | PubChem:10140,Glycocholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])C[C@H](O)[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)NCC(=O)[O-])[C@]1([H])[C@H](O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01590758,NCT01590758_EG000,No,All,Adult | Older Adult,Phase 3,85,"Inclusion Criteria:

Diabetes mellitus.
Male or female at least 18 years old.
Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
Subject is to be treated on an outpatient basis.
Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
Localized mild infection of the ulcer.
The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

IDSA-defined moderate infection.
IDSA-defined severe infection.
Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
> 1 infected foot ulcer.
Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
Subject has received a systemic antibiotic within 48 hours prior to Screening.
Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
Bone or joint involvement is suspected based on clinical examination or plain X-ray.
Clinically significant peripheral arterial disease requiring vascular intervention.
Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.",Topical pexiganan cream 0.8%: 14 days of treatment,ChEMBL:CHEMBL1275802 | DrugBank:DB16293,PEXIGANAN,CC[C@H](C)[C@H](NC(=O)CN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)[C@@H](C)CC)C(C)C,,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
NCT01592773,NCT01592773_EG000,No,All,Child,Phase 2,747,"Inclusion Criteria:

Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of ""yes"" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior","To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.

Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.",PubChem:181458,Memantine Hydrochloride,CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl,,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
NCT01593722,NCT01593722_EG001,No,All,Adult,Phase 4,6,"INCLUSION CRITERIA (SCREENING):

A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:

male or non-pregnant and not breastfeeding female subjects,
age 20-60 years (per participant self-report)
resident of Akonolinga
Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or did not participate in the prior screening
consent to a blood draw to screen for infection with Loa loa
must be willing to have blood samples stored

EXCLUSION CRITERIA (SCREENING):

A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:

Known to be pregnant (by history) or breastfeeding
Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
History of hypersensitivity reaction to DEC or IVM

INCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will be eligible for participation in the interventional portion of the study only if all of the following additional inclusion criteria apply:

Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and 2:30 pm measured within 30 days prior to the baseline visit
The subject agrees to storage of samples for study

EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:

Pregnancy (by serum or urine beta-HCG) or breastfeeding
Chronic kidney or liver disease
Hgb < 10 gm/dL
Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti)
Use of DEC or IVM within the past 6 months
Use of immunosuppressive therapies, including steroids, within the past month
Any condition that in the investigator s opinion places the subject at undue risk by participating in the study

EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be excluded from this study since it involves administration of medications contraindicated in pregnancy and more than minimal risk with no prospect of direct benefit, respectively.","ivermectin 200 mcg/kg single oral dose

Ivermectin: single dose",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01594762,NCT01594762_EG000,No,All,Adult | Older Adult,Phase 3,97,"Inclusion Criteria:

Diabetes mellitus.
Male or female at least 18 years old.
Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
Subject is to be treated on an outpatient basis.
Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
Localized mild infection of the ulcer.
The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
IDSA-defined severe infection, including systemic toxicity or metabolic instability.
Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
> 1 infected foot ulcer.
Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
Subject has received a systemic antibiotic within 48 hours prior to Screening.
Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
Bone or joint involvement is suspected based on clinical examination or plain X-ray.
Clinically significant peripheral arterial disease requiring vascular intervention.
Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.","Drug: Topical pexiganan cream 0.8%

Topical pexiganan cream 0.8%: 14 days of treatment",ChEMBL:CHEMBL1275802 | DrugBank:DB16293,PEXIGANAN,CC[C@H](C)[C@H](NC(=O)CN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(N)=O)[C@@H](C)CC)C(C)C,,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
NCT01595646,NCT01595646_EG001,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Age 50-89
Diagnosed with mild cognitive impairment, or mild/moderate AD

Exclusion Criteria:

Excessively high or low blood pressure, heart rate
Pre-existing diabetes not controlled by exercise/diet
Previous/current use of insulin
Significant elevations in lipids, liver enzymes
Menstrual period within the last 12 months
Significant neurological or medical disorder (other than AD)
Significant use of nasal decongestants
Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications","20IU of Insulin Detemir taken twice per day (40IU total per day)

Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)",ChEMBL:CHEMBL2104391,INSULIN DETEMIR,CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O,A10AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01603043,NCT01603043_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Ability to provide informed consent and comply with the protocol.
Diagnosis of bilateral geographic atrophy (GA) of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization.
Study eye: Maximum best-corrected visual acuity (BCVA) of 55 letters (20/80 Snellen equivalent) and a minimum BCVA of 20 letters (20/400 Snellen equivalent) at screening
BCVA of 20 letters (20/400 Snellen equivalent) or better in the non treated eye at screening without conditions other than AMD that, in the opinion of the investigator, could cause a rapid loss of vision.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any history or current evidence of exudative (""wet"") AMD in study eye.
Retinal disease other than AMD in the study eye.
Any ophthalmologic condition in study eye that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination, such as advanced cataract or corneal abnormalities.
Any ophthalmologic condition in study eye that prevents adequate imaging of the retina judged by the site or reading center.
A history or current medical diagnosis of glaucoma or ocular hypertension in study eye.
Any ophthalmic condition in study eye that may require surgery during the study period.
Current ocular or periocular infection in the study eye.
History of any disease or current use of medication expected to cause systemic or ocular immunosuppression, such as RESTASIS®.
History of uveitis or endophthalmitis in the study eye.
History of intraocular surgery (including cataract surgery) in the study eye within 90 days prior to dosing.
History of intravitreal or periocular injection in the study eye at anytime.
Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or during active period of drug (whichever is longer) prior to the start of study treatment.
History of any medical or psychiatric condition, or substance abuse, that in the Investigator's opinion is likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
Women of child bearing potential UNLESS they are using a highly effective method of birth control.
Known or suspected allergy or hypersensitivity to fluorescein or other injectables.
Other protocol-defined exclusion criteria may apply.",1 mock injection per month for 12 months,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,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
NCT01611311,NCT01611311_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion criteria:

1. Healthy male/female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions",Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,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
NCT01611311,NCT01611311_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion criteria:

1. Healthy male/female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions",Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01611311,NCT01611311_EG004,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,9,"Inclusion criteria:

1. Healthy male/female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions",Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01611311,NCT01611311_EG005,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,9,"Inclusion criteria:

1. Healthy male/female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions",Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days,DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01614990,NCT01614990_EG000,No,All,Child | Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Subjects ≥18 years of age with histological diagnosis of incurable cancer (solid tumor),
ECOG performance status of 0-2,
Presence of cancer-related cachexia defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months, and
Provide written informed consent prior to screening.

Exclusion Criteria:

Obesity (body weight >140 Kg);
Recent active excessive alcohol or illicit drug use;
Severe depression as determined by the investigator;
Other causes of cachexia such as: Liver disease (AST or ALT > 3x normal levels); renal failure (creatinine >1.5 mg/dL), untreated thyroid disease, class III-IV CHF, AIDS, severe COPD requiring use of home O2;
Inability to increase food intake (e.g., esophageal obstruction, intractable nausea and vomiting);
Any condition that would prevent the subject from performing the research procedures (e.g. unstable coronary artery disease);
Use of growth hormone, megestrol, Marinol, or any other anabolic agents, appetite stimulants (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feeding, or parenteral nutrition during the 1 month prior to entering the study;
Recent administration (less than 1 week) of highly emetogenic chemotherapy (Hesketh scale class 4-5); subjects may otherwise be undergoing chemotherapy.
Being female and pregnant, breast-feeding or of childbearing potential. (Note: Lack of childbearing potential for female patients is satisfied by: a) being post menopausal; b) being surgically sterile; c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the duration of the study; or d) being sexually inactive. Confirmation that the patient is not pregnant will be established by a negative serum hCG pregnancy test at the time of enrollment.
Co-administration of drugs that prolong QT interval, CYP3A4 inducers, QTc equal to or greater than 450ms at screening, or other investigational agents (a wash-out period of five times the half life of drugs that prolong QT will be allowed with approval of prescriber).

Conditions that would preclude from successfully scanning subjects in MRI:

Claustrophobia (this would make lying in the scanner very uncomfortable); b. having a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants; c. History of Seizures d. History of head injuries resulting in loss of consciousness > 10 minutes.",Macimorelin: Subjects will receive macimorelin (1 mg/kg) and matching placebo (Powerade®) daily for 7 days.,ChEMBL:CHEMBL278623 | DrugBank:DB13074 | PubChem:9804938,Macimorelin,CC(C)(N)C(=O)N[C@H](Cc1c[nH]c2ccccc12)C(=O)N[C@H](Cc1c[nH]c2ccccc12)NC=O,V04CD06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01616160,NCT01616160_EG000,No,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

- The subject must fulfill all of the following conditions or characteristics to be considered for enrollment:

Male or female between ages 21 - 70 years residing in the Boston area

History of chronic rhinosinusitis (symptoms for at least 3 months). Subject must have two or more of the following:

Facial pain/pressure or headache
Nasal congestion
Anterior or posterior nasal drainage
Hyposmia/anosmia
Abnormal CT scan in at least 2 sinuses areas within 3 months

Evidence of bilateral polyps or polypoid mucosa (on nasal endoscopy) with minimum polyp/polypoid score of 4 (see scoring system below).

Exclusion Criteria:

4. History of suggestive of immunodeficiency (i.e. those who have had > one pneumonia in the past 12 months or those with known immune deficiency).
History of cystic fibrosis, Kartagener's syndrome, immotile cilia syndrome, hypogammaglobulinemia or bleeding disorder
URI within six weeks prior to enrollment
Intranasal cocaine use
Pregnancy (if applicable

History of fainting

MEDICATION EXCLUSIONS prior to NP biopsies:

Use of prescription blood thinners
Use of systemic glucocorticoids for two weeks prior to enrollment
Use of intranasal corticosteroids and anticholinergics for three days prior to enrollment
Use of an antibiotic for three days prior to enrollment
Use of antihistamines for one week prior to enrollment","Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01620060,NCT01620060_EG000,No,All,Child,Phase 1,105,"Inclusion Criteria:

Subjects must provide written informed consent, if emancipated, written assent and be willing to participate in the study. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated.
Male or female subjects 6 to 17 years of age, inclusive. Subject must be 17 years or less at the follow-up visit.
Subject is judged by the investigator to be clinically stable (ie, no psychiatric hospitalization within the past 12 weeks; no imminent risk of suicide or injury to self, others or property; no recent addition, or change in dosage, of psychotropic medication intended for the treatment of the primary psychiatric condition in the past 4 weeks) but symptomatic (ie, some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option).
Subjects with the following diagnoses will be eligible for participation: primary schizophrenia spectrum diagnosis (schizophrenia, schizoaffective, schizophreniform or psychotic disorder Not Otherwise Specified (NOS), bipolar spectrum disorder (bipolar I, II or bipolar NOS), pervasive developmental disorder (PDD) including autistic spectrum disorder (autistic disorder, Asperger's syndrome, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), attention-deficit hyperactivity (ADHD) with aggressive behavior [meeting co-morbid diagnostic criteria for Conduct Disorder/Disruptive Behavior Disorders Not Otherwise Specified (CD/DBD NOS), or Tourette's syndrome, via clinical interview (using MINI-Kid plus diagnostic interview and the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) as a reference). Autistic disorder should also be confirmed by the Autism Diagnostic Interview, Revised (ADI-R).
Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
No clinically relevant abnormal laboratory values.
No clinically relevant abnormal vital sign values/findings.
Females who participate in this study:
are unable to become pregnant (eg, premenarchal, surgically sterile etc) -OR-
are willing to remain sexually abstinent (not engage in sexual intercourse) from Day 1 to 30 days after discharge on Day 11; -OR-
are sexually active and willing to use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from Day -1 to 30 days after discharge on Day 11.
Males must be willing to remain sexually abstinent or use an effective method of birth control (eg, condom) from Day -1 to 30 days after discharge on Day 11.
Willing and able to remain off any antipsychotic medication other than lurasidone for the duration of the study, if, in the investigator's opinion the subject is not at risk for worsening symptoms.
Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
Willing and able to adhere to protocol-specified meal requirements during dosing.
Have a stable living arrangement for at least 3 months prior to Day -1 and agrees to return to a similar living arrangement after discharge on Day 11. Homeless subjects may not be enrolled.

Exclusion Criteria:

Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being enrolled to the study.
Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, Parkinson's disease, or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
Known presence or history of hepatic insufficiency or subject's estimated creatinine clearance is < 80 mL/min/1.73 m2 by the following Bedside Schwartz equation for use with creatinine methods with calibration traceable to isotope dilution mass spectrometry (IDMS): Creatinine clearance (mL/min/1.73 m2) = (0.41 height) / serum creatinine concentration, where height in cm and serum creatinine in mg/dL.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes, moderate to severe dystonia, or moderate to severe tardive dyskinesia.
Clinically significant alcohol abuse/dependence or drug abuse/dependence based on MINI-Kid criteria within the last 6 months prior to screening.
Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing up).
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Positive breath alcohol test at screening or on Day -1.
Positive test results at screening or on Day -1 for:
Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, and methadone). However, a positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of prescription medicine(s).
Pregnancy test (only in female subjects ≥ 8 years old).
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C, or a positive test for Hepatitis B or C at screening (for subjects without a history).
Participated in another clinical trial or receiving an investigational product within 30 days prior to study drug administration.
Use of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge on Day 11. Exceptions (eg, for grapefruit juice consumption) may be discussed on a case-by-case basis with the medical monitor.
Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to Day -1 to follow-up.
Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to Screening, whichever is longer.
Received treatment with antidepressants within 3 days, fluoxetine or olanzapine plus fluoxetine combination within 28 days, MAO inhibitors within 14 days prior to Day -1 to follow-up.
Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine or fluvoxamine, within 3 days prior to Day -1 (7 days prior to Day -1 for aripiprazole) and until follow-up.
Does not tolerate venipuncture or has any bleeding disorder that would complicate blood drawing.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Donation or loss of whole blood within 60 days prior to drug administration.
Has a prolactin concentration greater than or equal to 100 ng/mL at screening.
Unwilling to abstain from vigorous exercise from Days -1 to 1 and from Days 9 to 10.
Subject answers ""yes"" to ""Suicidal Ideation"" Items 4 or 5 on the C-SSRS.
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 12 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.","Lurasidone 20, 40, 80, 120 or 160 mg/day

Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01620138,NCT01620138_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,9,"Inclusion Criteria

Male or female patients aged 18 years or greater
Patients with confirmed diagnosis of NFPA evidenced by: magnetic resonance imaging (MRI) confirmation of pituitary adenoma and No pituitary tumoral hormone hypersecretion
Patients with no previous medical treatment
Patients who had been submitted to surgery but not cured. Lack of cure is defined as presence of remnant tumor on MRI at least three months after surgery (without any possible misinterpretation of postsurgical changes)
Patients with confirmed diagnosis of resistant prolactinoma by lack of prolactin normalization with a tolerated cabergoline dosage during 12 weeks
Patients who had been submitted to surgery due to resistance to cabergoline and not cured. Lack of cure is defined as lack of serum prolactin normalization or complete removal of tumor load
Patients who signed the informed consent

Exclusion Criteria

Previous pituitary radiotherapy
High risk for transsphenoidal surgery
Patients with symptomatic cholelithiasis
Diabetic patients on antidiabetic medications those fasting blood glucose is poorly controlled as evidenced by HbA1C > 8%
Patients with abnormal coagulation (prothrombin time (PT) or partial thromboplastin time (PTT) elevated by 30% above normal limits);
Patients receiving anticoagulants that affect PT or PTT
Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
Patients with risk factors for torsade de pointes, i.e. patients with a baseline corrected QT interval (QTc) > 480 ms, hypokalemia, family history of long QT syndrome, and concomitant medications known to prolong QT interval
Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with (alanine aminotransferase) ALT/ (aspartate aminotransferase) AST more than 2 X upper limit of normal (ULN), serum creatinine > 2.0 X ULN, serum bilirubin > 2.0 X ULN, serum albumin < 0.67 X lower limit of normal (LLN)
Patients with white blood cell (WBC) < 3 X 109/L; Hgb < LLN; Platelet count (PLT) < 100 X 109/L
Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Female patients must use barrier contraception with condoms. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study and for one month after the last dose of study drug. Male patients who are sexually active are required to use condoms during the study and for 1 month afterwards
Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide","In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.

cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.

The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.",ChEMBL:CHEMBL1201087 | DrugBank:DB00248 | PubChem:54746,Cabergoline,[H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N(CCCN(C)C)C(=O)NCC)CN2CC=C,G02CB03 | N04BC06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01620190,NCT01620190_EG000,No,All,Adult | Older Adult,Phase 2,26,"Inclusion Criteria:

Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation
At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
Platelet count >= 100,000/uL
Absolute neutrophil count >= 1,500/uL
Hemoglobin >= 9 g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Bilirubin =< 1.5 mg/dL
Creatinine =< 1.5 mg/dL
Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Life expectancy of > 12 weeks
Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
Radiotherapy within 7 days of study treatment
Peripheral neuropathy grade 2 or greater
Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Pregnant or breast feeding females","Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01625000,NCT01625000_EG000,No,All,Adult,Phase 2 | Phase 3,126,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01625000,NCT01625000_EG001,No,All,Adult,Phase 2 | Phase 3,133,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01625000,NCT01625000_EG002,No,All,Adult,Phase 2 | Phase 3,67,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01625897,NCT01625897_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,83,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia

Patients who meet at least one of the following:

current diagnosis of schizophrenia of chronic phase
between 65 and 74 years of age
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01626859,NCT01626859_EG000,No,All,Adult,Phase 2 | Phase 3,11,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01626885,NCT01626885_EG000,No,All,Adult,Phase 2 | Phase 3,42,"Inclusion Criteria:

Written informed consent obtained from the patient before the initiation of any study-specific procedures
Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
Patients who receive 1 or more antipsychotic drugs
Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01629329,NCT01629329_EG001,No,All,Adult | Older Adult,Phase 4,93,"Inclusion Criteria:

18 years or older

Headache must meet the IHS criteria for migraine or probable migraine

2 out of 4 of following:

Unilateral location
Throbbing (pulsating) quality
Moderate to severe intensity (inhibits/prohibits daily activities)
Exacerbation with moderate activity or mild activity

During HA, at least 1 out of 3 of following:

Nausea and/or vomiting
Photophobia
Phonophobia

Exclusion Criteria:

Known allergy to study medications
Pregnancy
< 18 years old
Inability to provide written, informed consent
Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
History of peptic ulcer disease
History of liver failure
History of coagulopathy
Gastrointestinal bleeding within the last 3 months
Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications
Ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of ASA or acetaminophen (> 100mg/kg for ASA or acetaminophen)
Vomiting within one hour of receiving oral study medications.","Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills

Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.",ChEMBL:CHEMBL728 | DrugBank:DB00433 | PubChem:4917,Prochlorperazine,CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1,N05AB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01631331,NCT01631331_EG000,No,All,Adult | Older Adult,Early Phase 1,15,"Inclusion Criteria:

Study patients must have at least one BCC, > 5 mm, eligible for Mohs surgical removal; patients with BCCs that have been treated before (recurrent BCCs, BCCs that failed other chemotherapy) are eligible for this trial, if they meet size criteria
No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will be employed
Normal hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x the upper limit of normal (ULN)
Normal renal function : normal serum creatinine defined as <= 2.5 mg/dL
Clinically acceptable complete blood count (CBC)
Ability to understand and the willingness to sign a written informed consent document
The patient is willing to forego surgical treatment of BCCs by up to 6 months, except when the principal investigator (PI) believes that delay in treatment potentially might compromise the health of the subject
Documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib
For men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug
Be willing to not donate blood or semen for three months following discontinuation of study medications

Exclusion Criteria:

The patient 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 chronic lymphocytic leukemia (CLL) stage 0

The subject has uncontrolled systemic disease, including known human immunodeficiency virus (HIV) positive patients:

The patient has history of congestive heart failure
The patient has clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis
The patient has any condition or situation which in the investigator's opinion may put the patient at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study; this includes history of other skin conditions or disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
The patient has a history of hypersensitivity to any of the ingredients in the study medication formulations
The patient is willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations; for example, topical preparations containing corticosteroids or vitamin A derivatives are not allowed
Pregnant or nursing patients will be excluded from the study","Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.

vismodegib: Given PO

Mohs surgery: Undergo Mohs surgery",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT01634854,NCT01634854_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,130,"Inclusion Criteria:

Clinical candidate for labor induction utilizing either misoprostol or oxytocin
Greater than or equal to 18 years of age
Multiparous
Singleton gestation;
Greater than 37 weeks gestation;
Cephalic presentation

Exclusion Criteria:

Any clinical contraindication to misoprostol as induction drug
Age less than 18 years
Contraindication to vaginal birth
Nonreassuring fetal heart rate tracing
Prior uterine surgery
Active labor
Active maternal bleeding
Chorioamnionitis (infection)","Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal

Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01636063,NCT01636063_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,42,"Inclusion Criteria:

Age greater or equal to 18 years
Fluency in English or Spanish
Intrauterine pregnancy between 11 0/7 and 15 0/7 on the day of the abortion procedure
Desire for pregnancy termination
Ability to return for abortion procedure 24-48 hours after the preoperative visit

Exclusion Criteria:

Allergy or contraindication to study agents
Requirement of general anesthesia to perform the abortion
Diagnosis of missed abortion, spontaneous abortion, incomplete abortion, or threatened abortion at time of initial preoperative evaluation","Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.

Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01642901,NCT01642901_EG000,No,All,Adult | Older Adult,Phase 3,10,"Inclusion Criteria:

Ages 18-65, male or female
Traumatic SCI with Neurological level C4-T10, American Spinal Injury Association (ASIA) Impairment Scale (AIS) A,
Serum calcium level >7.0 mg/dL) at time of study drug administration
Screening baseline serum 25-hydroxy (25-OH) vitamin D of at least 13 ng/ml
No medical contraindication to supplemental vitamin D for participants whose levels are >13 ng/ml but sub-therapeutic (<32ng/ml)
No medical contraindication to supplemental calcium
Weight under 300 pounds, which is the maximum permitted on the dual-energy X-ray absorptiometry (DXA) scanner

Exclusion Criteria:

Ventilator-dependent individuals
Chronic steroid use (defined as >6 months)
Rheumatoid disease with use of prior disease modifying anti-rheumatic drugs (DMARDs) affecting bone density
History of osteoporosis or of treatment for osteopenia or osteoporosis with bisphosphonates, or selective reuptake estrogen modifying agents
Current use of medications* including bisphosphonates to treat osteoporosis (*note that prior calcium or vitamin D use is not an exclusion criteria)
History of more than one lower extremity osteoporosis-related fracture
Chronic renal insufficiency, creatinine clearance < 35 ml/min, during screening
End stage liver or kidney disease
Medical conditions resulting in hypogonadal states that affect bone density
Uncontrolled thyroid disease/thyrotoxicosis
Hereditary or acquired metabolic bone disorder
History of use of unfractionated heparin for >1 year
History of selected antiseizure medications, specifically phenobarbital, phenytoin, carbamazepine, sodium valproate >1 year
Acute or chronic bilateral lower extremity fractures involving tibia or femur, with placement of surgical hardware in any areas of above locations
Severe hypotension requiring use of intravenous blood pressure agents such as dopamine, norepinephrine or phenylephrine. Exception may allow for patients on pressors who arm experiencing hypotension as they acclimate to upright posture.
Inability to provide informed consent and understand the consent process
Facial fractures requiring oral surgery
Dental surgery or oral maxillofacial surgery within 2 weeks of anticipated study drug administration
Pregnancy present on admission
Vitamin D deficiency on admission testing (serum 25-OH D reported as < 13 ng/mL)
Patients with an established reaction to, or history of, anaphylactic shock to aspirin","Single infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.

Zoledronic acid: 5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01647217,NCT01647217_EG000,No,All,Child | Adult | Older Adult,Phase 1,17,"Inclusion Criteria:

Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
Age range: 15-80 years old.
Both genders and all ethnic groups comparable with the local community.
Able to understand and willing to sign a written informed consent
Able and willing to cooperate with the investigational plan.
Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
Children under 15.
Pregnant women or expecting to be pregnant during the study.
Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
Concomitant use of systemic antibiotics or steroids.
Contact lens wear (unless discontinued for ≥ 30 days before randomization)
Active ocular infection or allergy
Unable to close eyes or uncontrolled blinking
Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
Previous allergic reaction to TTO-containing products or cosmetic fragrance.","10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.

Terpinen-4-ol: Lid scrub once or twice per day for one month.",DrugBank:DB12816 | PubChem:11230,Terpinen-4-ol,CC1=CCC(O)(C(C)C)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01648322,NCT01648322_EG000,No,Female,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Females ≥ 18 years of age.
Diagnosed with Stage I-IV breast cancer.
Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).
ECOG Performance status of ≤ 2.
White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide are also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

Subject is <18 or ≥ 75 years of age.
Disease progression has occurred while receiving a taxane regimen.
Subject has undergone radiation therapy within 4 weeks of enrollment.
Subject has undergone bone marrow or stem-cell transplantation.
Subject has a history of prior malignancy other than breast cancer.
Subjects that have used G-CSF within 6 weeks of the screening period are also excluded
Subject has had chemotherapy within 365 days of screening
Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Unwillingness to participate in the study.
Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
Any condition, which can cause splenomegaly.
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
ALT, AST, alkaline phosphatase > 2.5 upper limit of normal.
Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.","This dose of F-627 given only to subjects that are to have TC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.",DrugBank:DB12269 | PubChem:66571548,PF-06273340,CC(C)(CO)n1cc(C(=O)c2cncc(NC(=O)Cc3ccc(Cl)cn3)c2)c2cnc(N)nc21,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01648322,NCT01648322_EG001,No,Female,Adult | Older Adult,Phase 2,67,"Inclusion Criteria:

Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Females ≥ 18 years of age.
Diagnosed with Stage I-IV breast cancer.
Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).
ECOG Performance status of ≤ 2.
White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide are also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

Subject is <18 or ≥ 75 years of age.
Disease progression has occurred while receiving a taxane regimen.
Subject has undergone radiation therapy within 4 weeks of enrollment.
Subject has undergone bone marrow or stem-cell transplantation.
Subject has a history of prior malignancy other than breast cancer.
Subjects that have used G-CSF within 6 weeks of the screening period are also excluded
Subject has had chemotherapy within 365 days of screening
Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Unwillingness to participate in the study.
Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
Any condition, which can cause splenomegaly.
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
ALT, AST, alkaline phosphatase > 2.5 upper limit of normal.
Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.","This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.",DrugBank:DB12269 | PubChem:66571548,PF-06273340,CC(C)(CO)n1cc(C(=O)c2cncc(NC(=O)Cc3ccc(Cl)cn3)c2)c2cnc(N)nc21,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01654302,NCT01654302_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,39,"Inclusion Criteria:

Men and women, age 40 years and above
Meet American College of Rheumatology criteria for knee OA
Knee pain most days of the week for the past month
Knee pain > 5/10 after exercise intervention
Capable of undertaking exercise intervention
Stable cardiovascular function
Able to return for all clinic visits
Able to read and understand the informed consent document

Exclusion Criteria:

Use of a walker to ambulate or inability to ambulate
Other forms of arthritis
Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
History of myocardial infarction
Blood Pressure > 140 systolic/100 diastolic
Scheduled for and likely to need joint replacement surgery in the next 3 months
Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.",70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours,PubChem:11720242,Lidocaine and tetracaine,CCCCNc1ccc(C(=O)OCCN(C)C)cc1.CCN(CC)CC(=O)Nc1c(C)cccc1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01656187,NCT01656187_EG000,No,All,Adult | Older Adult,Phase 4,42,"Inclusion Criteria:

Diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patient assessment by Dr. Khan (co-I).
Receiving prednisone therapy of at least 5 mg of prednisone/day for at least 6 months with anticipated treatment for ≥ 12 additional months.
Age 18-65 years.
Baseline CVLT-II total T score ≤ 54.

Exclusion Criteria:

Illnesses associated with CNS involvement (e.g., seizures, brain tumors, head injury with loss of consciousness) or cognitive impairment (e.g., substance dependence within the past 2 years, bipolar disorder) Potential participants with mood symptoms secondary to corticosteroids (based on SCID) will not be excluded because this could selectively exclude subjects who are sensitive to the CNS effects of corticosteroids.
Vulnerable populations (e.g. severe cognitive impairment, pregnant or nursing women, prisoners).
Severe or life-threatening medical illness that would make completion of study unlikely
Contraindications to memantine therapy (e.g. severe side effects in the past)
Danger to self or others as defined by > 1 lifetime suicide attempt or assault, any suicide attempt or assault within the past year, and active suicidal or homicidal ideation with plan and intent.
Metal implants, claustrophobia, or other contraindications to MRI",Participants who received Memantine 10 mg capsule twice per day for 24 weeks.,PubChem:181458,Memantine Hydrochloride,CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01658839,NCT01658839_EG000,No,All,Child,Phase 1,25,"Inclusion Criteria:

Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
Intraocular surgery within the past 30 days prior to the Screening Visit.
Any abnormality preventing reliable tonometry.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
Body weight < 5kg.
Other protocol-defined exclusion criteria may apply.","Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01660672,NCT01660672_EG000,No,All,Child,Phase 1 | Phase 2,7,"Inclusion Criteria:

Comatose with Blantyre Comas Score ≤ 3
P. falciparum parasitemia
Active seizure

Exclusion Criteria:

Serum creatinine > 2mg/dL
Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications","Open label, dose escalation to optimal dose.

LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01664039,NCT01664039_EG000,No,All,Adult | Older Adult,Phase 4,51,"Inclusion Criteria:

Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Able to follow instructions and be willing and able to attend all study visits.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
Must read, sign, and date an Ethics Committee-approved informed consent form.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
Contact lens wear.
Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
Unwilling to risk the possibility of darkened iris or eyelash changes.
Participation in any other investigational study within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.",One drop to the study eye(s) once a day in the evening for 6 months,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01677741,NCT01677741_EG005,No,All,Child,Phase 1 | Phase 2,28,"Inclusion Criteria:

Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines.
Male or female >=12 months and <18 years of age at the time of signing the informed consent form.
Recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease. Note: Subjects with metastatic (and surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma subjects with CNS involvement may be enrolled.
At least one evaluable lesion.
BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing; centralized testing can confirm V600E and V600K mutations only).
Performance score of >=50% according to the Karnofsky/Lansky performance status scale (subjects with a performance status of <=50% can be enrolled if the subject's confinement to bed and inability to carry out activities is due solely to cancer-related pain, as assessed by the investigator).
Females of child-bearing potential (with negative serum pregnancy test within 7 days prior to the first dose of study medication) must be willing to practice acceptable methods of birth control .
Sexually active males, who do not agree to abstinence, must be willing to use a condom during intercourse while taking the study drug, and for 16 weeks after stopping treatment and should not father a child in this period.
Must have adequate organ function as defined by the following values: Adequate bone marrow function defined as-absolute neutrophil count (ANC) >=1000/ microliter (µL), hemoglobin >=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions), platelets >=75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment).
Adequate renal and metabolic function defined as: calculated glomerular filtration rate (eGFR) (Schwartz formula), or radioisotope GFR >=90 milliliters/minutes (mL/min)/1.73 meter square (m^2); or a serum creatinine within the institutional reference range upper limit of normal (for age/gender, if available).
Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=1.5 x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) <=2.5 x ULN; AST/ALT may be <5 x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).
Adequate cardiac function defined as: left ventricular ejection fraction (LVEF) of either >=50% by ECHO or greater than institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function), corrected QT using Bazett's (QTcB) interval <450 milliseconds (msecs).

Exclusion Criteria:

Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with sorafenib is permitted).
Malignancy OTHER than the BRAF mutant malignancy under study.
Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or mitomycin C) prior to administration of the first dose of study treatment.
The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 28 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data).
History of another malignancy. Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission are eligible.
Current use of a prohibited medication or herbal preparation or requires any of these medications during the study.
Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).
Has leukaemia.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and its excipients.
Autologous or allogeneic stem cell transplant within 3 months prior to enrolment [NOTE: subjects with evidence of active graph versus host disease are excluded].
History of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.
Subjects with abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (NOTE: subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).
Subjects with moderate valvular thickening.
Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks
Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
Presence of active GI disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
Hepatitis B Virus, or Hepatitis C Virus infection (subjects with laboratory evidence of Hepatitis B Virus clearance may be enrolled).
Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females who are actively breast feeding.","Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.",ChEMBL:CHEMBL2028663 | DrugBank:DB08912 | PubChem:44462760,Dabrafenib,CC(C)(C)c1nc(-c2cccc(NS(=O)(=O)c3c(F)cccc3F)c2F)c(-c2ccnc(N)n2)s1,L01EC02 | L01XE23,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01677741,NCT01677741_EG007,No,All,Child,Phase 1 | Phase 2,2,"Inclusion Criteria:

Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines.
Male or female >=12 months and <18 years of age at the time of signing the informed consent form.
Recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease. Note: Subjects with metastatic (and surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma subjects with CNS involvement may be enrolled.
At least one evaluable lesion.
BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing; centralized testing can confirm V600E and V600K mutations only).
Performance score of >=50% according to the Karnofsky/Lansky performance status scale (subjects with a performance status of <=50% can be enrolled if the subject's confinement to bed and inability to carry out activities is due solely to cancer-related pain, as assessed by the investigator).
Females of child-bearing potential (with negative serum pregnancy test within 7 days prior to the first dose of study medication) must be willing to practice acceptable methods of birth control .
Sexually active males, who do not agree to abstinence, must be willing to use a condom during intercourse while taking the study drug, and for 16 weeks after stopping treatment and should not father a child in this period.
Must have adequate organ function as defined by the following values: Adequate bone marrow function defined as-absolute neutrophil count (ANC) >=1000/ microliter (µL), hemoglobin >=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions), platelets >=75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment).
Adequate renal and metabolic function defined as: calculated glomerular filtration rate (eGFR) (Schwartz formula), or radioisotope GFR >=90 milliliters/minutes (mL/min)/1.73 meter square (m^2); or a serum creatinine within the institutional reference range upper limit of normal (for age/gender, if available).
Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) <=1.5 x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) <=2.5 x ULN; AST/ALT may be <5 x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).
Adequate cardiac function defined as: left ventricular ejection fraction (LVEF) of either >=50% by ECHO or greater than institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function), corrected QT using Bazett's (QTcB) interval <450 milliseconds (msecs).

Exclusion Criteria:

Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with sorafenib is permitted).
Malignancy OTHER than the BRAF mutant malignancy under study.
Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or mitomycin C) prior to administration of the first dose of study treatment.
The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 28 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data).
History of another malignancy. Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission are eligible.
Current use of a prohibited medication or herbal preparation or requires any of these medications during the study.
Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).
Has leukaemia.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and its excipients.
Autologous or allogeneic stem cell transplant within 3 months prior to enrolment [NOTE: subjects with evidence of active graph versus host disease are excluded].
History of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.
Subjects with abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (NOTE: subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).
Subjects with moderate valvular thickening.
Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks
Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
Presence of active GI disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
Hepatitis B Virus, or Hepatitis C Virus infection (subjects with laboratory evidence of Hepatitis B Virus clearance may be enrolled).
Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females who are actively breast feeding.","Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.",ChEMBL:CHEMBL2028663 | DrugBank:DB08912 | PubChem:44462760,Dabrafenib,CC(C)(C)c1nc(-c2cccc(NS(=O)(=O)c3c(F)cccc3F)c2F)c(-c2ccnc(N)n2)s1,L01EC02 | L01XE23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01694186,NCT01694186_EG000,No,All,Adult | Older Adult,Phase 3,42,"Inclusion Criteria

Male or non-pregnant female at least 18 years of age at time of consent
One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration.
During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis

OR the study eye has experienced recurrence:

at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
Visual acuity of study eye is at least 15 letters on the ETDRS chart
Subject is not planning to undergo elective ocular surgery during the study
Subject has ability to understand and sign the Informed Consent Form
Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

Allergy to fluocinolone acetonide or any component of the FAI insert
History of posterior uveitis only that is not accompanied by vitritis or macular edema
History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
Uveitis with infectious etiology
Vitreous hemorrhage
Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
Ocular malignancy in either eye, including choroidal melanoma
Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
Previous viral retinitis
Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure
Media opacity precluding evaluation of retina and vitreous
Peripheral retinal detachment in area of insertion
Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg)
Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
Chronic hypotony (< 6 mmHg)
Ocular surgery on the study eye within 3 months prior to study Day 1
Capsulotomy in study eye within 30 days prior to study Day 1
Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
Subjects who test positive for human immune deficiency virus (HIV) or syphilis during screening
Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
Systemic infection within 30 days prior to study Day 1
Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
Treatment with an investigational drug or device within 30 days prior to study Day 1
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years","sham injection

Sham injection",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01698710,NCT01698710_EG000,No,All,Adult | Older Adult,Not Applicable,5,"Inclusion Criteria:

Mucinous cysts (premalignant or malignant cysts of the pancreas)
Normal organ and marrow function
Baseline CT within 6 months of enrollment

Exclusion Criteria:

Pregnant or breastfeeding
Acute active pancreatitis
Complicated pancreatic cysts
Subjects who do not speak English","Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.

Albumin bound paclitaxel: Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01701375,NCT01701375_EG000,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria:

Adults age ≥ 18 years

Multilineage bone marrow failure
Serum creatinine ≤ 2.0 mg/dl
Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)
Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic infiltration
Left ventricular ejection fraction ≥ 45%
QTc ≤ 470 msec
RB expression is required for the action of PD 0332991. Because rb deletions and mutations are rare in acute leukemias and MDS, screening for RB expression will not be required before enrollment. Pretreatment biopsies will be stored and analyzed for RB expression if needed subsequently.

Exclusion Criteria:

• No more than 5 cytotoxic regimens

Previous allogeneic or autologous stem cell transplantation permitted
≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy
≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine
If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning PD 0332991
No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning PD 0332991","PD 0332991 will be given orally days 1,2,3
Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose",ChEMBL:CHEMBL189963 | DrugBank:DB09073 | PubChem:5330286,Palbociclib,CC(=O)c1c(C)c2cnc(Nc3ccc(N4CCNCC4)cn3)nc2n(C2CCCC2)c1=O,L01EF01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01706536,NCT01706536_EG001,No,All,Adult | Older Adult,Phase 2,55,"Inclusion Criteria:

Male and female subjects age 35 through 75 years, inclusive.
A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
c. Abstinence.
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 clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
Concomitant pulmonary disease or 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 the Screening Period.
Use of daily oxygen therapy > 10 hours per day.
Use of systemic steroids within 3 months prior to the Screening Period.
Respiratory tract infection within 6 weeks prior to or during the Screening Period.
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 QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
Female subject who is pregnant or lactating","EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM",PubChem:7832,"1,2-Epoxy-4-vinylcyclohexane",C=CC1CCC2OC2C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01706536,NCT01706536_EG002,No,All,Adult | Older Adult,Phase 2,54,"Inclusion Criteria:

Male and female subjects age 35 through 75 years, inclusive.
A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
c. Abstinence.
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 clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
Concomitant pulmonary disease or 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 the Screening Period.
Use of daily oxygen therapy > 10 hours per day.
Use of systemic steroids within 3 months prior to the Screening Period.
Respiratory tract infection within 6 weeks prior to or during the Screening Period.
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 QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
Female subject who is pregnant or lactating","EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM",PubChem:7832,"1,2-Epoxy-4-vinylcyclohexane",C=CC1CCC2OC2C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01706536,NCT01706536_EG003,No,All,Adult | Older Adult,Phase 2,57,"Inclusion Criteria:

Male and female subjects age 35 through 75 years, inclusive.
A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
c. Abstinence.
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 clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
Concomitant pulmonary disease or 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 the Screening Period.
Use of daily oxygen therapy > 10 hours per day.
Use of systemic steroids within 3 months prior to the Screening Period.
Respiratory tract infection within 6 weeks prior to or during the Screening Period.
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 QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
Female subject who is pregnant or lactating","EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM",PubChem:7832,"1,2-Epoxy-4-vinylcyclohexane",C=CC1CCC2OC2C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01706536,NCT01706536_EG004,No,All,Adult | Older Adult,Phase 2,59,"Inclusion Criteria:

Male and female subjects age 35 through 75 years, inclusive.
A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
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 MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
c. Abstinence.
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 clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
Concomitant pulmonary disease or 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 the Screening Period.
Use of daily oxygen therapy > 10 hours per day.
Use of systemic steroids within 3 months prior to the Screening Period.
Respiratory tract infection within 6 weeks prior to or during the Screening Period.
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 QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
Female subject who is pregnant or lactating","EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM",PubChem:7832,"1,2-Epoxy-4-vinylcyclohexane",C=CC1CCC2OC2C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01706588,NCT01706588_EG004,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Out-patients of either gender.
Patients aged ≥ 18 to ≤ 65 years old.
Subjects able and willing to give their written consent prior to inclusion in the study.
Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion Criteria:

General

Patients refusing to give written informed consent.
Patients not able to understand the purposes of the study or not willing to return for the control visits.
Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
Patients enrolled in any clinical trial in the previous 3 months.
Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
Pregnant or breast-feeding women.
Alcohol or drug abuse in the previous 12 months.
Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.",One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.,PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,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
NCT01711177,NCT01711177_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,14,"Inclusion Criteria:

good systemic health
irido-corneal angle open
intraocular pressure more than 18 mmHg

Exclusion Criteria:

having cardiovascular problem
Hypertension or diabetes
under systemic medication for high blood pressure
had an ocular surgery in the past","Treated with Travoprost (0.04%)

travoprost: Travatan Z is administered to newly diagnosed glaucoma patient",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01714544,NCT01714544_EG000,No,All,Adult | Older Adult,Phase 4,60,"Inclusion Criteria:

Subject understands the study procedures and agrees to participate by giving written informed consent.
Subjects must be at least 18 years of age.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.
Subjects must have an IGA Grade of 3 at the Baseline Visit.

Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception or remain sexually inactive throughout the study.

All women of childbearing potential must be willing to undergo a urine pregnancy test at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).

Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to topical treatments.
History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).
Have received treatment for any type of cancer within 5 years of the Baseline Visit except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and intranasal steroids are allowed.
Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
Subjects with known hypersensitivity to clocortolone pivalate or any component of Cloderm Cream.
Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.
Subjects unable to comply with study requirements.
Female subjects who are pregnant (or planning to become pregnant) or breast-feeding.","Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Cloderm Cream",ChEMBL:CHEMBL1200975 | PubChem:5282493 | PubChem:546453,Cloderm,CC1CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1C(=O)COC(=O)C(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
NCT01720225,NCT01720225_EG000,No,All,Adult | Older Adult,Phase 2,73,"Inclusion Criteria:

Sign an Institutional Review Board (IRB)-approved informed consent document.
Age >/= than18 years
de novo or secondary International Prostate Symptom Score (IPSS) low- or intermediate-1 - risk MDS, including CMML
Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

Breast feeding females
Prior therapy with decitabine or azacitidine","Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.

Decitabine: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.",ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01720316,NCT01720316_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Triplication of glycine decarboxylase gene

Exclusion Criteria:

Normal glycine decarboxylase copy number","Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks

glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine",ChEMBL:CHEMBL773 | DrugBank:DB00145 | PubChem:750,Glycine,NCC(=O)O,B05CX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01721460,NCT01721460_EG000,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

Exclusion Criteria:

Hypersensitivity to dexmedetomidine
Bradycardia: Sinus rhythm slower than 50 bpm
Known or suspected obstructive sleep apnea
Suspected difficult intubation
Pregnancy
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form","Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.

Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01726049,NCT01726049_EG000,No,All,Adult | Older Adult,Phase 3,26,"Inclusion Criteria:

>18 years
Written inform consent
PH secondary to diastolic left heart failure defined as
PAP mean >25 mmHg
Wedge mean >15 mmHg
Normal systolic left ventricular (LV) function on echo/nuclear imaging (left ventricular ejection fraction (LVEF) > or =45%)
New York Heart Association class (NYHA) II-IV despite heart failure therapy

Exclusion Criteria:

Severe noncardiac limitation to exercise (as severe chronic obstructive pulmonary disease)
Other cause of PH besides diastolic heart failure
Coronary ischemia or recent myocardial infarction (<6 months)
Hypotension ( <90/50 mmHg)
Ongoing nitrate therapy
Ongoing therapy with citochrome P450 3A4 ( CYP3A4) inhibitors (ketoconazole, erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease inhibitors) or CYP3A4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin, Sint Janskruid ). Furthermore patients will be informed not to drink grapefruit juice while on study medication because of the known impact of grape fruit on pharmacokinetics of Sildenafil.
Ongoing therapy with alpha -inhibitors
Significant mitral or aortic valve dysfunction
Severe liver dysfunction
Pregnancy
Unable to read and comprehend Dutch language","Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01727726,NCT01727726_EG001,No,All,Adult | Older Adult,Phase 3,100,"Inclusion Criteria:

Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
Subjects currently treated with insulin for diabetes.
Subjects with uncontrolled hypertension
Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
Inability to swallow tablets or tolerate oral medication
Abnormal laboratory test results, vital signs and ECG results
Subjects who previously participated in any prior brexpiprazole clinical trial.","Seroquel XR, flexible dose and assigned ADT

Seroquel XR: tablet/capsule",PubChem:441261 | PubChem:45358180 | PubChem:5281025,Quetiapine Fumarate,O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01728376,NCT01728376_EG001,No,All,Child,Phase 4,10,"Inclusion Criteria:

To be included in this study, participants must:

Sign a parental consent form; if appropriate, sign an assent form
Be between 1 and 17 years of age
Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
If male, must take appropriate measures to not get partner pregnant
Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
Anticipate to require other antibiotics that may be potentially effective against S. aureus;
Have shock or hypotension unresponsive to standard therapy;
Have received an investigational product or have participated in an experimental procedure within 30 days;
Have an intolerance or hypersensitivity to daptomycin;
Have renal insufficiency;
Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
Have S. aureus pneumonia, empyema, meningitis, or endocarditis","Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01728376,NCT01728376_EG003,No,All,Child,Phase 4,9,"Inclusion Criteria:

To be included in this study, participants must:

Sign a parental consent form; if appropriate, sign an assent form
Be between 1 and 17 years of age
Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
If male, must take appropriate measures to not get partner pregnant
Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
Anticipate to require other antibiotics that may be potentially effective against S. aureus;
Have shock or hypotension unresponsive to standard therapy;
Have received an investigational product or have participated in an experimental procedure within 30 days;
Have an intolerance or hypersensitivity to daptomycin;
Have renal insufficiency;
Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
Have S. aureus pneumonia, empyema, meningitis, or endocarditis","Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0
NCT01728376,NCT01728376_EG005,No,All,Child,Phase 4,7,"Inclusion Criteria:

To be included in this study, participants must:

Sign a parental consent form; if appropriate, sign an assent form
Be between 1 and 17 years of age
Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
If male, must take appropriate measures to not get partner pregnant
Able to comply with the protocol requirements

Exclusion Criteria:

Participants will not be allowed into the study if they:

Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
Anticipate to require other antibiotics that may be potentially effective against S. aureus;
Have shock or hypotension unresponsive to standard therapy;
Have received an investigational product or have participated in an experimental procedure within 30 days;
Have an intolerance or hypersensitivity to daptomycin;
Have renal insufficiency;
Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
Have S. aureus pneumonia, empyema, meningitis, or endocarditis","Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01731912,NCT01731912_EG000,No,Male,Adult | Older Adult,Not Applicable,16,"Inclusion Criteria:

Willing and able to provide written informed consent
Written authorization for use and release of health and research study information has been obtained
Histologically proven adenocarcinoma of the prostate

Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:

Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen (PSA) 10-20
High risk disease: Gleason 8-10, or PSA > 20, or T3/4
Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the principal investigator
Patients must allow biopsy at the time of fiducial placement

Exclusion Criteria:

Patients may not be receiving any investigational agents
Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
History of pituitary dysfunction
Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible; patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the principal investigator on a case by case basis
Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible
Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer
Patients unwilling to use contraceptives while on study",Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician,ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01733329,NCT01733329_EG000,Accepts Healthy Volunteers,Female,Child | Adult | Older Adult,Phase 4,123,"Inclusion Criteria:

Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below:

Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)
Twin or Multiple pregnancy.
Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
Intravenous oxytocin therapy for at least 4 hours before cesarean section.
Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (> 160 beats per minute), maternal tachycardia (>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid.
Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion Criteria:

Misoprostol incorrect administration
Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.","women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Misoprostol",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01736254,NCT01736254_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,24,"Inclusion Criteria:

Healthy participants as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion Criteria:

Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation
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
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Currently smoke cigarettes or use tobacco or nicotine substitutes",Single oral dose of 600 mg gemfibrozil on Day 1.,ChEMBL:CHEMBL457 | DrugBank:DB01241 | PubChem:3463,Gemfibrozil,Cc1ccc(C)c(OCCCC(C)(C)C(=O)O)c1,C10AB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01736254,NCT01736254_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,24,"Inclusion Criteria:

Healthy participants as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion Criteria:

Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation
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
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Currently smoke cigarettes or use tobacco or nicotine substitutes",Oral doses of 130 mg evacetrapib QD for 10 days (Day 2 through Day 12).,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01739933,NCT01739933_EG000,No,All,Adult | Older Adult,Phase 3,438,"Inclusion Criteria:

Consecutive patients will be eligible for inclusion in the MENDS2 study if they are: [1] adult patients (≥18 years old) [2] in a medical and/or surgical ICU and [3] on MV and requiring sedation and [4] have suspected or known infection

Exclusion Criteria:

Patients will be excluded (i.e., not consented) for any of the following reasons:

Rapidly resolving organ failure, indicated by planned immediate discontinuation of MV, at time of screening for study enrollment
Pregnant or breastfeeding
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. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital mental retardation, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients in coma or with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.
History of 2nd or 3rd degree heart block, bradycardia < 50 beats/minute, pacemaker for bradyarrythmias or uncompensated shock.If patient has a pacemaker for bradyarrythmias, then patient does not meet this exclusion criterion and may be enrolled.
Benzodiazepine dependency or history of alcohol dependency based on the medical team's decision to institute a specific treatment plan involving benzodiazepines (either as continuous infusions or intermittent intravenous boluses) for this dependency.
Active seizures during this ICU admission being treated with intravenous benzodiazepines.
Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family/medical team (e.g., likely to withdraw life support measures within 24 hrs of screening)
Inability to understand English or deafness or vision loss that will preclude delirium evaluation. The inability to understand English (for example in Spanish-only or Mandarin-only speaking patients) will not result in exclusion at centers where the research staff is proficient and/or translation services are actively available in that particular language; these patients will not be followed in the long-term follow-up phase of the trial since the testing materials are primarily available only in English. Patients with laryngectomies and those with hearing deficits are eligible for enrollment if their medical condition permits them to communicate with research staff.

Inability to obtain informed consent from an authorized representative within 48 hours of meeting all inclusion criteria, i.e., developing sepsis and qualifying organ dysfunction criteria for the following reasons:

Attending physician refusal.
Patient and/or surrogate refusal.
Patient unable to consent and no surrogate available.
48-hour period of eligibility was exceeded before the patient was screened.
Prisoners.
Medical team following patient unwilling to use the sedation regimens.
Documented allergy to propofol or dexmedetomidine.
Current enrollment in a study that does not allow co-enrollment or that uses delirium as a primary outcome.
Patients who are on muscle relaxant infusions at time of screening with plans to maintain paralysis >48 hours.
Greater than 96 hours on mechanical ventilation prior to meeting all inclusion criteria.","Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 5 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.

Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a ""goal"" or ""target"" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr.

Dexmedetomidine: For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01746225,NCT01746225_EG000,No,Female,Adult | Older Adult,Phase 2,83,"Inclusion Criteria:

Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
Female aged 18 years or older.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
Normal hematologic status.
Normal renal function.
Normal liver function.
Normal cardiac function.
Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
Completed baseline Quality of Life Form.
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.

Exclusion Criteria:

Any prior chemotherapy for metastatic breast cancer.
Presence of central nervous system (CNS) metastasis.
Peripheral neuropathy grade 2 or higher (CTCAE version 4).
Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
Pregnant or lactating.
Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Contraindications or known hypersensitivity to the study medication or excipients.
The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.","Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01746225,NCT01746225_EG001,No,Female,Adult | Older Adult,Phase 2,86,"Inclusion Criteria:

Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
Female aged 18 years or older.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
Normal hematologic status.
Normal renal function.
Normal liver function.
Normal cardiac function.
Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
Completed baseline Quality of Life Form.
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.

Exclusion Criteria:

Any prior chemotherapy for metastatic breast cancer.
Presence of central nervous system (CNS) metastasis.
Peripheral neuropathy grade 2 or higher (CTCAE version 4).
Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
Pregnant or lactating.
Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Contraindications or known hypersensitivity to the study medication or excipients.
The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.","Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01746225,NCT01746225_EG002,No,Female,Adult | Older Adult,Phase 2,86,"Inclusion Criteria:

Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
Female aged 18 years or older.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
Normal hematologic status.
Normal renal function.
Normal liver function.
Normal cardiac function.
Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
Completed baseline Quality of Life Form.
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.

Exclusion Criteria:

Any prior chemotherapy for metastatic breast cancer.
Presence of central nervous system (CNS) metastasis.
Peripheral neuropathy grade 2 or higher (CTCAE version 4).
Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
Pregnant or lactating.
Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Contraindications or known hypersensitivity to the study medication or excipients.
The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.","Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01748955,NCT01748955_EG000,No,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

Patient suffering from an episode of major depressive disorder (MDD)
Age range 18-65 years
History of a past suicide attempt or score > 2 on HDRS item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees with the plan to enroll the patient.
Patients 60 years of age and older must score at least 25 on MMSE at screening.
Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

Bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; persons already taking SSRIs or bupropion for other indications (such as anxiety disorders).
Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression.
Drug or alcohol dependence within past six months; persons with current drug or alcohol abuse may be enrolled if this is assessed as being of lesser importance than the major depressive episode.
Blood pressure reading ≥ 140/90
Active and/or unstable medical problems including a significant risk for seizures
Antipsychotic medication required
Patients who have become hypomanic or manic on antidepressants
Contraindication to the use of an SSRI or bupropion, or currently using Zyban. Anorexia nervosa in remission at least one year is not an exclusion.
Failure to respond to adequate trials of 3 SSRIs or paroxetine or bupropion in the last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal PDR dose for at least 6 weeks).
Lacks capacity to consent
Pregnancy, lactation, or plans to conceive during the course of study participation.
Patients currently on effective treatment, who require adjunctive antipsychotic or mood stabilizing medication, or who are unlikely to respond to single agent treatment for depression will be excluded.
Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.","Participants will receive bupropion XL for 8 weeks.

Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.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
NCT01751451,NCT01751451_EG000,No,Male,Adult | Older Adult,Phase 2,42,"Inclusion Criteria:

Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Male aged 18 years and above
Patients must have undergone local treatment via radical prostatectomy
Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.
Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible
Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:
Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND
PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR
Rising PSA as defined above AND
Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes < 2 cm in short axis.
Patients must have a serum testosterone of 150 ng/dL or greater
ECOG performance status of ≤ 2 (Appendix A)
Adequate bone marrow, hepatic, and renal function, as evidenced within 14 days prior to treatment initiation by:
Absolute neutrophil count (ANC) ≥ 1500/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation
Aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of the normal range (x ULN)
Alanine aminotransferase (ALT) ≤ 1.5 x ULN
Total bilirubin ≤ 1.5 x ULN
Serum creatinine of ≤ 1.5 mg/dl or Calculated creatinine clearance of ≥ 60 mL/min
Serum albumin ≥ 3.0 g/dL
Serum potassium ≥ 3.5 mEq/L
Prothrombin time (PT) ≤ 1.5 x ULN (or international normalized ratio [INR] ≤ 1.3) unless the patient is receiving anticoagulant therapy
Partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy At least 4 weeks and recovery to Grade 0-1 from reversible effects of prior surgery (i.e., incisional pain, wound drainage)
Able to swallow the study drug whole as a tablet
Willing to take abiraterone acetate on an empty stomach; 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 who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate.

Exclusion Criteria:

Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex) Note: Patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol.
Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.
Known brain metastasis or evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
Patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible
Currently active second malignancy

Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Severe hepatic impairment (Child-Pugh Class C)
History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Active or symptomatic viral hepatitis or chronic 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 (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Uncontrolled diabetes mellitus
Active psychiatric condition Use of any prohibited concomitant medications (Section 5.5) within 30 days prior to Cycle 1, Day 1
Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Grade > 2 treatment-related toxicity from prior therapy
Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone or degarelix
Administration of an investigational therapeutic within 30 days of Cycle 1, Day1
Any condition which, in the opinion of the investigator, would preclude participation in this trial","Group 1

Abiraterone acetate 1000 mg daily x 8 months
Prednisone 5 mg once daily x 8 months

Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.",ChEMBL:CHEMBL271227 | PubChem:9821849,ABIRATERONE ACETATE,CC(=O)O[C@H]1CC[C@@]2(C)C(=CC[C@@H]3[C@@H]2CC[C@]2(C)C(c4cccnc4)=CC[C@@H]32)C1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01751451,NCT01751451_EG002,No,Male,Adult | Older Adult,Phase 2,42,"Inclusion Criteria:

Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Male aged 18 years and above
Patients must have undergone local treatment via radical prostatectomy
Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.
Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible
Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:
Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND
PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR
Rising PSA as defined above AND
Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes < 2 cm in short axis.
Patients must have a serum testosterone of 150 ng/dL or greater
ECOG performance status of ≤ 2 (Appendix A)
Adequate bone marrow, hepatic, and renal function, as evidenced within 14 days prior to treatment initiation by:
Absolute neutrophil count (ANC) ≥ 1500/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation
Aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of the normal range (x ULN)
Alanine aminotransferase (ALT) ≤ 1.5 x ULN
Total bilirubin ≤ 1.5 x ULN
Serum creatinine of ≤ 1.5 mg/dl or Calculated creatinine clearance of ≥ 60 mL/min
Serum albumin ≥ 3.0 g/dL
Serum potassium ≥ 3.5 mEq/L
Prothrombin time (PT) ≤ 1.5 x ULN (or international normalized ratio [INR] ≤ 1.3) unless the patient is receiving anticoagulant therapy
Partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy At least 4 weeks and recovery to Grade 0-1 from reversible effects of prior surgery (i.e., incisional pain, wound drainage)
Able to swallow the study drug whole as a tablet
Willing to take abiraterone acetate on an empty stomach; 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 who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate.

Exclusion Criteria:

Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex) Note: Patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol.
Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.
Known brain metastasis or evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
Patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible
Currently active second malignancy

Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Severe hepatic impairment (Child-Pugh Class C)
History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Active or symptomatic viral hepatitis or chronic 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 (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Uncontrolled diabetes mellitus
Active psychiatric condition Use of any prohibited concomitant medications (Section 5.5) within 30 days prior to Cycle 1, Day 1
Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Grade > 2 treatment-related toxicity from prior therapy
Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone or degarelix
Administration of an investigational therapeutic within 30 days of Cycle 1, Day1
Any condition which, in the opinion of the investigator, would preclude participation in this trial","Group 3

• Degarelix subcutaneous depot injection q 1 month x 8 months

Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01751984,NCT01751984_EG000,No,All,Adult | Older Adult,Phase 2,37,"Key Inclusion Criteria:

A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG <400 mg/dL

Key Exclusion Criteria:

Acute significant cardiovascular disease
Poorly controlled hypertension","Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.",ChEMBL:CHEMBL3545313 | DrugBank:DB11936 | PubChem:10472693,BEMPEDOIC ACID,CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O,C10AX15 | C10BA10,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01756352,NCT01756352_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

1. GBM patients with changes on MRI suggestive of recurrence who have not yet initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival >3 months 4. Able to give informed consent 5. Capable of undergoing scan without the need for sedation or general anesthesia.

Exclusion Criteria:

Active intracranial infection or nonglial brain mass.
Recent large intracranial hemorrhage (<1 month; size to be determined by principal investigator)
Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the initial and each -subsequent FET- PET scan on all females of childbearing potential. Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG pregnancy tests.

Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.

-","Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin

18F-FET: Radiotracer, surrogate marker for protein synthesis",PubChem:9834479,(18F)fluoroethyltyrosine,NC(Cc1ccc(OCCF)cc1)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
NCT01757288,NCT01757288_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
Patients with Zubrod performance status 0-1
Adequate hematologic function
FEV1 with ≥ 1200 cc or ≥ 50% predicted

Exclusion Criteria:

Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Exudative, bloody, or cytologically malignant effusions
Prior therapy with any molecular targeted drugs (for lung cancer)
Active pulmonary infection not responsive to conventional antibiotics
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Patients with > grade 1 neuropathy","NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01769586,NCT01769586_EG000,No,All,Adult | Older Adult,Not Applicable,100,"Inclusion Criteria:

Patients >18 years-old who are undergoing elective colonoscopy with conscious sedation

Exclusion Criteria:

allergy or prior adverse reactions to diphenhydramine
medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
pregnancy","Increments of 25 mcg to maximum of 3 times (total 75 mcg)

Diphenhydramine",ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01774305,NCT01774305_EG000,No,All,Adult | Older Adult,Phase 4,71,"Inclusion Criteria:

ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

Exclusion Criteria:

Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean","We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01777568,NCT01777568_EG000,No,All,Adult | Older Adult,Not Applicable,2853,"Inclusion Criteria:

adult colorectal surgical patients","Inspired oxygen will be maintained at 30%.

30% oxygen: Inspired oxygen will be maintained at 30%.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01777568,NCT01777568_EG001,No,All,Adult | Older Adult,Not Applicable,2896,"Inclusion Criteria:

adult colorectal surgical patients","Inspired oxygen will be maintained at 80%.

80% oxygen: Inspired oxygen will be maintained at 30%.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01778062,NCT01778062_EG001,No,All,Adult | Older Adult,Phase 3,68,"Inclusion Criteria:

Male and female adults aged ≥ 19 years in international age
Patients with a diagnosis of moderate-to-severe COPD as classified by the GOLD guidelines (2009)
Patients with at least one finding of destructed pulmonary parenchyma in the chest X-ray and the sum of all legion volumes equivalent to over 1/3 of one lung
Patients with a history of tuberculosis and no change in the chest imaging test over the past one year
Patients who can voluntarily sign an Informed Consent Form prior to initiation of any study-related procedure

Exclusion Criteria:

Pregnant or nursing (lactating) women

Women of childbearing potential not willing to use effective contraception. However, those who have a negative pregnancy test and agree to use effective contraception can participate. Effective contraception does not include periodical abstinence (e.g. basal body temperature, menstrual cycle contraceptive method, etc) but means use of contraception which must include one of barrier contraceptive methods.

e.g.) condom (barrier contraceptive method), diaphragms (barrier contraceptive method), oral contraceptives, intrauterine device, Depo injection, etc.

Patients who have been admitted to hospital for COPD worsening within 6 weeks prior to visit 1
Patients with a history of respiratory infection within 6 weeks prior to visit 1
Patients requiring long-term oxygen therapy (>15 hours/1 day) for chronic hypoxemia (it is allowed to use up to a total of 10 out of 24 hours on a PRN basis)
Patients with a history of asthma
Unstable ischaemic heart disease, arrhythmia (except for stable ventricular fibrillation) and uncontrolled hypertension
Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 is prolonged: >450 ms (males) or >470 ms (females)
Uncontrolled hypothyroidism and hyperthyroidism
Hypokalemia: plasma potassium level < 3.0 mEq/L
Patients with creatinine level ≥2 the upper limit of normal
Patients with AST/ALT level ≥2 the upper limit of normal
Patients with lung cancer or a history of lung cancer
Patients with active cancer or a history of cancer with less than 5 years disease-free survival (whether or not there is evidence of local recurrence or metastases; localized basal cell carcinoma of the skin without metastases is acceptable).
Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
Patients who have had live attenuated vaccinations within 30 days prior to Visit 1
Patients who have had treatment with investigational drugs, within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
Patients unable to successfully use a dry powder inhaler device, metered dose inhaler or perform spirometry measurements
Other cases which are considered ineligible for this clinical study by the principal investigator and subinvestigator",Placebo,ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01779869,NCT01779869_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI study within 10 days prior to cardiac PET-MRI examination
Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous myocardial segments
Patients for whom standard of care coronary ICA is planned

Exclusion Criteria:

An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the SPECT-MPI and before the cardiac MRI examination
Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI examination
Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)
Renal insufficiency (GFR < 60 mL/min/1.73m2)
Allergy or other contraindication to gadolinium-based MR contrast agent
Second or third degree atrioventricular (AV) block
Active asthma
Seizures
Current hypotension (<100/60)
Current hypertension (>160/90)
Pregnancy
Breast feeding
Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac PET-MRI examination
Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination","All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.

Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01783847,NCT01783847_EG000,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,117,"Inclusion Criteria:

Having indirect traumatic optic neuropathy, not more than 3 weeks between trauma and treatment, normal fundoscopy

Exclusion Criteria:

Having other injuries that effect on visual function, direct optic neuropathy, glaucoma, diabetic retinopathy, uncontrolled hypertension, polycythemia, creatinin more than 3 mg/dl, sensitivity to EPO, hyperkalemia, women who use contraceptive pill, pregnant and breast feeding women, history of stroke and cardiovascular diseases, having malignancy","20,000 unit per day of EPO, Intravenous infusion for three sequential days.

Recombinant human erythropoietin (EPO): 4000 units per vial",DrugBank:DB01873 | PubChem:447865,Epothilone D,[H][C@@]1(/C(C)=C/c2csc(C)n2)C/C=C(/C)CCC[C@H](C)[C@H](O)[C@@H](C)C(=O)C(C)(C)[C@@H](O)CC(=O)O1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01784523,NCT01784523_EG001,No,All,Adult,Phase 3,11,"Inclusion Criteria:

Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:

aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations

Selected Exclusion Criteria:

History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
History of Transient Ischemic Attack Confirmed by a Neurologist
SLE Diagnosis based on the ACR Classification Criteria > 4/11
Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
Current Hydroxychloroquine or another antimalarial treatment (-3 months)
Current warfarin treatment (-3 months)
Current heparin therapy( -3 months)
Current pregnancy
History of Hydroxychloroquine eye toxicity
History of Hydroxychloroquine allergy
Known glucose-6-phosphate dehydrogenase deficiency","Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.

Hydroxychloroquine",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01785459,NCT01785459_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Age 18-65 years old
Diagnosis of benign or primary headache

Exclusion Criteria:

Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or other drugs in the same class, dopaminergic blockers.
Overlying signs of infection at site of injection (Erythema, purulence, open skin)
Neck pathology ( History of surgery to the cervical spine, History of surgical hardware in place, Documented disc abnormality, History of vertebral artery or carotid artery dissection, Torticollis)
Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive syndrome)
History of increased intracranial pressure (ICP)
A known history of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
Known pregnancy
Narcotic seeking patients as determined by the treating physician with optional assistance from medical record review and North Carolina Drug Database","intravenous Prochlorperazine

Standard Care: 10 mg Intravenous injection of Prochlorperazine",ChEMBL:CHEMBL728 | DrugBank:DB00433 | PubChem:4917,Prochlorperazine,CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1,N05AB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01791855,NCT01791855_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening","An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).",DrugBank:DB14955 | PubChem:46198579,PF-04634817,CO[C@@H]1COCC[C@@H]1N[C@@H]1CC[C@@](C(=O)N2C[C@@H]3C[C@H]2CN3c2cc(C(F)(F)F)ncn2)(C(C)C)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
NCT01791855,NCT01791855_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening","An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).",DrugBank:DB14955 | PubChem:46198579,PF-04634817,CO[C@@H]1COCC[C@@H]1N[C@@H]1CC[C@@](C(=O)N2C[C@@H]3C[C@H]2CN3c2cc(C(F)(F)F)ncn2)(C(C)C)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
NCT01793883,NCT01793883_EG001,No,All,Adult,Phase 2,211,"Main Inclusion Criteria:

Provide written informed consent
Males or females aged 18-64 years, inclusive

Symptomatic presumptive influenza A or B infection defined as the presence of:

a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND
≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

Main Exclusion Criteria:

Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
Presence of clinically significant signs of acute respiratory distress during screening
Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results","80 mg Laninamivir Octanoate

80 mg Laninamivir Octanoate",ChEMBL:CHEMBL467058 | DrugBank:DB11888 | PubChem:10412535 | PubChem:20751579 | PubChem:9847629,Laninamivir octanoate,CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=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
NCT01803282,NCT01803282_EG001,No,All,Adult | Older Adult,Phase 1,3,"Key Inclusion Criteria:

Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available

Part B: Pancreatic Adenocarcinoma

Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma

Part B: NSCLC

Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
Absence of known epidermal growth factor receptor (EGFR) mutation
Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)

Part B: Esophagogastric Adenocarcinoma:

Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)

Part B: First-Line Colorectal Cancer

Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
No prior cytotoxic chemotherapy to treat their metastatic disease

Part B: Second-Line Colorectal Cancer

Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion

Part B: Breast Cancer

Histologically or cytologically confirmed metastatic breast cancer
Radiographically measureable disease
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
HER-2 negative tumor (primary tumor or metastatic lesion)
Adequate organ function

Key Exclusion Criteria:

Pregnant or lactating
Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.",PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01810432,NCT01810432_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,39,"Inclusion Criteria:

Healthy participants as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

Have known allergies to evacetrapib, related compounds or any components of the formulation
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
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes",Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01815515,NCT01815515_EG000,No,Male,Adult | Older Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Histological confirmation of prostate cancer
Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
Rising PSA on two observations taken at least 1 week apart
Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria:

Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
Serum creatinine > 3 times the upper limit of normal
Total bilirubin > 3 times the upper limit of normal
Liver Transaminases > 5times the upper limit of normal
Unable to lie flat during or tolerate PET/CT
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.",18F-DCFBC,DrugBank:DB14772 | PubChem:25067411,DCFBC F-18,O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01818414,NCT01818414_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,14,"Inclusion Criteria:

Age greater than or equal to 18 years (no upper age limit)
Gestational age between 16+0 and 20+6 weeks gestation on day of D&E with confirmation of gestational age by ultrasound
Desires D&E for termination of pregnancy or for fetal demise
Able to provide written informed consent
Able to comply with study procedures
English-speaking

Exclusion Criteria:

Known allergy or contraindication to misoprostol
Pregnancy with a multiple gestation
Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
Active bleeding or hemodynamically unstable at enrollment
Signs of chorioamnionitis or clinical infection at enrollment
Signs of spontaneous labor or cervical insufficiency at enrollment",Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01819922,NCT01819922_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,12,"Inclusion Criteria:

Healthy male and/or female subjects of non child bearing potential only, between the ages of 18 and 40 years, 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).
Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).
Subjects with maximum effort studies (peak RER >1.05) and normal exercise capacity as defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days prior to initiation of the study.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -3 (±1).
Dry eye symptoms",Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.,DrugBank:DB12096 | PubChem:52934180,PF-05175157,Cc1nc2ccc(C(=O)N3CCC4(CC3)CC(=O)c3c(cnn3C(C)C)C4)cc2[nH]1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01820559,NCT01820559_EG001,No,All,Adult | Older Adult,Phase 2,135,"Inclusion Criteria:

Women or men, 18 years of age or older (according to Amendment #1 for Czech Republic [24 Mar 2009]: 18 to 65 years of age).
Diagnosis (established prior to 50 years of age) of migraine headaches for at least 1 year, and a well-documented history of migraine headaches with or without aura according to the criteria of the IHS (see Section 3.5.6.1) for at least 3 months (according to Amendment #1 for Czech Republic [24 Mar 2009]: for at least 3 months with at least 3 migraine attacks per month in each of these 3 months).
At least 2 (according to Amendment #1 for Czech Republic [24 Mar 2009]: at least 3) (and no more than 10) well-defined migraine headache attacks per month, with at least 24 h of freedom from headaches and other symptoms of migraine between attacks.
Able to distinguish the migraine headache attacks from other types of common headaches (tension-type headaches, sinus-related headaches, etc.).
Not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (V2). Flunarizine had to be discontinued at least 4 weeks prior to V2.
Able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form (ICF).
Able and willing to comply with all study requirements, in the judgment of the investigator.
Women were surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, were sexually abstinent or agreed to use medically acceptable non-hormonal methods of contraception (see Section 3.3.3). (According to Amendment #1 for Czech Republic [24 Mar 2009]: Women were sexually abstinent or agreed to use a double-barrier method of contraception. Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.)

Exclusion Criteria:

A known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine), or to any of the excipients.
Suspected or confirmed medication-overuse headache.
More than 14 headache days (migraine or other headache types) per month in either of the 2 months prior to screening.
Consistent or recurrent frequent headaches (i.e. ≥6 headache days a month) other than migraine headaches.
Unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc.). A subject who received beta blockers or calcium channel blocker therapy for reasons other than migraine prophylaxis was eligible for inclusion, provided his/her dosing regimen had been stable for ≥2 months and was not expected to change during the course of the study.
Using prohibited concomitant medication (see Section 3.5.5.2).
A white blood cell (WBC) count <2.5 * 109/L, neutrophil count <1.5 * 109/L, sodium <125 mmol/L, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal at V1 (Screening Visit), or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
A creatinine clearance lower than 60 mL/min at screening.
A second- or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator.
Pregnant or nursing women.
A history of chronic alcohol or drug abuse or addiction within the last 2 years.
A severe hepatic, renal, respiratory, haematological, or immunologic illness, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
Received an investigational drug (or a medical device) within 3 months of screening or was currently participating in another study of an investigational drug (or medical device).
An employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or was a family member of the employees or the investigator.","eslicarbazepine acetate 800 mg

ESL 800 mg :",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT01820559,NCT01820559_EG002,No,All,Adult | Older Adult,Phase 2,139,"Inclusion Criteria:

Women or men, 18 years of age or older (according to Amendment #1 for Czech Republic [24 Mar 2009]: 18 to 65 years of age).
Diagnosis (established prior to 50 years of age) of migraine headaches for at least 1 year, and a well-documented history of migraine headaches with or without aura according to the criteria of the IHS (see Section 3.5.6.1) for at least 3 months (according to Amendment #1 for Czech Republic [24 Mar 2009]: for at least 3 months with at least 3 migraine attacks per month in each of these 3 months).
At least 2 (according to Amendment #1 for Czech Republic [24 Mar 2009]: at least 3) (and no more than 10) well-defined migraine headache attacks per month, with at least 24 h of freedom from headaches and other symptoms of migraine between attacks.
Able to distinguish the migraine headache attacks from other types of common headaches (tension-type headaches, sinus-related headaches, etc.).
Not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (V2). Flunarizine had to be discontinued at least 4 weeks prior to V2.
Able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form (ICF).
Able and willing to comply with all study requirements, in the judgment of the investigator.
Women were surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, were sexually abstinent or agreed to use medically acceptable non-hormonal methods of contraception (see Section 3.3.3). (According to Amendment #1 for Czech Republic [24 Mar 2009]: Women were sexually abstinent or agreed to use a double-barrier method of contraception. Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.)

Exclusion Criteria:

A known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine), or to any of the excipients.
Suspected or confirmed medication-overuse headache.
More than 14 headache days (migraine or other headache types) per month in either of the 2 months prior to screening.
Consistent or recurrent frequent headaches (i.e. ≥6 headache days a month) other than migraine headaches.
Unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc.). A subject who received beta blockers or calcium channel blocker therapy for reasons other than migraine prophylaxis was eligible for inclusion, provided his/her dosing regimen had been stable for ≥2 months and was not expected to change during the course of the study.
Using prohibited concomitant medication (see Section 3.5.5.2).
A white blood cell (WBC) count <2.5 * 109/L, neutrophil count <1.5 * 109/L, sodium <125 mmol/L, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal at V1 (Screening Visit), or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
A creatinine clearance lower than 60 mL/min at screening.
A second- or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator.
Pregnant or nursing women.
A history of chronic alcohol or drug abuse or addiction within the last 2 years.
A severe hepatic, renal, respiratory, haematological, or immunologic illness, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
Received an investigational drug (or a medical device) within 3 months of screening or was currently participating in another study of an investigational drug (or medical device).
An employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or was a family member of the employees or the investigator.","eslicarbazepine acetate 1200 mg

ESL 1200 mg :",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01820585,NCT01820585_EG001,No,All,Adult | Older Adult,Phase 2,130,"Inclusion Criteria:

Subject was male or female, 18 years of age or older (according to Amendment #1 for Czech Republic [24 MARCH 2009]: 18 to 65 years of age).
Subject was able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form.
Subject met the American College of Rheumatology (ACR) 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points) (according to Amendment #1 for Czech Republic [24 MARCH 2009]: and the subject's current FMS treatment was either inefficacious or had intolerable side effects).
Subject was willing and able to understand and comply with all study requirements, in the judgment of the investigator.
Subject had negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the subject at the Screening Visit.
Subject use of allowable non-pharmacological therapies was stable for at least 4 weeks prior to V1 (Screening Visit) and would be maintained at the stable regimen throughout the study.
Female subject was surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 2 years post-menopausal or, if of childbearing potential, she was sexually abstinent or agreed to use a medically acceptable non-hormonal method of contraception
Addendum according to Amendment #1 for Czech Republic [24 MARCH 2009]: Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.
Addendum according to Amendment #1 for Spain [19 JANUARY 2009] and for United Kingdom [24 MARCH 2009]: Male subject was sexually abstinent or agreed to use reliable contraceptive methods (i.e. double-barrier method: 1 male barrier [male condom] plus 1 female barrier method [female condom, spermicide or intrauterine device]. This was mandatory even for sexually active men who had been sterilised.
Subject had a negative urine test for drugs of abuse.
The subject had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days prior to V2 and the average pain score was ≥4 and ≤9.

Exclusion Criteria:

Subject had a known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients.
Subject had a history of or current active malignancy except for the following: basal cell carcinoma which had been treated; and malignancies that were successfully treated and had no recurrence within 5 years before V1 (Screening Visit).
Subject had a severe hepatic, renal, respiratory, hematologic or immunologic illness, unstable cardiovascular disease or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
Subject had a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator.
Subject had a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit).
Subject had received an investigational drug (or a medical device) within 3 months of Screening or was currently participating in another study of an investigational drug (or a medical device).
Subject was pregnant or nursing.
Subject was an employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre or was a family member of the employees or the investigator.
Subject had any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo- or hyper-thyroidism of any type.
Subjects whose pain was not due primarily to FMS.
Subject underwent tender point injection within 30 days before V1 (Screening Visit) and/or subject was unwilling to refrain from tender point injection throughout the study.
Subject had a white blood cell (WBC) count <2.5 × 109/L, neutrophil count <1.5 × 109/L, Na+ <125 mmol/L or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 × the upper limit of normal at V1 (Screening Visit) or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
Subject had abnormal values for antinuclear antibody (ANA >1/160) or rheumatoid factor (RF >15 IU/mL) at V1 (Screening Visit). After approval of the global amendment in respective countries, the limit for ANA was changed to ≥1/160.
Subject had abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR >40 mm/h).
Subject had creatinine clearance (CLCr) lower than 60 mL/min at Screening.
Subject had a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥35 or a score of 4 to 6 on question 10 of the MADRS at V1 (Screening Visit).
Subject used prohibited concomitant medications during the 2-week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit).
Subject used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS.
Exclusion criterion at V2:
Subject had a MADRS total score ≥35 or a score of 4 to 6 on question 10 of the MADRS.","Eslicarbazepine acetate (BIA 2-093) tablets

ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT01820585,NCT01820585_EG003,No,All,Adult | Older Adult,Phase 2,132,"Inclusion Criteria:

Subject was male or female, 18 years of age or older (according to Amendment #1 for Czech Republic [24 MARCH 2009]: 18 to 65 years of age).
Subject was able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form.
Subject met the American College of Rheumatology (ACR) 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points) (according to Amendment #1 for Czech Republic [24 MARCH 2009]: and the subject's current FMS treatment was either inefficacious or had intolerable side effects).
Subject was willing and able to understand and comply with all study requirements, in the judgment of the investigator.
Subject had negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the subject at the Screening Visit.
Subject use of allowable non-pharmacological therapies was stable for at least 4 weeks prior to V1 (Screening Visit) and would be maintained at the stable regimen throughout the study.
Female subject was surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 2 years post-menopausal or, if of childbearing potential, she was sexually abstinent or agreed to use a medically acceptable non-hormonal method of contraception
Addendum according to Amendment #1 for Czech Republic [24 MARCH 2009]: Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.
Addendum according to Amendment #1 for Spain [19 JANUARY 2009] and for United Kingdom [24 MARCH 2009]: Male subject was sexually abstinent or agreed to use reliable contraceptive methods (i.e. double-barrier method: 1 male barrier [male condom] plus 1 female barrier method [female condom, spermicide or intrauterine device]. This was mandatory even for sexually active men who had been sterilised.
Subject had a negative urine test for drugs of abuse.
The subject had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days prior to V2 and the average pain score was ≥4 and ≤9.

Exclusion Criteria:

Subject had a known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients.
Subject had a history of or current active malignancy except for the following: basal cell carcinoma which had been treated; and malignancies that were successfully treated and had no recurrence within 5 years before V1 (Screening Visit).
Subject had a severe hepatic, renal, respiratory, hematologic or immunologic illness, unstable cardiovascular disease or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
Subject had a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator.
Subject had a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit).
Subject had received an investigational drug (or a medical device) within 3 months of Screening or was currently participating in another study of an investigational drug (or a medical device).
Subject was pregnant or nursing.
Subject was an employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre or was a family member of the employees or the investigator.
Subject had any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo- or hyper-thyroidism of any type.
Subjects whose pain was not due primarily to FMS.
Subject underwent tender point injection within 30 days before V1 (Screening Visit) and/or subject was unwilling to refrain from tender point injection throughout the study.
Subject had a white blood cell (WBC) count <2.5 × 109/L, neutrophil count <1.5 × 109/L, Na+ <125 mmol/L or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 × the upper limit of normal at V1 (Screening Visit) or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
Subject had abnormal values for antinuclear antibody (ANA >1/160) or rheumatoid factor (RF >15 IU/mL) at V1 (Screening Visit). After approval of the global amendment in respective countries, the limit for ANA was changed to ≥1/160.
Subject had abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR >40 mm/h).
Subject had creatinine clearance (CLCr) lower than 60 mL/min at Screening.
Subject had a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥35 or a score of 4 to 6 on question 10 of the MADRS at V1 (Screening Visit).
Subject used prohibited concomitant medications during the 2-week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit).
Subject used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS.
Exclusion criterion at V2:
Subject had a MADRS total score ≥35 or a score of 4 to 6 on question 10 of the MADRS.","Eslicarbazepine acetate (BIA 2-093) tablets

ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01823835,NCT01823835_EG005,No,Female,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Phase 1a portion

Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer
ER-positive, human epidermal growth factor 2 (HER2) negative
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
Postmenopausal status
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate organ function

Phase Ib portion

All above inclusion criteria, except:
Postmenopausal status, pre- and peri-menopausal participants will also be included
ECOG performance status less than 2
At least 2 months must have elapsed from the use of tamoxifen not applicable
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Documented sensitivity to prior hormonal therapy
Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor

Phase IIa portion

All above inclusion criteria for Phase Ia, except:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
Cohort A2 only: prior fulvestrant allowed
Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
Cohort B1 only: no prior fulvestrant allowed
Cohort B2 only: prior fulvestrant allowed

Exclusion Criteria:

Phase 1a portion

Untreated or symptomatic central nervous system (CNS) metastases
Endometrial disorders
More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred greater than or equal to 12 months prior to enrollment)
Current treatment with any systemic anticancer therapies for advanced disease
Any significant cardiac dysfunction within 12 months prior to enrollment
Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Known human immunodeficiency virus (HIV) infection
Known clinically significant history of liver disease
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment

Phase Ib portion - all above exclusion criteria, plus:

Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to enrollment

Phase IIa portion - all above exclusion criteria, plus:

Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the advanced/metastatic setting
Cohort B1 only: prior chemotherapy in the advanced/metastatic setting",300 mg GDC-0810 twice daily (BID) in fasting state.,ChEMBL:CHEMBL3581693 | DrugBank:DB12253 | PubChem:56941241,GDC-0810,CC/C(=C(/c1ccc(/C=C/C(=O)O)cc1)c1ccc2[nH]ncc2c1)c1ccc(F)cc1Cl,,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01823835,NCT01823835_EG006,No,Female,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Phase 1a portion

Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer
ER-positive, human epidermal growth factor 2 (HER2) negative
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
Postmenopausal status
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate organ function

Phase Ib portion

All above inclusion criteria, except:
Postmenopausal status, pre- and peri-menopausal participants will also be included
ECOG performance status less than 2
At least 2 months must have elapsed from the use of tamoxifen not applicable
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Documented sensitivity to prior hormonal therapy
Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor

Phase IIa portion

All above inclusion criteria for Phase Ia, except:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
Cohort A2 only: prior fulvestrant allowed
Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
Cohort B1 only: no prior fulvestrant allowed
Cohort B2 only: prior fulvestrant allowed

Exclusion Criteria:

Phase 1a portion

Untreated or symptomatic central nervous system (CNS) metastases
Endometrial disorders
More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred greater than or equal to 12 months prior to enrollment)
Current treatment with any systemic anticancer therapies for advanced disease
Any significant cardiac dysfunction within 12 months prior to enrollment
Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Known human immunodeficiency virus (HIV) infection
Known clinically significant history of liver disease
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment

Phase Ib portion - all above exclusion criteria, plus:

Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to enrollment

Phase IIa portion - all above exclusion criteria, plus:

Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the advanced/metastatic setting
Cohort B1 only: prior chemotherapy in the advanced/metastatic setting",800 mg GDC-0810 QD in fasting state.,ChEMBL:CHEMBL3581693 | DrugBank:DB12253 | PubChem:56941241,GDC-0810,CC/C(=C(/c1ccc(/C=C/C(=O)O)cc1)c1ccc2[nH]ncc2c1)c1ccc(F)cc1Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01823835,NCT01823835_EG008,No,Female,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Phase 1a portion

Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer
ER-positive, human epidermal growth factor 2 (HER2) negative
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
Postmenopausal status
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate organ function

Phase Ib portion

All above inclusion criteria, except:
Postmenopausal status, pre- and peri-menopausal participants will also be included
ECOG performance status less than 2
At least 2 months must have elapsed from the use of tamoxifen not applicable
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Documented sensitivity to prior hormonal therapy
Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor

Phase IIa portion

All above inclusion criteria for Phase Ia, except:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
Cohort A2 only: prior fulvestrant allowed
Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
Cohort B1 only: no prior fulvestrant allowed
Cohort B2 only: prior fulvestrant allowed

Exclusion Criteria:

Phase 1a portion

Untreated or symptomatic central nervous system (CNS) metastases
Endometrial disorders
More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred greater than or equal to 12 months prior to enrollment)
Current treatment with any systemic anticancer therapies for advanced disease
Any significant cardiac dysfunction within 12 months prior to enrollment
Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Known human immunodeficiency virus (HIV) infection
Known clinically significant history of liver disease
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment

Phase Ib portion - all above exclusion criteria, plus:

Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to enrollment

Phase IIa portion - all above exclusion criteria, plus:

Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the advanced/metastatic setting
Cohort B1 only: prior chemotherapy in the advanced/metastatic setting",400 mg GDC-0810 BID in fasting state.,ChEMBL:CHEMBL3581693 | DrugBank:DB12253 | PubChem:56941241,GDC-0810,CC/C(=C(/c1ccc(/C=C/C(=O)O)cc1)c1ccc2[nH]ncc2c1)c1ccc(F)cc1Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01825889,NCT01825889_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Female participants are not of child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)
Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90 milliliters per minute [mL/min] at screening)
Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis

Exclusion Criteria:

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Participants who are unwilling to comply with the dietary requirements/restrictions during the study
Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease",Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01830790,NCT01830790_EG000,Accepts Healthy Volunteers,All,Older Adult,Phase 2,10,"Inclusion Criteria:

has been diagnosed with AMD (362.50-52) or healthy controls as detailed above
at least 65 years of age
capable and willing to provide consent

Exclusion Criteria:

History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
History of central serous chorioretinopathy, polypoidal choroidal vasculopathy, uveitis, or diabetic retinopathy
History of amblyopia, glaucoma, retinal detachment, retinal dystrophy, ocular trauma, ocular tumor, proliferative retinopathy, or epiretinal membrane with distortion of central macula
History of myopia of more than 6 diopters (D) spherical equivalent
History of uncontrolled diabetes or hypertension
Current use of oral phosphodiesterase type 5 inhibitors (including sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast)
Current use of systemic corticosteroids
Any contraindication to sildenafil use, including history of cardiovascular disease or stroke, hepatic cirrhosis (Child-Pugh A and B), severe renal impairment (creatinine clearance <30mL/min), anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), disorders predisposing to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia), or current use of organic nitrates, alpha-blockers, or potent cytochrome P450 3A4 inhibitors","Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness

Sildenafil citrate: Single dose of 100mg Sildenafil citrate",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01830790,NCT01830790_EG001,Accepts Healthy Volunteers,All,Older Adult,Phase 2,10,"Inclusion Criteria:

has been diagnosed with AMD (362.50-52) or healthy controls as detailed above
at least 65 years of age
capable and willing to provide consent

Exclusion Criteria:

History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
History of central serous chorioretinopathy, polypoidal choroidal vasculopathy, uveitis, or diabetic retinopathy
History of amblyopia, glaucoma, retinal detachment, retinal dystrophy, ocular trauma, ocular tumor, proliferative retinopathy, or epiretinal membrane with distortion of central macula
History of myopia of more than 6 diopters (D) spherical equivalent
History of uncontrolled diabetes or hypertension
Current use of oral phosphodiesterase type 5 inhibitors (including sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast)
Current use of systemic corticosteroids
Any contraindication to sildenafil use, including history of cardiovascular disease or stroke, hepatic cirrhosis (Child-Pugh A and B), severe renal impairment (creatinine clearance <30mL/min), anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), disorders predisposing to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia), or current use of organic nitrates, alpha-blockers, or potent cytochrome P450 3A4 inhibitors","Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness

Sildenafil citrate: Single dose of 100mg Sildenafil citrate",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG001,No,All,Adult | Older Adult,Phase 1,5,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.,PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG002,No,All,Adult | Older Adult,Phase 1,5,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants received a single IV infusion of andecaliximab 2.5 mg/kg on Day 1.,PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG003,No,All,Adult | Older Adult,Phase 1,5,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants received a single IV infusion of andecaliximab 5.0 mg/kg on Day 1.,PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,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
NCT01831427,NCT01831427_EG007,No,All,Adult | Older Adult,Phase 1,8,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received 3 single IV infusions of andecaliximab 1.0 mg/kg on Days 1, 15, and 29.",PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG008,No,All,Adult | Older Adult,Phase 1,8,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received 3 single IV infusions of andecaliximab 2.5 mg/kg on Days 1, 15, and 29.",PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG009,No,All,Adult | Older Adult,Phase 1,8,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received 3 single IV infusions of andecaliximab 5.0 mg/kg on Days 1, 15, and 29.",PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01831427,NCT01831427_EG011,No,All,Adult | Older Adult,Phase 1,10,"Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received 5 single SC doses of andecaliximab 150 mg on Days 1, 8, 15, 22, and 29.",PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01834586,NCT01834586_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Confirmed diagnosis of Multiple Sclerosis based on McDonald or Poser criteria (no sub-type restrictions)
Aged >18
Regular use of one of the follow Multiple Sclerosis medication treatments: interferon beta subcutaneous (15 subjects, Betaseron, Extavia or Rebif), or glatiramer acetate subcutaneous (15 subjects, Copaxone).
No change in disease modifying therapy in 60 days.
Mean score of ≥1.0 on Local Injection Site Reaction scale and Mean Pain Upon Injection score ≥4.0 during baseline period.
At least 4 valid diary entries over screening period.
No Multiple Sclerosis exacerbation for 60 days prior to screening.
Written informed consent

Exclusion Criteria:

Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
Concurrent application of any topical medication to treat injection site reactions from screening through final visit.
History of allergy to lidocaine, tetracaine or PABA (para-amino benzoic acid) containing products.
Patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine)
Any other serious and/or unstable medical condition","Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.

Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week",PubChem:11720242,Lidocaine and tetracaine,CCCCNc1ccc(C(=O)OCCN(C)C)cc1.CCN(CC)CC(=O)Nc1c(C)cccc1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01836185,NCT01836185_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol","Group 1: 130 mg evacetrapib administered once, orally as a tablet to participants with normal hepatic function",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01836185,NCT01836185_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol","Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01836185,NCT01836185_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol","Group 3: 130 mg evacetrapib administered once, orally, as a tablet to participants with moderate hepatic impairment",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01836185,NCT01836185_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

Participants have given written informed consent approved by the ethical review board (ERB) governing the site
Female participants should be of non-childbearing potential
Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion Criteria:

Has had esophagus variceal bleeding within 3 months of check-in
Have the need to take medications that may interfere with how the liver removes the drug
Have evidence of cancer in the liver
Consumes excessively large amounts of drinks with caffeine or alcohol","Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01842035,NCT01842035_EG000,No,All,Adult | Older Adult,Not Applicable,90,"Inclusion criteria:

Age 19-80 years
Female subjects must be (a) at least one year post-menopause or surgically sterile or (b) be non-pregnant and (c) non-lactating.
Subject must be able and willing to provide written informed consent

Subject must be referred for a clinically indicated ICD and fall into one of the following groups:

subjects with left ventricular ejection fraction less than 35% due to prior myocardial infarction who are at least 40 days post-myocardial infarction and are in NYHA functional Class II or III.
subjects with non-ischemic dilated cardiomyopathy who have a left ventricular ejection fraction less than or equal to 35% and who are in NYHA functional Class II or III.
Subjects with left ventricular dysfunction due to prior myocardial infarction who are at least 40 days post-myocardial infarction, have a left ventricular ejection fraction less than 30%, and are in NYHA functional Class I.

Exclusion Criteria:

Female subject who is pregnant or lactating
Subject with active severe asthma or chronic obstructive pulmonary disease which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
Treatment with dipyridamole, theophylline, aminophylline or pentoxifylline within 24 hours of receiving regadenoson
Treatment with any investigational drug within 30 days or 5 half lives - whichever is longer prior to study entry
Subject with any prior allergic response to aminophylline or other contraindication to receiving intravenous regadenoson
Subjects with second or third degree atrioventricular block or dependent on pacemaker
Subject with uncontrolled severe hypertension (systolic > 200 mmHg or diastolic >120 mmHg) or pretreatment hypotension (systolic BP <90 mmHg)
Subject with hemodynamically significant aortic stenosis or outflow tract obstruction
Subject with decompensated heart failure (NYHA functional class IV)
Subject with acute myocardial infarction, new onset of ischemia, percutaneous coronary intervention, or coronary artery bypass grafting within 30 days of receiving regadenoson
Subject is on dialysis for end stage renal disease or has an estimated glomerular filtration rate < 15 mL/min
Subjects with cardiac transplantation","Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.

--------------------------------------------------------------------------------

regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01845441,NCT01845441_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Patients with acute ischemic stroke who require endovascular intervention with whom mNIHSS score can be obtained
Patients with cerebral vasospasm suspiciousness with or without subarachnoid hemorrhage with whom mNIHSS score can be obtained.

Exclusion Criteria:

History of severe hepatic disease or severe renal disease (GFR<20).
Hemodynamic instability.
Pregnancy.
Known allergy to study drug.
Evidence or history of cardiac electrophysiology instability including uncontrolled hemodynamically unstable complex atrial/ventricular arrhythmia or conduction block at the time of evaluation with the exception of atrial fibrillation, and heart rate less than 60 or systolic blood pressure less than 90.
Respiratory compromise requiring intubation.
Any medical (including history of cardiac conduction block, major hepatic or renal disease) or laboratory abnormality that may increase the risk associated with the trial participation or drug administration or may interfere with interpretation of trial results.","Precedex will be started after randomization/prior to catheterization and will be stopped at the end of the procedure. It will be used for an average of 90 minutes and will be used as a continuous intravenous infusion started at 0.3 mcg/kg/hour. If HR > 80 and BP > 120/70, a full loading dose (1.0 mcg/kg/hour) will be administered over 10 minutes. If HR is 60 - 80 or systolic BP is 90 - 120, or age > 65 years, a reduced loading dose of 0.5 mcg/kg will be given over 10 minutes. If no volume overload history, 500mL of colloid (hespan or albumin) will be bolused with 0.2mg of glycopyrrolate. Every 10 minutes, Precedex will be titrated by 0.1 mcg/kg/hour to achieve and maintain RASS of 0 to -1.

Dexmedetomidine: Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01845792,NCT01845792_EG000,No,All,Adult | Older Adult,Phase 2,5,"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, in combination with abiraterone acetate and prednisone taken daily.

Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.",ChEMBL:CHEMBL271227 | PubChem:9821849,ABIRATERONE ACETATE,CC(=O)O[C@H]1CC[C@@]2(C)C(=CC[C@@H]3[C@@H]2CC[C@]2(C)C(c4cccnc4)=CC[C@@H]32)C1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01847131,NCT01847131_EG000,No,All,Adult | Older Adult,Phase 4,25,"Inclusion Criteria:

Patient 18 years of age or greater
Diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction
Being treated with intranasal steroid and oral antihistamine

Exclusion Criteria:

Underlying disease of hypertension
Use oral or nasal decongestant 7 days prior to entering the study
Nasal polyp or significant deviated nasal septum
Respiratory tract infection 14 days prior to entering the study","0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily

oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.",ChEMBL:CHEMBL762 | DrugBank:DB00935 | PubChem:4636,Oxymetazoline,Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1,D11AX27 | R01AA05 | R01AB07 | S01GA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01866423,NCT01866423_EG000,No,Male,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
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
Patients, even if surgically sterilized (i.e., status post vasectomy), who agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or
Agree to completely abstain from intercourse
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be =< 2.5 x the upper limit of normal (ULN)
Total bilirubin =< 1.5 x ULN
Estimated creatinine clearance using the Cockcroft-Gault formula must be > 40 mL/minute
Absolute neutrophil count (ANC) >= 1500 cells/microliter
Platelet count >= 100,000 cells/microliter
Testosterone < 50 ng/dL
Screening calculated ejection fraction of >= 50% by multiple gated acquisition (MUGA) scan or echocardiogram; metastatic progression on primary androgen-deprivation therapy (medical or surgical castration)

Progression requiring a change in oncologic therapy defined by any of the following:

Radiographic progression: appearance or increase in measurable lesions on cross-sectional imaging or appearance of one or more new lesions on bone scan * Rising PSA (>= 2 ng/ml) which has risen on two occasions >= 1 week apart
Clinical progression evidenced by increased pain or other cancer-related symptoms

Patients should have recovered from prior oncologic therapies to a Common Terminology Criteria (CTC) grade =< 1 except stable neuropathy or alopecia at National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2; if rapid clinical progression is documented by imaging, changes in PSA, or symptoms, then study treatment can begin >= 2 weeks from prior therapy; otherwise, the following time periods between prior anti-cancer therapies and study treatment day 1 will apply:

>= 3 weeks for prior cytotoxic therapies
>= 4 weeks for flutamide or nilutamide
>= 6 weeks for bicalutamide
>= 6 weeks since bone targeted radiopharmaceutical (e.g. samarium-153, radium-223)
Gonadotropin-releasing hormone (GnRH) agonists (leuprolide acetate, goserelin, etc.) or antagonists (degarelix, etc.) should be continued in patients without surgically-induced castrate androgen levels
For chemotherapy naïve castration-resistant prostate cancer who are moderately symptomatic or who have hepatic metastasis: subjects must not be a candidate for docetaxel-based chemotherapy.

Exclusion Criteria:

History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (NCI CTCAE, version 4), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months prior to first dose of study drug; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
New York Heart Association class III or IV heart failure

Electrocardiogram (ECG) abnormalities of:

Q-wave infarction, unless identified 6 or more months prior to screening
Corrected QT (QTc) interval > 460 msec
Patient has received other investigational drugs within 28 days before enrollment
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
Known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients
Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications
Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing tablets
Prior treatment with >= 3 lines of cytotoxic chemotherapy for metastatic prostate cancer
Prior treatment with TAK-700","Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

orteronel: Given PO

laboratory biomarker analysis: Correlative studies",ChEMBL:CHEMBL1921976 | DrugBank:DB12066 | PubChem:10335364 | PubChem:9796590 | PubChem:9883029,Orteronel,CNC(=O)c1ccc2cc(C3(O)CCn4cncc43)ccc2c1,,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01873417,NCT01873417_EG000,No,All,Adult | Older Adult,Phase 4,233,"Key Inclusion Criteria:

Decision to treat with DMF must precede enrollment.
Naïve to DMF or fumaric acid esters.
Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
Satisfies the approved therapeutic indication(s) for DMF.

Key Exclusion Criteria:

Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
Is participating in any other interventional clinical trial.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.",120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01879332,NCT01879332_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial. Female subjects were required to have a negative pregnancy test at screening and upon check-in to the study facility.
BMI within the range of 18-30 kg/m2.
Ability to communicate effectively with the study personnel.
No significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic.
Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
Nonsmokers defined as not having smoked in the past 6 months.
Subjects were to be adequately informed of the nature and risks of the study and were required to provide written informed consent prior to study entry.

Exclusion Criteria:

Known hypersensitivity or allergy to eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
Women who were pregnant or breast feeding.
Any disease or condition (medical or surgical) which, in the opinion of the investigator, had the potential to compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that could interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
A sustained supine systolic blood pressure > 140 mmHg or <100mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline.
A resting ECG heart rate of <50 bpm or >100 bpm.
An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (msec), QTc (Fridericia correction) > 450 msec, PR interval > 240 msec. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant.
The presence of abnormal laboratory values which were considered clinically significant.
Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1 or 2).
Receipt of an investigational drug within a period of 30 days prior to enrollment in the study.
Receipt of any drug therapy, including hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
A history of difficulty with donating blood.
Donation of blood or blood products within 45 days prior to enrollment.
Subjects with, or with a history of, additional risk factors for Torsades de Points (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.","Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)

BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01879332,NCT01879332_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial. Female subjects were required to have a negative pregnancy test at screening and upon check-in to the study facility.
BMI within the range of 18-30 kg/m2.
Ability to communicate effectively with the study personnel.
No significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic.
Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
Nonsmokers defined as not having smoked in the past 6 months.
Subjects were to be adequately informed of the nature and risks of the study and were required to provide written informed consent prior to study entry.

Exclusion Criteria:

Known hypersensitivity or allergy to eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
Women who were pregnant or breast feeding.
Any disease or condition (medical or surgical) which, in the opinion of the investigator, had the potential to compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that could interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
A sustained supine systolic blood pressure > 140 mmHg or <100mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline.
A resting ECG heart rate of <50 bpm or >100 bpm.
An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (msec), QTc (Fridericia correction) > 450 msec, PR interval > 240 msec. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant.
The presence of abnormal laboratory values which were considered clinically significant.
Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1 or 2).
Receipt of an investigational drug within a period of 30 days prior to enrollment in the study.
Receipt of any drug therapy, including hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
A history of difficulty with donating blood.
Donation of blood or blood products within 45 days prior to enrollment.
Subjects with, or with a history of, additional risk factors for Torsades de Points (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.","Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)

BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01880528,NCT01880528_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Histological confirmation of small cell and non-small cell carcinoma of the lung receiving thoracic radiotherapy > 45 Gy, with volume of lung receiving 20 Gy or more (V20Gy) >= 20%
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Absolute neutrophil count (ANC) >= 1500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin > 9.0 g/dL
Creatinine clearance >= 30 mL/min as calculated using actual body weight and Cockroft Gault formula
Initial physical exam with systolic blood pressure (BP) of > 100 mmHg and diastolic BP of > 60 mmHg
Potassium within institutional normal limits
Sodium within institutional normal limits
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Provide informed written consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to provide blood samples for correlative research purposes

Exclusion Criteria:

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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
Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (e.g., maintenance or adjuvant chemotherapy or hormonal therapy) for their cancer
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of prior radiation therapy treatment to the lungs or thorax
Existing contraindications to angiotensin-converting enzyme (ACE) inhibitors such as hypersensitivity to ACE inhibitors, bilateral renal artery stenosis, angioedema, or previously documented adverse drug reaction to ACE inhibitors

Any of the following:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Use of ACE inhibitors (including lisinopril) or ACE receptor blockers (ARB) of any kind =< 90 days prior to registration","Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01882764,NCT01882764_EG000,No,All,Adult | Older Adult,Phase 3,46,"Inclusion Criteria:

Completion of induction study HMPL-004-03 or HMPL-004-05 and achieving clinical remission or response with no disruption of study treatment in the transition to HMPL-004-04, or, for the open label induction phase of the study: have active mild to moderate Ulcerative Colitis defined by a modified Mayo Score of 4 to 10 and with endoscopy score activity of 2-3 points confirmed by a full colonoscopy within 2 weeks prior to study.
Subjects must be currently receiving mesalamine ≥ 2.4 g/day (or the equivalent) for at least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior to entering the screening phase of the study to ensure a stable dose is established at least 2 weeks prior to the endoscopic procedures.
Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
Age ≥ 18 years
All fertile male and female subjects must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one and continues for the duration of the trial, contraceptive patch, or condom with spermicide.
Show evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

Subjects with intolerance to mesalamine (or equivalent medications).
Diagnosed with Crohn's disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope, which would be suspicious for Crohn's disease, or with a diagnosis of indeterminate colitis.
Severe disease with a Ulcerative Colitis modified Mayo Clinic score above 10 points at baseline.
Positive stool test for pathogens on sample taken within the 2 weeks prior to study entry.
Active clostridium difficile (C. diff) infection.
Use of Inflammatory Bowel Disease related herbal supplements including supplements containing andrographis or the use of probiotics two weeks prior to study entry or during the study.
Toxic megacolon or toxic colitis.
Probable requirement for intestinal surgery within 12 weeks after the start of investigational product.
Receiving oral or rectal steroids within 1 month prior to study entry.
Receiving rectal mesalamine within 1 week prior to study entry.
Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy at the time of screening or within the preceding 6 weeks.
Receiving anti-tumor necrosis factor-α (TNF-α)agents such as infliximab, adalimumab, golimumab, or certolizumab pegol at the time of screening or within the preceding 8 weeks.
Receiving other investigational drugs or biologics within 1 month or five half-lives, whichever is longer.
Receiving antibiotics within 2 weeks of study entry.
Hemoglobin concentration <9 g/dl.
White blood cell count (WBC) below 3,000/cm3, or platelets below 100,000/cm3.
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase >2.5 upper limit of normal.
Serum creatinine >1.5 times upper limit of normal.
Significant concurrent medical diseases including: active peptic ulcer disease; uncompensated congestive heart disease; myocardial infarction within the last 12 months; unstable angina pectoris; uncontrolled hypertension; and pulmonary disease requiring oxygen therapy.
Chronic Hepatitis B or any history of Hepatitis C.
Previous colonic surgery except for simple polypectomy.
History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, and/or in situ cervical cancer.
Subjects with a history of or concurrent colonic dysplasia associated with UC, except those with completely excised sporadic colorectal polyps.
Women who are pregnant or breast feeding.
Subjects known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Known allergy to plants of the Acanthaceae family.
Unwillingness to participate in the study.
Any underlying medical condition that in the Investigator's opinion will make the administration of study drug hazardous to the subject or would obscure the interpretation of Adverse Events.","Subjects qualifying for entry into the Maintenance Phase of the study were randomized to take an oral dose of HMPL-004 (600 mg TID; total dose 1800 mg/day) daily, for 52 weeks.

Those subjects who demonstrated clinical remission or response after completing the HMPL-004-03 Induction Study, or after completing the Open Label Phase of this study, were eligible for enrollment in the Maintenance Phase of this study.",DrugBank:DB05767 | PubChem:5318517,Andrographolide,[H][C@]12CCC(=C)[C@@H](C/C=C3/C(=O)OC[C@H]3O)[C@]1(C)CC[C@@H](O)[C@@]2(C)CO,,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
NCT01883427,NCT01883427_EG001,Accepts Healthy Volunteers,All,Child,Phase 2,20,"Inclusion Criteria:

Children below 4 years of age

Exclusion Criteria:

None","Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.

Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01884740,NCT01884740_EG000,No,All,Child | Adult,Phase 1 | Phase 2,13,"Inclusion:

Male or female patients, under 22 years of age, with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed brainstem glioma

Patients must have at least one confirmed and evaluable tumor site.

*A confirmed tumor site is one in which is biopsy-proven with the exception of brainstem glioma which will be eligible with radiographic diagnosis. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.

Patients must have a Karnofsky or Lansky performance status 70%. Karnofsky is used for patients older than or equal to the age of 16 years and Lansky for those under 16 years old and an expected survival three months.
No chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
Patients must have adequate hematologic reserve with absolute neutrophils greater than or equal to 1000/mm3 and platelets greater than or equal 100,000/mm3.
Pre-enrollment chemistry parameters must show: bilirubin less than 1.5X the institutional upper limit of normal (IUNL); AST or ALT less than 2.5X IUNL and creatinine less than 1.5X IUNL.
Pre-enrollment coagulation parameters (PT and PTT) must be less than 1.5X the IUNL.

Concomitant Medications:

Growth factor(s): Must not have received within 1 week of entry onto this study.

Steroids: Systemic corticosteroid therapy is permissible in patients with CNS tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.

Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to IA therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks.

Exclusion:

Previous treatment with Avastin and Cetuximab
Females who are pregnant or lactating.
Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study.
Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.","Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 m/m^2) and Bevacizumab (15 mg/kg)

SIACI of Erbitux and Bevacizumab: Subjects will receive a single intra-arterial dose of Cetuximab (200 m/m^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).",PubChem:136170999,FOLFIRI regimen,CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=c1[nH]cc(F)c(=O)[nH]1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT01889251,NCT01889251_EG001,No,All,Adult | Older Adult,Phase 3,58,"Inclusion Criteria:

Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
BCVA of 20/800 or better in the non-study eye;
Provide written informed consent;
Follow specified instructions during study period;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
Vitreous hemorrhage or other opacification;
High myopia in the study eye;
Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
Uncontrolled glaucoma in the study eye;
History of retinal detachment in either eye;
Active infection in either eye;
Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
Participation in another investigational drug study within 30 days prior to this study;
Other protocol-defined exclusion criteria may apply.",Single sham injection to the study eye at baseline,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01891890,NCT01891890_EG002,No,All,Child,Phase 3,72,"Inclusion Criteria:

Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment
Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry

Child has diagnosed epilepsy as defined by one of the following definitions :

At least two unprovoked seizures occurring more than 24-hours apart, or
One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures (approximately 75% or more), or
At least two seizures in a setting of reflex epilepsy
Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) criteria and which may include Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs.
Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may include temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may include Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell).
Participants must either be antiepileptic drug (AED) therapy naïve or on an AED (excluding benzodiazepines) for 1-week or less. Children may be on a stable dose of psychostimulants at the time of enrollment, but no change in medication, dose, or schedule in 3 months prior to study enrollment, with no anticipated dosing changes during the 6 months of the study. If participants are taking psychostimulants at the time of study entry, they should plan on continuing them for the 6 month duration of the study protocol including the 3-month and 6-month cognitive and behavioral testing time points.
Females of child bearing potential must agree to acceptable forms of birth control, which may include abstinence.
The child's parent/guardian must be able to keep an accurate seizure diary and be able and willing to comply with instructions and study procedures.
Informed consent from the child's legal guardian or legal representative.
Assent will be obtained from children according to each site's institutional guidelines.

Exclusion Criteria:

Children with history of primary generalized seizures (absence, myoclonic, drop)
Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome)
Children with sensory seizures only (i.e., auras)
Children with 6+ seizures in the previous week
Children with a history of status epilepticus
Children with a history of neonatal seizures
Children with diagnoses of pervasive developmental disorders (e.g., autism/autism spectrum disorders)
Children with progressive neurological disease (e.g., degenerative, progressive neoplasm)
Children with major medical disease (e.g., Insulin-Dependent Diabetes Mellitus (IDDM), cancer, renal failure)
Children with diseases with cognitive impact (e.g., inborn errors of metabolism, sickle cell disease with history of stroke)
Children with active cysticercosis documented on MRI
Children with cognitive impairment of sufficient severity that, in the opinion of the investigator, would diminish the likelihood of valid test performance (roughly corresponding to Full Scale Intelligence Quotient (FSIQ) less than 70)
Children with suicide attempt(s) at any point during their lifetime
Children with active suicide ideation
Children with chronic use of first generation antihistamines
Children using recreational drugs (including alcohol)
Children not fluent in either English or Spanish
Female children who are pregnant
Female children who are using oral contraceptives for birth control or for any other indication (e.g. acne treatment)","Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01896505,NCT01896505_EG005,No,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded.
Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months

Exclusion Criteria:

Patients with known liver metastases
Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy
Patients with known brain metastasis
Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
Patients with known intolerance to low or high fat meals
In the opinion of the investigator, patients who are significantly below their ideal body weight","Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m^2 orally in treatment sequence BCA (Treatment B: new [2nd generation] tablets on Day 1 of Week 1; Treatment C: suspension dose of current [1st generation] tablets on Day 1 of Week 2; Treatment A: current [1st generation] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.",ChEMBL:CHEMBL3545185 | DrugBank:DB11942 | PubChem:71481097,Selinexor,O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1,L01XX66,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01898598,NCT01898598_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

Prior treatment with vismodegib
Known hypersensitivity to any of the study drug excipients
Any metastatic basal cell carcinoma
Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
Recent, current, or planned participation in another experimental drug study",Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.,ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01901588,NCT01901588_EG000,No,All,Child,Phase 4,63,"Inclusion Criteria:

ASA physical status of I or II
male or female, aged 1-7
has no significant lab abnormalities

Exclusion Criteria:

ASA physical status of III, IV or V
Presence of medicated behavioral disorder
Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
Parental refusal","dexmedetomidine/precedex

Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01904760,NCT01904760_EG000,No,All,Adult | Older Adult,Phase 4,39,"Inclusion Criteria:

patients undergoing selected maxillofacial surgery with free flap reconstruction
American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria:

bradycardia (< 50 bpm)
severe heart block
low blood pressure(SBP<80mmHg)
Known allergy to alpha 2 agonists","Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01908582,NCT01908582_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,26,"Inclusion Criteria:

Overtly healthy males and females (of non child-bearing potential)
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator","Period 1:

Evacetrapib 130 mg administered orally as a single dose on Day 1.",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01910831,NCT01910831_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this study:

Male and female subjects who are 60-80 years of age, with phototypes I to IV.
Subjects who have provided written, informed consent.
Subjects with multiple bruises on both forearms and hands.
Subjects with moderate to severe photodamage on forearms and hands.
Subjects with relatively equal photodamage on both forearms and hands.
Subjects who are willing to follow the treatment schedule.
Subjects who are willing to maintain their usual sunscreen or use of photoprotective clothing during outdoor activities.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

Participation in a clinical drug or device research study within 30 days of enrollment or participation in a research study concurrent with this study;
Subjects with history of bleeding disorders;
Subjects with use of isotretinoin in the past 12 months;
Subjects with a pacemaker or internal defibrillator;
Subjects who take more than 2 anticoagulant therapies.
Treatment of any type of cancer within the last 6 months;
Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any ingredient;
Concomitant use of potentially irritating over-the-counter products that contain ingredients such as arnica, alpha-hydroxy acid, salicylic acid, retinol or glycolic acid;
Subjects who present with one or more conditions which, in the opinion of the investigator, making the subject unsuitable for participation.
Subjects who apply any topicals other than the study treatment or their usual sunscreen.",Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.,PubChem:73957,Pramoxine Hydrochloride,CCCCOc1ccc(OCCCN2CCOCC2)cc1.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
NCT01911429,NCT01911429_EG000,No,All,Child,Phase 3,110,"Inclusion Criteria:

Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.
Male or female subjects 13 to 17 years of age, inclusive, at the time of consent.
DSM-IV-TR axis I primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes) and confirmation of the schizophrenia diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL).
PANSS total score ≥ 70 at screening and Baseline.
CGI-S ≥ 4 at screening and Baseline.
Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
In good physical health on the basis of medical history, physical examination, and laboratory screening.
Females who participate in this study:

are unable to become pregnant (eg, premenarchal, surgically sterile, etc.); -OR-

practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 30 days after the last dose of study drug has been taken;

-OR-

are sexually active and willing to use a medically effective method of birth control (e.g., male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 30 days after the last dose of study drug has been taken.
In the judgement of the clinician, the subject has an acute exacerbation of psychotic symptoms (no longer than 2 months in duration) and marked deterioration of function from baseline (by history) or, the subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol.
Willing and able to adhere to protocol-specified meal requirements during dosing.

Exclusion Criteria:

Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
Any of the following:

Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).

Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.

PANSS total scores ≥ 120 at screening or Baseline.
Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
Lifetime history of electroconvulsive therapy (ECT).
Resistant to antipsychotic treatment based on at least two different prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of schizophrenia.
Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.

Has a history of malignancy < 5 years prior to signing the informed consent.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.

Note: If any laboratory results are outside the normal range, the site may have the subject retested. If upon retesting the value remains outside the normal range, the significance of this value must be discussed with the Medical Monitor for enrollment consideration.

A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Clinically significant alcohol abuse/dependence or drug abuse/dependence based on DSM-IV-TR criteria within the last 6 months prior to screening.

Positive test results at screening or Baseline for:

Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, and methadone). A positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol) or alcohol, the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor.
Pregnancy test.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to randomization.
Donation of whole blood within 60 days prior to randomization.
Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes.
Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
Received treatment with antidepressants, stimulants, or atomoxetine within 3 days prior to randomization, fluoxetine hydrochloride within 21 days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine within 120 days of randomization.
Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine, eslicarbazepine acetate, or fluvoxamine, within 3 days prior to randomization (7 days prior to randomization for aripiprazole) and until follow-up.
Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma.
At screening or Baseline the subject answers ""yes"" to ""Suicidal Ideation"" Items 4 or 5 on the C-SSRS.
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 3 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
Adhering to a special diet for the 28 days prior to drug administration (eg, liquid, protein, raw food diet).
Subject is planning to move during the study, is chronically homeless, or is unable to attend all planned study visits. The Medical Monitor will be consulted for individual cases, as needed.
Demonstrates a decrease (improvement) of > 25% in the PANSS score between screening and Baseline visits.
Subject with newly diagnosed Type 2 diabetes during screening. A subject with Type 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:

Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126 mg/dL.

HbA1c ≤ 6.5%; and If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.

Subject has required hospitalization for diabetes or related complications in the past 12 months.
Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up.
Clinically significant orthostatic hypotension (ie., a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).","Lurasidone 40 mg once daily

Lurasidone 40 mg: Lurasidone 40 mg once daily",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01911429,NCT01911429_EG001,No,All,Child,Phase 3,104,"Inclusion Criteria:

Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.
Male or female subjects 13 to 17 years of age, inclusive, at the time of consent.
DSM-IV-TR axis I primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes) and confirmation of the schizophrenia diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL).
PANSS total score ≥ 70 at screening and Baseline.
CGI-S ≥ 4 at screening and Baseline.
Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
In good physical health on the basis of medical history, physical examination, and laboratory screening.
Females who participate in this study:

are unable to become pregnant (eg, premenarchal, surgically sterile, etc.); -OR-

practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 30 days after the last dose of study drug has been taken;

-OR-

are sexually active and willing to use a medically effective method of birth control (e.g., male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 30 days after the last dose of study drug has been taken.
In the judgement of the clinician, the subject has an acute exacerbation of psychotic symptoms (no longer than 2 months in duration) and marked deterioration of function from baseline (by history) or, the subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol.
Willing and able to adhere to protocol-specified meal requirements during dosing.

Exclusion Criteria:

Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
Any of the following:

Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).

Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.

PANSS total scores ≥ 120 at screening or Baseline.
Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
Lifetime history of electroconvulsive therapy (ECT).
Resistant to antipsychotic treatment based on at least two different prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of schizophrenia.
Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.

Has a history of malignancy < 5 years prior to signing the informed consent.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.

Note: If any laboratory results are outside the normal range, the site may have the subject retested. If upon retesting the value remains outside the normal range, the significance of this value must be discussed with the Medical Monitor for enrollment consideration.

A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Clinically significant alcohol abuse/dependence or drug abuse/dependence based on DSM-IV-TR criteria within the last 6 months prior to screening.

Positive test results at screening or Baseline for:

Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, and methadone). A positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol) or alcohol, the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor.
Pregnancy test.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to randomization.
Donation of whole blood within 60 days prior to randomization.
Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes.
Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
Received treatment with antidepressants, stimulants, or atomoxetine within 3 days prior to randomization, fluoxetine hydrochloride within 21 days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine within 120 days of randomization.
Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine, eslicarbazepine acetate, or fluvoxamine, within 3 days prior to randomization (7 days prior to randomization for aripiprazole) and until follow-up.
Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma.
At screening or Baseline the subject answers ""yes"" to ""Suicidal Ideation"" Items 4 or 5 on the C-SSRS.
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 3 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
Adhering to a special diet for the 28 days prior to drug administration (eg, liquid, protein, raw food diet).
Subject is planning to move during the study, is chronically homeless, or is unable to attend all planned study visits. The Medical Monitor will be consulted for individual cases, as needed.
Demonstrates a decrease (improvement) of > 25% in the PANSS score between screening and Baseline visits.
Subject with newly diagnosed Type 2 diabetes during screening. A subject with Type 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:

Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126 mg/dL.

HbA1c ≤ 6.5%; and If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.

Subject has required hospitalization for diabetes or related complications in the past 12 months.
Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up.
Clinically significant orthostatic hypotension (ie., a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).","Lurasidone 80 mg once daily

Lurasidone 80 mg: Lurasidone 80 mg once daily",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01911442,NCT01911442_EG001,No,All,Child,Phase 3,51,"Inclusion Criteria:

Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
Male or female subjects 6 to 17 years of age, inclusive, at the time of consent.
A reliable informant (eg, parent, legal guardian, or caregiver) who has past and current direct knowledge of the subject must accompany the subject at each visit and must oversee the administration of the study drug.
DSM-IV-TR primary diagnosis of autistic disorder confirmation of the diagnosis by a trained clinician (eg, psychiatrist, psychologist, social workers, etc) at the time of screening, by means of the Autism Diagnostic Interview, Revised (ADI-R).
Screening and Baseline ABC irritability subscale score ≥ 18.
Screening and Baseline CGI-S ≥ 4.
Within 5th to 95th percentile for gender specific Growth Charts from Centers for Disease Control (CDC).
No clinically relevant abnormal laboratory values.

No clinically relevant abnormal vital sign values/findings

Females who participate in this study:

are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken;

-OR-

•are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol (See Table 4 for study drug tablet size).
Able to adhere to protocol-specified meal requirements during dosing.
Have a stable living arrangement for at least 3 months prior to screening.
Non-pharmacologic therapy (eg, behavior modification) must be stable for at least 4 weeks before screening and consistent throughout the study.

Exclusion Criteria:

Subjects with profound intellectual disability.
Current diagnosis of bipolar disorder, psychosis, schizophrenia or major depression, or childhood disintegrative disorder as confirmed by the MINI-Kid (as appropriate) at screening. Confirmed genetic disorders with cognitive and behavioral disturbances are also exclusionary.
Clinically significant neurological, metabolic (including type 1 and type 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during screening.

Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
If the subject has a history of seizures, the subjects must not currently be taking any antiepileptic drugs (AEDs) and be seizure-free for at least 6 months.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes, severe dystonia, or moderate to severe tardive dyskinesia.
Clinically significant alcohol abuse/dependence or drug abuse/dependence based on Mini International Neuropsychiatric Interview for children and adolescents (MINI-Kid) criteria within the last 6 months prior to screening.
Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.

Positive test results at screening for:

Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, cannabinoids, methamphetamine, and methadone). However, a positive test for amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result in exclusion of subjects if the investigator determines that the positive test is as a result of prescription medicine(s).
Pregnancy test (only in female subjects ≥ 11 years old).
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to study drug administration.
Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
Subject has received treatment with antidepressants within 3 days, fluoxetine hydrochloride at any time within 21 days, an MAO inhibitor within 21 days of randomization or clozapine within 120 days of randomization. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine or fluvoxamine, within 3 days prior to randomization.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Donation of whole blood within 60 days prior to randomization.
Has a prolactin concentration greater than or equal to 100 ng/mL at screening.
Subject is considered by the investigator to be at imminent risk of suicide during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 12 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
Subject requires use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing informed consent until follow-up.","Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01912404,NCT01912404_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Able to provide written informed consent (either from patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
Male or female patients 21 years of age or older

Patients with alcoholic hepatitis defined as:

History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for most days in a minimum period of 6 months
Consumed alcohol within 6 weeks of entry into the study
Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10
Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment

Patients with established contraindications to steroid use including but not limited to the following:

GI bleed
Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
Renal failure

Exclusion Criteria:

Other or concomitant cause of liver disease as a result of:

Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
Metabolic liver disease (abnormal ceruloplasmin levels)
Vascular liver disease
Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
Co-infection with human immunodeficiency virus (HIV)
Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
History of renal transplant and/or on dialysis at time of entry into study
Inflammatory bowel disease
Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
Hepatocellular carcinoma (HCC) at entry into the study
Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Active tuberculosis on chest x-ray at study entry
History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
Patients requiring the use of vasopressors or inotropic support
Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study Note: Investigational drug includes any drug that is used off-label.
If female, known pregnancy, or has a positive urine or serum pregnancy test, or lactating/breastfeeding
If male, if partner is known to be pregnant at time of entry into study or becomes pregnant while patient is on study drug or up to 1 month after completion of study drug
Appropriate candidate for corticosteroid therapy
Treatment for alcohol hepatitis within 1 month of study entry with use of corticosteroids for >1 week or corticosteroid use at the time of entry into the study.","IDN-6556 capsules, 25 mg twice daily for 28 days",ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01914510,NCT01914510_EG000,No,Female,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Have histologically documented diagnosis of ovarian clear cell carcinoma.
Any number of prior chemotherapy regimens will be allowed but must include 1 line of platinum based therapy, and may include chemotherapy, biologics or other targeted therapies (except for Aurora A targeted therapies).
Meet RECIST criteria (version 1.1) within 28 days of start of treatment by having measurable disease defined as one or more lesions that can be accurately measured in one or more dimensions. Areas of previous radiation may not serve as measurable disease unless there is evidence of progression post radiation.
At time of registration, if the patient has had previous treatment it must have been at least 4 weeks since major surgery or radiation therapy; four weeks from any other previous anti-cancer therapy including biologics. Patients must have recovered from their treatment-related events with the exception of alopecia.
Are ≥18 years of age

Have clinically acceptable laboratory screening results within certain limits specified below:

AST and ALT ≤ 2.5 times upper limit of normal (ULN) or less than or equal to 5 times ULN if liver metastases are present
Total bilirubin ≤ 1.5 x ULN
Creatinine ≤ 1.5 x UL
Absolute neutrophil count ≥ 1500 cells/mm
Platelets ≥ 150,000/mm3
Hemoglobin ≥ 9.0 g/dl
Have an ECOG performance status of ≤ 2
Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential.
Have the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
Able to tolerate oral medication.

Exclusion Criteria:

Women who are pregnant or nursing
Have active, acute, or chronic clinically significant infections or bleeding.
Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2).
Have active angina pectoris, stroke, previous myocardial infarction within the past 12 months and not clinically stable, or any other pre-existing uncontrolled cardiovascular condition.
Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec.
Have additional uncontrolled serious medical or psychiatric illness.
Require therapeutic doses of anti-coagulation with warfarin or other coumarin derivatives. However, treatment with low molecular weight heparin (LMWH) is allowed.
Known CNS metastases
Have any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting or diarrhea
Have persistent 2+ protein by urinalysis (patients with 2+ proteinuria that have a spot protein:creatinine ratio of less than 0.3 may be enrolled) or a history of nephrotic syndrome
Have an active or history of additional malignancy which in the opinion of the study doctor would make assessment of outcome difficult.
Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 at the time of registration","ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.",PubChem:16041424,(E)-N-(5-Methyl-1H-pyrazol-3-yl)-6-(4-methylpiperazin-1-yl)-2-styrylpyrimidin-4-amine,Cc1cc(Nc2cc(N3CCN(C)CC3)nc(C=Cc3ccccc3)n2)n[nH]1,,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01933984,NCT01933984_EG000,No,All,Adult | Older Adult,Not Applicable,51,"Inclusion Criteria:

chronic obstructive pulmonary disease
acute respiratory failure under ventilator support for less than 72 hours
endotracheal tube inserted

Exclusion Criteria:

confirmed asthma
Acute Physiology and Chronic Health Evaluation II score over 35
a co-morbidity of septic shock","Ventilator support
Determining personal target airway resistance
Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0",ChEMBL:CHEMBL32800 | DrugBank:DB01288 | PubChem:3343,Fenoterol,CC(Cc1ccc(O)cc1)NCC(O)c1cc(O)cc(O)c1,G02CA03 | R03AC04 | R03AL01 | R03CC04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01933984,NCT01933984_EG001,No,All,Adult | Older Adult,Not Applicable,51,"Inclusion Criteria:

chronic obstructive pulmonary disease
acute respiratory failure under ventilator support for less than 72 hours
endotracheal tube inserted

Exclusion Criteria:

confirmed asthma
Acute Physiology and Chronic Health Evaluation II score over 35
a co-morbidity of septic shock","Ventilator support
Determining personal target airway resistance
Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th",ChEMBL:CHEMBL32800 | DrugBank:DB01288 | PubChem:3343,Fenoterol,CC(Cc1ccc(O)cc1)NCC(O)c1cc(O)cc(O)c1,G02CA03 | R03AC04 | R03AL01 | R03CC04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01936181,NCT01936181_EG000,No,All,Adult | Older Adult,Phase 3,290,"Inclusion Criteria:

Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months
Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 6 months after the last dose of investigational product

Inclusion Criteria for Transition-Extension Period:

Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study
In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period

Exclusion Criteria:

Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
Have a known hypersensitivity to human immunoglobulin proteins or other components of Remicade or SB2
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
Have a current diagnosis of active tuberculosis
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.

Have any of the following conditions

Other inflammatory or rheumatic diseases.
History of any malignancy within the previous 5 years prior to Screening
History of lymphoproliferative disease including lymphoma.
History of congestive heart failure
Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
History of demyelinating disorders.

Exclusion Criteria for Transition-Extension Period:

Have been withdrawn from the SB2-G31-RA study for any reason
Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator","SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

SB2 (proposed biosimilar to infliximab)",ChEMBL:CHEMBL1279 | DrugBank:DB00998 | PubChem:77992,Frovatriptan,CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1,N02CC07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01937130,NCT01937130_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
Subjects with an acute deterioration of liver function

Subjects who meet one of the following criteria:

Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
Subjects with two organ failures
If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with HIV
Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
Subjects with clinical evidence of disseminated intravascular coagulation
Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
Subjects with evidence of significant and/or uncontrolled bleeding
Subjects requiring mechanical ventilation
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Subjects previously exposed to IDN-6556
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)","Dosed twice daily

IDN-6556",ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01937130,NCT01937130_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
Subjects with an acute deterioration of liver function

Subjects who meet one of the following criteria:

Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
Subjects with two organ failures
If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with HIV
Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
Subjects with clinical evidence of disseminated intravascular coagulation
Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
Subjects with evidence of significant and/or uncontrolled bleeding
Subjects requiring mechanical ventilation
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Subjects previously exposed to IDN-6556
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)","Dosed twice daily

IDN-6556",ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01937130,NCT01937130_EG002,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
Subjects with an acute deterioration of liver function

Subjects who meet one of the following criteria:

Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
Subjects with two organ failures
If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with HIV
Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
Subjects with clinical evidence of disseminated intravascular coagulation
Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
Subjects with evidence of significant and/or uncontrolled bleeding
Subjects requiring mechanical ventilation
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Subjects previously exposed to IDN-6556
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)","Dosed twice daily

IDN-6556",ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01948518,NCT01948518_EG000,No,All,Adult | Older Adult,Not Applicable,15,"Inclusion Criteria:

Adult patients over age 18 years of age who are able to consent
Diagnosis of diffuse parenchymal lung disease with concomitant pulmonary hypertension

Exclusion Criteria:

None","20 mg of oral sildenafil, single dose at baseline

Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01949155,NCT01949155_EG001,No,All,Child,Phase 3,87,"Inclusion Criteria includes, but is not limited to:

Subject is a male or female aged 6 months to 17 years, inclusive
Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
Subject has a history of sensorineural hearing loss
Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study","Sham: Simulated single, intratympanic injection:

One sham injection into each ear during surgery.",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01955837,NCT01955837_EG000,No,All,Adult | Older Adult,Phase 3,271,"Inclusion Criteria:

Has provided written informed consent
Has adenocarcinoma of the colon or rectum
Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Is able to take medication orally
Has adequate organ function (bone marrow, kidney and liver)
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.","TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.",ChEMBL:CHEMBL1129 | DrugBank:DB00432 | PubChem:6256,Trifluridine,O=c1[nH]c(=O)n([C@H]2C[C@H](O)[C@@H](CO)O2)cc1C(F)(F)F,L01BC59 | S01AD02,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01960075,NCT01960075_EG002,No,All,Child | Adult | Older Adult,Phase 3,150,"Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures","Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.

Levetiracetam",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01962103,NCT01962103_EG005,No,All,Child | Adult,Phase 1 | Phase 2,7,"Inclusion Criteria:

Patients must meet all of the following criteria to be enrolled in the study:

Patient has a confirmed solid tumor diagnosis according to the

following:

Phase 1: patient has a recurrent or refractory solid tumor that has

progressed or did not respond to standard therapy, or for which no

standard anticancer therapy exists

Phase 2: patient has radiologically documented measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for neuroblastoma, evaluable disease by 123^I-metaiodobenzylguanidine [MIBG]/Curie score is also acceptable) in 1 of the following tumor types and has failed up to 3 lines of treatment: Group 1: neuroblastoma, Group 2: rhabdomyosarcoma; Group 3: Ewing's sarcoma.
The patient has a Lansky/Karnofsky performance status score of ≥ 70%.

The patient has adequate serum chemistry levels, evidenced by the

following laboratory values

aspartate aminotransferase (AST)/serum glutamic-oxaloacetric

transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic

pyruvate transaminase (SGPT) ≤ 2.5 × upper limit of normal range (ULN)

Total bilirubin ≤ 1.5 × ULN
Creatinine ≤ 1.5 × ULN

The patient has adequate bone marrow function, evidenced by the

following:

Absolute neutrophil count ≥ 1.0 × 10^9 cells/L

Platelets ≥ 80 × 10^9 cells/L (transfusion independent, defined as not

receiving platelet transfusions within 7 days prior to laboratory sample). In the phase 2 portion, for patients with known bone marrow involvement, platelets ≥ 50 × 10^9 cells/L

Hemoglobin ≥ 8 g/dL (transfusion is permitted to fulfill this criterion).

The patient (when applicable) or patient's parent(s) or legal guardian(s)

understand(s) and voluntarily signed an informed consent document prior

to any study-related assessments/procedures being conducted. Where

locally applicable, the patient also understands and voluntarily provides

his/her assent prior to any study-related assessments/procedures being

conducted.

Male patients of childbearing potential must use a condom during

sexual intercourse and shall not father a child during the study and for 6 months after the last dose of study medication.

Female patients of childbearing potential [defined as all female

patients ≥ 12 years old or who have reached menarche, whichever occurs

first] must have both of the following:

a. Agree to the use of two physician-approved contraceptive methods

simultaneously or practice complete abstinence while on study medication or for a longer period if required by regulations.

i. True abstinence: When this is in line with the preferred and usual

lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,

symptothermal, postovulation methods) and withdrawal are not

acceptable methods of contraception.

ii. Acceptable contraceptive methods include: oral, injectable, or

implantable hormonal contraceptive; tubal ligation; intra-uterine device;

barrier contraceptive with spermicide; or vasectomized partner) including

at least one barrier method.

b. Have negative serum pregnancy test result at screening confirmed by

negative urine pregnancy dipstick within 72 hours prior to first dose of

investigational product (if serum test occurred > 72 hours from first

dose); pregnancy test with sensitivity of at least 25 mIU/mL.

Exclusion Criteria:

The presence of any of the following will exclude a patient from enrollment:
The patient has a primary brain tumor(s) or brain metastasis (unless metastasis is treated and stable for > 28 days). In patients who are symptomatic, a brain scan is required to exclude metastasis.
The patient has received therapeutic dose chemotherapy or radiotherapy ≤ 21 days prior to start of investigational product.
The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ≤ 7 days from the first dose of investigational product.
The patient has received any investigational therapy ≤ 28 days prior to start of investigational product. Investigational therapy is defined as any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric.
The patient has received any biological therapy ≤ 7 days prior to the start of investigational product, or monoclonal antibody ≤ 3 half-lives or 28 days, whichever is shorter, prior to the first dose of investigational product.
The patient has received any hematopoietic stem cell transplantation (HSCT) ≤ 3 months prior to start of investigational product.
The patient has received allogeneic hematopoietic stem cell transplantation (HSCT) ≤ 3 months or autologous HSCT ≤ 21 days prior to start of investigational product.
The patient has not recovered from the acute toxic effects of prior chemotherapy, radiation, or major surgery/significant trauma.
The patient has had minor surgery ≤ 7 days from the start of study treatment (excluding the placement of central/peripheral lines, skin biopsy).
The patient has a known history of stroke, myocardial infarction, peripheral vascular disease, or recent (within 3 months) uncontrolled deep venous thrombosis.
The patient has a known history or current diagnosis of human immunodeficiency virus (HIV) infection, regardless of treatment status.
The patient has an uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
The patient has any condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk if he/she were to participate in the study.
The patient has any condition that confounds the ability to interpret data from the study.
The patient or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator.
The patient has ≥ Grade 2 peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) at screening.","nab-paclitaxel 270 mg/m^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01966419,NCT01966419_EG001,No,All,Adult | Older Adult,Phase 2,114,"Inclusion Criteria:

Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
Elevated venous ammonia

Exclusion Criteria:

Renal failure with serum creatinine > 3 mg/dL or need for dialysis
Molecular Adsorbent Recirculation System utilized
Pregnancy or breastfeeding",Participants receive ornithine phenylacetate up to 5 days via continuous IV infusion in addition to SOC,PubChem:44247677,Ornithine phenylacetate,NCCCC(N)C(=O)O.O=C(O)Cc1ccccc1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01967433,NCT01967433_EG000,No,All,Adult,Phase 4,61,"Inclusion Criteria:

Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months

Exclusion Criteria:

Inability to execute informed consent
Allergy to Diphenhydramine, fentanyl or midazolam
Known or suspected pregnancy
Endoscopic procedure without sedation
Patient scheduled to have other endoscopic procedures on the same day
Prior alimentary tract surgery
Severe cardiopulmonary disease (ASA IV)
Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure",Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives,ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01973452,NCT01973452_EG000,No,All,Adult | Older Adult,Phase 3,148,"Inclusion Criteria:

Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

Exclusion Criteria:

2nd or 3rd degree heart block as assessed by preoperative EKG
Use of dexmedetomidine within 28 days prior to day of surgery
Use of long acting opioids pre-operatively 28 days prior to day of surgery
Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
Planned use of an epidural for surgery or post-operative pain relief
Contraindication to use of NSAID, Acetaminophen or IV opioids.
Any known hypersensitivity to dexmedetomidine
Pregnant or breastfeeding
Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen

Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 75 U/L)?

Abnormal renal function tests as related to contraindications to use of IV Ketorolac

Yes or No?; Is Serum Creatinine < 1.5 mg/dl?","continuous infusion of 0.4 mcg/kg/hr

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01974700,NCT01974700_EG000,No,All,Adult | Older Adult,Phase 4,5,"Inclusion Criteria:

Adult (≥18 years)
Presence of intracranial aneurysm (without rupture)
Treating surgeon has recommended surgical repair of the aneurysm.

Exclusion Criteria:

History of seizures within last 10 years
History of epilepsy
History of prior stroke
Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
Brain tumor
Pregnant or nursing woman
Known levetiracetam allergy",Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01978535,NCT01978535_EG000,No,All,Child | Adult,Phase 1 | Phase 2,3,"Inclusion criteria

aged 12-21 years
chronic (>3 months)symptoms of orthostatic intolerance (including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and palpitations)
symptomatic orthostatic heart rate increase of greater than or equal to 40 beats per minute during a 10 minute 70 degree head up tilt study
presence of non-anemic iron deficiency, defined as serum ferritin level less than or equal to 20 ug/L with normal hemoglobin

Exclusion criteria

orthostatic hypotension within 3 minutes of 70 degree head up tilt
pregnant or lactating females
presence of other organ failure or systemic illness that can affect autonomic function
concurrent medication therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists unless medication is held for five half-lives prior to study
laboratory evidence of anemia or iron overload
personal history of hematochromatosis or first degree relative with hematochromatosis
known sensitivity to Venofer (TM) or other intravenous iron preparations",Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.,DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01979003,NCT01979003_EG000,No,Female,Adult | Older Adult,Early Phase 1,100,"Inclusion Criteria:

Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
No known allergy to fluorescein dye
Ability to understand and sign informed consent
18 years of age or older

Exclusion Criteria:

Prior hysterectomy
Known sensitivity to fluorescein dye","All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.

Fluorescein",ChEMBL:CHEMBL4297067 | DrugBank:DB00693 | PubChem:16850,Fluorescein,O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21,S01JA01 | S01JA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01981759,NCT01981759_EG001,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Age 18-68
Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder
Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic naive for lifetime
Willing to participate in CBT
Sufficient proficiency in English to complete assessments
Score of at least 3 on the SAPS at two assessments, four weeks apart

Exclusion Criteria:

Current treatment with clozapine
SSRI treatment
Active alcohol or other substance abuse within six weeks
Unstable medical illness
Pregnant or nursing
Anemia
Renal insufficiency","Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01982695,NCT01982695_EG000,No,Male,Child | Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

Duchenne muscular dystrophy patients of all ages
Null mutation of the dystrophin gene or muscle with <5% dystrophin
Doppler echocardiogram with ejection fraction (EF) <55% within 30 days of enrollment
Ability to cooperate for testing
Glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort

Exclusion Criteria:

Patients with EF 55% or greater
Patients with EF <40% after washout
Patients taking >5 mg lisinopril, or >25 mg losartan or >5 mg enalapril
Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography",Lisinopril,ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01982812,NCT01982812_EG000,No,All,Child,Phase 2,23,"Inclusion Criteria:

Comatose with Blantyre Comas Score ≤ 2
P. falciparum parasitemia via thick blood film or rapid diagnostic test
Active seizure in past 24 hours

Exclusion Criteria:

Serum creatinine > 2mg/dL
Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications","Oral Levetiracetam administered by NG tube.

Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01985685,NCT01985685_EG000,No,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria:

Adult patients (age > 18 yrs) admitted to an ICU
Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
Upper central venous line in place

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temperature >100.5
FIO2>60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Positive end expiratory pressure > 12cmH2O
Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
Protected populations (pregnant woman, prisoners, cognitively impaired)","200mg intravenous thiamine in 50ml 5% dextrose, single dose

Thiamine: 200 mg IV thiamine",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01985685,NCT01985685_EG001,No,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria:

Adult patients (age > 18 yrs) admitted to an ICU
Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
Upper central venous line in place

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temperature >100.5
FIO2>60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Positive end expiratory pressure > 12cmH2O
Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
Protected populations (pregnant woman, prisoners, cognitively impaired)","50ml intravenous 5% dextrose, single dose

Thiamine: 200 mg IV thiamine",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01988246,NCT01988246_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

Must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule
History of Type I or Type II diabetes
NPDR: non-proliferative diabetic retinopathy (mild, moderate, or severe) or inactive proliferative disease in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
Willing and able to comply with clinic visits and study-related procedures
Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)
Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
Patients must have visual acuity of 20/20-20/200

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator
Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision other that diabetic retinopathy
Active proliferative diabetic retinopathy in the study eye
Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant)
Patients who have received corneal transplants in the study eye
Patients with current or history of chronic or recurrent ocular infections or inflammation in the study eye
Patients with a visually nonfunctional fellow eye based upon the assessment by the investigator
Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis
Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day
Use of systemic steroids, NSAIDS (non-steroidal anti-inflammatory drugs), anti-VEGF agents within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted.
Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
Treatment with intraocular or periocular steroids in the study eye within 3 months prior to surgery
Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
Intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye within 6 months of the pre-operative baseline visit
Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either medical or surgical intervention during the 90 day study period.
Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
Pregnant or breast-feeding women -","Patients will be sequentially randomized to treatment with a ""sham"" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01995136,NCT01995136_EG000,No,All,Adult | Older Adult,Phase 4,32,"Inclusion Criteria:

Diagnosis of normal tension glaucoma.
Must sign an Informed Consent form.
IOP within protocol-specified range.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Pregnant and lactating women, or women who intend to become pregnant during the study period.
Advanced and serious glaucoma, as specified in protocol.
Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
History of ocular trauma, intraocular surgery or laser surgery for the included eye.
Ocular-infection and severe ocular complication.
Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
Use of any adrenocorticosteroids during the study period.
Use of IOP lowering ophthalmic solution within the past 30 days.
Regarded by doctor as not suitable for study participation.
Other protocol-specified exclusion criteria may apply.","Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02004613,NCT02004613_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,394,"Inclusion Criteria:

18-85 years old;
Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
Able to provide a written informed consent;
Hemodynamically stable (heart rate>= 55).

Exclusion Criteria:

Sick sinus syndrome or Wolff-Parkinson-White syndrome
Atrio-ventricular block
Hypersensitivity or known allergy to dexmedetomidine
Hepatic disease, e.g. twice the normal level of liver enzymes
Atrial fibrillation within 1 preoperative month;
Permanent pacemaker;
Use of amiodarone or dexmedetomidine within the last 30 days;
Patients with an ejection fraction under 30% or who had severe heart failure
Myocardial infarction in the previ¬ous 7 days;
Body mass index =< 40 (BMI= mass (kg) / height (m)2);
Those taking clonidine within last 48 hours.","Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02012491,NCT02012491_EG000,No,Female,Adult | Older Adult,Phase 3,151,"Inclusion Criteria:

between 5 and 12 completed weeks gestation
18 years or older
hemodynamically stable
confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
willing and able to give informed consent

Exclusion Criteria:

diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os)
contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
most recent hemoglobin <9.5 g/dL
diagnosis of porphyria
known clotting defect or receiving anticoagulants
pregnancy with an intrauterine device (IUD) in place
breastfeeding during the first 7 days of study participation
unwilling to comply with the study protocol and visit schedule
any evidence of viable pregnancy
possibility of ectopic pregnancy
known or suspected pelvic infection
concurrent participation in any other interventional trial","800 micrograms of vaginal misoprostol alone

Misoprostol",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02013778,NCT02013778_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,8,"Inclusion Criteria:

Patient capable of giving informed consent
Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL.
Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania.
Age 18 years old
Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5
Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L
Child-Turcotte-Pugh Classification A or B
Eastern Clinical Oncology Group performance status 0 or1.

Exclusion Criteria:

Prior TACE
Active GI hemorrhage within 2 weeks of study enrollment
Ascites refractory to medical therapy
Contraindication to receiving HCQ or TACE
Unilobar HCC
Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging)
Women who are pregnant
Participation in another concurrent treatment protocol","Subjects will receive HCQ plus standard of care TACE.

HCQ",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02022007,NCT02022007_EG002,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","Saxagliptin-Metformin XR (combination pill)

5mg Saxagliptin/2000 mg Metformin XR QD for 16 weeks

Saxagliptin-Metformin XR: Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks

Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study",PubChem:56842229,Kombiglyze,CN(C)C(=N)N=C(N)N.N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02026141,NCT02026141_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

Exclusion Criteria:

Contraindication to Dexmedetomidine. (second or third degree heart block, renal or hepatic dysfunction) Contraindication to Spinal Anesthetic Pain being treated by opioids prior to operation Contraindication to premedication Previous total knee arthroplasty","Standardized pre-op meds and spinal anesthetic.

Once the patient's spinal is performed, patient will receive the following:

Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.

Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02026232,NCT02026232_EG000,No,All,Adult | Older Adult,Not Applicable,10,"Inclusion Criteria:

Subjects between the age of 18 and 75, either gender, any ethnic group
Subjects must have type 2 diabetes and the following:
A1c of 6.5-9.0%
Treated with at least 1000 mg of metformin daily with or without a dipeptidyl peptidase-4(DPP4)inhibitor, a sulfonylurea (glipizide, glyburide, glimepiride),bromocriptine or colesevelam.
Subjects should have a BMI >27

Exclusion Criteria:

Prior treatment with chloroquine or hydroxychloroquine as follows:

any exposure in the past 2 years,
>30 days of therapy if exposure was between 2 and 5 years ago,
>90 days of therapy if exposure was between 5 and 10 years ago,
>6 months of therapy if exposure was 10 to 20 years ago,
>1 year of therapy if exposure was 20 to 30 years ago,
No limit if last exposure was >30 years ago, e.g. during the Vietnam conflict.
Morbid obesity (BMI >45)
Coronary artery disease or other vascular disease
History of stroke
Serum creatinine >-4 mg/dl for women and >-5 mg/dl for men.
Seizure disorder
History of psoriasis
Hematologic disorders, including anemia (WHO criteria for anemia:hemoglobin <13g/dL in men and <12 g/dL in women)
Current malignancy or active treatment for recurrence prevention,e.g. tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if continuous positive airway pressure(CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
Treatment with 50mg or greater of Metoprolol or treatment with digoxin
Liver disease, or Liver Function Test >2 times normal
Active infection (including HIV)
Serious illness requiring ongoing medical care or medication
Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm/day of fish oils
Uncontrolled hypertension (BP >150/90 mm Hg) at enrollment
Need for daily Over The Counter medications, or currently taking cimetidine or >1000 IU vitamin E daily and unwilling to reduce or discontinue vitamin E or discontinue cimetidine for the duration of the study. Patients taking more than 1000 IU vitamin E daily should reduce or discontinue the vitamin for 30 days before randomization.
Pregnant or lactating women, or women intending to become pregnant
Women not using adequate birth control (hormonal birth control is acceptable, also double barrier)
QT corrected >450 msec on screening ECG
Glucose-6-phosphate dehydrogenase (G6PD) deficiency","hydroxychloroquine twice daily for 4 weeks

Hydroxychloroquine: 200mg twice daily",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02033876,NCT02033876_EG000,No,All,Adult | Older Adult,Phase 2,24,"Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin, receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than T2DM) and unstable psychiatric disease.

Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.","Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily

Ursodiol",DrugBank:DB01586,Ursodeoxycholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2,A05AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02033876,NCT02033876_EG001,No,All,Adult | Older Adult,Phase 2,24,"Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin, receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than T2DM) and unstable psychiatric disease.

Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.","matching placebo capsules to be taken twice daily

Ursodiol",DrugBank:DB01586,Ursodeoxycholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2,A05AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02039817,NCT02039817_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,16,"Inclusion Criteria:

All Subjects:

Male or female subjects 18 - 75 years of age, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >50 kg
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Matched Healthy Volunteers:

Medically healthy as determined by the Investigator
Screening creatinine clearance ≥90 mL/min using the Cockcroft-Gault equation
Supine blood pressure ≤145/90 mmHg
No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study

Demographically comparable to subjects with severe renal impairment as follows:

Mean body weight within ±10 kg
Mean age within ±5 years
Similar gender ratio

Severe Renal Impaired Subjects:

Screening creatinine clearance (CLCR) <30 mL/min using the Cockcroft-Gault equation
Supine blood pressure ≤170/110 mmHg
Documented renal impairment indicated by reduced creatinine clearance within 12 months of screening or longer
Stable renal function as evidenced by ≤30% difference in two measurements of creatinine clearance on two separate occasions separated by at least 28 days with one measurement being the value at screening.

Exclusion Criteria:

History of renal trasplant
Acute renal failure
Subjects undergoing any method of dialysis or hemofiltration
Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
History of febrile illness within 5 days prior to dosing
Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
Known infection with human immunodeficiency virus (HIV) upon serological testing
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec) for subjects with severe renal impairment or >450 msec for matched healthy volunteers
Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)",A single 50mg dose of IDN-6556,ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)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
NCT02046369,NCT02046369_EG000,No,All,Child,Phase 3,175,"Inclusion Criteria:

Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. If emancipated, subjects must provide written informed consent. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.

Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). Note: The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
Subject has a lifetime history of at least one manic episode. A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history.
Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration.
CDRS-R score ≥ 45 at screening and Baseline.
YMRS score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at screening and Baseline.
Within 3rd to 97th percentile for gender specific BMI-for-age growth charts from the World Health Organization (WHO) growth charts
In good physical health on the basis of medical history, physical examination, and laboratory screening.

Females who participate in this study:

are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol
Willing and able to adhere to protocol-specified meal requirements during dosing.
Subjects may have a lifetime diagnosis of ADHD. If a subject is taking psychostimulants for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the investigator and noted in the source records.

Exclusion Criteria:

Has an Axis I or Axis II (DSM-IV or any DSM-5) diagnosis other than bipolar I disorder that has been the primary focus of treatment within 3 months of screening.
Subject has been hospitalized for a bipolar manic or mixed episode within the 30 days prior to randomization.
Has a history or current diagnosis of intellectual disability, autism spectrum disorder, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
Any of the following:
Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).
Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood - eg, Duchenne muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
CDRS-R total score > 85 at screening or Baseline
Demonstrates a decrease (improvement) of ≥ 25% in the CDRS-R adjusted total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline.
Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
Lifetime history of electroconvulsive therapy (ECT).
Resistant to antipsychotic treatment based on at least two prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of depression, or subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode.
Clinically significant neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
Has a history of malignancy < 5 years prior to signing the informed consent.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.
A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Clinically significant substance abuse disorder (with the exception of caffeine or tobacco) based on DSM-5 criteria within the last 6 months prior to screening.

Positive test results at screening or Baseline for:

Urine drugs of abuse (including amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opioids, phencyclidine, and cannabinoids). A positive test for amphetamines/methamphetamines, barbiturates, opioids, or benzodiazepines may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor.
Pregnancy test.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to screening.
Donation of whole blood within 60 days prior to randomization.
Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes.
Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation.
Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization.
Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer.
Received treatment with antidepressants, atomoxetine or alpha 2 agonists (eg, guanfacine) within 3 days prior to randomization, fluoxetine hydrochloride within 21 days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine within 120 days of randomization.
Use of all psychotropic medications prior to randomization with the exception of those medications explicitly permitted within 3 days prior to randomization (7 days prior to randomization for aripiprazole).
Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma.
At screening or Baseline the subject answers ""yes"" to ""Suicidal Ideation"" Items 4 or 5 on the C-SSRS or has a score of 7 on item 13, Suicidal Ideation, on the CDRS-R.
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 3 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation.
Adhering to a special diet for the 28 days prior to drug administration (eg, liquid, protein, raw food diet).
Subject is planning to move during the study, is chronically homeless, or is unable to attend all planned study visits. The Medical Monitor will be consulted for individual cases, as needed.

Subject with newly diagnosed Type 2 diabetes during screening or subject is on injectable medication for the treatment of Type 2 diabetes. A subject with Type 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:

Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126 mg/dL.
HbA1c ≤ 6.5%; and
If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
Subject has required hospitalization for diabetes or related complications in the past 12 months.
The use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system during the trial (from signing informed consent until follow-up).
Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up).","Luradisone 20- 80 mg administered once daily

Lurasidone: Lurasidone flexibly dosed 20-80 mg once daily",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02048371,NCT02048371_EG000,No,All,Child | Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
Weight ≥ 15 kg (33 lb)
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Subject must be able to swallow and retain oral medication
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
Adequate organ function within 14 days of registration
Written, voluntary informed consent
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 3 months after last study drug administration in both sexes, as assessed by the investigator. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test less than or equal to seven days prior to Day 1 of study. The definition of adequate contraception will be based on the judgement of the investigator.
Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy

Exclusion Criteria:

Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
Patients who have had prior autologous, or allogeneic bone marrow transplant
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Patients with seizure disorder requiring medication
Proteinuria > 100 mg/dl on urine analysis
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Inability to comply with protocol required procedures
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])","Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Regorafenib

Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02048371,NCT02048371_EG002,No,All,Child | Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
Weight ≥ 15 kg (33 lb)
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Subject must be able to swallow and retain oral medication
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
Adequate organ function within 14 days of registration
Written, voluntary informed consent
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 3 months after last study drug administration in both sexes, as assessed by the investigator. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test less than or equal to seven days prior to Day 1 of study. The definition of adequate contraception will be based on the judgement of the investigator.
Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy

Exclusion Criteria:

Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
Patients who have had prior autologous, or allogeneic bone marrow transplant
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Patients with seizure disorder requiring medication
Proteinuria > 100 mg/dl on urine analysis
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Inability to comply with protocol required procedures
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])","Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Regorafenib

Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02048371,NCT02048371_EG004,No,All,Child | Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
Weight ≥ 15 kg (33 lb)
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Subject must be able to swallow and retain oral medication
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
Adequate organ function within 14 days of registration
Written, voluntary informed consent
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 3 months after last study drug administration in both sexes, as assessed by the investigator. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test less than or equal to seven days prior to Day 1 of study. The definition of adequate contraception will be based on the judgement of the investigator.
Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy

Exclusion Criteria:

Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
Patients who have had prior autologous, or allogeneic bone marrow transplant
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Patients with seizure disorder requiring medication
Proteinuria > 100 mg/dl on urine analysis
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Inability to comply with protocol required procedures
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])","Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Regorafenib

Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02048371,NCT02048371_EG005,No,All,Child | Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
Weight ≥ 15 kg (33 lb)
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Subject must be able to swallow and retain oral medication
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
Adequate organ function within 14 days of registration
Written, voluntary informed consent
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 3 months after last study drug administration in both sexes, as assessed by the investigator. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test less than or equal to seven days prior to Day 1 of study. The definition of adequate contraception will be based on the judgement of the investigator.
Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy

Exclusion Criteria:

Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
Patients who have had prior autologous, or allogeneic bone marrow transplant
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Patients with seizure disorder requiring medication
Proteinuria > 100 mg/dl on urine analysis
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Inability to comply with protocol required procedures
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])","Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Regorafenib

Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0
NCT02048371,NCT02048371_EG007,No,All,Child | Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Age ≥ 10 year for Liposarcoma, Osteosarcoma, Ewing sarcoma and Mesenchymal Chondrosarcoma; Age ≥ 5 years for Rhabdomyosarcoma cohorts
Weight ≥ 15 kg (33 lb)
Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, Ewing/Ewing-like sarcoma of soft tissue or bone, fusion-positive alveolar rhabdomyosarcoma or embryonal rhabdomyosarcoma/fusion-negative alveolar rhabdomyosarcoma , or mesenchymal chondrosarcoma
WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Subject must be able to swallow and retain oral medication
At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1
Adequate organ function within 14 days of registration
Written, voluntary informed consent
Fertile men and women of childbearing potential must agree to use an effective method of birth control from Day 1 of study and for 3 months after last study drug administration in both sexes, as assessed by the investigator. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test less than or equal to seven days prior to Day 1 of study. The definition of adequate contraception will be based on the judgement of the investigator.
Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 20% growth of index lesions) within 6 months of registration
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy

Exclusion Criteria:

Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib and trametinib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
Patients who have had prior autologous, or allogeneic bone marrow transplant
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Patients with seizure disorder requiring medication
Proteinuria > 100 mg/dl on urine analysis
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.03 Grade 2 dyspnea)
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Inability to comply with protocol required procedures
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])","Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Regorafenib

Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02051309,NCT02051309_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,121,"Inclusion Criteria:

Age 18-65
Able to read, write and comprehend English
Smoker
Able to take oral medications and willing to adhere to a medication regimen
Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems

Exclusion Criteria:

Any significant current medical conditions that would contraindicate smoking
Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
Positive test results at intake appointment on urine drug screen for illicit drugs
Past 30 days use of any psychoactive drugs including anxiolytics and antidepressants
Women who are pregnant or nursing
Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days
Only one member per household can participate in the study
Specific exclusions for administration of guanfacine not already specified include:
EKG evidence at baseline screening for any clinically significant conduction abnormalities or arrhythmias
Known intolerance for guanfacine or any alpha blocker
History of fainting, syncopal attacks
Heart failure or myocardial infarction
Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3x normal)
Renal function (as indicated by estimated creatinine clearance <60cc/min)
Treatment with any antihypertensive drug or any alpha-adrenergic blocker
Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice
Subjects may not have donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us","Guanfacine 6mg/day extended release

Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02054325,NCT02054325_EG001,No,Female,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

females
with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg
clinical classification of chronic venous disease C1(mild venous disease),
minimum age of 18 year-old and maximum age 69 year-old
agreement with the study
signing the free and informed consent ( IC)
not use anticoagulant drugs .

Exclusion Criteria:

male
varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
restrict mobility
arterial insufficiency
be allergic to any substance that may be related to the study drugs
any cause of dermatitis on application site
free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
pregnancy
previous deep vein thrombosis (DVT)
family history of DVT
thrombophilia
do not agree with the search terms","An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02061202,NCT02061202_EG000,No,All,Child | Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Age 15 or older
Sever SCD phenotypes (Hb SS and Sβthalassemia0)
A positive response to cough/wheeze questions

Exclusion Criteria:

Patient carries a physician diagnosis of asthma
Patient is prescribed asthma medications
Patient is currently having a painful crisis (as defined by validated pain diary questions)
Patient has acute respiratory symptoms
Known hypersensitivity to milk proteins
Meets criteria for our operational diagnosis of asthma
More than 15 ED visits for pain over the preceding 12 months
Admitted or discharged from the hospital for SCD pain within the last 7 days",1 puff daily (220mcg) for 16 weeks,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02063698,NCT02063698_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Absolute neutrophil count (ANC) >= 1500/mm^3
Platelet count (PLT) >= 100,000/mm^3
Creatinine =< 2 x upper limit of normal (ULN)
Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
Total/direct bilirubin =< 1.5 x ULN
Alkaline phosphatase =< 1.5 x ULN
Hemoglobin >= 9 mg/dL
Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required
Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization
Ability to complete the questionnaires or to do so with assistance

Exclusion Criteria:

Pregnant women
Nursing women
Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
Currently receiving immune-modulating therapies",Patients receive auranofin PO on day 2.,DrugBank:DB00995 | PubChem:16667669 | PubChem:24199313 | PubChem:6918453,Auranofin,CC(=O)OCC1OC([S-])C(OC(C)=O)C(OC(C)=O)C1OC(C)=O.CCP(CC)CC.[Au+],M01CB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02066311,NCT02066311_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Subject is capable of providing written informed consent
Subject is ≥ 18 years old and ≤ 65 years old
Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of Systemic Lupus Erythematosus

Has mild to moderate disease activity defined as

A minimum SLEDAI score of 2 excluding points for serology (anti-dsDNA antibody and complement)
No active renal or nervous system disease
No BILAG A in any organ system
No expectation by the investigator that corticosteroids will need to be added or doses increased during the 8 week treatment period for any reason
No expectation by the investigator that immunosuppressive medication will need to be added or doses increased during the 8 week treatment period
Has elevated titers of anti-ds DNA antibody at the time of screening (defined as the titer that meets criteria for ""high"" in the Core Laboratory at the North Shore/LIJ Health Systems; unequivocal high titer as opposed to borderline, indeterminate or intermediate).
Has elevated titers of cross-reactive anti-DNA/DWEYS antibodies at the time of screening (the assays for anti-DNA/DWEYS antibodies will be performed in Dr. B. Diamond's laboratory; study sites will be notified of results within 3 days of receipt of the samples).
If on glucocorticoids, the dose must be ≤10 mg daily and stable for the 4 weeks prior to screening and baseline
If on immunosuppressive or immunomodulatory medication such as azathioprine, methotrexate, leflunomide, mycophenolate, or hydroxychloroquine, the dose must have been stable for the 3 months prior to screening, and expected to remain stable over the course of the study.
Males and females with potential for reproduction must agree to practice effective birth control measures (2 approved methods of contraception). Nelfinavir can decrease serum levels of oral contraceptives; the slightly increased risk of pregnancy due to an interaction between oral contraception and nelfinavir will be discussed when appropriate and the requirement for a second approved method of contraception will be addressed.

Exclusion Criteria:

Current or prior treatment with rituximab, belimumab or anti-CD22 monoclonal antibody in the 12 months prior to this study or any other biologic agent for 90 days prior to this study
Treatment with cyclophosphamide within the 6 months prior to screening
Increase in glucocorticoid dose within 4 weeks of screening or addition of a DMARD in the three months prior to study
A history of drug or alcohol abuse within the 6 months prior to screening

Elevated LFT's:

ALT or AST ≥ 2 x upper limit of normal at screening
serum unconjugated bilirubin > 3mg/dL at screening
Dialysis or serum creatinine >1.5mg/dL
Hypercholesterolemia: total cholesterol >230 mg/dL or LDL >150 mg/dl or hypertriglyceridemia (triglyceride >200mg/dL) at screening
Laboratory/clinical evidence of: pancreatitis: amylase/lipase >3x upper limit of normal at screening
Known current/active infections including HIV, Hepatitis B, Hepatitis C
History of cancer, excluding skin cancers (squamous cell or basal cell that have been treated)
Known active tuberculosis or untreated tuberculosis
Hemoglobin < 8 g/dL
Expectation by the investigator to increase corticosteroid or immunosuppressive, or immunomodulatory medication dose at screening, baseline, or over the course of the study
Pregnancy or lactation
Consumption of > 2 cups of grapefruit juice per day
Treatment with medications metabolized using the cytochrome P3A4 pathway, such as cyclosporine, tacrolimus, gemfibrozil, niacin, itraconazole, ketoconazole, erythromycin, azithromycin, clarithromycin, bosentan, nefazodone, tricyclic antidepressants
Any condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the study drug.","All subjects will be dosed with nelfinavir 750 mg orally three times daily. This dose may be decreased to 750 mg twice daily if not tolerated. For both stages of the trial the dosing period is 8 weeks followed by a 4 week observation period.

A maximum of 13 subjects will be enrolled in Stage 1. From the 13 subjects enrolled in Stage 1; if 3 or fewer subjects achieve a Response (a ≥35% reduction in serum anti-dsDNA antibody titer), the trial will be terminated. If 4 or more subjects achieve a Response, the study will be expanded to enroll an additional maximum of 30 patients in Stage 2.",ChEMBL:CHEMBL584 | DrugBank:DB00220 | PubChem:64143,Nelfinavir,[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2,J05AE04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02066727,NCT02066727_EG001,No,All,Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
Subject's American Society of Anesthesiologists physical status is I-II.
The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

Subject has a diagnosis of abnormal coagulation function.
Subject has a diagnosis of Diabetes mellitus.
Subject has a preexisting neurologic deficits of the lower extremities.
Subject has a history of alcohol or drug abuse.
Subject is pregnant or breast-feeding.
Subject is obese (body mass index >30kg/m2).",Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02067104,NCT02067104_EG001,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects
Comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
At least 18 years of age at the time of informed consent.
History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit.
No active skin cancers.
Women of reproductive potential must agree to use two forms of acceptable contraception
Male subjects must agree to use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 2 months after the last dose to avoid exposing a pregnant partner and the unborn fetus to vismodegib.
Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
Agreement not to donate blood or blood products during the study and for 7 months after the last dose.
Ability to understand and the willingness to sign a written informed consent document in English

Exclusion Criteria:

Women who are pregnant or lactating, or planning pregnancy while enrolled in the study or for 7 months after the last dose of the study drug.
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. Subjects with clinically stable chronic medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
Inability or unwillingness to swallow capsules.
Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed.
Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
Currently receiving vismodegib, biologics or chemotherapy
Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including Imiquimod, fluorouracil
Subjects who have Gorlins syndrome
Subjects who have received any type of solid organ transplant
Subjects taking immunosuppressive medications at the screening visit. (Day 0)
Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
Other severe acute or chronic medical or psychiatric condition 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 subject inappropriate for entry into this study.
Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
Subjects unable to speak and read the English language
A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.","receive 150 mg of vismodegib daily for a period of 2 months

Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02068092,NCT02068092_EG000,No,Female,Adult | Older Adult,Phase 2 | Phase 3,51,"Inclusion Criteria

Female aged ≥18 years of age.

Elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:

Diagnosis of lobular carcinoma in situ (LCIS), atypical ductal, or lobular hyperplasia.
A known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53. (Note: The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per National Comprehensive Cancer Network guidelines to be eligible per this criterion.)
Modified Gail/CARE model risk at 5 years ≥ 1.67%. (Note: Risk models are to be used only if there is no known previous diagnosis of resected ductal carcinoma in situ [DCIS] or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53)
10% or more probability of BRCA mutation by BRCAPRO or similar model

Must have at least one breast available for imaging and biopsy. A previously irradiated breast (i.e., for resected DCIS) is not evaluable for breast imaging or biopsy.

a. Allow for submission of core needle breast material for future use.

Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, ""scattered fibroglandular densities""; 3 = 51-75%, heterogeneously dense; 4 = >75%, extremely dense). Women with a baseline mammographic density of ≤ 10% (1 = ≤10%, breasts are almost entirely fat) will not be eligible
Eastern Cooperative Oncology Group performance status of 0-1.
Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ≤ 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ≤ ULN prior to the breast biopsy.
Must agree to use effective consistent contraception. Hormone-based birth control (pills, patches, or shots) is allowed. Hormone replacement therapy is not allowed for postmenopausal participants.
Must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. Participants must also agree not to join such a trial while participating in this study.
Provide written informed consent.

Exclusion Criteria

DCIS or previous invasive ductal carcinoma.
Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
Prior tamoxifen or raloxifene use in the past 1 year.
Pregnant or breastfeeding.
Bilateral breast implants. Prior breast reduction surgery is allowed.
Mammograms that are reported as suspicious.",Hydroxytyrosol 25 mg orally once daily for 1 year.,DrugBank:DB12771 | PubChem:82755,Hydroxytyrosol,OCCc1ccc(O)c(O)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02074631,NCT02074631_EG000,No,All,Child | Adult,Phase 2,32,"Inclusion Criteria:

Allogeneic hematopoietic cell transplant for hematologic malignancy (i.e. leukemia, lymphoma including ALL, AML, CML, NHL, HL) in complete remission; myelodysplastic syndrome (active dysplasia and/or blasts are permitted, but must not have active leukemia) or idiopathic severe aplastic anemia (SAA)

Non-malignant diseases including idiopathic severe aplastic anemia (SAA) and other bone marrow failure disorders, hemoglobinopathies, adrenoleukodystrophy, immune deficiencies/dysregulation disorders who will be receiving myeloablative or reduced toxicity preparative regimens that meet the following criteria:

Regimens include those that are TBI based if the TBI dose is > 500cGy single dose or > 800cGy fractionated, or doses <500 cGy if combined with busulfan or treosulfan. These also include chemotherapy only based regimens that contain myeloablative doses of busulfan (>8mg/kg) or treosulfan without TBI.
Patients with severe aplastic anemia are eligible regardless of conditioning regimen
Myeloablative preparative regimen (for SAA any conditioning therapy allowed)
Male or female ≥1 but ≤ 20 years of age at time of study enrollment
Patient or parent(s)/legal guardian(s) is able and willing to provide informed consent. Assent will be obtained per local institutional policy. Subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staff.

Exclusion Criteria:

History of a primary bone malignancy involving the lumbar spine
Prior and/or planned concomitant medical therapy during the study period (through Day 360 post-HCT) with other bisphosphonates, Denosumab, or Teriparatide
Pregnancy or breastfeeding - menstruating females must have a negative pregnancy test prior to study enrollment and agree to repeat pregnancy testing and contraception use per protocol as pamidronate is Pregnancy Category D - positive evidence of human fetal risk based on adverse reaction data
Renal insufficiency, defined as creatinine level greater than the upper limit of normal for age
Hereditary metabolic bone disease or skeletal dysplasia (e.g., osteopetrosis or OI) or primary hyperparathyroidism
Other indications for HCT, including Fanconi anemia, other form of inherited bone marrow failure diseases, metabolic disorder, hemoglobinopathy, or immune deficiency
Clinically significant fractures as defined by ISCD (a long bone fracture of the lower extremities, vertebral compression fracture, or two or more long bone fractures of the upper extremities) (88,89) indicated by a cast or a spine x-ray within the last 2 weeks
Known or suspected allergy to pamidronate or related products
Planned administration of an investigational study drug or agent that either can interact with pamidronate or have an independent effect on bone mineral density within the 4 weeks prior to randomization (Day 90) or planned use during study participation (Day 90 through Day 360)
Impending invasive dental procedure that would be expected to occur during study participation (through Day 360)","Subjects will receive a standard recommended dose of calcium and vitamin D.

Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.",ChEMBL:CHEMBL1536 | DrugBank:DB00153 | PubChem:5280793,Ergocalciferol,[H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C,A11CC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02076243,NCT02076243_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Histologically confirmed unresectable locoregional or distantly metastatic squamous cell carcinoma arising from a cutaneous surface, lip, or ear. Basosquamous histology is eligible.
ECOG PS 0 or 1
Life expectancy of more than 4 months
Adequate renal, hepatic, and bone marrow function:
Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis, Bilirubin < 1.5 mg/dL
Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL, WBC > 3,000 cells/mm3, and ANC > 1,500 cells/mm3
Patients must have adequate renal function: creatinine <1.5 mg/dL
Age > 18 years old
Women of childbearing potential and sexually active males must agree to use effective contraception during treatment and for three months after completing treatment
Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
No previous or concurrent malignancy except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, treated grade 1 papillary bladder cancer, localized prostate cancer detected via biopsy only and being treated with ""watchful waiting"", or other cancers where the patient has no evidence of recurrence for more than 5 years
Must be at least 28 days since surgical procedure and/or radiation therapy and at least 4 weeks since last treatment with targeted therapies such as cetuximab or immunotherapy.
No significant inter-current illness such as serious infection requiring intravenous antibiotics.
Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE v4.0)
Ability to provide informed consent

Exclusion Criteria:

Prior systemic cytotoxic chemotherapy for unresectable SCC. Prior adjuvant or neoadjuvant cytotoxic chemotherapy provided not within prior 28 days is allowed. Prior systemic therapies with a targeted agent (cetuximab) or immunotherapy in the setting of unresectable SCC (is allowed).
Prior taxane based chemotherapy
The presence of any CNS tumor that has not been stable for at least 3 months off of corticosteroids and confirmed by imaging.
Prior major organ transplant or autoimmune disease requiring chronic immunosuppression
Psychiatric illness or social situation that would preclude compliance.
Active or chronic infection with HIV, hepatitis B or hepatitis C. Formal testing should be performed if clinical suspicion.
Patients with New York Heart Association class II, III, or IV disease or arrhythmia requiring treatment (rate controlled Atrial fibrillation is allowed)
Lack of measurable disease on imaging studies as defined by RECIST 1.
Any condition that in the opinion of the treating physician is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk
Known allergy to treatment medication","weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.

nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02077465,NCT02077465_EG000,No,All,Adult | Older Adult,Phase 1,8,"Key Inclusion Criteria:

Weight: ≥ 45 kg to < 120 kg at screening
Males or non-pregnant, non-lactating females
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. Male individuals must refrain from sperm donation for 90 days post last infusion of the study drug
Diagnosis of COPD per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for at least 6 months prior to screening and anticipated to remain on stable therapy for the duration of the study
Post-bronchodilator forced expiratory volume in one second (FEV1) ≥ 40% predicted
No changes in COPD medications within 30 days prior to randomization
Hepatic panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH)] ≤ 2 times the upper limit of the normal range (ULN)
Serum creatinine ≤ 2.0
Hemoglobin ≥ 8.5 g/dL (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 mm^3)
Platelets ≥ 100 x 10^9/L

Key Exclusion Criteria:

Clinically significant active infection as judged by the investigator during screening
Known history of HIV, hepatitis B or C during screening. Individuals who are hepatitis B surface antigen positive, but who received a successful series of hepatitis B vaccinations and never had the disease remain eligible
A positive QuantiFERON-TB GOLD test during screening
History of malignancy within the last 5 years except for patients who have been treated locally for non-melanoma skin cancer or cervical carcinoma in situ
Any serious cardiac event such as myocardial infarction, unstable or life-threatening arrhythmia, hospitalization for cardiac failure within 6 months prior to randomization or any significant or new electrocardiogram (ECG) finding at Visit 1 as judged by the Investigator
A hospitalization for a respiratory event such as, but not limited to, COPD, pneumonia, bronchiolitis, within the previous 6 months prior to randomization
Chronic lung disease other than COPD such as: asthma, cystic fibrosis or fibrotic disease, α-1-antitrypsin deficiency, interstitial lung disease, pulmonary thromboembolic disease, or bronchiectasis
Chronic use of systemic corticosteroids and/or treatment with systemic corticosteroids for an acute exacerbation of COPD (AECOPD) event, or other medical condition not requiring hospitalization, within 90 days of randomization.
Treatment with antibiotics for an AECOPD event, or other medical condition not requiring hospitalization within 90 days of randomization, or any minor medical event not requiring hospitalization within 14 days of randomization.
Treatment with any marketed or investigational biologic within 5 half-lives of the molecule or if unknown within 90 days of screening
Individuals currently on nonbiologic immune modulator medications such as: azathioprine, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, mycophenolate mofetil, sulfasalazine, tofacitinib, within 90 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants received IV infusion of andecaliximab 200 mg once every 2 weeks for a total of 3 infusions.,PubChem:56776542,1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene,COc1ccc(Br)c(F)c1[N+](=O)[O-],,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02079077,NCT02079077_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,91,"Inclusion criteria:

Age greater than 18 years old and less than 50 years old
Uterus and cervix present
Willing to take daily acetylsalicylic acid or HCQ
Willing to undergo pelvic exams
In general good health, no chronic infection and not taking any anti-inflammatory or immunosuppressors
Being HIV negative
Without any cardiovascular disease
Being active in sex work (for the Female commercial sex worker group)

Exclusion criteria:

Age less than 18 years or more than 50 years old
Pregnancy (if a women becomes pregnant during the 10 weeks of the project she will be excluded)
Breast feeding
Pregnant in the last 12 months
Being positive for Sexual transmissible disease or bacterial vaginosis at week 0
Menopausal
No longer involve in sex work (for the female sex worker group)
Having a chronic disease
Taking any of the medication listed in annex 1 for health conditions
Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine dye or chloroquine, hydroxuchloroquine, primaquine or any other medication
Having heartburn, stomach pain, stomach ulcer, anemia, hemophilia, kidney or liver disease, psoriasis, porphyria or other blood disease, G-6-PD deficiency, dermatitis (skin inflammation), alcoholism
Having experienced previous vision changes while taking chloroquine, hydroxychloroquine (Aralen) or primaquine.
Having a history of a diagnosed cardiovascular event, heart failure, peripheral arterial disease, angina, stoke, transient ischemic attack
Having a current or recurrent condition with a high risk of major bleeding
Having anemia

Current participation in a clinical trial

-

-","Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.

Hydroxychloroquine (HCQ): Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02082912,NCT02082912_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

between the ages of 18 and 95 years
of either sex
of diverse ethnic background
have experienced a single unilateral hemispheric or brainstem stroke 3 or more months prior
if have experienced more than one stroke, will be accepted only if all strokes are on the same side of the brain, there is no history of a clinical ischemic or hemorrhagic event affecting the other hemisphere, and there is no CT or MRI evidence of more than one a lacune or minor ischemic demyelination affecting the other hemisphere.
active motions of the wrist and hand: 10 of wrist extension from a relaxed flexed position; 10 of extension of any two digits at any joint, and 10 of thumb extension at either joint. All active motions must be repeated 3 times within one minute.
passive range of motion: 90 of flexion and abduction and 45 external and internal rotation at the shoulder; 45 elbow supination and pronation; elbow extension limited by no more than 30; wrist extension to at least neutral; and digit extension limited by no more than 30.
participants will not be required to exhibit any active shoulder or elbow motion
ability to sit independently for at least 2 minutes
Mini Mental Status Examination score greater than 24
Motor Activity Log score less than 3
Prospective participants who qualify but who have profound postural instability will undergo the intervention while walking with contact guarding or, when feasible, using their leg and more involved arm to propel a wheelchair.
must have a score below 16 on the Center for Epidemiologic Studies Depression Scale
must receive a score greater than 25 on the Folstein Mini Mental State Exam.

Exclusion Criteria:

any history of more than minor head trauma, subarachnoid hemorrhage, dementia or any other neurodegenerative disease, multiple sclerosis, HIV infection, drug or alcohol abuse, serious medical illness, schizophrenia, major refractory depression
insufficient cardiopulmonary function to participate in low-intensity sustained upper extremity exercise
severe visual impairment
pregnancy
breast feeding
participation in intensive physical therapy within the prior 12 months
inability to understand the potential risks and benefits of the study, personally provide informed consent, and understand and cooperate with treatment
participating in other upper extremity rehabilitation, clinical or experimental, during the course of this trial.
a score of less than 24 on the Folstein Mini-Mental State Exam
a score of less than10 on the Boston Naming Test
a first stroke less than 3 months or more than 48 months prior to the initiation of therapeutic intervention
less than 18 years old
clinical judgment of excessive frailty or lack of stamina
serious uncontrolled medical conditions
excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention
passive range of motion less than 45 degrees for: abduction, flexion or external rotation at shoulder, or pronation of forearm
greater than 30 degrees flexion contracture at any finger joint
unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand
current participation in other pharmacological or physical intervention studies, or have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future
receiving any anti-spasticity drugs orally at the time of expected participation
received phenol injections less than 12 months prior to receiving therapy
contemplating a move from proximity to the treatment site in less than 6 months from the randomization date.",Participants taking D-cycloserine and using the HandMentor Pro for robotic therapy,ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02101983,NCT02101983_EG000,No,All,Adult | Older Adult,Not Applicable,4,"Inclusion Criteria:

Inclusion Criteria for Outpatient Administration of HiDAC

Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
Documented complete remission (CR) following induction chemotherapy as defined as (18):
Bone marrow with <5% blasts; absence of blasts with Auer rods
Absolute neutrophil count >1000/mcL
Platelets >100,000/mcL
Independence of red cell transfusions
Absence of extramedullary disease
Age ≥ 55 years.
Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria.
Good performance status of (ECOG 0-2), see appendix 15.3.
Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase <3.0 x upper limit of normal, total bilirubin <1.5 x upper limit of normal unless there is a history of Gilbert's disease).

Inclusion Criteria for Quality of Life Comparison Group

All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison.
Age ≥ 18 years

Exclusion Criteria:

Exclusion Criteria for All Patients

Active, uncontrolled viral, bacterial, or fungal infection.
Documented CNS leukemia.
If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
History of prior autologous or allogeneic bone marrow/stem cell transplant.
New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
Pregnant or lactating women (women and men of childbearing age should use effective contraception).
Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.","Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.

Cytosine Arabinoside",ChEMBL:CHEMBL803 | DrugBank:DB00987 | DrugBank:DB02097 | PubChem:114682 | PubChem:596 | PubChem:6175 | PubChem:6253,Cytidine,Nc1ccn(C2OC(CO)C(O)C2O)c(=O)n1,L01BC01 | L01XY01,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02101983,NCT02101983_EG001,No,All,Adult | Older Adult,Not Applicable,6,"Inclusion Criteria:

Inclusion Criteria for Outpatient Administration of HiDAC

Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
Documented complete remission (CR) following induction chemotherapy as defined as (18):
Bone marrow with <5% blasts; absence of blasts with Auer rods
Absolute neutrophil count >1000/mcL
Platelets >100,000/mcL
Independence of red cell transfusions
Absence of extramedullary disease
Age ≥ 55 years.
Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria.
Good performance status of (ECOG 0-2), see appendix 15.3.
Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase <3.0 x upper limit of normal, total bilirubin <1.5 x upper limit of normal unless there is a history of Gilbert's disease).

Inclusion Criteria for Quality of Life Comparison Group

All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison.
Age ≥ 18 years

Exclusion Criteria:

Exclusion Criteria for All Patients

Active, uncontrolled viral, bacterial, or fungal infection.
Documented CNS leukemia.
If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
History of prior autologous or allogeneic bone marrow/stem cell transplant.
New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
Pregnant or lactating women (women and men of childbearing age should use effective contraception).
Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.","Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.

Cytosine Arabinoside",ChEMBL:CHEMBL803 | DrugBank:DB00987 | DrugBank:DB02097 | PubChem:114682 | PubChem:596 | PubChem:6175 | PubChem:6253,Cytidine,Nc1ccn(C2OC(CO)C(O)C2O)c(=O)n1,L01BC01 | L01XY01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02108171,NCT02108171_EG000,No,All,Adult,Not Applicable,40,"Inclusion Criteria:

Surgery:The laryngoscope vocal polyp excision
Aged 18 to 60 years old
Body mass index (BMI) < 30 kg/m2
American society of Anesthesiologist (ASA) I -II

Exclusion Criteria:

The investigator refused to participate
Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
With previous history of heart disease
Pregnant women; no reliable contraceptive measures in postmenopausal women
Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
Asthma
Sleep apnea syndrome
Liver and kidney dysfunction
Known to suffer from mental illness
Long-term use of sedatives and analgesics in patients","intranasal dexmedetomidine

Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02109744,NCT02109744_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

4.1.1 Age >/= 18 4.1.2 Diagnosis of AML according to World Health Organization (WHO) criteria except acute promyelocytic leukemia AND 4.1.3 Refractory AML defined as failure to achieve Complete Remission (CR) after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR 4.1.4 Relapsed AML defined as any evidence of disease recurrence after achieving a documented first or greater Complete Remission (CR) OR 4.1.5 Relapsed AML after stem cell transplantation. 90 days (since stem cell infusion) must have elapsed between transplant and emergence of recurrent AML OR 4.1.6 Newly diagnosed AML in a patient >65 years old not considered fit for standard 7+ 3 chemotherapy or who declines such therapy after discussion of therapeutic options available.

4.1.7 Eastern Cooperative Oncology Group (ECOG) performance status <3

Exclusion Criteria:

4.2.1 Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30 ml/min (Cockcroft-Gault formula (Appendix 2) 4.2.2 Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase(s) more than 2.5x the upper limits of normal 4.2.3 Active systemic infection not responding to antibiotics 4.2.4 Known diagnosis of human immunodeficiency virus infection (HIV) 4.2.5 Patients who are post-allogeneic transplantation should not have active Graft vs. Host Disease (GVHD) greater than grade 1 of skin at time of enrollment. They may have had donor lymphocyte infusion (DLI) but not within 4 weeks of beginning the study.

4.2.6 Pregnant or breastfeeding female subjects 4.2.7 Known or suspected Central Nervous System (CNS) leukemia involvement; past involvement is not an exclusion.

-","Decitabine 20 mg/M2/day will be given as an IV infusion daily for 10 consecutive days starting on day 1 of cycle 1; in subsequent cycles, decitabine will be given for five days (days 1-5). Ribavirin will be dosed from day 11-day 28 beginning with dose level 1 (1000mg orally twice daily). Number of patients with Dose Limiting Toxicities (DLT) at a given dose level is 0 of out of 3: enter 3 patients at the next dose level (dose Level 2- 1200mg orally twice daily; and then dose Level 3-1400 mg orally twice daily).(Arm B: For patients with morphologic M4/M5 subtypes).

Decitabine",ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02111187,NCT02111187_EG000,No,Male,Adult | Older Adult,Phase 1,7,"Inclusion Criteria:

Provide written informed consent prior to any screening procedures.
Age 18 years or older.
Histologically-documented prostatic adenocarcinoma in ≥2 cores
ECOG performance status ≤2

Localized prostate cancer with at least one of the following NCCN high-risk features:

Gleason sum ≥8
PSA >20 ng/mL
Clinical stage ≥T3
Must be a candidate for radical prostatectomy
No evidence of known metastatic disease (M0 or Mx allowed)

Adequate bone marrow, liver and renal function as specified below:

Absolute neutrophil count (ANC) ≥ 1500/µL
Hemoglobin (Hgb) ≥ 9.0 g/dL
Platelets ≥100,000/µL
Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal)
AST and ALT ≤ 2.5 x ULN
Plasma creatine phosphokinase (CK) < 1.5 x ULN, if known
Serum creatinine ≤ 1.5 x ULN [or 24-hour creatinine clearance ≥ 50ml/min]
Patient is able to swallow and retain oral medications

Exclusion Criteria:

Patients who have had major surgery within 4 weeks of enrollment.
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study.
Patients unable to take oral drugs (e.g. lack of physical integrity of the upper GI tract or known malabsorption syndromes).
Patients who have previously been treated with LDE225 or other Hh pathway inhibitors
Patients who have neuromuscular or muscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are known to cause rhabdomyolysis (such as statins and fibrates), and that cannot be discontinued at least 2 weeks prior to starting LDE225. If it is essential that the patient stays on a statin for hyperlipidemia, only pravastatin may be used with extra caution. Patients should not plan to embark on a new strenuous exercise regimen after initiation of study treatment. (NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment).
Patients who have taken part in an experimental drug study within 4 weeks or 5 half-lives (whichever is longer) of initiating treatment with LDE225.
Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting LDE225.
Patients taking moderate/strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
No concurrent use of statins (except for pravastatin, if absolutely necessary)
No concurrent warfarin or Coumadin-derivatives

Impaired cardiac function or significant heart disease, including any one of the following:

Angina pectoris within 3 months
Acute myocardial infarction within 3 months
QTc >450 msec on the screening ECG
A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome
Other clinically significant heart disease (e.g. heart failure, uncontrolled/labile hypertension, or history of poor compliance with an antihypertensive regimen)

Patients who are not willing to apply highly effective contraception during the study and through the duration of LDE225 treatment.

Male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the last dose of the study drug. A condom is also required to be used by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid. Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child during this period.
Patients unwilling or unable to comply with the research protocol.","Treatment arm (Arm 1) will receive LDE225 by mouth 800 mg daily for 4 weeks (+/- 3 days)

LDE225",ChEMBL:CHEMBL2105737 | DrugBank:DB09143 | PubChem:24775005,Sonidegib,[H][C@]1(C)CN(c2ccc(NC(=O)c3cccc(-c4ccc(OC(F)(F)F)cc4)c3C)cn2)C[C@@]([H])(C)O1,L01XJ02,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02116608,NCT02116608_EG000,No,All,Child,Phase 4,9,"Inclusion Criteria:

Children's Hospital Colorado inpatient or outpatient
31 days to 17 years (inclusive)
Needs treatment for a tracheostomy granuloma

Exclusion Criteria:

Tracheostomy granuloma has been treated in the last two weeks","Apply locally as needed.

Betadine: Apply locally as needed.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02120365,NCT02120365_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,22,"Inclusion Criteria:

males and females
between the ages of 21 and 55 years;
Nontreatment-seeking Heavy Drinkers (NTSHDs)as defined above, and must have had at least 5 Standard Drinks (SD) in one day on at least some occasions in the past and been able to tolerate it without an adverse reaction
generally medically and neurologically healthy on the basis of history, physical examination, Electrocardiogram, screening laboratory results (Complete Blood Count w/ differential, Thyroid Stimulating Hormone, Free-T4, Aspartate Transferase, Alanine Transferase, Gamma-Glutamyl Transferase, Blood Urea Nitrogen, creatinine, electrolytes, urinalysis, beta-Human Chorionic Gonadotropin). Individuals with Liver Function Tests (LFT) that are no more than 3 times above the normal levels will be included;
women with a negative pregnancy test and not nursing, must be regularly using birth control
negative breath alcohol at screening and on each test day;
not taking any psychoactive medication or opioids (in past 30-days);
are non-treatment seeking.

Exclusion Criteria:

they need detoxification determined by a Clinical Institute Withdrawal Assessment (CIWA) score of >8 or have had a history of alcohol detoxification in the past;
have been in treatment for an alcohol problem within the last 6 months, or if the severity of their alcohol problem based on the research physician's assessment warrants definitive treatment;
meet criteria for Diagnostic Statistical Manual (DSM) -IV psychiatric and substance use disorder diagnosis (other than alcohol abuse/dependence, cannabis abuse/dependence and nicotine dependence; those diagnoses will be allowed; participants can be either smokers up to 1 pack per day or non-smokers) based on history and psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for DSM-IV Axis I Disorders: SCID)
unwillingness to remain alcohol-free 12 hours prior to test days;
have a significant ongoing serious medical condition such as Diabetes Mellitus, liver disease (see above LFT guideline), renal disease (as evidenced by serum creatinine above our laboratory's reference limit of 1.7 mg/dL, or have a history of adverse reaction to IV placement/blood draw","Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with placebo 7 days prior to each test day, and then observed dosing of placebo in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.

Placebo: Placebo given in place of perampanel during the pre-treatment period and lab session days.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02120365,NCT02120365_EG002,No,All,Adult | Older Adult,Phase 1 | Phase 2,22,"Inclusion Criteria:

males and females
between the ages of 21 and 55 years;
Nontreatment-seeking Heavy Drinkers (NTSHDs)as defined above, and must have had at least 5 Standard Drinks (SD) in one day on at least some occasions in the past and been able to tolerate it without an adverse reaction
generally medically and neurologically healthy on the basis of history, physical examination, Electrocardiogram, screening laboratory results (Complete Blood Count w/ differential, Thyroid Stimulating Hormone, Free-T4, Aspartate Transferase, Alanine Transferase, Gamma-Glutamyl Transferase, Blood Urea Nitrogen, creatinine, electrolytes, urinalysis, beta-Human Chorionic Gonadotropin). Individuals with Liver Function Tests (LFT) that are no more than 3 times above the normal levels will be included;
women with a negative pregnancy test and not nursing, must be regularly using birth control
negative breath alcohol at screening and on each test day;
not taking any psychoactive medication or opioids (in past 30-days);
are non-treatment seeking.

Exclusion Criteria:

they need detoxification determined by a Clinical Institute Withdrawal Assessment (CIWA) score of >8 or have had a history of alcohol detoxification in the past;
have been in treatment for an alcohol problem within the last 6 months, or if the severity of their alcohol problem based on the research physician's assessment warrants definitive treatment;
meet criteria for Diagnostic Statistical Manual (DSM) -IV psychiatric and substance use disorder diagnosis (other than alcohol abuse/dependence, cannabis abuse/dependence and nicotine dependence; those diagnoses will be allowed; participants can be either smokers up to 1 pack per day or non-smokers) based on history and psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for DSM-IV Axis I Disorders: SCID)
unwillingness to remain alcohol-free 12 hours prior to test days;
have a significant ongoing serious medical condition such as Diabetes Mellitus, liver disease (see above LFT guideline), renal disease (as evidenced by serum creatinine above our laboratory's reference limit of 1.7 mg/dL, or have a history of adverse reaction to IV placement/blood draw","Participants will have 3 test days each, 2 weeks apart, in a randomized order, following either pretreatment with daily perampanel 2mg 7 days prior to each test day, and then observed dosing of high dose perampanel (10mg) in the lab 1 hour before a one-time alcohol infusion . Each lab session occurs exactly a week after starting the medication for that round. The wash out period between lab test session phases will be 7-10 days. Subjects will receive 2 days of 2mg perampanel after each lab to taper down (included in the washout period). The next appointment will be brief at the start of the next phase, at which point the next week of low dose perampanel or placebo will be started. With the washout period and the 7 day taper of the next phase, the actual lab sessions will occur 14-17 days apart. All test days will involve administration of alcohol with the same 3 target doses (target BrAc=20mg%, 60mg%, and 100mg%) in a step-wise fashion.

Perampanel: Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02121860,NCT02121860_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,36,"Inclusion Criteria:

All Subjects:

Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >45 kg
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug

Matched Healthy Volunteers:

Medically healthy as determined by the Investigator
Supine blood pressure ≤145/90 mmHg
No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study

Demographically comparable to subjects with hepatic impairment as follows:

Mean body weight within ±15 kg
Mean age within ±10 years
Similar gender ratio

Subjects with Hepatic Impairment:

Evidence of hepatic disease

Score ≥ 2 on one of the Child-Pugh parameters, or
Histological or imaging diagnosis of cirrhosis, or
Presence of esophageal varices, or
Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels

Meet one of the following criteria for Child-Pugh classification for hepatic impairment during Screening

Mild hepatic impairment: Class A (Child-Pugh Scores 5-6 points)
Moderate hepatic impairment: Class B (Child-Pugh Scores 7-9 points)
Severe hepatic impairment: Class C (Child Pugh Scores 10-15 points)
Supine blood pressure ≤160/100 mmHg

Exclusion Criteria:

All Subjects:

Known infection with human immunodeficiency virus (HIV) upon serological testing
Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Dosing in another clinical trial within 30 days prior to the study drug administration
If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding

Matched Healthy Volunteers:

Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is considered clinically significant by the Investigator, etc.)
Screening creatinine clearance <80 mL/min using the Cockcroft-Gault equation
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >450 milliseconds (msec)
History of regular alcohol consumption exceeding 28 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of Screening

Subjects with Hepatic Impairment:

Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment during Screening period and up to Day -1 (e.g., advanced ascites, infection of ascites, fever, active gastrointestinal bleeding)
History of liver transplant, or have a transjugular intrahepatic portosystemic shunt, and/or have undergone portacaval shunting
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
Screening creatinine clearance <50 mL/min using the Cockcroft-Gault equation",Single 50 mg oral dose of IDN-6556,ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02125604,NCT02125604_EG000,No,All,Adult | Older Adult,Phase 4,211,"Key Inclusion Criteria:

Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)
Naïve to dimethyl fumarate and fumaric acid esters

Key Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy
Known active malignancies
History of anaphylaxis or severe allergic reactions or known drug hypersensitivity
Current use of B vitamin supplements
In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use

NOTE: Other protocol-defined inclusion/exclusion criteria may apply",Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02135900,NCT02135900_EG000,No,All,Adult | Older Adult,Phase 2,32,"Inclusion Criteria:

Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

Exclusion Criteria:

Professional singers.
Television or Radio hosts.
Disk Jockeys.
Subjects requiring oxygen therapy.
Subjects younger than 18 year old.
Pregnant women.
Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
History of anatomic upper airway obstruction.
Uncontrolled asthma.","Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.

Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.",PubChem:123812,Heliox,O=O.[He],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02138253,NCT02138253_EG000,No,All,Adult | Older Adult,Phase 2,41,"Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
History of orthotopic liver transplantation for HCV-induced liver disease
Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1
Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be enrolled)
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
History of renal transplant and/or severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min/1.73 m2
Evidence of tumor burden >Milan criteria, or evidence of micro- or macrovascular invasion in explanted liver
Hepatocellular carcinoma (HCC) at entry into the study
Concurrent sirolimus (rapamycin) use
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding","IDN-6556 25 mg BID

IDN-6556",ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02141399,NCT02141399_EG000,No,All,Adult | Older Adult,Phase 3,1485,"Inclusion Criteria:

Agree to use an approved method of contraception for the duration of the study
Have the potential to safely benefit from the administration of ALKS 5461
Have a diagnosis of major depressive disorder (MDD)
Additional criteria may apply

Exclusion Criteria:

Have a positive test for drugs of abuse
Currently pregnant or breastfeeding
Have a current primary Axis-I disorder other than MDD
Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
Have attempted suicide within the past 2 years
Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
Have had a significant blood loss or blood donation within the past 60 days
Additional criteria may apply",ALKS 5461 adjunctive treatment,PubChem:53373584,Buprenorphine/samidorphan,COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.NC(=O)c1ccc2c(c1O)C13CCN(CC4CC4)C(C2)C1(O)CCC(=O)C3,,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
NCT02141555,NCT02141555_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 2 | Phase 3,4,"Inclusion Criteria:

Women ages 18-50 who are English or Spanish speaking
First trimester pregnancy (less than 13 weeks and 0 days)
Desires medical management of an early pregnancy loss with misoprostol

Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

Crown-rump length > 7mm with no cardiac activity
Mean gestational sac diameter of > 25 mm and no embryo
Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac
Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

Evidence of infection, acute hemorrhage, or hemodynamic instability
Hemoglobin less than 9.5 including use of point of care Hgb testing
Known allergy to misoprostol
Underwent surgical or medical abortion during current pregnancy
Currently breastfeeding
Currently has intrauterine device in place
Suspicion of ectopic or gestational trophoblastic disease
History of clotting disorder or on anticoagulant therapy (excluding aspirin)
Unreliable for follow up","Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.

Vaginal Misoprostol: Misoprostol inserted into vagina",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02141555,NCT02141555_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 2 | Phase 3,4,"Inclusion Criteria:

Women ages 18-50 who are English or Spanish speaking
First trimester pregnancy (less than 13 weeks and 0 days)
Desires medical management of an early pregnancy loss with misoprostol

Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

Crown-rump length > 7mm with no cardiac activity
Mean gestational sac diameter of > 25 mm and no embryo
Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac
Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

Evidence of infection, acute hemorrhage, or hemodynamic instability
Hemoglobin less than 9.5 including use of point of care Hgb testing
Known allergy to misoprostol
Underwent surgical or medical abortion during current pregnancy
Currently breastfeeding
Currently has intrauterine device in place
Suspicion of ectopic or gestational trophoblastic disease
History of clotting disorder or on anticoagulant therapy (excluding aspirin)
Unreliable for follow up","Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.

Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02153788,NCT02153788_EG000,No,All,Adult | Older Adult,Phase 4,23,"Inclusion Criteria:

males or females age 18-69;
females must utilize an approved form of birth control during the study;
have at least a 3 month history of insomnia as defined in the DSM-IV criteria for primary insomnia;
self report > 60 minutes of wakefulness after initial sleep onset on at least 4 nights of 7 consecutive nights;
self report > 30 minutes of self-reported latency to sleep onset on at least 4 nights of 7 consecutive nights;
Self report < 6.5 hours of total sleep time at least 4 nights of 7 consecutive nights;
be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures;
agree to participate for the entire study period (a total of approximately 6 months); and
provide documentation of HIV seropositivity and be enrolled in ongoing care for their HIV disease in an infectious disease clinic with their last examination not exceeding 3 months prior to screening date

Exclusion Criteria:

Have a clinically significant unstable medical abnormality, or history or presence of significant neurological disorders (including cognitive disorders), or frequent nightly urination, defined as > 2 times per night;
Had a clinically significant illness, as determined by the Investigator, within 30 days of Initial Screening (Visit 1);
Have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
Have a known or exaggerated pharmacological sensitivity or hypersensitivity or intolerance to doxepin HCl, any tricyclic antidepressant or antihistamine, temazepam or any benzodiazepine;
Have a positive urine drug screen for amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids at Initial Screening (Visit 1);
Self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly;
Have a history of epilepsy or serious head injury;
Have been on current HAART or antiretroviral regimen for less than 1 month;
Have a recent history (within one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-IV-TR criteria;
Have used temazepam for any indication within the 30 days prior to Initial Screening (Visit 1);
Have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug (other than the study drug) during the study;
Current use of any of the following medications: antipsychotics, appetite suppressants, systemic corticosteroids, theophylline, respiratory stimulants and decongestants;
The following medications may be discontinued for the purpose of entry into the study provided the medication is taken at bedtime for the indication of sleep. If the indication is other than sleep, the medication cannot be discontinued for the purpose of entry into the study: anxiolytics, antidepressants, anticonvulsants, histamine-1 receptor antagonists (except for loratadine, desloratidine, and fexofenadine), narcotic analgesics, sedative/hypnotics (other than study drug) or OTC sleep aids;
Have symptoms consistent with the diagnosis of any other sleep disorder other than primary insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, restless leg syndrome, etc.);
Have a body mass index (BMI) greater than or equal to 34;
Have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
Self reports intentional napping more than two times per week;
Have a variation in bedtime of more than three hours on five of seven consecutive nights as recorded on the sleep diary;
Have a history of non-adherence to treatment or clinical visit attendance; or,
subjects taking any benzodiazepine within 5 half-lives prior to the study baseline","After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.

Temazepam: Temazepam 15 mg orally at bedtime",ChEMBL:CHEMBL967 | DrugBank:DB00231 | PubChem:5391,Temazepam,CN1C(=O)C(O)N=C(c2ccccc2)c2cc(Cl)ccc21,N05CD07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02155829,NCT02155829_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,37,"Inclusion Criteria:

Active-duty service member or an Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), or Operation New Dawn (OND) veteran.
Clinical diagnosis of PTSD and have not achieved remission with an adequate trial of medication treatment (8 weeks) as indicated by self-report at referral and confirmed by baseline CAPS score of greater than or = to 40 after informed consent is obtained.

Exclusion Criteria:

Female subjects of childbearing capacity who test positively for ß-HCG, or are either self-reporting as pregnant, planning to become pregnant, or nursing.
Presence of psychotic features.
Unable to provide informed consent or comply with study procedures.
Previous treatment with riluzole.
Serious, unstable illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, hematologic disease, or HIV. This includes individuals with a history of COPD by diagnosis as well as persons taking inhalers for Asthma or Reactive Airway Disease.
Clinically significant abnormal levels (3x ULN or greater) of serum transaminases (ALT/SGPT; AST/SGOT), current or past blood dyscrasia.
Subjects with uncorrected hypothyroidism or hyperthyroidism.
DSM-IV alcohol or substance abuse or dependence within 90 days of the screening visit.
Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week, or any change in fluoxetine dosing within 8 weeks prior to visit 2. Use of antidepressant and sedative/hypnotic drugs at stable dose is permitted.
Documented history of hypersensitivity or intolerance to riluzole.
Subjects with a current or past history of other axis I disorders including schizophrenia, schizoaffective disorder, bipolar disorder or dementia. However, those with a co-morbid history of other Axis I disorder like major depression, dysthymia or other anxiety disorders will be included; the justification for this is that approximately 70% of subjects with PTSD have co-morbid depression and or alcohol abuse, and restricting the sample to PTSD patients without depression will not accurately reflect the scope of this disorder.
Patients who are currently at high risk for homicide or suicide, as indicated by an affirmative answer to the question: ""In the last three months, have you attempted to kill yourself, made specific plans to kill yourself, or had the intention to kill yourself?""
Current or planned litigation regarding the traumatic event.
Patients who recently started trauma focused cognitive behavioral psychotherapy (Patient's underlying educational or supportive individual or group therapy will be included).
Patient's actively enrolled in an evidence based psychotherapy treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure Therapy) will be excluded until that therapy has concluded, but may be re-approached at that time if patient self-report or clinician referral suggests persistent PTSD symptoms upon conclusion of that treatment.
Subjects with an artificial cardiac pacemaker or metallic implants within their body will be enrolled at WRNMMC for the placebo-control clinical trial portion of the study only. These individuals, due to their pre-existing medical condition, are medically ineligible to participate in the 1H MRS imaging portion of the study. Further, the Magnetic Resonance (MRI) Screening Form is use at WRNMMC will be used for participant screening prior to any imaging procedures.
Use of benzodiazepines.","Weeks 1 and 2: Riluzole 50 mg tablet by mouth every 12 hours (100 mg/day) for 2-weeks

Weeks 3 to 8 (optional dose increase): 2 Riluzole 50 mg tablets by mouth every 12 hours (200 mg/day) for 6-weeks",ChEMBL:CHEMBL744 | DrugBank:DB00740 | PubChem:5070,Riluzole,Nc1nc2ccc(OC(F)(F)F)cc2s1,N07XX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02156492,NCT02156492_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,62,"Inclusion Criteria:

Are native Chinese and living in China.
Are overtly healthy males or females as determined by medical history and physical examination.

Female participants:

Women not of child-bearing potential
Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.
Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)
BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg
Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)
Have no known liver disease
Have given written informed consent

Exclusion Criteria:

Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Show evidence of significant active neuropsychiatric disease.
Regularly use known drugs of abuse
Are women with a positive pregnancy test or women who are lactating.

Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.

Hormonal contraceptives are permitted.
Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.
Donated blood of >400 mL within the last month.
Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Are unwilling to comply with the dietary requirements/restrictions during the study","Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02156492,NCT02156492_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,62,"Inclusion Criteria:

Are native Chinese and living in China.
Are overtly healthy males or females as determined by medical history and physical examination.

Female participants:

Women not of child-bearing potential
Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.
Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)
BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg
Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)
Have no known liver disease
Have given written informed consent

Exclusion Criteria:

Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
Have a history within the last year or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Show evidence of significant active neuropsychiatric disease.
Regularly use known drugs of abuse
Are women with a positive pregnancy test or women who are lactating.

Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.

Hormonal contraceptives are permitted.
Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.
Donated blood of >400 mL within the last month.
Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Are unwilling to comply with the dietary requirements/restrictions during the study","Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days.",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02160730,NCT02160730_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion criteria:

Male and female patients at least 18 years old

Patients with confirmed pituitary origin of excess adrenocorticotropic hormone (ACTH) production:

Persistent hypercortisolemia established by two consecutive 24 h UFC levels at least 1.5x the upper limit of normal
Normal or elevated ACTH levels
Pituitary macroadenoma (>1 cm) on MRI OR
Inferior Petrosal Sinus Sampling (IPSS) central to peripheral ACTH gradient >2 at baseline and >3 after CRH stimulation
Recurrent or persistent Cushing disease is defined as pathologically confirmed resected pituitary ACTH-secreting tumor, and 24 hour UFC above the upper limit of normal reference range beyond post-surgical week 6
Patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed:
Inhibitors of steroidogenesis (metyrapone, ketoconazole): 2 weeks
Somatostatin analogs (pasireotide): 2 weeks
Progesterone receptor antagonist (mifepristone): 2 weeks
Dopamine agonists (cabergoline): 4 weeks
CYP3A4 strong inducers or inhibitors: varies between drugs; minimum 5-6 times the half-life of drug

Exclusion criteria:

Patients with compromised visual fields, and not stable for at least 6 months
Patients with abutment or compression of the optic chiasm on MRI and normal visual fields
Patients with Cushing's syndrome due to non-pituitary ACTH secretion
Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
Patients with cyclic Cushing's syndrome defined by any measurement of UFC over the previous 1 months within normal range
Patients with pseudo-Cushing's syndrome, i.e. non-autonomous hypercortisolism due to overactivation of the HPA axis in uncontrolled depression, anxiety, obsessive compulsive disorder, morbid obesity, alcoholism, and uncontrolled diabetes mellitus
Patients who have undergone major surgery within 1 month prior to screening
Patients with serum K+< 3.5 while on replacement treatment
Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%

Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by

- Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry

Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 1.5 x ULN, serum total bilirubin more than ULN, serum albumin less than 0.67 x LLN at screening
Serum creatinine > 2 x ULN
Patients not biochemically euthyroid

Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as

History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
Presence of active or suspected acute or chronic uncontrolled infection
History of, or current alcohol misuse/abuse in the 12 month period prior to screening
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with seliciclib
Patients with any ongoing or likely to require additional concomitant medical treatment to seliciclib for the tumor
Patients with concomitant treatment of strong CYP3A4 inducers or inhibitors.
Patients who were receiving mitotane and/or long-acting somatostatin analogs (octreotide LAR or lanreotide)
Patients who were receiving pasireotide or ketoconazole before study entry must complete a 2 week washout period prior to receiving seliciclib
Patients who have received pituitary irradiation within the last 5 years prior to the baseline visit
Patients who have been treated with radionuclide at any time prior to study entry
Patients with known hypersensitivity to seliciclib
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Patients with presence of Hepatitis B surface antigen (HbsAg)
Patients with presence of Hepatitis C antibody test (anti-HCV)",• R-roscovitine 400 mg oral administration twice daily for 4 days every week for total of 4 weeks.,ChEMBL:CHEMBL14762 | DrugBank:DB06195 | PubChem:160355,Seliciclib,CC[C@H](CO)Nc1nc(NCc2ccccc2)c2ncn(C(C)C)c2n1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02162433,NCT02162433_EG002,No,All,Child,Phase 4,21,"Inclusion Criteria:

Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
ASA 1 & 2

Exclusion Criteria:

Known allergy or hypersensitivity reaction to dexmedetomidine
Organ dysfunction (renal/hepatic failure or leukemia)
Cardiac disease (congenital or acquired)
Airway or thoracic malformation
Cerebral palsy
Hypotonia
Need for premedication
Current/recent upper respiratory infection (within four weeks prior to the surgery)
Asthma
Allergy or intolerance to clonidine
Non-English speaking parents/patients.","Deep extubation receiving dexmedetomidine.

Dexmedetomidine: to arms 1,3",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02162979,NCT02162979_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
Presence of drug-induced dyskinesias
Age>40 years.
Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
History of stereotaxic brain surgery.
Clinical history of dementia.
Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
History of major hematological, renal, or hepatic abnormalities.
Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
History of stroke within the last 6 months.
Abnormal EKG consistent with cardiac ischemia.
Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.
History of priapism.
Known history of retinitis pigmentosa.
Positive pregnancy test.
History of bleeding disorder.
Patients with active peptic ulcer disease associated with bleeding.
Unwillingness to use adequate contraceptive methods if of childbearing potential.
Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
Use of Viagra or any experimental drugs within 30 days of screening visit.","subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02168439,NCT02168439_EG000,No,All,Child,Phase 4,20,"Inclusion Criteria:

Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Laceration <5 cm in total length
Require simple suture laceration repair

Exclusion Criteria:

Allergies/intolerance/contraindication to the study drugs
Lacerations requiring complex (multilayer) repair or total laceration length>5cm","Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02168803,NCT02168803_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,30,"Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery",130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02168803,NCT02168803_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,32,"Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery",130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02168803,NCT02168803_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,39,"Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery",130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.,ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02170064,NCT02170064_EG000,No,All,Child,Phase 2,12,"Inclusion Criteria:

The following inclusion criteria were applied in selecting patients for participation in the trial.

Patient was eligible for entry into the baseline phase if he/she fulfilled the following criteria at Visit 1:

Written informed consent given by the parent(s)/guardian(s), and by the patient when appropriate.
Male or female patient aged between 2 and 17 years.
Body weight within the 10th and 90th percentiles, by age and sex.
A documented diagnosis of partial-onset seizures (simple or complex seizures with or without secondary generalisation), classified according to the International Classification of Epileptic Seizures.
Currently treated with 1 to 3 AEDs (any except OXC or CBZ), in a stable dosage regimen during at least 1 month prior to screening.
Good general health (apart from epilepsy) based on medical history and physical examination.
In case of a female patient, she was premenarchal, surgically sterile or presented a urine pregnancy test consistent with a non-gravid state and practiced an effective non-hormonal contraception method.

At Visit 2, patient was eligible for entry into the Eslicarbazepine acetate treatment phase if he/she fulfilled the following criteria:

At least 4 partial-onset seizures during the last 4 weeks of the baseline phase.
Brain CT scan or MRI that excluded rapidly progressive neurological diseases.
ECG without clinically significant abnormalities.
Good general health (apart from epilepsy) based on medical history, physical examination and laboratory tests at screening.
Diaries satisfactorily completed by the patient or his/her caregiver during the baseline phase.
Satisfactory compliance with the study requirements during the baseline phase.
In case of a female patient of childbearing potential, she presented a urine pregnancy test consistent with a non-gravid state and practiced an effective non-hormonal contraception method.

Exclusion Criteria:

Patient was not allowed for entry into the screening phase if he/she fulfilled the following criteria at Visit 1:

Primarily generalised epilepsy.
Clinically relevant medical condition, other than epilepsy.
History of status epilepticus in the last 3 months.
History of suicide attempt.
History of alcohol or drug abuse.
History of hypersensitivity or intolerance to OXC or CBZ.
Use of any investigational drug or participated in any clinical trial within the previous 2 months.
Patient and/or his/her caregiver(s) unlikely to co-operate with the requirements of the study.
If female, she was sexually active and of child-bearing potential and she did not use reliable contraception.
Patients with non-epileptic attacks (syncopes, pseudoseizures).
Previous poor compliance with anti-epileptic therapy.
Need for rescue benzodiazepines more frequently than twice per week on average.
Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate.
Any other condition or circumstance that, in the opinion of the investigator, might compromise the patient's ability to comply with the clinical trial protocol (CTP).

At Visit 2, patient was not eligible for entry into the Eslicarbazepine acetate treatment phase if he/she fulfilled the following criteria:

Inadequate compliance to concomitant AEDs during the baseline phase.
Clinically relevant clinical laboratory test abnormalities at screening.
Occurrence of any other condition or circumstance that, in the opinion of the investigator, might compromise the patient's ability to comply with the CTP.",Safety population (SP),ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02170649,NCT02170649_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,12,"Inclusion Criteria:

Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:

Male subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
Subjects who were healthy as determined by pre study medical history, physical examination, neurological examination, EEG, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable to the investigator.
Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for alcohol and drugs of abuse at screening and admission.
Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria.
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 21 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening and/or admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had an acute infection such as influenza at the time of screening and/or admission.
Subjects who had used prescription drugs within four weeks of first dosing.
Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within two months of their first admission to this study.
Subjects who had previously received BIA 2-093.
Subjects who had donated and/or received any blood or blood products within the previous two months prior to screening.
Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.","2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02171130,NCT02171130_EG000,No,All,Adult | Older Adult,Phase 3,87,"Inclusion Criteria:

Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
With a history of type 1 diabetes >1 year
At least 18 years of age but not older than 75 years
Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
For female subjects, a urine pregnancy test must be negative.

Exclusion Criteria:

Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.",Nasal Glucagon powder (3mg),PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0
NCT02172755,NCT02172755_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,14,"Inclusion Criteria:

Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.
If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.
Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests acceptable to the Investigator.
Subjects who were negative for HBsAg, HCVAb and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for alcohol and drugs of abuse at screening.
Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.
(If female and with less than 40 years old) She had a negative pregnancy test at screening.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria.
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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.
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 and/or admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had used drugs within 2 weeks of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
Subjects who had previously received BIA 2-093.
Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
(If female) She was pregnant or breast-feeding
(If female) She was of childbearing potential and she did not use an authorised effective contraceptive method.","14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.

BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02172755,NCT02172755_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,16,"Inclusion Criteria:

Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.
If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.
Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests acceptable to the Investigator.
Subjects who were negative for HBsAg, HCVAb and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for alcohol and drugs of abuse at screening.
Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.
(If female and with less than 40 years old) She had a negative pregnancy test at screening.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria.
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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.
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 and/or admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had used drugs within 2 weeks of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
Subjects who had previously received BIA 2-093.
Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
(If female) She was pregnant or breast-feeding
(If female) She was of childbearing potential and she did not use an authorised effective contraceptive method.","16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.

BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02174523,NCT02174523_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,10,"Inclusion Criteria:

After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the informed consent form voluntarily.
Male subjects are 18≤ age <40 years of age when signing the informed consent.
Subjects with body weight of 50.0≤ and ≤80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.

Exclusion Criteria:

Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day -1) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
Subjects with past diabetic history.
Subjects has an HbA1c level of >6.2% at screening.
Subjects with history of gastrointestinal operations (excluding appendectomy).
Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
Subjects with past history of allergy to drugs.
Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day_-7) and before administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day_-14) and administration of study drug on the medication day (Day 1).
Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day_-7) and before administration of study drug on medication day.
Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
Subjects have history of drug abuse or positive urine drug tests.
Subjects with positive immunologic test results.
Average amount of daily smoking>20 cigarettes.
Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before medication.
Subjects received lurasidone orally before.
Subjects have history of blood donations of 400 mL within 3 months (Day_-90~Day 1) before medication; 200 mL within 1 month (Day_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day_-14~Day 1) before medication.
Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day_-3) and before administration of study drug on medication day.
Subjects can not tolerate venipuncture or have poor peripheral venous access.
Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.
Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.","Single oral administration of 40 mg study drug lurasidone after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone, once daily between Day 4 and Day 8.",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02178098,NCT02178098_EG001,No,All,Adult | Older Adult,Phase 2,71,"Inclusion Criteria:

Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
Fasting LDL-C between 100 and 220 mg/dL
Fasting triglycerides less than 400 mg/dL
Body mass index (BMI) between 18 and 45 kg/m2

Exclusion Criteria:

Known or suspected secondary hypertension or history of malignant hypertension
Taking more than two anti-hypertension medications at the first visit
History or current clinically significant cardiovascular disease
History or current type 1 diabetes or type 2 diabetes",Participants received oral bempedoic acid 180 milligrams (mg) daily for 6 weeks.,ChEMBL:CHEMBL3545313 | DrugBank:DB11936 | PubChem:10472693,BEMPEDOIC ACID,CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O,C10AX15 | C10BA10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02187809,NCT02187809_EG000,No,All,Child,Phase 3,3,"The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

Inclusion Criteria:

The patient has a diagnosis of Dravet Syndrome supported by:

onset of seizures in the first year of life

history of fever-induced prolonged seizures as determined by the Investigator

these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

multiple seizure types which may include:

generalised tonic-clonic (required for inclusion)
clonic (required for inclusion)
myoclonic jerks/seizures
history of normal development prior to seizure onset followed by development delay or regression after seizure onset
abnormal EEG consistent with Dravet Syndrome
The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months

Other protocol-defined inclusion and exclusion criteria may apply.","A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally

Clobazam",ChEMBL:CHEMBL70418 | DrugBank:DB00349 | PubChem:2789,Clobazam,CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21,N05BA09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02190279,NCT02190279_EG000,No,Male,Adult | Older Adult,Early Phase 1,16,"INCLUSION CRITERIA:
Subject is greater than or equal to18 years old
Platelet count > 50,000/mm^3
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

Categories

ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

ARM 2 only:

For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
OR
For patients status post prostatectomy, a PSA >/=0.2 ng/ml
Nonspecific or no evidence for disease on standard imaging modality

ARM 3 only:

Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

EXCLUSION CRITERIA:

Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Serum creatinine > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal","Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.",DrugBank:DB14772 | PubChem:25067411,DCFBC F-18,O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02190279,NCT02190279_EG001,No,Male,Adult | Older Adult,Early Phase 1,69,"INCLUSION CRITERIA:
Subject is greater than or equal to18 years old
Platelet count > 50,000/mm^3
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

Categories

ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

ARM 2 only:

For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
OR
For patients status post prostatectomy, a PSA >/=0.2 ng/ml
Nonspecific or no evidence for disease on standard imaging modality

ARM 3 only:

Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

EXCLUSION CRITERIA:

Subjects for whom participating would significantly delay the scheduled standard of care therapy
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Serum creatinine > 2 times the upper limit of normal
Total bilirubin > 2 times the upper limit of normal
Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal","Patients with biochemical prostate cancer relapse after definitive treatment

18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.",DrugBank:DB14772 | PubChem:25067411,DCFBC F-18,O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)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
NCT02193490,NCT02193490_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,25,"Inclusion Criteria:

Aged 18 years or older.
Capable of giving informed consent and does provide informed consent.
Documented Dry Eye Disease for at least 6 months.
Schirmer I <10
Corneal/ conjunctival (Rose Bengal) staining ≥1
Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild).
Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study.

Exclusion Criteria:

Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease eye drops 0.1%.
Receiving or have received within 30 days any experimental systemic medication.
Active ocular infection or ocular allergies.
Any history of eyelid surgery or ocular surgery within the past 3 months.
Corneal epithelial defect larger than 1 mm2 in either eye.
The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment
Have active drug/alcohol dependence or abuse history","DNase 0.1% eye drops four times a day for 8 weeks

DNase: DNase 0.1% eye drops four times a day for 8 weeks",ChEMBL:CHEMBL253582 | DrugBank:DB02772 | PubChem:5988,Sucrose,OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02201251,NCT02201251_EG001,No,All,Child,Phase 3,35,"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 levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day [mg/kg/day] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02202577,NCT02202577_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,932,"Inclusion Criteria:

cesarean delivery
age 18-65
ability to consent in English or Spanish

Exclusion Criteria:

inability or unwillingness to consent to study participation in English or Spanish
current incarceration
pre-operative diagnosis of chorioamnionitis
perceived inability to complete follow up for data collection
any prior known allergy or adverse reaction to either study preparation","Pre-operative skin preparation with Povidone-Iodine Scrub and Paint

Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02205983,NCT02205983_EG003,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 recieve Dextrose (placebo).

dextrose: We are administering dextrose to healthy volunteers for our placebo group.",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02206776,NCT02206776_EG001,No,All,Adult,Phase 2,1,"Inclusion Criteria:

Age 18-55
Physically healthy and not currently pregnant
Primary diagnosis of OCD
Sufficient severity of symptoms
For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
Able to provide consent

Exclusion Criteria:

First degree relative with schizophrenia
Psychiatric conditions that would make participation unsafe determined by study doctor
Female patients who are either pregnant or nursing
Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
Nasal obstruction or history of nasal surgery
Currently on psychotropic medication or other medication likely to interact with the glutamate system
Medical conditions that make participation unsafe
Allergy or intolerance to ketamine or midazolam","A single dose of intranasal ketamine up to 50 mg

Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg",PubChem:15851 | PubChem:44632368,Ketamine Hydrochloride,CNC1(c2ccccc2Cl)CCCCC1=O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02209545,NCT02209545_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 4,47,"Inclusion Criteria:

Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
Age ≥ 18 years and ≤ 50 years
Pre-operative hemoglobin >8 g/dl
Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
Ability to understand and the willingness to sign a written informed consent.
Admissible medical/surgical history
Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
Intraoperative use of vasopressin and uterine tourniquet is permissible
Can have had prior Cesarean delivery

Exclusion Criteria:

Patients who have had a prior abdominal myomectomy
Post-menopausal women
Patients with known bleeding/clotting disorders
Patients with a history of gynecologic malignancy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
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.","25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.

Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02213133,NCT02213133_EG001,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

18 years of age or older
confirmed SCC of the head and neck, lung, or esophagus
1 to 2 prior therapies
measurable disease at screening and documented progression within the past 6 weeks

Exclusion Criteria:

patients requiring total parenteral nutrition
unstable cardiovascular function
substantially impaired gastrointestinal function
Symptomatic brain metastases
another malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer","Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets <100*10^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.",ChEMBL:CHEMBL3545185 | DrugBank:DB11942 | PubChem:71481097,Selinexor,O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1,L01XX66,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02222168,NCT02222168_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,18,"Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)","Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02222168,NCT02222168_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,18,"Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)","Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,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
NCT02222168,NCT02222168_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,18,"Inclusion criteria:

Healthy male and female volunteers
Age 18 (incl.) to 50 (incl.) years
Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

Any evidence of a clinically relevant concomitant disease
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
Positive pregnancy test
No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)","Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02223338,NCT02223338_EG001,No,All,Adult | Older Adult,Not Applicable,120,"Inclusion Criteria:

Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given in either Dr. Fan's clinic using povidone-iodine and post-injection topical ciprofloxacin 0.3% 4x daily for 3 days, or in Dr. Rauser's clinic where povidone-iodine only is applied to the injection site and conjunctival fornix but no post-injection antibiotics are given.

Exclusion Criteria:

Administration of anti-VEGF agents outside of Dr. Fan's or Dr. Rauser's clinics
Intraocular surgery
Use of topical antibiotics other than ciprofloxacin 0.3%
Infections of the eye or ocular adnexa within the last 3 months
Use of oral antibiotics within the last 30 days
Contact lens wear.","Standard Aseptic Technique:

Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given with povidone-iodine only applied to the injection site and conjunctival fornix prior to injection, but no post-injection antibiotics were given. On the visit of their next injection, a conjunctival swab will be taken in the inferior fornix prior to instillation of any ophthalmic drops.

Standard Aseptic Technique: Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02228525,NCT02228525_EG000,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Written informed consent in accordance with federal, local, and institutional guidelines
Age ≥18 years
Patients with Myelodysplastic Syndromes refractory (primary or acquired resistance) to hypomethylating agents(decitabine or 5-azacytidine). At least 4 1- month cycles of prior decitabine or SGI-110 OR 6 1-month cycles of 5-azacytidine (IV, subcutaneous, or oral is required unless the patient has progressive disease prior to completing the required number of cycles.
Histologically confirmed diagnosis of a Myelodysplastic Syndrome, meeting criteria for any subtype in the FAB or WHO classification systems with any IPSS score.
Patients with MDS who relapse after allogeneic stem cell transplant are eligible if they received standard dose decitabine or 5-azacytidine prior to or after stem cell transplant as defined in inclusion criteria 3.
If patient has undergone prior allogeneic stem cell transplant, they must be greater than 100 days post transplant and have ≤ grade 2 graft-versus-host disease
There is no upper limit on the number of prior treatments provided all inclusion/exclusion criteria are met.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Patients receiving erythropoietin (darbepoetin, epoetin alfa) must be on a stable dose and with stable transfusion requirement or hemoglobin level during the 8 weeks prior to study entry.
Adequate hepatic function within 21 days prior to C1D1: total bilirubin <2 times the upper limit of normal (ULN), asparate aminotransferase (AST) <2.5 times ULN and alanine aminotransferase (ALT) <2.5 times ULN.
Adequate renal function within 21 days prior to C1D1: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault.
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.

Exclusion Criteria:

Patients who are pregnant or lactating;
Chemotherapy or immunotherapy or any other anticancer therapy ≤3 weeks prior to cycle 1 day 1. Hydroxyurea may be continued until 72 hours prior to first dose and at least 24 hours before the baseline bone marrow aspiration is performed;
Major surgery within four weeks before Day 1;
Unstable cardiovascular function defined as symptomatic ischemia, uncontrolled clinically significant conduction abnormalities (ie: ventricular tachycardia on antiarrhythmics are excluded and 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), congestive heart failure (CHF) of NYHA Class ≥3, or myocardial infarction (MI) within 3 months;
Uncontrolled active infection requiring systemic antibiotics, antivirals, or antifungals within one week prior to first dose; Prophylactic antimicrobials are permitted.
Known to be HIV seropositive;
Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
Patients with another active malignancy. Asymptomatic sites of disease are not considered active. Treated or untreated sites of disease may be considered inactive if they are stable for at least 2 months and are not expected to require therapy for 4 months.
Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
Grade ≥2 peripheral neuropathy at baseline (within 21 days prior to cycle 1 day 1).
History of seizures, movement disorders or cerebrovascular accident within the past 1 years prior to cycle 1 day 1.
Patients with macular degeneration with markedly decreased visual acuity, patients with markedly decreased visual acuity (no specific etiology) or uncontrolled glaucoma.
Patients who are significantly below their ideal body weight (BMI < 17)..
Serious psychiatric or medical conditions that could interfere with treatment.","Patients with myelodysplastic syndromes who are refractory to hypomethylating agents (decitabine or 5-azacytidine) will receive oral selinexor at a starting dose of 60 mg twice weekly for 2 weeks, followed by 1 week of no therapy. Dose reductions are permitted for patients who are benefiting from selinexor but have poor tolerance. After discontinuation from treatment, patients will be followed by the study staff for survival status approximately every three months.

selinexor (KPT-330)",ChEMBL:CHEMBL3545185 | DrugBank:DB11942 | PubChem:71481097,Selinexor,O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1,L01XX66,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02230670,NCT02230670_EG000,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
Clinical, radiological, or biochemical evidence of liver cirrhosis
Model for End-Stage Liver Disease (MELD) Score of 11 to 18 during the Screening period
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug.

Exclusion Criteria:

Known infection with human immunodeficiency virus (HIV)
Auto-immune hepatitis
Subjects with evidence of uncontrolled infection, defined as persistent bacterial culture positivity despite adequate antibiotic therapy
HCV infected subjects who are receiving or plan to receive anti-viral therapy during the study
Untreated esophageal varices with high risk stigmata for hemorrhage
Variceal hemorrhage within 3 months of Screening
Ascites not adequately controlled on stable background medication
Other non-liver organ failure
Child-Pugh score of 10-15 (Child-Pugh C classification)
Use of vasoactive drugs (at or within 3 months of Screening) that may impair hepatic blood flow

Change in dose or regimen within 3 months of Screening of:

Fibrates or statins
Angiotensin II receptor antagonist or angiotensin converting enzyme (ACE) inhibitor
Use of chronic anticoagulation therapy including but not limited to Vitamin K/Factor Xa antagonists/inhibitors

Use of the following drugs within 2 months of Screening:

Systemic corticosteroids
Known or suspected use of illicit drugs or drugs of abuse (allowed if medically prescribed or indicated)
Concomitant pancreatitis
Active inflammatory bowel disease
Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years",25 mg BID of IDN-6556 (Baseline-Month 3).,ChEMBL:CHEMBL197672 | DrugBank:DB05408 | PubChem:12000240,Emricasan,C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02238483,NCT02238483_EG000,No,All,Adult | Older Adult,Phase 2,108,"Inclusion Criteria:

Provision of signed and dated written informed consent prior to any study specific procedures.
Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically sterile or agree to use an acceptable method of contraception for the duration of the study and for 3 months after the last dose of investigational product to prevent pregnancy in a partner.
A weight of ≥50 kg.
Diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment to be continued unchanged during the study.
A post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value. Documented history of 2 or more moderate to severe COPD exacerbations within 12 months of randomisation, but not within the last 6 weeks before randomisation.
Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion Criteria:

Involvement in the planning and conduct of the study.
Previous randomisation in the present study.
Participation in another clinical study with any investigational medicinal product within 3 months of randomisation. Previously intake of any p38 inhibitor.
Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study.
Planned in-patient surgery or hospitalisation during the study.
Significant disease or disorder other than COPD which, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines.
A clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis.
Plasma myoglobin and CK above the upper reference range of the analysing laboratory at randomization.
A clinically relevant abnormal findings in physical examination, pulse or blood pressure.
A positive result on screening for serum hepatitis B hepatitis C and Human Immunodeficiency Virus (HIV).
History or family history of muscle diseases. Abnormal vital signs, defined as Systolic Blood Pressure (SBP) above 140 mmHg if <60 years of age and above 150 mmHg if ≥60 years of age; Diastolic Blood Pressure (DBP) above 90 mmHg; Pulse <50 or >100 bpm.
Prolonged QTcF >450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval of clinical significance, PR(PQ) > 250 ms.
Intermittent AV block of 2nd and 3rd degree or AV dissociation.
Patients with a QRS duration >120 ms.
Patients with persistent, and/or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker.
Patients with recent Cardiovascular (CV) events or unstable CV disease or a myocardial infarction or stroke within 6 months of screening. History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624.
Any exacerbation or respiratory infection within 6 weeks of randomization.
Plasma donation within one month of Visit 1, or any blood donation/blood loss >500 mL during the 3 months prior to Visit 1.
History of, or current alcohol or drug abuse.
Treatment with any GCS (apart from prescribed steroids at run-in) within 6 weeks of Visit 3 regardless of indication.
Treatment with strong CYP3A inhibitors within 4 weeks prior to randomisation.",Active treatment 2 x 0.5mg inhalation qd,PubChem:25143624,N-Cyclopropyl-3-fluoro-4-methyl-5-(3-((1-(2-(2-(methylamino)ethoxy)phenyl)cyclopropyl)amino)-2-oxopyrazin-1(2H)-yl)benzamide,CNCCOc1ccccc1C1(Nc2nccn(-c3cc(C(=O)NC4CC4)cc(F)c3C)c2=O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02241720,NCT02241720_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Histological diagnosis of metastatic or locally advanced inoperable adenocarcinoma of the esophagus, gastroesophageal junction or stomach.
Patients must show signs of progression during or less than 4 months after being treated with a first line therapy for their metastatic or locally advanced inoperable cancer.
Patients must have measureable disease at screening by Response Evaluation Criteria for Solid Tumors 1.1 criteria
Age greater than or equal to 18 years.
Eastern Cooperative Oncology Group Performance Status 0-1
Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 1 or less at the time of signing the Informed Consent Form. Alopecia (any grade) and peripheral neuropathy less than grade 2 is allowed.
Adequate bone marrow, liver and liver function as assessed by laboratory requirement
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 3 months after the last dose of study drug. Highly effective contraception must be used (male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) by both sexes.
Subject must be able to swallow and retain oral medication.

Exclusion Criteria:

Prior use of regorafenib
Uncontrolled hypertension (systolic pressure greater than 140 mm Hg or diastolic pressure greater than 90 mm Hg National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 on repeated measurement) despite optimal medical management.
Active or clinically significant cardiac disease including:
Congestive heart failure - New York Heart Association greater than Class 2.
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers.
Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
Evidence or history of bleeding diathesis or coagulopathy.
Any hemorrhage or bleeding event greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events Grade 3 within 4 weeks prior to start of study medication.
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to start of study treatment.
Patients with severe hepatic impairment (Child-Pugh Class C)
Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Patients requiring intravenous antiviral or intravenous antibiotic treatment for ongoing infections
Symptomatic metastatic brain or meningeal tumors.
Presence of a non-healing wound, non-healing skin ulcer, or bone fracture.
Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade 3.
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Pleural effusion or ascites that causes respiratory compromise (greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 2 dyspnea). Patients may undergo thoracentesis and paracentesis to improve symptoms prior to enrollment.
History of organ allograft (including corneal transplant).
Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results.
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 28 days of starting study treatment. Palliative radiation is allowed.
Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment.
Concurrent use of strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)
Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks before start of study medication.",regorafenib,ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02246530,NCT02246530_EG001,No,All,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

subjects between ages 19 to 75, both male and female
radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
Failed a trial of physical therapy of at least 4 weeks

Exclusion Criteria:

Full thickness tears (well documented need for surgical correction)
sensory or neurologic complaint affecting the shoulder of interest
Coagulation disorder, platelet disorder
Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
Prior surgery to either cervical spine or shoulder
Active military
Injury part of worker compensation claim","Current standard of care for treatment of resistant partial thickness rotator cuff tears

Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound",ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02250703,NCT02250703_EG001,No,All,Child | Adult,Phase 3,75,"Inclusion Criteria:

Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms.
ASA classification 1 or 2

Exclusion Criteria

Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol.
uncorrected congenital heart disease or history of cardiac arrhythmia,
children at risk for airway obstruction (OSA or cranio facial syndrome),
pregnant minors","In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).

Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02259517,NCT02259517_EG000,Accepts Healthy Volunteers,All,Child,Not Applicable,38,"Inclusion Criteria:

ADHD Participants:

The participant satisfies Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of ADHD, any subtype.

Healthy Control Participants:

The participant must have no current DSM Axis I psychiatric disorder.

All Participants:

Participants must provide assent and a legal guardian must provide consent.
The participant is male or female and between 6 - 17 years of age and in good physical health.
Girls of childbearing potential must have a negative urine pregnancy test and, if sexually active, must be using adequate contraception.
The participant is English speaking.

Exclusion Criteria:

ADHD Participants:

The participant has a current comorbid DSM Axis I psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the study doctor, will contraindicate lisdexamfetamine or guanfacine treatment or confound safety assessments.
The participant meets DSM-5 criteria for current substance abuse and/or dependence.
The participant is currently taking or has taken within the past 4 months, a psychotropic medication.
The participant has a documented allergy or intolerance to lisdexamfetamine or guanfacine products.
The participant has a diagnosis or a history of cardiovascular disease or any other serious medical illness.
The participant is pregnant or lactating.
The participant is actively suicidal.
MRI contraindications (e.g., irremovable metal on the body, pacemaker, braces)
The participant has a full-scale intelligence quotient (IQ) less than 70.
The participant has a history of seizure (except febrile seizure).

Healthy Controls:

The participant meets DSM criteria for current substance abuse and/or dependence.
The participant is currently taking a psychotropic medication.
The participant has a history of a serious medical illness.
The participant is pregnant or lactating.
MRI contraindications (e.g., irremovable metal on the body, pacemaker, braces)
The participant has a full-scale intelligence quotient (IQ) less than 70.
The participant has a history of seizure (except febrile seizure).","Participants will be administered extended-release guanfacine, which is in tablet form, and will be instructed to take the medication once daily for 6 weeks. The daily dose will range between 1 and 4 mg.

Guanfacine: Participants will meet with the study doctor on a weekly basis during the treatment phase of the study. In the first few weeks, the daily dose of the medication will be individually adjusted by the study doctor according to participants' clinical response to and tolerability of the medication. The optimal dose will then be maintained for the remainder of the treatment period.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02273388,NCT02273388_EG000,No,All,Adult | Older Adult,Phase 1,4,"Inclusion criteria:

Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
Age 18 years or older
Written informed consent consistent with ICH-GCP and local legislation
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2

Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

The 18 additional patients recruited at the MTD must also meet the following criterion:

Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

Exclusion criteria:

Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
Pregnancy or breastfeeding
Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
Clinical evidence of active brain or leptomeningeal disease during the past 12 months
Second malignancy currently requiring active therapy
Absolute neutrophil count less than 1500 / mm3
Platelet count less than 100 000 / mm3
Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent)
Known history of relevant QT-prolongation, e.g. long QT-syndrome
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
Patients unable to comply with the protocol
Active alcohol or drug abuse",12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).,ChEMBL:CHEMBL1233528 | DrugBank:DB12062 | PubChem:10461508,Volasertib,CC[C@@H]1C(=O)N(C)c2cnc(Nc3ccc(C(=O)N[C@H]4CC[C@H](N5CCN(CC6CC6)CC5)CC4)cc3OC)nc2N1C(C)C,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02273388,NCT02273388_EG001,No,All,Adult | Older Adult,Phase 1,3,"Inclusion criteria:

Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
Age 18 years or older
Written informed consent consistent with ICH-GCP and local legislation
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2

Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

The 18 additional patients recruited at the MTD must also meet the following criterion:

Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

Exclusion criteria:

Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
Pregnancy or breastfeeding
Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
Clinical evidence of active brain or leptomeningeal disease during the past 12 months
Second malignancy currently requiring active therapy
Absolute neutrophil count less than 1500 / mm3
Platelet count less than 100 000 / mm3
Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent)
Known history of relevant QT-prolongation, e.g. long QT-syndrome
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
Patients unable to comply with the protocol
Active alcohol or drug abuse",24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).,ChEMBL:CHEMBL1233528 | DrugBank:DB12062 | PubChem:10461508,Volasertib,CC[C@@H]1C(=O)N(C)c2cnc(Nc3ccc(C(=O)N[C@H]4CC[C@H](N5CCN(CC6CC6)CC5)CC4)cc3OC)nc2N1C(C)C,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02273388,NCT02273388_EG003,No,All,Adult | Older Adult,Phase 1,2,"Inclusion criteria:

Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
Age 18 years or older
Written informed consent consistent with ICH-GCP and local legislation
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2

Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

The 18 additional patients recruited at the MTD must also meet the following criterion:

Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

Exclusion criteria:

Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
Pregnancy or breastfeeding
Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
Clinical evidence of active brain or leptomeningeal disease during the past 12 months
Second malignancy currently requiring active therapy
Absolute neutrophil count less than 1500 / mm3
Platelet count less than 100 000 / mm3
Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent)
Known history of relevant QT-prolongation, e.g. long QT-syndrome
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
Patients unable to comply with the protocol
Active alcohol or drug abuse",75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).,ChEMBL:CHEMBL1233528 | DrugBank:DB12062 | PubChem:10461508,Volasertib,CC[C@@H]1C(=O)N(C)c2cnc(Nc3ccc(C(=O)N[C@H]4CC[C@H](N5CCN(CC6CC6)CC5)CC4)cc3OC)nc2N1C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02280252,NCT02280252_EG000,No,Female,Adult | Older Adult,Phase 2,69,"Inclusion Criteria:

Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
Measureable disease required
Adequate laboratory values:

Hgb > 10 ANC > 1500 Platelets > 150,000 Creatinine < 1.5 Liver function < 3x normal

Patient ≥ 18 years of age
Medically and psychologically able to comply with all study requirements
ECOG performance score 0-1
CT chest, abdomen, and pelvis performed
Mammogram or USG performed
Signed informed consent

Exclusion Criteria:

Breast cancer patients with Stage 0, Stage I, or Stage IIA
Previous XRT or chemotherapy
Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
Pregnancy
Inflammatory breast cancer
Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites)","Patients will be administered pre-operatively over 12 weeks either:

Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule
Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule

Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:

Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)

Paclitaxel: Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.

Radiation therapy: Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02281422,NCT02281422_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age, with body mass not less than 50 kg.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

The receipt of any investigational drug within 30 days prior to this study.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.","normal renal function (creatinine clearance > 80 mL/min)

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02281422,NCT02281422_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age, with body mass not less than 50 kg.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

The receipt of any investigational drug within 30 days prior to this study.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.","mild renal impairment (creatinine clearance 50-80 mL/min)

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02281422,NCT02281422_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age, with body mass not less than 50 kg.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

The receipt of any investigational drug within 30 days prior to this study.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.","moderate renal impairment (creatinine clearance 30-50 mL/min)

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02281422,NCT02281422_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age, with body mass not less than 50 kg.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

The receipt of any investigational drug within 30 days prior to this study.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.","severe renal impairment (creatinine clearance <30 mL/min)

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02281422,NCT02281422_EG004,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age, with body mass not less than 50 kg.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

The receipt of any investigational drug within 30 days prior to this study.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.","end stage renal disease, requiring haemodialysis (ESRD)

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02281526,NCT02281526_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Males and females at least 18 years of age.
Female subjects had to be post-menopausal, surgically sterilized or using a reliable non-hormonal method of contraception. Examples of reliable non-hormonal methods of contraception include tubal ligation, hysterectomy, intrauterine device, or a barrier method combined with a spermicide. Hormonal contraceptives were not allowed because the effect of BIA 2-093 on the metabolism of oral contraceptives was not yet known.
Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as not able to influence the outcome of the study.
For subjects to be included in Group 1, a stage of moderate hepatic impairment, the extent of which, as measured by the Child-Pugh classification, resulted in recruitment into the study (Group 1 only). This did not apply to subjects that were recruited into Group 2, whose liver functioning was to be normal.
Body mass not less than 50 kg.

Exclusion Criteria:

The receipt of any investigational drug within the 30 days prior to this trial.
Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in hepatic impairment: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
A history or laboratory evidence of renal impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of renal impairment would have had a confounding effect on the PK analysis.
Positive test for Human Immunodeficiency Virus (HIV)-1 or HIV-2 antibodies, Hepatitis B surface antigen and Hepatitis C antibodies. HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would be further worsened by the fact that the patients are hepatically impaired, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the subjects, which might be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would confound the safety and tolerability analysis. In addition, by administering the study medication to these patients, any AEs that might have occurred would add to the discomfort of the patient.
A history of any illness that, in the opinion of the investigator and/or sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject.
Any planned procedures and/or devices to be performed/added during the course of the study, which might influence the evaluation of the endpoints of the study.
Current addiction to alcohol as determined by the investigator.
Use of any medication, prescribed or over-the-counter, except drugs indicated for the treatment of concomitant illnesses in subjects with moderate hepatic impairment, or if the drugs would not have affected the outcome of the study in the opinion of the investigator. Vitamin use was allowed, but should have been stable during the course of the study.
Current treatment with oxcarbazepine.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Subjects with a supine pulse rate at screening, after resting for 5 min, outside the range of 50 - 100 beats per minute (bpm).
A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
Known or suspected allergy to trial product or related products (e.g carbamazepine or oxcarbazepine).
Female subjects who were pregnant or lactating.
Previous participation in (recruitment into) this trial.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before dose administration.
Any history of a bleeding tendency, or an active bleed in the preceding 3 months.","This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,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
NCT02287675,NCT02287675_EG001,No,Female,Adult | Older Adult,Phase 4,22,"Inclusion Criteria:

The subject must be female and 18 years of age or older.
The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer
The subject must have a diagnosis of primary breast cancer.
The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.
The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2
The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study

Exclusion Criteria:

The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.
The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.
The subject has a positive pregnancy test or is lactating.
The subject has had prior surgery to the indicated breast or axilla.","Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:

In adults, to assist in the:

localization of lymph nodes draining a primary tumor in patients with
breast cancer or malignant melanoma when used with a hand-held gamma counter.
evaluation of peritoneovenous (LeVeen) shunt patency in adults.",ChEMBL:CHEMBL1235452 | DrugBank:DB09353 | PubChem:5362487,SULFUR,S1SSSSSSS1,D10AB02 | D11AC08,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02288312,NCT02288312_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,18,"Inclusion Criteria:

Male or female subjects aged between 18 and 55 years, inclusive.
Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
Subjects who had a negative screen for alcohol and drugs of abuse at screening.
Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
Subjects who were able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
(If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

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 drug hypersensitivity.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans or have medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
(If female) She was pregnant or breast-feeding.
(If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.","Tablets 800 mg. Administration:Oral.

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT02288312,NCT02288312_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,17,"Inclusion Criteria:

Male or female subjects aged between 18 and 55 years, inclusive.
Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
Subjects who had a negative screen for alcohol and drugs of abuse at screening.
Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
Subjects who were able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
(If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

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 drug hypersensitivity.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans or have medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
(If female) She was pregnant or breast-feeding.
(If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.","Tablets 800 mg. Administration:Oral.

BIA 2-093",ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02289833,NCT02289833_EG000,No,All,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Histologically or cytologically documented diagnosis of Stage IIIB not amenable to radical treatment or Stage IV NSCLC (pathological characterization must determine the non-squamous or squamous histological subtype as well as adenocarcinoma subtype classification)
HER2 status of IHC 2+ or 3+ as determined by a Sponsor-designated central laboratory
Prior treatment with at least one regimen of platinum-based (cisplatin or carboplatin) chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment
Participants with a known anaplastic lymphoma kinase (ALK) fusion oncogene (must be documented in the participant's chart) must have also experienced disease progression or intolerance with a first-line ALK Tyrosine Kinase Inhibitor (TKI) approved for the treatment of ALK fusion oncogene NSCLC (for example, crizotinib). Disease progression or intolerance must be documented
Participants with a known mutation in the epidermal growth factor receptor (EGFR) gene (must be documented in the participant's chart) must have also experienced disease progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant NSCLC (for example, gefitinib, erlotinib, afatinib). Disease progression or intolerance must be documented
Measurable disease determined as per the RECIST v1.1
Life expectancy of at least (>/=) 12 weeks
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Left ventricular ejection fraction (LVEF) >/= 50 percent (%) by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan
Use of highly effective contraception

Exclusion Criteria:

Cancer-Related Criteria:

Any approved anti-cancer therapy less than or equal to (</=) 21 days (including chemotherapy or hormonal therapy) before the first study treatment; the following exceptions are allowed: (1) TKIs approved for the treatment of NSCLC must be discontinued greater than (>) 7 days prior to the first study treatment on D1C1 (The baseline computed tomography [CT] scan must be completed after discontinuation of TKIs); (2) Hormone-replacement therapy or oral contraceptives; (3) Anti-emetics, Granulocyte-colony stimulating factor (GCS-F), and prophylactic antibiotics according to local standards
Investigational therapy participation in another clinical study with therapeutic intent </= 21 days before first study treatment
Previous irradiation is permitted if >/=14 days since the last fraction of radiotherapy have elapsed before the first study treatment on Day 1 as long as a sufficient number of target lesions remain to allow for measurable disease as per RECIST v1.1
Participants who have untreated brain metastases or are symptomatic; participants with treated brain metastases must have discontinued corticosteroid therapy and not have any neurological symptoms
History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any excipient of the product
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 milligram per meter-square (mg/m^2); Epirubicin > 900 mg/m^2; Mitoxantrone > 120 mg/m^2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m^2 doxorubicin
Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v. 4.0)
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above

Cardiopulmonary Function Criteria:

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
Clinical history of active hemoptysis
Evidence of active pneumonitis during screening
Current unstable ventricular arrhythmia requiring treatment
History of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) classes II-IV
History of myocardial infarction or unstable angina within 6 months of enrollment
History of a decrease in LVEF to <50%

General Criteria:

Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
Current pregnancy or lactation
Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)","Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.",PubChem:166596981 | PubChem:168318470,Kadcyla,COc1cc2cc(c1Cl)N(C)C(=O)CC(OC(=O)C(C)N(C)C(=O)CCSC1CC(=O)N(CC3CCC(C(N)=O)CC3)C1=O)C1(C)OC1C(C)C1CC(O)(NC(=O)O1)C(OC)C=CC=C(C)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02299050,NCT02299050_EG000,No,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

Type 2 diabetes male or female subjects between the ages of 30 and 70 years of age, inclusive, at Screening
BMI = 24-40 kg/m2
HbA1c = 7.5-10.0%
Stable body weight (±3-4lbs) over the preceding 3 months
Subjects currently receiving a stable dose of exenatide (2mg/week) or liraglutide (1.2-1.8 mg/day) for at least 90 days prior to determination of baseline HbA1C and eligibility for enrollment in the study protocol.
Subjects with a daytime feeding/night time sleeping schedule
Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
Women must be of non-childbearing potential as defined by one of the following:
Women >45 and < 60 years of age at Screening, who have been amenorrheic for at least 2 years
Women who have had a documented hysterectomy and/or bilateral oophorectomy
Women > 60 years of age
Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): Oral contraceptive, Injectable progesterone, subdermal implant, spermicidal foam/gel/film/cream/suppository, diaphragm with spermicide, copper or hormonal containing IUD (intrauterine device), sterile male partner vasectomized > 6 month pre-dosing
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

Exclusion Criteria:

Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
No history of T2DM
BMI of less 24 and greater 40 kg/m2
Unstable body weight (change of greater than ±3-4lbs over the preceding 3 months
Subjects not currently receiving exenatide or liraglutide
Subjects participating in an excessively heavy exercise program
Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neuro synaptic function are excluded.
Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
Pregnant subjects or subjects unwilling to use birth control during their study enrollment
Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening 12. Subjects that are allergic to bromocriptine or any of the other ingredients in Cycloset, or take ergot medicines, breastfeeding or have history of syncope or Type 1 diabetes mellitus
Other severe acute or chronic medical or psychiatric condition 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 that, in the judgment of the investigator, would make the subject inappropriate for entry into this study subjects of reproductive potential","Drug - Cycloset Cycloset 2.4 -3.2 mg/day

Other Names:

Bromocriptine Mesylate Quick Release

Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR",PubChem:31100,Bromocriptine Mesylate,CC(C)CC1C(=O)N2CCCC2C2(O)OC(NC(=O)C3C=C4c5cccc6[nH]c(Br)c(c56)CC4N(C)C3)(C(C)C)C(=O)N12.CS(=O)(=O)O,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02300077,NCT02300077_EG000,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","Control (Intra-operative administration of opioids, other than methadone)

Control (Intra-operative administration of opioids, other than methadone): Intra-operative administration of opioids, other than methadone",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02303405,NCT02303405_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Male or female, age 18-75, inclusive
Known type 2 diabetes (diagnosed according to 1997 ADA diagnostic criteria)
At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea
Hemoglobin A1c ≥ 7.5% and < 11.0%
Body mass index (BMI) < 45 kg/m2
Able to comply with all scheduled visits and requirements of the protocol

Exclusion Criteria:

Any contraindications to the use of metformin or a sulfonylurea
Extreme hyperglycemia (FPG ≥ 300 mg/dL), symptoms of polyuria or polydipsia, or Hemoglobin A1c ≥ 11.0%
Current use of insulin; history or clinical suspicion of type 1 diabetes mellitus
Symptomatic hypoglycemia occurring at an average frequency > once per day
Highly erratic dietary schedules, extremely food insecure households, or homelessness that may adversely affect good glycemic control, as judged by the investigators
Occupations that involve regular operation of motor vehicles or other heavy machinery that may pose a hazard in the event of unanticipated blurred vision
Known history of Class III or IV heart failure, cardiac arrhythmias, severe peripheral edema, advanced osteoporosis, documented bladder malignancies, or other intolerance to pioglitazone
Known history of collagen vascular disorders, glucose-6-phosphate dehydrogenase deficiency, hematologic disorders, psoriasis, or any known intolerance to hydroxychloroquine
Known history of pre-proliferative or proliferative retinopathy, or any clinically significant retinal abnormalities noted on the patient's most recent (i.e., within 1 year) ophthalmologic exam; subjects who have not received their routine annual ophthalmologic surveillance for diabetic retinopathy within the past year must have their annual surveillance performed before screening
An estimated GFR (by the Modification of Diet in Renal Disease (MDRD) formula) < 45 mL/min, or a history of nephrotic syndrome (defined as a spot urine protein-creatinine ratio of > 3500 mg per g urine creatinine)
Subjects with active hemoglobin abnormalities that render the Hemoglobin A1c measurement unreliable
History of any clinically significant hepatic, cardiovascular, infectious, dermatologic, psychiatric, or other major systemic disease that, in the opinion of the investigator, may make the use of pioglitazone or hydroxychloroquine unsafe, or otherwise make the interpretation of the data difficult.
Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception or do not agree to use a reliable form of contraception. Reliable forms of contraception include systemic contraceptives (oral, implant or injection), diaphragm with spermicide, cervical cap, IUD, or condoms with spermicide.
Current pregnancy or lactation.
Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study (e.g., glucocorticoids).
Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.","Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months

Hydroxychloroquine: Anti-inflammatory and anti-malarial agent",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02304432,NCT02304432_EG000,No,All,Adult,Early Phase 1,2,"Inclusion Criteria:

Carriers of a triplication in the glycine decarboxylase gene

Exclusion Criteria:

Not carriers of a triplication in the glycine decarboxylase gene","Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02304432,NCT02304432_EG003,No,All,Adult,Early Phase 1,2,"Inclusion Criteria:

Carriers of a triplication in the glycine decarboxylase gene

Exclusion Criteria:

Not carriers of a triplication in the glycine decarboxylase gene","Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.

D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02304705,NCT02304705_EG001,No,All,Adult | Older Adult,Phase 4,33,"Inclusion Criteria:

Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated
indication for right heart catheterization
pulmonary artery mean pressure >25 mmHg
pulmonary capillary wedge pressure > 15 mmHg
pulmonary vascular resistance > 3 Wood units

Exclusion Criteria:

hypersensitivity, allergy, or intolerable side effect to sildenafil
history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

co-morbidities, limited exercise intolerance:

morbid obesity (BMI >40)
COPD with oxygen dependence
severe peripheral vascular disease with intermittent claudication
status post amputation of lower extremity at any level
severe degenerative joint disease preventing normal walking","Sildenafil 20 mg three times per day, orally

Sildenafil: 20 mg TID PO for 90 days",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02314728,NCT02314728_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Not Applicable,230,"Inclusion Criteria:

All pregnant women diagnosed with PROM without evidence of labor requiring induction
Gestational Age > 34 weeks
Bishop score < 6
Category I Fetal heart rate tracing

Exclusion Criteria:

Contraindication to Induction of Labor
Multiple gestation
Fetal Anomalies
Previous C-Section
HIV Positive Patients","Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.

Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider.",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02316340,NCT02316340_EG001,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Histological documentation of metastatic colorectal cancer (mCRC)
ECOG performance status of 0-2
Radiographical documentation of metastatic disease with imaging up to 6 weeks prior to enrollment
Patients with mCRC must have been previously treated with irinotecan and/or oxaliplatin and/or VEGF/EGFR therapy or intolerant to these agents
Documentation of K-Ras mutational status
Adequate hematologic, renal and liver function (i.e. absolute neutrophil count > 1000/mm3, platelets > 75,000/mm3); creatinine < 2 times the upper limits of normal (ULN) total bilirubin < 1.5 mg/dl, ALT and AST< 3 times above the ULN, ALT and AST can be < 5 times ULN if patients have hepatic involvement.
Able to provide written informed consent
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the investigational product
Tumor blocks available from previous surgery/biopsy, or if not available, patients willing to have biopsy

Exclusion Criteria:

Patients receiving prior therapy with RGF, VOR, and/or HCQ
Patients with uncontrolled brain metastases. Patients with brain metastases must be asymptomatic and off corticosteroids for at least one week
Due to risk of disease exacerbation, patients with porphyria are not eligible
Due to risk of disease exacerbation, patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
Patients with previously documented macular degeneration or diabetic retinopathy
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. For targeted therapies, patients will need to clear for 5 half-lives
Patients may not be receiving any other investigational agents
Patients should not have taken valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to enrollment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to VOR or HCQ
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
Major surgery or significant traumatic injury occurring within 21 days prior to treatment
QTc > 500 ms at baseline (average of 3 determinations at 10 minutes interval)
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. Patients with NG-tube, J-tube, or G-tube will not be allowed to participate
Pregnant women are excluded from this study because vorinostat has the potential for teratogenic or abortifacient effects. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued
Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document will be excluded from study entry",All study participants that enrolled and were randomized to the study control,ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02321111,NCT02321111_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2)
normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Presence of diabetes or impaired glucose tolerance based on ADA criteria;
Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.","IV administration of 5% Dextrose in water/D5W (vehicle) 12 mg every 12 hours plus Saline infusion at a rate of 30 mL/hour

D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle",ChEMBL:CHEMBL1279 | DrugBank:DB00998 | PubChem:77992,Frovatriptan,CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1,N02CC07,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02321111,NCT02321111_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2)
normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Presence of diabetes or impaired glucose tolerance based on ADA criteria;
Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.","IV Administration of 5% Dextrose in water /D5W (vehicle) 12 mg plus Intralipid infusion at a rate of 30 ml/hour

D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle",ChEMBL:CHEMBL1279 | DrugBank:DB00998 | PubChem:77992,Frovatriptan,CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1,N02CC07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02322892,NCT02322892_EG001,No,All,Adult | Older Adult,Phase 2,64,"Inclusion Criteria:

Adult (≥ 21 years)
Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
EuroSCORE II > 1.5%

Exclusion Criteria:

Current thiamine supplementation
Known allergy to thiamine
Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
Research-protected populations (pregnant women, prisoners, the intellectually disabled)
Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)
Off-pump surgery (i.e. surgery without cardiopulmonary bypass)","200 mg thiamine in 50 mL normal saline solution

Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02331589,NCT02331589_EG000,No,All,Adult | Older Adult,Phase 4,75,"Inclusion Criteria:

aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

Exclusion Criteria:

viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer","KRG capsule (3,000 mg/day) for 3 weeks

KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)",PubChem:53308655,"3-(3,5-Dimethyl-1,2-Oxazol-4-Yl)-5-Ethoxybenzoic Acid",CCOc1cc(C(=O)O)cc(-c2c(C)noc2C)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
NCT02337517,NCT02337517_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy of greater than 12 months
Leukocytes >= 3,000/microliter (mcL)
Absolute neutrophil count >= 1,500/mcL
Platelets >= 50,000/mcL
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 =< 1.5 mg/dl OR creatinine clearance >= 55 mL/min using the Cockcroft-Gault equation for patients with creatinine levels above 1.5 mg/dl
Patients with chronic GVHD diagnosed within 3 years after hematopoietic stem cell transplant (HSCT) for any disease, with any graft, and any conditioning regimen with at least one manifestation secondary to fibrosis, including: sclerodermatous skin changes, dry mouth, dry eye, esophageal strictures, or vaginal GVHD

Failure to respond to corticosteroids, defined as:

Progression of chronic GVHD despite optimal first line therapy (> 0.5 mg/kg/day of prednisone dose equivalent (PDE) for two weeks) or
No improvement after 4-8 weeks of sustained therapy; sustained therapy should include 2 weeks of > 0.5 mg/kg/day of PDE or
Inability to taper steroid dosage to less than 0.5 mg/kg/day of PDE without worsening of chronic GVHD or
Need for second or third line therapy beyond corticosteroids and calcineurin inhibitors or sirolimus, irrespective of other criteria

Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, and for at least 24 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 milli-international unit (mIU)/mL) within 7 days prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of GDC-0449 cause serious or life-threatening birth defects; patients must continue highly effective contraception during therapy and for 24 months after the last dose of GDC-0449

Women of childbearing potential are defined as follows:

Patients with regular menses
Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding
Women who have had a tubal ligation

Women are considered not to be of childbearing potential for the following reasons:

The patient has undergone hysterectomy and/or bilateral oophorectomy
The patient is post-menopausal defined by amenorrhea for at least 12 months in a woman > 45 years old
Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with GDC-0449 and for 3 months after the last dose to avoid exposing an embryo or fetus to GDC-0449

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are eligible provided that they meet the following criteria in addition to the other protocol criteria:

Cancer as the only acquired immunodeficiency syndrome (AIDS)-defining condition
Cluster of differentiation (CD)4 cell count >= 250
Treatment sensitive HIV and prospects for long term survival on the basis of HIV disease alone
Willing to take anti-HIV therapy that will have minimal potential for pharmacokinetic interactions with GDC-0449

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 recovered from adverse events due to agents administered more than 4 weeks earlier
Patients who are receiving any other investigational agents
Patients with known brain metastases should be excluded from this clinical trial
History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449
Patients receiving any medications or substances that are strong inducers/inhibitors or substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), CYP2C8, or CYP2C19 are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow capsules
Patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis are ineligible
Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this 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; breastfeeding should be discontinued if the mother is treated with GDC-0449
More than 2 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
Relapsed malignancy after transplantation","Patients receive vismodegib PO daily, every other day, every three days, or twice weekly for 6-12 months in the absence of disease progression or unacceptable toxicity.",ChEMBL:CHEMBL473417 | DrugBank:DB08828 | PubChem:24776445,Vismodegib,CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1,L01XJ01 | L01XX43,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02353169,NCT02353169_EG000,No,All,Child,Phase 4,64,"Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate","0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02353169,NCT02353169_EG001,No,All,Child,Phase 4,64,"Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate","0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02353169,NCT02353169_EG002,No,All,Child,Phase 4,64,"Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate","0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02355821,NCT02355821_EG001,No,Female,Child | Adult | Older Adult,Not Applicable,57,"Inclusion Criteria:

Female with age 45 years and older.
Postmenopausal (absence of menstrual periods for a minimum of 12 months) at the moment of Informed Consent sign.
Arterial hypertension grade I / II per ESH/ESC 2013 guidelines (diastolic pressure ≥ 90 and <110 mm Hg, systolic pressure ≥140 and <180 mm Hg).
Not achieving BP targets <140/90 mmHg either during antihypertensive therapy or naive.
Absence of moxonidine or bisoprolol treatment at least 6 months before the study
Osteopenia of lumbar spine and/or proximal part of the femur (osteoporosis T-score from -1 to -2.5 standard deviations [SD]) by X-Ray densitometry.

Signed Informed Consent for participation in the study

-

Exclusion Criteria:

Hypersensitivity to moxonidine, bisoprolol or any other ingredient of the respective formulations
Any Contraindications for moxonidine, bisoprolol
Osteoporosis (Т-score below - 2.5 SD).
Primary or secondary hyperparathyroidism.
Paget's disease of bones.
History of low traumatic bone fractures.
Malabsorption syndrome.
History of gastro-intestinal surgery.
Severe disturbance of peripheral circulation.
Raynaud's disease.
Symptomatic (secondary) hypertension (caused by any primary internal diseases)
Morbid obesity (BMI over 40 kg/m2).
Symptoms of estrogen deficiency such as hot flushes, nights sweat, vaginal dryness
Administration of any hormone-replacement therapy (HRT) or intake of isoflavones
Secondary hypogonadism.
Sistolic BP ≥180 mm Hg and/or Diastolic BP ≥110 mm Hg.
Clinical presentations of cardiovascular disease: coronary heart disease (CHD), history of stroke, transient ischemic attack (TIA), Charcot's syndrome.
Severe heart failure.
Hemodynamically significant congenital heart disease.
Heart rhythm disorders which require permanent use of any antiarrhythmic medications (including β-adrenoblockers and calcium antagonists).
Diabetes mellitus of any genesis.
Severe liver failure.
Severe kidney failure including patients on dialysis
Thyroid diseases accompanied by functional disorders (thyrotoxicosis or uncompensated hypothyroidism).
Alcohol and drug abuse.
Patients with oncological diseases diagnosed within 5 years before IC execution.
Inability of the patient to comprehend the essence of the program and to provide his/her consent for participation in the program.
Patients with any condition, which in the opinion of the Investigator makes the patient unsuitable for inclusion based on clinical judgment.
Corticosteroid therapy

Participation in any other clinical study during the whole course of this investigation including participation in a study within 30 days prior to providing the informed consent for this trial

-","5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID

Bisoprolol: 5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D",ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02362646,NCT02362646_EG001,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
Age 18 years or older
If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure
Female subjects of childbearing potential must have a negative serum pregnancy test at screening
Admitted to the clinical center at the time of randomization
Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

Planned percutaneous LVAD implantation
Anticipated requirement for biventricular mechanical support

Concomitant arrhythmia ablation at time of LVAD implantation

-- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation

Cardiothoracic surgery within 30 days prior to randomization
Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
Stroke within 30 days prior to randomization
Platelet count < 100,000/ul within 24 hours prior to randomization
Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
Presence of human immunodeficiency virus (HIV)
Received investigational intervention within 30 days prior to randomization
Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
Active participation in other research therapy for cardiovascular repair/regeneration
Prior recipient of stem precursor cell therapy for cardiac repair
Pregnant or breastfeeding at time of randomization.
History of known or suspected hypercoagulable state in the opinion of the investigator","Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

Control Solution",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02363933,NCT02363933_EG000,No,All,Adult | Older Adult,Phase 4,8,"Inclusion Criteria:

Patients must be diagnosed with a primary glioma and have refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period) on levetiracetam monotherapy
Adult patients (≥ 18 years old)
Karnofsky ≥ 70%
Hematocrit ≥ 29%, ANC ≥ 1,500 cells/L, platelets ≥ 100,000 cells/L
Serum creatinine ≤ 1.5 mg/dL, serum AST and bilirubin ≤ 1.5 times the upper limit of normal
If sexually active, patients will take contraceptive measures for the duration of protocol treatment and continue until two months after treatment. The effectiveness of hormonal contraceptives containing levonorgestrel has been shown to be reduced by perampanel at a 12 mg dose.1 Therefore, alternative or back-up methods of contraception are recommended.
Signed informed consent approved by the Duke Institutional Review Board

Exclusion Criteria:

Pregnant or breastfeeding (Both perampanel and other Anti-epileptic drugs are classified as Pregnancy Category C drugs.)
Chronic excessive use of psycho-pharmaceuticals, alcohol, illicit drugs, or narcotics
Inability to complete or perform measures of patient-reported outcomes or neurocognitive testing on the computer
Known allergy to perampanel
Concomitant use of known cytochrome P450 inducers such as carbamazepine, phenytoin, or oxcarbazepine (see Appendix A)
Previous history of suicidal ideation, homicidal ideation, depression leading to hospitalization or mood disturbance leading to hospitalization.","Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.

Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02365558,NCT02365558_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,34,"Inclusion Criteria:

Overtly healthy participants, as determined by medical history and physical examination
Females must be of non-child-bearing potential
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion Criteria:

Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations","Single oral dose of Evacetrapib administered alone on Day 1 of Period 1.

Evacetrapib: Administered orally",ChEMBL:CHEMBL2017179 | DrugBank:DB11655 | PubChem:49836058,Evacetrapib,Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02365636,NCT02365636_EG000,No,All,Adult | Older Adult,Phase 2,100,"Inclusion Criteria:

Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.

Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study

Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
Patient has PHN affecting the face (trigeminal nerve distribution).
Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.

Patient has a history of fibromyalgia.

Other criteria apply, please contact the investigator for more information",TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.,ChEMBL:CHEMBL3707218 | DrugBank:DB11769 | PubChem:49836093,Funapide,O=C1N(Cc2ccc(C(F)(F)F)o2)c2ccccc2[C@]12COc1cc3c(cc12)OCO3,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02385266,NCT02385266_EG000,No,Male,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Males greater than 18 years of age, with no racial/ethnic restrictions;
Meets diagnostic criteria for Interstitial Cystitis with Painful Bladder Syndrome (IC/PBS) and/or Chronic Prostatitis with Chronic Pelvic Pain Syndrome (CP/CPPS);
Reports symptoms of discomfort or pain in the pelvic or abdominal region for at least a 3 mo period within the last 6 mo;
Must have a Visual Analog Scale (VAS) pain score >40 mm (of 100 mm maximum) at the baseline visit (UCPPS pain moderate to severe);
Must be in generally stable health;
Must be willing to abstain from drinking alcohol during the course of the study;
Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion Criteria:

Urological pain associated with any systemic signs or symptoms, e.g., fever, chills;
Evidence of a facultative Gram negative or enterococcus with a value of ≥ 100,000 CFU/ml in mid-stream urine (VB2);
Has a second chronic pain condition (e.g., chronic low back pain, temporomandibular joint syndrome, etc.) that would prevent a clear interpretation of the study results;
History of tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer;
History of significant pelvic comorbidities, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy, or has been treated with intravesical Bacillus Calmette-Guerin (BCG) or unilateral orchialgia without other pelvic symptoms, has an active urethral stricture, ureteral calculi, urethral diverticulum, or has a neurological disease or disorder affecting the bladder;
Significant other medical conditions/diseases, such as significant renal disease or a history of renal insufficiency, unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
Neurologic disorder, including history of seizures;
Major psychiatric disorder during the past 6 months;
Moderate or severe depression, as determined by the Hospital Anxiety and Depression Scale, or any active suicidal ideation;
History of, or current, substance abuse/dependence including alcohol;
Known sensitivity to D-cycloserine;
Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, Selective Serotonin Reuptake Inhibitor (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs); low doses used for sleep may be allowed), as these medications can alter pain transmission;
Current use of low dose aspirin;
Indication that the subject is unlikely to be compliant due to unmanaged medical or psychological condition(s), including neurological, psychological, or speech/language problems that will interfere or prevent with his understanding of consent, his ability to comply with the protocol or ability to complete the study;
Any change in medication for urological pain in the last 30 days;
High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;
Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
Evidence of poor treatment compliance, in the judgment of the investigator;
Intra-axial implants (e.g. spinal cord stimulators or pumps); and
All exclusion criteria for Magnetic Resonance (MR) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia.","D-cycloserine 200mg/bid and Acetaminophen prn

D-Cycloserine: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.",ChEMBL:CHEMBL771 | DrugBank:DB00260 | PubChem:6234,Cycloserine,N[C@@H]1CONC1=O,J04AB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02396316,NCT02396316_EG001,No,All,Adult | Older Adult,Phase 3,27,"Inclusion Criteria:

Japanese men and women aged 20 years or older,
Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
Patients with Intraocular pressure (IOP) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization.

Exclusion Criteria:

Patients with angle-closure due to conditions other than Neovascular glaucoma
Patients with a known or suspected ocular or peri-ocular infection,
Patients with severe intraocular inflammation in the study eye,
Women who are pregnant, suspected of being pregnant or lactating,
Patients with known allergy to aflibercept.","Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.

Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :

IOP higher than 21mmHg;
Incomplete regression of iris neovascularization and;
Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02402933,NCT02402933_EG000,No,All,Child,Phase 3,22,"Inclusion Criteria:

Availability for the entire study period.
Motivated Child/Adolescent with diabetes (C/AWD) and caregiver(s) and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the qualified investigator or designee.
C/AWD lives with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia.
Male or female C/AWD with a history of type 1 diabetes >1 year.
C/AWD aged of at least 4 years of age but less than 18 years.

A female C/AWD must meet one of the following criteria:

a) Participant is of child-bearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the pre-trial evaluation and enrollment visit until study completion). An acceptable method of contraception includes one of the following: (i) Abstinence from heterosexual intercourse (ii) Systemic contraceptives (birth control pills, injectable/implantable/ insertable hormonal birth control products, transdermal patch) (iii) Intrauterine device (iv) Condom with spermicide, OR b) Participant is of non-child-bearing potential, defined as a female who had had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.

In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a suitable candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
Willingness to adhere to the protocol requirements.

Exclusion Criteria:

Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or lactating.
History of significant hypersensitivity to glucagon, or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs.
Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects.
Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Concomitant maintenance therapy with any drug that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.
Regular consumption of 3 or more units of alcoholic beverages per day.
Current participation in another clinical trial, intent to enroll in another clinical trial during this clinical study or use of an Investigational Product (in another clinical trial) within the prior 30 days.",3 mg glucagon powder,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0
NCT02404103,NCT02404103_EG000,No,All,Child | Adult,Not Applicable,10,"Inclusion Criteria:

Diagnosis of asthma
Informed consent by parent or legal guardian
6 years to 18 years of age at screening visit
ability to comply with medication use, study visits and study procedures as judged by the site investigator
FEF 25-75% <65% of predicted as a marker for small airway disease

Exclusion Criteria:

Acute wheezing at screening visit or at Baseline visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
Oxygen saturation <95% at screening visit or at Baseline visit
Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
Potential subjects who are pregnant may not enroll in the study","Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period

Flunisolide HFA",ChEMBL:CHEMBL1512 | DrugBank:DB00180 | PubChem:82153,Flunisolide,[H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,R01AD04 | R03BA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02404103,NCT02404103_EG001,No,All,Child | Adult,Not Applicable,9,"Inclusion Criteria:

Diagnosis of asthma
Informed consent by parent or legal guardian
6 years to 18 years of age at screening visit
ability to comply with medication use, study visits and study procedures as judged by the site investigator
FEF 25-75% <65% of predicted as a marker for small airway disease

Exclusion Criteria:

Acute wheezing at screening visit or at Baseline visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
Oxygen saturation <95% at screening visit or at Baseline visit
Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
Potential subjects who are pregnant may not enroll in the study","Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period

Flunisolide HFA",ChEMBL:CHEMBL1512 | DrugBank:DB00180 | PubChem:82153,Flunisolide,[H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,R01AD04 | R03BA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02409810,NCT02409810_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,20,"Inclusion Criteria:

Patients age 18- 89 admitted for initial management of a thermal burn injury (flame, scald, contact) with >1% total body surface area
Expected stay on the Burn Center for 3 or more days
Read, write and speak English
Burn injury experienced <48 hours prior to admission to the Burn Center for care

Exclusion Criteria:

Patients who are pregnant
Patients that are incarcerated
Patients in active alcohol withdrawal
Patients with current hemodynamic instability (current hypotension systolic blood pressure <100 mmHg, sustained heart rate < 60 beats/min without a pacemaker, symptomatic bradycardia, or second or third degree heart block)
Cannot use push button PCA device (i.e., paralysis)
Acute hepatitis
Acute liver failure
Acute stroke
Acute seizures
Acute myocardial infarction
Severe cognition or communication difficulties (e.g., coma, deafness without signing literacy, dementia, non-English speaking)
Chemical or electrical burn injury
Any condition precluding inclusion at the discretion of the burn surgeons","Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10mins by nurse staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg.

Dexmedetomidine: Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10 minutes by nursing staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg. This dosage is within the FDA-approved package insert parameters. Heart rate, blood pressure and oxygen saturation will be closely monitored by a staff RN already trained to provide care in the procedure room. 1 hour prior to- and after completion of the burn dressing change each day using a 100-mm visual analog scale. Patients will both rate their satisfaction with PCA-DEX for anxiety management after each completion of the burn dressing change.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02410200,NCT02410200_EG000,No,All,Child,Phase 2,22,"Key Inclusion Criteria:

Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
Must have a body weight of ≥30 kg at Screening and Day 1.
Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman 2011] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for pediatric MS (2013) [Krupp 2013].

Key Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS (as defined by [Lublin and Reingold 1996]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.",BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02414204,NCT02414204_EG000,No,All,Adult | Older Adult,Not Applicable,4,"Inclusion Criteria:

Age ≥19 years of age male or female
Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery

Exclusion Criteria:

Patient currently on nitrate therapy or any nitric oxide donor in any form
Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg.
Patient life expectancy < nine months.
Patient unable or unwilling to meet study requirements.","20 mg twice a day orally

Sildenafil: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02415439,NCT02415439_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters",Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02415439,NCT02415439_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters",Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02415439,NCT02415439_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters",Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02415439,NCT02415439_EG004,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters",Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02415439,NCT02415439_EG005,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters",Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02423408,NCT02423408_EG000,No,All,Adult | Older Adult,Phase 2,78,"Inclusion Criteria:

Capable of reading and understanding English and able to provide written informed consent to participate.
Male or female adults ≥ 18 and < 65 years of age at the time of Visit 1.
Body mass index (BMI) ≥ 18.5 and ≤ 45.0.
Greater than 1 year history of episodic tension-type headache with onset prior to 50 years of age.
History of tension-type headaches that typically last ≥ 4 hours if untreated.
History of 2-14 tension-type headaches per month for the last 3 months prior to Visit 1.
Diagnosis must comply with the International Headache Society (IHS) diagnostic criteria.
No significant ECG findings at Screening
If female, is either not of childbearing potential or is practicing a predefined medically acceptable method of birth control (hormonal methods, intrauterine device, double-barrier method, sexually-exclusive vasectomized male partner, same-sex relationship) throughout the study.
Willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulation.
Use of any excluded concomitant medications.
Current use of opiate analgesics.
Use of any prophylactic drug therapy for headache control within 4 weeks of screening (e.g., anticonvulsants, mood stabilizers, beta-blocker, antidepressants, muscle relaxants, botulinum toxin). Subjects taking any of these medications for an indication other than headache (e.g., a beta-blocker for hypertension) will require medical monitor's approval prior to initiation of the Run-In Period.
History of medication use for acute headache on ≥ 10 days per month on average during the 3 months prior to Visit 1.
Positive results for addictive substances (e.g., cocaine, phencyclidine (PCP), amphetamines, opiates) at Screening.
History of migraine that exceeds a mean of four attacks per month during the preceding calendar year.
Lifetime history of schizophrenia, schizoaffective disorder, bipolar I/II disorder, delusional disorder, or psychotic disorder not otherwise specified.
Chronic pain disorders requiring medical treatment with opioids, chronic daily use of NSAIDs at the time of screening
History of coronary artery disease, coronary vasospasm, aortic aneurysm, peripheral vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome).
Inadequately controlled hypertension or persistently elevated systolic blood pressure or diastolic blood pressure upon repeat assessment at screening or on the day of randomization.
Current history of two or more CAD risk factors at Screening (tobacco use, receiving anti-hypertensive medication for hypertension, high LDL cholesterol or low HDL cholesterol levels, family history of premature CAD, diabetes mellitus)
History cerebral vascular accident, transient ischemic attack, seizure disorders.
Other clinically significant cardiac disease.
History of concurrent illness that requires hospitalization within 30 days prior to Visit 1.
Current evidence of human immunodeficiency virus infection or clinically significant hepatitis B or C infection.
Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history.
Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial. Subjects who have participated in non-interventional trials may be permitted to participate on a case-by-case basis after review with the Medical Monitor.
Women who are pregnant, breast-feeding, or planning to become pregnant during this trial.
Any other household member currently participating in a Tonix-sponsored study or family member or relative of investigative staff.
Any condition and/or medical history that would make the subject unsuitable for study participation and completion.","4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs

TNX-201: TNX-201 capsule",ChEMBL:CHEMBL1476245 | DrugBank:DB16136 | PubChem:76853225,Dexisometheptene mucate,CN[C@H](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
NCT02427607,NCT02427607_EG000,No,All,Child | Adult | Older Adult,Phase 3,7,"Inclusion Criteria

Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel).
Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained.
Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).

Exclusion Criteria

Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study.
Female participants who are nursing, pregnant, or planning to become pregnant.",Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.,ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02438137,NCT02438137_EG000,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Age of 18-65 years at screening;
Diagnosis of OSA as confirmed by previous clinical sleep study (polysomnography, PSG);
Refusal, inability, or high reluctance to use CPAP regularly for treatment of OSA, despite medical advice;
Willingness to undergo repeat sleep study (PSG) and blood studies;
Normal immune cell counts, as evidenced by complete blood count (CBC) done at screening

Exclusion Criteria:

Regular use of CPAP within the last 2 months
Physical, psychiatric or cognitive impairment that prevents informed consent, PSG, or reliable follow-up;
Cardiac conditions that may increase sleep apnea severity (e.g., congestive heart failure or recent heart attack);
Current successful treatment for obstructive or central sleep apnea, for example by CPAP, and patient agreement to continue with that treatment;
History of surgical treatment for OSA within past 6 months, or subsequent to last PSG confirmation that OSA is present;
Active nervous system diseases that may predispose subjects to OSA;
Systemic autoimmune disease that could increase inflammation and influence apnea severity (such as rheumatoid arthritis or lupus);
Pregnancy or breastfeeding;
Use of immunotherapies or immunosuppressants, currently or within past 6 months;
Anticipated initiation or dose change in tricyclic antidepressants, selective serotonin uptake inhibitors, or related compounds;
Participants with a history of active, serious or persistent infections.
Participants with recent surgery (within 3 months prior to screening), or anticipated surgery during the length of the study.
Systemic steroid use within the last 2 months (does not include local steroid injections or intranasal steroid spray);
Current diagnosis of cancer that is not considered to be cured or in remission by the treating physician, cancer treatment of any kind within the last 6 months prior to screening (chemo, radiation, surgery), or anticipated cancer treatment during the length of the study;
History of a lymphoproliferative disorder (such as leukemia);
History of Multiple Myeloma
History of decreased immune cell counts per a blood test known as a CBC, specifically lymphocyte counts less than 1.2 K/μL at screening.
Refusal to use at least one reliable method of birth control (for women of childbearing age)
Newly diagnosed (within 2 months) OSA subjects who have an AHI > 30 and history of serious, recent, or unstable cardiovascular disease (including but not limited to recent MI, recent stroke/TIA, or unstable angina)
Participants who report previous motor vehicle accidents or near-misses presumed to be due to excessive sleepiness while driving.
Any other condition or treatment that in the opinion of the investigator could affect subject safety or study eligibility.","The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.

Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose.",ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02439957,NCT02439957_EG001,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.",900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.,ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02439970,NCT02439970_EG001,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 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.","900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02459119,NCT02459119_EG000,No,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

Patients must have pathologically or cytologically proven transitional cell carcinoma of the urothelium.
Progressive disease after 1-3 prior chemotherapy regimens (perioperative chemotherapy within 12 months will be considered one regimen).
Prior regimen must be within 6 months of registration
Measurable disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M1) or locally advanced unresectable (T4b) transitional cell carcinoma.
Age ≥19 years
Life expectancy of at least 12 weeks (3 months)
Subjects must be able to understand and be willing to sign the written informed consent form.

Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:

Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
Serum creatinine ≤ 1.5 x the ULN
International normalized ratio (INR) less than or equal to 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.
Platelet count >100,000/mm3, hemoglobin (Hb) >8 g/dL, absolute neutrophil count (ANC) 1500/mm3. The patient cannot be transfused in order to meet study entry criteria.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post- menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
Subject must be able to swallow and retain oral medication.

Exclusion Criteria:

Component of small-cell cancer or sarcomatoid cancer
Prior therapy with any systemic therapy (chemotherapy or biologic therapy) within twenty-eight days prior to study entry
Patients must have recovered from toxicities from prior systemic anticancer treatment or local therapies.
Patients who have undergone major surgery <4 weeks or minor surgery <2 weeks prior to registration. Wounds must be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of a vascular access device is not considered major or minor surgery in this regard.
Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least three weeks prior to enrollment. If the irradiated area is the only site of disease, there must be evidence of progressive disease.
Uncontrolled central nervous system (CNS) metastases (previously treated with radiation and off steroids is acceptable).
Patient with active or uncontrolled infection.
Recent or active bleeding diathesis or arterial vascular event within 4 weeks.
Pregnant or nursing (Fertile patients must use effective contraception during and for up to 3 months after completion of study treatment.)
Patients may not be receiving any other investigational agents.
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg on repeated measurement) despite optimal medical management.

Active or clinically significant cardiac disease including:

Congestive heart failure - New York Heart Association (NYHA) Class II.
Active coronary artery disease.
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
Unstable angina (angina symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
Evidence or history of bleeding diathesis or coagulopathy.
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent.
Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated localized basal cell carcinoma, Gleason score 6 prostate cancer or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments for another malignancy must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).
Patients with pheochromocytoma.
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
Ongoing infection >Grade 2 NCI-CTCAE v4.0.
Symptomatic metastatic brain or meningeal tumors.
Presence of a non-healing wound, non-healing ulcer, or bone fracture.
Renal failure requiring hemo-or peritoneal dialysis.
Dehydration Grade >1 NCI-CTCAE v4.0.
Patients with seizure disorder requiring medication.
Persistent proteinuria greater than or equal to Grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample).
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
Pleural effusion or ascites that causes respiratory compromise (≥ NCI- CTCAE version 4.0 Grade 2 dyspnea).
History of organ allograft (including corneal transplant).
Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
Any malabsorption condition.
Women who are pregnant or breast-feeding.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.","Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.

Regorafenib: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar.",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02466009,NCT02466009_EG000,No,All,Older Adult,Phase 2,27,"Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma
Measurable metastatic disease.
Age +/> 70
Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
Life expectancy >/= 12 weeks
Able to understand and willing to sign written informed consent.
Laboratory requirements:
Total bili ≤ 1.5 x upper limit or normal
Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
Serum creatinine ≤ 1.5 x upper limit or normal
International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
Glomerular filtration rate ≥ 60 ml/min
Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
Must be able to swallow and retain oral medications

Exclusion Criteria:

Currently receiving other systemic therapy for metastatic colorectal cancer
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
Uncontrolled hypertension despite optimal medical management
Active or clinically significant cardiac disease.
Evidence or history of bleeding diathesis or coagulopathy
Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
History of other active malignancy within past 2 years.
Patients with phaeochromocytoma
Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
Ongoing infection > grade 2
Symptomatic metastatic brain or meningeal tumors
Presence of non-healing wound, non-healing ulcer, or bone fracture
Renal failure requiring hemo- or peritoneal dialysis
Dehydration ≥ grade 1
Patients with seizure disorder requiring medication
Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
History of organ allograft including corneal transplant
Known or suspected allergy or hypersensitivity to the study drug
Any malabsorption condition
Any condition which makes the subject unsuitable for trial participation
Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.","120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)

Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.

Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02472223,NCT02472223_EG000,No,All,Adult | Older Adult,Not Applicable,28,"Inclusion Criteria:

Age: Patients will be 18 years and older.
Duration of pink eye symptoms: No more than 4 days in first affected eye Positive immunoassay test ""AdenoPlus(TM)"" for presence of adenovirus.
Sex: ""Pink eye"" {adenoviral conjunctivitis (Ad-Cs)} occurs with equal prevalence in males and females, therefore we will recruit both genders.
Race/Ethnicity: Individuals of all races and ethnicities will be invited to participate in this study. Patient recruitment will reflect the distribution of race/ethnicity demographics for the patient population specific to each study site.

Exclusion Criteria:

Patients with history of herpes simplex infection or corneal ulceration
Eye surgery in the last 3 months","One time in-office use (4-5 drops)

Betadine 5%: One-time, in-office administration of Betadine 5%.

Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02473913,NCT02473913_EG000,No,All,Child | Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Males and females ages 10-65.
Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
Hair-pulling behavior within 2 weeks prior to enrollment;
Child able and willing to provide active assent for participation;
Legal guardian available to provide consent for participation.

Exclusion Criteria:

Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;
Unstable medical illness as determined by the investigator;
History of seizures;
Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;
Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
Previous treatment with milk thistle;
Any history of psychiatric hospitalization in the past year.","Each subject will have a 6 week treatment phase with milk thistle.

Milk Thistle",ChEMBL:CHEMBL9509 | DrugBank:DB09298 | PubChem:124304713 | PubChem:1548994 | PubChem:1549163 | PubChem:24832061 | PubChem:3086637 | PubChem:31553 | PubChem:45933924 | PubChem:5213 | PubChem:5748849 | PubChem:6610285,Silibinin,COc1cc(C2Oc3cc(C4Oc5cc(O)cc(O)c5C(=O)C4O)ccc3OC2CO)ccc1O,A05BA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02474589,NCT02474589_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,359,"Inclusion Criteria:

18 to 80 years old, inclusive
Available for clinical follow-up for the duration of the study
Able and willing to give informed consent
In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for the last 2 years
Able to comply with dietary requirements throughout the study drug dosing period
Adequate venous access for those individuals participating in PK testing
PE and laboratory results without clinically significant findings within the 14 days before receipt of study drug
Agree not to drink alcohol from the beginning of the Screening Period through the completion of the Day 28 Follow up Visit
Agree not to use any nicotine products, including electronic vapor cigarettes, nicotine patches or nicotine gum for at least 30 days before the Day 1 Visit and through completion of the Day 15 Dosing complete Visit
Agree not to consume caffeine during all study visits, including overnight stays if participating in PK subset
Agree not to receive any immunizations/vaccinations
Agree not to take herbal products
Able and willing to refrain from taking any prescriptions and nonprescription medications with exceptions
For women of childbearing potential, negative serum and urine pregnancy testing
If male, agree not to donate sperm
Meet 1 of the following criteria: The subject or their partner has undergone surgical sterilization; the subject is postmenopausal; the subject agrees to be abstinent; the subject agrees to consistently use a method of approved birth control.

Exclusion Criteria:

Pregnant or breast-feeding or planning pregnancy
Have a history of any clinically significant conditions
Have any limitation of activity related to cardiac disease
Have a bleeding disorder diagnosed by a doctor, or a history of significant bruising or bleeding with intramuscular injections or blood draws
Currently using certain medications
Have a malignancy that is active or a treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study
Have a history of seizure
Have a clinically significant blood dyscrasia
Have a history of drug allergy that contraindicates participation in the trial
Have a medical, psychiatric, or social condition or any occupational reason, or other responsibility that in the judgment of the investigator would render the subject unable to comply with the protocol
Have an inability to swallow medication
Have a clinically significant abnormal ECG
Have participated in a clinical trials within 30 days of study entry or planning to participate in any experimental treatment study during the study period
Have a history or current drug or alcohol abuse
Have received immunizations/vaccines
Have a current clinically significant acute bacterial, fungal, or mycobacterial infection requiring administration of systemic antibiotics
Have known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection with the exception of clinically significant dermal infections
Have known hepatitis B or C infection, or positive test result
Have known HIV infection or AIDS or a positive test for HIV
Have a current clinically significant viral infection
Have known clinically significant chronic viral infection
have received treatment with greater than 20 mg prednisone or equivalent dose or any immunosuppressant or immunomodulary medication
Have abnormal laboratory testing during screening
Have a greater than or equal than 20% risk of suffering a major cardiovascular event
Have been previously enrolled in this or any clinical trial involving tecovirimat","600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects

tecovirimat: Study is based on Animal Regulatory Rule",ChEMBL:CHEMBL1257073 | DrugBank:DB12020 | PubChem:16124688,Tecovirimat,O=C(NN1C(=O)[C@@H]2[C@@H]3C=C[C@@H]([C@H]4C[C@@H]34)[C@@H]2C1=O)c1ccc(C(F)(F)F)cc1,J05AX24,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02476448,NCT02476448_EG003,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,44,"Inclusion Criteria:

adult
undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

Chronic kidney disease
known prior surgical removal of kidney or ureteral obstruction
Current ureteral stent placed
Allergy to any of the interventions","Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.

Sodium Fluorescein: Administered intravenously and assessed during cystoscopy",ChEMBL:CHEMBL4297067 | DrugBank:DB00693 | PubChem:16850,Fluorescein,O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21,S01JA01 | S01JA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02487563,NCT02487563_EG001,No,All,Child | Adult | Older Adult,Phase 3,30,"Inclusion Criteria:

Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;
Neutrophil and hemoglobin were well recovered;
Full donor chimerism was achieved;
No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Exclusion Criteria:

Patients with malignancy relapse;
Active infections;
Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;
Severe organ damage;
Thrombosis requiring treatment;
Received decitabine following the current transplantation.",Decitabine 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3) alone.,ChEMBL:CHEMBL1201129 | DrugBank:DB01262 | PubChem:451668,Decitabine,Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1,L01BC08,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02495831,NCT02495831_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,24,"Inclusion Criteria:

Signed written informed consent before inclusion in the study
Males and females, 25-55 years old
Body Mass Index (BMI): 18.5-30 kg/m2
Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm
Ability to comprehend the full nature and purpose of the study
Females of child-bearing potential must use at least one of the following :

A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit A male sexual partner who agreed to use a male condom with spermicide A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year were admitted.

Exclusion Criteria:

Contraindications to MAO-B inhibitors, antiepileptic drugs, or to any NSAIDs
Clinically significant abnormalities in ECG
Clinically significant abnormal physical findings
Clinically significant abnormal laboratory values
Hypersensitivity or history of anaphylaxis to drugs or allergic reactions in general
Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases
Medications, including over the counter medications and herbal remedies, NSAID or anticoagulant use for 2 weeks before and during the entire study; morphine or other similar opioids, SSRIs, SNRIs, tri- or tetracyclic antidepressant, tramadol, pethidine, dextromethorphan, MAO inhibitors, meperidine derivatives and antiepileptic drugs, medicinal products that are BCRP substrates, any known enzyme inhibiting or inducing agent within 4 weeks preceding the screening visit.
Participation in the evaluation of any investigational product for 3 months before the study.
Blood donations for 3 months before the study
History of drug, alcohol, caffeine or tobacco abuse
Positive drug test at screening or day -1
Positive alcohol breath test at day -1
Abnormal diets or substantial changes in eating habits in the 4 weeks before the study; vegetarians
Positive or missing pregnancy test at screening or day -1, pregnant or lactating women","Diclofenac sodium 50 mg oral tablets, single dose",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT02508935,NCT02508935_EG000,No,All,Child,Phase 4,23,"Inclusion criteria:

Male or nonpregnant, nonlactating females between 12 and 17 years of age.
Minimum weight of 100 pounds (45 kg); body mass index (BMI) >5% and <95% for their age.
Moderate or severe acute pain [as determined from the Numerical Pain Rating scale (NPRS)]; must have a level of 4 or more) after surgical procedure requiring hospitalization.
If, of child-bearing/reproductive potential, must abstain from unprotected sexual activity during study and 2 weeks after study exit.
Females of childbearing potential must have negative pregnancy test.
Subject's legally authorized representative (eg, parent, legal guardian) must sign a parental permission/informed consent and subject must sign an assent.
Subject and subject's parent/legal guardian must be able to read, understand, and follow study procedures and requirements and communicate meaningfully in English.

Exclusion criteria:

Subject is from a vulnerable population (including mentally disabled children), other than a pediatric population.
Subject requires surgery that could influence the study outcome.
Abnormal electrocardiogram (ECG).
Screening pulse oximetry reading of <95% while awake.
Has presence of human immunodeficiency virus (HIV) or indications of hepatitis A, B or C.
Lab values greater than 2 times the upper limit of normal.
History of renal disease or bleeding or clotting disorders or conditions.
Known or suspected alcoholism, marijuana or illicit drug abuse or misuse within 2 years before screening.
Smoked or used nicotine-containing products within 6 months prior to screening.
Psychiatric disorders, such as major depression disorder, anxiety disorders, or psychotic disorders within 6 months prior to screening. A history of attention deficit hyperactivity disorder requiring medication is acceptable.
Diagnosis of epilepsy or other seizure disorder.
Previous cardiothoracic surgery.
Conditions which might be specifically contraindicated or require caution while using OC, APAP, and/or ibuprofen.
Drug allergy, hypersensitivity, or intolerance including OC, APAP, ibuprofen or excipients, or any opioid drug product.
Donated or had significant loss of whole blood (480 mL or more) within 30 days of or plans to donate blood or plasma during the course of the study.
Pathologic, iatrogenic or surgical condition that would compromise subject's ability to swallow, absorb, metabolize, or excrete XARTEMIS XR.
History of a GI event within 6 months prior to screening.
Subject has used any product containing OC or APAP within 48 hours prior to the first dose of XARTEMIS XR.
Any other medical condition, abnormal vital sign (blood pressure, pulse rate, respiratory rate), body temperature, pulse oximetry; or any physical examination or ECG finding at screening which would preclude safe participation in a clinical study.
Received any investigational product or device within 30 days before screening, or is scheduled to receive an investigational device or another investigational drug during the course of this study.",XARTEMIS XR is a combination of oxycodone and acetaminophen administered to postsurgical adolescent participants with moderate to severe acute pain.,PubChem:6321309,Acetaminophen and oxycodone hydrochloride,CC(=O)Nc1ccc(O)cc1.COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,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
NCT02515942,NCT02515942_EG002,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

Sign written informed consent form;
Geographic atrophy in both eyes;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Pregnant or lactating women and women of child-bearing potential;
Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
Any contraindications to IVT injections;
Ocular surgery in either eye within 90 days of screening;
Uncontrolled ocular hypertension or glaucoma in the study eye;
Other protocol-specified exclusion criteria may apply.",All subjects exposed to sham injection,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02525874,NCT02525874_EG000,No,All,Adult | Older Adult,Phase 3,218,"Key Inclusion Criteria:

Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

History of or positive test result at Screening for:
human immunodeficiency virus
hepatitis C virus antibody
hepatitis B infection
Drug or alcohol abuse within 1 year prior to Screening.
Prior treatment with any of the following:
cladribine
mitoxantrone
total lymphoid irradiation
alemtuzumab
T-cell or T-cell receptor vaccination
any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
cyclosporine
azathioprine
methotrexate
mycophenolate mofetil
intravenous (IV) Ig
plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply",Participants received 120 mg BID orally for the first 7 days and 240 mg BID thereafter until 96 weeks.,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02527512,NCT02527512_EG000,Accepts Healthy Volunteers,All,Child | Adult,Phase 4,173,"Inclusion Criteria:

Age 3 to 18 years on day of surgery
diagnosis of spinal deformity
undergoing elective posterior spine multi-level instrumentation surgery

Exclusion Criteria:

Documented renal failure
documented allergy to iodine or shellfish
previous spine fusion surgery
undergoing elective posterior spine single-level instrumentation surgery
undergoing anterior spine multi-level instrumentation surgery
current antibiotic use.","0.35% povidone-iodine (""Betadine"")

Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02534883,NCT02534883_EG000,No,Female,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

45-80yrs of age
Postmenopausal (amenorrhea for greater than 1 year)
May or may not be using hormone replacement therapy
Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures

Exclusion Criteria:

Pregnant
Known Cancer
Known hypersensitivity to prostaglandins.
Those who are breastfeeding","Group 1 will receive 200 ug of misoprostol to be placed into the posterior vaginal fornix 12 hours and 2 hours before the scheduled surgery (a total of 400 ug misoprostol).

Misoprostol: To be placed vaginally",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02542410,NCT02542410_EG001,No,Female,Child | Adult,Phase 2,5,"Inclusion Criteria:

Surgically confirmed endometriosis
Age between 15-40 y, and premenopausal
Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

Exclusion Criteria:

Use of other concurrent hormone medications (such as birth control pills)
Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)
Pregnancy
Breast cancer
Active thromboembolic disease
Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders","cabergoline 0.5 mg PO twice weekly x 6 months

Cabergoline",ChEMBL:CHEMBL1201087 | DrugBank:DB00248 | PubChem:54746,Cabergoline,[H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N(CCCN(C)C)C(=O)NCC)CN2CC=C,G02CB03 | N04BC06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02545127,NCT02545127_EG000,No,Female,Adult,Phase 2,2,"Inclusion Criteria:

Delivered at the hospital system associated with the trial center
Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
Produced < 200 mL milk in 24 hours prior to randomization
Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria:

Pre-pregnancy body mass index (BMI) > 50 kg/m^2
Mastitis
History of breast trauma, breast surgery, nipple piercing
Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
Unstable thyroid disease
Moderate or severe renal or hepatic impairment
Mental illness
Significant nasal congestion or mucous production
Use of anti-psychotic drugs within past 12 months","Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).",PubChem:76073634,Merotocin,CCC(C)C1NC(=O)C(Cc2ccc(O)cc2)NC(=O)CCCSCC(C(=O)N(CC(=O)NC(CC(C)C)C(=O)NCC(N)=O)Cc2ccc(F)cc2)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC1=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
NCT02550795,NCT02550795_EG000,No,Female,Adult | Older Adult,Not Applicable,150,"Inclusion Criteria:

ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

uncontrolled cardiovascular disease
history of chronic pain
smoker
previous history of steroid administraion
neoajuvant chemotherapy","administration of 0.9% normal saline 10ml

Control: administration of normal saline",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02550795,NCT02550795_EG001,No,Female,Adult | Older Adult,Not Applicable,150,"Inclusion Criteria:

ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

uncontrolled cardiovascular disease
history of chronic pain
smoker
previous history of steroid administraion
neoajuvant chemotherapy","administration of 0.5ug/kg of dexmedetomidine (5ml)

Dexmedetomidine: administration of dexmedetomidine only",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02554786,NCT02554786_EG002,No,All,Child | Adult | Older Adult,Phase 3,440,"Inclusion Criteria:

Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of < 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines >=07 days
A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

Reversibility should be repeated once-
Participants may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
Alternatively, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
Participants who have ever required intubation for a severe asthma attack/exacerbation.
Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Participants with severe narcolepsy and/or insomnia.
Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once

Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
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 of study treatment and for 30 days after stopping of study treatment.
Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101","MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02555215,NCT02555215_EG000,No,All,Child,Phase 3,20,"Key Inclusion Criteria:

Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.

Key Exclusion Criteria:

Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.",Participants will receive 120 mg capsule(s) taken orally.,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02561000,NCT02561000_EG001,No,All,Adult | Older Adult,Phase 2,31,"Inclusion Criteria:

The subject is at least 18 years of age and may be of either sex/gender and of any race and ethnicity.

The subject is scheduled to undergo non-emergent PCI or non-emergent cardiac catheterization with the intention of performing PCI. The following classifications of the urgency of the procedure at the time the operator decides to perform it will be used for randomization stratification:

Elective: The cardiac catheterization procedure ± PCI can be performed on an outpatient basis or during a subsequent hospitalization without significant risk of MI or death. For stable inpatients, this is a procedure that is performed during the hospitalization for convenience and ease of scheduling only and not because the subject's clinical situation demands that the procedure be performed prior to discharge.

OR

Urgent: The cardiac catheterization ± PCI procedure should be performed on an inpatient basis and before discharge because of significant concerns about the risk of myocardial ischemia, MI and/or death. For subjects who are outpatients or in the emergency department at the time that the cardiac catheterization is requested, this is a procedure that would warrant hospital admission based on clinical presentation.
There is no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to the initiation of the cardiac catheterization ± PCI procedure if the subject were not a participant in the current research study, and no anticipation of use during the procedure.
The subject is willing and able to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules (i.e., subject signs an approved informed consent document(s) and provides HIPAA authorization);
The subject will undergo all of the pre-enrollment parameters according to the study protocol prior to randomization and have them completed within 14 days prior to the scheduled cardiac catheterization ± PCI procedure and study drug administration.
Women of childbearing potential (all postmenarchal women who are <1 year menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception from the time written informed consent is given up until 90 days following the study drug administration.

Subject Exclusion Criteria:

The subject will be excluded from entry if any of the criteria listed below are met:

(General Exclusions)

Subject is pregnant, intends to become pregnant or is breast-feeding (all women of child-bearing potential must have a negative pregnancy test result confirmed prior to randomization and it must be repeated to be within 24 hours prior to the study drug administration if necessary).

Any of the following allergy history(s):

History of an allergic reaction* or contraindication to any of the following protocol-directed drugs: aspirin, heparin, P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor), antihistamines (benadryl, famotidine); or
History of an allergic reaction* to contrast media; or
History of an allergic reaction* to a drug which required emergency medical treatment;

History of an allergic reaction* to a Hymenoptera sting which currently necessitates the subject to carry an EpiPen/injector or the subject has been prescribed one to treat an allergic reaction to a sting.

An allergic (anaphylactic) reaction is characterized by an adverse local or general response from exposure to an allergen involving skin/mucosal tissue manifestations (hives, pruritus, flushing, angioedema), and/or respiratory compromise (dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia), and/or hemodynamic effects (hypo/hypertension, hypotonia, syncope).
Participation in another research study of investigational therapy (drug or device) within the past 30 days prior to randomization or planned use of other investigational therapy(s) during this research study (until 90 days following the study drug administration).
Subject is part of the study staff personnel directly involved with this trial, or is a family member of the study staff (clinical site or sponsor).
Prior enrollment (randomization) in this research study.

Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the research study or which would, in the opinion of the investigator, unacceptably increase the subject's risk by participating in the research study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts.

(Exclusionary Prior/Concomitant Conditions)

Evidence of an ST-segment elevation myocardial infarction (STEMI) on presentation or during current hospitalization or a history of STEMI within the past 30 days prior to randomization.
Subject is scheduled to undergo PCI for known unprotected left main coronary artery (LMCA) disease (i.e., left main stenosis ≥50% not protected by at least 1 patent bypass graft).
Any history of a prior stroke (hemorrhagic or ischemic) or transient ischemic attack (TIA) of any etiology.
Cardiogenic or any type of shock on presentation or during current hospitalization (i.e., systolic blood pressure <90 mm Hg requiring vasopressor or hemodynamic support).
History of heparin-induced thrombocytopenia (HIT).
Any active bleeding within the past 30 days prior to randomization.
Any condition or personal belief (e.g., Jehovah's Witness) which would interfere with the subject's ability or willingness to undergo a blood transfusion.

Any of the following conditions associated with increased risk of bleeding:

history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra- articular bleeding;
gastrointestinal bleeding within the past 30 days prior to randomization;
gastric or duodenal ulcer disease verified by endoscopy or barium meal contrast technique within the past 6 months prior to randomization;
history of bleeding disorder or diathesis;
major surgical procedure or trauma within the past 60 days prior to randomization or a planned surgical procedure to take place within 30 days following the study drug administration;
history or suspicion of intracranial neoplasm, arteriovenous malformation, or aneurysm; or
clinical finding(s) in the judgment of the investigator that poses an increased risk of bleeding.
Sustained severe hypertension: systolic blood pressure >185 mm Hg or diastolic blood pressure >105 mm Hg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >185/105 mm Hg including the final BP measurement before randomization).
Hypotension: systolic blood pressure <95 mm Hg (as demonstrated by repeated systolic BP measurements <95 mm Hg including the final systolic BP measurement prior to randomization).
Known active hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to ≥2.5 times the upper limit of the reference range within the past 30 days prior to randomization.
Hemoglobin <10 g/dL or hematocrit <30%.
Platelet count <75,000/mm3.
Stage 4-5 Chronic Kidney Disease (National Kidney Foundation) or on dialysis.
Active sepsis or suspected sepsis.
Body weight <60 kg or >175 kg.
Current evidence of invasive cancer (persistent disease excluding basal cell carcinoma of the skin) or treatment for invasive cancer within the past 6 months prior to randomization.

Left ventricular ejection fraction <25% if known (any imaging technique) or New York Heart Association (NYHA) Class IV congestive heart failure.

(Exclusionary Prior/Concomitant/Anticipated Medication/Therapy)

Coronary interventional procedure of any kind within the past 30 days prior to randomization.
Anticipated subsequent staged multi-vessel PCI within 30 days following the study drug administration.
History of treatment with any parenteral GP IIb/IIIa inhibitor (GPI) within the past 30 days prior to randomization. (As stated in the Inclusion section, the planned treatment with a GPI prior to initiation of the cardiac catheterization ± PCI is not allowed; however, GPI for thrombotic bailout may be used during the PCI at the investigator's discretion).
Concurrent or anticipated treatment with a parenteral direct thrombin inhibitor (e.g., bivalirudin) for the cardiac catheterization ± PCI procedure.
History of treatment with another PAR1 inhibitor within the past 60 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
History of treatment with another IV anti-platelet drug within 30 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.

Any of the following anticoagulant or thrombolytic/fibrinolytic treatment(s):

History of treatment with warfarin within 5 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
History of treatment with oral Factor Xa or direct thrombin inhibitors within 2 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
History of treatment with thrombolytic/fibrinolytic agents within 7 days prior to randomization or the concurrent/anticipated use of any of those agents after randomization up until 30 days following the study drug administration.","PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion

PZ-128",DrugBank:DB11839,PZ-128,CCCCCCCCCCCCCCCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1ccccc1)C(N)=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02561000,NCT02561000_EG002,No,All,Adult | Older Adult,Phase 2,31,"Inclusion Criteria:

The subject is at least 18 years of age and may be of either sex/gender and of any race and ethnicity.

The subject is scheduled to undergo non-emergent PCI or non-emergent cardiac catheterization with the intention of performing PCI. The following classifications of the urgency of the procedure at the time the operator decides to perform it will be used for randomization stratification:

Elective: The cardiac catheterization procedure ± PCI can be performed on an outpatient basis or during a subsequent hospitalization without significant risk of MI or death. For stable inpatients, this is a procedure that is performed during the hospitalization for convenience and ease of scheduling only and not because the subject's clinical situation demands that the procedure be performed prior to discharge.

OR

Urgent: The cardiac catheterization ± PCI procedure should be performed on an inpatient basis and before discharge because of significant concerns about the risk of myocardial ischemia, MI and/or death. For subjects who are outpatients or in the emergency department at the time that the cardiac catheterization is requested, this is a procedure that would warrant hospital admission based on clinical presentation.
There is no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to the initiation of the cardiac catheterization ± PCI procedure if the subject were not a participant in the current research study, and no anticipation of use during the procedure.
The subject is willing and able to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules (i.e., subject signs an approved informed consent document(s) and provides HIPAA authorization);
The subject will undergo all of the pre-enrollment parameters according to the study protocol prior to randomization and have them completed within 14 days prior to the scheduled cardiac catheterization ± PCI procedure and study drug administration.
Women of childbearing potential (all postmenarchal women who are <1 year menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception from the time written informed consent is given up until 90 days following the study drug administration.

Subject Exclusion Criteria:

The subject will be excluded from entry if any of the criteria listed below are met:

(General Exclusions)

Subject is pregnant, intends to become pregnant or is breast-feeding (all women of child-bearing potential must have a negative pregnancy test result confirmed prior to randomization and it must be repeated to be within 24 hours prior to the study drug administration if necessary).

Any of the following allergy history(s):

History of an allergic reaction* or contraindication to any of the following protocol-directed drugs: aspirin, heparin, P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor), antihistamines (benadryl, famotidine); or
History of an allergic reaction* to contrast media; or
History of an allergic reaction* to a drug which required emergency medical treatment;

History of an allergic reaction* to a Hymenoptera sting which currently necessitates the subject to carry an EpiPen/injector or the subject has been prescribed one to treat an allergic reaction to a sting.

An allergic (anaphylactic) reaction is characterized by an adverse local or general response from exposure to an allergen involving skin/mucosal tissue manifestations (hives, pruritus, flushing, angioedema), and/or respiratory compromise (dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia), and/or hemodynamic effects (hypo/hypertension, hypotonia, syncope).
Participation in another research study of investigational therapy (drug or device) within the past 30 days prior to randomization or planned use of other investigational therapy(s) during this research study (until 90 days following the study drug administration).
Subject is part of the study staff personnel directly involved with this trial, or is a family member of the study staff (clinical site or sponsor).
Prior enrollment (randomization) in this research study.

Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the research study or which would, in the opinion of the investigator, unacceptably increase the subject's risk by participating in the research study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts.

(Exclusionary Prior/Concomitant Conditions)

Evidence of an ST-segment elevation myocardial infarction (STEMI) on presentation or during current hospitalization or a history of STEMI within the past 30 days prior to randomization.
Subject is scheduled to undergo PCI for known unprotected left main coronary artery (LMCA) disease (i.e., left main stenosis ≥50% not protected by at least 1 patent bypass graft).
Any history of a prior stroke (hemorrhagic or ischemic) or transient ischemic attack (TIA) of any etiology.
Cardiogenic or any type of shock on presentation or during current hospitalization (i.e., systolic blood pressure <90 mm Hg requiring vasopressor or hemodynamic support).
History of heparin-induced thrombocytopenia (HIT).
Any active bleeding within the past 30 days prior to randomization.
Any condition or personal belief (e.g., Jehovah's Witness) which would interfere with the subject's ability or willingness to undergo a blood transfusion.

Any of the following conditions associated with increased risk of bleeding:

history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra- articular bleeding;
gastrointestinal bleeding within the past 30 days prior to randomization;
gastric or duodenal ulcer disease verified by endoscopy or barium meal contrast technique within the past 6 months prior to randomization;
history of bleeding disorder or diathesis;
major surgical procedure or trauma within the past 60 days prior to randomization or a planned surgical procedure to take place within 30 days following the study drug administration;
history or suspicion of intracranial neoplasm, arteriovenous malformation, or aneurysm; or
clinical finding(s) in the judgment of the investigator that poses an increased risk of bleeding.
Sustained severe hypertension: systolic blood pressure >185 mm Hg or diastolic blood pressure >105 mm Hg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >185/105 mm Hg including the final BP measurement before randomization).
Hypotension: systolic blood pressure <95 mm Hg (as demonstrated by repeated systolic BP measurements <95 mm Hg including the final systolic BP measurement prior to randomization).
Known active hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to ≥2.5 times the upper limit of the reference range within the past 30 days prior to randomization.
Hemoglobin <10 g/dL or hematocrit <30%.
Platelet count <75,000/mm3.
Stage 4-5 Chronic Kidney Disease (National Kidney Foundation) or on dialysis.
Active sepsis or suspected sepsis.
Body weight <60 kg or >175 kg.
Current evidence of invasive cancer (persistent disease excluding basal cell carcinoma of the skin) or treatment for invasive cancer within the past 6 months prior to randomization.

Left ventricular ejection fraction <25% if known (any imaging technique) or New York Heart Association (NYHA) Class IV congestive heart failure.

(Exclusionary Prior/Concomitant/Anticipated Medication/Therapy)

Coronary interventional procedure of any kind within the past 30 days prior to randomization.
Anticipated subsequent staged multi-vessel PCI within 30 days following the study drug administration.
History of treatment with any parenteral GP IIb/IIIa inhibitor (GPI) within the past 30 days prior to randomization. (As stated in the Inclusion section, the planned treatment with a GPI prior to initiation of the cardiac catheterization ± PCI is not allowed; however, GPI for thrombotic bailout may be used during the PCI at the investigator's discretion).
Concurrent or anticipated treatment with a parenteral direct thrombin inhibitor (e.g., bivalirudin) for the cardiac catheterization ± PCI procedure.
History of treatment with another PAR1 inhibitor within the past 60 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
History of treatment with another IV anti-platelet drug within 30 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.

Any of the following anticoagulant or thrombolytic/fibrinolytic treatment(s):

History of treatment with warfarin within 5 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
History of treatment with oral Factor Xa or direct thrombin inhibitors within 2 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
History of treatment with thrombolytic/fibrinolytic agents within 7 days prior to randomization or the concurrent/anticipated use of any of those agents after randomization up until 30 days following the study drug administration.","PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion

PZ-128",DrugBank:DB11839,PZ-128,CCCCCCCCCCCCCCCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1ccccc1)C(N)=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02565485,NCT02565485_EG001,No,Female,Adult,Not Applicable,276,"Inclusion Criteria:

Singleton pregnancy with gestational age ≥ 35 weeks
Admission for delivery
Age 18 or older
Desires neuraxial analgesia in labor
No exclusion criteria
Maternal pulse pressure < 45 mmHg on admission (verified by repeat blood pressure)
Category 1 FHT on admission/prior to epidural placement
Epidural placement within 6 hours of admission to Labor and Delivery

Exclusion Criteria:

Multiple gestation
Intrauterine growth restriction
Hypertensive disorders (gestational hypertension, chronic hypertension, and preeclampsia/eclampsia)
Gestational or pregestational diabetes mellitus
Substance abuse
Intrauterine fetal demise
Congenital or chromosomal fetal abnormalities
Category II or III FHR tracing on admission to L&D (pre-epidural)
Contraindication to neuraxial aesthesia (e.g. thrombocytopenia)
Maternal cardiomyopathy, congenital heart disease, active pulmonary edema or any other underlying maternal cardiopulmonary condition that increases the risk of pulmonary edema
Maternal renal insufficiency (serum creatinine > 1.0)
Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement","Patients in this arm will receive 1500mL of Lactated Ringer's solution

Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration",PubChem:6335487,Ringer's lactate,CC(O)C(=O)O.[Ca+2].[Cl-].[Cl-].[Cl-].[Cl-].[K+].[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
NCT02569801,NCT02569801_EG000,No,Female,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER- (defined by local guidelines) metastatic or inoperable, locally advance breast cancer
Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer

Exclusion Criteria:

HER2-positive disease
Prior treatment with fulvestrant
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine therapies for advanced or metastatic disease","Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.",ChEMBL:CHEMBL3581693 | DrugBank:DB12253 | PubChem:56941241,GDC-0810,CC/C(=C(/c1ccc(/C=C/C(=O)O)cc1)c1ccc2[nH]ncc2c1)c1ccc(F)cc1Cl,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02589977,NCT02589977_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,55,"ALL

Inclusion Criteria:

estimated glomerular filtration rate (eGFR) > 60 ml/min
preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

coronary artery disease
diabetes mellitus
contraindications to cardiac magnetic resonance imaging (CMR)
weight >350 lbs
inability to lie flat for imaging
anemia
contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

normal cardiac structure and function on echocardiography
BP < 140/90

Exclusion criteria:

known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

history of BP >140/90
1 or more antihypertensive medications
LV ejection fraction (LVEF) at least 50%
current BP < 160/90

Exclusion criteria:

known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

physician-confirmed diagnosis of HF
symptomatic HF
LVEF at least 50%
elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
current BP < 160/90

Exclusion criteria:

prior history of LVEF below 50%
acute decompensated HF
moderate or greater valvular disease
significant cardiac arrhythmias
pericardial disease
congenital heart disease
primary pulmonary hypertension","No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.

Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.

regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02589977,NCT02589977_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,55,"ALL

Inclusion Criteria:

estimated glomerular filtration rate (eGFR) > 60 ml/min
preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

coronary artery disease
diabetes mellitus
contraindications to cardiac magnetic resonance imaging (CMR)
weight >350 lbs
inability to lie flat for imaging
anemia
contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

normal cardiac structure and function on echocardiography
BP < 140/90

Exclusion criteria:

known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

history of BP >140/90
1 or more antihypertensive medications
LV ejection fraction (LVEF) at least 50%
current BP < 160/90

Exclusion criteria:

known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

physician-confirmed diagnosis of HF
symptomatic HF
LVEF at least 50%
elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
current BP < 160/90

Exclusion criteria:

prior history of LVEF below 50%
acute decompensated HF
moderate or greater valvular disease
significant cardiac arrhythmias
pericardial disease
congenital heart disease
primary pulmonary hypertension","No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.

Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.

regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02589977,NCT02589977_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,55,"ALL

Inclusion Criteria:

estimated glomerular filtration rate (eGFR) > 60 ml/min
preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

coronary artery disease
diabetes mellitus
contraindications to cardiac magnetic resonance imaging (CMR)
weight >350 lbs
inability to lie flat for imaging
anemia
contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

normal cardiac structure and function on echocardiography
BP < 140/90

Exclusion criteria:

known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

history of BP >140/90
1 or more antihypertensive medications
LV ejection fraction (LVEF) at least 50%
current BP < 160/90

Exclusion criteria:

known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

physician-confirmed diagnosis of HF
symptomatic HF
LVEF at least 50%
elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
current BP < 160/90

Exclusion criteria:

prior history of LVEF below 50%
acute decompensated HF
moderate or greater valvular disease
significant cardiac arrhythmias
pericardial disease
congenital heart disease
primary pulmonary hypertension","No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.

Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.

regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants",ChEMBL:CHEMBL317052 | DrugBank:DB06213 | PubChem:219024,Regadenoson,CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1,C01EB21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02603146,NCT02603146_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,71,"Inclusion Criteria:

Subjects who meet all of the following criteria are eligible for enrollment into the study:

Able and willing to give written informed consent and comply with requirements of the study;
Age ≥18 years-old at the Screening Visit; and
Elevation of autoantibody anti-cyclic citrullinated peptide-3 (anti-CCP3) defined by result of anti-CCP3 ≥40 units, at Screening.

Exclusion Criteria:

Subjects who meet any of the following criteria are ineligible to participate in the study:

-A medical history of inflammatory arthritis (IA) of any type and/or rheumatic disease and immunologic disease(s) that may be associated with IA . These diseases include but are not limited to:

rheumatoid arthritis (RA);
systemic lupus erythematosus (SLE);
seronegative spondyloarthropathies;
inflammatory bowel disease;
Sjögren's syndrome;
polymyalgia rheumatic; or
vasculitis.

Note: Crystalline arthropathies are not exclusionary.

A medical history of:

congestive heart failure or functional status of New York Heart Association (NYHA) Class III or higher at the Screening Visit;
cardiomyopathy or significant cardiac conduction disorders;
chronic liver disease;
psoriasis (due to potential for increased risk for flare of skin disease);
porphyria;

and/or serologic evidence during Screening Visit of chronic infections including, but not limited to, human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV);

---Exception: hepatitis C antibody positive subjects are eligible with documentation of:

receipt of HCV treatment AND
a negative hepatitis C viral load test post-treatment.
malignancy within the last 5 years, except for treated basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I; or
alcohol or substance abuse within 1 year of treatment randomization.
Prior or current systemic treatment with disease modifying anti-rheumatic agents, immunomodulatory agents, or glucocorticoids for IA, other rheumatic diseases, or other immunologic diseases;
Tetracycline class antibiotic use for autoimmune conditions, taken within 12 months prior to Screening;
Systemic corticosteroid use for non-IA conditions taken 28 days prior to Screening;
More than 3 local corticosteroid injections, including but not limited to intra-articular, epidural, and intrabursal injections, during the 3 months prior to randomization;
A history of a chronic condition that, in the opinion of the investigator, is highly likely to require therapy with systemic corticosteroids (oral or intravenous) within the study period, including but not limited to severe asthma and severe crystalline arthropathy;
Women who are pregnant, breastfeeding or desire to become pregnant and/or breast feed within the duration of the 12-month treatment phase of the study;
Women of childbearing potential who are not using or who do not agree to use adequate birth control measures (for example, total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants) during the treatment phase of the study;
An ideal or actual body weight ≤ 24.4 kg (e.g., ≤53 lbs) at Screening Visit;

Any of the following laboratory abnormalities at the Screening Visit:

Serum Creatinine Clearance < 50ml/min (as calculated by the Cockcroft-Gault formula: Creatinine clearance (CrCl)= (140-age) X (Weight in kg) X (0.85 if female) / (72 X Creatinine));
Alanine Aminotransferase (ALT) > 2 times the upper limit of normal (ULN);
Aspartate Aminotransferase (AST) > 2x the upper limit of normal (ULN);
Total white blood count (WBC) < 3.0 x 10^9/L;
Platelet count ≤ 150 x10^9/L;
Hemoglobin < 11.5g/dL;
Absolute Neutrophil Count (ANC) < 2.0 x 10^9/L;

Evidence of significant retinal disease upon eye examination during the screening period that in the opinion of the examiner would make identification of potential future retinal toxicity from HCQ difficult to evaluate:

-- Retinal exam results may be applied to evaluations of subject eligibility for up to 6 months after the initial retinal exam.

When, in the opinion of the study physician, the subject is not a good study candidate.","Participants self-administered 1-2 200 mg HCQ pills per day, based on ideal body weight at screening, from the Baseline visit to Week 52.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02603809,NCT02603809_EG001,No,All,Adult | Older Adult,Phase 2,82,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol","Participants received aprocitentan 5 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.",ChEMBL:CHEMBL2165326 | DrugBank:DB15059 | PubChem:25099191,Aprocitentan,NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1,C02KN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02603809,NCT02603809_EG002,No,All,Adult | Older Adult,Phase 2,82,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol","Participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.",ChEMBL:CHEMBL2165326 | DrugBank:DB15059 | PubChem:25099191,Aprocitentan,NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1,C02KN01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02603809,NCT02603809_EG003,No,All,Adult | Older Adult,Phase 2,82,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol","Participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.",ChEMBL:CHEMBL2165326 | DrugBank:DB15059 | PubChem:25099191,Aprocitentan,NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1,C02KN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02603809,NCT02603809_EG004,No,All,Adult | Older Adult,Phase 2,81,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol","Participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.",ChEMBL:CHEMBL2165326 | DrugBank:DB15059 | PubChem:25099191,Aprocitentan,NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1,C02KN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02603809,NCT02603809_EG005,No,All,Adult | Older Adult,Phase 2,81,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol","Participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.",ChEMBL:CHEMBL1237 | DrugBank:DB00722 | PubChem:5362119,Lisinopril,NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O,C09AA03 | C09BA03 | C09BB03 | C10BX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02604940,NCT02604940_EG000,No,All,Adult,Phase 4,46,"Inclusion Criteria:

Patients must be undergoing open bariatric surgery at WVUH-ruby hospital. - They must be ASA class 1, 2 and 3.
Consented individuals.
They must be between the age of 18 to 55.

Exclusion Criteria:

History of bradycardia or tachy-brady syndrome HR<45.
1st degree heart block or higher.
Patient refusal.
On pain medication for any reason for more than 24 hrs within 2 weeks of procedure.
Allergy to medication.
History of alcohol or drug abuse.
History of Cardiac/ liver/ kidney disease","Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure

Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02610231,NCT02610231_EG000,No,All,Adult | Older Adult,Phase 3,239,"Inclusion Criteria:

Written informed consent;
Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
Subject who have had neurosurgical operation for PD;
Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).","Treatment for 52 weeks

Istradefylline 20 mg or 40 mg",ChEMBL:CHEMBL431770 | DrugBank:DB11757 | PubChem:5311037,Istradefylline,[H]/C(=C(/[H])c1nc2c(c(=O)n(CC)c(=O)n2CC)n1C)c1ccc(OC)c(OC)c1,N04CX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02625974,NCT02625974_EG000,No,All,Child,Phase 3,219,"Inclusion Criteria:

Part 1:

Male and female pediatric subjects aged 0 days to younger than 18 years
Chagas' disease diagnosed/ confirmed for a) Subjects < 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to < 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA

Part 2:

- Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment

Exclusion Criteria:

Part 1:

Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score < 7 at 5 minutes
Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease
Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease
Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis
Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy
Clinically significant psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy
Subjects with contraindications/ warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox
Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to immunosuppression by several diseases or treatment with steroids)
Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country

Part 2:

Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study
Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country
Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease
Immuno-compromised subjects (e.g. with human immunodeficiency virus or treated with immunosuppressive drugs)","Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)",ChEMBL:CHEMBL290960 | DrugBank:DB11820 | PubChem:6842999,Nifurtimox,CC1CS(=O)(=O)CCN1/N=C/c1ccc([N+](=O)[O-])o1,P01CC01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02633371,NCT02633371_EG000,No,All,Child | Adult,Not Applicable,10,"Inclusion Criteria:

Eligible subjects must be 12-25 years old and meet consensus criteria for primary focal hyperhidrosis: focal, visible, excessive sweating of at least 6 months duration without apparent cause with at least two of the following characteristics: 1) Bilateral and relatively symmetric, 2) Impairs daily activities, 3) Frequency of at least one episode per week, 4) Age of onset less than 25 years, 5) Positive family history, 6) Cessation of focal sweating during sleep.
Eligible subjects must have moderate to severe hyperhidrosis which correlates to a score of 3 or 4 on the HDSS.
Hyperhidrosis must affect the bilateral axilla; however, patients with concurrent focal hyperhidrosis affecting the palms, soles, face, or other area will not be excluded.
Subjects must be willing to comply with the study protocol.

Exclusion Criteria:

Subjects with hyperhidrosis of less than 6 months duration or hyperhidrosis secondary to an underlying infectious, endocrine, or neurologic disorder.
Treatment with botulinum toxin injections to the axillae or other affected areas within the last 12 weeks OR treatment with other agents (oral anticholinergic medications, topical aluminum chloride) in the last 4 weeks.
Subjects with active skin inflammation or infection affecting the axilla
Subjects who report history of closed-angle glaucoma, urinary retention, decreased gastrointestinal motility, hiatal hernia, cardiac arrhythmia, coronary artery disease, congestive health failure, hyperthyroidism, myasthenia gravis, xerostomia, renal insufficiency, or hepatic impairment.
Subjects with hypertension defined as systolic blood pressure > 140 or diastolic blood pressure > 90 on more than 1 occasion separated by 1 week.
Subjects with the following: history of somnolence, confusion, hallucinations OR subjects taking other medications that may cause somnolence, confusion, hallucinations OR subjects with other medical conditions that may predispose them for somnolence, confusion, or hallucinations.
Subjects who have demonstrated hypersensitivity to the drug substance or other components of the product
Subjects taking drugs which inhibit Cytochrome P450 3A4 (CYP3A4)
Pregnant and/or nursing females
Any other disease that would interfere with the study or place them at undue risk or who are in any way unable to comply with study requirements.","Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks

Oxybutynin 3% gel",PubChem:91505,Oxybutynin Chloride,CCN(CC)CC#CCOC(=O)C(O)(c1ccccc1)C1CCCCC1.Cl,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02638623,NCT02638623_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,52,"Inclusion Criteria:

All patients >= 18 years of age, undergoing a total primary knee or hip arthroplasty

Exclusion Criteria:

Patients weighing less than 80 kg.
Patients undergoing irrigation and debridement, explantation, or revision will not be eligible.
history of kidney disease, congestive heart failure, pulmonary edema, cirrhosis of the liver, or history of systemic fluid overloard will be excluded from the study.
No one will be excluded based on gender, ethnicity or race.","Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement

Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty",PubChem:56841910,Natrii lactatis solutio composita,CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02639429,NCT02639429_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,236,"Inclusion Criteria

Nulliparous women aged 18 or above
BMI ≥ 30 at the time of labor induction
Singleton gestation
Cephalic presentation (includes successful external cephalic version)
Intact fetal membranes
Unfavorable cervix (Bishop score of ≤ 6)
Gestational age ≥ 32 weeks

Exclusion Criteria

Patient not candidate for IOL with misoprostol as deemed by the treating physician
Multiple gestation
Major fetal anomalies
Fetal demise","These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.

Vaginal Misoprostol",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02654782,NCT02654782_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Non-pregnant female patients
Patients undergoing elective cardiac surgery
Aspirin, heparin, or warfarin preoperatively accepted

Exclusion Criteria:

Previous sternotomy
Emergency surgery
Combined procedures (vascular or thoracic operations)
Congenital heart repair
Hypothermic cardiopulmonary bypass (CPB) < 28 degrees C
Serum creatinine greater than or equal to 1.5 mg/dL
Dialysis dependent renal failure
Neurologic injury or event within 30 days (including transient ischemic attack)
Cerebrovascular accident with significant residual neurologic deficit
Severe chronic obstructive pulmonary disease with Forced Expiratory Volume in 1 Second (FEV1) < 45% of predicted value
Home oxygen use
Previous difficult intubation
Acute normovolemic blood conservation techniques
Liver disease with serum aspartate aminotransferase (AST) > 31 U/L
Circulatory arrest
Thrombolysis
Pre-existing clotting disorder
Platelet receptor glycoprotein IIb/IIIa (GP IIb/IIIa) antagonist medication received within 48 hours
Steroids
Ejection Fraction < 40%
Intra-aortic balloon pumps
Ongoing congestive heart failure
Ventricular assist devices
Total hearts
Pregnant women
Adults lacking capacity to consent
Any patients initially enrolled in the study that end up with an intra-aortic balloon pump, left ventricular assist device, or on extracorporeal membrane oxygenation will be eliminated from the study.","Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs.

Lactated Ringer's: Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.",PubChem:56841910,Natrii lactatis solutio composita,CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02658734,NCT02658734_EG000,No,All,Adult | Older Adult,Phase 4,70,"Inclusion Criteria:

Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site
Documented progression of unresectable, locally advanced, or mBC, determined by the investigator
Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.

Exclusion Criteria:

Prior treatment with trastuzumab emtansine
Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab
Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])
History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria
History of exposure to cumulative doses of anthracyclines, as defined in the protocol
History of radiation therapy within 14 days of enrollment
Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment
CNS only disease
History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
History of myocardial infarction or unstable angina within 6 months of enrollment
Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
Current severe, uncontrolled systemic disease
Pregnancy or lactation
Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines
Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol",3.6 mg/kg of trastuzumab emtansine was administered to participants intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle and was repeated every 3 weeks.,PubChem:166596981 | PubChem:168318470,Kadcyla,COc1cc2cc(c1Cl)N(C)C(=O)CC(OC(=O)C(C)N(C)C(=O)CCSC1CC(=O)N(CC3CCC(C(N)=O)CC3)C1=O)C1(C)OC1C(C)C1CC(O)(NC(=O)O1)C(OC)C=CC=C(C)C2,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02660229,NCT02660229_EG001,No,All,Adult | Older Adult,Phase 4,32,"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: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection",PubChem:5464280,Morphine sulphate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02670538,NCT02670538_EG001,No,All,Adult | Older Adult,Phase 3,167,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
Currently treated as an outpatient at the time of enrollment

A verified previous manic or mixed episode. Verification must include one of the following sources:

Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania
Hospital records/Medical records
Patient report corroborated by caretaker or previous or current treating clinician
17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
HAMD-17 item 1 score ≥ 2
CGI-S score ≥ 4
Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Exclusion Criteria:

Young Mania Rating Scale (YMRS) total score > 12
Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias

History of meeting DSM-5 criteria for:

Dementia, amnesic, or other cognitive disorder
Schizophrenia, schizoaffective, or other psychotic disorder
Mental retardation
DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1

Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception:

Patients with a positive cannabinoid on entry may be retested before randomization. If the patient remains positive, the patient is no longer eligible
Patients positive for opiates on entry, discussion with Study Physician is required.
Electroconvulsive therapy in the 3 months before Visit 1
Previous lack of response to electroconvulsive therapy
Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
Known history of cataracts or retinal detachment
Known human immunodeficiency virus infection
Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center","Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02670538,NCT02670538_EG002,No,All,Adult | Older Adult,Phase 3,158,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
Currently treated as an outpatient at the time of enrollment

A verified previous manic or mixed episode. Verification must include one of the following sources:

Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania
Hospital records/Medical records
Patient report corroborated by caretaker or previous or current treating clinician
17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
HAMD-17 item 1 score ≥ 2
CGI-S score ≥ 4
Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Exclusion Criteria:

Young Mania Rating Scale (YMRS) total score > 12
Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias

History of meeting DSM-5 criteria for:

Dementia, amnesic, or other cognitive disorder
Schizophrenia, schizoaffective, or other psychotic disorder
Mental retardation
DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1

Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception:

Patients with a positive cannabinoid on entry may be retested before randomization. If the patient remains positive, the patient is no longer eligible
Patients positive for opiates on entry, discussion with Study Physician is required.
Electroconvulsive therapy in the 3 months before Visit 1
Previous lack of response to electroconvulsive therapy
Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
Known history of cataracts or retinal detachment
Known human immunodeficiency virus infection
Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center","Following a 7 to 14 day screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02670551,NCT02670551_EG001,No,All,Adult | Older Adult,Phase 3,157,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
Currently treated as an outpatient at the time of enrollment
A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician
17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
HAMD-17 item 1 score ≥ 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4
Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Exclusion Criteria:

Young Mania Rating Scale (YMRS) total score > 12
Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias

History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder

○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study

History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
Electroconvulsive therapy in the 3 months before Visit 1
Previous lack of response to electroconvulsive therapy
Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
Known history of cataracts or retinal detachment
Known human immunodeficiency virus infection
Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center","Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02670551,NCT02670551_EG002,No,All,Adult | Older Adult,Phase 3,165,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
Currently treated as an outpatient at the time of enrollment
A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician
17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
HAMD-17 item 1 score ≥ 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4
Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Exclusion Criteria:

Young Mania Rating Scale (YMRS) total score > 12
Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias

History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder

○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study

History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
Electroconvulsive therapy in the 3 months before Visit 1
Previous lack of response to electroconvulsive therapy
Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
Known history of cataracts or retinal detachment
Known human immunodeficiency virus infection
Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center","Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02671760,NCT02671760_EG001,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.","2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02680314,NCT02680314_EG000,No,Female,Adult,Phase 2,243,"Inclusion Criteria:

Any pregnant woman undergoing induction of labor
Live singleton pregnancy ≥ 37 week gestation
Bishop score < 6
Category I fetal heart rate

Exclusion Criteria:

Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
Pregnancies complicated by major fetal anomalies
Any contraindication to the use of misoprostol, including
History of previous c-section or major uterine surgery
Prior allergic reaction
Category II or III fetal heart rate
Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
Estimated fetal weight < 10 percentile
Premature rupture of membranes
Age < 18 years old
Women who do not have the capacity to consent",single dose of misoprostol,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02680314,NCT02680314_EG001,No,Female,Adult,Phase 2,243,"Inclusion Criteria:

Any pregnant woman undergoing induction of labor
Live singleton pregnancy ≥ 37 week gestation
Bishop score < 6
Category I fetal heart rate

Exclusion Criteria:

Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
Pregnancies complicated by major fetal anomalies
Any contraindication to the use of misoprostol, including
History of previous c-section or major uterine surgery
Prior allergic reaction
Category II or III fetal heart rate
Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
Estimated fetal weight < 10 percentile
Premature rupture of membranes
Age < 18 years old
Women who do not have the capacity to consent",multiple doses of misoprostol,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02681809,NCT02681809_EG002,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria:

Male or female aged 18 years or older
Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
HbA1c ≤ 12%, as assessed by the central laboratory
Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
No evidence of total PVD in the study eye
Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
Presence of epiretinal membrane in the study eye
Presence of foveal ischemia in the study eye
Presence of pre-retinal or vitreous haemorrhage in the study eye
Presence of iris or angle neovascularisation in the study eye
Any active ocular / intraocular infection or inflammation in either eye
Aphakic study eye
Uncontrolled hypertension in the opinion of the Investigator
Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability",Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02682901,NCT02682901_EG000,No,All,Adult | Older Adult,Phase 4,43,"Inclusion Criteria:

Type 2 diabetes subjects between the ages of 30 and 80 years of age, inclusive, at Screening
Hemoglobin A1c (HbA1c) ≤10.0% at screening
Male or female (female of child bearing age must use definitive contraceptive therapy)
Type 2 Diabetes Mellitus subjects on a stable anti-diabetes regimen of diet and/or metformin alone therapy or on metformin plus an insulin secretion enhancer (sulfonylureas, dipeptidyl peptidase 4 (DPP4) Inhibitors, Glucagon-like peptide (GLP-1) analogs) therapy for a 60 day period prior to randomization. Subjects with diabetes duration of ≥ 4 years must be using an insulin secretion enhancer (e.g. sulphonylureas (SU), DPP4, GLP-1 analog). Subjects must have a documented C-peptide level (either fasting or random) of >2 ng/ml from the screening visit.

Exclusion Criteria:

Presence of type 1 diabetes mellitus (defined as C-peptide <1 ng /ml)
Type 2 diabetes mellitus subjects on insulin.
Use of prescription sympathomimetics, ergot alkaloid derivatives, or anti-migraine medications, dopamine2 (D2)-like receptor antagonists (e.g. metoclopramide, domperidone) or systemic corticosteroids
Uncontrolled hypertension (systolic BP >160 or diastolic BP > 100 at screening) or a history of orthostatic hypotension
History of significant gastroparesis
Presence of diabetic retinopathy that is more severe than ""background"" level
Presence of diabetic nephropathy, or renal impairment defined by blood urea nitrogen (BUN) >40mg/dl and serum creatinine > 1.4 mg/dl if female taking metformin, >1.5 mg/dl. if male taking metformin, and >1.6 mg/dl if not taking metformin
Presence of clinically significant peripheral or autonomic neuropathy that is clearly of non-diabetic origin
History of major macrovascular events such as myocardial infarction or cerebrovascular event such as stroke within the past 6 months. Other exclusions include coronary artery bypass graft or coronary angioplasty in the previous 3 months, unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the emergency room or hospital for chest pain) within the previous 3 months, or seizure disorders.
Active infection (e.g., human immunodeficiency virus (HIV), hepatitis), or a history of severe infection during the 30 days prior to screening
Major surgical operation during the 30 days prior to screening
Cancer, other than non-melanoma skin or non-metastatic prostate cancer, within the past 5 years
Uncontrolled or untreated hypothyroidism as evidenced by thyroid stimulating hormone (TSH) concentrations >4.8 µU/ml
Other serious medical conditions which, in the opinion of the investigator, would compromise the subject's participation in the study, including any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen, or conditions or abnormalities (e.g., blindness) that might interfere with interpretation of safety or efficacy data, or history of non-compliance
Clinically significant abnormalities on screening laboratory evaluation, unless approved by the Sponsor
Abnormalities of liver function defined as any liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum glutamic-pyruvic transaminase (SGPT), Serum glutamic oxaloacetic transaminase (SGOT) greater than 3 times the upper limit of normal
History of New York Heart Association (NYHA) Class III-IV congestive heart failure.
Concurrent participation in another clinical trial with use of an experimental drug or device within 30 days of study entry.
History of alcohol or substance abuse or dementia
Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening. Women who become pregnant will be discontinued from the study.
Known hypersensitivity to any of the formulation components
Working rotating, varying or night shifts
Use of unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc)
Patients who have started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients may not begin treatment with an erectile dysfunction drug during the study period; patients currently taking erectile dysfunction drugs should do so only under medical supervision.
Donation of blood in the previous 30 days. Blood donation is also not allowed during the study or for 30 days after completion of the study.","Subjects were randomized in a double blind 1:1 ratio to receive UDT (usual diabetes therapy) plus bromocriptine-QR. Following randomization subjects were titrated to the maximum tolerated dose of the study drug over a four-week period. During these first 4 weeks, the daily dose of the study drug was titrated up by one tablet (0.8 mg bromocriptine-QR) per day on a weekly basis until a maximal tolerated dose of at least two tablets (1.6 mg/day bromocriptine-QR) and no more than four tablets (3.2 mg/per day b-QR) was achieved. Subjects were maintained at their maximum tolerated dose of between two to four tablets per day (1.6 to 3.2 mg bromocriptine-QR per day) for the duration of the study (24 weeks). Subjects were evaluated at 4 weeks after randomization, at 12 weeks after randomization, and then at study end (week 24 or early termination).

Cycloset: Cycloset 1.6 -3.2 mg/day",PubChem:31100,Bromocriptine Mesylate,CC(C)CC1C(=O)N2CCCC2C2(O)OC(NC(=O)C3C=C4c5cccc6[nH]c(Br)c(c56)CC4N(C)C3)(C(C)C)C(=O)N12.CS(=O)(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02685033,NCT02685033_EG001,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

A diagnosis of osteomyelitis (first episode) defined by:
Pain or point tenderness upon palpation or probing to bone
Plain radiograph or Magnetic resonance imaging (MRI) consistent with osteomyelitis (indistinctly marginated edema-like pattern of bone marrow hypointensity on unenhanced T1-weighted sequences, hyperintensity on fat-saturated T2-weighted and Short tau inversion recovery (STIR) sequences and/or abnormal enhancement on gadolinium-enhanced fat-saturated T2-weighted sequences, with or without visible periostitis or cortical bone destruction) OR Gram-positive cocci documented on a baseline Gram-stain from a bone specimen
Elevated C-reactive protein (CRP) (low sensitivity) above the upper limit of normal (ULN) (reference range for low sensitivity CRP is 3-10 mg/L)
Participants must be willing and able, if discharged from the hospital, to return to the hospital or a designated clinic for scheduled visits, treatment, laboratory tests, and other outpatient procedures as required by the protocol.

Exclusion Criteria:

Treatment with an investigational drug within 30 days preceding the first dose of investigational product.
Receipt of > 24 hours of potentially effective IV antibacterial therapy for osteomyelitis within 96 hours of randomization, unless the pathogen isolated was documented to be Methicillin-resistant Staphylococcus aureus (MRSA) that was resistant to the administered antibiotic.
A prior episode of osteomyelitis, or a failed course of therapy for osteomyelitis.
Infection associated with a burn wound, with a sacral decubitus ulcer, or with multiple sites of osteomyelitis.
Septic arthritis that is non-contiguous to osteomyelitis, as diagnosed by isolation of a pathogen from synovial fluid culture.
Immunosuppression/immune deficiency
Evidence of Gram-negative bacteria by Gram stain in the absence of Gram-positive organisms.
Gram-negative bacteremia
Patients with concomitant endocarditis, necrotizing fasciitis, or prosthetic material at the site of infection at the time of study initiation.
Infection due to an organism known prior to study entry to not be susceptible to dalbavancin (dalbavancin mean inhibitory concentration [MIC] > 0.12 μg/mL) or vancomycin (vancomycin MIC > 2 μg/mL).
Concomitant systemic antibacterial therapy for Gram-positive infections (eg, rifampin, gentamicin).
Known or suspected hypersensitivity to glycopeptide antibiotics.
Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
Pregnant or nursing females; positive urine (or serum) pregnancy test at Screening (pre-menopausal females only) or after admission (prior to dosing)
Sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least the first dose of study drug until the last pregnancy test.","Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02687217,NCT02687217_EG001,No,All,Child | Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

Clinical diagnosis or Radiological diagnosis of acute appendicitis.
Appendectomy through the Mc Burney incision.

Exclusion Criteria:

Patients with chronic obstructive pulmonary diseases.
Immunodeficiency disease.
Patients requiring midline incision.
Patients requiring general anaesthesia after failure of spinal anaesthesia.
Patients requiring higher oxygen in perioperative period.","Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.

oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02690727,NCT02690727_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,16,"Inclusion Criteria:

Healthy male volunteers; aged 18 to 45 years;
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
Non- smokers or ex-smokers;
Able to give informed consent.

Exclusion Criteria:

Subjects with evidence or history of clinically significant disease;
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
Subjects who have received any investigational drug in the previous 28 days;
Subjects participated in a study with PI3k inhibitors at least once in past year;
Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.","A single dose of RP6530 following fast condition

RP6530: Single oral dose",DrugBank:DB15295 | PubChem:86291103,Tenalisib,CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02690727,NCT02690727_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 1,16,"Inclusion Criteria:

Healthy male volunteers; aged 18 to 45 years;
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
Non- smokers or ex-smokers;
Able to give informed consent.

Exclusion Criteria:

Subjects with evidence or history of clinically significant disease;
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
Subjects who have received any investigational drug in the previous 28 days;
Subjects participated in a study with PI3k inhibitors at least once in past year;
Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.","A single dose of RP6530 following fed condition

RP6530: Single oral dose",DrugBank:DB15295 | PubChem:86291103,Tenalisib,CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02690935,NCT02690935_EG000,No,All,Adult | Older Adult,Phase 4,51,"Inclusion Criteria:

Age ≥18 years, male and female
Woman of childbearing age using effective contraceptive means
Patient having the faculties to understand and respect the constraints of the study
Symptomatic since at least two seasons and confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE positive if at least class 3 (≥ 3.5 kU / L); these tests must have been performed at the latest at the first screening visit
Signature of the Informed Consent Form

Exclusion Criteria:

Pregnant woman or woman wishing to become pregnant
Breastfeeding woman
Patient with an acute exacerbation of allergic rhinitis
Patient with uncontrolled asthma
Immunotherapy received within the last two years
Patient with a known lactose intolerance
Patient who participated in a clinical study in the previous three months
Patient who is not sufficiently motivated to engage on a follow-up period of 6 months or more, unable to complete the patient diary, or likely to travel or to move before the end of the study,
Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient's records)","Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug",ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02707055,NCT02707055_EG000,No,All,Adult | Older Adult,Phase 2,37,"INCLUSION CRITERIA:
Male or female individuals 18-70 years old (inclusive)
Current Alcohol Use Disorder (AUD) by DSM-5 criteria based on the SCID
Most recent urine drug test for illegal drugs of abuse is negative
Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is less than or equal to 8
Heart rate less than or equal to 100 on two separate measurements, both assessed after CIWA-Ar score is less than or equal to 8

Female subjects must be of non childbearing potential as defined by at least one of the following criteria:

a) Females 45-70 years old, who are menopausal, defined as follow:

i) Females who are between 45-55 years old: they will be considered menopausal if they satisfy all the following three requirements during screening: 1) they are in amenorrhea, defined as absence of menstruation for the previous 12 months; 2) they have a negative urine pregnancy test; and 3) they have a serum FSH level within the laboratory s reference range for postmenopausal females.

ii) Females who are between 56-70 years old: they will be considered menopausal if they are in amenorrhea, defined as absence of menstruation for the previous 12 months before screening.

OR

b) Females 21-70 years old, who have a documented hysterectomy and/or bilateral oophorectomy.

All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy) will be considered to be of childbearing potential.

Male subjects must use one of the following methods of contraception from the first dose of study medication and until 28 days after dosing (given that it is unknown whether the effects of this drug can cause birth defects):

Abstinence.

A condom AND one of the following:

Vasectomy for more than 6 months.

Female partner who meets one of the following conditions:

Has had a tubal ligation, hysterectomy, or bilateral oophorectomy;
Is post menopausal;

Uses one of the following forms of contraception:

Copper or hormonal containing IUD;

Spermicidal foam/gel/film/cream/suppository;

Diaphragm with spermicide;

Oral contraceptive;

Injectable progesterone;

Subdermal implant.

EXCLUSION CRITERIA:

Lifetime clinical diagnosis of schizophrenia or bipolar disorder
EKG with QTc > 450 msec as determined by the Fridericia formulas.
BMI less than or equal to 18.5 kg/M(2) or anorexia
BMI greater than or equal to 40 kg/m(2)
History of epilepsy and/or seizures

NOTE: individuals who have a history of alcohol withdrawal seizures may be in the study as long as they have been abstinent from alcohol for at least 2 weeks prior to consent and during that period of abstinence, there were no seizure episodes (otherwise, participant remains not eligible).

Most recent blood tests show creatinine greater than or equal to 2 mg/dL, AST or ALT > 3 times the upper normal limit, hemoglobin <10.5 g/dl
Subjects who have diabetes and/or are treated with any drug with glucose lowering properties such as sulfonylurea, insulin, metformin, thiazolidinediones (TZD), Dipeptidyl peptidase-4 (DPP4) inhibitors, or Glucagon-like peptide-1(GLP-1)agonists (due to the glucose-lowering properties of PF-05190457 observed in healthy volunteers)

Exclusionary Medications:

A. Naltrexone, acamprosate, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, baclofen, drugs that are known to prolong the QTc interval and barbiturates as well as hormone replacement therapy; medications and dietary/herbal supplements (like St. John's wort) that interact with Cytochrome P450 3A4. Patients who take these medications may be enrolled in the study only if the potentially interacting medication has been stopped for a period of at least 5 half-lives of the interacting medication before PF-05190457 administration. Patients who take these medications on an as needed (PRN) schedule or take

the medication as a one-time dose as part of a medical procedure or a diagnostic test, for example, may not have to wait the 5 half-lives period of time before enrollment; this will be evaluated on a case by case basis by the MAI and/or PI, based on the specific pharmacological properties of the medication.

Unable to pass a finger rub hearing test
Vision is unable to be corrected to (Snellen) 20/100
Clinically-significant history of motion or car sickness, or history of vestibular disorders
Any other reason or clinical condition for which the PI or the MAI will consider unsafe for a possible participant to participate in this study

EXCLUSION CRITERIA FOR fMRI ONLY:

Have contraindications for brain fMRI, as determined by the NIAAA MRI Safety screening form (conducted under the 14-AA-0181 Screening Protocol)
Colorblindness (this would prevent subject from completing the Stroop task) using the Ishihara Test for Color Deficiency, Concise Edition, 2014.",Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days,PubChem:58438464,"2-(2-methylimidazo[2,1-b][1,3]thiazol-6-yl)-1-[2-[(1R)-5-(6-methylpyrimidin-4-yl)-2,3-dihydro-1H-inden-1-yl]-2,7-diazaspiro[3.5]nonan-7-yl]ethanone",Cc1cc(-c2ccc3c(c2)CCC3N2CC3(CCN(C(=O)Cc4cn5cc(C)sc5n4)CC3)C2)ncn1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02707757,NCT02707757_EG000,No,All,Adult | Older Adult,Phase 4,88,"Inclusion Criteria:

All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion Criteria:

Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.","Iron sucrose 200mg for 5 doses

Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02726074,NCT02726074_EG000,No,All,Child | Adult | Older Adult,Phase 4,102,"Inclusion Criteria:

Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)

Exclusion Criteria:

Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
Presence of previous history of Lennox-Gastaut syndrome
Presence of nonmotor simple partial seizures only
Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
Participant who is participating in other intervention clinical trial","During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02735343,NCT02735343_EG000,No,All,Adult | Older Adult,Phase 3,5,"THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria

Age 18 to 65 years who present to the ED with complaint of a headache
Temperature less than 100.4 F
Diastolic blood pressure less than 104 mm Hg
Normal neurologic exam and normal mental status

Exclusion Criteria

Pregnant or breastfeeding
Meningeal signs are present
Acute angle closure glaucoma is suspected
Head trauma within the previous two weeks
Lumbar puncture within the previous two weeks
Thunderclap (rapid) onset of the headache
Weight more than 150 kg or less than 40 kg
Known allergy to diphenhydramine
Known allergy to ondansetron. (Zofran)
Known allergy to Compazine
Known allergy to Ketamine
History of schizophrenia or bipolar disorder
History of intracranial hypertension
Is a prisoner
Patient declined informed consent
Non-English speaking patient
Attending provider excludes patient
Elderly patients with dementia
Patients with severe headaches that diminish their decision making capability will not be able to participate","compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously

Compazine: Compazine 10mg with diphenhydramine 25 mg IV",ChEMBL:CHEMBL728 | DrugBank:DB00433 | PubChem:4917,Prochlorperazine,CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1,N05AB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02737332,NCT02737332_EG000,No,Male,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Written informed consent obtained prior to any study-related procedure being performed
Male subjects at least 18 years of age or older at time of consent
Pathologically confirmed adenocarcinoma of the prostate
Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening
Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.

Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:

Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,
Imaging progression (CT/MRI) by RECIST criteria
Nuclear scan progression by new lesion.
Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.
Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.
ECOG performance status of 0-1 at screening

Screening blood counts of the following:

Absolute neutrophil count > 1500/µL
Platelets > 100,000/µL
Hemoglobin > 9 g/dL

Screening chemistry values of the following:

ALT and AST < 2.5 x ULN
Total bilirubin < 1.5 x ULN
Creatinine< 1.5 x ULN
Albumin > 3.0 g/dL
Potassium > 3.5 mmol/L
Life expectancy of at least 6 months at screening
Subject is willing and able to comply with all protocol requirements assessments
Agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

History of impaired pituitary or adrenal gland function
Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
Prior therapy with enzalutamide
Prior use of experimental androgen receptor antagonist
Previous exposure to Ra-223:Xofigo
Previous chemotherapy
Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.
Therapy with estrogen within 30 days prior to the start of study medication
Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients who have discontinued or have reduced dose to < 10 mg prednisone within 14 days prior to the start of study medication will be eligible
Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
Known metastases to the brain or CNS involvement
History of other malignancy within the previous 2 years
Major surgery within 30 days prior to the start of study medication
Blood transfusion within 30 days of screening
Serious, persistent infection within 14 days of the start of study medication
Persistent pain that requires the use of a narcotic analgesic
Known gastrointestinal disease or condition that may impair absorption
Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
Have poorly controlled diabetes.
Uncontrolled hypertension
History of New York Heart Association (NYHA) class III or IV heart failure
Serious concurrent illness, including psychiatric illness, that would interfere with study participation
Inability to swallow tablets whole
Known hypersensitivity to any excipients in study medications
Moderate to severe hepatic impairment (Child-Pugh Classes B and C)","1,000 MG (4 x 250 mg qd)

Zytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg",ChEMBL:CHEMBL271227 | PubChem:9821849,ABIRATERONE ACETATE,CC(=O)O[C@H]1CC[C@@]2(C)C(=CC[C@@H]3[C@@H]2CC[C@]2(C)C(c4cccnc4)=CC[C@@H]32)C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02746991,NCT02746991_EG000,No,All,Adult | Older Adult,Phase 3,52,"Inclusion Criteria:

Male or non pregnant female at least 18 years of age at time of consent
One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration
At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Subject is not planning to undergo elective ocular surgery during the study
Subject has ability to understand and sign the Informed Consent Form
Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:

systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis

OR the study eye has experienced recurrence:

• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid

Exclusion Criteria:

Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert
History of posterior uveitis only that is not accompanied by vitritis or macular edema
History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
Uveitis with infectious etiology
Vitreous hemorrhage
Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
Ocular malignancy in either eye, including choroidal melanoma
Toxoplasmosis scar in study eye or scar related to previous viral retinitis
Previous viral retinitis
Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures
Media opacity precluding evaluation of retina and vitreous
Peripheral retinal detachment in area of insertion
Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)
IOP > 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye
Chronic hypotony (< 6 mmHg)
Ocular surgery on the study eye within 3 months prior to study Day 1
Capsulotomy in study eye within 30 days prior to study Day 1
Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis
Systemic infection within 30 days prior to study Day 1
Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
Treatment with an investigational drug or device within 30 days prior to study Day 1
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years",Placebo Injection,DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02753699,NCT02753699_EG000,No,All,Adult | Older Adult,Phase 3,164,"Inclusion Criteria:

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Exclusion Criteria:

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.",All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.,ChEMBL:CHEMBL1651956 | DrugBank:DB12139 | PubChem:11513676,Alisporivir,C/C=C/C[C@@H](C)[C@@H](O)[C@H]1C(=O)N[C@@H](CC)C(=O)N(C)[C@H](C)C(=O)N(CC)[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@H](C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](C(C)C)C(=O)N1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02753699,NCT02753699_EG001,No,All,Adult | Older Adult,Phase 3,397,"Inclusion Criteria:

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Exclusion Criteria:

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.",All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.,ChEMBL:CHEMBL1651956 | DrugBank:DB12139 | PubChem:11513676,Alisporivir,C/C=C/C[C@@H](C)[C@@H](O)[C@H]1C(=O)N[C@@H](CC)C(=O)N(C)[C@H](C)C(=O)N(CC)[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@H](C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](C(C)C)C(=O)N1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02761694,NCT02761694_EG002,No,All,Adult | Older Adult,Phase 1,1,"Inclusion Criteria

Signed written informed consent granted prior to initiation of any study-specific procedures
18 years of age and older
Histologically and/or cytologically documented diagnosis of a selected tumor type that is locally advanced, inoperable, metastatic or recurrent (including but not restricted to breast cancer, TNBC [triple negative]; HR-positive [HR+]/HER2-negative [HER2-] or endometrial cancer)

Documented AKT genetic alterations or known actionable PIK3CA/PTEN mutations by genetic testing

• Participants with tumors with PTEN null/PTEN loss-of-function mutations are not eligible

For combination arms; participants should be eligible for paclitaxel or fulvestrant therapy as per Investigator assessment

Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable

Participants in single agent arm (with AKT genetic alterations) and participants in dose escalation cohorts of combination therapy arms should have at least one line of standard systemic therapy
Participants in single agent arm (with PIK3CA/PTEN actionable mutations) and participants in the expansion cohorts of combination therapy arms should have no more than 3 prior systemic regimens for the advanced disease
Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgery
If the participant is refractory or has disease progression within 6 months after completion of the adjuvant treatment, then the adjuvant treatment should be considered as the line of treatment rather than an adjuvant therapy.
Endocrine (hormonal) therapy does not count toward total lines of therapy
Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued
Has at least one measurable target lesion according to RECIST v. 1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

Adequate organ function as indicated by the following laboratory values. (All laboratory tests must be obtained within 14 days prior to the first dose of study treatment):

Hematological

Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
Platelet count (Plt) ≥ 100 x 10⁹/L
Hemoglobin (Hb) ≥ 9 g/dL
International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for participants receiving anticoagulant therapy such as Coumadin or heparin

Renal

Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with serum creatinine levels > 1.5 x institutional ULN

Hepatic

Total bilirubin ≤ 1.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5 x ULN for participants with known liver metastases

Metabolic

Glycated hemoglobin (HbA1c) ≤ 8% (≤ 64 mmol/mol)

If a participant is currently receiving bisphosphonates or any other drug for treatment of osteoporosis, treatment-induced bone loss and metastases to bone, the participant must have received the bisphosphonates for at least four weeks prior to the first dose of study treatment

• Initiation of bisphosphonates or similar agents during the study may be allowed provided the participant completes the first cycle of treatment without any dose limiting toxicity (DLT) and the Investigator rules out tumor progression

Male or female participants of child-producing potential must agree to use adequate contraception, including double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after the last dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test. ""Women of childbearing potential"" is defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months prior to the first dose of study treatment

Exclusion Criteria

Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of study treatment

To be eligible for study treatment, toxicity from prior treatment(s) must recover to Grade ≤ 1, except for alopecia
Concurrent systemic high-dose corticosteroids (in dosing exceeding 10 mg QD of prednisone equivalent) when used intermittently in an antiemetic regimen, for central nervous system (CNS) metastases management, or as a part of the premedication regimen are allowed

Radiation therapy within four weeks, or palliative radiation therapy within two weeks, prior to administration of the first dose of study treatment

To be eligible for study treatment, radiation therapy-related toxicity must recover to Grade ≤ 1 prior to administration of the first dose of study treatment
Concurrent palliative radiotherapy for local pain-control or prevention of fracture (for known bone metastases) may be allowed provided the participant completes the first cycle of treatment, does not meet criteria of progressive disease, and treated lesions will not be included in the target/non-target lesion assessment

Major surgical procedure within four weeks prior to administration of the first dose of study treatment

• To be eligible for the study treatment, all surgical wounds must be fully healed, and any surgery-related adverse events must recover to Grade ≤ 1.

Unable or unwilling to swallow the complete daily dose of vevorisertib

Previous treatment with

AKT inhibitors (e.g., ARQ 092, MK-2206, GSK2141795, AZD5363; prior treatment with PI3K or mammalian target of rapamycin (mTOR) inhibitor are allowed)
Prior taxane therapy for the advanced, metastatic disease (for participants considered for vevorisertib +paclitaxel combination arm only)
Known prior allergic reaction to or severe intolerance of paclitaxel or fulvestrant. Intolerance is defined as a serious adverse event (AE), a grade 3 or 4 AE per Common Terminology Criteria for Adverse Events (CTCAE) v.4.03, or permanent treatment discontinuation
History of Type 1 diabetes mellitus or Type 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL at Screening visit
Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of vevorisertib (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, extensive gastric resection)

Known untreated or active CNS metastases and/or carcinomatous meningitis

• To be eligible for the study treatment, participants must have stable disease ≥ 1 month, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications

History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV congestive heart failure within 6 months of the administration of the first dose of study treatment (MI occurring > 6 months of the first dose of study treatment will be permitted); Grade 2 or worse conduction defect (e.g., right or left bundle branch block)
A heart rate corrected QT (QTc) interval ≥ 480 msec, using the Fridericia's formula QTcF
Left ventricular ejection fraction (LVEF) <50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) in participants who received prior treatment with anthracyclines

Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements, including but not limited to:

Psychiatric illness, substance abuse
Ongoing or active known infection, including human immunodeficiency virus (HIV) infection, hepatitis B or C virus
Significant pulmonary dysfunction, including pneumonitis, interstitial lung disease (ILD), idiopathic pulmonary fibrosis, cystic fibrosis, severe chronic obstructive pulmonary disease (COPD)
Peripheral neuropathy grade ≥2 (vevorisertib+paclitaxel combination arm)
Bleeding diathesis, thrombocytopenia or coagulation disorders (vevorisertib+fulvestrant combination arm)
Thrombotic/coagulation disorders within 6 months prior to the first dose of study treatment unless stable on anticoagulation for > 3 months
Active or history of other malignancy other than the current cancer within 2 years of the first dose of study treatment, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma, and superficial bladder tumors curatively treated
Blood transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility
Pregnant or breastfeeding",Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.,PubChem:71138858,Vevorisertib,CC(=O)N(C)C1CCN(c2cccc(-c3ccc4nc(-c5cccnc5N)n(-c5ccc(C6(N)CCC6)cc5)c4n3)c2)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02761694,NCT02761694_EG004,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Signed written informed consent granted prior to initiation of any study-specific procedures
18 years of age and older
Histologically and/or cytologically documented diagnosis of a selected tumor type that is locally advanced, inoperable, metastatic or recurrent (including but not restricted to breast cancer, TNBC [triple negative]; HR-positive [HR+]/HER2-negative [HER2-] or endometrial cancer)

Documented AKT genetic alterations or known actionable PIK3CA/PTEN mutations by genetic testing

• Participants with tumors with PTEN null/PTEN loss-of-function mutations are not eligible

For combination arms; participants should be eligible for paclitaxel or fulvestrant therapy as per Investigator assessment

Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable

Participants in single agent arm (with AKT genetic alterations) and participants in dose escalation cohorts of combination therapy arms should have at least one line of standard systemic therapy
Participants in single agent arm (with PIK3CA/PTEN actionable mutations) and participants in the expansion cohorts of combination therapy arms should have no more than 3 prior systemic regimens for the advanced disease
Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgery
If the participant is refractory or has disease progression within 6 months after completion of the adjuvant treatment, then the adjuvant treatment should be considered as the line of treatment rather than an adjuvant therapy.
Endocrine (hormonal) therapy does not count toward total lines of therapy
Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued
Has at least one measurable target lesion according to RECIST v. 1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

Adequate organ function as indicated by the following laboratory values. (All laboratory tests must be obtained within 14 days prior to the first dose of study treatment):

Hematological

Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
Platelet count (Plt) ≥ 100 x 10⁹/L
Hemoglobin (Hb) ≥ 9 g/dL
International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for participants receiving anticoagulant therapy such as Coumadin or heparin

Renal

Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with serum creatinine levels > 1.5 x institutional ULN

Hepatic

Total bilirubin ≤ 1.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5 x ULN for participants with known liver metastases

Metabolic

Glycated hemoglobin (HbA1c) ≤ 8% (≤ 64 mmol/mol)

If a participant is currently receiving bisphosphonates or any other drug for treatment of osteoporosis, treatment-induced bone loss and metastases to bone, the participant must have received the bisphosphonates for at least four weeks prior to the first dose of study treatment

• Initiation of bisphosphonates or similar agents during the study may be allowed provided the participant completes the first cycle of treatment without any dose limiting toxicity (DLT) and the Investigator rules out tumor progression

Male or female participants of child-producing potential must agree to use adequate contraception, including double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after the last dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test. ""Women of childbearing potential"" is defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months prior to the first dose of study treatment

Exclusion Criteria

Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of study treatment

To be eligible for study treatment, toxicity from prior treatment(s) must recover to Grade ≤ 1, except for alopecia
Concurrent systemic high-dose corticosteroids (in dosing exceeding 10 mg QD of prednisone equivalent) when used intermittently in an antiemetic regimen, for central nervous system (CNS) metastases management, or as a part of the premedication regimen are allowed

Radiation therapy within four weeks, or palliative radiation therapy within two weeks, prior to administration of the first dose of study treatment

To be eligible for study treatment, radiation therapy-related toxicity must recover to Grade ≤ 1 prior to administration of the first dose of study treatment
Concurrent palliative radiotherapy for local pain-control or prevention of fracture (for known bone metastases) may be allowed provided the participant completes the first cycle of treatment, does not meet criteria of progressive disease, and treated lesions will not be included in the target/non-target lesion assessment

Major surgical procedure within four weeks prior to administration of the first dose of study treatment

• To be eligible for the study treatment, all surgical wounds must be fully healed, and any surgery-related adverse events must recover to Grade ≤ 1.

Unable or unwilling to swallow the complete daily dose of vevorisertib

Previous treatment with

AKT inhibitors (e.g., ARQ 092, MK-2206, GSK2141795, AZD5363; prior treatment with PI3K or mammalian target of rapamycin (mTOR) inhibitor are allowed)
Prior taxane therapy for the advanced, metastatic disease (for participants considered for vevorisertib +paclitaxel combination arm only)
Known prior allergic reaction to or severe intolerance of paclitaxel or fulvestrant. Intolerance is defined as a serious adverse event (AE), a grade 3 or 4 AE per Common Terminology Criteria for Adverse Events (CTCAE) v.4.03, or permanent treatment discontinuation
History of Type 1 diabetes mellitus or Type 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL at Screening visit
Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of vevorisertib (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, extensive gastric resection)

Known untreated or active CNS metastases and/or carcinomatous meningitis

• To be eligible for the study treatment, participants must have stable disease ≥ 1 month, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications

History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV congestive heart failure within 6 months of the administration of the first dose of study treatment (MI occurring > 6 months of the first dose of study treatment will be permitted); Grade 2 or worse conduction defect (e.g., right or left bundle branch block)
A heart rate corrected QT (QTc) interval ≥ 480 msec, using the Fridericia's formula QTcF
Left ventricular ejection fraction (LVEF) <50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) in participants who received prior treatment with anthracyclines

Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements, including but not limited to:

Psychiatric illness, substance abuse
Ongoing or active known infection, including human immunodeficiency virus (HIV) infection, hepatitis B or C virus
Significant pulmonary dysfunction, including pneumonitis, interstitial lung disease (ILD), idiopathic pulmonary fibrosis, cystic fibrosis, severe chronic obstructive pulmonary disease (COPD)
Peripheral neuropathy grade ≥2 (vevorisertib+paclitaxel combination arm)
Bleeding diathesis, thrombocytopenia or coagulation disorders (vevorisertib+fulvestrant combination arm)
Thrombotic/coagulation disorders within 6 months prior to the first dose of study treatment unless stable on anticoagulation for > 3 months
Active or history of other malignancy other than the current cancer within 2 years of the first dose of study treatment, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma, and superficial bladder tumors curatively treated
Blood transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility
Pregnant or breastfeeding",Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.,PubChem:71138858,Vevorisertib,CC(=O)N(C)C1CCN(c2cccc(-c3ccc4nc(-c5cccnc5N)n(-c5ccc(C6(N)CCC6)cc5)c4n3)c2)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02761694,NCT02761694_EG005,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria

Signed written informed consent granted prior to initiation of any study-specific procedures
18 years of age and older
Histologically and/or cytologically documented diagnosis of a selected tumor type that is locally advanced, inoperable, metastatic or recurrent (including but not restricted to breast cancer, TNBC [triple negative]; HR-positive [HR+]/HER2-negative [HER2-] or endometrial cancer)

Documented AKT genetic alterations or known actionable PIK3CA/PTEN mutations by genetic testing

• Participants with tumors with PTEN null/PTEN loss-of-function mutations are not eligible

For combination arms; participants should be eligible for paclitaxel or fulvestrant therapy as per Investigator assessment

Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable

Participants in single agent arm (with AKT genetic alterations) and participants in dose escalation cohorts of combination therapy arms should have at least one line of standard systemic therapy
Participants in single agent arm (with PIK3CA/PTEN actionable mutations) and participants in the expansion cohorts of combination therapy arms should have no more than 3 prior systemic regimens for the advanced disease
Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgery
If the participant is refractory or has disease progression within 6 months after completion of the adjuvant treatment, then the adjuvant treatment should be considered as the line of treatment rather than an adjuvant therapy.
Endocrine (hormonal) therapy does not count toward total lines of therapy
Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued
Has at least one measurable target lesion according to RECIST v. 1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

Adequate organ function as indicated by the following laboratory values. (All laboratory tests must be obtained within 14 days prior to the first dose of study treatment):

Hematological

Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
Platelet count (Plt) ≥ 100 x 10⁹/L
Hemoglobin (Hb) ≥ 9 g/dL
International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for participants receiving anticoagulant therapy such as Coumadin or heparin

Renal

Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with serum creatinine levels > 1.5 x institutional ULN

Hepatic

Total bilirubin ≤ 1.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5 x ULN for participants with known liver metastases

Metabolic

Glycated hemoglobin (HbA1c) ≤ 8% (≤ 64 mmol/mol)

If a participant is currently receiving bisphosphonates or any other drug for treatment of osteoporosis, treatment-induced bone loss and metastases to bone, the participant must have received the bisphosphonates for at least four weeks prior to the first dose of study treatment

• Initiation of bisphosphonates or similar agents during the study may be allowed provided the participant completes the first cycle of treatment without any dose limiting toxicity (DLT) and the Investigator rules out tumor progression

Male or female participants of child-producing potential must agree to use adequate contraception, including double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after the last dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test. ""Women of childbearing potential"" is defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months prior to the first dose of study treatment

Exclusion Criteria

Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of study treatment

To be eligible for study treatment, toxicity from prior treatment(s) must recover to Grade ≤ 1, except for alopecia
Concurrent systemic high-dose corticosteroids (in dosing exceeding 10 mg QD of prednisone equivalent) when used intermittently in an antiemetic regimen, for central nervous system (CNS) metastases management, or as a part of the premedication regimen are allowed

Radiation therapy within four weeks, or palliative radiation therapy within two weeks, prior to administration of the first dose of study treatment

To be eligible for study treatment, radiation therapy-related toxicity must recover to Grade ≤ 1 prior to administration of the first dose of study treatment
Concurrent palliative radiotherapy for local pain-control or prevention of fracture (for known bone metastases) may be allowed provided the participant completes the first cycle of treatment, does not meet criteria of progressive disease, and treated lesions will not be included in the target/non-target lesion assessment

Major surgical procedure within four weeks prior to administration of the first dose of study treatment

• To be eligible for the study treatment, all surgical wounds must be fully healed, and any surgery-related adverse events must recover to Grade ≤ 1.

Unable or unwilling to swallow the complete daily dose of vevorisertib

Previous treatment with

AKT inhibitors (e.g., ARQ 092, MK-2206, GSK2141795, AZD5363; prior treatment with PI3K or mammalian target of rapamycin (mTOR) inhibitor are allowed)
Prior taxane therapy for the advanced, metastatic disease (for participants considered for vevorisertib +paclitaxel combination arm only)
Known prior allergic reaction to or severe intolerance of paclitaxel or fulvestrant. Intolerance is defined as a serious adverse event (AE), a grade 3 or 4 AE per Common Terminology Criteria for Adverse Events (CTCAE) v.4.03, or permanent treatment discontinuation
History of Type 1 diabetes mellitus or Type 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL at Screening visit
Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of vevorisertib (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, extensive gastric resection)

Known untreated or active CNS metastases and/or carcinomatous meningitis

• To be eligible for the study treatment, participants must have stable disease ≥ 1 month, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications

History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV congestive heart failure within 6 months of the administration of the first dose of study treatment (MI occurring > 6 months of the first dose of study treatment will be permitted); Grade 2 or worse conduction defect (e.g., right or left bundle branch block)
A heart rate corrected QT (QTc) interval ≥ 480 msec, using the Fridericia's formula QTcF
Left ventricular ejection fraction (LVEF) <50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) in participants who received prior treatment with anthracyclines

Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements, including but not limited to:

Psychiatric illness, substance abuse
Ongoing or active known infection, including human immunodeficiency virus (HIV) infection, hepatitis B or C virus
Significant pulmonary dysfunction, including pneumonitis, interstitial lung disease (ILD), idiopathic pulmonary fibrosis, cystic fibrosis, severe chronic obstructive pulmonary disease (COPD)
Peripheral neuropathy grade ≥2 (vevorisertib+paclitaxel combination arm)
Bleeding diathesis, thrombocytopenia or coagulation disorders (vevorisertib+fulvestrant combination arm)
Thrombotic/coagulation disorders within 6 months prior to the first dose of study treatment unless stable on anticoagulation for > 3 months
Active or history of other malignancy other than the current cancer within 2 years of the first dose of study treatment, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma, and superficial bladder tumors curatively treated
Blood transfusion or administration of growth factors within 5 days prior to a blood draw being used to confirm eligibility
Pregnant or breastfeeding",Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.,PubChem:71138858,Vevorisertib,CC(=O)N(C)C1CCN(c2cccc(-c3ccc4nc(-c5cccnc5N)n(-c5ccc(C6(N)CCC6)cc5)c4n3)c2)CC1,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02777190,NCT02777190_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Pregnant Female Patients greater than or equal to 18 years of age
Induction of labor for a single live intrauterine pregnancy
Greater than or equal to 37 weeks gestational age
Cephalic presentation
20 minute reassuring fetal heart rate (reactive nonstress test (NST))
Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

Previous uterine scar
Contraindication to vaginal delivery
Patients with preeclampsia
Grand multiparty - greater than or equal to 5 live births or stillbirths
Premature rupture of membranes
Suspected intrauterine growth restriction
Fetal anomalies
Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)",oral misoprostol given 25 mcg every 2 hours,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02777190,NCT02777190_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Pregnant Female Patients greater than or equal to 18 years of age
Induction of labor for a single live intrauterine pregnancy
Greater than or equal to 37 weeks gestational age
Cephalic presentation
20 minute reassuring fetal heart rate (reactive nonstress test (NST))
Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

Previous uterine scar
Contraindication to vaginal delivery
Patients with preeclampsia
Grand multiparty - greater than or equal to 5 live births or stillbirths
Premature rupture of membranes
Suspected intrauterine growth restriction
Fetal anomalies
Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)",vaginal misoprostol given 25 mcg every 4 hours,ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02783820,NCT02783820_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Completion of the written informed consent process.
Men or WNCBP age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

Male subjects agree to use acceptable methods of contraception if the male subject's partner could become pregnant from the time of the first administration of study medication until 130 (90+40) days following administration of the investigational medicinal product. One of the following acceptable methods of contraception must be utilized:

Condom and occlusive cap (diaphragm or cervical/vault caps)
Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
The subject's female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
The subject's female partner uses medically prescribed topically-applied transdermal contraceptive patch and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
The subject's female partner has undergone documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
The subject's female partner has undergone documented placement of an intrauterine device or intrauterine system. In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
True 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. Abstinent subjects have to agree to use 1 of the above-mentioned contraceptive methods, if they start sexual relationships during the study and for up to 100 days after the last dose of study drug.

Women subjects must be of non-childbearing potential (WNCBP) as per one of the following definitions:

Natural (spontaneous) post-menopausal defined as being amenorrhoeic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level consistent with local laboratory levels for post-menopause.
Premenopausal with irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy or salpingectomy at least 6 months before screening (as determined by subject medical history).
Haematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator. More specifically, serum creatinine, hepatic transaminase enzymes (AST ALT), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm and haemoglobin must be equal to or higher than the lower limit of the normal range.
Total body weight greater than 50 kg and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
Non-smoker or ex-smoker for more than 90 days prior to screening, or smoke no more than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Agree to stay in contact with the study site for the duration of the study and up to 2 weeks following the end of study visit, provide updated contact information as necessary, and have no current plans to move away from the study area for the duration of the study.

Exclusion Criteria:

Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal (including gallbladder), cardiovascular (including a family history of long QT syndrome or sudden death), hepatic, psychiatric, neurologic, or allergic disease (including drug or food allergies, anaphylaxis or other severe allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
Other severe acute or chronic medical or psychiatric condition 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 subject inappropriate for entry into this study.
Any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion.
Previous splenectomy.
A history of photosensitivity.

Subject positive for any of the following

Anti-human immunodeficiency virus 1 or 2 antibodies (anti-HIV1 or anti-HIV2 Ab) (ELISA)
Hepatitis B surface antigen (HBsAg)
Anti-hepatitis B core antibodies (anti-HBcAb)
Anti-hepatitis C antibodies (anti-HCV)

Resting vital signs (measured after 5 minutes in the supine position) at screening, pre-dose (Part A) or pre-inoculation (Part B) outside of the following study-specific normal ranges:

tympanic body temperature < 38.0 °C
90 < SBP < 140 mmHg
50 < DBP < 90 mmHg
40 < pulse rate < 100 bpm
Symptomatic postural hypotension at screening, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg 2 minutes after changing from a supine to standing position.

A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening, pre-dose (Part A and B) or pre-inoculation (Part B):

PR >210 ms
QRS complex >120 ms
QTcF >450 ms
Second or third degree atrioventricular block
Incomplete, complete or intermittent bundle branch block
Abnormal T wave morphology
Left ventricular hypertrophy with repolarisation abnormalities
Right ventricular hypertrophy.
Presence of acute infectious disease or fever (i.e. tympanic body temperature ≥38.5 ºC) within five days prior to the first dose of study medication (Part A) or the inoculation administration (Part B).
Use of prescription or non-prescription drugs, herbal and dietary supplements within 14 days or 5 half-lives (whichever is the longer) prior to the first dose of study medication (Part A) or the inoculation administration (Part B). [As an exception, paracetamol may be used at doses of up to 1 g/day (Part A) or 2 g/day (Part B), or ibuprofen up to 1.2 g/day (Part B). Limited use of other non-prescription medications not believed to affect subject safety or the overall results of the study, may be permitted on a case-by-case basis following approval by the sponsor.]
Recipient of any vaccination within 28 days prior to the first dose of study medication (Part A) or the inoculation administration (Part B).
Urine drug screen at screening, pre-dose (Part A) or pre-inoculation (Part B) positive for any drug as listed in Section 9.2.4 unless there is an explanation acceptable to the medical Investigator (e.g. the subject has stated in advance that they consumed a prescription or over the counter product which contained the detected drug) and/or the subject has a negative urine drug screen on retest by the pathology laboratory.
Ingestion of any poppy seeds within the 24 hours prior to the screening blood test.
A positive alcohol breath test at screening, pre-dose (Part A) or pre-inoculation (Part B).
History of regular alcohol consumption exceeding a weekly intake of more than 21 units for males and more than 14 units for females (one unit is equivalent to 8-10 g of ethanol, 285 ml of beer or lager, one glass [125 ml] of wine, or 25 ml of spirits) within 6 months of screening.
History of drug habituation, or any prior intravenous usage of an illicit substance.
Participation in any investigational product study within 12 weeks or five half-lives (whichever is longer) prior to the first dose of the study medication.
Intake of grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g. Seville oranges, pomelos) within 28 days prior to the first dose of the study medication.
Excessive consumption of beverages containing xanthine bases (e.g. more than 400 mg of caffeine per day, equivalent to approximately 4 cups of coffee).
Pregnant or nursing (lactating) women.
Participation in any research study involving blood sampling (more than 450 ml/ unit of blood), or blood donation to the Australian Red Cross Blood Service (ARCBS) or other blood bank during the 8 weeks prior to IMP administration (Part A) or inoculation (Part B).
Blood donation (excluding plasma donation) of any volume, within 1 month prior to screening.
Medical requirement for intravenous immunoglobulin or blood transfusions.
Subject with poor peripheral venous access.
Subject unwilling or unable to comply with the restrictions described in this protocol.
Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.).","MMV390048 40 mg, tablets, single dose",PubChem:53311393,"5-(4-(Methylsulfonyl)phenyl)-6'-(trifluoromethyl)-3,3'-bipyridine-2-amine",CS(=O)(=O)c1ccc(-c2cnc(N)c(-c3ccc(C(F)(F)F)nc3)c2)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02784834,NCT02784834_EG000,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria:

Clinical and phenotypic verification of B cell CLL/ SLL/ or MBL and measurable disease.
Relapsed or refractory disease
Previously treated with at least 1 regimen for CLL/SLL

Not appropriate or amenable to all approved therapies.

All patients must have progressed on or after B-cell receptor targeted kinase inhibitor (eg: ibrutinib, idelalisib, ACP-196, CC-292), unless there is a relative contraindication (eg: history of recent bleeding, history of atrial fibrillation, unacceptable high out-of-pocket cost despite patient assistance programs).
Patients with Del(17p) CLL must have progressed on or after BCL-2 inhibitor therapy (eg: venetoclax), unless there is a relative contraindication (eg: Creatinine clearance < 50ml/min, or unable to monitor for TLS due to living remotely from the medical center, unacceptably high out-of-pocket cost).
Patients must have received a CD20-directed monoclonal antibody (eg: obinutuzumab, ofatumumab, rituximab), unless there is a relative contraindication (eg: history of hepatitis virus infection).
Has recovered from the toxic effects of prior therapy to their clinical baseline.
Women of childbearing potential must agree not to become pregnant for the duration of the study.
Both men and women must agree to use a barrier method of contraception for the duration of the study and until 8 weeks after the final dose.

Subjects must have at least one of the following indications for treatment:

Symptomatic or progressive splenomegaly;
Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy;
Progressive anemia;
Progressive thrombocytopenia;
Weight loss > 10% body weight over the preceding 6 month period;
Fatigue attributable to CLL;
Fever or night sweats for > 2 weeks without evidence of infection;
Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 12 months.
ECOG performance status of 0-2.
Adequate hematologic function
Adequate renal function
Adequate hepatic function

Exclusion Criteria:

Pregnant or breast-feeding women will not be entered on this study.
Patients who are currently receiving another investigational agent are excluded.
Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of DMF or at any time during the study.
Patients who have had prior (within 8 weeks of initiation of DMF) or concurrent antibody therapy directed against CLL (i.e. Rituxan and Campath)
Patients who have had tyrosine kinase inhibitor therapy (eg: ibrutinib or idelalisib) within 7 half lives (or 28 days, which ever is shorter) of initiation of DMF.
Current infection requiring parenteral antibiotics.
Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
Insufficient recovery from surgical-related trauma or wound healing.

Impaired cardiac function including any of the following:

Myocardial infarction within 6 months of starting study drug;
Other clinically significant heart disease",Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.,ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02785172,NCT02785172_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,62,"Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA (Body Surface Area) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA (Investigators Global Assessment) score of 3 or 4. (The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.","Cream

Ultravate Cream: Cream",ChEMBL:CHEMBL1200908 | PubChem:129009989 | PubChem:129364810 | PubChem:133662452 | PubChem:145706202 | PubChem:4474064 | PubChem:48175 | PubChem:6918178,HALOBETASOL PROPIONATE,CCC(=O)OC1(C(=O)CCl)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C,D07AC21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02785185,NCT02785185_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,57,"Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.","Cream

Ultravate Cream: Cream",ChEMBL:CHEMBL1200908 | PubChem:129009989 | PubChem:129364810 | PubChem:133662452 | PubChem:145706202 | PubChem:4474064 | PubChem:48175 | PubChem:6918178,HALOBETASOL PROPIONATE,CCC(=O)OC1(C(=O)CCl)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C,D07AC21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02788006,NCT02788006_EG000,No,All,Older Adult,Phase 2,42,"Inclusion Criteria:

Metastatic colorectal cancer with histological proof
Measurable disease according RECIST 1.1
Age ≥ 70 years
ECOG ≤ 1
Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
Geriatric Questionnaires answered
Life-expectancy ≥ 3 months
Informed Consent Signed

Exclusion Criteria:

Not able to swallow tablets (crushed tablets are not allowed)
Previous treatment with regorafenib or other multikinase treatment
Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
Toxicity > grade 1 not resolved with previous treatment
Major surgery in the 28 days before the inclusion
Non cicatrized injury, ulcer or bone fracture
Congestive Cardiac insufficiency classe >2 (NYHA)
Unstable angor in the last 3 months
Myocardial Infraction in the 6 months before inclusion
HTA not controlled
Pheochromocytome
Arterial or venous thromboembolism in the past 6 months
Infection of grade > 2
VIH infection
B or C hepatitis necessiting a specific treatment
Cirrhosis
Suspicion of brain metastasis or brain metastasis
Haemorraghe ofgrade >3 in the last weeks
Symptomatic Pulmonary fibrosis
Proteinuria > grade 3
Malabsorption
Allergy know to the treatment or to one similar treatment or to one treatment component
Systemic anti-cancer drug during the study or the the last 4 weeks
Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
Social, psychological or medical condition which can interfere with the study participation","Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)",ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02795117,NCT02795117_EG000,No,All,Adult | Older Adult,Phase 3,486,"Inclusion Criteria:

Must sign an Institutional Review Board (IRB) approved written informed consent for this study.
Must be at least 18 years of age
Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea
Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed.
Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
Current or past ocular rosacea.
Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment.
History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication.
Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
Current use of anticoagulation therapy and use throughout the study.
Use of medicated make-up (including anti-aging make-up) throughout the study
Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
Use of medicated cleansers on the face (throughout the study.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
Previous enrollment in this study or current enrollment in this study at another participating site.
Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study",Ivermectin cream,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02795117,NCT02795117_EG001,No,All,Adult | Older Adult,Phase 3,486,"Inclusion Criteria:

Must sign an Institutional Review Board (IRB) approved written informed consent for this study.
Must be at least 18 years of age
Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea
Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed.
Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
Current or past ocular rosacea.
Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment.
History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication.
Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
Current use of anticoagulation therapy and use throughout the study.
Use of medicated make-up (including anti-aging make-up) throughout the study
Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
Use of medicated cleansers on the face (throughout the study.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
Previous enrollment in this study or current enrollment in this study at another participating site.
Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study",Ivermectin (reference) cream,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02796560,NCT02796560_EG000,No,All,Adult | Older Adult,Phase 4,76,"Inclusion Criteria:

Be apt to give consent
Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

Angle closure glaucoma or having benefited from a peripheral iridotomy
Known allergies to travoprost or to one of the ingredients
Current usage of other glaucoma drops other than travoprost
Current usage of topical corticosteroids
Pregnancy
Breast feeding
Monophthalmic
Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
Active intraocular inflammation
Ocular surface disease that interferes with accurate measuring of the intraocular pressure
Any clinically significant ocular disease that could interfere with the study",Participants received Brand Name Travoprost one drop once daily for 3 weeks.,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02796560,NCT02796560_EG001,No,All,Adult | Older Adult,Phase 4,76,"Inclusion Criteria:

Be apt to give consent
Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

Angle closure glaucoma or having benefited from a peripheral iridotomy
Known allergies to travoprost or to one of the ingredients
Current usage of other glaucoma drops other than travoprost
Current usage of topical corticosteroids
Pregnancy
Breast feeding
Monophthalmic
Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
Active intraocular inflammation
Ocular surface disease that interferes with accurate measuring of the intraocular pressure
Any clinically significant ocular disease that could interfere with the study",Participants received Generic Travoprost one drop once daily for 3 weeks.,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02797067,NCT02797067_EG001,No,All,Adult | Older Adult,Phase 4,1370,"Inclusion Criteria:

any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
at least 18 years old
provides informed consent

Exclusion Criteria:

readmitted to the hospital during the enrollment of the study
contraindications to ESWL
suspected or established malignancy
pancreatic ascites
receiving NSAIDs within 7 days
contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
presence of coagulopathy or received anticoagulation therapy within 3 days
acute pancreatitis within 3 days
known active cardiovascular or cerebrovascular disease
pregnant or breastfeeding women
without a rectum (ie, status post-total proctocolectomy)","Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.

Glycerin Suppository: 30min before ESWL",ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02806414,NCT02806414_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,25,"Inclusion Criteria:

Subject is male or non-pregnant female, 18 - 70 years of age.
Subjects willing and able to give informed consent.
Subjects willing and able to comply with the requirements of the study.
Subject has the clinical diagnosis of rosacea with at least one inflammatory papule and at least mild erythema.
Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
Subject is in general good health in the opinion of the investigator.
Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Exclusion Criteria:

Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans).
Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
Subject has had laser or light-based treatment for rosacea within the prior 3 months.
Subject has had systemic retinoids and retinoid derivatives over the past 6 months
Subject has a known hypersensitivity or allergy to topical ivermectin or components of the vehicle.
Subject is pregnant or lactating or planning a pregnancy during the duration of the study
Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation","All subjects will be treated with topical ivermectin daily for up to 12 weeks.

Ivermectin",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02806960,NCT02806960_EG000,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)

A female participant must meet one of the following criteria:

Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study",Single NG dose of 3 mg.,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02806960,NCT02806960_EG001,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)

A female participant must meet one of the following criteria:

Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study",NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02806960,NCT02806960_EG002,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)

A female participant must meet one of the following criteria:

Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study",NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02806960,NCT02806960_EG003,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)

A female participant must meet one of the following criteria:

Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study",NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02818569,NCT02818569_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

Age between 18-50
Native English speaking
ASA physical status classification P1 and P2 (stable chronic condition)
Normal body habitus.

Exclusion Criteria:

Abnormal sleep habits
Sleeping less than 5 hours each night
Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
Waking up before 5:00 AM or after 10:00 AM on a regular basis.
Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.
Younger than 18 or older than 50 years of age.
Known or suspected sleep disorder(s).","Oral Dexmedetomidine

Dexmedetomidine: Oral form",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02822287,NCT02822287_EG000,No,All,Child | Adult | Older Adult,Phase 3,58,"Inclusion Criteria:

Participants must give written informed consent before any assessment is performed. In the case of adolescents Informed Consent must be signed by one or both parents or legal guardian as per local regulations and an Informed Assent must be signed by the participant.
Must be males or females ≥ 12 years.
Willingness and ability to communicate, to comply with all study requirements and to complete the study.
Productive cough of less than 7 days duration, rated based on interview with the participant as mild to moderate severity on a four- point ordinal scale (not present, mild, moderate, severe) due to upper respiratory tract infection.

Exclusion Criteria:

Use of other investigational drugs before enrollment, or within 30 days or 5 half-lives before enrollment, whichever is longer.
Pre-dose productive cough or sore throat rated as severe on a four-point ordinal scale (not present, mild, moderate, severe) based on interview with the participant.
Pre-dose temperature equal or above 39.4°C at screening measured by oral thermometer.
History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes.
Pregnant , nursing (lactating women) or women with child bearing potential UNLESS they are using effective methods of contraception.
Use of any medication for sore throat containing a local anaesthetic, methanol or any topical products containing menthol, peppermint, spearmint or within the 6 hours prior to dosing.
Use of any paracetamol, non-steroidal anti-inflammatory drug (NSAID) or any oral/nasal decongestant within 6 hours prior to dosing.
Use of substances of abuse, herbal medications, or antihistamines within 48 hours of dosing.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, or heart disease.
Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.
Drinking of any hot beverages 1 hour prior to dosing.
Participant is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products) or smoked or chewed tobacco products within 12 hours before dosing.
Participant is taking nitroglycerin and nitrate drug treatments.
Participants who took antibiotic treatments such as semisynthetic penicillins, tetracyclines, cephalosporins and aminoglycosides within 2 hours of dosing. Amoxicillin, doxycycline, erythromycin, thiamphenicol and cefuroxime are allowed without this restriction.
Participants with gastroduodenal (peptic) ulcers, asthma.
Participants with intolerance to histamines.
Participants who have used antitussives (e.g., dextromethorphan, codeine), anticholinergic drugs (atropine-like) within the past 24 hours.
Participants who have taken heavy metal salts such as calcium, gold and iron within 2 hours of enrollment.
A history of alcohol abuse or an admission by the participant that they regularly consume alcohol in excess of the recommended weekly limits of 21 units for females and 28 units for males.
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.",Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.,PubChem:87067662,Acetylcystine,CC(=O)C(SSCC(N)C(=O)O)C(N)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02829268,NCT02829268_EG000,No,All,Child | Adult,Phase 1 | Phase 2,8,"Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for enrolment:

The patient has a definitive diagnosis of Wolfram syndrome, as determined by the following:

a. Documented functionally relevant recessive mutations on both alleles of the WFS1 gene or dominant mutation on one allele of the WFS1 gene based on historical test results (if available) or from a qualified laboratory at screening.

The patient is at least 5 years of age (biological age) at the time of written informed consent.
The patient, patient's parent(s), or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and patient's assent, as relevant, must be obtained.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

The patient has clinically significant non-Wolfram related CNS involvement which is judged by the investigator to be likely to interfere with the accurate administration and interpretation of protocol assessments.
The patient has a known defect in oxidative phosphorylation (such as a confirmed mitochondrial myopathy)
The patient has abnormal liver function (defined as serum transaminases more than twice the upper limit of normal for the reference laboratory)
The patient has a significant medical or psychiatric co-morbidity that might affect study data or confound the integrity of study results.
The patient has received treatment with any investigational drug within the 30 days prior to study entry.
The patient has received blood product transfusions within 90 days prior to screening.
The patient is unable to comply with the protocol, (e.g. has a clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, known clinically significant psychiatric/behavioural instability, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the Investigator.
The patient has a known history of central apnea and/or ventilation requirements.
The patient has a known history of chronic obstructive pulmonary disease, pleural effusion, and/or myocardial disease.","Pediatric patients treated with dantrolene sodium

dantrolene sodium: The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions.

There is a screening period up to 56 days, a 6-month treatment period and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.",ChEMBL:CHEMBL1201288 | DrugBank:DB01219 | PubChem:2952 | PubChem:5378825 | PubChem:6914273,Dantrolene,O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1,M03CA01,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02829268,NCT02829268_EG001,No,All,Child | Adult,Phase 1 | Phase 2,11,"Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for enrolment:

The patient has a definitive diagnosis of Wolfram syndrome, as determined by the following:

a. Documented functionally relevant recessive mutations on both alleles of the WFS1 gene or dominant mutation on one allele of the WFS1 gene based on historical test results (if available) or from a qualified laboratory at screening.

The patient is at least 5 years of age (biological age) at the time of written informed consent.
The patient, patient's parent(s), or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and patient's assent, as relevant, must be obtained.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

The patient has clinically significant non-Wolfram related CNS involvement which is judged by the investigator to be likely to interfere with the accurate administration and interpretation of protocol assessments.
The patient has a known defect in oxidative phosphorylation (such as a confirmed mitochondrial myopathy)
The patient has abnormal liver function (defined as serum transaminases more than twice the upper limit of normal for the reference laboratory)
The patient has a significant medical or psychiatric co-morbidity that might affect study data or confound the integrity of study results.
The patient has received treatment with any investigational drug within the 30 days prior to study entry.
The patient has received blood product transfusions within 90 days prior to screening.
The patient is unable to comply with the protocol, (e.g. has a clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, known clinically significant psychiatric/behavioural instability, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the Investigator.
The patient has a known history of central apnea and/or ventilation requirements.
The patient has a known history of chronic obstructive pulmonary disease, pleural effusion, and/or myocardial disease.","Adult patients treated with dantrolene sodium

dantrolene sodium: The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions.

There is a screening period up to 56 days, a 6-month treatment period, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.",ChEMBL:CHEMBL1201288 | DrugBank:DB01219 | PubChem:2952 | PubChem:5378825 | PubChem:6914273,Dantrolene,O=C1CN(N=Cc2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1,M03CA01,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02830880,NCT02830880_EG000,No,Male,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
Ability to lie still for PET scanning
Ability to provide written informed consent

Exclusion Criteria:

Age less than 18 years
Inability to lie still for PET scanning
Inability provide written informed consent
Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.",Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan.,ChEMBL:CHEMBL1908917 | DrugBank:DB15237,FLUCICLOVINE,N[C@]1(C(=O)O)C[C@@H](F)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
NCT02838628,NCT02838628_EG001,No,All,Adult | Older Adult,Phase 2,84,"Inclusion Criteria:

Males and females ≥18 years old
Clinical diagnosis of stable, clinically typical actinic keratosis
A define treatment area on the face or scalp
Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
Males who have not had a vasectomy must agree to use barrier contraception
Participants who in the judgment of the Investigator, are in good general health
Willing to avoid excessive sun exposure
Able to comprehend and are willing to sign an informed consent form (ICF)

Exclusion Criteria:

Clinically atypical and/or rapidly changing AK lesions on the treatment area
Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
A history of sensitivity and/or allergy to any of the ingredients in the study medication
A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
Females who are pregnant or nursing
Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.","Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.",ChEMBL:CHEMBL571546 | DrugBank:DB06137 | PubChem:23635314,Tirbanibulin,O=C(Cc1ccc(-c2ccc(OCCN3CCOCC3)cc2)cn1)NCc1ccccc1,D06BX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02851108,NCT02851108_EG000,No,All,Child,Phase 2,50,"Inclusion Criteria:

Weight ≥ 6 kg
Uncomplicated malaria caused by P. falciparum
Asexual parasites ≥ 2 000/µl and ≤ 100 000/µl
Axillary temperature ≥ 37.5°C or a history of fever during the last 24 hours
Burkinabe nationality
Permanent residence in the study area with no intention of leaving during the surveillance period
Written informed consent of parents or care takers

Exclusion Criteria:

Severe malaria
Mixed malaria infection
Vomiting (>2 times within 24 hours before the visit)
Any apparent significant disease, including severe malnutrition
A history of a previous, significant adverse reaction or known allergy to one or more of the study drugs
Anaemia (haemoglobin < 7 g/dl)
Treated in the same trial before
All modern antimalarial treatment prior to inclusion (last seven days)
Therapy with serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, Paroxetine, Sertraline)
Simultaneous participation in another investigational study
Patients with known HIV/AIDS disease
Therapy with drugs known to inhibit the liver enzymes cytochrome 2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or cytochrome 2C8 (e.g. trimethoprim, ketoconazole, ritonavir, saquinavir, lopinavir, gemfibrozil, montelukast)","Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.

Methylene Blue: 50 patients will receive methylene blue",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02856594,NCT02856594_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2 | Phase 3,469,"Inclusion Criteria:

Age ≥ 60
Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours
Scheduled same day surgical admission

Exclusion Criteria:

Blind, deafness or the inability to speak English
Greater than 2 days of ICU admission in the month preceding the current surgical procedure
Renal and liver failure requiring dialysis or Child-Pugh score > 5
Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
Previous cardiac surgery within 1 year of surgical procedure
Allergy to dexmedetomidine
Chronic therapy with benzodiazepines and/or antipsychotics
Severe deficit due to structural or anoxic brain damage
Surgical procedure requiring total circulatory arrest

Objective Drop Criteria

Scheduled for a second surgical procedure during hospital stay
Post-operative intubation > 12 hours","Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.

Dexmedetomidine: Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02858362,NCT02858362_EG001,No,Male,Child | Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Be able to provide written informed consent/assent as per local requirements.
Be male.
Have phenotypic evidence of dystrophinopathy based on the onset of characteristic clinical symptoms or signs (e.g., proximal muscle weakness, waddling gait, and Gowers' manoeuvre), an elevated serum creatinine kinase level, and ongoing difficulty with walking.
Have prior confirmation of the duchenne muscular dystrophy (DMD) diagnosis through:

Documentation of the presence of a mutation in the dystrophin gene as determined by gene sequencing from a laboratory certified by the College of American Pathologists, the Clinical Laboratory Improvement Act/Amendment or an equivalent organisation or documentation of the absence of dystrophin in the muscle (via biopsy).

Be able to undergo MRI examination.
Participants must have used stable systemic corticosteroids (prednisone, prednisolone or deflazacort) for a minimum of 6 months immediately prior to the start of the Treatment Phase, with no significant change in dosage or dosing regimen (not related to body weight change) and a reasonable expectation that dosage and dosing regimen will not change significantly for the duration of the study.
Confirmed screening laboratory values within the central laboratory ranges (haematology, renal and serum electrolyte parameters and serum chemistry parameters) or considered not clinically significant in the opinion of the Investigator. Variations in specific parameters expected in a DMD population classed by the Investigator as not clinically significant will not exclude the participant.
Be willing and able to comply with scheduled visits, drug administration plan, study procedures, laboratory tests and study restrictions.

Cohort 1 and 2 Specific Inclusion Criteria:

Be aged ≥5 years to <10 years of age (from 5th birthday to 10th birthday).
Be willing and able to comply with 2 muscle biopsy procedures.
Have the ability to walk at least 300 meters unassisted during the screening 6 minute walk distance (6MWD) and be below the protocol-specified threshold for 80%-predicted 6MWD.
Have results of 2 6MWD by Baseline determined as valid. The results of the second 6MWD (baseline) must be within 20% of the first 6MWD (screening).
Have cardiac echocardiogram (ECHO) measurements showing an ejection fraction of ≥55% and fractional shortening of ≥28%.

Cohort 3 Specific Inclusion Criteria:

Have taken part in a prior SMT C1100 study.

Exclusion Criteria:

Have physical exam findings that in the Investigator's opinion should be exclusionary e.g., lower limb injury that may affect 6MWD performance.
Have any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation or reinitiation) in prophylaxis/treatment for congestive heart failure (CHF) within 3 months prior to the start of study treatment.
Have uncontrolled clinical symptoms and signs of CHF (American College of Cardiology/American Heart Association Stage C or Stage D).
Have abnormal glutamate dehydrogenase (GLDH) at baseline (>1.5 x upper limit of normal [ULN]).
Have abnormal coagulation times at baseline (>1.5 x ULN).
Have an abnormal electrocardiograms (ECG).
Use herbal supplements and be unwilling to stop these for the duration of the study.
Have been exposed to another investigational drug or DMD interventional agent within 3 months prior to start of the Treatment Phase. Prior exposure to SMT C1100 or participation in an approved deflazacort access program within this period would not exclude the participant (provided they have been on stable treatment for 6 months).
Have a history of major surgical procedure within 12 weeks prior to the start of the Treatment Phase (Week 1).
Be undertaking ongoing immunosuppressive therapy (other than corticosteroids).
Require daytime ventilator assistance.
Have a prior or ongoing medical condition, medical history, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Be dairy or lactose intolerant or have any other dietary restrictions that might interfere with the conduct of the study.
Be a smoker, use other tobacco or nicotine products or be exposed to daily passive smoking (including parent/legal guardian, siblings) so as to minimise environmental factors causing CYP1A induction.
Be using an approved DMD medication or anticipates using one during the duration of the study. Participants who are taking part in the FOR-DMD and ACCESS DMD studies will be allowed to take part.
Be using an inducer of CYP1A1 or CYP1A2.
Be using a substrate of CYP2B6.
All prescription, over the counter, and herbal products that are known CYP2B6 sensitive substrates will be excluded 14 days prior to study conduct (beginning at screening) through 14 days after study conduct completion. Please note, this is not an exhaustive list of CYP2B6 substrates and a discussion with the Medical Monitor may be warranted.
Be using drugs that have serotonergic, norepinephrinergic or dopaminergic activity, or treatments used in attention deficit hyperactivity disorder.
Use of substrates of BRCP.

Cohort 1 and 2 Specific Exclusion Criteria:

Use beta blockers (however, if during the course of the study they are clinically indicated they can be initiated).

Cohort 1 and 3 Specific Exclusion Criteria:

Have a known hypersensitivity to any of the ingredients or excipients of the investigational medicinal product: Poloxamer 188, Methylparaben, Propylparaben, Hydroxypropylmethyl cellulose, Glycerol, Non-crystallising sorbitol [70%], Xanthan gum, Strawberry cream flavour [PHS-132963].

Cohort 2 Specific Exclusion Criteria:

Have a known hypersensitivity to any of the ingredients or excipients of the investigational medicinal product: hypromellose acetate succinate.",Participants received 1 g SMT C1100 formulation 2 orally twice-daily for at least 48 weeks.,DrugBank:DB12888 | PubChem:25109292,Ezutromid,CCS(=O)(=O)c1ccc2oc(-c3ccc4ccccc4c3)nc2c1,,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02858362,NCT02858362_EG002,No,Male,Child | Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Be able to provide written informed consent/assent as per local requirements.
Be male.
Have phenotypic evidence of dystrophinopathy based on the onset of characteristic clinical symptoms or signs (e.g., proximal muscle weakness, waddling gait, and Gowers' manoeuvre), an elevated serum creatinine kinase level, and ongoing difficulty with walking.
Have prior confirmation of the duchenne muscular dystrophy (DMD) diagnosis through:

Documentation of the presence of a mutation in the dystrophin gene as determined by gene sequencing from a laboratory certified by the College of American Pathologists, the Clinical Laboratory Improvement Act/Amendment or an equivalent organisation or documentation of the absence of dystrophin in the muscle (via biopsy).

Be able to undergo MRI examination.
Participants must have used stable systemic corticosteroids (prednisone, prednisolone or deflazacort) for a minimum of 6 months immediately prior to the start of the Treatment Phase, with no significant change in dosage or dosing regimen (not related to body weight change) and a reasonable expectation that dosage and dosing regimen will not change significantly for the duration of the study.
Confirmed screening laboratory values within the central laboratory ranges (haematology, renal and serum electrolyte parameters and serum chemistry parameters) or considered not clinically significant in the opinion of the Investigator. Variations in specific parameters expected in a DMD population classed by the Investigator as not clinically significant will not exclude the participant.
Be willing and able to comply with scheduled visits, drug administration plan, study procedures, laboratory tests and study restrictions.

Cohort 1 and 2 Specific Inclusion Criteria:

Be aged ≥5 years to <10 years of age (from 5th birthday to 10th birthday).
Be willing and able to comply with 2 muscle biopsy procedures.
Have the ability to walk at least 300 meters unassisted during the screening 6 minute walk distance (6MWD) and be below the protocol-specified threshold for 80%-predicted 6MWD.
Have results of 2 6MWD by Baseline determined as valid. The results of the second 6MWD (baseline) must be within 20% of the first 6MWD (screening).
Have cardiac echocardiogram (ECHO) measurements showing an ejection fraction of ≥55% and fractional shortening of ≥28%.

Cohort 3 Specific Inclusion Criteria:

Have taken part in a prior SMT C1100 study.

Exclusion Criteria:

Have physical exam findings that in the Investigator's opinion should be exclusionary e.g., lower limb injury that may affect 6MWD performance.
Have any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation or reinitiation) in prophylaxis/treatment for congestive heart failure (CHF) within 3 months prior to the start of study treatment.
Have uncontrolled clinical symptoms and signs of CHF (American College of Cardiology/American Heart Association Stage C or Stage D).
Have abnormal glutamate dehydrogenase (GLDH) at baseline (>1.5 x upper limit of normal [ULN]).
Have abnormal coagulation times at baseline (>1.5 x ULN).
Have an abnormal electrocardiograms (ECG).
Use herbal supplements and be unwilling to stop these for the duration of the study.
Have been exposed to another investigational drug or DMD interventional agent within 3 months prior to start of the Treatment Phase. Prior exposure to SMT C1100 or participation in an approved deflazacort access program within this period would not exclude the participant (provided they have been on stable treatment for 6 months).
Have a history of major surgical procedure within 12 weeks prior to the start of the Treatment Phase (Week 1).
Be undertaking ongoing immunosuppressive therapy (other than corticosteroids).
Require daytime ventilator assistance.
Have a prior or ongoing medical condition, medical history, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Be dairy or lactose intolerant or have any other dietary restrictions that might interfere with the conduct of the study.
Be a smoker, use other tobacco or nicotine products or be exposed to daily passive smoking (including parent/legal guardian, siblings) so as to minimise environmental factors causing CYP1A induction.
Be using an approved DMD medication or anticipates using one during the duration of the study. Participants who are taking part in the FOR-DMD and ACCESS DMD studies will be allowed to take part.
Be using an inducer of CYP1A1 or CYP1A2.
Be using a substrate of CYP2B6.
All prescription, over the counter, and herbal products that are known CYP2B6 sensitive substrates will be excluded 14 days prior to study conduct (beginning at screening) through 14 days after study conduct completion. Please note, this is not an exhaustive list of CYP2B6 substrates and a discussion with the Medical Monitor may be warranted.
Be using drugs that have serotonergic, norepinephrinergic or dopaminergic activity, or treatments used in attention deficit hyperactivity disorder.
Use of substrates of BRCP.

Cohort 1 and 2 Specific Exclusion Criteria:

Use beta blockers (however, if during the course of the study they are clinically indicated they can be initiated).

Cohort 1 and 3 Specific Exclusion Criteria:

Have a known hypersensitivity to any of the ingredients or excipients of the investigational medicinal product: Poloxamer 188, Methylparaben, Propylparaben, Hydroxypropylmethyl cellulose, Glycerol, Non-crystallising sorbitol [70%], Xanthan gum, Strawberry cream flavour [PHS-132963].

Cohort 2 Specific Exclusion Criteria:

Have a known hypersensitivity to any of the ingredients or excipients of the investigational medicinal product: hypromellose acetate succinate.","Participants in this cohort had previously received SMT C1100, but were not eligible for Cohorts 1 or 2. Participants received 2.5 g SMT C1100 formulation 1 orally twice-daily for at least 48 weeks.",DrugBank:DB12888 | PubChem:25109292,Ezutromid,CCS(=O)(=O)c1ccc2oc(-c3ccc4ccccc4c3)nc2c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02872103,NCT02872103_EG000,No,Female,Adult | Older Adult,Phase 3,83,"Inclusion Criteria:

Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Females ≥ 18 years of age and < 75 years of age.
Diagnosed with Stage II-IV breast cancer.
Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
ECOG Performance status of ≤ 2.
White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

Subject is <18 or ≥ 75 years of age.
Disease progression has occurred while receiving a taxane regimen.
Subject has undergone radiation therapy within 4 weeks of enrollment.
Subject has undergone bone marrow or stem-cell transplantation.
Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
Subject has had chemotherapy within 365 days of screening.
Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Unwillingness to participate in the study.
Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
Any condition, which can cause splenomegaly.
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.
Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.","F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.",DrugBank:DB12269 | PubChem:66571548,PF-06273340,CC(C)(CO)n1cc(C(=O)c2cncc(NC(=O)Cc3ccc(Cl)cn3)c2)c2cnc(N)nc21,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02872103,NCT02872103_EG002,No,Female,Adult | Older Adult,Phase 3,83,"Inclusion Criteria:

Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Females ≥ 18 years of age and < 75 years of age.
Diagnosed with Stage II-IV breast cancer.
Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
ECOG Performance status of ≤ 2.
White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

Subject is <18 or ≥ 75 years of age.
Disease progression has occurred while receiving a taxane regimen.
Subject has undergone radiation therapy within 4 weeks of enrollment.
Subject has undergone bone marrow or stem-cell transplantation.
Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
Subject has had chemotherapy within 365 days of screening.
Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Unwillingness to participate in the study.
Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
Any condition, which can cause splenomegaly.
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.
Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.","F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.",DrugBank:DB12269 | PubChem:66571548,PF-06273340,CC(C)(CO)n1cc(C(=O)c2cncc(NC(=O)Cc3ccc(Cl)cn3)c2)c2cnc(N)nc21,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02880241,NCT02880241_EG001,No,All,Adult,Phase 2,8,"Inclusion Criteria:

Body weight between 40 kg and 90 kg inclusive
Presence of P. vivax or P. falciparum monoinfection confirmed by:
Fever, as defined by axillary temperature ≥37.5°C or oral/rectal/tympanic temperature ≥38°C, or history of fever in the previous 48 hours for P. vivax and 24 hours for P. falciparum and,
Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
Written informed consent provided by the patient in accordance with local practice. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication
The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned
Willing to be hospitalized for at least 72 hours or until malarial parasites are not detected by microscopy on 2 consecutive occasions whichever comes later and return to clinic for all follow-up visits
Women must be of non-childbearing potential (WNCBP) as per one of the following definitions:
postmenopausal defined as having age-appropriate, natural (spontaneous) amenorrhea for at least 12 months prior to screening in the absence of an alternative medical cause for the amenorrhea, or
premenopausal with irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy or salpingectomy at least 6 months prior to screening (as determined by subject medical history)
Sexually active men must agree to comply with strict appropriate contraception rules (barrier contraception, e.g. condom) or complete abstinence when this is in line with the preferred and usual lifestyle of the patient. The contraception coverage in this situation should ensure full elimination of MMV390048, i.e. until 120 days after MMV390048 administration to the enrolled male patient (covering a full sperm cycle of 90 days starting after 5 x t½ of the drug). Abstinent patients must agree to use the above-mentioned contraceptive methods if they start sexual relationships during the study, and to continue these methods until 120 days after study medication.

Exclusion Criteria:

Patients with signs and symptoms of severe / complicated malaria according to the World Health Organisation Criteria 2012
Mixed Plasmodium infection
Vomiting more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or diarrhea equivalent to three or more watery stools per day
Women who are nursing (lactating)
Presence of other serious or chronic clinical condition requiring hospitalisation
Severe malnutrition (defined as a body mass index [BMI] of less than 16 kg/m2 as per local guidelines)
Presence of concurrent febrile illness (e.g. typhoid fever)
Known history or evidence of clinically significant:
cardiovascular disease (including arrhythmia, QTcF interval >450 msec, personal or family history of long QT syndrome, PR interval >200msec; any relevant intra-ventricular heart block [QRS >120msec]),
respiratory conditions (including active tuberculosis),
history of jaundice or other hepatic dysfunction,
renal insufficiency,
gastrointestinal disorder, or any condition that may affect absorption of the study medication (e.g. vomiting or diarrhea),
immunological disorders (including known pre-existing HIV infection),
endocrine disorders (including any type of diabetes mellitus whether controlled or not, diabetes insipidus, uncontrolled hypo- or hyperthyroidism, endocrine reproductive disorders not requiring concurrent medication, disorders of adrenal function),
infectious conditions (other than minor skin or soft tissue infections or confirmed minor lower urinary tract infection),
malignancy,
psychiatric or neurological disorders (including a history of convulsions, major head trauma, focal neurological signs, psychosis, bipolar or major depressive disorder), or
any other disorder or condition that in the opinion of the investigator may render the patient unfit for participation in the trial, may limit his/her ability to provide informed consent, may interfere with protocol adherence or place the patient at increased risk through participation in the study
Known to have any of the following markers of active hepatitis:
Hepatitis A IgM (HAV-IgM),
Hepatitis B surface antigen (HBsAg), or
Hepatitis C antibody (HCV Ab) and HCV RNA
Have received any antimalarial treatment (alone or in combination) during the following periods before screening (list of prohibited medication is provided in Appendix 2):
Piperaquine, mefloquine, naphthoquine or sulphadoxine-pyrimethamine within 6 weeks prior to screening
Amodiaquine, chloroquine, pyronaridine or tafenoquine within 4 weeks prior to screening
Any artemisinin derivative (artesunate, artemether, arteether or dihydroartemisinin), quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening
Any herbal products or traditional medicines during the 7 days prior to screening
Receipt of an investigational drug within 8 weeks or 5 half-lives (whichever is longer) prior to screening
Current participation in any other clinical trial
A history of regular abuse of alcohol, or use of drugs of abuse during the past 6 months, or any clinical signs of substance abuse
Neutrophil count <1,000/µL
Elevated liver function tests as follows:
AST/ALT >2 x the upper limit of normal (ULN), regardless of the level of total bilirubin
AST/ALT >1.5 and ≤2 x ULN and total bilirubin >ULN
AST/ALT >ULN and ≤1.5 x ULN
and total bilirubin >1.5 and ≤2 x ULN,
and conjugated bilirubin ≥35% of the total bilirubin
Total bilirubin >2 x ULN, regardless of the level of AST/ALT
Hb level <8g/dL
Serum creatinine levels >2 x ULN
Platelet level <50,000/mm3.","A single oral dose of up to 120mg MMV390048

MMV390048: Tablets of 20mg each",PubChem:53311393,"5-(4-(Methylsulfonyl)phenyl)-6'-(trifluoromethyl)-3,3'-bipyridine-2-amine",CS(=O)(=O)c1ccc(-c2cnc(N)c(-c3ccc(C(F)(F)F)nc3)c2)cc1,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02880540,NCT02880540_EG001,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,26,"Inclusion Criteria:

BMI ≥ 95th percentile.
Hospitalized overnight after surgery

Exclusion Criteria:

History or a family (parent or sibling) history of malignant hyperthermia
Renal or hepatic disorders
Allergy to opioid analgesics
An allergy to α2-adrenergic agonists or sulfa drugs
Uncontrolled hypertension
Clinically significant neurologic diseases
Pregnancy or lactating female","Dexmedetomidine IV bolus 1.5microgram/kilogram and a continuous infusion starting at 0.1 microgram/kilogram/hour during surgery

Dexmedetomidine",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02882854,NCT02882854_EG000,No,All,Adult | Older Adult,Not Applicable,84,"Inclusion Criteria:

VUMC patients undergoing sinus surgery in MCE OR

Exclusion Criteria:

Inability to read and freely consent
Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)
Patients undergoing sinus surgery planned for greater than 3 hours
Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part
Patients with preoperative nausea/vomiting at baseline.
Pregnant or lactating women","Guanfacine 1 mg capsule by mouth, one time prior to surgery.

Guanfacine: Patients will receive 1 mg of guanfacine to take orally.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02892344,NCT02892344_EG001,No,All,Child | Adult | Older Adult,Phase 3,399,"Inclusion Criteria:

Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
Adult patients who are symptomatic at screening despite treatment with existing therapy.

Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).

Adolescent patients :
If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102
Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.

Exclusion Criteria:

Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
Patients who ever required intubation for a severe asthma attack/exacerbation
Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Patients with Type I diabetes or uncontrolled Type II diabetes.
Patients with narcolepsy and/or insomnia.
Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.

Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.

Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.",MF 200 microgram o.d. delivered via Twisthaler®,ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02908490,NCT02908490_EG000,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Meets 2010 American College of Rheumatology (ACR) classification criteria for diagnosis of RA
Aged 18 years or older
No known history of CVD (see Exclusion Criteria)
At least one traditional CV risk factor (i.e., older age [men ≥45 years, women ≥55 years], obesity [defined as body mass index (BMI) >30 kg/m2], smoking, hypertension, hyperlipidemia, diabetes mellitus, family history of premature [defined as diagnosed at <65 years old] CVD in first-degree relative)
On stable baseline doses of RA medications, defined as no change in dose within past 4 weeks and no anticipated changes over the next 6 months
On no higher than 10 mg per day of prednisone or prednisone-equivalent within past 4 weeks
RA disease duration (from symptom onset) of more than 6 months
Having clinical disease activity index (CDAI) of >2.8 but ≤22 (i.e., either low or moderate disease activity), within 30 days of study enrollment

Exclusion Criteria:

Aged <18 years
Pregnant women
Known personal history of CVD (clinical diagnoses of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, peripheral arterial disease, percutaneous coronary intervention or coronary bypass graft surgery)
Use of high-dose statins (e.g., atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day) currently or within past 3 months, or any dose changes of statins or of blood pressure medications that may affect endothelial function (i.e., angiotensin-converting-enzyme [ACE] inhibitors or angiotensin receptor blockers [ARBs]) within past 3 months. If on statin or an ACE-I or ARB, there should be no anticipated dose changes over the next 6 months.
Persons with intra-cardiac and intra-pulmonary shunts, unstable cardiopulmonary conditions, or anyone on chronic oxygen therapy
Persons taking nitric oxide donors, organic nitrites and nitrates, such as glyceryl trinitrate (nitroglycerin), sodium nitroprusside, amyl nitrite (""poppers"")
Severe hepatic impairment (liver function tests >1.5 times upper limit of normal) within past 4 weeks
Severe impairment in renal function (serum creatinine ≥1.5 mg/dL) within past 4 weeks
Hypotension (defined as blood pressure [BP] <90/60)
Hereditary degenerative retinal disorders (including genetic disorders of retinal phosphodiesterases)
Persons already taking (or taken within 3 months) sildenafil or other PDE inhibitors (i.e., tadalafil, vardenafil)
Persons unable to provide voluntary written informed consent
Severe hypertension (BP >170/110)
Persons with HIV/AIDS",Participants who received Sildenafil 50 mg once daily in either the first or last 3 months of the study,ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02911324,NCT02911324_EG000,No,All,Adult,Phase 1 | Phase 2,9,"Inclusion Criteria:

Age 18-60
Physically healthy, not pregnant
Primary Obsessive-Compulsive Disorder (OCD)
Patient off all psychotropic (except selective serotonin reuptake inhibitors [SSRIs]) and other types of drugs likely to interact with nabilone
Ability to provide informed consent
Ability to tolerate a treatment free-period

Exclusion Criteria:

History of any significant medical condition that may increase the risk of participation
Females who are pregnant or nursing
Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder)
Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid
Patients already receiving EX/RP","Will receive nabilone at 1 mg daily (BID) over 4 weeks.

Nabilone: Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's ""endocannabinoid system,"" which has been hypothesized to play a role in OCD.",ChEMBL:CHEMBL2218896 | DrugBank:DB00486 | PubChem:39860 | PubChem:5284592,Nabilone,CCCCCCC(C)(C)c1cc(O)c2c(c1)OC(C)(C)C1CCC(=O)CC21,A04AD11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02911948,NCT02911948_EG001,No,All,Adult | Older Adult,Phase 3,105,"Inclusion Criteria:

Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
T2DM (type 2 diabetes mellitus) subjects (diagnosed clinically) for at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.5-11.0 per cent [58 mmol/mol-97 mmol/mol] (both inclusive) by central laboratory analysis
Subjects on stable daily insulin doses for at least 60 days prior to screening administered once or twice daily, either as basal insulin (e.g. IDeg, insulin glargine, insulin detemir, NPH insulin) or pre-mix/combination insulin (e.g. biphasic insulin aspart, insulin degludec/insulin aspart). Total daily insulin dose in the previous 60 days should be within 20-50 units, both inclusive, and on the day of screening, but fluctuations of plus/minus 20 per cent within the 60 days prior to screening are acceptable. The specified insulin treatment should be administered in combination with a stable daily dose of metformin within current approved Japanese label for at least 60 days prior to screening - additionally, the anti-diabetic treatment can be with or without a stable daily dose of one of the following other OADs (oral anti-diabetic drug): SU (sulfonylureas), glinides, alpha-glucosidase inhibitor, SGLT2i (sodium glucose co-transporter 2 inhibitor) or TZD (thiazolidinedione) within current approved Japanese label for at least 60 days prior to screening
Body Mass Index (BMI) equal or above 23 kg/m^2

Exclusion Criteria:

Receipt of any investigational medicinal product (IMP) within 30 days before screening
Use of any anti-diabetic drug in a period of 60 days before screening (except premix/ combination or basal insulin, metformin, SU, glinides, α-GI, SGLT2i, or TZD) or anticipated change in concomitant medication, which in the investigators opinion could interfere with glucose metabolism (e.g. systemic corticosteroids or bolus insulin)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist during the last 60 days prior to screening and furthermore, the discontinuation of GLP-1 receptor agonist at any point in time must not have been due to safety concerns, tolerability issues or lack of efficacy, as judged by the investigator
Treatment with dipetidyl peptidase-4 (DPP-4) inhibitors during the last 60 days prior to screening - Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal or above 2.5 times upper limit of normal
Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Screening calcitonin equal or above 50 ng/L
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV","Eligible subjects were treated with insulin degludec (IDeg) in combination with metformin (at stable pre-trial dose and frequency level) for 26 weeks. The starting dose of IDeg was 10 units IDeg, with the option of choosing up to 16 units IDeg at the investigator's discretion. IDeg was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 units IDeg, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). IDeg was injected subcutaneously (s.c.), once daily (OD) in the thigh, upper arm (deltoid region) or abdomen. One follow-up contact was scheduled at least 7 to 10 days after end of treatment.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02912364,NCT02912364_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,29,"Inclusion Criteria:

Healthy adults between the ages of 18 and 55 years old.
Male or female

Exclusion Criteria:

Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
Presence or history of drug or alcohol abuse.
The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
Prior participation in studies involving anticonvulsant medications.
Subjects who have received any investigational drug within the previous thirty days.
Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.
Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.",Eslicarbazepine Acetate (800mg once daily).,ChEMBL:CHEMBL87992 | DrugBank:DB09119 | PubChem:179344,ESLICARBAZEPINE ACETATE,CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02913521,NCT02913521_EG000,No,All,Adult | Older Adult,Phase 3,316,"Inclusion Criteria:

Ambulatory male and non-pregnant females 35 years and older diagnosed with osteoarthritis according to the American College of Rheumatology Criteria (ACR) in one knee. Target knee is the one with higher level of pain.

ACR Criteria includes: Knee Pain and at least 3 of the following: age ≥ 50, stiffness lasting < 30 mins, bony tenderness, crepitus, bony enlargement, and no palpable warmth.

Symptom onset of > 6 Months prior to Screening for the target knee.
If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., IUD, oral, transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.
After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 50mm on a 0-100-mm Visual Analogue Scale for the target knee.
After a minimum of 7-day wash out of all pain medication has Baseline WOMAC Pain sub scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
Willing and able to use only acetaminophen as rescue medication.
Willing and able to comply with the study requirements.

Exclusion Criteria:

Females who are pregnant, breast feeding, or planning a pregnancy.
Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale.
History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 20mm on a 0-100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or rheumatoid arthritis.
Known history of other chronic inflammatory diseases, (e.g., colitis) or fibromyalgia during last 5 years. Patients whose disease was diagnosed at least 5 (five) years prior to screening visit and have had no known disease activity (i.e., no disease related complaints nor disease treatment prescribed) since then may enter into the study.
History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. Patients who have had high blood pressure measured at least 2 (two) years prior to screening visit and have had no disease activity (i.e., no record of hypertension or anti-hypertensive treatment prescribed) for at least 2 (two) years prior to screening visit may enter into the study.
History of coronary artery bypass graft within 6 months of screening.
Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max. 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
Use of warfarin or other anticoagulant therapy within 30 days of screening.
Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
Known history of gastrointestinal bleeding or peptic ulcer disease.
Abnormal screening clinical laboratory evaluations which the Investigator deems clinically significant.
Known allergy to aspirin or NSAIDs.
Skin lesions or wounds in the affected area.
Significant (requiring surgery) injury or major knee surgery to either knee within six months prior to screening.
Transaminase levels that are more than two times the upper limit of the normal range at screening.
Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
Receipt of any drug as part of a research study within 30 days prior to screening.
Previous randomization into this study.
Known allergy (hypersensitivity) to acetaminophen.","Apply 4 g of gel to the knee four times a day

Diclofenac Sodium Gel 1%",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02913521,NCT02913521_EG001,No,All,Adult | Older Adult,Phase 3,312,"Inclusion Criteria:

Ambulatory male and non-pregnant females 35 years and older diagnosed with osteoarthritis according to the American College of Rheumatology Criteria (ACR) in one knee. Target knee is the one with higher level of pain.

ACR Criteria includes: Knee Pain and at least 3 of the following: age ≥ 50, stiffness lasting < 30 mins, bony tenderness, crepitus, bony enlargement, and no palpable warmth.

Symptom onset of > 6 Months prior to Screening for the target knee.
If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., IUD, oral, transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.
After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 50mm on a 0-100-mm Visual Analogue Scale for the target knee.
After a minimum of 7-day wash out of all pain medication has Baseline WOMAC Pain sub scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
Willing and able to use only acetaminophen as rescue medication.
Willing and able to comply with the study requirements.

Exclusion Criteria:

Females who are pregnant, breast feeding, or planning a pregnancy.
Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale.
History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
After a minimum of 7-day wash out of all pain medication has Baseline pain on movement score of ≥ 20mm on a 0-100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) of the knee or rheumatoid arthritis.
Known history of other chronic inflammatory diseases, (e.g., colitis) or fibromyalgia during last 5 years. Patients whose disease was diagnosed at least 5 (five) years prior to screening visit and have had no known disease activity (i.e., no disease related complaints nor disease treatment prescribed) since then may enter into the study.
History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. Patients who have had high blood pressure measured at least 2 (two) years prior to screening visit and have had no disease activity (i.e., no record of hypertension or anti-hypertensive treatment prescribed) for at least 2 (two) years prior to screening visit may enter into the study.
History of coronary artery bypass graft within 6 months of screening.
Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max. 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
Use of warfarin or other anticoagulant therapy within 30 days of screening.
Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
Known history of gastrointestinal bleeding or peptic ulcer disease.
Abnormal screening clinical laboratory evaluations which the Investigator deems clinically significant.
Known allergy to aspirin or NSAIDs.
Skin lesions or wounds in the affected area.
Significant (requiring surgery) injury or major knee surgery to either knee within six months prior to screening.
Transaminase levels that are more than two times the upper limit of the normal range at screening.
Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
Receipt of any drug as part of a research study within 30 days prior to screening.
Previous randomization into this study.
Known allergy (hypersensitivity) to acetaminophen.","Apply 4 g of gel to the knee four times a day

Voltaren Gel",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02914509,NCT02914509_EG000,No,All,Adult | Older Adult,Phase 3,348,"Inclusion Criteria:

Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
A history of an inadequate response or no response to topical prostaglandin
Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products",Three hundred forty eight (348) subjects were randomized to OTX-TP,ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02926027,NCT02926027_EG000,No,All,Adult | Older Adult,Phase 4,80,"Inclusion Criteria:

Elevated triglycerides (fasting value between 200-499 mg/dl) at qualifying or baseline visit.
LDL-C ≤115 mg/dL on appropriate statin therapy
LDL-C >40 mg/dL
Stable diet and exercise, as defined as the same pattern for the previous 4 weeks
Stable treatment with a statin+/- ezetimibe for at least 4 weeks
Patients with at least 1 angiographic stenosis with at least 20% narrowing by coronary computed tomography angiography (CTA).
Willingness to be on birth control for women of childbearing age or established post-menopausal

Exclusion Criteria:

A contraindication to fish or fish oils including: known hypersensitivity to drug or fish.
Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
Non-study lipid altering medications or supplements (ie - Niacin, PCSK9, fibrates, bile acid Sequestrants, dietary fish oil supplement capsules, orlistat [OTC (Alli®) as well as Rx (Xenical®)] or other drugs used for weight loss).
Stable (same daily dose for the last 4 weeks) on medications that can affect lipids (retinoids, hormones, steroids, HIV medications, chemotherapy, thyroid medications).
BMI > 40
Bleeding disorder
Uncontrolled hypertension (SBP≥ 180 mmHg or DBP≥100 mmHg)
History of known myocardial infarction, stroke or life-threatening arrhythmia within the prior six months.
NYHA Class III- IV heart failure
History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy.
Serum creatinine > 1.4 mg/dl
Drug or alcohol abuse, or current intake of more than 14 ounces of alcohol per week for men and 10 ounces for women
Concurrent enrollment in another placebo-controlled trial or within 30 days of finishing another trial
Partial ileal bypass or known gastrointestinal disease limiting drug absorption
History of hypertensive encephalopathy or cerebrovascular accident
Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
Pregnancy
Genetic mutations/polymorphisms having an effect on blood lipids
History of coronary artery bypass surgery
Allergy to contrast material
Allergy to beta-blocker in subjects with resting heart rate >70 bpm","Vascepa (4 gm/day), oral dose

Vascepa: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.",ChEMBL:CHEMBL2095209 | DrugBank:DB08887 | PubChem:9831415,ICOSAPENT ETHYL,CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02933606,NCT02933606_EG000,No,All,Adult | Older Adult,Phase 2,48,"Key Inclusion Criteria:

Signed and dated informed consent.
Male or female between 18 and 70 years of age, inclusive.
Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.

Currently not using any psychiatric medications except for:

No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the licensed prescribing dose range. Subjects must have been on a stable dose for at least 3 months prior and through Screening, with the intent to remain on the same dose through to Week 16.
As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days per week in the 3 months prior to Screening. The total dose must not exceed 30 mg/day in diazepam equivalents.
Subjects not currently receiving psychotherapy except long term supportive counseling or subjects that have received intensive regular psychotherapy for a minimum of three months prior to Screening.
Females of childbearing potential must have a negative serum pregnancy. Females not of childbearing potential must be postmenopausal. Sterilized male patients must be at least 1 year post-vasectomy to be considered of non-child bearing potential. Females and males of childbearing potential must agree to use two effective methods of contraception.

Key Exclusion Criteria

Current and ongoing exposure to the trauma that caused the PTSD.
Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a failed attempt. A trial that was terminated due to intolerability or side effects does not constitute a failed attempt.
The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric medications include (but are not limited to) antidepressants not allowed by inclusion criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4), mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase inhibitors.
History of significant traumatic brain injury.
Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating > 23.
Bipolar and psychotic disorders as identified at Screening using the MINI International Neuropsychiatry Interview (V7.0) (M.I.N.I).
A score ≥ 7 on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) at Screening.
History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.

Increased risk of suicide, defined as:

Any previous suicide attempt disclosed by the participant at Screening using the Columbia Suicide Severity Rating Scale (C-SSRS).
Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior in the past year, as captured at Screening using the C-SSRS.
A score > 4 on item 10 of the MADRS at Screening.
The use of alprazolam or flunitrazepam within 3 months of Screening.
Any clinically significant abnormalities in laboratory test results, vitals signs, or ECG at Screening.
Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) at Screening.
Any moderate to severe substance use disorder (any type) in the 12 months prior to Screening as identified by the DSM-5 using the M.I.N.I (V7.0).
Current Australian serving Defense personnel or any member of the US military currently serving on active duty.
Participants involved with ongoing insurance or workplace claims that in the opinion of the Investigator are likely to have an impact on the mental health, presentation or capacity of the patient to engage in the study.",Suspension administered orally for 12 weeks.,PubChem:7019085,Isoleucyl-Tryptophan,CCC(C)C(N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02933606,NCT02933606_EG001,No,All,Adult | Older Adult,Phase 2,48,"Key Inclusion Criteria:

Signed and dated informed consent.
Male or female between 18 and 70 years of age, inclusive.
Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.

Currently not using any psychiatric medications except for:

No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the licensed prescribing dose range. Subjects must have been on a stable dose for at least 3 months prior and through Screening, with the intent to remain on the same dose through to Week 16.
As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days per week in the 3 months prior to Screening. The total dose must not exceed 30 mg/day in diazepam equivalents.
Subjects not currently receiving psychotherapy except long term supportive counseling or subjects that have received intensive regular psychotherapy for a minimum of three months prior to Screening.
Females of childbearing potential must have a negative serum pregnancy. Females not of childbearing potential must be postmenopausal. Sterilized male patients must be at least 1 year post-vasectomy to be considered of non-child bearing potential. Females and males of childbearing potential must agree to use two effective methods of contraception.

Key Exclusion Criteria

Current and ongoing exposure to the trauma that caused the PTSD.
Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a failed attempt. A trial that was terminated due to intolerability or side effects does not constitute a failed attempt.
The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric medications include (but are not limited to) antidepressants not allowed by inclusion criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4), mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase inhibitors.
History of significant traumatic brain injury.
Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating > 23.
Bipolar and psychotic disorders as identified at Screening using the MINI International Neuropsychiatry Interview (V7.0) (M.I.N.I).
A score ≥ 7 on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) at Screening.
History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.

Increased risk of suicide, defined as:

Any previous suicide attempt disclosed by the participant at Screening using the Columbia Suicide Severity Rating Scale (C-SSRS).
Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior in the past year, as captured at Screening using the C-SSRS.
A score > 4 on item 10 of the MADRS at Screening.
The use of alprazolam or flunitrazepam within 3 months of Screening.
Any clinically significant abnormalities in laboratory test results, vitals signs, or ECG at Screening.
Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) at Screening.
Any moderate to severe substance use disorder (any type) in the 12 months prior to Screening as identified by the DSM-5 using the M.I.N.I (V7.0).
Current Australian serving Defense personnel or any member of the US military currently serving on active duty.
Participants involved with ongoing insurance or workplace claims that in the opinion of the Investigator are likely to have an impact on the mental health, presentation or capacity of the patient to engage in the study.",Suspension administered orally for 12 weeks.,PubChem:7019085,Isoleucyl-Tryptophan,CCC(C)C(N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02933606,NCT02933606_EG002,No,All,Adult | Older Adult,Phase 2,47,"Key Inclusion Criteria:

Signed and dated informed consent.
Male or female between 18 and 70 years of age, inclusive.
Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.

Currently not using any psychiatric medications except for:

No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the licensed prescribing dose range. Subjects must have been on a stable dose for at least 3 months prior and through Screening, with the intent to remain on the same dose through to Week 16.
As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days per week in the 3 months prior to Screening. The total dose must not exceed 30 mg/day in diazepam equivalents.
Subjects not currently receiving psychotherapy except long term supportive counseling or subjects that have received intensive regular psychotherapy for a minimum of three months prior to Screening.
Females of childbearing potential must have a negative serum pregnancy. Females not of childbearing potential must be postmenopausal. Sterilized male patients must be at least 1 year post-vasectomy to be considered of non-child bearing potential. Females and males of childbearing potential must agree to use two effective methods of contraception.

Key Exclusion Criteria

Current and ongoing exposure to the trauma that caused the PTSD.
Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a failed attempt. A trial that was terminated due to intolerability or side effects does not constitute a failed attempt.
The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric medications include (but are not limited to) antidepressants not allowed by inclusion criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4), mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase inhibitors.
History of significant traumatic brain injury.
Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating > 23.
Bipolar and psychotic disorders as identified at Screening using the MINI International Neuropsychiatry Interview (V7.0) (M.I.N.I).
A score ≥ 7 on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) at Screening.
History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.

Increased risk of suicide, defined as:

Any previous suicide attempt disclosed by the participant at Screening using the Columbia Suicide Severity Rating Scale (C-SSRS).
Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior in the past year, as captured at Screening using the C-SSRS.
A score > 4 on item 10 of the MADRS at Screening.
The use of alprazolam or flunitrazepam within 3 months of Screening.
Any clinically significant abnormalities in laboratory test results, vitals signs, or ECG at Screening.
Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) at Screening.
Any moderate to severe substance use disorder (any type) in the 12 months prior to Screening as identified by the DSM-5 using the M.I.N.I (V7.0).
Current Australian serving Defense personnel or any member of the US military currently serving on active duty.
Participants involved with ongoing insurance or workplace claims that in the opinion of the Investigator are likely to have an impact on the mental health, presentation or capacity of the patient to engage in the study.",Suspension administered orally for 12 weeks.,PubChem:7019085,Isoleucyl-Tryptophan,CCC(C)C(N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02935699,NCT02935699_EG001,No,All,Adult | Older Adult,Phase 3,135,"Inclusion Criteria:

Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;
18 years of age or older;
Be willing and able to give informed consent;
Patients with a Patient rated Pruritus Severity Score ≥ 1

Exclusion Criteria:

Receipt of an investigational drug or device, within the past 30 days;
Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
Receipt of an H2 antagonist within the past 2 hours;
Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties;
Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction;
Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
Pregnancy or breastfeeding;
Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
History of HIV or other known immunodeficiency;
Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
Inability to provide informed consent.
Patients on concomitant p-glycoprotein inhibitors","Diphenhydramine Injection, 50 mg/mL, 1 mL

Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL",ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02940860,NCT02940860_EG001,No,All,Adult | Older Adult,Phase 3,506,"Inclusion Criteria includes:

Men and women, ≥ 18 years
Hb ≤ 11 g/dL
Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

Anaemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compounds
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Undergoing dialysis for treatment of CKD
Planned surgical procedure within the trial period
Decompensated liver cirrhosis or active hepatitis
Alcohol or drug abuse within the past 6 month.
Pregnant or nursing women.","Iron sucrose, administered IV",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02940886,NCT02940886_EG001,No,All,Adult | Older Adult,Phase 3,494,"Inclusion criteria includes:

Men or women ≥ 18 years
Subjects having IDA caused by different etiologies
Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
Haemoglobin (Hb) ≤ 11 g/dL
Transferrin Saturation (TSAT) < 20 %
S-ferritin < 100 ng/mL
Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

Anemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compound
Erythropoiesis stimulating agent (ESA) treatment
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal
Required dialysis for treatment of chronic kidney disease (CKD)
Alcohol or drug abuse within the past 6 months
Pregnant or nursing women","Iron sucrose, administered IV",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02961062,NCT02961062_EG000,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Normal eye exam except for refractive error at baseline.
Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline.

Exclusion Criteria:

Monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.
Any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.
Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy, pterygium removal, corneal transplantation).
Chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing.

Other inclusion and exclusion criteria apply.",treatment participants from both sequences,PubChem:25138363,4-(7-Hydroxy-2-isopropyl-4-oxoquinazolin-3(4H)-YL)benzonitrile,CC(C)c1nc2cc(O)ccc2c(=O)n1-c1ccc(C#N)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02970292,NCT02970292_EG000,No,All,Adult,Phase 3,198,"Inclusion Criteria:

Adults patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year

The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

Aripiprazole

Aripiprazole long-acting injectables:

Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine
Has had a partial but inadequate response to antipsychotic treatment
Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria:

Patient has a psychiatric disorder other than schizophrenia
Patient has a history of resistance to antipsychotic treatment

A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).","Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.

Patients were to continue their background antipsychotic treatment.",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02970305,NCT02970305_EG000,No,All,Adult,Phase 2,201,"Inclusion Criteria:

Adult patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year
Has predominant negative symptoms according to predefined study criteria

The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

Aripiprazole

Aripiprazole long-acting injectables:

Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine

Exclusion Criteria:

Patient has a psychiatric disorder other than schizophrenia

A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient has a family or personal history or symptoms of long QT syndrome
Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).","Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).

Patients were to continue their background antipsychotic treatment",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02978781,NCT02978781_EG000,No,All,Adult | Older Adult,Phase 2,2,"Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.","Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02978781,NCT02978781_EG001,No,All,Adult | Older Adult,Phase 2,14,"Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.","Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02978781,NCT02978781_EG004,No,All,Adult | Older Adult,Phase 2,18,"Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.","Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02988115,NCT02988115_EG000,No,All,Adult | Older Adult,Phase 3,234,"Inclusion Criteria:

Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

Total fasting triglyceride ≥500 mg/dL
Renal dysfunction or nephrotic syndrome or history of nephritis
Body Mass Index (BMI) ≥50 kg/m2
Significant cardiovascular disease or cardiovascular event in the past 3 months",Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.,ChEMBL:CHEMBL3545313 | DrugBank:DB11936 | PubChem:10472693,BEMPEDOIC ACID,CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O,C10AX15 | C10BA10,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02991118,NCT02991118_EG001,No,All,Adult | Older Adult,Phase 3,522,"Inclusion Criteria:

Fasting LDL-C ≥100 mg/dL
High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs

Exclusion Criteria:

Total fasting triglyceride ≥500 mg/dL
Renal dysfunction or nephrotic syndrome or history of nephritis
Body Mass Index (BMI) ≥50kg/m2
Significant cardiovascular disease or cardiovascular event in the past 3 months","Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.",ChEMBL:CHEMBL3545313 | DrugBank:DB11936 | PubChem:10472693,BEMPEDOIC ACID,CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O,C10AX15 | C10BA10,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02992132,NCT02992132_EG001,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Male or female, 50 years of age or older

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months
Has a history or symptoms of long QT syndrome
Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients

10. Has previously participated in a clinical study with pimavanserin

11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline","Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth

Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02992132,NCT02992132_EG002,No,All,Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Male or female, 50 years of age or older

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months
Has a history or symptoms of long QT syndrome
Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients

10. Has previously participated in a clinical study with pimavanserin

11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline","Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth

Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02993406,NCT02993406_EG000,No,All,Adult | Older Adult,Phase 3,7001,"Inclusion Criteria:

Age between 18 and 85 years
History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event

Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:

2 or more statins at any dose, or
1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.

Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.

Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
Men and nonpregnant, nonlactating women
Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening

Exclusion Criteria:

Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
History of severe heart failure
Uncontrolled hypertension or uncontrolled diabetes",Participants were administered with Bempedoic acid 180 mg tablet once daily orally.,ChEMBL:CHEMBL3545313 | DrugBank:DB11936 | PubChem:10472693,BEMPEDOIC ACID,CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O,C10AX15 | C10BA10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03000530,NCT03000530_EG000,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

Participant has a history of suicide attempt
Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
Participant has active psychosis
Participant has a medical history of seizures
Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder","Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT03000530,NCT03000530_EG002,No,All,Adult | Older Adult,Phase 2,45,"Inclusion Criteria:

Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

Participant has a history of suicide attempt
Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
Participant has active psychosis
Participant has a medical history of seizures
Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder","Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,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
NCT03030222,NCT03030222_EG000,No,All,Adult | Older Adult,Phase 4,33,"Inclusion Criteria:

Established diagnosis of heart failure (for at least 16 weeks prior to the screening visit) with either preserved (LVEF>40%) or reduced systolic function (LVEF≤40%), due to either ischemic or non-ischemic etiology, documented by an imaging modality (echocardiography, nuclear imaging, LV angiography, magnetic resonance imaging) within the past 24 months.
No major change in diuretic management for 48 hours prior to screening visit or 48 hours prior to randomization visit (major change defined by doubling of diuretic dose or addition of another diuretic medication)
New York Heart Association (NYHA) class II, III or IV heart failure symptoms at the screening and randomization visit
Presence of previously (≥ 2 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study.
Pulmonary artery diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit).
Ability to provide informed consent prior to initiating screening visit procedures

Exclusion Criteria:

Decompensated heart failure (hospitalization for heart failure within the 2 weeks prior to screening) or between screening and randomization
History of type 1 diabetes
Major change in diuretic management during 48 hours prior to screening visit or 48 hours prior to randomization visit. (major change defined by doubling of diuretic dose or addition of another diuretic medications)
Significant variability in baseline pulmonary artery diastolic pressures during screening period. Defined as changes greater than +/- 6 mmHg from average pulmonary artery diastolic pressure during week 1 of the screening phase and average pulmonary artery diastolic pressure during week 2 of the screening phase for those patients with an average baseline pulmonary artery diastolic pressure during week 1 of the screening phase of <30 mmHg. If the average baseline pulmonary artery diastolic pressure during week 1 of the screening phase is ≥30 mmHg, then ≥20% relative change in average pulmonary diastolic pressure between week 1 and week 2 of the screening phase will be used to define significant variability.
Initiation of hydralazine, long-acting nitrates, beta blockers, angiotensin-converting enzyme inhibitors (ACEIs) , angiotensin II receptor blockers (ARBs) or valsartan/sacubitril in the prior 4 weeks prior to screening
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at the screening visit
Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit.
Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days.
Implantation of the CardioMEMs device within the past 2 weeks.
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), or planned implantation of cardiac resynchronization therapy (CRT) device within the 90 days after the screening visit.
Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within the 4 weeks prior to the screening visit.
History of hypersensitivity to empagliflozin
For women of child-bearing potential: Current or planned pregnancy or currently lactating
Life expectancy <1 year at the screening visit
Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
Pulmonary artery diastolic pressure < 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit).
Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 8 weeks prior to the screening visit
Average supine systolic BP <90 mmHg at the screening or randomization visit
Current documented history of bladder cancer
Active Gross Hematuria
Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and hypertrophic obstructive cardiomyopathy (HOCM).
History of heart transplant.
Patients on heart transplant list as 1a and 1b status","Empagliflozin 10 mg tab, once daily, for 12 weeks

Empagliflozin 10 mg Tab: Empagliflozin 10 mg Tab",ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03054922,NCT03054922_EG001,No,All,Child | Adult,Phase 3,59,"Inclusion Criteria:

Major surgical procedure requiring arterial access

Exclusion Criteria:

Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.","Each 100 mL of Lactated Ringer's Injection USP contains:

Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs

Lactated Ringer: IV infusion of lactated ringer throughout surgery.",PubChem:56841910,Natrii lactatis solutio composita,CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03057951,NCT03057951_EG001,No,All,Adult | Older Adult,Phase 3,2996,"Inclusion criteria:

Male or female patient, age >= 18 years at screening. For Japan only: Age >=20 years at screening
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
Stable dose of oral diuretics, if prescribed
Signed and dated written ICF (informed consent form)
Further inclusion criteria apply

Exclusion criteria:

Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
Heart transplant recipient or listed for heart transplant
Acute decompensated HF (Heart Failure)
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
Symptomatic hypotension and/or a SBP < 100 mmHg
Indication of liver disease,
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
History of ketoacidosis
Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
Currently enrolled in another investigational device or drug trial
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Further exclusion criteria may apply",1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03057977,NCT03057977_EG001,No,All,Adult | Older Adult,Phase 3,1863,"Inclusion criteria:

Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening

Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
Signed and dated written ICF (Informed Consent Form)
Further inclusion criteria apply

Exclusion criteria:

Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
Heart transplant recipient, or listed for heart transplant
Acute decompensated HF
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
Symptomatic hypotension and/or a SBP < 100 mmHg
Indication of liver disease
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
History of ketoacidosis
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
Currently enrolled in another investigational device or drug study
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Further exclusion criteria apply",Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily.,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03065933,NCT03065933_EG000,No,All,Adult,Phase 4,5,"Inclusion Criteria:

meet SCID criteria for bipolar disorder, type I, Mania with YMRS > 15
No significant improvement in symptoms after three or more days of hospitalization
documented medical evaluation without identified acute or serious medical illness
negative pregnancy test in women of child-bearing age

Exclusion Criteria:

involuntary commitment or lack of capacity to provide informed consent
low blood pressure","Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.

extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.",PubChem:20179,Clonidine Hydrochloride,Cl.Clc1cccc(Cl)c1NC1=NCCN1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03077659,NCT03077659_EG001,No,Male,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Male; 18 years of age and older
Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
ECOG of 0 or 1

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Creatinine <2 mg/dL
Normal PT/INR and PTT;
Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
Willing to receive an mpMRI

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc
Prior prostatectomy
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery
Treatment with a prior investigational agent within 30 days of first dose of investigational medication
Any previous local treatment of the prostate (i.e. radiation)
Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
Known sensitivity to any of the study medication components
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.",NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT03077659,NCT03077659_EG002,No,Male,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Male; 18 years of age and older
Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
ECOG of 0 or 1

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Creatinine <2 mg/dL
Normal PT/INR and PTT;
Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
Willing to receive an mpMRI

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc
Prior prostatectomy
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery
Treatment with a prior investigational agent within 30 days of first dose of investigational medication
Any previous local treatment of the prostate (i.e. radiation)
Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
Known sensitivity to any of the study medication components
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.",NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 4 weeks prior to prostatectomy.,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03081884,NCT03081884_EG000,No,Male,Adult | Older Adult,Phase 2,61,"Inclusion Criteria:

High-risk prostate cancer patients eligible for standard of care surgery

At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

Exclusion Criteria:

Definitive findings of systemic metastasis on conventional imaging.","Individuals diagnosed with primary prostate carcinoma and without definitive findings of systemic metastasis with conventional imaging, had a whole body FACBC positron emission tomography (PET)-computerized tomography (CT)(PET-CT) scan followed by robotic radical prostatectomy with extended pelvic lymph node dissection.",ChEMBL:CHEMBL1908917 | DrugBank:DB15237,FLUCICLOVINE,N[C@]1(C(=O)O)C[C@@H](F)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
NCT03087851,NCT03087851_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC","Zoledronate: administrated at baseline.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03087851,NCT03087851_EG001,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC","Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l) or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 3.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03087851,NCT03087851_EG002,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Postmenopausal women (postmenopausal for at least two years)
Men above 50 years
Treatment for at least two years with denosumab
Last denosumab injection less than five months ago

Exclusion Criteria:

Low-energy vertebral fracture at any time
Low-energy hip fracture within the last 12 months
BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
Alendronate treatment for more than three years prior to denosumab treatment
Ongoing treatment with glucocorticoids
Metabolic bone disease
Hormone replacement therapy
Cancer
Estimated glomerular filtration rate (eGFR) < 35 mL/min
Allergy to zoledronic acid
Hypocalcaemia
Contraindications for zoledronic acid according to the SPC","Zoledronate: administrated depending on increase in s-CTX (above 1.26 ug/l), decrease in BMD (more than 5% at any site), or the occurrence of an osteoporotic clinical vertebral or hip fracture, but no later than at month 6.

Zoledronate re-administrated: If s-CTX increases above 1.26 ug/l or BMD decreases more than 5% at any site.",ChEMBL:CHEMBL924 | DrugBank:DB00399 | PubChem:68740,Zoledronic acid,O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O,M05BA08 | M05BB08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03096418,NCT03096418_EG000,No,Female,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Women with pathologically demonstrated breast cancer
Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel.
Patients must not have metastatic disease on staging work-up with CBC and liver function studies.
A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor or lymph node. A minimum of 8 slides must be available.
The primary tumor or lymph node must be readily biopsied by surgery or radiology teams.
The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians.
Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted.
Patients must have adequate organ and marrow function as determined by the treating oncologist.
Patient must be willing to undergo additional biopsy of breast tumor or lymph node.
Patient must have the ability and willingness to sign a written informed consent document.
Women of childbearing potential (per UWCCC policy definition) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.

Exclusion Criteria:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).
Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.
Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.","Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.

Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.

Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03096444,NCT03096444_EG001,Accepts Healthy Volunteers,All,Adult,Phase 2,13,"Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.","Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.",PubChem:15851 | PubChem:44632368,Ketamine Hydrochloride,CNC1(c2ccccc2Cl)CCCCC1=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
NCT03096444,NCT03096444_EG002,Accepts Healthy Volunteers,All,Adult,Phase 2,13,"Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.","Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.",PubChem:11065,Amitriptyline Hydrochloride,CN(C)CCC=C1c2ccccc2CCc2ccccc21.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
NCT03096444,NCT03096444_EG003,Accepts Healthy Volunteers,All,Adult,Phase 2,13,"Inclusion Criteria:

Healthy subjects (absence of disease) 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 48 hours prior to the study visits.
Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease or a painful condition.
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 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.","Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.",PubChem:6314,Lidocaine Hydrochloride,CCN(CC)CC(=O)Nc1c(C)cccc1C.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
NCT03099148,NCT03099148_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,27,"Inclusion Criteria:

Are overtly healthy males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
Have clinical laboratory test results within normal reference range for the population or investigative site
Are able and willing to give signed informed consent

Exclusion Criteria:

Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
Have significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study","A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods",DrugBank:DB16299 | PubChem:56644522,Poseltinib,C=CC(=O)Nc1cccc(Oc2nc(Nc3ccc(N4CCN(C)CC4)cc3)nc3ccoc23)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
NCT03112863,NCT03112863_EG000,Accepts Healthy Volunteers,All,Adult,Early Phase 1,44,"Inclusion Criteria:

• Individuals aged 30-55

Exclusion Criteria:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant or breast feeding women
Prisoners
Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
Those who have used isotretinoin in the last 6 months
Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
Those who have used topical antibiotics or topical retinoids in the last 30 days
Those who are currently smoking or have smoked within the past 3 years.
Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries","Bakuchiol 0.5% applied to face twice daily

Bakuchiol: This group will receive bakuchiol",DrugBank:DB16102 | PubChem:5468522,Bakuchiol,C=C[C@@](C)(/C=C/c1ccc(O)cc1)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
NCT03118947,NCT03118947_EG000,No,All,Adult | Older Adult,Phase 2,78,"Inclusion Criteria:

Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

Patient was significantly non-compliant in Study ACP-103-032
The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment","All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03133767,NCT03133767_EG000,No,All,Adult | Older Adult,Phase 4,157,"Inclusion Criteria:

Emergency department patient
Chief complaint of nausea, vomiting or emesis, diarrhea, abdominal pain, dehydration, heat stroke or exhaustion
ED provider approves administration of two liters of fluid
ED provider states patient is likely to be discharged
Patient has followed up with PCP in the last two years
Patient has access to phone for next two days following ED discharge

Exclusion Criteria:

Prisoners
Children
Women known to be pregnant
Jaundice
Current chemotherapy","Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV",PubChem:56841910,Natrii lactatis solutio composita,CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03134183,NCT03134183_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 4,36,"Inclusion Criteria:

The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

Exclusion Criteria:

Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol","Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository

Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03134183,NCT03134183_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 4,34,"Inclusion Criteria:

The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

Exclusion Criteria:

Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol","Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder

Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E",ChEMBL:CHEMBL606 | DrugBank:DB00929 | PubChem:5282381,Misoprostol,CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC,A02BB01 | G02AD06 | M01AE56,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03154476,NCT03154476_EG000,No,All,Adult | Older Adult,Phase 3,20,"Inclusion criteria:

All adult Fontan patients who have no contraindications for magnetic resonance imaging (MRI) will be eligible for the study.

Exclusion criteria:

Subjects with implantable pacemakers
Residual cardiac lesions (severe ventricular dysfunction, severe atrioventricular valve regurgitation, Fontan baffle or conduit obstruction)
Viral hepatitis
Severe renal dysfunction
History of sildenafil use in the six months prior to study enrollment
Ongoing sildenafil therapy
Patients currently taking nitrates
Hypotension at baseline (BP <90/50 mmHg)
Pulmonary veno-occlusive disease
Hearing/vision impairment
Pulmonary hypertension due to sickle cell disease
Women of child-bearing potential with a positive pregnancy test will additionally be excluded","Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.

Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03155945,NCT03155945_EG000,No,All,Adult | Older Adult,Phase 2,6,"Key Inclusion Criteria:

A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500 mcg/g within 4 weeks before Screening.
Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Key Exclusion Criteria:

Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
History of extensive colonic resection, subtotal or total colectomy.
History of >3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

Note: other protocol defined Inclusion/Exclusion criteria may apply.",Participants received olorinab 25 milligrams (mg) oral tablets three times daily (TID) for 8 weeks,ChEMBL:CHEMBL4175981 | DrugBank:DB14998,OLORINAB,CC(C)(C)[C@@H](CO)NC(=O)c1nn(-c2c[n+]([O-])ccn2)c2c1C[C@@H]1C[C@H]21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03165955,NCT03165955_EG000,No,Female,Adult | Older Adult,Phase 1,28,"Inclusion Criteria:

Signed written informed consent
Women ≥18 years of age on day of consent
Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
Measurable disease as per RECIST v1.1 criteria

Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:

Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
Platelet count ≥100 x 10^9/L
Hemoglobin (Hgb) ≥9 g/dL

Adequate liver function

Total bilirubin of ≤1.5 mg/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present
Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if bone metastasis is present
Gamma glutamyl transferase (GGT) <10 x ULN
Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week
Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.

Exclusion Criteria:

Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
Known CNS metastasis, including leptomeningeal involvement
Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
Are currently receiving other medications intended for the treatment of their malignancy
Women who are pregnant or breastfeeding
Taking prohibited medications:
Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
Known allergic reaction or intolerance to study medication components
Known allergic reaction or intolerance to contrast media
Subjects who, in the Investigator's opinion, are not suitable for participation in this study",Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.,ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03172494,NCT03172494_EG001,No,All,Adult | Older Adult,Phase 3,175,"Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Type 2 diabetes mellitus (clinically diagnosed)
Male or female, age at least 18 years at the time of signing informed consent
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
Metformin (above or equal to 1500 mg or max tolerated dose) or
Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or
Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or
Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or
Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)

Exclusion Criteria:

Treatment with insulin (except for short-term treatment at the discretion of the investigator)
Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range
Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin
Screening calcitonin above or equal to 50 ng/L
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures
Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg
Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
History of pancreatitis (acute or chronic)",Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03172780,NCT03172780_EG000,No,All,Adult | Older Adult,Phase 3,398,"Inclusion Criteria:

Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
Able to tolerate rescue medication with acetaminophen
Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

Pregnancy, lactation
OA of Kellgren-Lawrence grade 4
OA pain in the contralateral knee requiring medication (OTC or prescription)
History of OA of either Hip or Hands
History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
History of Drugs or Alcohol abuse within the previous year
Symptomatic peripheral vascular disease of the study leg
Any musculoskeletal condition
Skin disease at the application site
Active asthma requiring periodic treatment with systemic steroids
Known history of positive HIV, hepatitis C virus, or HBsAg
Uncontrolled hypertension
History of myocardial infarction, thrombotic events, stroke etc.
Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).","Diclofenac Sodium Gel, 1%

Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT03172780,NCT03172780_EG001,No,All,Adult | Older Adult,Phase 3,405,"Inclusion Criteria:

Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
Able to tolerate rescue medication with acetaminophen
Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

Pregnancy, lactation
OA of Kellgren-Lawrence grade 4
OA pain in the contralateral knee requiring medication (OTC or prescription)
History of OA of either Hip or Hands
History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
History of Drugs or Alcohol abuse within the previous year
Symptomatic peripheral vascular disease of the study leg
Any musculoskeletal condition
Skin disease at the application site
Active asthma requiring periodic treatment with systemic steroids
Known history of positive HIV, hepatitis C virus, or HBsAg
Uncontrolled hypertension
History of myocardial infarction, thrombotic events, stroke etc.
Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).","Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[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
NCT03175120,NCT03175120_EG001,No,All,Adult | Older Adult,Phase 3,151,"Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - Metformin (above or equal to 1500 mg or max tolerated dose) or - Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - Impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)",Participants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT03188991,NCT03188991_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Signed informed consent;
Patients over the age of 18;
Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the discretion of the Investigator;
Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;
Normal hematologic, hepatic, and renal function at study entry;

Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year postmenopausal or has undergone tubal ligation. For the purposes of this study, adequate birth control includes at least one medically approved and highly effective method of birth control, defined as those which result in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables and oral contraceptives combined with the use of condoms. Only male patients whose vasectomy has been confirmed by semen analysis at least 3 months after the vasectomy are allowed not to use acceptable contraceptive methods.

Exclusion Criteria:

Positive cytology indicating malignancy;
Thrombotic or embolic events;
Known hypersensitivity to study agent;
Known drug or alcohol abuse;
Pregnant or breastfeeding women.","Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03196219,NCT03196219_EG000,Accepts Healthy Volunteers,All,Child | Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Males and females, 12-75 years of age
Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent
Female subjects of childbearing potential must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
Negative urine pregnancy test in all females of childbearing potential (past menarche)
Male subjects of sexual activity age: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination

Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (general, extraoral, head and neck) during Screening.

Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the medical monitor on a case-by-case basis.

Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants
Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
Willing and able to comply with oral hygiene and diet instructions
Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times

Exclusion Criteria:

Advanced periodontal disease

Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded.

Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and are not required to be repeated at Screening

Partially erupted teeth where the entire crown is not erupted or an operculum is present
Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
Pathologic lesions of the oral cavity (suspicious or confirmed)
Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets. Note: Partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study
Use of systemic antibiotics, topical oral antibiotics, any immunosuppressant therapy, and steroids, beginning 30 days prior to Screening until the end of study participation
Medical history indicating the woman is pregnant, breastfeeding/lactating or has a positive urine pregnancy test
Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded)
Participation in a previous C16G2 clinical trial having received either C16G2 Strip, C16G2 Varnish or Placebo Varnish
Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results","Eight subjects will be enrolled in an open-label manner and will receive a daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip administered over 7 days. Following the three C16G2 Varnish applications, each subject will receive 7 days of AM and PM dosing with C16G2 Strip.

C16G2: C16G2",PubChem:90684551,Unii-1aao72P26F,CC(C)CC(NC(=O)CNC(=O)CNC(=O)C(N)CCCNC(=N)N)C(=O)NC1CSSCC(C(=O)NC(C(=O)NCC(=O)NC(CCCNC(=N)N)C(N)=O)C(C)C)NC(=O)C(C(C)C)NC(=O)C2CSSCC(NC(=O)C(Cc3ccc(O)cc3)NC1=O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1ccccc1)C(=O)N2.Cl.O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03196219,NCT03196219_EG001,Accepts Healthy Volunteers,All,Child | Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Males and females, 12-75 years of age
Adults subjects provide written informed consent and adolescent subjects give written or verbal assent, as appropriate, and parent(s) or legal guardian(s) give written informed consent
Female subjects of childbearing potential must agree to use one of the following forms of contraception from screening through the last study visit: hormonal (oral, implant, or injection) begun >30 days prior to screening; barrier (condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD). Acceptable contraceptive options may also include abstinence, relationship with a same sex partner or partner who has had a vasectomy at least six (6) months prior to the screening visit
Negative urine pregnancy test in all females of childbearing potential (past menarche)
Male subjects of sexual activity age: willing to use contraception or abstain from sexual activity beginning with the first exposure to study drug and continuing until discharged from the study due to completion or Early Termination

Healthy, as determined by the Investigator (in consultation with the Medical Monitor, as needed), based on medical and dental history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (general, extraoral, head and neck) during Screening.

Note: Subjects on a stable dose of medication may be eligible for screening and will be assessed by the medical monitor on a case-by-case basis.

Have a minimum of 12 bicuspids and molars with a minimum of 8 molars and bicuspids NOT having restorations, crowns or sealants
Demonstrated ability to expectorate ≥2 mL of stimulated saliva in 5 minutes
Have a salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening using mitis salivarius-bacitracin (MSB) agar plating
Willing to refrain from using non-study dentifrice and other non-study oral care products (oral care rinses, fluoride products, etc.) during the study
Willing to postpone elective dental procedures (e.g., dental cleanings) between Screening and final post-treatment visit (End of Study or Early Termination)
Willing and able to comply with oral hygiene and diet instructions
Able to communicate with the Investigator/study center personnel, understand and comply with the study requirements, and willing to return for protocol-specified visits at the appointed times

Exclusion Criteria:

Advanced periodontal disease

Active caries lesion(s) within 30 days prior to study drug administration (confirmed by comprehensive caries examination including standard radiographs). Subjects presenting with insipient, non-cavitated lesion(s) are not excluded.

Note: If radiographs are deemed appropriate for the study and taken within 6 months prior to the Screening visit, these may be used for determining eligibility and are not required to be repeated at Screening

Partially erupted teeth where the entire crown is not erupted or an operculum is present
Medical condition (e.g., artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
Pathologic lesions of the oral cavity (suspicious or confirmed)
Full dentures or permanent orthodontic appliances, e.g., braces, buccal or lingual brackets. Note: Partial dentures, removable retainers and night guards are not excluded, provided that they are cleaned regularly throughout the duration of the study
Use of systemic antibiotics, topical oral antibiotics, any immunosuppressant therapy, and steroids, beginning 30 days prior to Screening until the end of study participation
Medical history indicating the woman is pregnant, breastfeeding/lactating or has a positive urine pregnancy test
Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to study drug administration (depending on the specifics, participation in an observational study is not necessarily excluded)
Participation in a previous C16G2 clinical trial having received either C16G2 Strip, C16G2 Varnish or Placebo Varnish
Presence of any condition or concurrent illness, which in the opinion of the Investigator, would compromise normal immune function (e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results","Twelve subjects will be enrolled in a single-blind manner. Subjects will receive four C16G2 Varnish or Placebo applications over 7 days (Days 0, 2, 5 & 7), followed by 3 additional weekly varnish administrations. The treatment allocation will be 1:1 (6 subjects C16G2 Varnish, 6 subjects Placebo).

C16G2: C16G2

Placebo: Varnish Placebo",PubChem:90684551,Unii-1aao72P26F,CC(C)CC(NC(=O)CNC(=O)CNC(=O)C(N)CCCNC(=N)N)C(=O)NC1CSSCC(C(=O)NC(C(=O)NCC(=O)NC(CCCNC(=N)N)C(N)=O)C(C)C)NC(=O)C(C(C)C)NC(=O)C2CSSCC(NC(=O)C(Cc3ccc(O)cc3)NC1=O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1ccccc1)C(=O)N2.Cl.O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03212963,NCT03212963_EG000,No,All,Child,Phase 4,16,"Inclusion Criteria:

Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The ""Treatment Area"" is defined as the entire body exclusive of the face, scalp, groin, axillae, and other intertriginous areas.

4. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.

5. Subject 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.

6. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline Visits and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease.
Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
Subject is currently using lithium or Plaquenil (hydroxychloroquine).
Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
Subject has a history of sensitivity to any of the ingredients in the test article.
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
Subject has been previously enrolled in this study and treated with the test article.
Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
Subject has a screening Cosyntropin Stimulation Test (CST) with a post 30-minute stimulation cortisol level of less than equal to 18 μg/dL.
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion","All subjects will receive Halobetasol Topical Lotion, 0.05%.

Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.",DrugBank:DB00596,Ulobetasol,[H][C@@]12C[C@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D05AX55 | D07AC21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03228914,NCT03228914_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.

Exclusion Criteria:

pregnancy
known coagulopathy
an international normalized ratio greater than 1.3
a partial thromboplastin time greater than 50 seconds
use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
having any adverse reaction to topical epinephrine or oxymetazoline.","Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Oxymetazoline: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.",ChEMBL:CHEMBL762 | DrugBank:DB00935 | PubChem:4636,Oxymetazoline,Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1,D11AX27 | R01AA05 | R01AB07 | S01GA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03230097,NCT03230097_EG001,No,All,Child | Adult,Phase 2,24,"Inclusion criteria

Meet diagnostic criteria for attenuated psychosis syndrome as defined in DSM-5 and determined by SIPS administered at screening and diagnosis confirmed by NeuroCog Trials after review of video-taped SIPS interview.
Age ≥16 and ≤ 30 years at the time of consent/assent.

Male or female patients willing to use highly effective methods of contraception.

Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to any study-related procedures OR signed and dated informed consent provided by the patient's parent(s) (or legal guardian) and assent by the patient prior to any study-related procedures in accordance with GCP and local legislation. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Exclusion criteria

Present or past diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder I, major depressive disorder with psychotic features, delusional disorder, brief psychotic disorder, other specified schizophrenia spectrum and other psychotic disorder (except attenuated psychosis syndrome), and unspecified schizophrenia spectrum and other psychotic disorder, according to DSM-5.
Patients taking antipsychotic medication for less than 8 weeks, or patients taking antipsychotic medication for a longer duration but who have not been on a stable dose for 8 weeks prior to informed consent.
Patients who begin taking an antipsychotic between Visit 1 and Visit 2.
Patients who have discontinued an antipsychotic medication less than two weeks prior to randomization.
Patients taking Clozapine.
Suicidal behavior in the past 2 years reported in the Columbia Suicide Severity Rating Scale (C-SSRS) with a lethality of attempt ≥1, or with a lethality of 0 but a potential lethality of 2, or that in the judgement of the investigator would jeopardize the patient's safety while participating in the trial. The investigator/qualified rater must review all screening C-SSRS reports prior to randomization, documenting an additional interview assessing lethality of the behavior history when appropriate.
Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial.
Known diseases of the central nervous system (including but not limited to any kind of seizures or stroke).
History of significant head injury (>5 minutes without consciousness).
A serious developmental disorder that in the judgement of the investigator would inhibit the patient's ability to comply with all study procedures, or mental retardation (documented IQ <70), or acute attenuated symptoms exclusively related to intoxication from a psychotropic substance.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
Meets criteria for Substance Use Disorder (DSM-5) within the six months prior to informed consent/assent.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be a strong or moderate inhibitor of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.).
Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.)
Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).
Patients with a history of moderate to severe renal impairment (Stage 3 - 5).
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
Previous participation in any BI 409306 study.
Further exclusion criteria apply","Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03250624,NCT03250624_EG000,No,All,Adult,Phase 2,32,"Inclusion Criteria:

The participant was a male or female aged 18 to 60 years old inclusive at Screening.
The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;

Exclusion Criteria:

The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1.
The participant presented with an acute flare of AD at Day 1.
The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.",Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03252431,NCT03252431_EG000,No,Female,Adult | Older Adult,Phase 3,197,"Inclusion Criteria:

Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Females ≥18 years of age.
Diagnosed with Stage I-III breast cancer.
Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).
ECOG Performance status of ≤2.
WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L.
Demonstrate adequate renal, hepatic, and cardiac function (liver function tests [alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

Exclusion Criteria:

Subject is <18 years of age.
Disease progression has occurred while receiving a taxane regimen.
Subject has undergone radiation therapy within 4 weeks of enrollment.
Subject has undergone bone marrow or stem-cell transplantation.
Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.
Subject has had chemotherapy within 180 days of screening.
Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test.
History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
Unwillingness to participate in the study.
Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less.
Any condition, which can cause splenomegaly.
Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN.
Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.","F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.

F-627: single dose pre-filled syringe",DrugBank:DB12269 | PubChem:66571548,PF-06273340,CC(C)(CO)n1cc(C(=O)c2cncc(NC(=O)Cc3ccc(Cl)cn3)c2)c2cnc(N)nc21,,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
NCT03263442,NCT03263442_EG000,No,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria:

Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell transplant
At least 18 years of age
Able to speak English
Able to provide informed consent

Exclusion Criteria:

A history of adverse reaction to IV thiamine
Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment","Thiamine 200 mg IV

Thiamine: 200 mg IV three times daily for seven days",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03275870,NCT03275870_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Patients with hidradenitis suppurativa Hurley stage I or II

Exclusion Criteria:

Current systemic immunosuppression, current use of biologic medication or use of these medications in the prior 3 months, patients with known retinal disease, hepatic disease (HCV, cirrhosis, aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal), psoriasis, porphyria cutanea tarda, platelets < 50,000/ul, leukocytes <4000/ul, or Hb<8g/dl), pregnant patients or women trying to conceive","Hydroxychloroquine 200mg BID for 6 months

Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03283150,NCT03283150_EG002,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

All patients scheduled to undergo DBS electrode implantation surgery with MER that agree to participate in the experiment and sign an informed consent are candidates to participate in the study, unless one of the exclusion criteria is met

Exclusion Criteria:

Known or suspected obstructive sleep apnea.
Suspected difficult intubation.
Pregnancy (pregnancy test is standard care for women of childbearing age)
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form.","Dexmedetomidine will be administered to subjects during MER.

Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03283566,NCT03283566_EG000,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria:

Clinically confirmed diagnosis of chronic pancreatitis (CP)
Intractable abdominal pain
History of failed operation(s) for CP
Recurrent acute pancreatitis
HbA1c <8.0%
Sustained alcohol remission
Chronic narcotic use

Exclusion Criteria:

Insulin dependence
Pancreatic carcinoma
Pancreatic mass suspicious for carcinoma
Cirrhosis
Portal hypertension
Continued alcohol abuse
Manufacturer's product label-contraindicated use of HCQ
History of retinopathy
Actual weight at enrollment <40 Kg","Administered pre-transplant through 3 months after surgery.

Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03287687,NCT03287687_EG000,No,All,Child | Adult,Phase 4,88,"Inclusion Criteria:

Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.

Exclusion Criteria:

Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.","In this arm of patients, air which is currently used as standard of care will be used for insufflation

Air: Air is the standard of practice and will be used in the control arm",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03288129,NCT03288129_EG000,No,All,Child | Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

Participants will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.

Participants must have a diagnosis of epilepsy with POS with or without SGS or with PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:

At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of seizures
Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.
If antidepressants or antianxiety drugs are used, participants must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).

Exclusion Criteria:

Participants should not have previously received or currently be receiving perampanel.
Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.

Females of childbearing potential who:

Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:

Total abstinence (if it is their preferred and usual lifestyle)
An intrauterine device or intrauterine hormone-releasing system
An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel); participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation
Have a vasectomized partner with confirmed azoospermia
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.

NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).

Presence of or previous history of Lennox-Gastaut syndrome
Presence of non-motor simple partial seizures only
A history of status epilepticus within 1 year before Screening Visit (Visit 1)
Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)
Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)
Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or participants who receive hemodialysis
Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal.
Hypersensitivity to perampanel or any excipients
Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Participants who are participating in other interventional clinical trial
Participant who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)
Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering ""Yes"" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
Any lifetime suicidal behavior based on the C-SSRS
Concomitant use of any form of cannabidiol (CBD)
Planned brain surgery during study participation","During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03296553,NCT03296553_EG000,No,All,Adult | Older Adult,Phase 2,18,"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.","Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.

Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.

20 experimental included 2 eliminated

18 patients included finally.",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03301415,NCT03301415_EG000,No,All,Child,Phase 2,7,"Inclusion Criteria:

Parent(s)/legal guardian(s) have signed informed consent documents*
Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
Infant </= 30 days of age at initiation of study drug
Weight at study enrollment >/= 1775 grams

Gestational age >/= 32 weeks at birth

There is a screening informed consent for screening phase of study participation, and a treatment informed consent for treatment phase of study participation.

Exclusion Criteria:

Symptomatic congenital cytomegalovirus (CMV) disease*
Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
Maternal receipt of CMV hyperimmune globulin during pregnancy
Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
Infants known to be born to women who are HIV positive (HIV testing is not required for study entry)

Current receipt of other investigational drugs

Symptomatic disease is defined as one or more of the following: 1) thrombocytopenia, if known; 2) petechiae; 3) hepatomegaly; 4) splenomegaly; 5) intrauterine growth restriction; 6) hepatitis (elevated transaminases and/or direct bilirubin), if known; 7) central nervous system involvement of the CMV disease (such as microcephaly; radiographic abnormalities indicative of CMV CNS disease, if known; abnormal CSF indices for age, if known; chorioretinitis, if known; and/or positive CMV PCR from CSF, if known).","Valganciclovir, 16 mg/kg/dose given orally twice daily for four months",ChEMBL:CHEMBL1201314 | DrugBank:DB01610 | PubChem:135398519 | PubChem:135413535,Valganciclovir,CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21,J05AB14,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03305159,NCT03305159_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,63,"Inclusion Criteria:

Undergoing hysteroscopy
Gynecologic dilation & curettage
Endometrial ablation
Essure without concomitant laparoscopy

Exclusion Criteria:

Pregnant
Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.","Patients to receive povidone iodine for the surgical preparation of the vagina.

Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03310970,NCT03310970_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,23,"Inclusion Criteria:

Men or non-pregnant women, of any ethnic background, between the age of 18 and 65 years old.
Provide written informed consent before initiation of any study procedures.
Available for follow-up for the planned duration of the study.
Able to communicate well with the investigators.
Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated by a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
Able to adhere to the study protocol schedule, study restrictions and examination schedule.
Subjects must be non-smokers and not regular users of tobacco. They must have refrained from regular and habitual use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and must have not used any nicotine-containing products in the previous 30 days.
Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI), as determined by medical history, physical examination, and medication history.
Negative urine drug screening test.
Have a normal blood pressure (systolic: 90-139 mmHg; diastolic: 60-89 mmHg) and heart rate (55-100 bpm).
Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST.
Female subjects must be of non-childbearing potential. This is defined as surgically sterile (i.e. history of hysterectomy or tubal ligation), or postmenopausal for more than 1 year (no bleeding for 12 consecutive months). If the person is of childbearing potential they must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment procedure day (a urine pregnancy test will be administered if it has been >30 days since serum pregnancy test for enrollment). The person must also agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
Agrees not to participate in another clinical study during the study period unless the study is in the follow-up phase and it has been one month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 30 days after last procedure day.
Agrees not to donate blood to a blood bank throughout participation in the study and for at least 60 days after last procedure day.
Have a normal ECG; must not have any of the following: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block, advanced A-V heart block, non-sinus rhythm, excluding isolated premature atrial contractions (sinus rhythm is not between 55-100 beats per minute), or any other abnormality that, in the opinion of the MAI, makes it unsafe for the subject to participate in the study.

Exclusion Criteria:

Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test at any time during the study.
Smokers. A ""smoker"", for the purposes of the study, will be defined as an individual who has regularly and habitually used nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the past 12 months. Occasional recreational use (less than once monthly) will not warrant exclusion unless the individual has used nicotine-containing substances in the previous 30 days before study enrollment.
Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow-up phase and it has been ≥ one month since the subject received any experimental agents or treatments.

Abnormal vital signs, defined as:

Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) at rest on two separate days.
Heart rate <55 at rest on two separate days
Respiratory rate ≤ 11 to ≥ 18 breaths per minute
Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within seven days of administration of a study product.
History of chronic obstructive pulmonary disease.
Positive urine drug screening test.
Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications will be allowed).
Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product. This includes antihistamines (within 72 hours prior to dosing), systemic or topical corticosteroids within four weeks prior to dosing, use of monoamine oxidase inhibitors 21 days prior to study, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, or radiation therapy.
Donation or loss of greater than one pint of blood within 60 days of entry to the study.
Any prior serious adverse reaction or hypersensitivity to lidocaine administered by any route.
Current diagnosis of any major psychiatric illness.
Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days before enrollment in this study or expects to receive an experimental agent during the study.
Medical history of a serious chronic condition, including (but not limited to): allergic conditions such as anaphylaxis to food or drugs; asthma; generalized drug reactions; any seizure disorder; any central nervous system disorder; glaucoma (open or closed angle); history of pyloric or urinary bladder neck obstruction; intestinal obstruction; difficulty swallowing; stomach or bowel problems (e.g, blockage, muscle weakness, ulcerative colitis, Crohn's disease); bleeding disorders; acid reflux disease; myasthenia gravis; allergy to belladonna alkaloids; impaired hepatic or renal function.
Any condition that would, in the opinion of the Principal Investigator (PI) or MAI, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Inability to communicate or cooperate with the investigators.
Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).
History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.
History of consumption of alcohol within 24 hours prior to dose administration.
Subject has an obvious difference in skin color at patch sites (compared to neighboring skin), or the presence of a skin condition, excessive hair at the application site, sunburn, raised moles and scars, open sores at application site, scar tissue, tattoo, or coloration that would interfere with placement of test articles, or the assessment of the skin and/or reactions to drug.",A single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject.,PubChem:6314,Lidocaine Hydrochloride,CCN(CC)CC(=O)Nc1c(C)cccc1C.Cl,,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03312023,NCT03312023_EG002,No,All,Adult | Older Adult,Phase 2,4,"INCLUSION CRITERIA

Participants in Groups A, C & D (Chronic HBV, low replicative state not requiring treatment):

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 or older at screening

Diagnosed with chronic hepatitis B infection defined as one of the following:

HBsAg or HBV DNA positivity for at least 6 months
Medical records indicating a chronic HBV infection
HBeAg negative at screening
HBV DNA > lower level of quantitation (LLOQ)
Quantitative HBsAg at least 10 IU/mL at screening
Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
Ability to communicate effectively with the study investigator and key staff
Medical management provided by a primary care provider
Ability to store medications at a room temperature of less than 86 degrees Fahrenheit
Not on antiviral therapy or requiring treatment for HBV during screening

Participants in Group B (Chronic HBV, virally suppressed):

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 or older at screening

Diagnosed with chronic hepatitis B infection defined as one of the following:

HBsAg or HBV DNA positivity for at least 6 months
Medical records indicating a chronic HBV infection
Receiving oral anti-HBV medications (either tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, or a combination of no more than 2 of these agents) for at least three months prior to enrollment
HBV DNA ˂ lower level of quantitation (LLOQ) at screening and for at least three months prior
Quantitative HBsAg at least 10 IU/mL at screening
Ability to take oral medication and be willing to adhere to the twelve week study drug regimen
For females of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 30 days after the end of study drug administration
For males of reproductive potential: usual practice of complete abstinence from sexual intercourse with a member of the opposite sex OR use of at least one form of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 14 days after the end of study drug administration
Ability to communicate effectively with the study investigator and key staff
Medical management provided by a primary care provider
Ability to store medications at a room temperature of less than 86 degrees Fahrenheit

EXCLUSION CRITERIA

Coinfection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)
Pregnancy or lactation
Known allergic reactions to sofosbuvir or ledipasvir
Treatment with another investigational drug or other intervention within three months

Evidence of cirrhosis or hepatic decompensation such as:

Platelets less than 100,000 /mm3
Albumin less than 3.5 g/dL
INR greater than 1.7 or Prothrombin time of 1.5 times the upper limit of normal (ULN)
Total bilirubin of 1.5 times the upper limit of normal
FibroTest (or FibroSure®) of 0.75 or greater

Abnormal hematological and biochemical parameters at screening including:

White blood cell count less than 2500 cells/uL
Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects)
Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females
AST or ALT of two times the upper limit of normal
Estimated GFR less than 50 mL/min
Glycosylated hemoglobin (HbA1c) greater than 8.5%

Current or prior history of any of the following:

Immunodeficiency disorders or autoimmune disease (e.g. Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel diseases, sarcoidosis, psoriasis of greater than mild severity)
Severe pulmonary disorders, significant cardiac diseases
Gastrointestinal disorder with post-operative condition that could interfere with the absorption of the study drugs
Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Any malignancy diagnosed within 5 years (not including recent localized treatment of squamous or non-invasive basal cell skin cancer; cervical carcinoma in situ appropriately treated prior to screening)
Solid organ transplantation
Poor venous access
Screening ECG with clinically significant findings
Evidence of HCC (e.g., α fetoprotein > 50ng/mL or radiologic evidence)
Clinically significant illicit drug or alcohol abuse within 12 months of screening. Subjects on methadone maintenance treatment or prescribed opioid may be included.
Use of amiodarone within 90 days of enrollment; or carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort, rosuvastatin, or interferon within 30 days of enrollment or expected use of these prohibited drugs during study participation. Use of or expected need of proton-pump inhibitors more than 20 mg omeprazole equivalent or H2 receptor antagonist more than 40 mg famotidine BID equivalent within 7 days of enrollment.","12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state.

Randomized 1:1 with Group D.

Sofosbuvir 400 MG [Sovaldi]: 1 pill once daily for 12 weeks for Group C",ChEMBL:CHEMBL1259059 | DrugBank:DB08934 | PubChem:25094462 | PubChem:45375806 | PubChem:45375808 | PubChem:91302628,Sofosbuvir,CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1,J05AP08 | J05AP51 | J05AP55 | J05AP56,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03325972,NCT03325972_EG000,No,All,Adult | Older Adult,Phase 4,33,"Inclusion Criteria:

Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
Subject is non-lactating and is either:
Not of childbearing potential
Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

Subject is pregnant or breastfeeding
Any subject whom the investigators deem unable to complete any/all research related tasks
Subjects who are cognitively impaired (by history)
Subject requires antipsychotic medications
Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
Subject has known allergy to dexmedetomidine
Subjects with impaired renal or hepatic function
Subjects with advanced heart block
Subjects with severe ventricular dysfunction","Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.

Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03330119,NCT03330119_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 3,1494,"Inclusion Criteria:

Scheduled to undergo a cesarean section

Exclusion Criteria:

Existing diagnosis of chronic pain
Need to undergo a vertical skin incision
AST > 50; ALT > 70
Platelets below 80,000 on admission
Need to undergo general anesthesia
Tubal ligation at time of Cesarean section
Prior or known allergy to any of the medications being utilized in this study","The regular Lankenau cesarean section order set.

Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request.",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03332212,NCT03332212_EG001,No,All,Adult | Older Adult,Phase 3,35,"Inclusion Criteria:

Chronic heart failure diagnosed at least 3 months before informed consent
NYHA class II-IV at screening
Age ≥ 18 years at screening
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Cohort A Heart Failure with Reduced Ejection Fraction (HFrEF)

Left ventricular ejection fraction (LVEF) ≤ 40% as measured by ECHO at screening

The following signs of heart failure;

Elevated NT-proBNP (>125 pg/mL) at screening in patient without atrial fibrillation (AF)
Elevated NT-proBNP (>600 pg/mL) at screening in patient with AF
Appropriate dose of medical therapy for HF (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international HF guidelines, stable for at least one week prior to Visit 1 and during screening period until Visit 2 (Randomisation) with the exception of diuretics which must be stable for at least one week prior to Visit 2 to control symptoms. If required, the investigator must document in the source documents the reason why the patient is not on the target dose per local guidelines.

Cohort B Heart Failure with Preserved Ejection Fraction (HFpEF)

Left ventricular ejection fraction (LVEF) ≥ 50% as measured by ECHO at screening and no previous measurement of LVEF ≤ 40%.

The following combined signs of heart failure;

Structural heart disease (LA enlargement [LAVI >34 mL/m2] and/or LVH [LVMI ≥ 115 g/m2 for males and ≥ 95 g/m2 for females]) by ECHO at screening or within 3 months prior to informed consent AND
NT-proBNP > 125pg/mL at screening in patient without AF or NT-pro-BNP > 600 pg/mL in patient with AF
Oral diuretics, if prescribed, should be stable for at least one week prior to Visit 1 and during screening period until Visit 2 (Randomisation).

Exclusion Criteria:

Stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
Any patients with myocardial scars and/or non-viable myocardium in the interventricular septum, unstable angina due to significant coronary artery disease (CAD), or major (in the opinion of the investigator) cardiovascular surgery.
Any contraindication for MRI, CPET and/or dobutamine stress test in accordance with the institution guidance, including implanted left ventricular assist device (LVAD),implantable cardioverter defibrillator (ICD), cardiac resynchronisation therapy (CRT) or any cardiac device.
Heart transplant recipient or listed for heart transplant
Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
Moderate to severe uncorrected valvular heart disease, obstructive or regurgitant, or any valvular heart disease expected to lead to surgery in the Investigator's opinion
Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or LVAD or hospitalisation within 1 week prior to Visit 1 (Screening), or during screening period until Visit 2 (Randomisation)
Systolic blood pressure (SBP) ≥ 180 mmHg at screening. If SBP >150 mmHg and <180mmHg at screening, the patient is ineligible if receiving 3 or more antihypertensive drugs
Symptomatic hypotension and/or a SBP < 100 mmHg at Screening
Atrial fibrillation which is uncontrolled in the opinion of the investigator
Untreated ventricular arrhythmia with syncope documented within the 3 months prior to informed consent in patients without ICD
Diagnosis of cardiomyopathy induced by chemotherapy or peripartum within the 12 months prior to informed consent
Symptomatic bradycardia or second or third degree heart block in need of a pacemaker after adjusting beta-blocker therapy or any other negative inotropic agents, if appropriate
Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalisation for exacerbation within 12 months prior to informed consent, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT),or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening
Impaired renal function, defined as estimated Creatinine Clearance < 30 mL/min (using Cockcroft-Gault formula) or requiring dialysis, as determined at screening
Haemoglobin < 10 g/dL at screening
Type 1 Diabetes Mellitus (T1DM)
History of ketoacidosis
Major surgery (major according to the investigator's assessment) performed within 3 months prior to informed consent, or scheduled major elective surgery (e.g. hip replacement) within 3 months after Visit 1
Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator's opinion
Any documented active or suspected malignancy or history of malignancy within 6 months prior to informed consent, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer (patients with pretreatment PSA <10 ng/mL, and biopsy Gleason score of ≤ 6 and clinical stage T1c or T2a)
Presence of any other disease than heart failure with a life expectancy of <1 year in the investigator's opinion
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Patients with requirement for treatment with empagliflozin according to local standard of care
Treatment with any SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor within 1 week prior to informed consent or during screening period until Visit 2 (Randomisation)
Currently enrolled in another investigational device or drug study, or less than 30 days between randomisation and ending another investigational device or drug study, or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded.
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
Women who are pregnant, breastfeeding, or who plan to become pregnant while in the trial
Any clinical condition that would jeopardise patients safety while participating in this trial, or may prevent the subject from adhering to the trial protocol",Once a day oral administration of a single 10 milligram (mg) film-coated empagliflozin tablet for 12 weeks. Cohort A: Heart failure (HF) with reduced ejection fraction (HFrEF) and Cohort B: Heart failure (HF) with preserved ejection fraction (HFpEF).,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03346083,NCT03346083_EG000,No,All,Child,Phase 1,3,"Inclusion Criteria:

Pediatric participants in the following age categories: 12 to < 18 years of age and 2 to < 12 years of age. Part 1 of the study enrolled only adolescent participants 12 to < 18 years of age.

Pediatric participant who was assessed to be at risk for VTE but did not require immediate anticoagulant therapy, for example:

Had previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, or
Had any stable disease with a risk for arterial or venous thromboembolism, or
Had any functional central venous access device in the upper or lower venous system.
Participant had normalized coagulation parameters (international normalized ratio or partial thromboplastin time, as appropriate) within 7 days of study drug administration.

Exclusion Criteria:

Participants who meet any one of the following exclusion criteria were excluded from the study:

Participant received any dose of anti-coagulant therapy within 7 days of Day 1.
Participant had active bleeding or had a comorbid disorder that placed the participant at high risk for bleeding.
Participant had a comorbid disorder that placed the participant at risk of death within 90 days of enrollment.
Participant had abnormal coagulation tests at baseline.
Participant had recent or planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study.

Participant had hepatic disease associated with one or more of the following:

Transaminase levels ≥ 2.5 × upper limit of normal (ULN) or bilirubin ≥ 1.5 × ULN at baseline.
Coagulopathy leading to a clinically relevant bleeding risk, or hepatic transaminase level of > 2 × ULN or total bilirubin > 2 × ULN with direct bilirubin > 20% of the total.
Platelet count < 75 × 10^9/liter or hemoglobin < 10.0 mg/deciliter.
Hypertension.
Participant had known congenital or acquired bleeding diathesis.
Participant required concomitant therapy with a strong P-glycoprotein inhibitor.
Participant had previous history of any non-traumatic bleeding event that was life threatening or required medical attention.
Participant had been administered thrombolytic therapy, or had undergone thrombectomy, or insertion of a caval filter to treat prior VTE.
Participant had known inherited or acquired bleeding diathesis or coagulopathy.
Participant had abnormal QTcF interval on baseline electrocardiogram.
Participant received a dose of any antiplatelet medication (including aspirin) within 14 days before study drug dosing.
Participant had malabsorption disorders (for example, cystic fibrosis or short bowel syndrome).
Participant had an estimated glomerular filtration rate < 30 milliliters/minute.
Participant was unable or reluctant to cooperate with the study procedures.
Participant had hypersensitivity to other Factor Xa inhibitors, or the components of the dosage form.
Participant had participated in a study with an investigational drug or medical device within 30 days prior to administration of betrixaban.
Participant was female and of childbearing potential and was either pregnant or breastfeeding a child.
Participant was sexually active and was not using medically accepted contraceptive method (if applicable).","Participants received a single, oral dose of betrixaban at 40 mg in a fed state, and had 10 PK blood sampling time points.",ChEMBL:CHEMBL512351 | DrugBank:DB12364 | PubChem:10275777,Betrixaban,COc1ccc(NC(=O)c2ccc(C(=N)N(C)C)cc2)c(C(=O)Nc2ccc(Cl)cn2)c1,B01AF04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03346083,NCT03346083_EG001,No,All,Child,Phase 1,18,"Inclusion Criteria:

Pediatric participants in the following age categories: 12 to < 18 years of age and 2 to < 12 years of age. Part 1 of the study enrolled only adolescent participants 12 to < 18 years of age.

Pediatric participant who was assessed to be at risk for VTE but did not require immediate anticoagulant therapy, for example:

Had previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, or
Had any stable disease with a risk for arterial or venous thromboembolism, or
Had any functional central venous access device in the upper or lower venous system.
Participant had normalized coagulation parameters (international normalized ratio or partial thromboplastin time, as appropriate) within 7 days of study drug administration.

Exclusion Criteria:

Participants who meet any one of the following exclusion criteria were excluded from the study:

Participant received any dose of anti-coagulant therapy within 7 days of Day 1.
Participant had active bleeding or had a comorbid disorder that placed the participant at high risk for bleeding.
Participant had a comorbid disorder that placed the participant at risk of death within 90 days of enrollment.
Participant had abnormal coagulation tests at baseline.
Participant had recent or planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study.

Participant had hepatic disease associated with one or more of the following:

Transaminase levels ≥ 2.5 × upper limit of normal (ULN) or bilirubin ≥ 1.5 × ULN at baseline.
Coagulopathy leading to a clinically relevant bleeding risk, or hepatic transaminase level of > 2 × ULN or total bilirubin > 2 × ULN with direct bilirubin > 20% of the total.
Platelet count < 75 × 10^9/liter or hemoglobin < 10.0 mg/deciliter.
Hypertension.
Participant had known congenital or acquired bleeding diathesis.
Participant required concomitant therapy with a strong P-glycoprotein inhibitor.
Participant had previous history of any non-traumatic bleeding event that was life threatening or required medical attention.
Participant had been administered thrombolytic therapy, or had undergone thrombectomy, or insertion of a caval filter to treat prior VTE.
Participant had known inherited or acquired bleeding diathesis or coagulopathy.
Participant had abnormal QTcF interval on baseline electrocardiogram.
Participant received a dose of any antiplatelet medication (including aspirin) within 14 days before study drug dosing.
Participant had malabsorption disorders (for example, cystic fibrosis or short bowel syndrome).
Participant had an estimated glomerular filtration rate < 30 milliliters/minute.
Participant was unable or reluctant to cooperate with the study procedures.
Participant had hypersensitivity to other Factor Xa inhibitors, or the components of the dosage form.
Participant had participated in a study with an investigational drug or medical device within 30 days prior to administration of betrixaban.
Participant was female and of childbearing potential and was either pregnant or breastfeeding a child.
Participant was sexually active and was not using medically accepted contraceptive method (if applicable).","Participants received a single, oral dose of betrixaban at 80 mg in a fed state, and had 5 PK sampling time points.",ChEMBL:CHEMBL512351 | DrugBank:DB12364 | PubChem:10275777,Betrixaban,COc1ccc(NC(=O)c2ccc(C(=N)N(C)C)cc2)c(C(=O)Nc2ccc(Cl)cn2)c1,B01AF04,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03351244,NCT03351244_EG000,No,All,Adult,Phase 2,89,"Inclusion Criteria:

International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) diagnosis of schizophrenia >= one year prior to randomisation.
Outpatients in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with treating clinician.
Patients currently taking a stable dose of antipsychotic medication(s) for at least 12 weeks prior to randomisation.
Detectable level of current antipsychotic medication(s) in plasma from blood drawn at Visit 1 (unless no assay is available for the antipsychotic(s) currently prescribed).

Patients who have experienced at least 2 relapses within the past 5 years or at least 1 relapse if they were diagnosed less than 3 years ago. Relapse is defined as the patient having any of the following using the above number of relapses and time frames:

Hospitalization for psychosis (involuntary or voluntary admission), intensive outpatient therapy or use of home treatment as an alternative to hospitalization (verified via medical record).
Emergency Department visit for worsening schizophrenia symptoms (verified via medical record).
Deliberate self-injury and/or violent behaviour resulting in significant injury to another person or property (verified by police record or treating mental health provider written record or documented phone conversation).
Change in the patient's antipsychotic medication or increase in antipsychotic medication dosage due to worsening of schizophrenia symptoms (verified by pharmacy records or treating mental health provider written record or documented phone conversation).
Clinical Global Impressions-Severity (CGI-S) score ≤4 at Visit 1 and 2.
Positive and Negative Syndrome Scale (PANSS) total score <80 and a score of ≤ 4 on individual PANSS items conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content at Visit 1.
Of full age (according to local legislation, usually ≥ 18 years) and ≤ 55 years at the time of informed consent.
Patients must have an identified informant who will be consistent throughout the study.
Patients who report living at the same address for the 3 months prior to randomisation.

Male or female patients.

-- Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Exclusion criteria:

Patients treated with more than two antipsychotic medications (including more than two dosage forms).
Patients who are currently being treated with clozapine, or who have been treated with clozapine in the past 5 years.
Patients with a categorical diagnosis of another current major psychiatric disorder per the Mini-international neuropsychiatric Interview (M.I.N.I.).
Homicidal behaviour (in the investigator's judgement) in the past 2 years.
Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial.
Other known neurological diseases (including but not limited to any kind of seizures or stroke).
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
Significant history of drug or alcohol dependence or abuse (Substance Use Disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or ICD-10) within the last six months prior to informed consent. (Not including caffeine or nicotine).
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the Investigator Site File (ISF)).
Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF)
Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).
Patients with a history of moderate to severe renal impairment (Stage 3 - 5).
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
Currently enrolled in another investigational device or drug study, or less than 6 months from Visit 1 since ending another investigational device or drug study(s), or participation in > 2 investigational drug clinical trials in the past 2 years.
Previous randomisation in any BI 409306 study.","1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.

Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.

Taper period: 2 tablets of 10 mg BI 409306 and 2 tablets of placebo q.d. on Day 1 of the taper period; 2 tablets of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 2-3 of taper period; 1 tablet of 10 mg BI 409306 and 1 tablet of placebo q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03351244,NCT03351244_EG001,No,All,Adult,Phase 2,88,"Inclusion Criteria:

International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) diagnosis of schizophrenia >= one year prior to randomisation.
Outpatients in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with treating clinician.
Patients currently taking a stable dose of antipsychotic medication(s) for at least 12 weeks prior to randomisation.
Detectable level of current antipsychotic medication(s) in plasma from blood drawn at Visit 1 (unless no assay is available for the antipsychotic(s) currently prescribed).

Patients who have experienced at least 2 relapses within the past 5 years or at least 1 relapse if they were diagnosed less than 3 years ago. Relapse is defined as the patient having any of the following using the above number of relapses and time frames:

Hospitalization for psychosis (involuntary or voluntary admission), intensive outpatient therapy or use of home treatment as an alternative to hospitalization (verified via medical record).
Emergency Department visit for worsening schizophrenia symptoms (verified via medical record).
Deliberate self-injury and/or violent behaviour resulting in significant injury to another person or property (verified by police record or treating mental health provider written record or documented phone conversation).
Change in the patient's antipsychotic medication or increase in antipsychotic medication dosage due to worsening of schizophrenia symptoms (verified by pharmacy records or treating mental health provider written record or documented phone conversation).
Clinical Global Impressions-Severity (CGI-S) score ≤4 at Visit 1 and 2.
Positive and Negative Syndrome Scale (PANSS) total score <80 and a score of ≤ 4 on individual PANSS items conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content at Visit 1.
Of full age (according to local legislation, usually ≥ 18 years) and ≤ 55 years at the time of informed consent.
Patients must have an identified informant who will be consistent throughout the study.
Patients who report living at the same address for the 3 months prior to randomisation.

Male or female patients.

-- Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Exclusion criteria:

Patients treated with more than two antipsychotic medications (including more than two dosage forms).
Patients who are currently being treated with clozapine, or who have been treated with clozapine in the past 5 years.
Patients with a categorical diagnosis of another current major psychiatric disorder per the Mini-international neuropsychiatric Interview (M.I.N.I.).
Homicidal behaviour (in the investigator's judgement) in the past 2 years.
Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial.
Other known neurological diseases (including but not limited to any kind of seizures or stroke).
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
Significant history of drug or alcohol dependence or abuse (Substance Use Disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or ICD-10) within the last six months prior to informed consent. (Not including caffeine or nicotine).
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the Investigator Site File (ISF)).
Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF)
Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).
Patients with a history of moderate to severe renal impairment (Stage 3 - 5).
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
Currently enrolled in another investigational device or drug study, or less than 6 months from Visit 1 since ending another investigational device or drug study(s), or participation in > 2 investigational drug clinical trials in the past 2 years.
Previous randomisation in any BI 409306 study.","1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Participants were randomized to either withdrawal or taper period in 1:1 ratio at the randomization of treatment groups.

Withdrawal period: 4 tablets of 10 mg placebo once daily (q.d.) on Day 1 of withdrawal period; 3 tablets of 10 mg placebo q.d. on Day2-3 of withdrawal period; 2 tablets of 10mg placebo q.d. on Day 4-5 of withdrawal period; 1 tablet of 10mg placebo q.d. on Day 6-7 of withdrawal period.

Taper period: 4 tablets of 10 mg BI 409306 q.d. on Day 1 of taper period; 3 tablets of 10 mg BI 409306 q.d. on Day 2-3 of taper period; 2 tablets of 10 mg BI 409306 q.d. on Day 4-5 of taper period; 1 tablet of 10 mg BI 409306 q.d. on Day 6-7 of taper period.",DrugBank:DB16274 | PubChem:135908617,Osoresnontrine,O=c1[nH]c(Cc2ccccn2)nc2c1cnn2C1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03352323,NCT03352323_EG000,No,All,Adult | Older Adult,Phase 3,50,"Inclusion Criteria:

Male or non-pregnant, non-lactating female, 18 years of age or older.
Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
Females of childbearing potential must not be pregnant or lactating.
Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
Have < 3 inflammatory lesions on the face.
Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that is reflective of the overall targeted areas.
Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study.

Exclusion Criteria:

Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
Patients with moderate to severe telangiectasial masses
History of blood dyscrasia.
Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the Investigator, would put the subject at undue risk or compromise the study assessments.
History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would place the subject at undue risk.
Female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study.
Previous participation in this study.
Employees of the Investigator or research center or their immediate family members.
Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.",Rhofade cream,ChEMBL:CHEMBL762 | DrugBank:DB00935 | PubChem:4636,Oxymetazoline,Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1,D11AX27 | R01AA05 | R01AB07 | S01GA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03355326,NCT03355326_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,6,"Inclusion Criteria:

Diagnosis of uncomplicated gastroschisis
Gestational age >33 weeks at time of delivery
Weight >1900g at time of delivery
Transfer of patient to Riley Hospital for Children prior to any abdominal surgery

Exclusion Criteria:

Neurological Congenital malformations and/or those known to impair intestinal motility
Additional congenital gastrointestinal abnormalities requiring surgical intervention
Congenital Cyanotic heart disease
Surgical Closure of abdominal wall defect with prosthetic material (e.g. prosthetic or bio-prosthetic mesh)",Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.,ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03368170,NCT03368170_EG001,No,All,Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Male or female ≥18 and ≤79 years of age.
Signed a current Ethics Committee approved informed consent form.
Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.
On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.
Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.
Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis).
Patient must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
Able to complete at least one valid 24-hour patient diary at Visit 1.

Exclusion Criteria:

History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation).
Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).
History of seizures within two years prior to screening.
History of stroke or transient ischemic attack (TIA) within two years prior to screening.
History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening.
A Hoehn and Yahr score of five when ""off"" as per Question 3.18 of the MDS-UPDRS, assessed during screening.
Any history of a significant heart condition or cardiac arrhythmias within the past 5 years, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator
Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; clinically significant symptomatic orthostatic hypotension; clinically significant hepatic disease, renal failure or abnormal renal function.
Any history of a neurological other than Parkinson's disease or a psychiatric disorder, including history of DSM IV diagnosed major depression or psychosis. Patients with illusions or hallucinations with no loss of insight will be eligible. Patients with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.
Enrolment in any other clinical study involving medication, medical devices or surgical procedures, current or within three months prior to screening visit, or previous participation in the present study. Patients enrolled in non-interventional clinical trials will be eligible.
Drug and/or alcohol abuse.
History of severe drug allergy or hypersensitivity.
If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose.
Patients unwilling to use two forms of contraception 90 days for men and 30 days for women after last IMP dose
Any planned major surgery within the duration of the study.
Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgement.","Placebo: Matching placebo capsule, white hard HPMC capsule, oral administration",DrugBank:DB16229 | PubChem:70980485,Mesdopetam,CCCNCCOc1cc(F)cc(S(C)(=O)=O)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03371836,NCT03371836_EG000,No,All,Child,Phase 4,20,"Inclusion Criteria:

Established diagnosis of epilepsy, characterized by focal seizures with suspected or documented localization in the temporal lobe. All participants will have active epilepsy that requires treatment with anticonvulsant medication.

Although it is not necessary to be seizure free, a seizure baseline period will be established in the 60 days prior to enrollment into the study.
Current regimen of anticonvulsant drugs must have been stable for 30 days prior to entry into the study.
No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
Established symptoms of anxiety with functional impairment.
A diagnosis of an anxiety disorder based on the administration of the K-SADS Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
Good general health as determined by medical history and physical examination.
Ability to swallow pills (participant will receive pill swallowing instruction if necessary). The medicine may be cut into pieces and/or mixed with applesauce.
If female of childbearing age, a negative urine or serum pregnancy test must be established or assured at baseline. Additionally, the participant must agree to use abstinence or appropriate contraception methods or be otherwise incapable of pregnancy for the duration of the study. Pregnancy test results will be shared with parent or guardian. Pregnancy status (or prevention) and abstinence or contraception methods will be addressed throughout the study for females of childbearing age as well as for post-pubertal males.
Previous subjects who failed at any point to meet continuation criteria and withdrew early may be considered for re-enrollment by the PI on a case-by-case basis.
Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.

Exclusion criteria:

Previous allergic or hypersensitivity reactions to Onfi® or benzodiazepines
Active substance abuse or dependence within 30 days of enrollment
DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.
Current standing use of benzodiazepines (except as ""rescue"" medicine)
Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
Participation in a previous experimental drug study within 30 days of baseline visit.
Estimated IQ<70 as indicated by initial clinical assessment (rendering rating scales invalid)
Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures","open label

Clobazam: Clobazam is used as an adjunct medicine for all participants.",ChEMBL:CHEMBL70418 | DrugBank:DB00349 | PubChem:2789,Clobazam,CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21,N05BA09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03378973,NCT03378973_EG000,No,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

Allergy to dexmedetomidine, propofol
Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
Hepatic disease","Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min

Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03378973,NCT03378973_EG001,No,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

Allergy to dexmedetomidine, propofol
Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
Hepatic disease","Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min

Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03395223,NCT03395223_EG000,No,All,Child | Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Pediatric or adult patients (males and females of all ages are included) diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the treating physician's diagnosis and hospital standard of care.

Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or ≤30% in case of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).

Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.

Exclusion Criteria:

Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlueTM.","Methylene Blue 0.5% will be administered.

1 mg/kg will be administered intravenously over 5-30 minutes. If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose.

Methylene Blue: Administration of Methylene Blue to treat acquired methaemoglobinaemia",DrugBank:DB09241 | PubChem:6099,Methylene Blue,CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-],V03AB17 | V04CG05,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03395288,NCT03395288_EG000,No,Female,Adult | Older Adult,Phase 2 | Phase 3,27,"Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

≥ 2 symptomatic, culture-proven UTI in 6 months OR

≥ 3 symptomatic, culture-proven UTI in 12 months

ii. Postmenopausal defined as no menses for at least 12 months or surgical menopause

b. At least one documented prior uropathogen susceptible to D-mannose

c. Using VET for a minimum of four weeks prior to study day 1

Inclusion criteria for the Observational arm of the study are the same with the exception of item 'c.' above (using VET for a minimum of four weeks) as participants will not be on vaginal estrogen therapy.

Exclusion Criteria:

For the RCT arms of the study, the exclusion criteria are as follows:

Not postmenopausal
Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
History of interstitial cystitis/painful bladder syndrome
Urothelial cancer
Non-English speaking
Enrolled in other clinical trials for UTIs
Currently using D-mannose or Methenamine for UTI prevention

Exclusion criteria for the Observational arm of the study are the same with the exception of item 'e.' above (known contraindication to VET) as participants will not be on vaginal estrogen therapy.","Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.

D-Mannose: A total of 2 g D-mannose daily",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03395288,NCT03395288_EG002,No,Female,Adult | Older Adult,Phase 2 | Phase 3,4,"Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

≥ 2 symptomatic, culture-proven UTI in 6 months OR

≥ 3 symptomatic, culture-proven UTI in 12 months

ii. Postmenopausal defined as no menses for at least 12 months or surgical menopause

b. At least one documented prior uropathogen susceptible to D-mannose

c. Using VET for a minimum of four weeks prior to study day 1

Inclusion criteria for the Observational arm of the study are the same with the exception of item 'c.' above (using VET for a minimum of four weeks) as participants will not be on vaginal estrogen therapy.

Exclusion Criteria:

For the RCT arms of the study, the exclusion criteria are as follows:

Not postmenopausal
Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
History of interstitial cystitis/painful bladder syndrome
Urothelial cancer
Non-English speaking
Enrolled in other clinical trials for UTIs
Currently using D-mannose or Methenamine for UTI prevention

Exclusion criteria for the Observational arm of the study are the same with the exception of item 'e.' above (known contraindication to VET) as participants will not be on vaginal estrogen therapy.","Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.

D-Mannose: A total of 2 g D-mannose daily",DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03421379,NCT03421379_EG000,No,All,Adult | Older Adult,Phase 3,71,"Inclusion Criteria:

Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)",A single dose of 3 mg glucagon nasal powder was administered intranasally,PubChem:44278361,Glucagon Emergency Kit,CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03421379,NCT03421379_EG001,No,All,Adult | Older Adult,Phase 3,70,"Inclusion Criteria:

Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)",A single dose of 1 mg glucagon hydrochloride solution was administered IM,PubChem:16186213,Glucagon (hydrochloride),CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03428945,NCT03428945_EG000,No,All,Child | Adult | Older Adult,Phase 2,183,"Inclusion Criteria:

Participant in TrialNet Pathway to Prevention Study (TN01)
Age 3 years or greater at the time of randomization
Willing to provide informed consent
Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
Two or more diabetes-related autoantibodies present on two separate samples
Weight of 12 kg or greater at screening
If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
Anticipated ability to swallow study medication.

Exclusion Criteria:

Abnormal Glucose Tolerance or Diabetes
History of treatment with insulin or other diabetes therapies
Ongoing use of medications known to influence glucose tolerance
Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
Known hypersensitivity to 4-aminoquinoline compounds
G6PD deficiency
History of retinopathy
Have an active infection at time of randomization
Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Be pregnant or breastfeeding.","Hydroxychloroquine compound for oral use

Hydroxychloroquine: Hydroxychloroquine for oral administration, dosed by weight",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0
NCT03436433,NCT03436433_EG001,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);
Safe for surgery per treating neurosurgeon;
Due to the potential implications of the treatment on the developing central nervous system (CNS), all patients must be ≥ 18 years of age at the time of entry into the study;

Laboratory Studies:

Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
Creatinine ≤ 1.5
A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men.

Exclusion Criteria:

Pregnant or need to breast feed during the study period (Negative urine β-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED;
Patients already on AED(s);
Known history of epilepsy/seizure disorder;
Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;
Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate therapy, per the discretion of the treating investigator;
Known allergy to LCM or LEV.","Enrolled subjects will be randomized to receive Levetiracetam.

Levetiracetam: LEV 1000mg twice a day.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03439670,NCT03439670_EG000,No,Male,Child,Phase 2,28,"Inclusion Criteria:

Subject's parent(s) or legal guardian(s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures; participants will be asked to give written or verbal assent according to local requirements

Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis of DMD as defined as:

Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR
Identifiable mutation within the DMD gene (deletion/duplication of one or more exons), where reading frame can be predicted as 'out-of-frame,' and clinical picture consistent with typical DMD, OR
Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, other) that is expected to preclude production of the dystrophin protein (i.e., nonsense mutation, deletion/duplication leading to a downstream stop codon), with a clinical picture consistent with typical DMD;
Subject is ≥ 4 years and <7 years of age at time of enrollment in the study;
Subject weighs >13.0 kg and ≤ 39.9 kg at the Screening Visit;
Subject is able to walk independently without assistive devices;
Subject is able to complete the Time to Stand Test (TTSTAND) without assistance in <10 seconds, as assessed at the Screening Visit;
Clinical laboratory test results are within the normal range at the Screening Visit, or if abnormal, are not clinically significant, in the opinion of the Investigator. [Notes: Serum gamma glutamyl transferase (GGT), creatinine, and total bilirubin all must be ≤ upper limit of the normal range at the Screening Visit. An abnormal vitamin D level that is considered clinically significant will not exclude a subject from randomization];

Subject has evidence of chicken pox immunity as determined by:

Presence of IgG antibodies to varicella, as documented by a positive test result from the local laboratory from blood collected during the Screening Period, OR
Documentation, provided at the Screening Visit, that the subject has had 2 doses of varicella vaccine, with or without serologic evidence of immunity; the second of the 2 immunizations must have been given at least 14 days prior to randomization.
Subject is able to swallow tablets, as confirmed by successful test swallowing of placebo tablets during the Screening Period; and
Subject and parent(s)/guardian(s) are willing and able to comply with scheduled visits, study drug administration plan, and study procedures.

Exclusion Criteria:

Subject has current or history of major renal or hepatic impairment, diabetes mellitus or immunosuppression;
Subject has current or history of chronic systemic fungal or viral infections;
Subject has had an acute illness within 4 weeks prior to the first dose of study medication;
Subject has used mineralocorticoid receptor agents, such as spironolactone, eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium), mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of study medication;
Subject has a history of primary hyperaldosteronism;
Subject has evidence of symptomatic cardiomyopathy [Note: Asymptomatic cardiac abnormality on investigation would not be exclusionary];
Subject is currently being treated or has received previous treatment with oral glucocorticoids or other immunosuppressive agents [Notes: Past transient use of oral glucocorticoids or other oral immunosuppressive agents for no longer than 1 month cumulative, with last use at least 3 months prior to first dose of study medication, will be considered for eligibility on a case-by-case basis, unless discontinued for intolerance. Inhaled and/or topical glucocorticoids are permitted if last use is at least 4 weeks prior to first dose of study medication or if administered at stable dose beginning at least 4 weeks prior to first dose of study medication and anticipated to be used at the stable dose regimen for the duration of the study];
Subject has an allergy or hypersensitivity to the study medication or to any of its constituents;
Subject has used idebenone within 4 weeks prior to the first dose of study medication;
Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the Investigator;
Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator;
Subject is taking (or has taken within 4 weeks prior to the first dose of study medication) herbal remedies and supplements which can impact muscle strength and function (e.g., Co-enzyme Q10, creatine, etc);
Subject is taking (or has taken within 3 months prior to the first dose of study medication) any medication indicated for DMD, including Exondys51 and Translarna;
Subject has been administered a live attenuated vaccine within 14 days prior to the first dose of study medication;
Subject is currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of study medication;
Subject has a sibling who is currently enrolled in any vamorolone study or Expanded Access Program, or who intends to enroll in any vamorolone study or Expanded Access Program during the subject's participation in the VBP15-004 study; or
Subject has previously been enrolled in the study. Note: Any parameter/test may be repeated at the Investigator's discretion during Screening to determine reproducibility. In addition, subjects may be rescreened if ineligible due to a transient condition which would prevent the subject from participating, such as an upper respiratory tract infection or injury, or if ineligible due to negative anti-varicella IgG antibody test result.",Patients enrolled in Treatment Group 1 (experimental group) will receive vamorolone 2.0 mg/kg/day for 24 weeks followed by vamorolone 2.0mg/kg/day for 20 weeks.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03439670,NCT03439670_EG001,No,Male,Child,Phase 2,28,"Inclusion Criteria:

Subject's parent(s) or legal guardian(s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures; participants will be asked to give written or verbal assent according to local requirements

Subject has a centrally confirmed (by TRiNDS central genetic counselor[s]) diagnosis of DMD as defined as:

Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, OR
Identifiable mutation within the DMD gene (deletion/duplication of one or more exons), where reading frame can be predicted as 'out-of-frame,' and clinical picture consistent with typical DMD, OR
Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, other) that is expected to preclude production of the dystrophin protein (i.e., nonsense mutation, deletion/duplication leading to a downstream stop codon), with a clinical picture consistent with typical DMD;
Subject is ≥ 4 years and <7 years of age at time of enrollment in the study;
Subject weighs >13.0 kg and ≤ 39.9 kg at the Screening Visit;
Subject is able to walk independently without assistive devices;
Subject is able to complete the Time to Stand Test (TTSTAND) without assistance in <10 seconds, as assessed at the Screening Visit;
Clinical laboratory test results are within the normal range at the Screening Visit, or if abnormal, are not clinically significant, in the opinion of the Investigator. [Notes: Serum gamma glutamyl transferase (GGT), creatinine, and total bilirubin all must be ≤ upper limit of the normal range at the Screening Visit. An abnormal vitamin D level that is considered clinically significant will not exclude a subject from randomization];

Subject has evidence of chicken pox immunity as determined by:

Presence of IgG antibodies to varicella, as documented by a positive test result from the local laboratory from blood collected during the Screening Period, OR
Documentation, provided at the Screening Visit, that the subject has had 2 doses of varicella vaccine, with or without serologic evidence of immunity; the second of the 2 immunizations must have been given at least 14 days prior to randomization.
Subject is able to swallow tablets, as confirmed by successful test swallowing of placebo tablets during the Screening Period; and
Subject and parent(s)/guardian(s) are willing and able to comply with scheduled visits, study drug administration plan, and study procedures.

Exclusion Criteria:

Subject has current or history of major renal or hepatic impairment, diabetes mellitus or immunosuppression;
Subject has current or history of chronic systemic fungal or viral infections;
Subject has had an acute illness within 4 weeks prior to the first dose of study medication;
Subject has used mineralocorticoid receptor agents, such as spironolactone, eplerenone, canrenone (canrenoate potassium), prorenone (prorenoate potassium), mexrenone (mexrenoate potassium) within 4 weeks prior to the first dose of study medication;
Subject has a history of primary hyperaldosteronism;
Subject has evidence of symptomatic cardiomyopathy [Note: Asymptomatic cardiac abnormality on investigation would not be exclusionary];
Subject is currently being treated or has received previous treatment with oral glucocorticoids or other immunosuppressive agents [Notes: Past transient use of oral glucocorticoids or other oral immunosuppressive agents for no longer than 1 month cumulative, with last use at least 3 months prior to first dose of study medication, will be considered for eligibility on a case-by-case basis, unless discontinued for intolerance. Inhaled and/or topical glucocorticoids are permitted if last use is at least 4 weeks prior to first dose of study medication or if administered at stable dose beginning at least 4 weeks prior to first dose of study medication and anticipated to be used at the stable dose regimen for the duration of the study];
Subject has an allergy or hypersensitivity to the study medication or to any of its constituents;
Subject has used idebenone within 4 weeks prior to the first dose of study medication;
Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the Investigator;
Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the Investigator;
Subject is taking (or has taken within 4 weeks prior to the first dose of study medication) herbal remedies and supplements which can impact muscle strength and function (e.g., Co-enzyme Q10, creatine, etc);
Subject is taking (or has taken within 3 months prior to the first dose of study medication) any medication indicated for DMD, including Exondys51 and Translarna;
Subject has been administered a live attenuated vaccine within 14 days prior to the first dose of study medication;
Subject is currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of study medication;
Subject has a sibling who is currently enrolled in any vamorolone study or Expanded Access Program, or who intends to enroll in any vamorolone study or Expanded Access Program during the subject's participation in the VBP15-004 study; or
Subject has previously been enrolled in the study. Note: Any parameter/test may be repeated at the Investigator's discretion during Screening to determine reproducibility. In addition, subjects may be rescreened if ineligible due to a transient condition which would prevent the subject from participating, such as an upper respiratory tract infection or injury, or if ineligible due to negative anti-varicella IgG antibody test result.",Patients enrolled in Treatment Group 2 (experimental group) will receive vamorolone 6.0 mg/kg/day for 24 weeks followed by vamorolone 6.0mg/kg/day for 20 weeks.,ChEMBL:CHEMBL3707311 | DrugBank:DB15114 | PubChem:3035000,Vamorolone,CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C,H02AB18,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03447639,NCT03447639_EG000,No,Male,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
Male
Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal

Exclusion Criteria:

Patients planned for discharge with an indwelling catheter in place
Patients unable to report urinary symptoms accurately
Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
Clinical signs or symptoms of urinary tract infection at the time of consent
Patients currently being treated for UTI
Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
Patients unable to comply with study requirements
Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data","Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal

Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03448406,NCT03448406_EG001,No,All,Adult | Older Adult,Phase 3,157,"Inclusion Criteria:

Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1

Patients must have at least one of the following evidence of heart failure (HF):

Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).

Exclusion Criteria:

Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
Type 1 Diabetes Mellitus (T1DM)
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
Unstable angina pectoris in past 30 days prior to Visit 1
Largest distance walked in 6 minutes (6MWTD) at baseline <100m.

Any presence of condition that precludes exercise testing such as:

claudication,
uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
significant musculoskeletal disease,
primary pulmonary hypertension,
severe obesity (body mass index ≥40.0 kg/m2),
orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
amputation with artificial limb without stable prosthesis function for the past 3 months
Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
Implanted cardiac resynchronisation therapy (CRT)
Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
Further exclusion criteria applies",1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF > 40%).,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03448419,NCT03448419_EG001,No,All,Adult | Older Adult,Phase 3,155,"Inclusion Criteria:

Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
6MWT distance ≤350 m at screening and at baseline.
Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in NYHA class II-IV
Chronic HF with reduced EF defined as LVEF ≤ 40 % as per echocardiography at Visit 1 as per local reading (obtained under stable condition).
Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR NTproBNP > 600 pg/ml for patients with AF as analysed at the Central laboratory at Visit 1
Patients must be clinically stable and on appropriate and stable dose of medical therapy for HF (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine), consistent with prevailing CV guidelines, stable for at least 4 weeks prior to Visit 1(screening) with the exception of diuretics which must have been stable for at least two weeks prior to Visit 1. The investigator must document the reason in case the patient is not on such medication or if not on target dose of any heart failure medication as per local guidelines.
Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines, and if a device is required, it must have been implanted for at least 3 months prior to visit 1 for CRT and 1 month prior to visit 1 for ICD.

Exclusion Criteria:

Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
Acute decompensated HF (exacerbation of chronic HF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0167)
Type 1 Diabetes Mellitus (T1DM)
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
Symptomatic hypotension or a SBP < 100 mmHg at Visit 1 or 2
Systolic blood pressure (SBP) ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1 (Screening)
Unstable angina pectoris in past 30 days prior to Visit 1
Largest distance walked in 6 minutes (6MWTD) at baseline <100m.

Any presence of condition that precludes exercise testing such as:

claudication,
uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
significant musculoskeletal disease,
primary pulmonary hypertension,
severe obesity (body mass index ≥40.0 kg/m2),
orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
amputation with artificial limb without stable prosthesis function for the past 3 months
Any condition that, in the opinion of the investigator, would contraindicate the assessment of 6MWT
Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
Planned implantation of ICD or CRT during the course of the trial.
Treatment with i.v. iron therapy or erythropoietin within 3 months prior to screening
Treatment with i.v. iron therapy or erythropoietin within 3 months prior to screening
Further exclusion criteria applies",1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with reduced left ventricular ejection fraction (LVEF≤40%).,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03450707,NCT03450707_EG000,No,All,Adult | Older Adult,Phase 2,93,"Inclusion Criteria:

Adult patient (age ≥ 18 years)
Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous circulation (ROSC)
Within 4.5 hours of cardiac arrest event
Lactate >/=3

Exclusion Criteria:

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Traumatic etiology of arrest
Comfort measures only or anticipated withdrawal of support within 24 hours
Protected populations (pregnant women, prisoners)
Known allergy to thiamine","Patients randomized to the thiamine arm will receive thiamine 500mg in 100mL of normal saline intravenously every 12 hours for 5 doses. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.

Thiamine 500 mg IV: Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03457129,NCT03457129_EG000,No,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
Subjects aged 18 to 75.
Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
Can be safely treated, in the opinion of the investigator, with Fycompa.
Able and agrees to follow the specified titration schedule.
Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion Criteria:

Any history of non-epileptic or psychogenic seizures.
Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
Subjects with a suicidal attempt in the 12 months prior to Visit 1
Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).","Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.

Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03457129,NCT03457129_EG001,No,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
Subjects aged 18 to 75.
Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
Can be safely treated, in the opinion of the investigator, with Fycompa.
Able and agrees to follow the specified titration schedule.
Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion Criteria:

Any history of non-epileptic or psychogenic seizures.
Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
Subjects with a suicidal attempt in the 12 months prior to Visit 1
Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).","Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.

Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.",ChEMBL:CHEMBL1214124 | DrugBank:DB08883 | PubChem:9924495,Perampanel,N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O,N03AX22,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03459794,NCT03459794_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Early Phase 1,8,"Inclusion Criteria:

Weight over 110 pounds and under 185 pounds

Exclusion Criteria:

Pregnancy or nursing mothers.
Immunosuppressed individuals.
Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).
Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present
Hepatitis/HIV
Currently taking warfarin
Lactose intolerance (Lactose present in placebo)
Currently taking Steroid medications (inhaled, oral or injection)
Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)
Liver or renal dysfunction","Ivermectin will be administered once at 150mcg/kg, orally.

Ivermectin: 150 mcg/kg ivermectin, by mouth.",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03463512,NCT03463512_EG001,No,All,Child,Phase 3,124,"Inclusion Criteria:

Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
Children and adolescents, both genders, age from 3 months to < 18 years of age
Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

Known allergy to Racecadotril or any of its ingredients
Subjects suffering from renal or hepatic impairment
Subjects who need treatment for diarrhea other than ORS alone
Subjects with fever > 39 degrees Celsius
Subjects with bloody and/or purulent stools
Subjects suffering from antibiotic-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
Subjects with alternating bouts of diarrhea and constipation
Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease or pancreatic exocrine insufficiency
Cystic fibrosis or coeliac disease
Subjects suffering from prolonged or uncontrolled vomiting
Subjects with rare hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency
Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study
Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
Subjects with severe dehydration required for intravenous/parenteral rehydration
Subjects who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
Subjects with combined diseases or medical situations that would prevent to be enrolled depending in the judgment of the investigator
Intake of experimental drug within 30 days prior to study start
Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply
Adolescents (≥ 60 kg) not able to swallow capsules
Pregnancy and lactation",ORS: ORS,PubChem:155289109,"Dichloro[(1,2,3,4,5-eta)-pentamethylcyclopentadienyl]rhodium",Cc1c(C)c(C)[c-](C)c1C.Cl[Rh]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
NCT03471507,NCT03471507_EG001,No,All,Adult | Older Adult,Phase 2,83,"INCLUSIONARY CRITERIA:

Subject with acute and chronic localized musculoskeletal pain
Ages 18 to 80 years
Subjects of all races, gender or ethnic groups
Female subjects of childbearing age must have a negative pregnancy test Female subjects of childbearing age who are sexually active must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
Willing to provide written informed consent
Patients taking opioid or NSAID for their musculoskeletal pain may be included if pain is inadequately controlled

EXCLUSIONARY CRITERIA:

Patients meeting any of the following criteria will be excluded from the study: Use within 3 days of any topical agents on the affected area
Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses
Subject with history of uncontrolled diabetes (A1C of more than 9)
Subject with history of uncontrolled hypertension (SBP > 160 and DBP > 95)
Subject with active uncontrolled GERD (defined as more than 2 episodes per week) or history of peptic ulcer disease
Subject with active cancer, spinal cord lesions or spine surgery
Subject with allergies to diclofenac or to other non-steroid anti-inflammatory drugs (NSAID)
Known allergies to any oils, methyl salicylate and/or camphor
Subject is pregnant or lactating
Subject with history of heart attack, stroke or blood clot, or recent coronary artery bypass graft surgery (CABG) (i.e., within the last six months)
Subject with history of alcohol or drug abuse within 1 year
Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the subject's ability to participate in the study as determined by the Investigator",Diclofenac sodium topical solution 1.5%: Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.,PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03471767,NCT03471767_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,27,"Key Inclusion Criteria:

Age 18 years or above
Daily smoker using 10 or more cigarettes per day
Willing to be smoke-free for 7 days
Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.
Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.

Key Exclusion Criteria:

Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)
Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
Not pregnant or breastfeeding
Contraindication to the use of bupropion.
Additional criteria may apply.","Bupropion SR: Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks",PubChem:62884,Bupropion Hydrochloride,CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03485222,NCT03485222_EG000,No,All,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Patients should meet the following inclusion criteria:
Ambulatory patients age 18-85 years
Diagnosis of Heart failure (NYHA II to III)
LVEF<50% on echocardiography or CMRI in the previous 6 months
Have stable symptoms and therapy for HF within the last 3 months.

Exclusion Criteria:

Pregnant or lactating women.
Any history of diabetes by medical history or by any of the established criteria by the American Diabetes Association. It also includes patients with history of diabetes in remission.
ACS or cardiac surgery within the last 3 months.
Cancer or any other life-threatening condition.
Pancreatitis.
Glomerular Filtration Rate < 45 ml/Kg/min.
Use of continuous parental inotropic agents.
Systolic BP < 90 mm Hg.
Psychiatric disease incompatible with being in study.
Any contraindication to MRI procedures.
Any other medical or physical condition considered to be inappropriate by a study physician.",10mg once a day for 6 months,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03489304,NCT03489304_EG000,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV
Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.
Subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study
Current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week))
Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study)
Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury
Clinically significant history of liver disease
Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis
Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness
History of substance abuse or dependence over the past 6 months
Currently taking medication to assist with sleep (e.g., Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam, Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon, Sonata/Zaleplon, Melatonin, Unisom, Benadryl).
Pregnant","Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent",ChEMBL:CHEMBL1521 | DrugBank:DB00962 | PubChem:5719,Zaleplon,CCN(C(C)=O)c1cccc(-c2ccnc3c(C#N)cnn23)c1,N05CF03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03539432,NCT03539432_EG000,No,All,Adult,Phase 2,2,"Inclusion Criteria:

males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
interested in cutting down or quitting drinking
able to provide voluntary informed consent
have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days

Exclusion Criteria:

severe liver disease; severe kidney disease; gallbladder disease or gallstones
chronic renal or hepatic failure
recent pancreatitis
insulin-dependent diabetes
other urgent medical problems
moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)
schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)
active legal problems with the potential to result in incarceration
pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)
current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics
regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68
a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years
a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30 minutes69)
left-handedness
any contraindications for MRI","Gemfibrozil 600 mg by mouth twice daily

Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day",ChEMBL:CHEMBL457 | DrugBank:DB01241 | PubChem:3463,Gemfibrozil,Cc1ccc(C)c(OCCCC(C)(C)C(=O)O)c1,C10AB04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03550794,NCT03550794_EG000,No,All,Adult | Older Adult,Phase 2,95,"Inclusion Criteria:

Adult ≥18 years of age
Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
Serum lactate ≥2mmol/L
Creatinine >1.0mg/dL

Exclusion Criteria:

Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
Renal replacement therapy within the past 30 days
Comfort measures only or anticipated withdrawal of support within 24 hours
Protected populations (pregnant women, prisoners)
Known thiamine allergy","200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)

Thiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.",ChEMBL:CHEMBL1547 | DrugBank:DB00152 | PubChem:1130,Thiamine,Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1,A11DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03573297,NCT03573297_EG000,No,All,Adult | Older Adult,Phase 3,896,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).

Exclusion Criteria:

Four or more episodes of a mood disturbance within the 12 months before Visit 1;
Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.","Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03573297,NCT03573297_EG002,No,All,Adult | Older Adult,Phase 3,144,"Inclusion Criteria:

Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).

Exclusion Criteria:

Four or more episodes of a mood disturbance within the 12 months before Visit 1;
Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.",Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03591406,NCT03591406_EG001,No,All,Adult | Older Adult,Phase 3,180,"Inclusion Criteria:

At least 18 years of age
Hb <11 g/dL (females) or Hb <12 g/dL (males) at the screening visit
Serum ferritin <100 ng/mL for subjects with underlying inflammatory disease (e.g., inflammatory bowel disease (IBD), chronic kidney disease (CKD) or chronic heart failure (CHF), as determined by high sensitive C-reactive protein [hsCRP] levels above the normal range) otherwise ≤14 ng/mL in subjects with no apparent underlying inflammatory disease (as determined by hsCRP levels within normal range) at the screening visit
Transferrin Saturation (TSAT) <16% (any subject) at the screening visit
Microcytic, hypochromic anaemia defined as: a) Mean corpuscular Hb concentration (MCHC) <32%; b) Mean corpuscular volume (MCV) < 80 fL; c)Mean corpuscular Hb (MCH) <27 pg
Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments
Before any study-specific procedure is conducted, the appropriate written informed consent must be obtained

Exclusion Criteria:

Subject has known hypersensitivity to any of the products to be administered during dosing
Any history of iron storage diseases such as haemochromatosis
Any history or clinical findings of iron utilisation disorders such as sideroachrestic anaemia
Known haemoglobinopathy (e.g. thalassaemia)
Any history or clinical findings of anaemia associated with: a) Haematuria b) Vitamin B12 or folic acid deficiency that requires treatment (subjects can be included after deficiency is corrected)
Any allergic predispositions, i.e. any history of asthma or atopic allergy. This includes drug allergies.
Planned surgery with anticipated blood loss (defined as Hb drop >2 g/dL) in the 3 months post randomisation
Subject has known malignancy (with or without current treatment), except basal cell or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
Haemodialysis (current or planned within the next 3 months)
History of IV iron therapy, erythropoiesis stimulating agent (ESA) therapy and/or blood transfusion in previous 4 weeks prior to screening, and oral iron or oral iron-containing products including Chinese herbal medicines (>75mg iron/day) in the 7 days prior to screening
Body weight <35 kg
Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above 3 times the upper limit of the normal range
Known human immunodeficiency virus infection, acquired immunodeficiency syndrome, tuberculosis
Known active hepatitis B or C or other active infection (acute or chronic)
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s)
Subject is pregnant or is breast feeding
Female subject of childbearing potential not using adequate contraceptive methods during the study and for up to 1 month after the last dose of the study medication. Adequate contraceptive methods are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhoea for at least 12 months
Male subjects planning to father a child within 7 days from the last study drug administration.
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures and/or other reason(s) that render subject not appropriate for study participation in the opinion of the treating physician","Participants treated with IS given by IV injection or drip infusion

Dosage Form: Sterile solution for injection containing 2% w/v iron

Strength: 5 mL ampoules containing 100 mg iron per ampoule

Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given

Route of administration: IV injection or drip infusion

Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.",DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03593213,NCT03593213_EG000,No,All,Adult,Phase 3,587,"Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.","Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03593213,NCT03593213_EG003,No,All,Adult,Phase 3,49,"Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.",Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03593213,NCT03593213_EG004,No,All,Adult,Phase 3,54,"Inclusion Criteria:

Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

Currently meeting DSM-5 criteria for any of the following:
Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
Bipolar I and II disorder
Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.",Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.,ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03595618,NCT03595618_EG002,No,All,Adult | Older Adult,Phase 2,232,"Inclusion Criteria:

Male participants or female participants of non-childbearing potential and not breastfeeding.
Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.
Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.
Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion Criteria:

Severe clinical knee malalignment according to the investigator.
Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).
Knee prosthesis already foreseen within the study period (whichever side).
Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).
Previous osteotomy on the inferior limbs (whichever side).
Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
Other pathologies affecting the target knee.
Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.","Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.",ChEMBL:CHEMBL4650334 | PubChem:121448788,ALDUMASTAT,C[C@H]1CN(C(=O)CC[C@@]2(C3CC3)NC(=O)NC2=O)CCN1c1cc(F)cc(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03598140,NCT03598140_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 2,22,"Inclusion Criteria:

For Athletes

Age 18-35
Male or female professional boxers/MMA fighters
Ability to undergo MR imaging procedures

At least one of the following:

Knockout (KO)/Technical Knockout (TKO) scored by fight referee.
Greater than 25 blows to the head.
Significant post-concussive symptoms (Symptom Score > 1 on at least 3 items from the Rivermead Post-Concussion Questionnaire)

For Controls

Age 18-35
Male of female who do not participate in contact sports
Screen negative for mild TBI (mTBI) using Ohio State TBI Identification

Exclusion Criteria:

Contraindication to sildenafil which includes the following:

Current use of organic nitrate vasodilators
Use of ritonavir (HIV-protease inhibitor)
Current use of erythromycin, ketoconazole, or itraconazole
Current use of cimetidine
Current resting hypotension (BP < 90/50 mm Hg)
Current severe renal insufficiency (Creatinine Clearance < 30 milliliters/minute)
Current hepatic cirrhosis
Current cardiac failure or coronary artery disease causing unstable angina
Retinitis pigmentosa
Known hypersensitivity or allergy to sildenafil of any of its components
Daily therapy with a PDE5 inhibitor within the past 2 months
Immediate hospitalization for severe concussion
History of neurological or psychiatric disorder not related to TBI
Known inclusion in another interventional clinical trial
Subjects with metal implants that would interfere with the MR imaging procedures
Sickle cell disease
History of priapism","If randomized to sildenafil (60mg), the participant will receive single (Group 1) or multiple (once-a-day for 14 days; Group 2) treatments.

Sildenafil Citrate: Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03602976,NCT03602976_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Systemic sarcoidosis with evidence of liver involvement as denoted by any of the following:

Elevated liver-specific alkaline phosphatase
Granulomas on liver biopsy
Hepatomegaly on imaging
Portal Hypertension (via imaging or endoscopy)
Stable dose of immunosuppressant, if taking (no dose variation for 6 months)
If cirrhotic, absence of hepatocellular carcinoma as indicated by imaging within 6 months of screening

Exclusion Criteria:

Female who is pregnant, planning to become pregnant during the study, or breastfeeding
Clinically significant abnormalities, co-morbidities, or recent alcohol/drug abuse that make the subject an unsuitable candidate
Concurrent liver disease including hepatitis B, hepatitis C, alcohol-related liver disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
Currently on UDCA
Prior intolerance to UDCA
Receipt of any investigational product within a time period equal to 10 half-lives of the product, or 6 weeks (whichever is longer), to study drug administration
Current evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites). In the event potential participant is post-transplant, no evidence of hepatic decompensation since transplantation",Ursodeoxycholic Acid: weight-based dosing,DrugBank:DB01586,Ursodeoxycholic acid,[H][C@@]12C[C@H](O)CC[C@]1(C)[C@@]1([H])CC[C@@]3(C)[C@@]([H])(CC[C@]3([H])[C@H](C)CCC(=O)O)[C@]1([H])[C@@H](O)C2,A05AA02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03610048,NCT03610048_EG000,No,All,Adult | Older Adult,Phase 3,175,"Inclusion Criteria:

Completed study ALK5461-217
Be willing to abide by the contraception requirements as outlined in the study protocol
Be willing and able to follow the study procedures and visits as outlined in the protocol
Additional criteria may apply

Exclusion Criteria:

Pregnant, planning to become pregnant, or breastfeeding
A positive urine drug test for drugs of abuse
Poses a current suicide risk
Additional criteria may apply","All subjects assigned to ALKS 5461

Sublingual tablets

ALKS 5461: samidorphan + buprenorphine administered sublingually",PubChem:53373584,Buprenorphine/samidorphan,COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.NC(=O)c1ccc2c(c1O)C13CCN(CC4CC4)C(C2)C1(O)CCC(=O)C3,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03613129,NCT03613129_EG001,No,All,Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Provision of signed and dated informed consent form
Ability to read, understand and speak English
Living at an altitude between 3,500 and 5,500 feet above sea level for the past 1 year
Willing to perform an exercise test
Diagnosed with ME/CFS and meet the following 3 case definitions: Fukuda Research Case Definition for CFS (1994), Revised Canadian Consensus Criteria for ME/CFS (2010) and the Institute of Medicine (IOM) Clinical Diagnostic Criteria for ME/CFS (2015)
Relatively stable state of illness for the individual patient over the past 3 months
Male or female, between the ages of 18 and 60 years old
Males or females of reproductive potential agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception, starting from the time of informed consent through 28 days after the last dose of study drug. Acceptable methods of birth control during the study are intrauterine device, diaphragm with spermicide, contraceptive sponge, condom or vasectomy. Oral contraceptive pills may not be used as the sole method of contraception because the effect of CT38 on the efficacy of oral contraceptive pills has not yet been established
Stated willingness to comply with all study procedures and remain available for the study duration
Have mobile (smart) phone and access to the internet

Exclusion Criteria:

Alternate medical or psychiatric illness that could explain the ME/CFS symptoms
Unwilling or unable to perform an exercise test
Active or uncontrolled co-morbidities which in the opinion of the PI may interfere with the ability of the patient to participate in the study. Co-morbidities may include acute infection, Crohn's disease, diabetes mellitus (Type 1 or Type 2, evidenced by a history of glycated hemoglobin (A1C) > 7 at any time), Guillain-Barre syndrome, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis, or other such diseases that may be exclusionary. Particularly conditions or medications that cause immunodeficiency or immunosuppression will be excluded. Examples of such conditions can be found in the tables ""Causes of Secondary Immunodeficiency"" and ""Some Drugs that Cause Immunosuppression"" in the ""Merck Manual""
Pregnancy, or while breast feeding. Women should not be enrolled within 6 months of giving birth and within 3 months of cessation of breast feeding
A Body Mass Index > 35
Cigarette smoker or former smoker who has smoked within 6 months of the start of the study
Living at an altitude that is more than 1,000 feet (lower or higher) from the study site (which is 4,500 feet above sea level)

History of:

Major depression with psychotic or melancholic features before the diagnosis of ME/CFS, or active depression (major depression with psychotic or melancholic features) as determined by self-report
Untreated endocrine diagnoses including hypothyroidism (Hashimoto's, etc.), Grave's disease, adrenal insufficiency, hypogonadism (testosterone deficiency), diabetes mellitus or insipidus
Acute infection within the past 30 days
Within the last 3 years, any significant head injury, e.g., concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, other traumatic brain injury
A supra-ventricular tachycardia or ventricular tachycardia, e.g., atrial fibrillation or flutter, paroxysmal atrial fibrillation, junctional tachycardia, ventricular tachycardia
Severe baseline hypotension defined as rested sitting systolic BP < 100 mmHg or rested sitting diastolic BP < 60 mmHg
Renal impairment based upon the local lab normal estimated glomerular filtration rate (eGFR) (drug is cleared by passive renal filtration)
Known hypersensitivity or clinically significant allergies to tromethamine or Tween 80 (both excipients in the drug product)
Substance abuse in the past 12 months as determined by self-report
Improvement in overall ME/CFS symptoms as a result of any treatment intervention in the past 3 months
Current treatment with medications that interact with pathways involving: (i) 5-hydroxytryptamine (5HT) (e.g., selective 5HT re-uptake inhibitors or selective serotonin reuptake inhibitors (SSRIs), 5HT and norepinephrine re-uptake inhibitors or serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors, triptans); (ii) norepinephrine (e.g., adrenergic agonists or antagonists, norepinephrine re-uptake inhibitors, norepinephrine and dopamine re- uptake inhibitors); (iii) dopamine (e.g., norepinephrine and dopamine re-uptake inhibitors); and (iv) cortisol pathways (e.g., oral glucocorticoids, fludrocortisone).

Prior treatment with

Short-term (< 2 weeks) antiviral or antibiotic medication or flu shot within the past 4 weeks
Long-term (> 2 weeks) antiretrovirals within the past 12 months
RituximabTM within 6 months
Any new prescription drug or herbal remedy within 2 weeks prior to the onset of the trial
Current participation in another clinical treatment trial","Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days",PubChem:49834265,Unii-JH0PQ88XA2,Cc1cccc(-c2oc(C)nc2C(=O)Nc2cnn(Cc3nc(C(C)(F)F)co3)n2)c1,,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT03613129,NCT03613129_EG004,No,All,Adult,Phase 1 | Phase 2,2,"Inclusion Criteria:

Provision of signed and dated informed consent form
Ability to read, understand and speak English
Living at an altitude between 3,500 and 5,500 feet above sea level for the past 1 year
Willing to perform an exercise test
Diagnosed with ME/CFS and meet the following 3 case definitions: Fukuda Research Case Definition for CFS (1994), Revised Canadian Consensus Criteria for ME/CFS (2010) and the Institute of Medicine (IOM) Clinical Diagnostic Criteria for ME/CFS (2015)
Relatively stable state of illness for the individual patient over the past 3 months
Male or female, between the ages of 18 and 60 years old
Males or females of reproductive potential agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception, starting from the time of informed consent through 28 days after the last dose of study drug. Acceptable methods of birth control during the study are intrauterine device, diaphragm with spermicide, contraceptive sponge, condom or vasectomy. Oral contraceptive pills may not be used as the sole method of contraception because the effect of CT38 on the efficacy of oral contraceptive pills has not yet been established
Stated willingness to comply with all study procedures and remain available for the study duration
Have mobile (smart) phone and access to the internet

Exclusion Criteria:

Alternate medical or psychiatric illness that could explain the ME/CFS symptoms
Unwilling or unable to perform an exercise test
Active or uncontrolled co-morbidities which in the opinion of the PI may interfere with the ability of the patient to participate in the study. Co-morbidities may include acute infection, Crohn's disease, diabetes mellitus (Type 1 or Type 2, evidenced by a history of glycated hemoglobin (A1C) > 7 at any time), Guillain-Barre syndrome, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis, or other such diseases that may be exclusionary. Particularly conditions or medications that cause immunodeficiency or immunosuppression will be excluded. Examples of such conditions can be found in the tables ""Causes of Secondary Immunodeficiency"" and ""Some Drugs that Cause Immunosuppression"" in the ""Merck Manual""
Pregnancy, or while breast feeding. Women should not be enrolled within 6 months of giving birth and within 3 months of cessation of breast feeding
A Body Mass Index > 35
Cigarette smoker or former smoker who has smoked within 6 months of the start of the study
Living at an altitude that is more than 1,000 feet (lower or higher) from the study site (which is 4,500 feet above sea level)

History of:

Major depression with psychotic or melancholic features before the diagnosis of ME/CFS, or active depression (major depression with psychotic or melancholic features) as determined by self-report
Untreated endocrine diagnoses including hypothyroidism (Hashimoto's, etc.), Grave's disease, adrenal insufficiency, hypogonadism (testosterone deficiency), diabetes mellitus or insipidus
Acute infection within the past 30 days
Within the last 3 years, any significant head injury, e.g., concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, other traumatic brain injury
A supra-ventricular tachycardia or ventricular tachycardia, e.g., atrial fibrillation or flutter, paroxysmal atrial fibrillation, junctional tachycardia, ventricular tachycardia
Severe baseline hypotension defined as rested sitting systolic BP < 100 mmHg or rested sitting diastolic BP < 60 mmHg
Renal impairment based upon the local lab normal estimated glomerular filtration rate (eGFR) (drug is cleared by passive renal filtration)
Known hypersensitivity or clinically significant allergies to tromethamine or Tween 80 (both excipients in the drug product)
Substance abuse in the past 12 months as determined by self-report
Improvement in overall ME/CFS symptoms as a result of any treatment intervention in the past 3 months
Current treatment with medications that interact with pathways involving: (i) 5-hydroxytryptamine (5HT) (e.g., selective 5HT re-uptake inhibitors or selective serotonin reuptake inhibitors (SSRIs), 5HT and norepinephrine re-uptake inhibitors or serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors, triptans); (ii) norepinephrine (e.g., adrenergic agonists or antagonists, norepinephrine re-uptake inhibitors, norepinephrine and dopamine re- uptake inhibitors); (iii) dopamine (e.g., norepinephrine and dopamine re-uptake inhibitors); and (iv) cortisol pathways (e.g., oral glucocorticoids, fludrocortisone).

Prior treatment with

Short-term (< 2 weeks) antiviral or antibiotic medication or flu shot within the past 4 weeks
Long-term (> 2 weeks) antiretrovirals within the past 12 months
RituximabTM within 6 months
Any new prescription drug or herbal remedy within 2 weeks prior to the onset of the trial
Current participation in another clinical treatment trial","Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days",PubChem:49834265,Unii-JH0PQ88XA2,Cc1cccc(-c2oc(C)nc2C(=O)Nc2cnn(Cc3nc(C(C)(F)F)co3)n2)c1,,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03617289,NCT03617289_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,37,"Inclusion Criteria:

Age >18 years old and <100 years old.
Patients seen in the Emergency Department at Henry Ford Macomb hospital.
Patients that are A+Ox3.
Patients who have typical presentation for renal colic.

Exclusion Criteria:

Age <18 years.
Patients with a history of dementia, acute delirium or altered mental status.
Patients with inability to consent to study or inability to fill questionnaire independently.
Patients with chronic kidney disease and allergies to study drugs.
Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
Patients with stroke activation or symptoms.
Patients with trauma activations.
Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
Imaging study does not show evidence of ureteral stone.","Receiving D5W

D5W",ChEMBL:CHEMBL1279 | DrugBank:DB00998 | PubChem:77992,Frovatriptan,CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1,N02CC07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03621085,NCT03621085_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,43,"Inclusion Criteria:

18-45 years of age
Healthy
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg

Exclusion Criteria:

Subjects not in the defined age range
Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Body mass less than 65 kg
Current smokers, as well as individuals who regularly smoked within the past 3 years
Positive urine drug screen
Currently taking pain modifying medication(s)",Ketamine trials,PubChem:15851 | PubChem:44632368,Ketamine Hydrochloride,CNC1(c2ccccc2Cl)CCCCC1=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
NCT03640507,NCT03640507_EG001,No,Female,Adult | Older Adult,Phase 2 | Phase 3,30,"Intervention Group (vaginal preparation)

Inclusion Criteria:

Pregnant women admitted for cesarean delivery
Gestational age greater than or equal to 34 weeks

Exclusion Criteria:

Rupture of membranes or active labor
Chorioamnionitis (prior to enrollment)
Recent (within 4 weeks) antibiotic exposure
Maternal HIV infection or immunocompromised state
Known allergy to shellfish, iodine, or chlorhexidine","Subjects will receive vaginal preparation with povidine-iodine.

Povidine-iodine: Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03642873,NCT03642873_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,23,"Inclusion Criteria:

Males and/or females between the ages of 19 and 55 years, inclusive.

Females of childbearing potential were using one of the following acceptable birth control methods:

Intrauterine device (IUD) in place for at least 3 months prior to study;
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through 30 days beyond study completion;
Stable hormonal contraceptive for at least 3 months prior to study through 30 days beyond completion of study;

Abstinence was not an acceptable form of contraception.

Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.

Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.
Within 15% of Ideal Body Weight as defined by the 1983 Metropolitan Life chart.
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year.
Able to read, understand, and sign the informed consent after the nature of the study had been explained.
Negative finding on tests for Hepatitis B and C antigen as well as HIV and pregnancy test (if female).
Negative urine screen for drugs of abuse and alcohol at screening and the first check in.
Non-alcohol or drug abuser - for alcohol, defined as history of less then 4 drinks daily.

Exclusion Criteria:

Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
Females who were pregnant or nursing.
History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
Receipt of an investigational drug within 1 month prior to study enrollment.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.
Known or suspected use of illicit drugs (including codeine or hydrocodone, etc.).
The use of any medication on a chronic basis with the exception of oral contraceptives for women of childbearing potential. An appropriate drug-free period for prescription or over-the-counter (OTC) drugs provided to washout any especially long half-life drugs.
Consumption of alcohol within 48 hours prior to each dosing period.
Consumption of grapefruit 14 days prior to dosing and throughout the study.
Hemoglobin value < 12 g/dL. If a subject's hemoglobin dropped below 11.0 g/dL the subject was dropped from the study at the Principal Investigator's discretion.",Hydrocodone Bitartrate 10 mg (3.33 mg q4h X 3) tablet by mouth under fasted state,PubChem:20831824 | PubChem:5463977,Hydrocodone Bitartrate,COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314.O=C(O)C(O)C(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03655080,NCT03655080_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Patients with ≤ 37 points per the scoring system listed in the protocol
Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal column origin.
MRI or CT evidence of metastatic epidural spinal cord compression.
Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of chemotherapy could potentially be given. This means the latest nab-paclitaxel can start is the morning of the third fraction of radiotherapy. Radiotherapy should ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.
At least 18 years of age.

Normal bone marrow and organ function as defined below:

Absolute neutrophil count ≥ 1,500 cells/mm3
Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to blood draw)
Hemoglobin > 9.0 g/dL
Total bilirubin ≤ 1.5 mg/dL
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (< 5 x IULN) in the absence of liver metastasis)
Creatinine ≤ 1.5 mg/dL

Women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months) must:

Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting treatment with nab-paclitaxel and while on study; and
Have a negative serum pregnancy test result at screening and agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
Male subjects must practice true 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, during dose interruptions, and for 6 months following nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test prior to study entry.
Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Previous spinal cord radiotherapy that would overlap with the proposed treatment field.
Spinal instability or bony retropulsion causing the cord compression. That is, mechanical, not tumor, cord compression. In these cases surgery may be indicated.
Patients eligible for surgical decompression like laminectomy.","10 fractions of 3Gy radiation therapy will be delivered.
A total of 4 chemoradiation blocks should be delivered ideally in consecutive days
On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel)
On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day
There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03657407,NCT03657407_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,56,"Inclusion Criteria:

between ages 18 and 75,
undergoing level I total laparoscopic or robot-assisted hysterectomy with or without bilateral salpingo-oophorectomy, cystoscopy, lysis of adhesions, or surgical treatment of endometriosis

Exclusion Criteria:

contraindications to the use of B&O (i.e. glaucoma, severe hepatic or renal disease, bronchial asthma, history of narcotic idiosyncracies, respiratory depression, convulsive disorders, acute alcoholism or delirium tremens, or regular use of an anticholinergic medication (twice per week or more frequently)
additional surgical procedures being performed","27 women randomized to Glycerin suppository

Glycerin Suppository: Glycerine rectal suppository",ChEMBL:CHEMBL692 | DrugBank:DB09462 | PubChem:753,Glycerin,OCC(O)CO,A06AG04 | A06AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03658876,NCT03658876_EG000,No,All,Adult | Older Adult,Phase 4,88,"Inclusion Criteria:

All prevalent haemodialysis patients, established for greater than 3 months

Exclusion Criteria:

Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin",Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions,DrugBank:DB09146,Iron sucrose,O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-],B03AB02 | V03AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03672006,NCT03672006_EG001,No,All,Child | Adult,Phase 2,20,"Inclusion Criteria:

Age 0 - ≤ 18 years old
PICU admission
CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted central catheter (PICC), Broviac or Hickman, or untunneled) and in place during hospitalization

Exclusion Criteria:

Pregnancy
Non-English-speaking subjects and/or parent/guardian
Platelet count < 20,000
Active CVC infection-defined as positive blood culture from the in -situ CVC at time of enrollment
Current radiographically confirmed VTE
Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr, enoxaparin injections >=2mg/kg/day or >=60mg/day)
CVC diameter <1.9 Fr
Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to heparin or t-PA
Med-a-port catheters","9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)

Heparin: Medication administered to dwell in central venous catheter",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03672175,NCT03672175_EG002,No,All,Adult | Older Adult,Phase 3,192,"Inclusion Criteria:

Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

Participant had active psychosis.
Participant had attempted suicide associated with the current episode of MDD.
Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.","Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03692910,NCT03692910_EG000,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

1. Participant had a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode.

Exclusion Criteria:

Participant had a history of suicide attempt.
Participant had current suicidal ideation with plans.
Participant had a history of rapid cycling bipolar disorder.","Participants self-administered SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03698864,NCT03698864_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Male or female patients age 18 to 80 years of age, inclusive, at Screening.
Biopsy-confirmed diagnosis of NL. Biopsies of continually active lesions performed outside of this clinical study will need to be reviewed and the diagnosis confirmed by the study pathologist. For patients with no previous history of biopsy, no biopsy within the previous 5 years, a biopsy that is not confirmed to be NL, or newly active lesion, a biopsy to confirm a diagnosis of NL will be performed at the Screening visit.
Reference NL lesion with a score of 2 or greater on the Investigator Global Assessment: Necrobiosis Lipoidica (IGA:NL) Activity scale AND surface area with minimum size of 10 cm2. If more than one lesion is present, the reference lesion area is the lesion with the highest disease severity.
Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Baseline before dosing.
Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study: oral contraceptive medication, intrauterine device (IUD), hormonal implants, injectable contraceptive medications, double-barrier methods, or tubal ligation.
Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and increased follicle-stimulating hormone [FSH] > 40 mIU/mL. If necessary to confirm postmenopausal status, an FSH will be drawn at Screening) or who have undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing.
Male patients must be willing to use appropriate contraceptive measures and refrain from sexual activity with any female who is pregnant or lactating.
Patient must be willing and able to swallow whole tablets.
Patient must be willing and able to comply with study procedures.
Patient must be willing and able to provide signed, informed consent.

Exclusion Criteria:

Current or previous (within 4 weeks of Baseline) treatment with:

Oral, topical, or intralesional corticosteroids;
Systemic pentoxifylline, theophylline, or cilostazol
Oral or topical retinoid;
Other systemic or topical immunosuppressant drugs, including but not limited to calcineurin inhibitors (e.g., tacrolimus), thalidomide, apremilast, anti-malarials (e.g., hydroxychloroquine, chloroquine), cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, etc.
Current or previous (within 12 weeks of Baseline) treatment with any biologic therapy (e.g., adalimumab, etanercept, infliximab, anakinra, etc.).
Phototherapy/photochemotherapy (NBUVB, UVB, PUVA) within 6 weeks prior to Baseline
Skin grafting, or other surgical procedure (other than debridement) within 6 weeks prior to Baseline.
History of drug allergy, including but not limited to pentoxifylline or other xanthine derivatives, or other allergy, which in the opinion of the Investigator, contraindicates participation.
Anticipated concurrent use of a strong CYP1A2 inhibiting drug, including but not limited to cimetidine and/or fluvoxamine, during the course of the study (after Screening).
Fever (>38°C), or chronic, persistent, or recurring infection(s) at Screening or Baseline.
Any infection requiring oral antimicrobial therapy within 2 weeks prior to Baseline or any infection requiring parenteral antibiotics or hospitalization within 12 weeks prior to Baseline. Any treatment for such infections must have been completed and the infection cured for at least 2 weeks prior to Baseline.
History of sarcoidosis, pyoderma gangrenosum, or any other disorder (in the judgment of the Investigator) that would interfere with the evaluation of NL or require protocol prohibited medication.
History of any life threatening infection or sepsis within 12 months of Baseline:
Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of Baseline, and arrhythmia requiring therapy.
Patient has QTc interval ≥ 480 milliseconds on Screening Electrocardiogram (ECG); a second Screening ECG may be done at investigator's discretion but the average of the two QTc screening intervals must not be ≥ 480 milliseconds.History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of Baseline.
History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of Baseline.
Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to Baseline.
Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and/or any other clinically significant disease or disorder, which in the opinion of the Investigator (by its nature or by being inadequately controlled), may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.
History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration >= 5 millimeter (mm), or a positive QuantiFERON-TB test or positive or borderline T-Spot [Elispot] test); or positive TB test at Screening. Subjects with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.
Vaccination with live or live-attenuated virus vaccine within 1 month prior to Baseline.

The results of the following laboratory tests performed at the central laboratory at Screening meet any of the criteria below:

Hemoglobin < 8.0 g/dL (International System of Units (SI): < 80 g/L);
White blood cells < 3.0 x 10^3 cells/mm^3 (SI: < 3.0 x 10^9 cells/L);
Neutrophils < 1.0 x 10^3 cells/mm^3 (SI: < 1.0 x 10^9 cells/L);
Lymphocytes < 0.5 x 10^3 cells/mm^3 (SI: < 0.5 x 10^9 cells/L);
Platelets < 100 x 10^3 cells/mm^3 (SI: < 100 x 10^9 cells/L)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) ≥ 2 x upper limit of normal (ULN);
Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented;
Estimated glomerular filtration rate < 40 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) formula.
Positive HIV serology
Evidence of active Hepatitis B Virus (HBV) infection
Evidence of active Hepatitis C Virus (HCV) infection
Women who are pregnant or breastfeeding.
Patient unwilling or unable to swallow tablets whole.
Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
Use of any investigational product within 30 days prior to Baseline or currently enrolled in another study that involves clinical investigations.",PCS499: PCS499 900mg twice a day with food,ChEMBL:CHEMBL1411 | DrugBank:DB12406 | PubChem:501254 | PubChem:51041322 | PubChem:57782,Lisofylline,CC(O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03705793,NCT03705793_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,27,"Inclusion Criteria:

12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

mucopurulent drainage(anterior, posterior, or both)
nasal obstruction (congestion)
facial pain-pressure-fullness
and decreased sense of smell

AND inflammation documented by one or more of the following findings:

purulent mucus or edema in the middle meatus or ethmoid region
radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria:

inability to speak or understand English
nasal polyps
history of nasal or sinus surgery
comorbid mucociliary conditions
dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
history of oral or systematic antibiotic use in the past 2 weeks
history of allergy to MF or other topical steroids
pregnant or breastfeeding
participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.","The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.

Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03712280,NCT03712280_EG002,No,All,Adult | Older Adult,Phase 2,13,"Key Inclusion Criteria:

A potential participant may only be included if (at screening), he/she:

Understands the study and has signed informed consent
Is an adult, not pregnant or lactating
Has cirrhosis of the liver
Has had 1 instance of HE within 12 months
Has hyperammonaemia defined as ≥37 μmol/L at screening

Key Exclusion Criteria:

A potential participant will be excluded if (at screening), he/she:

Has contraindicated allergies
Expects liver transplant within 1 month
Has had a liver shunt within the last 3 months
Has inadequate kidney, gastrointestinal, or cardiac function

Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:

the safety and well-being of the participant or potential offspring
the safety of study staff
the analysis of results",Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days,PubChem:44247677,Ornithine phenylacetate,NCCCC(N)C(=O)O.O=C(O)Cc1ccccc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03714672,NCT03714672_EG003,No,All,Adult,Phase 3,207,"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 diclofenac sodium 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.

Diclofenac 50: Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.",PubChem:5018304,Diclofenac sodium,O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+],,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
NCT03736785,NCT03736785_EG002,No,All,Adult | Older Adult,Phase 2,132,"Inclusion Criteria:

Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):

dipeptidyl peptidase-4 (DPP-4) inhibitors
sodium-glucose cotransporter (SGLT-2) inhibitors
biguanides
alpha-glucosidase inhibitors
sulfonlyureas
HbA1c value of 6.5% to 10%, inclusive
Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion Criteria:

Type 1 diabetes mellitus or latent autoimmune diabetes
Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
Active or untreated malignancy
Chronic (>14 days) systemic glucocorticoid therapy",Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.,PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,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
NCT03738215,NCT03738215_EG001,No,All,Adult | Older Adult,Phase 3,252,"Inclusion Criteria:

Written informed consent has been obtained.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
Patient must be an outpatient at the time of Visit 1 (Screening).
Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
Diagnosis of MDD confirmed through a formal adjudication process.
Patient demonstrates ability to follow study instructions and likely to complete all required visits.
Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.","During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).

Cariprazine: Cariprazine supplied in capsules",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03738215,NCT03738215_EG002,No,All,Adult | Older Adult,Phase 3,252,"Inclusion Criteria:

Written informed consent has been obtained.
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
Patient must be an outpatient at the time of Visit 1 (Screening).
Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
Diagnosis of MDD confirmed through a formal adjudication process.
Patient demonstrates ability to follow study instructions and likely to complete all required visits.
Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.","During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).

Cariprazine: Cariprazine supplied in capsules",ChEMBL:CHEMBL2028019 | DrugBank:DB06016 | PubChem:11154555,Cariprazine,CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1,N05AX15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03739684,NCT03739684_EG000,No,Male,Adult | Older Adult,Phase 3,208,"Inclusion Criteria:

Male >/= 18 years of age
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy

Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:

Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
Life expectancy ≥6 months as determined by the investigator
Able and willing to provide informed consent and comply with protocol requirements

Exclusion Criteria:

Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
Treatment with ADT in the past 3 months of Day 1
Receipt of investigational therapy for prostate cancer within 60 days of Day 1
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study",Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.,DrugBank:DB14805,Piflufolastat F 18,O=C(O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)c1ccc([18F])nc1)C(=O)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
NCT03745898,NCT03745898_EG000,No,All,Adult | Older Adult,Phase 3,48,"Inclusion Criteria:

Aged ≥ 21 years at the date of consent.
History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 50% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).

New York Heart Association (NYHA) Class III or IV, or NYHA Class II with any of the following:

at least one hospitalization for heart failure within the 24 months prior to enrollment or;
a BMI corrected BNP ≥ 300 pg/ml or a corrected NT-proBNP ≥ 1500 pg/ml or;
an ED visit for HF exacerbation where the patient has received an IV diuretic within 12 months of enrollment.
Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization (reasons for intolerance to GDNT must be documented).
In the investigator's opinion, willing and able to comply with all study requirements.
Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent (including HIPAA authorization in the U.S.).

Exclusion Criteria:

Current positive airway pressure use or predominantly obstructive rather than central sleep apnea.
Oxygen saturation < 90% at rest during the day.
Nocturnal oxygen saturation < 88% for > 5 continuous minutes unaccompanied by apneas or hypopneas.
Chronic daytime or nighttime use of supplemental oxygen.
Participants and their bed-partners who currently smoke in the bedroom.
Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
Transient ischemic attack or stroke within the previous 3 months.
Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial.
Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
Life expectancy < 1 year for diseases unrelated to chronic HF.
Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.","Active nocturnal oxygen therapy

Oxygen: Active nocturnal oxygen concentrator",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03753113,NCT03753113_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 3,12,"Inclusion Criteria:

Men 18 to 50 years old
Written consent
Normal general health status
Men who have a presentation of androgenetic alopecia (Norwood II - V).

Exclusion Criteria:

Use of any topical product in the target region interfering with the study product in the last three months
Within the past 6 months receiving of chemotherapy/cytotoxic agents
Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
Uncontrolled hypertension
Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
Hormonal diseases such as thyroid disorders, diabetes and, ...
Smokers
Liver and kidney disease
History of hair transplants
History of surgical correction of hair loss on the scalp
Subject having dyed, bleached hair or, with a permanent wave prior to study start.
No written consent","The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks

Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months",ChEMBL:CHEMBL802 | DrugBank:DB00350 | PubChem:4201,Minoxidil,Nc1cc(N2CCCCC2)nc(N)[n+]1[O-],C02DC01 | D11AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03771664,NCT03771664_EG001,No,All,Adult,Phase 3,43,"Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition, clinical trials version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
Participant had an Insomnia Severity Index (ISI) score greater than or equal to (>=) 15 (moderate to severe insomnia).
Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

Exclusion Criteria:

Participant had attempted suicide associated within the current episode of MDD.
Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Participant had a medical history of seizures.
Participant had active psychosis per Investigator assessment.","Participants received SAGE-217 matching placebo capsules (single-blind), orally, once daily prior to Day 1 (Days -2 and -1) followed by self-administration of SAGE-217, 30 mg capsules, orally, once daily for 12 days. Thereafter participants received SAGE-217, 30 mg capsules, orally, once daily, 30 minutes prior to lights out (PSG) on Days 13 and 14 (double-blind). Thereafter participants self-administered SAGE-217 matching placebo capsules (single-blind), orally, once daily on Days 15 to 21.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,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
NCT03773796,NCT03773796_EG000,No,All,Adult | Older Adult,Phase 3,22,"Inclusion Criteria:

In order to be eligible for participation in the study, subjects must meet all inclusion criteria:

In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
Only patients without a drug-related serious adverse event (SAE) or (drug-related) moderate or severe AE during the NMS-Nab Study can be included in the study
Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
The patient is in good health as determined by medical examination and based on the investigator's judgement

Exclusion Criteria:

Patients with any of the following characteristics will be excluded from entering the study:

Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
Patients that experienced a drug-related SAE or had a (drug-related) moderate or severe AE during the NMS-Nab Study will be excluded in the study.
Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement).","Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg

Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis",ChEMBL:CHEMBL2218896 | DrugBank:DB00486 | PubChem:39860 | PubChem:5284592,Nabilone,CCCCCCC(C)(C)c1cc(O)c2c(c1)OC(C)(C)C1CCC(=O)CC21,A04AD11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03793751,NCT03793751_EG000,No,All,Adult | Older Adult,Phase 4,120,"Inclusion Criteria:

American society of Anesthesiology (ASA) status of I-III
Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria:

Patient not willing to be a part of the study
Patients were aged <60 or >75 years
Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
Patients who had recently received a sedative or opioid drug
Patients with a MoCA (Montreal Cognitive Assessment) score <26
Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study","Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03793751,NCT03793751_EG001,No,All,Adult | Older Adult,Phase 4,120,"Inclusion Criteria:

American society of Anesthesiology (ASA) status of I-III
Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria:

Patient not willing to be a part of the study
Patients were aged <60 or >75 years
Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
Patients who had recently received a sedative or opioid drug
Patients with a MoCA (Montreal Cognitive Assessment) score <26
Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study",The Control Group will receive placebo infusion of normal saline.,ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03799783,NCT03799783_EG000,No,All,Child | Adult,Phase 2,19,"Inclusion Criteria:

children affected by behavior disorders who underwent EEG procedure with sedation
written informed consent

Exclusion Criteria:

ASA > 2
hypersensitivity of active substance
therapy with beta blockers or digoxin, arrhythmia","2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03824912,NCT03824912_EG000,No,All,Adult | Older Adult,Phase 3,314,"Inclusion Criteria:

Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
Female patient of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-International unit (mIU/mL) or equivalent units of human chorionic gonadotropin).
Female patient of childbearing potential must agree to the use of a reliable method of contraception throughout the study (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. A sterile sexual partner is not considered an adequate form of birth control. If the female is using any estrogen or oral contraceptive therapy, the same product must have been taken for at least one month before Visit 1.
Have clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
The presence of tinea pedis infection provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae).

The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:

Signs: Fissuring/cracking, erythema, maceration and scaling
Symptoms: pruritus and burning/stinging In addition the target lesion must have a minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or scaling.

Exclusion Criteria:

Females who are pregnant, lactating or planning to become pregnant during the study period.
History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Current uncontrolled diabetes.
Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis.
Known history of or current impaired wound healing, presence of peripheral vascular disease and/or trophic changes of the lower limbs to an extent that, in the opinion of the Investigator, would make the patient unsuitable for the study or compromise patient's safety.
Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, immunosuppression (due to disease or therapy, including history of organ transplant), or other medical condition that, in the Investigator's opinion, would place the patient at undue risk by participating or compromise the integrity of the study data.
Use of antipruritics, including antihistamines, within 72 hours before Visit 1.
Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
Use of systemic (e.g., oral or injectable) antibiotics, systemic antifungal therapy, or systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g., allergic conjunctivitis, asthma/chronic obstructive pulmonary disease maintenance) is acceptable to the extent that, in the opinion of the Investigator, does not compromise safety of patient or integrity of data.
Use of oral terbinafine or itraconazole within 2 months before Visit 1.
Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
Receipt of any drug as part of a research study within 30 days before Visit 1.
Previous participation in this study.
Employee of the Investigator or research center or their immediate family members.
Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.","Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)

Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.",ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03824912,NCT03824912_EG001,No,All,Adult | Older Adult,Phase 3,319,"Inclusion Criteria:

Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
Female patient of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-International unit (mIU/mL) or equivalent units of human chorionic gonadotropin).
Female patient of childbearing potential must agree to the use of a reliable method of contraception throughout the study (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. A sterile sexual partner is not considered an adequate form of birth control. If the female is using any estrogen or oral contraceptive therapy, the same product must have been taken for at least one month before Visit 1.
Have clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
The presence of tinea pedis infection provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae).

The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:

Signs: Fissuring/cracking, erythema, maceration and scaling
Symptoms: pruritus and burning/stinging In addition the target lesion must have a minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or scaling.

Exclusion Criteria:

Females who are pregnant, lactating or planning to become pregnant during the study period.
History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Current uncontrolled diabetes.
Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis.
Known history of or current impaired wound healing, presence of peripheral vascular disease and/or trophic changes of the lower limbs to an extent that, in the opinion of the Investigator, would make the patient unsuitable for the study or compromise patient's safety.
Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, immunosuppression (due to disease or therapy, including history of organ transplant), or other medical condition that, in the Investigator's opinion, would place the patient at undue risk by participating or compromise the integrity of the study data.
Use of antipruritics, including antihistamines, within 72 hours before Visit 1.
Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
Use of systemic (e.g., oral or injectable) antibiotics, systemic antifungal therapy, or systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g., allergic conjunctivitis, asthma/chronic obstructive pulmonary disease maintenance) is acceptable to the extent that, in the opinion of the Investigator, does not compromise safety of patient or integrity of data.
Use of oral terbinafine or itraconazole within 2 months before Visit 1.
Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
Receipt of any drug as part of a research study within 30 days before Visit 1.
Previous participation in this study.
Employee of the Investigator or research center or their immediate family members.
Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.","Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)

Ketoconazole Cream 2% (G&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.",ChEMBL:CHEMBL157101 | DrugBank:DB01026 | PubChem:170836395 | PubChem:3823 | PubChem:456201 | PubChem:47576 | PubChem:5702077 | PubChem:73951506,Ketoconazole,CC(=O)N1CCN(c2ccc(OCC3COC(Cn4ccnc4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1,D01AC08 | G01AF11 | G01AF20 | H02CA03 | J02AB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03837938,NCT03837938_EG000,No,All,Adult | Older Adult,Phase 3,92,"Inclusion Criteria:

Subjects should meet the following inclusion criteria to be included into this clinical trial:

Signed Informed Consent Form
Male or female aged from 18 to 65 (inclusive)
Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06)
Daytime cough symptom score ≥ 3 points according to the ""Six-point daytime and nighttime cough assessment scale""
Pre-bronchodilator FEV1 ≥ 70% of the predicted values, post-bronchodilator FEV1 increase of ≤ 12% or ≤ 200 ml compared to the baseline, FEV1/FVC (Tiffeneau index) ≥ 0.7
Patient's consent to follow the protocol procedures, including the completion of the patient's diary

Patient's consent to use the adequate contraception methods throughout the study period. The adequate birth control methods are as follows:

Oral or transdermal contraceptives
Condoms or diaphragms (barrier method) with spermicide
Intrauterine contraceptive devices

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from the study:

Hypersensitivity or individual contraindications to Levodropropizine, Prenoxdiazine or additives of the study drug
Hereditary fructose intolerance, glucose-lactose malabsorption, lactase deficiency, sucrose-isomaltose deficiency
Tuberculosis, bronchial asthma, malignant tumors of lungs or bronchi, COPD, severe respiratory failure (cyanosis, need for respiratory support) or other lung pathology at screening or in history
Inhalation anesthesia within 3 months before screening
Smoking history of more than 10 pack-years
Previous use of cough medicines, ACE inhibitors or amiodarone within 30 days before screening
Contraindications or inability to perform spirometry
Necessity (in the Investigator's opinion) of prescribing mucolytic agents, expectorants, antibiotics or other medications prohibited by the protocol during the study
Excessive mucous excretion which (in the Investigator's opinion) could be a contraindication to prescribing anti-cough medicines; decreased mucociliary function (Kartagener's syndrome, ciliary dyskinesia)
Malignant tumors in the past 5 years (except for the basal cell carcinoma)
Serious cardiovascular disease at the moment or within 12 months prior to screening, including: Chronic heart failure class III or IV (according to the classification of the New York Heart Association), severe arrhythmias requiring treatment with antiarrhythmic drugs class Ia, Ib, Ic or III, unstable angina, myocardial infarction, heart surgery and coronary arteries, serious valvular heart disease, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure > 180 mmHg and diastolic blood pressure > 110 mmHg, pulmonary embolism or deep vein thrombosis
Gastric or duodenal ulcers, gastroesophageal reflux disease within a period of 12 months before screening
Systemic autoimmune disorders and connective tissue diseases that require (currently or previously) administration of systemic glucocorticosteroids, cytostatic medications or penicillamine
Signs of intensive non-controlled concurrent disease, including disorders of the nervous system, endocrine system, kidneys, liver or gastrointestinal tract, which (in the Investigator's opinion) could prevent the patient's participation in the study
History of alcohol or drug abuse at screening or in the past, which results in the inability of the patient to participate in the study at the Investigator's discretion
Taking part in another clinical trial or use of study drug within 30 days before screening
Pregnant or breast-feeding women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period of less than 2 years), not using appropriate methods of contraception
Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; violation of the drug administration regimen or procedure execution that, at the discretion of the Investigator, can impact he results of the study or safety of the patient and interfere his further participation in the study; any other concomitant medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of receiving an informed consent or may affect the patient's ability to participate in the study.","Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days.

Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).",ChEMBL:CHEMBL1288810 | ChEMBL:CHEMBL151445 | DrugBank:DB12472 | DrugBank:DB13785 | PubChem:3169 | PubChem:65859,Dropropizine,OCC(O)CN1CCN(c2ccccc2)CC1,R05DB19 | R05DB27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03850093,NCT03850093_EG001,No,All,Adult,Phase 4,22,"Inclusion Criteria:

patients who underwent functional endoscopic sinus surgery
ability to swallow tablets

Exclusion Criteria:

suspected difficult airway
basal HR <60/min.
chronic cardiovascular or cerebrovascular disease
bronchial asthma or COPD
DM
bleeding disorders
anemia (Hb level< 10 gm/dl)
renal or hepatic insufficiency
psychiatric disorders
chronic treatment by BBs, gabapentin or drugs that affect coagulation
acute nasal infection
allergy/contraindications to any of the study's drugs.",bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative,ChEMBL:CHEMBL645 | DrugBank:DB00612 | PubChem:2405,Bisoprolol,CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1,C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03852901,NCT03852901_EG000,No,All,Adult | Older Adult,Phase 1,21,"INCLUSION CRITERIA:

Age 55 years and older.
Healthy (see exclusion criteria below).
Able to understand the study risks and procedures, and consent to participate in the study.
Able to read and speak English.

EXCLUSION CRITERIA:

History of diabetes (requiring any medical treatment other than diet and exercise) or fasting plasma glucose > 126 mg/dl or HbA1c> 6.5 %.
History of hypoglycemia.
BMI > 35 kg/m(2).
Creatinine clearance less than 60 ml/min as measured by GFR.
Glucosuria
History of anemia within the past 6 months or Hgb <11.0 mg/dL for women and Hgb <12.5 mg/dL for men.
Current steroid use or steroid use within 90 days of screening, excluding eye drops.
Currently taking loop diuretics (Lasix, for example).
Participant presently following a calorie restriction diet, low carb/high fat diet.
HIV virus infection
Hepatitis B infection, as evidenced by a positive HBsAG at screen visit.
Hepatitis C infection that has not been treated. (The screen blood work must show HCV RNA quantitative is not detectable).
Active infection/fever that may cause changes in glucose metabolism.
Known allergy to sGLT2 inhibitors in the past.
Thyroid dysfunction that is not controlled or treated. This will be determined by Free T3, T4, Free T4 or TSH not within MedStar Harbor Hospital laboratory normal ranges for this pilot study.
Adrenal dysfunction as determined by a cortisol level not within the normal range for MedStar Harbor Hospital Laboratory for this pilot study.
Kidney or liver disease, (GFR < 60 mL/min/1.73 m(2) and/or liver enzymes not within normal ranges for MedStar Harbor Hospital Laboratory for this pilot study.
Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.
History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.
Patients with known, or evidence of, peripheral vascular disease.
History of chronic urinary tract infections.
History of recurrent or recent dehydration in the past year.
History of recurrent or recent vaginal yeast infection.
Alcohol intake greater than 30 grams (drink more than 2 beers OR equivalent per day).
History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.
Poor venous access.
Inability to walk 2,000 steps
Donation or loss of 400 mL or more of blood within 56 days prior to and subsequent to screening.
Participation in another study in the past 30 days, in which a study drug was administered.
Currently participating in another study unless the investigator feels it would not interfere with the study.
History of a medical condition or any other reason that, in the opinion of the investigator, will make participation in this study unsafe.
Blood work or urine tests that are not considered by the study physician to be in an acceptable range for the study.
Metal implants and devices incompatible with 3T Magnetic Resonance Imaging (MRI), or another contraindication to MRI.","The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.",ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03861559,NCT03861559_EG000,No,All,Child | Adult | Older Adult,Phase 3,101,"Inclusion Criteria:

Has a 2-year history of seasonal allergic rhinitis
Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
Is on immunotherapy with the exception of maintenance therapy
Has a clinically significant upper respiratory or sinus infection
Has used an investigational drug within the previous 30 days
Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
Has rhinitis medicamentosa
Is using of any chronic medication which could affect the course of seasonal allergic rhinitis","Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03870763,NCT03870763_EG000,No,All,Child,Phase 3,2,"Key Inclusion Criteria:

Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
Must have an EDSS score between 0.0 and 5.0.
Must have a body weight of ≥30 kg
Must have experienced ≥1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event.

Key Exclusion Criteria:

Participants having primary progressive, secondary progressive, or progressive RMS.
Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.",ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03879538,NCT03879538_EG001,No,All,Adult | Older Adult,Phase 3,44,"Inclusion Criteria:

Patients must be diagnosed with CRPS based on the revised International Association for the Study of Pain criteria.
Duration of disease must be at least 6 months.
Written informed consent.

Exclusion Criteria:

Patients who had no subjective benefit from ketamine infusions, as determined by interview during the recruitment process.
Patients taking more than 60mg of morphine equivalents or more daily for an alternative chronic pain condition.
Patients with both coronary artery disease (as determined by cardiac catheterization) and a functional status of less than 4 metabolic equivalents. The limited functional status must be secondary to cardiopulmonary symptoms (angina, dyspnea on exertion). Patients with coronary artery disease and a limited functional status (<4 METS) secondary to chronic pain can be included.
Patients with congestive heart failure of any etiology that are NYHA Class III or IV
Patients with moderate or severe pulmonary hypertension as determined by echocardiogram or right heart catheterization.
Patients with intraocular surgery within the past 14 days
Patients with worker's compensation claims and active litigation.
Patients who have been diagnosed with COPD.
Patients who use home oxygen therapy for any condition.
Diagnosis of Alcohol Use Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Illicit drug use within the past three months (not including marijuana).
Pregnant patients or patients with upcoming planned pregnancy.","Control group will receive 100% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

Oxygen: A total of three inhalation treatments with 100% oxygen (6 total exposure hours) over one week with 2 or 3 days between each session.",ChEMBL:CHEMBL1234886 | DrugBank:DB09140 | PubChem:977,Oxygen,O=O,V03AN01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03882970,NCT03882970_EG003,No,All,Adult | Older Adult,Phase 3,360,"Inclusion Criteria:

Participants must:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
Be of stable weight (± 5%) for at least 3 months before screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

Participants must not:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months","Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.

The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03883386,NCT03883386_EG000,No,All,Child | Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Diagnosis of neutropenia
Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)

Exclusion Criteria:

Other sources of chronic pain
Previously tried loratadine for 7 consecutive days or more for bone pain
Allergy to loratadine
Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication","Take treatment daily for 7 days.

Loratadine: 10 mg in a capsule

Placebo: Administered via capsule",ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03885661,NCT03885661_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,12,"Inclusion Criteria:

- 1. Triglyceridemia, defined as:

statin-treated TG > 200 mg/dL -and/or-

statin-treated TG > 150 mg/dL -plus- statin-treated HDL < 45 [men] or < 55 [women] 2. Self-reported Caucasian-majority race, defined as 3 out of 4 grandparents Caucasian 3. Subjects between the ages of 21 and 75 years of age inclusive 4. Ability to understand and agree to informed consent 5. Are reliable and willing to make themselves available for the duration of the study, comply with study procedures, agree not to participate in other clinical experiments, and agree not to donate blood products during the study

Exclusion Criteria:

1. Diagnosis of idiopathic or otherwise active diabetes: History of resolved gestational or drug-induced diabetes is acceptable, but history Type I or Type II diabetes are exclusionary.

2. Use of medications indicated for the treatment of diabetes within 6 weeks of the first experimental visit (see Prohibited Treatments) 3. History of a myocardial infarction (MI), unstable angina leading to hospitalization, coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI), uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention within 6 months of baseline.

4. Known inefficacy to TG-lowering doses of fish oils (e.g. >= 4 caps daily of prescription fish oil or >= 6 caps daily of supplemental fish oil).

5. TG > 500 mg/dL as the average of valid, statin-treated values 6. BMI > 40 kg/m2 7. BMI < 20 kg/m2 8. Evidence of previously undiagnosed diabetes: Average fasting glucose during screening > 125 mg/dL 9. Known familial lipoprotein lipase impairment or deficiency (Fredrickson Type I), Apo C II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III).

10. Severe allergy to fish, unless non-allergic response to fish oil is established (n.b. most fish allergies are to the proteins as opposed to the fats, so with highly-purified oils the risk of a true allergy is remote).

11. Known intolerance or contraindication to Vascepa, and if the former is unknown, known intolerance or contraindication to fish oil 12. Any surgical or medical condition that may interfere with absorption, distribution, metabolism, or excretion of EPA or DHA.

13. History of extreme triglyceridemia (TG > 1000 mg/dL) or pancreatitis from triglyceridemia, regardless of whether it is currently controlled.

14. Medical condition that would prohibit fasting (e.g. diagnosis of insulinoma or postabsorptive hypoglycemia).

15. Significant disinclination to dairy products (e.g. lactose intolerance, inviolable dietary restrictions). All participants will receive a test dose of the fat challenge during the screening visit, which consists of heavy cream and lactase enzyme. Many people with lactose intolerance successfully avert symptoms by correcting their lactase deficiency with lactase supplements. We will allow these people to participate because we will allow them to take their preferred brand and dose of lactase supplement beyond the lactase in the fat challenge if needed. However, we still require that they are able to tolerate the test dose given during screening.

16. History of a non-skin malignancy within the previous 5 years. 17. Uncontrolled thyroid disease. 18. Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition.

19. Major surgery within the previous 6 weeks. 20. Subjects who have undergone any organ transplant. 21. History of illicit drug use within the past 3 years, or regular alcohol use of greater than 14 drinks per week. For clarity, illicit substances are per Federal law or regulations in effect at the time of first approval of this protocol.

22. Women who are breast-feeding. 23. Women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits and be willing to have additional urine pregnancy tests during the study.

24. Sexually active subjects (both women and men) must be willing to use a medically accepted method of contraception from screening visit until month after last dose of study drug 25. Significant or unstable medical or psychological conditions, including known or suspected personality disorders, that could compromise the subject's safety or successful participation in the study in the opinion of the investigator.

26. Subject-reported history of HIV and/or use of HIV medications 27. History of symptomatic gallstone disease unless definitively treated (e.g. condition successfully treated with cholecystectomy without recurrent or residual biliary disease).

28. History of bariatric surgery or other major gastrointestinal surgery associated with major disruptions to drug absorption.

29. Anticipation of major surgery during the screening or treatment periods of the study 30. Participants with the following conditions will opt out of heparin exposure for lipase determinations, but will be allowed to participate in the overall protocol.

31. History of intolerance or adverse reaction to therapeutic or sub-therapeutic heparin regimens 32. History of intracerebral hemorrhage 33. History of significant GI bleed, unless definitively treated without recurrence 34. Women with dysfunctional uterine bleeding 35. Individuals with clinically-significant coagulopathy at screening 36. Individuals with clinically-significant thrombocytopenia at screening 37. Hemoglobin < 12 g/dL at screening 38. Mean corpuscular volume (MCV) < 80 fL or > 100 fL at screening 39. Donation of whole blood within 8 weeks prior to the first experimental visit. Participation in the screening phase is permitted.

40. History of inherent unremediable risks for anemia, such as hemoglobinopathies, hemolytic disorders, and bleeding disorders, regardless of whether their hemoglobin is currently normal.

41. History of a large-volume gastrointestinal (GI) bleeding, such as a bleed that required ER evaluation or admission, required acute endoscopic or surgical management, was managed by blood transfusion, or caused anemia.

42. History of NSAID-mediated peptic ulcer disease is excluded, irrespective of current medical treatment. A history of peptic ulcer disease from H. pylori does not exclude participation provided H. pylori was successfully eradicated. Other causes of peptic ulcer disease may be allowable, especially if definitively treated or the risk of recurrence is otherwise low.

43. Chronic, untreated conditions that predispose to anemia, such as significant iron or B vitamin malabsorption, persistent menorrhagia, or other chronic or intermittent bleeding.

44. Participation in an investigational drug study concurrently; participants who previously completed an investigational drug study cannot participate in the first experimental visit until at least 6 weeks after the final dose given during the previous investigational drug study. For the purposes of this exclusion, an investigational drug is a new chemical entity or a pharmaceutical investigated to support an initial new drug application. Furthermore, herbal or other supplements already deemed ""generally regarded as safe"" or legally sold in the U.S. would not be considered an investigational drug.

45. Use of medications indicated for the treatment of diabetes within 6 weeks of the first experimental visit 46. Daily therapy with non-statin lipid-altering medications within 6 weeks of the first experimental visit is exclusionary, including long-term therapy with the agents listed below. Subjects may wash off these medications so long as the first experimental visit occurs at least 6 weeks after chronic therapy ceases. Following a washout period, fasting lipids will be repeated prior to the first experimental visit to assure that these are not exclusionary as defined above.

Niacin > 100 mg/ day: (Niacor®, Slo-Niacin®, Niaspan®, Advicor®, Simcor®, Inositol Hexanicotinate, or supplemental niacin).
Fibrates: gemfibrozil (Lopid®), fenofibrate (Antara®, Lofibra®, Tricor®, Triglide®), fenofibric acid (Trilipix®, Certriad®).
Enterically active lipid altering drugs: colestipol (Colestid®), cholestyramine (Questran®), colesevelam (Welchol®), ezetimibe (Zetia®, Vytorin®), orlistat (Xenical®, Ali®).
Prescription fish oil: Vascepa®, Epanova®, Lovaza® (nee Omacor®)
Supplemental omega-3-enriched oils: flaxseed, fish, or algal oils
Foods enriched with omega-3 fatty acids
Consumption of up to 2 servings per week of fish is acceptable 47. Lipid-altering supplements
Sterol/stanol products (e.g. CholestOff), policosanols
Dietary fiber supplements, including >2 teaspoons of Metamucil® or psyllium containing supplements per day
Garlic supplements or soy isoflavones supplements
Supplemental vitamin B5 or related compounds unless part of a multi-vitamin
As above, red yeast statin will be switched to a GMP prescription statin
Any other medications, herbal products, or dietary supplements with known or potential lipid-altering effects 48. Anticoagulant therapy (except aspirin)
Warfarin
Rivaroxiban
Apixaba
Dabigantran 49. Anti-obesity medications or their components
Orlistat (Xenical)
Lorcaserin (Belviq)
Phentermine plus extended-release topiramate (Qsymia)","Icosapent ethyl with a total daily dose of 4 grams, as 2 x 1 gram capsules by mouth twice daily, against a statin background

Icosapent Ethyl 1000 MG [Vascepa]: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.",ChEMBL:CHEMBL2095209 | DrugBank:DB08887 | PubChem:9831415,ICOSAPENT ETHYL,CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT03890731,NCT03890731_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Participant must be age-eligible in the feeder study at the time of signing the informed consent.
Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion Criteria:

Medical reasons not to start the next treatment cycle in the respective feeder
Pregnancy",Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.,ChEMBL:CHEMBL1946170 | DrugBank:DB08896 | PubChem:11167602,Regorafenib,CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1,L01EX05 | L01XE21,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT03902613,NCT03902613_EG000,No,All,Adult,Phase 4,1,"Inclusion Criteria:

Bipolar I disorder, bipolar II disorder or other specified bipolar disorder
Currently in a major depressive episode and moderately depressed
Age 18-50 years old
Patients on psychiatric medications will not be benefitting from those medications
Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study

Exclusion Criteria:

Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa
Previous failed trial of lurasidone, or had intolerable side effects of lurasidone
Significant active physical illness
Actively suicidal
ECT within the past 6 months
Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating
Metal in the body that is not MRI compatible
Current, past or anticipated exposure to radiation
Currently taking an anticoagulant medication","Open-label treatment with lurasidone within the dose range of 20-60 mg daily

Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.",ChEMBL:CHEMBL1237021 | DrugBank:DB08815 | PubChem:213046,Lurasidone,[H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1,N05AE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03915470,NCT03915470_EG000,No,All,Adult | Older Adult,Phase 2,63,"Individuals who meet all of the following criteria are eligible to participate in the study.

Male or female patients between 18 and 75 years of age.
Patients who are confirmed nasal S. aureus carriers by polymerase chain reaction (PCR) screen assay, and due to undergo surgical procedure.
Patients who are willing to provide written informed consent.
Patients who are willing and able (as per Investigator judgment) to complete all protocol specified visits and assessments.

Woman of childbearing potential* with a negative urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin (hCG)).

Women of childbearing potential are defined as those women between menarche and menopause who have not undergone permanent sterilisation. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.

Individuals who meet any of the following criteria are not eligible to participate in the study.

Pregnancy (current) or currently lactating.
Uncontrolled acute or chronic illness (as determined by the investigator) in addition to those requiring the planned surgical intervention.
History of atopy, allergic reactions or hypersensitivity to the study medication or its components.
Current upper respiratory tract infection, cold or influenza with significant nasal symptoms that might impact on the patient's ability to comply with the gel application procedure.
History of photosensitivity.
Family history of porphyria.
Use of intra-nasal topical or systemic antibiotics or anti-infectives within the last 4 weeks before screening. (Patients who screen positive for nasal carriage of S. aureus and receive topical or systemic antibiotics or anti-infectives which are not part of their prophylactic peri-operative SOC between screening and first dose of investigational medicinal product (IMP) will be excluded from the study.) The use of intra-nasal antibiotics or anti-infectives other than the study medication prior to surgery is not allowed.
Use of other prescribed or over the counter nasal medication in the last 14 days, or oral decongestants in the last 7 days before first administration of study drug.
Participation in a clinical trial within the last 12 weeks before first administration of study drug.
Contemporaneous clinically significant abnormalities in vital signs or laboratory analyses reported within 14 days prior to randomization which in the opinion of the Investigator would preclude from the safety assessment of the medication under study.
Nasal polyps or significant anatomical or other nasal abnormality that would prevent from appropriate administration of the study treatment or represent an excessive risk for the patient's participation.
History of nasal surgery including cauterization.
A recent history of frequent epistaxis and/or an episode of epistaxis within 3 months of the planned surgery.
Use of in situ nasal jewellery or existence of open nasal piercings.","Participants received 0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel 4 times in one day prior to surgery and once more after surgery, for a cumulative dose of 6.0 mg of XF-73.",PubChem:135456185,Exeporfinium chloride,C[N+](C)(C)CCCOc1ccc(-c2c3nc(cc4ccc([nH]4)c(-c4ccc(OCCC[N+](C)(C)C)cc4)c4nc(cc5ccc2[nH]5)C=C4)C=C3)cc1.[Cl-].[Cl-],,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03940326,NCT03940326_EG000,No,All,Child | Adult | Older Adult,Phase 4,45,"Inclusion Criteria:

Age≥16
At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
Normal brain MRI or MRI without epileptogenic lesion
Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
Signing consent form

Exclusion Criteria:

History of treatment by sodium valproate or levetiracetam
History of treatment by any anti-epileptic drug in last 6 months
Plan for pregnancy
Using no certain contraceptive method
History of past or current hepatic disease
History of past or current renal disease
History of past or current hematologic disease
History of known psychiatric disease
History of status epilepticus",Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred,ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03962634,NCT03962634_EG001,No,All,Child | Adult,Phase 2,3,"Inclusion Criteria:

American Society of Anesthesiologists Class I or II
Preoperative heart rate of 55 to 100 beats per minute
Maximum blood pressure reading of 166/100 mmHg
Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia

Additional Pediatric Inclusion Criteria:

Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

Adults who require restorations in the maxillary teeth that would need local anesthesia

Exclusion Criteria:

Inadequately controlled thyroid disease
Five or more nosebleeds in the past month
Known allergy to any study drug or para-aminobenzoic acid
History of methemoglobinemia
Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.","Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Articaine Injection: Local anesthetic",ChEMBL:CHEMBL1093 | DrugBank:DB09009 | PubChem:32170,Articaine,CCCNC(C)C(=O)Nc1c(C)csc1C(=O)OC,N01BB08 | N01BB58,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03968159,NCT03968159_EG000,No,All,Adult | Older Adult,Phase 3,148,"Inclusion Criteria:

Adult patients, aged 18 years and above
A clinical diagnosis of major depressive disorder (MDD)

Is being treated with one of the following SSRI or SNRI antidepressants:

Citalopram
Escitalopram
Paroxetine
Fluoxetine
Sertraline
Duloxetine
Venlafaxine
Desvenlafaxine
Venlafaxine XR
Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
Has a known history or symptoms of long QT syndrome
Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).",Pimavanserin 34 mg administered orally as a single dose once daily,ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04000009,NCT04000009_EG000,No,All,Adult | Older Adult,Phase 3,235,"Inclusion Criteria:

Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
May benefit from longer term therapy with open-label pimavanserin treatment
If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

Is determined to be inappropriate for the study
Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).","Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks",ChEMBL:CHEMBL2111101 | DrugBank:DB05316 | PubChem:10071196,Pimavanserin,CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1,N05AX17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04007367,NCT04007367_EG000,No,All,Adult | Older Adult,Phase 3,53,"Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

Participant had attempted suicide associated with the current episode of MDD.
Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.","Participants self-administered SAGE-217, 30 mg, oral capsule, QD in the evening from Day 1 to Day 14.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04007367,NCT04007367_EG002,No,All,Adult | Older Adult,Phase 3,2,"Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

Participant had attempted suicide associated with the current episode of MDD.
Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.","Following the OL Phase, participants who exhibited a HAM-D response defined as a ≥ 50% reduction from baseline in HAM-D total score to SAGE-217 were randomized to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, up to study termination date (i.e., up to approximately 22 weeks) during the DB Phase of the study.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04041609,NCT04041609_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.

Exclusion Criteria:

Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study","In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04041609,NCT04041609_EG001,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.

Exclusion Criteria:

Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study","In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot",ChEMBL:CHEMBL1161 | DrugBank:DB14512 | PubChem:168322441 | PubChem:441336,Elocon,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl,D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04042324,NCT04042324_EG002,No,All,Adult | Older Adult,Phase 1 | Phase 2,12,"Inclusion Criteria:

Adult hemodialysis patients ≥18 years of age.
Signed informed consent to participate in the study.
Stable on hemodialysis prescription for ≥3 months.
Hemoglobin concentration >9.5 g/dL.
Serum TSAT ≥20%.
Able to receive continuous heparin infusion as their anticoagulation protocol.
Receiving hemodialysis via AV (arteriovenous) fistula or graft.
Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion Criteria:

Active bleeding disorder (GI, skin, nasal…)
Receiving hemodialysis via catheter.
Receiving heparin free dialysis.
Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
Receiving oral anti-coagulants or anti-platelet agents.
Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.","Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis

Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.",PubChem:107275093,(2-Bromo-4-imidazol-1-ylphenyl)methanamine,NCc1ccc(-n2ccnc2)cc1Br,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04110054,NCT04110054_EG000,No,All,Adult | Older Adult,Phase 2,101,"Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.",Participants received 50 mg S-600918 tablets orally once daily for 28 days,PubChem:117752163,Sivopixant,CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04110054,NCT04110054_EG001,No,All,Adult | Older Adult,Phase 2,103,"Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.",Participants received 150 mg S-600918 tablets orally once daily for 28 days,PubChem:117752163,Sivopixant,CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04110054,NCT04110054_EG002,No,All,Adult | Older Adult,Phase 2,100,"Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.",Participants received 300 mg S-600918 tablets orally once daily for 28 days,PubChem:117752163,Sivopixant,CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04157751,NCT04157751_EG001,No,All,Adult | Older Adult,Phase 3,260,"Inclusion Criteria:

Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital

Patients must fulfil the following stabilisation criteria (while in the hospital):

SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
no increase in i.v. diuretic dose for 6 hours prior to randomisation,
no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
no i.v. inotropic drugs for 24 hours prior to randomisation.
Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
Further Inclusion Criteria Apply

Exclusion Criteria:

Cardiogenic shock
Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;

Below interventions in the past 30 days prior to randomisation or planned during the study:

Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
All other surgeries that are considered major according to investigator judgement
Implantation of cardiac resynchronisation therapy (CRT) device
cardiac mechanical support implantation
Carotid artery disease revascularisation (stent or surgery)
Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
Type 1 Diabetes Mellitus (T1DM)
History of ketoacidosis, including diabetic ketoacidosis (DKA)
Further Exclusion Criteria Apply",1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04162795,NCT04162795_EG000,No,All,Adult | Older Adult,Phase 4,442,"Inclusion Criteria:

Female or male adults aged 18 to 65 years of age inclusive
Were in good general health
Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
Agreed to not use antihistamine products 24 hours before and after the treatment
Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing

Exclusion Criteria:

Individuals who had used oral/systemic medications 24 hours before the first administration of test product
Individuals who used medications which might influence taste perception
Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
Women who were pregnant or thinking of becoming pregnant or were nursing
Participants with congestion at the time of study visit
Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
History of alcohol or drug abuse
History of hypersensitivity or allergic reactions to any ingredients in the test product
Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet",Participants received one dose of loratadine chewable tablet to chew completely before swallowing.,ChEMBL:CHEMBL998 | DrugBank:DB00455 | PubChem:3957,Loratadine,CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1,R06AX13,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04175392,NCT04175392_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,7,"Inclusion Criteria:

Diagnosis of NAFLD and/or NASH
Subject aged 18 and older
Non-pregnant - Self-reported
Subject with decision making capacity to understand and consent to study procedures
Ability to follow study related activities regarding medications, diet and exercise

Exclusion Criteria:

Without diagnosis of NAFLD or NASH
History of liver disease from other causes, including but not limited to hepatitis, autoimmune, alcohol use, fatty liver of pregnancy, Wilson's disease, primary or secondary hemochromatosis
Patients aged less than 18 years
Self-reported pregnant patients
Inability to understand, follow and consent to study procedures
Hepatic decompensation defined as gastrointestinal bleeding, ascites, hepatic encephalopathy
Inability to engage in exercise
Currently immunocompromised or taking immunosuppressive drugs
Milk protein allergy
Recent or active chemotherapy for malignancy
Gastrointestinal malignancy
Gastrointestinal disease such as Ulcerative Colitis, Crohn's Disease as these alter the microbiome
Recent antibiotic therapy (within 6 months)
Known allergy to probiotics
History of major gastrointestinal surgery such as resection of the colon
No concomitant use of probiotic from any source (i.e., kefir, certain yogurts, live culture, sauerkraut)
Liver scan >2 months prior to enrollment
Weight loss >5 pounds in the last 2 months
Any implanted battery operated device (i.e. AICD, pacemaker, loop recorder, cochlear implant)","Probiotic 1 billion units Supplement Once Daily

Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily",ChEMBL:CHEMBL1908324 | DrugBank:DB13836 | PubChem:6713928,Metampicillin,C=N[C@@H](C(=O)N[C@@H]1C(=O)N2[C@@H]1SC(C)(C)[C@@H]2C(=O)O)c1ccccc1,J01CA14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04175834,NCT04175834_EG000,No,All,Adult | Older Adult,Phase 3,9,"Inclusion Criteria:

Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
Female patients of childbearing potential must practice effective contraception and continue contraception during the study.

Exclusion Criteria:

Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
Evidence of active hepatitis B infection at screening.
Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
Any persistent or severe infection.
Pregnancy or lactation.
Significant, uncontrolled somatic disease or severe depression in the last year.
Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
Any known allergy or inability to tolerate diphenhydramine or cetirizine.","25 mg diphenhydramine capsule, generic, sourced from Major Pharmaceuticals will be given orally 30-60 minutes prior to ocrelizumab infusion.

antihistamine: prophylaxis",ChEMBL:CHEMBL657 | DrugBank:DB01075 | PubChem:3100,Diphenhydramine,CN(C)CCOC(c1ccccc1)c1ccccc1,D04AA32 | D04AA33 | R06AA02 | R06AA52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04177680,NCT04177680_EG001,No,All,Adult | Older Adult,Phase 2,100,"Inclusion Criteria:

Male or female, ≥18 y of age
Judged to be in generally good health
Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening
Body mass index of ≥20.0 kg/m2
No clinically significant findings in a 12-lead ECG or physical examination
Willing and able to undergo the scheduled study procedures
Understands study procedures and signs forms documenting informed consent to participate in the study

Exclusion Criteria:

Laboratory test result of clinical significance
Uncontrolled hypertension
Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
History of human immunodeficiency virus, hepatitis B or hepatitis C infection
Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit
Active systemic infection
A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol","2g Vascepa capsules twice daily with meals

icosapent ethyl: Encapsulated omega-3 acid ethyl esters",ChEMBL:CHEMBL2095209 | DrugBank:DB08887 | PubChem:9831415,ICOSAPENT ETHYL,CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC,,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
NCT04177758,NCT04177758_EG000,No,All,Adult | Older Adult,Phase 4,137,"Inclusion Criteria:

Any patient undergoing primary total knee arthroplasty for osteoarthritis
Age ≥ 18 years old
Willingness to undergo randomization and return for all scheduled visits

Exclusion Criteria:

Age > 80 years old
American Society of Anesthesiologists (ASA) Score ≥ 4
Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol, calcitriol, dihydrotachysterol, and paricalcitol
Current cancer
Malabsorption syndromes
Inability to take medications orally
Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or creatinine >1.3 mg/dL
History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL","Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm.

Control: Patients randomized to the control will receive a placebo",ChEMBL:CHEMBL451 | DrugBank:DB00475 | PubChem:2712,Chlordiazepoxide,CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1,N05BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04193293,NCT04193293_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,2,"Inclusion Criteria

Eastern Cooperative Oncology Group performance status ≤ 1
Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that was considered incurable by local therapies
Eligible for pembrolizumab monotherapy based on the current prescribing information for pembrolizumab (Keytruda 2019)
Must have had 0 to 2 prior therapies for R/M HNSCC
At least 1 measurable lesion (which has not been previously irradiated) according to Response Evaluation Criteria in Solid Tumors version 1.1
For stage 1 only: Must have had at least 1 other lesion that could be biopsied and willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion
For stage 1 only: Must have been willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion

Adequate organ function defined by the following laboratory parameters:

Absolute neutrophil count ≥ 1.5 × 10^9/liter (L)
Platelet count ≥ 100 × 10^9/L
Hemoglobin level ≥ 9.0 grams/deciliter (dL)
A serum creatinine level < 1.5 milligrams/dL, or
Estimated creatinine clearance value ≥ 60 milliliters/minute (as determined by the Cockcroft-Gault method) for participants with creatinine levels > 1.5 × institutional upper limit of normal (ULN)
Total bilirubin level ≤ 1.5 × ULN (exception: participants with Gilbert's Syndrome may have a bilirubin level > 1.5 × ULN)
Aspartate aminotransaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase levels ≤ 2.5 × ULN or ≤ 5 × ULN in participants with liver metastases
International normalized ratio or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, unless participant was receiving anticoagulant therapy in which case PT or aPTT must have been within therapeutic range of intended use of anticoagulants

Exclusion Criteria

Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
Received anticancer treatment, major surgery, or any investigational drug within 30 days or 5 half-lives, whichever is shorter, before the start of study intervention
Received radiation therapy within 14 days before the start of study intervention, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation; Palliative radiation is allowed if > 7 days and any toxicity is ≤ Grade 1
Previous treatment with a PI3K, PD-1 or programmed cell death ligand 1 inhibitor
Have received organ or allogenic bone marrow or peripheral blood stem cell transplant
History of drug-induced colitis or drug-induced pneumonitis; history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function; tuberculosis treatment within 2 years prior to the start of study intervention; chronic liver disease or veno-occlusive disease/sinusoidal obstruction syndrome
Active cytomegalovirus or Epstein-Barr virus infection; history of or known human immunodeficiency virus infection
Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention Received a live or live attenuated vaccine within 6 weeks of first dose of duvelisib
Unable to receive prophylactic treatment for pneumocystis, HSV, or VZV at screening
Any active gastrointestinal dysfunction interfering with the participant's ability to be administered oral medications
Known active central nervous system metastases and/or carcinomatous meningitis
QT interval > 500 milliseconds (except for participants with a right or left bundle branch block)
New York Heart Association Class III or IV congestive heart failure","Stage 1: Duvelisib BID for 1 week followed by combination therapy with duvelisib BID + pembrolizumab q3w (Cycle 1 was 4 weeks consisting of the 1-week duvelisib monotherapy lead-in period followed by 1 dose of pembrolizumab in combination with 3 additional weeks of continuous dosing of duvelisib; subsequent cycles were 3 weeks).

Stage 2: Duvelisib BID + pembrolizumab q3w in 3-week cycles.",ChEMBL:CHEMBL3039502 | DrugBank:DB11952 | PubChem:50905713,Duvelisib,C[C@H](Nc1ncnc2[nH]cnc12)c1cc2cccc(Cl)c2c(=O)n1-c1ccccc1,L01EM04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04204057,NCT04204057_EG000,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

Patients with diagnosis of B-cell CLL
Disease status defined as refractory to or relapsed after at least one prior therapy.
Presence of measurable lymphadenopathy presence of > 1 nodal lesion
ECOG performance status ≤ 2.
Adequate bone marrow, liver, and renal function

Exclusion Criteria:

Richter's (large cell) transformation, or PLL transformation.
Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
Prior exposure to drug that inhibits PI3K
Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
Ongoing severe systemic bacterial, fungal or viral infection.
Central nervous system (CNS) involvement of leukemia or lymphoma.
Ongoing immunosuppressive therapy including systemic corticosteroids.
Known history of severe liver injury as judge by investigator.
Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
Women who are pregnant or lactating.

Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection

-","Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles

Tenalisib: Tenalisib 800 mg BID, Orally",DrugBank:DB15295 | PubChem:86291103,Tenalisib,CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04216251,NCT04216251_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,81,"Inclusion Criteria:

Participants must meet the following criteria on screening examination to be eligible to participate in the study:

Underwent screening or surveillance colonoscopy with removal of at least one adenoma;

Age 18-80 years.

This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of AMR101 over the age of 80 have not yet been well-characterized.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential 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 is participating in this study, she should inform her treating physician immediately.
Subjects must be able and willing to follow study procedures and instructions.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study

Currently using or have used any fish oil supplement at any dose more than once per week within the last month
Regularly consuming more than three servings of fish per week.
History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid.
Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years.
Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
Any adenoma that was not completely removed during previous colonoscopy.
Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium,Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants.
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.
Inability or unwillingness to abstain from non-protocol use of fish oil supplements or to provide blood or stool samples or colon biopsies during the study.
Participants who are receiving any other investigational agents.
Inability or unwillingness to swallow pills.
Pregnant or breastfeeding. The effects of AMR101 on the developing human fetus are unknown. For this reason,women of child-bearing potential 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 is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with AMR101. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, and because fresh tissue from patients with these infections cannot be harvested for research purposes, per institutional policy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.","The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy. Participants will be expected to take 4 0.5 gram capsules orally, twice daily (daily dose of 4 grams) for a minimum of 8 weeks and maximum of 12 weeks",ChEMBL:CHEMBL2095209 | DrugBank:DB08887 | PubChem:9831415,ICOSAPENT ETHYL,CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC,,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
NCT04221828,NCT04221828_EG000,No,Male,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

At least 18 years of age;

Histopathologically proven adenocarcinoma of the prostate:

Localized cancer;
Subjects with tumors classified as <T3 per TNM classification, Gleason score≥ 6;
Prostate tumor must be able to be visualized on mpMRI;
Already considered to be candidate for radical prostatectomy;
Considered appropriate for treatment with paclitaxel therapy;

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Calculated creatinine clearance ≥ 30 ml/min
Normal PT/INR and PTT;
ECOG of 0 or 1;
International Prostate Symptom Score (I-PSS) less than or equal to 20;
If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc;
Prior prostatectomy, including surgery for any benign condition (such as TURP);
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
Treatment with a prior investigational medication within 30 days of first dose of study agent;
Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
Known sensitivity to any of the study agent components;
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.","Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.",ChEMBL:CHEMBL428647 | DrugBank:DB01229 | PubChem:24791027 | PubChem:36314 | PubChem:441276,Paclitaxel,CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C,L01CD01 | L01CD51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04233801,NCT04233801_EG001,No,All,Adult | Older Adult,Phase 3,73,"Inclusion Criteria:

Age ≥18 years and ≤75 years old at Visit 1;
Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;

A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs

With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins should have duration of action up to 24 h such as insulin Degludec, insulin glargin, insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixed insulins could be once or twice daily posology only. The total insulin dose should not be changed by more than 20% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin & insulin analogue are acceptable;
If the patient is taking OADs, regimen has to be unchanged for at least 12 weeks prior to randomization (Visit 3);
If the patient is taking metformin, stable dose (at least 1500 mg daily or maximum tolerated dose) must be maintained for at least 12 weeks without dose adjustments prior to randomization (Visit 3);
HbA1c ≥7.5% and ≤11.0% at Visit 1;
Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

Diagnosis of Type 1 diabetes;
Patients receiving MDI insulin or insulin pump treatment;
eGFR <45ml/min/1.73m2 calculated based on MDRD formula;
Uncontrolled hyperglycemia [glucose level >13. 9 mmol/l after an overnight fast during placebo run-in];
Severe hypoglycemia episode (event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions) within 6 months prior to Visit 1;
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardial infarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
Bariatric surgery;
Further criteria apply","1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.

Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.",ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04233801,NCT04233801_EG002,No,All,Adult | Older Adult,Phase 3,73,"Inclusion Criteria:

Age ≥18 years and ≤75 years old at Visit 1;
Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;

A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs

With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins should have duration of action up to 24 h such as insulin Degludec, insulin glargin, insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixed insulins could be once or twice daily posology only. The total insulin dose should not be changed by more than 20% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin & insulin analogue are acceptable;
If the patient is taking OADs, regimen has to be unchanged for at least 12 weeks prior to randomization (Visit 3);
If the patient is taking metformin, stable dose (at least 1500 mg daily or maximum tolerated dose) must be maintained for at least 12 weeks without dose adjustments prior to randomization (Visit 3);
HbA1c ≥7.5% and ≤11.0% at Visit 1;
Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

Diagnosis of Type 1 diabetes;
Patients receiving MDI insulin or insulin pump treatment;
eGFR <45ml/min/1.73m2 calculated based on MDRD formula;
Uncontrolled hyperglycemia [glucose level >13. 9 mmol/l after an overnight fast during placebo run-in];
Severe hypoglycemia episode (event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions) within 6 months prior to Visit 1;
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardial infarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
Bariatric surgery;
Further criteria apply","1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.

Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.",ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04268303,NCT04268303_EG000,No,All,Adult | Older Adult,Phase 3,129,"Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand, and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

A subject will be excluded from the study if he or she meets the following criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.","Sublingual film containing 120 Micrograms dexmedetomidine

Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04268303,NCT04268303_EG001,No,All,Adult | Older Adult,Phase 3,126,"Inclusion Criteria:

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand, and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

A subject will be excluded from the study if he or she meets the following criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.","Sublingual film containing 180 Micrograms dexmedetomidine

Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501)",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04276883,NCT04276883_EG000,No,All,Adult | Older Adult,Phase 3,126,"Inclusion Criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for bipolar I or II disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide.
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.","Sublingual film containing 180 Micrograms Dexmedetomidine

Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04276883,NCT04276883_EG001,No,All,Adult | Older Adult,Phase 3,126,"Inclusion Criteria:

Male and female patients between the ages of 18 to 75 years, inclusive.
Patients who have met DSM-5 criteria for bipolar I or II disorder.
Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
Patients who read, understand and provide written informed consent.
Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
Patients who are judged to be at significant risk of suicide.
Female patients who have a positive pregnancy test at screening or are breastfeeding.
Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
Patients with serious or unstable medical illnesses.
Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.","Sublingual film containing 120 Micrograms Dexmedetomidine

Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04277936,NCT04277936_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,1,"Inclusion criteria for psychosis subjects:

Men and women age 18 - 65.
Communicative in English.
Provide voluntary, written informed consent.
Physically healthy by medical history.
BMI > 17.5 and < 45.
Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
Not breastfeeding/nursing at time of screening or at any time during the study.

Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.

Exclusion criteria for psychosis subjects

Age less than 18 or greater than 65.
Not communicative in English.
Unable to provide written informed consent.
Current medical or neurological illness.
History of severe head trauma.
BMI < 17.5 or > 45.
Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
Breastfeeding/nursing at time of screening or at any time during the study.
Conditions that preclude MR scanning
Conditions that preclude study drug administration

Exclusion criteria for healthy controls

All of the above and in addition:

Current use of psychotropic or potentially psychoactive prescription medication.
Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)","Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.

Levetiracetam 500 mg: Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.",ChEMBL:CHEMBL1286 | ChEMBL:CHEMBL1400561 | DrugBank:DB01202 | DrugBank:DB11868 | PubChem:5284583,Levetiracetam,CCC(C(N)=O)N1CCCC1=O,N03AX14,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04294966,NCT04294966_EG000,Accepts Healthy Volunteers,All,Adult,Early Phase 1,24,"Inclusion Criteria:

18-20 years old OR 30-40 years old
Body Mass Index 19-26
High school education, fluent in English
Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)

Exclusion Criteria:

History of daily cannabis use
Past or present severe substance use disorder
Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
Cardiovascular illness, high blood pressure, abnormal electrocardiogram
Current medications
Pregnant or planning to become pregnant",Dextrose: Administering dextrose to health volunteers for our placebo group,DrugBank:DB01914 | PubChem:18950 | PubChem:206 | PubChem:439507 | PubChem:5793 | PubChem:6036 | PubChem:64689 | PubChem:79025,Hexose,OCC1OC(O)C(O)C(O)C1O,V04CE01 | V06DC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04328467,NCT04328467_EG000,No,All,Adult | Older Adult,Phase 3,494,"Inclusion Criteria:

- A healthcare worker at high risk for COVID-19 exposure (defined below):

Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

Active COVID-19 disease
Prior COVID-19 disease
Current fever, cough, shortness of breath
Allergy to chloroquine or hydroxychloroquine
Prior retinal eye disease
Known Chronic Kidney disease, Stage 4 or 5 or dialysis
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Weight <40 kg
Prolonged QT syndrome
Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.","400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks

Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04328467,NCT04328467_EG001,No,All,Adult | Older Adult,Phase 3,495,"Inclusion Criteria:

- A healthcare worker at high risk for COVID-19 exposure (defined below):

Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

Active COVID-19 disease
Prior COVID-19 disease
Current fever, cough, shortness of breath
Allergy to chloroquine or hydroxychloroquine
Prior retinal eye disease
Known Chronic Kidney disease, Stage 4 or 5 or dialysis
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Weight <40 kg
Prolonged QT syndrome
Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.","400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks

Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04329091,NCT04329091_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,9,"Primary Inclusion Criteria for ""Healthy"" volunteers

Age between 18-35
Native English speaking
No hearing or speech difficulties
No psychiatric, neurologic, or sleep disorders
No chronic medical conditions, as reflected below under Primary Exclusion Criteria and above in 'Medical History'
Non-smokers (within 3 months)
Non-users of recreational or illicit drugs (including marijuana)
Must be willing and able to pass the drug tests (no psychoactive substances), no ingestion of alcohol or sleep-altering drugs for the 48 hours prior to the study session.
Normal weight

Primary Exclusion Criteria for ""Healthy"" volunteers

Speech difficulties/disorders
Hearing difficulties (including occluded or infected ear canals)
Current hairstyles that do not allow the high-density EEG cap to make contact with the scalp (e.g., individuals with hair extensions, braids, dreadlocks or hairstyles that restrict the ability of electrodes to touch the scalp)
Metal on/in/near their heads (including jewelry) that cannot be removed for the duration of the study
Metal implants
Serious abusers of alcohol or caffeine.
Existing or suspected psychological or neurological disorders
Pregnancy or suspected pregnancy (urine pregnancy test at visit 2)
Chronic or transient (e.g., jet lag) problems with sleep; suspected sleep disorder

Abnormal sleep habits, such as:

Sleeping less than 5 hours each night
Going to sleep before 8:00 PM or after 2:00 AM on a regular basis
Waking up before 5:00 AM or after 10:00 AM on a regular basis.
Currently taking medications that regulate blood pressure; a history of high blood pressure, diabetes or stroke
Chronic smokers
Current use of aspirin, or other medications which increase bleeding, prior to the study session.
Known drug allergies to anesthetics or a history of an adverse reaction to anesthesia.
Known allergy to adhesives or electrode gel
Medication that alters sleep, cognitive function, or both","Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point.

Dexmedetomidine: All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.",ChEMBL:CHEMBL778 | DrugBank:DB00633 | DrugBank:DB11428 | PubChem:5311068,Dexmedetomidine,Cc1cccc([C@H](C)c2c[nH]cn2)c1C,N05CM18,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04329832,NCT04329832_EG000,No,All,Adult | Older Adult,Phase 2,42,"Inclusion Criteria:

Adult (age ≥ 18 years)

Confirmed OR suspected COVID-19,

Confirmed: Positive assay for COVID-19 within the last 10 days
Suspected: Pending assay for COVID-19 WITH high clinical suspicion
Scheduled for admission or already admitted to an inpatient bed

Exclusion Criteria:

Allergy to hydroxychloroquine or azithromycin
History of bone marrow transplant
Known G6PD deficiency
Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
Psoriasis
Porphyria
Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
Known history of long QT syndrome
Current known QTc>500 msec
Pregnant or nursing
Prisoner
Weight < 35kg
Seizure disorder
Severe liver disease
Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
Treating physician refuses to allow patient participation in the study
Unable to obtain informed consent
Prior enrollment in this study","Hydroxychloroquine: Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04332991,NCT04332991_EG000,No,All,Adult | Older Adult,Phase 3,242,"Inclusion Criteria:

Age ≥18 years
Currently hospitalized or in an emergency department with anticipated hospitalization.

Symptoms of acute respiratory infection, defined as one or more of the following:

cough
fever (> 37.5° C / 99.5° F)
shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
sore throat
Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.

Exclusion Criteria:

Prisoner
Pregnancy
Breast feeding
Symptoms of acute respiratory infection for >10 days before randomization
>48 hours between meeting inclusion criteria and randomization
Seizure disorder
Porphyria cutanea tarda
Diagnosis of Long QT syndrome
QTc >500 ms on electrocardiogram within 72 hours prior to enrollment
Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
Inability to receive enteral medications
Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
Previous enrollment in this trial
The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient","Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.

Hydroxychloroquine: Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.

For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04333225,NCT04333225_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,101,"Inclusion Criteria:

Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent

Healthcare workers with

• One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.

OR

• Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.

Afebrile with no constitutional symptoms
Willing and able to comply with scheduled visits, treatment plan, and other study procedures
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures

Exclusion Criteria:

Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication
Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Having dermatitis, psoriasis or porphyria
Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate
Allergies: 4-Aminoquinolines
Pre-existing retinopathy of the eye
Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis
Untreated or uncontrolled active bacterial, fungal infection
Known or suspected active drug or alcohol abuse, per investigator judgment
Women who are pregnant or breastfeeding
Known hypersensitivity to any component of the study drug
A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval",Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks,ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04334148,NCT04334148_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,683,"Inclusion:

Completed Informed Consent
Age ≥ 18 years old
Currently working in any environment in which there is a risk of exposure to patients with COVID-19 infections (""healthcare worker"")

Exclusion Criteria:

Prior diagnosis of COVID-19 infection
Participation in another COVID-19 prophylaxis trial within 30 days of consent
Respiratory illness with new-onset fever (Temperature > 100°F) or ongoing cough or dyspnea within 14 days
Known allergy to HCQ or chloroquine
Congenital prolonged QT syndrome
Current or planned use of QT prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications
End stage renal disease
Pre-existing retinopathy
Current or planned use of Hydroxychloroquine (study drug) for any indication

Current or planned use of the following for treatment or prevention of COVID-19 infection:

Chloroquine

Azithromycin

Known cirrhosis or severe liver disease
History of severe skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis
History of psoriasis or porphyria
Ventricular arrhythmias requiring medical treatment
Severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms
Current or planned use of use of anti-seizure drugs
History of Glucose-6-phosphate dehydrogenase deficiency","Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04342169,NCT04342169_EG000,No,All,Adult | Older Adult,Phase 2,185,"Inclusion Criteria:

Patient age ≥18 years, competent to provide consent
Within 48 hours of positive nucleic acid test for SARS-CoV-2

Exclusion Criteria:

Patient already prescribed chloroquine or hydroxychloroquine
Allergy to hydroxychloroquine
History of bone marrow or solid organ transplant
Known G6PD deficiency
Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2
Known liver disease (e.g. Child Pugh score ≥ B or AST>2 times upper limit)
Psoriasis
Porphyria
Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval
Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
Seizure disorder
Prisoner
Weight < 35kg
Inability to follow-up - no cell phone or no address or not Spanish or English speaking
Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
Patient or another member of patient's household has been already enrolled in this study.","Participants randomized to the HCQ arm will receive HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days. The drug dose (2.4 gm over 5 days) falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20.

Hydroxychloroquine: HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04347954,NCT04347954_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

Diagnosis of COVID-19 by lab test within 5 days of study participation

Exclusion Criteria:

Allergy to ""iodine,"" shellfish, or food dye
Receiving intranasal steroids
Sinus surgery within 30 days of beginning the study
Intubated at the time of enrollment
Pregnancy
Participation in other COVID-19 studies - to be determined on a case by case basis","Participants administer 2 sprays of PVP-I 0.5% to each nare via nasal spray bottle, four times a day for 5 days.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04347954,NCT04347954_EG002,No,All,Adult | Older Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Diagnosis of COVID-19 by lab test within 5 days of study participation

Exclusion Criteria:

Allergy to ""iodine,"" shellfish, or food dye
Receiving intranasal steroids
Sinus surgery within 30 days of beginning the study
Intubated at the time of enrollment
Pregnancy
Participation in other COVID-19 studies - to be determined on a case by case basis","Participants administer 2 sprays of PVP-I 2% to each nare via nasal spray bottle, four times a day for 5 days.",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04349098,NCT04349098_EG000,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved testing (local labs).
Currently hospitalized.
Informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent).

Has symptoms of severe COVID-19 as demonstrated by:

At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress.
Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SaO2 <92% on room air in last 12 hours or requires > 4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or high flow nasal canula in order maintain SaO2 ≥92%, PaO2/FiO2 <300 millimeter per mercury (mm/hg).
Elevated C-reactive protein (CRP) > 2 x upper limit of normal (ULN).
Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form.
Female participants of childbearing potential must have a negative serum pregnancy test at Screening. Female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

Exclusion Criteria:

Evidence of critical COVID-19 based on:

Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
Septic shock (defined by Systolic blood pressure [BP] < 90 mm Hg, or Diastolic BP < 60 mm Hg)
Multiple organ dysfunction/failure
In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours.

Inadequate hematologic parameters as indicated by the following labs:

Participants with severe neutropenia (ANC <1000 x 10^9/L) or
Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)

Inadequate renal and liver function as indicated by the following labs:

Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault
Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x ULN
Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
Unable to take oral medication when informed consent is obtained.
Participants with a legal guardian or who are incarcerated.
Treatment with strong CYP3A inhibitors or inducers.
Pregnant and breastfeeding women.","Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).",ChEMBL:CHEMBL3545185 | DrugBank:DB11942 | PubChem:71481097,Selinexor,O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1,L01XX66,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT04353271,NCT04353271_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,3,"Inclusion Criteria:

Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
Male or Female age 19 to 89 years
Able to take oral medications
Patients not requiring hospitalization
Provision of informed consent

Exclusion Criteria:

Known history of EKG QTc prolongation abnormality
Contraindication or allergy to hydroxychloroquine
Retinal eye disease
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Known chronic kidney disease, stage 4 or 5 or receiving dialysis
Weight < 40 kg
Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
Known hepatic disease (cirrhosis, hepatitis)
Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
On immunosuppressive drugs steroids, antirejection medications.
Recipient of solid organ transplant
Pregnancy/breastfeeding
Past medical history Porphyria (may exacerbate disease)
PMH Psoariasis (can worsen disease)
No access to internet or email
Current suicidal thoughts according to Columbia scale
In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.","Subjects in this arm will receive the study drug

Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04354870,NCT04354870_EG000,No,All,Adult | Older Adult,Phase 2,83,"Inclusion Criteria for Group A and B

Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria

Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE
Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period
Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period
Willing and able to provide informed consent

Exclusion Criteria for Group A only :

Known hypersensitivity to hydroxychloroquine or chloroquine
Known diagnosis of COVID-19

Concomitant use of

amiodarone
digoxin
flecainide
procainamide
propafenone
History of Torsades de pontes
History of retinal disease
Known chronic kidney disease ≥ stage 4
Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)","Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ

Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04369742,NCT04369742_EG000,No,All,Adult | Older Adult,Phase 2,67,"Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
Informed consent signed by patient

Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:

Occur up to ≤72h prior to informed consent of participation in the study
Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization.
Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment.
Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment.
Unable to take oral medications.
History of allergic reaction or intolerance to CQ or HCQ.
Baseline corrected qT interval >470 milliseconds (male) or >480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest.
Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide
History of retinal disease including a documented history of diabetic retinopathy.
Known history of G6PD deficiency.","Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04372017,NCT04372017_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,1,"Inclusion Criteria:

Inclusion Criteria Cohort A:

≥ 18 years old

Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID-19 within the last 5 days

Occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper Personal Protective Equipment (PPE))
Criteria according to Center for Disease Control (CDC) guidelines
Community exposure (within 6 feet for at least 15 minutes)
No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)
No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
Ability to provide informed consent

Inclusion Criteria - Cohort B

≥ 18 years old
High-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a COVID-19 positive person within the last 5 days and is a South Dakota resident or high-risk person with close household contact of a COVID-19 positive Sanford employee
High-risk person defined by:
Age 18-44 with 2 or more comorbidities listed below
Age 45-79 with any comorbid condition listed below
Age 80 and above (regardless of comorbid conditions)

Co-morbid list

Congestive Heart Failure (CHF)
Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema)
Solid organ transplant or immunosuppression (Defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.)
Chronic Kidney Disease or End Stage Renal Disease
Diabetes mellitus
Cardiovascular disease/Hypertension
Smoking/Vaping (currently using or history of using in the past 1 year)
Obesity (calculated by height and weight per participant report)
Hyperlipidemia
No current symptoms attributable to COVID-19
No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
Ability to provide informed consent
Confirmed review of concomitant medications (with emphasis on cardiac medications)

Exclusion Criteria Cohort A & B:

Known allergy to hydroxychloroquine or quinine
Known history of long QT syndrome
Known history of arrhythmia or dysrhythmia
Known current QTc >500 ms
Known G6PD deficiency
Known history of hypoglycemia
Pregnant or Nursing by patient history
Use of any of the following concomitant medications: See Appendix D for Exclusion medication list
Concurrent diagnosis of dermatitis, porphyria, or psoriasis
History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)
History of chronic kidney disease
Pre-existing retinopathy
Already taking hydroxychloroquine
Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine
Enrollment in another clinical with investigational drug or device
Inability to swallow pills
Adults unable to provide informed consent",Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.,ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04372602,NCT04372602_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

A diagnosis of advanced COVID-19 as defined both of the following:

as a positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (e.g. nasopharyngeal, nasal, oropharyngeal swab, or saliva) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab with an FDA approved assay.

Critical disease manifested by any of the following:

Chest imaging with ≥ 50% lung involvement
Respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (eg. BiPAPA, OptiFlow), supplementary oxygen with FiO2 ≥ 6 LPM or extracorporeal membrane oxygenation (ECMO)
Shock - defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support

Cardiac dysfunction defined by:

New global systolic dysfunction with ejection fraction ≤ 40%
Takotsubo cardiomyopathy
Patients who have received prior investigational or off-label agents for COVID-19 does not exclude eligibility.
At least 18 years of age at the time of study registration
Adequate hematologic function defined as absolute neutrophil count ≥1000/mm3 and platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening.
Creatinine-clearance ≥ 15 mL/minute or receiving renal replacement therapy
Aminotransferase (AST/ALT) levels <3x the upper limit of normal
Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
Male patients if engaging in sex with a women of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.

Exclusion Criteria:

Known allergy or intolerance to duvelisib or another PI3K inhibitor.
Known or suspected active viral (including CMV, HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. CMV viral load will be assessed at screening and those with viremia will be excluded. Other virologic testing not required unless infection is suspected.
Pregnant and/or breastfeeding.
Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.",-Duvelisib 25 mg twice daily for up to 10 days.,ChEMBL:CHEMBL3039502 | DrugBank:DB11952 | PubChem:50905713,Duvelisib,C[C@H](Nc1ncnc2[nH]cnc12)c1cc2cccc(Cl)c2c(=O)n1-c1ccccc1,L01EM04,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT04374019,NCT04374019_EG002,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria

Age ≥18 years
Laboratory-confirmed SARS-CoV-2 infection within the past 7 days or the presence of symptoms or physical examination signs providing high probability of COVID-19 disease
Patients must have adequate organ and marrow function measured within the last 6 months

Subjects must have at least one of the following high-risk features for clinical deterioration:

Hypertension
Diabetes Mellitus
Moderate to severe Chronic Obstructive Pulmonary Disease, Emphysema, Cystic Fibrosis, or Asthma
Cancer patients who have received any immunosuppressive drugs within a year from enrollment
Sickle Cell disease or thalessemia
Age > or = 50
BMI > or = 30
Living in a nursing home or long-term facility
Underlying serious heart condition as determined by the treating physician
Immunocompromised subject as defined by the treating physician or COVID-19 Telehealth Treatment Team

Exclusion Criteria

Severe or life threating COVID
Weight less than 45 kg.
Pregnant or breast-feeding females
Subjects on dialysis or with creatinine clearance < 45 ml/min
Existing DMID Toxicity Scale for Determining Severity of Adverse Events grade 3 or greater hepatic failure
Previously documented moderate or severe retinopathy or macular degeneration
Uncontrolled Seizure disorder
Prolonged QT, defined as QTc ≥470 milliseconds for men and as QTc ≥480 for women using Bazett's formula
Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial.
Currently receiving any study medications for other indications
Concurrent use of medication that would cause drug-drug interactions
Patients with psychiatric illness/social situations that would limit compliance",Ivermectin,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04381988,NCT04381988_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Age ≥ 18
ECOG 0-3
For patients who have not started radiation at the time of screening: patients are required to have a plan in place for a minimum of 10 radiation treatments with or without concurrent systemic therapy
For patients who have already started radiation at the time of screening: patients must complete enrollment such that they are able to receive at least 10 radiation treatments with hydroxychloroquine.
Disease Site
Mandatory inclusion criteria:

No COVID-19 symptoms within 14 days of enrollment:

(Temp >38C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches, chills, diarrhea, and anosmia)
If symptoms are present within 14 days of enrollment, patients with a negative COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
No close contact with confirmed COVID-19 person

Close contact defined as:

Within 6 feet for prolonged period
Cohabitating

Optional laboratory criteria (Recommended if available)

Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of enrollment)
Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment) using MSKCC laboratory or outside laboratory assay
Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within 1 week of enrollment)
Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)

Disease site meets following criteria:

Head and Neck / High-Risk Skin Cancer
Lung Cancer
Breast Cancer
Prostate Cancer
Central Nervous System Tumors
Gastrointestinal System Cancer
Gynecologic cancer
Other disease sites permitted at PI discretion

Exclusion Criteria:

Previous positive test for SARS-CoV-2
Previous positive serology test for SARS-CoV-2
Recent Chest CT meeting CT exclusion criteria
Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or chills, diarrhea, anosmia)
Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
Pre-existing retinopathy
Known chronic kidney disease, stage 4 or 5, or receiving dialysis
Breast Feeding
Tamoxifen
Absolute neutrophil Count <1,000/ml at registration
Concurrent use of any other quinine derivative
Antiarrhythmic medications: amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide
Glucose-6-phosphate dehydrogenase deficiency
Pre-treatment corrected QT interval (QTc) ≥470 milliseconds**
Prisoners
Inability to participate
Psoriasis
History of suicidal ideation
CT Criteria for Enrollment Exclusion (Optional - only for patients who received a diagnostic CT as part of standard of care or a thoracic CT as part of radiation simulation): All patients with COVID-19 typical radiographic findings on CT Chest as defined by the RSNA will be excluded. Patients with any NEW COVID-19 indeterminate radiographic findings on CT Chest that are concerning for COVID-19 will be excluded. COVID-19 indeterminate features are permitted if they can be demonstrated as STABLE on prior (>14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND any intermediate or typical feature is present, the patient is not eligible.

COVID-19 Atypical Features

Isolated lobar or segmental consolidation without GGO
Discrete small nodules (centrilobular, ""tree-in-bud"")
Lung cavitation
Smooth interlobular septal thickening with pleural effusion

COVID-19 Indeterminate Features

Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation lacking a specific distribution and are non-rounded or non-peripheral
Few very small GGO with a non-rounded and non-peripheral distribution

COVID-19 Typical Features

Peripheral, bilateral GGO with or without consolidation or visible intralobular lines (""crazy paving"")
Multifocal GGO of rounded morphology with or without consolidation or visible intralobular lines (""crazy paving"")
Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment QTC can be decreased to <470, the patient can be re-considered for trial.","Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily.

Hydroxychloroquine: 400mg daily

Radiation therapy: Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04390022,NCT04390022_EG000,No,All,Adult,Phase 2,12,"Inclusion Criteria:

Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
Residents of the Pamplona basin (""Cuenca de Pamplona"")
The patient should be aged 18 to 59 years
Negative pregnancy test for women of child bearing age*
The patient or his/her representative, have given consent to participate in the study.

The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)

Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)

Exclusion Criteria:

Known history of Ivermectin allergy
Hypersensitivity to any component of Stromectol®

COVID-19 Pneumonia

Diagnosed by the attending physician
Identified in a chest X-ray
Fever or cough present for more than 48 hours
Positive IgG against SARS-CoV-2 by rapid test
Age under 18 or over 60 years

The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):

Immunosuppression
Chronic Obstructive Pulmonary Disease
Diabetes
Hypertension
Obesity
Acute or chronic renal failure
History of coronary disease
History of cerebrovascular disease
Current neoplasm
Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.","Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.

(Single dose of STROMECTOL® tablets at 400mcg/kg)",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT04397718,NCT04397718_EG001,No,Male,Adult | Older Adult,Phase 2,62,"Inclusion Criteria:

Male Veterans admitted to a VA hospital.
Age > 18
Hospitalized on an acute care ward with a diagnosis of COVID-19 contributing to hospitalization.
Positive RT-PCR assay for SARS-CoV-2 on a nasopharyngeal swab sample.
Severity of illness of level 3, 4 or 5 on the influenza severity scale (see Appendix A) at the time of randomization.
The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.

Exclusion Criteria:

History of severe hypersensitivity to degarelix or any component of their respective formulation.
History of congenital long QT syndrome or known history of prolonged QT interval corrected by the Fridericia correction formula (QTcF) > 500 msec on electrocardiogram performed at screening.
Planned discharge within 24 hours of treatment initiation.
Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Ongoing usage of a Class IA or Class III antiarrhythmic agent. At least 5 half lives must elapse since any prior use of a Class IA or III antiarrhythmic agent prior to administration of study drug.

--Baseline electrolyte abnormalities of Grade 3 or higher (based on CTCAE v5.0 criteria). Patients may be included if baseline electrolyte abnormalities are corrected to Grade 2 or lower prior to study drug administration.

Myocardial infarction in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease.
Enrollment in another investigational study within 30 days of Day 1.
Known psychiatric or substance abuse disorder that would interfere with the requirements of the trial.
Child-Pugh Class C liver disease.

Use of any of the following hormonal agents within Day 1 of treatment:

Androgen receptor antagonists or agonists within 4 weeks,
Ketoconazole or abiraterone acetate within 2 weeks,
Estrogens or progestins within 2 weeks,
Herbal products that contain hormonally active agents within 2 weeks.
Unwilling or unable to comply with the study protocol.
Any condition, which in the opinion of the investigator, would preclude participation in the trial.","Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.

Degarelix: Degarelix is an FDA-approved drug for prostate cancer",ChEMBL:CHEMBL415606 | DrugBank:DB06699 | PubChem:16136245,Degarelix,CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O,L02BX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT04405999,NCT04405999_EG000,No,All,Adult | Older Adult,Phase 4,25,"Inclusion Criteria:

Age of 18 years or more;
Negative test (PCR) for SARS-CoV-2 infection;
The absence of clinical manifestations of a respiratory infection;
Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2 infection;
Signed informed consent to participate in the study.

Exclusion Criteria:

Intolerance to Bromhexine hydrochloride;
Work out of contact with SARS-CoV-2 infection;
Non-compliance with the rules for the use of personal protective equipment when working with SARS-CoV-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the Ministry of Health of Russia and the internal orders of the Director General of Almazov NMRC, relevant to the dates of research);
Pregnancy and the period of breastfeeding;
Other circumstances that the researcher considers inappropriate to participate in this study","medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride

Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days",PubChem:5702220,Bromhexine Hydrochloride,CN(Cc1cc(Br)cc(Br)c1N)C1CCCCC1.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
NCT04407507,NCT04407507_EG000,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
Signed Informed Consent.

Exclusion Criteria:

Patients with severe disease COVID-19.
Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
Recurrent urinary tract infections.
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
Pregnant or lactating patients
Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
Patients with a known allergy or hypersensitivity to dewormers.
Patients who are using an antioxidant supplement.
Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.","Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04410159,NCT04410159_EG000,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

adult aged 18 years and above
able to understand instructions
Stage 1 COVID-19
< 5 days of illness or diagnosis

Exclusion Criteria:

Less than 18 years old
Unable to understand instructions
Stage 2 & 3 COVID-19
Respiratory symptoms or fever on admission
Abnormal chest radiograph or computed tomography (CT) findings on admission","gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days

Povidone-Iodine: Gargle",PubChem:410087,Povidone iodine,C=CN1CCCC1=O.II,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04435366,NCT04435366_EG001,No,All,Adult | Older Adult,Phase 3,222,"Inclusion Criteria:

Subjects of either gender aged ≥ 50 years
Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
Any intraocular surgery or thermal laser within 3 months of trial entry.
Any prior thermal laser in the macular region, regardless of indication
Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
Previous therapeutic radiation in the region of the study eye
Any sign of diabetic retinopathy in either eye","Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis",DrugBank:DB03819 | PubChem:66644,Salicylhydroxamic Acid,O=C(NO)c1ccccc1O,,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
NCT04435808,NCT04435808_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are asymptomatic for known presenting symptoms of SARS-CoV-2:
UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI's will consider study enrollment of HCWs from other settings, for example certain outpatient clinics or inpatient units.
Are not positive for SARS-CoV-2 testing
Willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures
Willing and able to provide informed consent

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, for example anti-arrhythmic agents, digoxin, cyclosporin, cimetidine, or tamoxifen.
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 (<100K)
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. There may be some exceptions to requiring a 30-day washout that will be evaluated by the Co-Investigators on a case by case basis.","Group A: 0 health care workers who chose to take hydroxychloroquine

Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.

Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily",ChEMBL:CHEMBL1535 | DrugBank:DB01611 | PubChem:3652,Hydroxychloroquine,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12,P01BA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04442490,NCT04442490_EG001,No,All,Adult,Phase 3,268,"Inclusion Criteria:

Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version [SCID-5-CT], with symptoms that have been present for at least a 4-week period.
Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.
Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.

Exclusion Criteria:

Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
Participant has onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period.
Participant has a body mass index (BMI) ≤18 or ≥45 kg/m^2 at Screening, which is subject to a broader evaluation of medical comorbidities.
Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment.
Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.
Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.","Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04442503,NCT04442503_EG001,No,Female,Adult,Phase 3,98,"Inclusion Criteria:

Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
Participant is ≤12 months postpartum at screening and Day 1.

Exclusion Criteria:

Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
Participant has active psychosis per investigator assessment.
Participant has a medical history of nonfebrile seizures.
Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Participant has a history of sleep apnea.

Note: Other protocol-defined inclusion/exclusion criteria applied.","Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.",ChEMBL:CHEMBL4105630 | DrugBank:DB15490 | PubChem:86294073,Zuranolone,[H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04448756,NCT04448756_EG002,No,All,Adult | Older Adult,Phase 2,46,"Inclusion Criteria:

Participant provides signed informed consent prior to the initiation of any study assessments
Has laboratory-confirmed SARS-CoV-2 Infection as determined by nucleic acid amplification test, polymerase chain reaction, antigen test or other commercial or public health assay (based on locally acceptable accepted guidelines) in a sample collected less than (<)10 days prior to randomization
Has chest imaging consistent with COVID-19 pneumonia (as per locally accepted guidelines) If chest imaging is not available during Screening, please discuss with Medical Monitor or designee regarding evidence of probable COVID-19 pneumonia for study participant eligibility
Not on mechanical ventilation or ECMO
Has an SpO2 less than (<) 94 percent in room air And able to maintain a partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) greater than or equal to (>=) 150 (Or equivalent SpO2/FiO2 >=190) with a maximum FiO2 0.4 if participant is on chronic low oxygen therapy (less than or equal to 2 Liter), assess their current baseline oxygen requirements for eligibility
Requires hospitalization
Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Any condition that could interfere with the study objectives, conduct or evaluation in the opinion of the Investigator or Sponsor or designee
Significantly uncontrolled medical illness (eg, cardiovascular disease, hypertension, diabetes mellitus, obstructive lung disease, neurological associated with seizures (example: cerebrovascular accident/stroke, acute brain infection, traumatic brain injury, progressive brain disease, congenital brain disease or neuropsychiatric disorder)
Known active infection other than COVID-19
Pregnancy or Breastfeeding
Other protocol defined exclusion criteria may apply",Participants received M5049 100 mg orally twice daily for 14 days.,ChEMBL:CHEMBL4802159 | PubChem:129240620,ENPATORAN,N#Cc1ccc(N2C[C@H](N)C[C@H](C(F)(F)F)C2)c2cccnc12,,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04450329,NCT04450329_EG000,No,All,Adult | Older Adult,Phase 3,224,"Inclusion Criteria:

Age ≥ 50 years at Screening
Treatment naïve, *active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
The area of CNV must occupy at least 50% of total lesion in the study eye
Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts or 2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation
Non-childbearing potential female, OR childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year from Screening until 3 months after the last IVT injection of IP
Written informed consent form (ICF) must be obtained from the subject prior to any study related procedure
Willingness and ability to undertake all scheduled visits and assessments

Exclusion Criteria:

Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea
Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
Study eye: Presence of retinal pigment epithelial tears or rips involving the macula
Study eye: Presence of macular hole at any stage
Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP or require medical or surgical intervention during the study period
Either eye: History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular oedema (DME)
Study eye: Current vitreous haemorrhage
Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
Any previous systemic anti-VEGF treatment
Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation. However, dietary supplements, vitamins, or minerals will be allowed.
Study eye: History of vitrectomy, scleral buckling (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation
Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation
Study eye: Topical ocular corticosteroids administered for ≥ 30 consecutive days or for ≥ 60 nonconsecutive days within 90 days prior to randomisation
Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomization (inhaled steroid is permitted).
Study eye: Any other intraocular surgery or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation.
Current use of medications known to be toxic to the lens, retina, or optic nerve at Screening.
Study eye: Previous radiation therapy near the region of the study eye
Previous participation in clinical studies with IP to treat neovascular AMD in either eye.
Previous participation in clinical studies with IP to treat disease other than neovascular AMD within 90 days prior to randomisation (excluding dietary supplementary, vitamins, and minerals).
Subject with only one functional eye (defined as BCVA of counting finger or less on the eye with worse vision)
Study eye: Spherical equivalent of the refractive error demonstrating more than 6 diopters of myopia. For subjects who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 6 diopters of myopia.
Study eye: Aphakia or absence of the posterior capsule (unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation)
Either eye: Active or suspected ocular and periocular infection at Screening or at randomisation
Either eye: Active intraocular inflammation including scleritis at Screening or at randomisation
Either eye: History of idiopathic or autoimmune-associated uveitis
Study eye: Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] ≥ 25 mmHg despite treatment with anti-glaucoma medication) at Screening
Known allergic reactions and/or hypersensitivity to any component of Eylea or SB15
History of allergy to the fluorescein sodium for injection in angiography
History of a medical condition that would preclude scheduled study visits or safe use of IP in the opinion of the Investigator
Uncontrolled systemic disease including but not limited to uncontrolled diabetes mellitus (in the opinion of the Investigator), uncontrolled systemic hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg on optimal medical regimen), or uncontrolled atrial fibrillation (resting heart rate ≥ 110 beats per minutes) at Screening
Stroke, transient ischaemic attacks, or myocardial infarction within 180 days prior to randomisation
History of recurrent significant infections and/or current treatment for systemic infection
Severe renal impairment with dialysis or a history of renal transplant
Malignancy (other than non-melanoma skin cancer) under treatment or with history of metastatic disease
Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or not using adequate birth control, as specified in protocol. For women of childbearing potential, a serum pregnancy test must result negative at Screening.
Employees of investigational sites, individuals directly involved with the conduct of the study","Subjects who were randomized at Week 0 to receive SB15 (Aflibercept) every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by once every 8 weeks until Week 32.

After re-randomization at Week 32, all the subjects continued to receive SB15 once every 8 weeks in transition period (Week 32 to Week 48).",ChEMBL:CHEMBL2035187 | DrugBank:DB11697 | PubChem:46216796,Pacritinib,C1=N/C2=N/c3ccc(OCCN4CCCC4)c(c3)COC/C=C/COCc3cccc(c3)C(=C1)N2,L01EJ03,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04450394,NCT04450394_EG001,No,All,Adult | Older Adult,Phase 2,135,"Inclusion Criteria:

Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

Have type 1 diabetes mellitus or latent autoimmune diabetes
Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²
Have active or untreated cancer
Are receiving chronic (>14 days) systemic glucocorticoid therapy","Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04450407,NCT04450407_EG002,No,All,Adult | Older Adult,Phase 2,126,"Inclusion Criteria:

Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
Participants must have been using multiple daily injections without interruption for at least 3 months
Participants must have HbA1c values of 5.6% to 9.5%, inclusive
Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)

Exclusion Criteria:

Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²
Have active or untreated cancer
Are receiving chronic (>14 days) systemic glucocorticoid therapy","Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.",PubChem:118984462,CID 118984462,CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04463615,NCT04463615_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines
Patients must have a life expectancy of > 3 months
Eastern Cooperative Oncology Group (ECOG) =< 2
Patients must have a diagnosis of cutaneous CD30+ LYPD
Patients must be relapsed or are refractory to at least 1 prior line of therapy
At least 2 weeks from prior therapy to time of start of treatment. Prior therapy includes steroids (except prednisone or equivalent - up to 10 mg/day is allowed)
Absolute neutrophil count (ANC) >= 1000/mm^3 (within 21 days prior to day 1 of protocol therapy). NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
Platelets >= 50,000/mm^3 (within 21 days prior to day 1 of protocol therapy). NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (within 21 days prior to day 1 of protocol therapy)
Aspartate aminotransferase (AST) =< 2.0 x ULN (within 21 days prior to Day 1 of protocol therapy)
Alanine aminotransferase (ALT) =< 2.0 x ULN (within 21 days prior to day 1 of protocol therapy)
Creatinine clearance of >= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 21 days prior to day 1 of protocol therapy)

Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 21 days prior to day 1 of protocol therapy)

If positive, hepatitis C RNA quantitation must be performed
Meets other institutional and federal requirements for infectious disease titer requirements. Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
Negative for tuberculosis antigen (e.g. T-Spot test)
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 21 days prior to day 1 of protocol therapy). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Agreement by females and males of childbearing potential* to use an effective method of birth control (hormonal or barrier method of birth control or abstinence) or abstain from heterosexual activity for the course of the study through at least three months after the last dose of protocol therapy. The effects of study treatment on a developing fetus have the potential for teratogenic or abortifacient effects. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 2 years (women only)

Exclusion Criteria:

Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
Current or planned growth factor or transfusion support. If growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible
Prior allogeneic transplant
Acute active infection requiring systemic therapy within 2 weeks prior to enrollment
Known history of hepatitis B or hepatitis C infection
Known HIV infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to leflunomide or cholestyramine

Non-hematologic malignancy within the past 3 years aside from the following exceptions:

Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Prostate cancer < Gleason grade 6 with a stable prostate specific antigen (PSA)
Successfully treated in situ carcinoma of the breast
Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent
Pregnant women and women who are lactating. Leflunomide has potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is enrolled on this study
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.

Leflunomide: Given PO",ChEMBL:CHEMBL960 | DrugBank:DB01097 | PubChem:3899,Leflunomide,Cc1oncc1C(=O)Nc1ccc(C(F)(F)F)cc1,L04AA13,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04474314,NCT04474314_EG000,No,All,Adult | Older Adult,Phase 2,47,"Inclusion Criteria:

Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+ thalassemia)
Hemoglobin of >5.5 and <10.5 g/dL; Hb values within 21 days post-transfusion will be excluded.
Subjects must have had at least 2 and no more than 12 documented episodes of VOCs in the past 12 months at the time of informed consent signing and at randomization (Day 1).
Subjects receiving HU must have received it continuously for at least 6 months prior to signing informed consent, and must have been on a stable dose for at least 3 months prior to signing the informed consent, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.
Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

Hospital discharge for sickle cell crisis or other vaso-occlusive event within the 4 days prior to randomization (Day 1).
Subjects participating in a chronic/prophylactic RBC transfusion program (i.e., regularly scheduled RBC transfusions); any transfusions within 21 days of screening or baseline Hb measurements
Subjects with HbF >25% at screening.
Significant kidney disease (eGFR <45mL/min) and liver dysfunction: alanine aminotransferase or aspartate aminotransferase >3x upper limit of normal.
Body mass index (BMI) <17.0 kg/m2 and a total body weight <45 kg; or a BMI >35 kg/m2.
Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).
Prior exposure to IMR-687.
Subjects taking direct acting oral anti-coagulants (apixaban, dabigatran, rivaroxaban, edoxaban, or ticagrelor) or taking warfarin unless they stopped the treatment at least 28 days prior to randomization (Day 1).
A history of use of crizanlizumab (Adakveo®) or voxelotor (Oxbryta®) within 6 months prior to signing the informed consent.
Receipt of erythropoietin, luspatercept (Reblozyl®)or other hematopoietic growth factor treatment within 3 months of signing the ICF or anticipated need for such agents during the study.
Prior gene therapy.","Oral administration of once daily IMR-687

IMR-687: Oral administration of once daily IMR-687",ChEMBL:CHEMBL4297290 | DrugBank:DB16193 | PubChem:124220601,Tovinontrine,C[C@@H]1CN(Cc2ncccn2)C[C@H]1c1cn2c(C3CCOCC3)ncc2c(=O)[nH]1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04474314,NCT04474314_EG001,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+ thalassemia)
Hemoglobin of >5.5 and <10.5 g/dL; Hb values within 21 days post-transfusion will be excluded.
Subjects must have had at least 2 and no more than 12 documented episodes of VOCs in the past 12 months at the time of informed consent signing and at randomization (Day 1).
Subjects receiving HU must have received it continuously for at least 6 months prior to signing informed consent, and must have been on a stable dose for at least 3 months prior to signing the informed consent, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.
Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

Hospital discharge for sickle cell crisis or other vaso-occlusive event within the 4 days prior to randomization (Day 1).
Subjects participating in a chronic/prophylactic RBC transfusion program (i.e., regularly scheduled RBC transfusions); any transfusions within 21 days of screening or baseline Hb measurements
Subjects with HbF >25% at screening.
Significant kidney disease (eGFR <45mL/min) and liver dysfunction: alanine aminotransferase or aspartate aminotransferase >3x upper limit of normal.
Body mass index (BMI) <17.0 kg/m2 and a total body weight <45 kg; or a BMI >35 kg/m2.
Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).
Prior exposure to IMR-687.
Subjects taking direct acting oral anti-coagulants (apixaban, dabigatran, rivaroxaban, edoxaban, or ticagrelor) or taking warfarin unless they stopped the treatment at least 28 days prior to randomization (Day 1).
A history of use of crizanlizumab (Adakveo®) or voxelotor (Oxbryta®) within 6 months prior to signing the informed consent.
Receipt of erythropoietin, luspatercept (Reblozyl®)or other hematopoietic growth factor treatment within 3 months of signing the ICF or anticipated need for such agents during the study.
Prior gene therapy.","Oral administration of once daily IMR-687

IMR-687: Oral administration of once daily IMR-687",ChEMBL:CHEMBL4297290 | DrugBank:DB16193 | PubChem:124220601,Tovinontrine,C[C@@H]1CN(Cc2ncccn2)C[C@H]1c1cn2c(C3CCOCC3)ncc2c(=O)[nH]1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04531462,NCT04531462_EG001,No,All,Older Adult,Phase 4,65,"Inclusion Criteria:

Japanese (defined as patient has parents who are Japanese) patients with diagnosis of Type 2 diabetes mellitus (T2DM) prior to informed consent

Glycated hemoglobin (HbA1c) ≥7.0% and ≤10.0% for patients at Visit 1 (screening). If the patient is on treatment with oral antidiabetic drug(s) potentially associated with severe hypoglycaemia (e.g., sulfonylurea or glinides), the following HbA1c value is used as criterion

HbA1c ≥7.5% and ≤10.0% for age ≥65 and <75
HbA1c ≥8.0% and ≤10.0% for age ≥75
Patients on diet and exercise regimen who are drug-naïve (drug-naïve is defined as no antidiabetic drugs for at least 12 weeks prior to informed consent) or on treatment with any oral antidiabetic drug (OAD) other than Glucagon-Like Peptide-1 (GLP-1) agonists and Sodium-glucose cotransporter 2 (SGLT-2) inhibitor. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomisation (any thiazolidinedione therapy has to be unchanged for at least 18 weeks prior to informed consent).
Age ≥65 years at informed consent
BMI ≥22 kg/m2 at Visit 1 (screening)
Male or post-menopausal (a point in time 12 months after a woman's last period) female patients
Patient signed and dated written informed consent in accordance with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) and local legislation prior to admission to the Trial

Exclusion Criteria:

Uncontrolled hyperglycaemia with a fasting glucose level >200 milligram per deciliter (mg/dL) (>11.1 millimol per Liter (mmol/L)) during run-in period
Treatment with insulin within 12 weeks prior to informed consent
Impaired cognitive ability as supported by Mini mental state examination (MMSE-J, defined as ≤23) and verified by the investigator at screening
Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT = serum glutamic-pyruvic transaminase [SGPT]), aspartate aminotransferase (AST = serum glutamic-oxaloacetic transaminase[SGOT]), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) as determined during screening and run-in period
Impaired renal function, defined as Estimated glomerular filtration rate (eGFR) <45 milliliter per minute per 1.73 square meter (mL/min/1.73 m2, severe renal impairment, Modification of Diet in Renal Disease (MDRD) formula) as determined during screening and run-in period
Low grip strength defined as <28 kilogram (kg) for male or as <18 kg for female at screening
Short length of calf circumference defined as <34 centimeter (cm) for male or 33 cm for female at screening
further exclusion criteria apply",Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment.,ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04552470,NCT04552470_EG001,No,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Patients with T2DM who are treated with diet and exercise
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion Criteria:

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC
Acute pancreatitis or history of chronic pancreatitis
Symptomatic gallbladder disease
Known medical history of active proliferative retinopathy and/or macular edema
Known history of HIV, hepatitis B, hepatitis C or syphilis
Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
Clinically relevant ECG abnormalities
Positive urine drug test","Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.",ChEMBL:CHEMBL4518483 | DrugBank:DB16043 | PubChem:134611040,DANUGLIPRON,N#Cc1ccc(COc2cccc(C3CCN(Cc4nc5ccc(C(=O)O)cc5n4C[C@@H]4CCO4)CC3)n2)c(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04552470,NCT04552470_EG002,No,All,Adult | Older Adult,Phase 1,9,"Inclusion Criteria:

Patients with T2DM who are treated with diet and exercise
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion Criteria:

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC
Acute pancreatitis or history of chronic pancreatitis
Symptomatic gallbladder disease
Known medical history of active proliferative retinopathy and/or macular edema
Known history of HIV, hepatitis B, hepatitis C or syphilis
Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
Clinically relevant ECG abnormalities
Positive urine drug test","Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.",ChEMBL:CHEMBL4518483 | DrugBank:DB16043 | PubChem:134611040,DANUGLIPRON,N#Cc1ccc(COc2cccc(C3CCN(Cc4nc5ccc(C(=O)O)cc5n4C[C@@H]4CCO4)CC3)n2)c(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04552470,NCT04552470_EG003,No,All,Adult | Older Adult,Phase 1,9,"Inclusion Criteria:

Patients with T2DM who are treated with diet and exercise
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion Criteria:

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC
Acute pancreatitis or history of chronic pancreatitis
Symptomatic gallbladder disease
Known medical history of active proliferative retinopathy and/or macular edema
Known history of HIV, hepatitis B, hepatitis C or syphilis
Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
Clinically relevant ECG abnormalities
Positive urine drug test","Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.",ChEMBL:CHEMBL4518483 | DrugBank:DB16043 | PubChem:134611040,DANUGLIPRON,N#Cc1ccc(COc2cccc(C3CCN(Cc4nc5ccc(C(=O)O)cc5n4C[C@@H]4CCO4)CC3)n2)c(F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04570670,NCT04570670_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,49,"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 Tecfidera 240 mg (1 × 240 mg dimethyl fumarate delayed-release capsule) at Hour 0 on Day 1

dimethyl fumarate 240 mg",ChEMBL:CHEMBL2107333 | DrugBank:DB08908 | PubChem:637568,DIMETHYL FUMARATE,[H]/C(C(=O)OC)=C(/[H])C(=O)OC,L04AX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT04578886,NCT04578886_EG001,No,All,Adult | Older Adult,Phase 3,100,"Inclusion criteria

Patients admitted to the UAB hospital Surgical Intensive Care Unit (SICU)
18 years of age or older
Expected total ICU length of stay of 72 hours or more per treating physician
Diagnosed with delirium based on CAM-ICU assessment (see attached CAM-ICU assessment form)

Exclusion Criteria

Patients younger than 18 years old
Expected discharge from ICU within 72 hours of admission
Expected or inevitable death with 48 hours of enrollment
Pregnancy or breast feeding
Non-English speaking
Patients unable to be assessed by CAM-ICU due to neurologic illness
Altered consciousness unable to participate in CAM-ICU assessment
Patients with previous diagnosis of chronic, acute, subacute neurologic disease, or neurodegenerative disease
Mental illness and/or psychosis
Acute alcohol withdrawal
No enteral route available for administration
Treating physician refusal of enrollment based on severe hypotension (defined as requiring a vasopressor for longer than 24 hours) or bradycardia (Hr<50 bpm) at the time of screening
Hepatic encephalopathy
Blind or Hearing impaired
Taking Guanfacine, for any reason
On CYP3A inhibitor such as azole antifungals or clarithromycin
On CYP3A inducers such as phenytoin or rifampin
Severe xerostomia
Enrolled in another interventional research trial","Guanfacine immediate-release, 2mg dose, over-encapsulated tablet, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol.

Guanfacine: Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.",ChEMBL:CHEMBL862 | DrugBank:DB01018 | PubChem:3519,Guanfacine,N=C(N)NC(=O)Cc1c(Cl)cccc1Cl,C02AC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04615403,NCT04615403_EG000,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Able and willing to attend scheduled follow-up exams for the duration of the study
Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
Best spectacle corrected visual acuity of 20/80 or better in each eye.
Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

Exclusion Criteria:

Glaucoma status as follows:

Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders

Corneal status as follows:

Any active inflammation or edema
Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
Implantation of Travoprost Intraocular Implant
Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)

Fellow eye status as follows:

Fellow eye actively enrolled in this trial or any other clinical trial

Subject status as follows:

Pregnant or planning to become pregnant during the course of the study","Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.

Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision",ChEMBL:CHEMBL1200799 | DrugBank:DB00287 | PubChem:5282226,Travoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O,S01EE04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04627038,NCT04627038_EG000,No,All,Adult | Older Adult,Phase 2,135,"Inclusion Criteria:

Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have a history of daily pain for at least 12 weeks based on participant report or medical history.
Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
Have presence of index knee pain for >12 weeks at screening.
Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
Have a positive human immunodeficiency virus (HIV) test result at screening.
Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Have an intolerance to acetaminophen or paracetamol or any of its excipients.
Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
Have presence of surgical hardware or other foreign body in the index knee.
Have an unstable index joint (such as a torn anterior cruciate ligament).
Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
Have a history of infection in the index joint.
Have a history of arthritis due to crystals (e.g., gout, pseudogout).
Have pain or functional impairment due to ipsilateral hip osteoarthritis.
Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
Are taking metformin therapy.
Are pregnant or breastfeeding.
Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.",Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.,PubChem:86294067,"US10166214, Example 47",Cc1cccnc1OCC(C)(C)NC(=O)C1C2CNCC21,,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
NCT04632706,NCT04632706_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Important Inclusion Criteria:

Subject is male of any ethnic origin.
Subject is aged between 18 to 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.
Subject is ≥50 kg.
Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.
Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.

Important Exclusion Criteria:

Clinically relevant history of abnormal physical or mental health (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening and Day -1 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
Evidence of previous SARS-CoV-2 infection from medical history.
Ophthalmologic disorder (moderate and sever retina or optic nerve pathology; cataracts excluded).
Subjects with a diagnosis of asthma or any other respiratory conditions.
A neurologic disorder that may compromise blood brain barrier permeability (stroke within 90 days, brain tumour, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy) or history of seizures.
Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to first dosing of current study medication.
Use of any drugs that are known substrates of CYP3A4, P-glycoprotein (P-gp) from within 4 weeks of Screening and unable to refrain from them until the end of the study (e.g., rifampicin, quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat). Use of critical CYP3A4 substrate drugs such as warfarin or coumarin anticoagulants.
Recent or expected microfilaricidal drug use, including ivermectin, or travel history to areas that are endemic for Loa loa or onchocerciasis (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
Use of medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin, in the 30 days prior to Screening and unable to refrain from them until the end of the study.
Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days prior to first dosing until the end of the study.",Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28.,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT04632706,NCT04632706_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Important Inclusion Criteria:

Subject is male of any ethnic origin.
Subject is aged between 18 to 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.
Subject is ≥50 kg.
Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.
Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.

Important Exclusion Criteria:

Clinically relevant history of abnormal physical or mental health (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening and Day -1 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
Evidence of previous SARS-CoV-2 infection from medical history.
Ophthalmologic disorder (moderate and sever retina or optic nerve pathology; cataracts excluded).
Subjects with a diagnosis of asthma or any other respiratory conditions.
A neurologic disorder that may compromise blood brain barrier permeability (stroke within 90 days, brain tumour, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy) or history of seizures.
Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to first dosing of current study medication.
Use of any drugs that are known substrates of CYP3A4, P-glycoprotein (P-gp) from within 4 weeks of Screening and unable to refrain from them until the end of the study (e.g., rifampicin, quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat). Use of critical CYP3A4 substrate drugs such as warfarin or coumarin anticoagulants.
Recent or expected microfilaricidal drug use, including ivermectin, or travel history to areas that are endemic for Loa loa or onchocerciasis (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
Use of medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin, in the 30 days prior to Screening and unable to refrain from them until the end of the study.
Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days prior to first dosing until the end of the study.",Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28.,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04632706,NCT04632706_EG002,Accepts Healthy Volunteers,Male,Adult,Phase 1,6,"Important Inclusion Criteria:

Subject is male of any ethnic origin.
Subject is aged between 18 to 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.
Subject is ≥50 kg.
Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.
Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.
Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.

Important Exclusion Criteria:

Clinically relevant history of abnormal physical or mental health (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening and Day -1 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
Evidence of previous SARS-CoV-2 infection from medical history.
Ophthalmologic disorder (moderate and sever retina or optic nerve pathology; cataracts excluded).
Subjects with a diagnosis of asthma or any other respiratory conditions.
A neurologic disorder that may compromise blood brain barrier permeability (stroke within 90 days, brain tumour, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy) or history of seizures.
Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to first dosing of current study medication.
Use of any drugs that are known substrates of CYP3A4, P-glycoprotein (P-gp) from within 4 weeks of Screening and unable to refrain from them until the end of the study (e.g., rifampicin, quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat). Use of critical CYP3A4 substrate drugs such as warfarin or coumarin anticoagulants.
Recent or expected microfilaricidal drug use, including ivermectin, or travel history to areas that are endemic for Loa loa or onchocerciasis (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
Use of medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin, in the 30 days prior to Screening and unable to refrain from them until the end of the study.
Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days prior to first dosing until the end of the study.",Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28.,ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04646109,NCT04646109_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,30,"Inclusion Criteria:

Patients who were hospitalised with a pre-diagnosis of ""severe COVID-19 pneumonia"" and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively.

Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;

Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in oxygen receiving patient
Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)
Mechanical ventilation requirement
Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure assessment) score >2

Exclusion Criteria:

Patients with the following characteristics were excluded from the study.

Pediatric patients; <18 years of old
Patients with chronic liver or kidney disease
Pregnant women
Patients with known ivermectin allergy","In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in > 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.

Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under ""Good Manufacturing Practices"" (GMP) certification conditions.",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04701333,NCT04701333_EG000,No,Female,Adult | Older Adult,Phase 2,73,"Inclusion Criteria:

Pregnant people, ages 18 years or older
Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit)
Consented for an induced, elective abortion or undergoing induction for demise
English or Spanish speaking
Able to consent for a research study, literate in English or Spanish
Willing to comply with study procedures and follow-up
Access to smart phone throughout study

Exclusion Criteria:

Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
Currently breastfeeding
Currently receiving dopamine agonist therapy for other indication (prolactinoma, Cushings syndrome, acromegaly, restless leg syndrome)

Contraindication to cabergoline (as per package insert)

Uncontrolled hypertension - defined as baseline BP > 150/100, or chronic hypertension requiring more than one baseline medication, or pregnancy-induced hypertension spectrum disorders (gestational hypertension, preeclampsia, eclampsia)
History of cardiac valvular disorders or valvular repair
History of pulmonary, pericardial, or retroperitoneal fibrotic disorders","After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.

Cabergoline 1 MG: Dopamine agonist",ChEMBL:CHEMBL1201087 | DrugBank:DB00248 | PubChem:54746,Cabergoline,[H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N(CCCN(C)C)C(=O)NCC)CN2CC=C,G02CB03 | N04BC06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04707157,NCT04707157_EG000,No,All,Adult | Older Adult,Phase 2,45,"Inclusion Criteria:

Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have a history of daily pain for at least 12 weeks based on participant report or medical history.
Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study.
Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Have a positive human immunodeficiency virus (HIV) test result at screening.
Have an intolerance to acetaminophen or paracetamol or any of its excipients.
Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
Have known hereditary motor, sensory or autonomic neuropathies.
Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.

Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.

Have a history or presence of lactic acidosis.
Have a history or presence of severe hepatic disease including cirrhosis.
Have uncontrolled or unstable congestive heart failure.
Are taking carbonic anhydrase inhibitors if also taking metformin.
Have had a change in metformin therapy in the last 12 weeks.
Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
Are pregnant or breastfeeding.
Have fibromyalgia.",Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.,PubChem:86294067,"US10166214, Example 47",Cc1cccnc1OCC(C)(C)NC(=O)C1C2CNCC21,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04709692,NCT04709692_EG001,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Male or female, aged 18 to 70 years of age (inclusive) at screening.
Body weight between 45 kg and 90 kg inclusive

Presence of mono-infection of P. falciparum or P. vivax confirmed by:

Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
Ability and willingness to participate and to comply with the study requirements
Agreement to hospitalization for at least 102 hours and/or until malarial parasites are not detected by microscopy on 2 consecutive occasions.
Agreement to come back to the hospital on Days 7, 10 or 11, 14, 17 or 18, 21, 24 or 25, 28, 35, and 42.

Women of child-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug:

Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone used in conjunction with barrier method as defined below.
Use of an intrauterine device with a documented failure rate of <1% per year.
Barrier method consisting of either condom or diaphragm.
Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female.
Complete abstinence from intercourse for 2 weeks prior to administration of study drug, throughout the study and for a period of 90 days after stopping study drug.

Exclusion Criteria:

Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010 (Attachment 1: Definition of Severe Malaria)
Mixed Plasmodium infection.
Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study, or severe diarrhea defined as 3 or more watery stools per day.
Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values)
Presence of a significant medical or psychiatric condition, or any other serious or chronic clinical condition requiring hospitalization, or any other condition that in the opinion of the investigator precludes participation in the study.
Female patients must not be either lactating or pregnant as demonstrated by a negative serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing).
Employment under the direct supervision of the investigators or study staff.

Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:

AST/ALT > 3 x upper limit of normal range (ULN) and total bilirubin is normal
AST/ALT > 2 x ULN and total bilirubin is >1 and <1.5 x ULN and conjugated bilirubin is > 35% of the total bilirubin
Total bilirubin > 1.5 x ULN
Serum creatinine levels > 2 x ULN
Hb level < 8 g/dL
Platelet level < 50,000/mm3
Participation in a clinical study of another investigational small molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.

Have received any antimalarial treatment (alone or in combination) in the past containing:

Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 6 weeks
Amodiaquine or chloroquine within the previous 4 weeks
Any artemisinin (artesunate, artemether, arteether or dihydroartemisinin) quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days
Any medication from the list of prohibited medications.","600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax

(+)-SJ000557733 (SJ733): Anti-Malarial",PubChem:89508529,Unii-VT3A7NA96K,N#Cc1cc(NC(=O)C2c3ccccc3C(=O)N(CC(F)(F)F)C2c2cccnc2)ccc1F,,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04732624,NCT04732624_EG001,No,All,Adult | Older Adult,Phase 3,15,"Inclusion Criteria:

All genders
Adults aged ≥18 years who present with moderate-sized burn injuries [20 - 40% total body surface areas (TBSA)] to the Nepal Cleft and Burn Center within 24 hours of injury.

Exclusion Criteria:

Patients with electrical burns, chemical burns, inhalation injury.
Patients in overt shock (defined as serum lactate >2.5, or hypotension and altered mental status).
Pregnant patients, psychiatrically unstable patients will be excluded.
Patients with oropharyngeal defects and/or previously known diagnoses leading to high risk of aspiration, and/or precluding safe nasal-enteric access will be excluded.
Patients will history of chronic nausea and/or vomiting, including those with a diagnosis of gastroparesis due to diabetes mellitus will be excluded.
Patients with a Baux score of over 100 (age + TBSA), patients with declared palliative intent on admission, and patients for whom clinicians have high level of clinical concern based on clinical judgement will also be excluded.","Administration of Intravenous Fluid using Lactated Ringer's solution per standard of care resuscitation protocol for patients with moderate sized burn injuries (20-40% TBSA).

Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation",PubChem:56841910,Natrii lactatis solutio composita,CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04770155,NCT04770155_EG004,Accepts Healthy Volunteers,All,Adult,Early Phase 1,8,"Inclusion Criteria:

Self-identification of their race and the race of their biological parents as being only Black (i.e., African American) or only White (i.e., Caucasian American)
Born and raised in the United States

Exclusion Criteria:

Mixed races
Any chronic or ongoing disease
Prescribed pharmacological treatment
Smoking or tobacco use
Obesity (body mass index > 30 kg / m2)","Upon arriving at the laboratory, participants will ingest a liquid mixture containing Sildenafil (100 mg), an inhibitor of phosphodiesterase 5.

Sildenafil 100 mg: Sildenafil inhibits phosphodiesterase 5, an enzyme that degrades cyclic guanosine monophosphate in the vascular smooth muscle cells inactivating the nitric oxide-mediated signal; thus, Sildenafil will prolong the availability of cyclic guanosine monophosphate, enhancing the nitric oxide-mediated intracellular cascade.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04770155,NCT04770155_EG005,Accepts Healthy Volunteers,All,Adult,Early Phase 1,8,"Inclusion Criteria:

Self-identification of their race and the race of their biological parents as being only Black (i.e., African American) or only White (i.e., Caucasian American)
Born and raised in the United States

Exclusion Criteria:

Mixed races
Any chronic or ongoing disease
Prescribed pharmacological treatment
Smoking or tobacco use
Obesity (body mass index > 30 kg / m2)","Upon arriving at the laboratory, participants will ingest a liquid mixture containing a placebo.

Sildenafil 100 mg: Sildenafil inhibits phosphodiesterase 5, an enzyme that degrades cyclic guanosine monophosphate in the vascular smooth muscle cells inactivating the nitric oxide-mediated signal; thus, Sildenafil will prolong the availability of cyclic guanosine monophosphate, enhancing the nitric oxide-mediated intracellular cascade.",ChEMBL:CHEMBL192 | DrugBank:DB00203 | PubChem:135398744,Sildenafil,CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12,G01AE10 | G04BE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04802837,NCT04802837_EG000,No,All,Child,Phase 3,2,"Inclusion Criteria:

Is aged 12 to <18 years.
Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.

Exclusion Criteria:

Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.","Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.

Ridinilazole: Ridinilazole 200mg dosed BID for 10 days.",ChEMBL:CHEMBL3753858 | DrugBank:DB15308 | PubChem:16659285,Ridinilazole,c1cc(-c2nc3ccc(-c4ccc5nc(-c6ccncc6)[nH]c5c4)cc3[nH]2)ccn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04874636,NCT04874636_EG000,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have a history of daily pain for at least 12 weeks based on participant report or medical history.
Have a value of ≤30 on the pain catastrophizing scale.
Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening.
Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

Have second or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement >450 milliseconds (msec) for male participants, >470 msec for female participants, or >480 msec for participants with bundle branch block.
Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
Have a positive human immunodeficiency virus (HIV) test result at screening.
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Have an intolerance to acetaminophen or paracetamol or any of its excipients.
Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
Have history of or current osteoporotic compression fracture.
Have had a recent major trauma (within 6 months of baseline).
Have had surgical intervention for the treatment of low back pain in the past 6 months.
Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
Are taking metformin therapy.
Are pregnant or breastfeeding.",Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.,PubChem:86294067,"US10166214, Example 47",Cc1cccnc1OCC(C)(C)NC(=O)C1C2CNCC21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04884191,NCT04884191_EG000,No,All,Adult | Older Adult,Phase 2,52,"Inclusion Criteria:

PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008)
DIPSS Intermediate-1, Intermediate -2, or High-risk (Passamonti et al 2010)

Prior ruxolitinib treatment with failure to benefit or intolerance as defined by at least one of the following:

Treatment for ≥3 months with inadequate efficacy response defined as <10% SVR by MRI or <30% decrease from baseline in spleen length by physical examination or regrowth to these parameters following an initial response; and/or
Treatment for ≥28 days complicated by either

i. Development of a red blood cell (RBC) transfusion requirement (at least 2 units/month for 2 months) ii. National Cancer Institute (NCI) CTCAE grade ≥3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of <20 mg BID

Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
TSS of ≥10 on the MPN-SAF TSS 2.0 or patients with a single symptom score of ≥5 or 2 symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats
Age ≥18 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Peripheral blast count of <10% throughout the Screening period
Absolute neutrophil count of >500/μL
Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase [SGPT]), ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN, if transaminase elevation is related to MF), direct bilirubin ≤4× ULN, and creatinine ≤2.5 mg/dL
Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ≤1.5 × ULN
Left ventricular cardiac ejection fraction of ≥45% by echocardiogram or multigated acquisition (MUGA) scan
If fertile, willing to use effective birth control methods during the study
Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
Able to understand and willing to complete symptom assessments using a PRO instrument
Provision of informed consent

Exclusion Criteria:

Life expectancy <6 months
Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete allo-SCT
History of splenectomy or planning to undergo splenectomy
Splenic irradiation within the last 6 months
Previously treated with pacritinib
Patients receiving high-dose ruxolitinib (more than 10 mg BID or 20 mg QD) who cannot tolerate tapering down ruxolitinib to 10 mg BID or less prior to the first dose of pacritinib
Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of ≤100 mg per day, within the last 2 weeks
Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks
Treatment with medications that can prolong the QTc interval within the last 2 weeks
Treatment with an experimental therapy within the last 28 days
Significant recent bleeding history defined as NCI CTCAE grade ≥2 within the last 3 months, unless precipitated by an inciting event (eg, surgery, trauma, or injury)
Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
New York Heart Association Class II, III, or IV congestive heart failure
Any history of CTCAE grade ≥2 cardiac dysrhythmias within the last 6 months. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the medical monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
QTc prolongation >450 ms based on the mean of triplicate ECGs or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval)
Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or constipation
Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection or psychiatric illness or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
Known seropositivity for human immunodeficiency virus
Known active hepatitis A, B, or C virus infection
Women who are pregnant or lactating
Concurrent enrollment in another interventional trial",Pacritinib: Pacritinib,ChEMBL:CHEMBL2035187 | DrugBank:DB11697 | PubChem:46216796,Pacritinib,C1=N/C2=N/c3ccc(OCCN4CCCC4)c(c3)COC/C=C/COCc3cccc(c3)C(=C1)N2,L01EJ03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04884191,NCT04884191_EG002,No,All,Adult | Older Adult,Phase 2,54,"Inclusion Criteria:

PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008)
DIPSS Intermediate-1, Intermediate -2, or High-risk (Passamonti et al 2010)

Prior ruxolitinib treatment with failure to benefit or intolerance as defined by at least one of the following:

Treatment for ≥3 months with inadequate efficacy response defined as <10% SVR by MRI or <30% decrease from baseline in spleen length by physical examination or regrowth to these parameters following an initial response; and/or
Treatment for ≥28 days complicated by either

i. Development of a red blood cell (RBC) transfusion requirement (at least 2 units/month for 2 months) ii. National Cancer Institute (NCI) CTCAE grade ≥3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of <20 mg BID

Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
TSS of ≥10 on the MPN-SAF TSS 2.0 or patients with a single symptom score of ≥5 or 2 symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats
Age ≥18 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Peripheral blast count of <10% throughout the Screening period
Absolute neutrophil count of >500/μL
Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase [SGPT]), ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN, if transaminase elevation is related to MF), direct bilirubin ≤4× ULN, and creatinine ≤2.5 mg/dL
Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ≤1.5 × ULN
Left ventricular cardiac ejection fraction of ≥45% by echocardiogram or multigated acquisition (MUGA) scan
If fertile, willing to use effective birth control methods during the study
Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
Able to understand and willing to complete symptom assessments using a PRO instrument
Provision of informed consent

Exclusion Criteria:

Life expectancy <6 months
Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete allo-SCT
History of splenectomy or planning to undergo splenectomy
Splenic irradiation within the last 6 months
Previously treated with pacritinib
Patients receiving high-dose ruxolitinib (more than 10 mg BID or 20 mg QD) who cannot tolerate tapering down ruxolitinib to 10 mg BID or less prior to the first dose of pacritinib
Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of ≤100 mg per day, within the last 2 weeks
Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks
Treatment with medications that can prolong the QTc interval within the last 2 weeks
Treatment with an experimental therapy within the last 28 days
Significant recent bleeding history defined as NCI CTCAE grade ≥2 within the last 3 months, unless precipitated by an inciting event (eg, surgery, trauma, or injury)
Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
New York Heart Association Class II, III, or IV congestive heart failure
Any history of CTCAE grade ≥2 cardiac dysrhythmias within the last 6 months. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the medical monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
QTc prolongation >450 ms based on the mean of triplicate ECGs or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval)
Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or constipation
Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection or psychiatric illness or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
Known seropositivity for human immunodeficiency virus
Known active hepatitis A, B, or C virus infection
Women who are pregnant or lactating
Concurrent enrollment in another interventional trial",Pacritinib: Pacritinib,ChEMBL:CHEMBL2035187 | DrugBank:DB11697 | PubChem:46216796,Pacritinib,C1=N/C2=N/c3ccc(OCCN4CCCC4)c(c3)COC/C=C/COCc3cccc(c3)C(=C1)N2,L01EJ03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04907214,NCT04907214_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion criteria:

Age 18 to 70 years old
Impaired glucose tolerance (two-hour plasma glucose 140-199 mg/dL) or impaired fasting glucose (100-125mg/dL) or HbA1c 5.7-6.4%
BMI ≥ 30 kg/M2
The ability to provide informed consent

Exclusion criteria:

Criteria Related to Medical Diagnoses/Conditions/Treatments:

Diabetes type 1 or type 2, as defined by a fasting plasma glucose of 126 mg/dL or greater, a two-hour plasma glucose of 200 mg/dL or greater, HbA1c ≥6.5%, or the use of anti-diabetic medication
Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control
Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
Presence of implanted cardiac defibrillator or pacemaker
History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
History of pancreatitis or pancreatic surgery
History or presence of immunological or hematological disorders
Clinically significant gastrointestinal impairment that could interfere with drug absorption
History of advanced liver disease with cirrhosis
Individuals with an eGFR<45 mL/min/1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg/dL and age in years: eGFR (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female)
Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
Treatment with anticoagulants
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 abuse (>14 per week for men and >7 per week for women) or illicit drug use
Treatment with any investigational drug in the one month preceding the study
Previous randomization in this trial
Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study

Inability to comply with the protocol in the opinion of the principal investigator, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Criteria Related to Known Adverse Effects of Drug:

Uncircumcised men or men with history of balanitis
History of urinary incontinence
History of recurrent (>3) episodes of vulvovaginitis per year, or severe symptoms
History of Fournier's gangrene
History of recurrent (≥3) UTIs per year or pyelonephritis
History of symptomatic hypotension or conditions predisposing to volume depletion
Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations
Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid
Known or suspected allergy to trial medications, excipients, or related products
Contraindications to study medications, worded specifically as stated in the product's prescribing information","Individuals receive empagliflozin 25mg/day orally for 12 weeks

Empagliflozin 25 MG: Oral empagliflozin daily",ChEMBL:CHEMBL2107830 | DrugBank:DB09038 | PubChem:11949646,Empagliflozin,OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O,A10BD19 | A10BD20 | A10BD27 | A10BK03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04993339,NCT04993339_EG001,No,All,Adult | Older Adult,Phase 3,26,"Inclusion Criteria:

any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion Criteria:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners","Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention

OOC: The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels",PubChem:86290234,Octyl 4-O-Beta-D-Allopyranosyl-1-Thio-Beta-D-Altropyranoside,CCCCCCCCSC1OC(CO)C(OC2OC(CO)C(O)C(O)C2O)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
NCT05137002,NCT05137002_EG001,No,All,Adult | Older Adult,Phase 2,63,"Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;","CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)",PubChem:71535962,Baxdrostat,CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21,,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
NCT05137002,NCT05137002_EG002,No,All,Adult | Older Adult,Phase 2,62,"Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;","CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)",PubChem:71535962,Baxdrostat,CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05137002,NCT05137002_EG003,No,All,Adult | Older Adult,Phase 2,60,"Inclusion Criteria:

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
Has a body mass index (BMI) >50 kg/m2;
Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
Has documented estimated eGFR <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;
Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;
Has planned dialysis or kidney transplantation planned during the course of the study;
Prior solid organ transplant and/or cell transplants;
Sodium <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >5 mEq/L;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;","CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).

After 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) or withdraw study participation depending on BP control",PubChem:71535962,Baxdrostat,CCC(=O)NC1CCCc2c(-c3ccc4c(c3)CCC(=O)N4C)cncc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05325853,NCT05325853_EG000,Accepts Healthy Volunteers,All,Child,Phase 3,61,"Inclusion Criteria:

Pre-pubescent with no childbearing potential
Capable of undergoing an eye exam
Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
Have a healthy, normal cornea.

Exclusion Criteria:

Have participated in an investigational study (drug or device) within the past 30 days.
Have a known contraindication to local anesthetics.
Children with known autism spectrum disorders or known to have heightened sensitivity.
Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
Have low visual acuity
Manifest nystagmus
Have had ocular surgery or general surgery within the past 45 days.
Have had an intravitreal injection in either eye within 14 days of randomization.
Have ocular surface disease.","Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.

AG-920: AG-920 Sterile Topical Ophthalmic Solution",ChEMBL:CHEMBL1093 | DrugBank:DB09009 | PubChem:32170,Articaine,CCCNC(C)C(=O)Nc1c(C)csc1C(=O)OC,N01BB08 | N01BB58,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05736861,NCT05736861_EG000,No,All,Adult | Older Adult,Phase 3,817,"Inclusion Criteria:

Completed Informed Consent
Age ≥ 30 years old
Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

Exclusion Criteria:

Prior diagnosis of COVID-19 infection (> 10 days from screening)
Current or recent (within 10 days of screening) hospitalization
Current use of study drug or study drug/device combination*
Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo*
Known contraindication(s) to study drug including prohibited concomitant medications*

[If only one study drug appendix is open at the time of enrollment. If multiple study drug appendices are open, a participant may opt-out of any study drug appendix or be excluded from any study drug appendix based on contraindications listed in the study drug appendix, current use of study drug, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study drug appendices.]

Arm-specific exclusion criteria:

End-stage renal disease on renal replacement therapy
Liver failure or decompensated cirrhosis
Use of warfarin, CYP3A4, P-gp inhibitor drugs, or CYP3A4 substrates
Nursing mothers
Pregnancy","Ivermectin - 7-mg tablets

Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.

Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with ""123"" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05894538,NCT05894538_EG000,No,All,Adult | Older Adult,Phase 3,708,"Inclusion Criteria:

Completed Informed Consent
Age ≥ 30 years old
Confirmed SARS-CoV-2 infection (or reinfection) by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

Exclusion Criteria:

Current or recent (within 10 days of screening) hospitalization for COVID-19 infection
Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI)
Current or recent use (within the last 14 days) of study drug or study drug/device combination*
Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo*
Known contraindication(s) to study drug including prohibited concomitant medications (see Appendices)*

Additional Appendix-Level Exclusion Criteria:

End-stage renal disease on renal replacement therapy
Liver failure or decompensated cirrhosis
Current or planned use of the following drugs during the study, listed by drug class:
Antiarrhythmic/antihypertensive drug class: quinidine, amiodarone, diltiazem, spironolactone, verapamil
Antibiotic-macrolides drug class: clarithromycin, erythromycin
Antifungal drug class: itraconazole, ketoconazole
Immunosuppressant drug class: cyclosporine, tacrolimus
Anti-HIV drug class: indinavir, ritonavir
Nursing mothers
Pregnancy","Ivermectin - 7-mg tablets

Participant will be instructed to take a pre-specified number of tablets for 6 consecutive days based on their weight for a daily dose of approximately 400-600 µg/kg.

Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with ""123"" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.",ChEMBL:CHEMBL1200633 | DrugBank:DB00602,IVERMECTIN,[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2,D11AX22 | P02CF01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0