sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 3 ]

74

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

null

Type 2 Diabetes Mellitus

Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Metformin

null

4

arm 1: MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. arm 2: MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893 arm 3: Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893. arm 4: Placebo tablets matching the MK-0893 and placebo tablets matching metformin.

[ 0, 0, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 10 mg and 100 mg tablets intervention 2: 500 mg metformin tablets intervention 3: Placebo tablets matching MK-0893 intervention 4: Placebo tablets matching metformin

intervention 1: MK-0893 intervention 2: Metformin intervention 3: Placebo intervention 4: Placebo

0

null

0

NCT02004886

[ 4 ]

93

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the National Cholesterol Expert Panel (NCEP) III LDL-C target goal of \<2.6 mmol/L (\<100 mg/dL) for subjects with diabetes mellitus and coronary heart disease.

null

Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease

null

2

arm 1: Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet. arm 2: Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet.

[ 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 1 x 10-mg tablet, provided as blinded study treatment intervention 2: 1 x 20-mg tablet, provided as open-label study treatment intervention 3: 1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment intervention 4: 1 x 20-mg tablet, provided as blinded study treatment intervention 5: 1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment

intervention 1: Ezetimibe 10 mg intervention 2: Simvastatin 20 mg intervention 3: Ezetimibe Placebo intervention 4: Simvastatin 20 mg intervention 5: Simvastatin Placebo

0

null

0

NCT00423488

[ 3, 4 ]

118

RANDOMIZED

PARALLEL

null

2DOUBLE

false

0ALL

null

The primary objective of this study is: * To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period. The secondary objectives of this study are: * To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%; * To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and * To assess the decrease in frequency of concomitant artificial tears use.

null

Conjunctivitis, Vernal

vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin

null

3

arm 1: four times daily arm 2: four times daily arm 3: administered four times daily

[ 0, 0, 3 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Cyclosporine NOVA22007 0.05% intervention 2: Cyclosporine NOVA22007 0.1% intervention 3: Vehicle

1

Paris | N/A | France | 2.3488 | 48.85341

0

NCT00328653

[ 4 ]

91

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.

null

Hereditary Angioedema (HAE)

null

2

arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections.

intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS),

1

Wheaton | Maryland | United States | -77.05526 | 39.03983

0

NCT00262080

[ 5 ]

1,000

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

false

The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine

null

Rhinitis, Allergic, Seasonal

once daily mountain cedar fexofenadine allergic rhinitis fluticasone furoate

null

0

null

1

[ 0 ]

intervention 1: Fluticasone furoate and fexofenadine

6

0

NCT00435461

[ 4 ]

273

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

null

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

null

Type 2 Diabetes Mellitus

null

3

arm 1: sitagliptin 100 mg arm 2: rosiglitazone 8 mg arm 3: placebo

[ 0, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks. intervention 2: Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks. intervention 3: placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks. intervention 4: Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.

intervention 1: Sitagliptin intervention 2: Comparator: Rosiglitazone intervention 3: Comparator: Placebo intervention 4: Comparator: Metformin

0

null

1

NCT00541775

[ 5 ]

491

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication. Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Depression Depressive Disorder

null

3

arm 1: Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 2: Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 3: Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine

[ 0, 1, 1 ]

3

[ 5, 5, 0 ]

intervention 1: brief supportive psychotherapy intervention 2: psychotherapy developed for chronic depression intervention 3: antidepressant medication

intervention 1: Brief Supportive Psychotherapy intervention 2: CBASP intervention 3: Medication Only

8

0

NCT00057551

[ 3 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

null

Non-Small Cell Lung Cancer

Tarceva NSCLC EGFR ECOG Performance Status 2 erlotinib Non-Small Cell Lung Cancer OSI-774

null

2

arm 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy arm 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy intervention 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

intervention 1: Tarceva (Trademark) (erlotinib HCl, OSI-774) intervention 2: Combination carboplatin and paclitaxel

19

0

NCT00085839

[ 2, 3 ]

51

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.

This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC. Participants were enrolled into the Panitumumab + Paclitaxel + Carboplatin + Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms.

Lung Cancer Non-Small Cell Lung Cancer

Lung cancer, Non-small cell lung cancer, NSCLC Clinical Trial, Panitumumab, AMG 706 Anti-angiogenesis Immunex, Abgenix, Amgen Stage IIIB, Stage IV, Unresectable

null

3

arm 1: Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort and up to 125 mg once daily was used in subsequent cohorts. A cycle was defined as the 3 weeks plus the time to recover from toxicity, if encountered. arm 2: Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of motesanib was 50 mg once daily administered in the initial cohort, up to 125 mg once daily was used in subsequent cohorts. arm 3: Chemotherapy naïve participants received panitumumab administered by IV at 9.0 mg/kg on Day 1 of each 21-day cycle, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. Participants were enrolled in this arm once a safe and tolerable dose of motesanib was established.

[ 0, 0, 0 ]

4

[ 2, 0, 0, 0 ]

intervention 1: 9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes. intervention 2: Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested. intervention 3: Paclitaxel 200 mg/m\^2 administered by IV infusion over 3 hours. intervention 4: Carboplatin was administered IV over approximately 30 minutes. Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to AUC/time curve of 6 mg/mL×min.

intervention 1: Panitumumab intervention 2: Motesanib diphosphate intervention 3: Paclitaxel intervention 4: Carboplatin

0

null

0

NCT00094835

[ 3 ]

4

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemotherapy. Unfortunately, current treatment options at this stage only provide a short term response. Thus, it is important that additional therapies are investigated to manage this malignancy. Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms heterodimers with a multitude of other nuclear receptors. One of these is the PPARγ (Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2 diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL). This pilot study will investigate this possible synergism in a small cohort of patients with stable or progressive CTCL already being treated with bexarotene.

Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome

Cutaneous T-cell Lymphoma CTCL Mycosis Fungoides Sezary Syndrome Bexarotene Targretin Rosiglitazone Avandia

null

0

null

1

[ 0 ]

intervention 1: rosiglitazone added to bexarotene capsules

intervention 1: Rosiglitazone and Bexarotene

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00178841

[ 3 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

true

Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder. This may be reflective of an attempt by individuals with ADHD to self-treat symptoms. Atomoxetine is an FDA-approved drug that is used to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. The drug is in a class of medications called selective norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine, a natural substance in the brain that affects a person's attention and impulsivity. It is possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their need for cocaine. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine. Participants in this open label study will receive atomoxetine for 12 weeks, and will take one dose each morning for the duration of the study. Doses will be increased gradually to minimize side effects and enhance treatment compliance. In addition, all participants will receive individualized relapse prevention therapy once weekly. Participants will be required to report to the study site three times a week to receive medication, complete questionnaires regarding ADHD symptoms and substance use behavior, and provide a urine sample while being supervised by study staff. Also, vital signs will be monitored and medication side effects will be assessed at each visit. Participants will report to the study site 6 months after starting in the study for a follow-up visit, at which time ADHD symptoms, substance use behavior, and social functioning will be assessed.

Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders

ADHD Cocaine Abuse

null

1

arm 1: Atomoxetine

[ 0 ]

1

[ 0 ]

intervention 1: At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.

intervention 1: Atomoxetine

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00218543

[ 3 ]

290

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

null

Dry Eye Syndromes

OPC-12759 Dry eye syndromes

null

4

arm 1: 0.5% OPC-12759 (rebamipide) ophthalmic suspension arm 2: 1% OPC-12759 (rebamipide) ophthalmic suspension arm 3: 2% OPC-12759 (rebamipide) ophthalmic suspension arm 4: placebo of OPC-12759 (rebamipide) ophthalmic suspension

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: 0.5% OPC-12759 intervention 2: 1% OPC-12759 intervention 3: 2% OPC-12759 intervention 4: placebo

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00234078

[ 4 ]

530

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

null

Type 2 Diabetes Mellitus

null

2

arm 1: sitagliptin 100 mg arm 2: placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks. intervention 2: placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

intervention 1: sitagliptin phosphate intervention 2: Comparator: placebo

0

null

0

NCT00289848

[ 4 ]

261

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

null

Hypertension

null

2

arm 1: Losartan arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks. intervention 2: Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.

intervention 1: Comparator: losartan +/- HCTZ intervention 2: Comparator: Placebo

0

null

0

NCT00289887

[ 4 ]

38

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Alpha 1-Antitrypsin Deficiency

alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema

null

1

arm 1: Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects.

[ 0 ]

1

[ 0 ]

intervention 1: 60 mg/kg weekly for 20 weeks

intervention 1: alpha-1 proteinase inhibitor (human)

10

0

NCT00301366

[ 5 ]

24

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

null

This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.

Specific Aims: This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. STUDY PROCEDURES: We have designed this trial to examine effects upon weight, lipids and glucose metabolism along with positive symptoms, negative symptoms, and depressive symptoms during a six-week open label study. Location: This study will be performed at the Freedom Trail Clinic by faculty of the Schizophrenia Program of the Massachusetts General Hospital and staff of the Freedom Trail Clinic. Subjects: Subjects will include 40 outpatients with schizophrenia or schizoaffective disorder treated with clozapine or olanzapine for at least one year. Twenty clozapine-treated subjects and twenty olanzapine-treated subjects with type 2 diabetes mellitus, impaired fasting glucose, or insulin resistance will be recruited. Patients will be excluded for significant medical illness, seizure disorder, substance abuse, or inability to provide informed consent. Methods: Medication Trial: Patients will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The clozapine or olanzapine dose will be unchanged during the trial. Patients will be given a two-week supply of medication at baseline and weeks 2 and 4 with additional capsules for study drug compliance and accountability. Following completion of the trial patients will have the option of continuing the ziprasidone. Subjects will return 4 weeks following study completion to examine whether any observed changes are persistent. Additionally, patients will be assessed at a 3 month follow-up post their 10 week assessment for metabolic changes. Screening Visit The diagnosis of schizophrenia or schizoaffective disorder will be confirmed by a research psychiatrist using DSM IV criteria. A physical examination will be performed and medical history, vital signs, weight, waist/hip circumference, EKG and demographic information will be obtained. Demographic information will also include the date of onset or the duration of diabetes mellitus. Laboratory measures will include a CBC, fasting glucose, insulin, cholesterol (total, HDL and LDL), triglycerides, hemoglobin A1C and leptin. Plasma will also be obtained for assay of clozapine, norclozapine, or olanzapine concentrations at the screening visit. Baseline Assessment: The following scales will be completed at baseline and will comprise the treatment efficacy battery: Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms (SANS), Clinical Global Impression Scale (CGI), Hamilton Depression Rating Scale (HAM-D), Global Assessment Scale (GAS), Fatigue Scale Inventory (FSI) and the Quality of Life Scale (QOL). Safety Assessments: Vital signs, weight, and waist/hip circumference will be performed at each visit (weeks 0, 2, 4, 6 and 10 and at the 3 month follow-up). Side effects will be monitored at baseline and weeks 2, 4, 6 and 10 using the SAFTEE (Levine and Schooler 1986). EPS will be evaluated at baseline and weeks 2, 4, 6 and 4 week follow-up using the Simpson-Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS). EKG will be performed at baseline, weeks 2, 4, 6, and 10. A patient will be discontinued from the study if their QTc interval is greater than 450. Changes in medication will be recorded throughout the study including changes to diabetes medication (weeks 0, 2, 4, 6 and 10 and at the 3-month follow-up). Energy Expenditure and Dietary Assessment: Patients will be asked to wear an accelerometer (Actigraph model 7164) to obtain an objective measure of physical activity. This is single channel accelerometer which measures and records vertical accelerations ranging from 0.05 to 2 G's with a frequency response of 0.25 to 2.50 hertz. These parameters detect normal body motion and filter out high frequency movement such as vibrations. The accelerometer is positioned at the waist and worn for four consecutive days except during sleep or while in water (i.e. swimming or taking a shower). The raw data is then read and processed by a custom data processing program to estimate energy expenditure. Patients will be instructed to complete a four-day food record to assess dietary intake. Food records will be reviewed for completeness and analyzed using Nutrition Data System (NDS). Energy expenditure and dietary intake will be assessed at baseline, weeks 4 and 6 and at the 3 month follow-up. Subject Recruitment: The Freedom Trail Clinic has well established procedures for identifying, referring and recruiting subjects for research. Each week clinicians and research staff meet to discuss the research projects that are currently being conducted and open to enrollment. Using this information, clinicians approach their patients they deem to be appropriate for research and that meet inclusion criteria. If a patient expresses interest in participating in research, the clinician completes a Clinician Referral Form and refers the patient to the appropriate research assistant for additional information regarding the study. A member of the research team will meet with the subject and explain the study protocol, including a review of risks and potential benefits. Patients who express interest after this first meeting will be evaluated for competency to provide informed consent by a physician who is not a member of the research team. Competence to provide consent is assessed by a research psychiatrist using the Assessment of Capacity to Participate in Clinical Research form. Patients who are judged to be competent will then be asked to meet with the principal investigator who will review the study protocol and consent form with the patient and obtain informed consent. A copy of the study consent form will be provided to the patient at this time. In addition, the prospective subject must ultimately score a 100% correct score on a True/False quiz about informed consent and the study they are interested in participating in. Potential Risks: Ziprasidone did not produce any serious adverse effects in animal and human safety studies. No consistent abnormality of vital signs, laboratory, or EEG has emerged. Prolongation of the QTC on EKG has been observed with ziprasidone treatment. In clinical trials, no side effects occurred at rates greater than 2x placebo. Nausea, vomiting, anxiety, headache, dyspepsia, somnolence, orthostatic hypotension, tachycardia, insomnia, akathisia, and EPS may be potential side effects. Benefits: It is not known if ziprasidone added to clozapine or olanzapine will help a subject's mood, motivation, hallucinations, and unusual experiences. Other patients may benefit if this study finds that ziprasidone added to clozapine or olanzapine is useful for treating symptoms of schizophrenia. Protection of Human Subjects: Principal members of our research team have all completed certification for protection of human subjects in clinical trials. The clinical protocol will be submitted for approval by the institutional review boards of the Massachusetts Department of Mental Health. Potential subjects will be referred by their clinicians. Clinicians will be asked to sign a statement that verifies that the patient is interested in participating, understands that participation is voluntary, and understands that declining participation will not affect treatment at the facility. A member of the research team will meet with the patient and explain the study protocol, including a review of risks and potential benefits. A copy of the study consent form will be provided to the patient at that time to share with family members or residential staff. Patients who continue to express interest after this first meeting will be evaluated by a physician for capacity to provide informed consent. Patients who are judged to be competent will then be asked to meet with the principal investigator or co-investigator who will review the study protocol and consent form with the patient and obtain informed consent. Each subject that enrolls in the study is asked to sign an authorization to release information to their clinician. Upon consent, a letter is sent to the clinician with notification of study enrollment, the duration of the study and the dose and duration of any study medications. All laboratory work and physical assessments performed during the study are either conducted or reviewed by a research physician. Side effects and vital signs are monitored routinely by the research assistants. Should any abnormal lab values or adverse events occur during the course of the subject's participation, the research physician would be notified immediately of these values and consulted on how to proceed with patient care. Furthermore, the subject's clinician would also be informed of the results.

Schizophrenia

Schizophrenia Ziprasidone Diabetes Insulin Resistance

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Ziprasidone

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00351000

[ 2, 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12 month treatment period with Androgel.

Background: Men are less susceptible to many autoimmune diseases including multiple sclerosis (MS). Possible causes for this include sex hormones and/or sex chromosome effects. Testosterone treatment ameliorates experimental allergic encephalomyelitis (EAE), an animal model of MS, but the effect of testosterone supplementation on men with MS is not known. Design, Setting and Participants: Ten men with relapsing remitting MS were studied using a crossover design whereby each patient served as his own control. There was a six-month pretreatment period followed by a twelve month period of daily treatment with 100mg of testosterone gel. Main Outcome Measures: Brain atrophy and Cognitive testing

Multiple Sclerosis

multiple sclerosis testosterone

null

1

arm 1: 6 months pretreatment, 12 months treatment intervention with Androgel 10 grams of gel containing 100mg of testosterone

[ 0 ]

1

[ 0 ]

intervention 1: testosterone gel

intervention 1: Androgel 10 grams of gel containing 100 mg of testosterone

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00405353

[ 3 ]

237

RANDOMIZED

PARALLEL

2DIAGNOSTIC

3TRIPLE

false

0ALL

false

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Safety issues are addressed in the Adverse Events section

Brain Diseases Spinal Cord Diseases

Contrast Agents

null

3

arm 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. arm 2: Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. arm 3: Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 2: Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 3: Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 4: Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

intervention 1: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 3: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 4: OptiMARK~0.1 mmol/kg BW

27

0

NCT00862459

[ 2 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

2MALE

false

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases; Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases

Epilepsy

null

2

arm 1: Day 1 to 2: Pre-treatment 1: 600 mg ESL Day 3 to 8: Treatment 1: 1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ 100 mg PHT Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT arm 2: Day 1 to 2: Pre-treatment 2: 100 mg PHT Day 3 to 8: Treatment 2: 300 mg PHT Day 9 to 10: Treatment 2 + Pre-treatment 1: 300 mg PHT + 600 mg ESL Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BIA 2-093 intervention 2: Phenytoin

0

null

0

NCT02283827

[ 3 ]

45

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

1FEMALE

false

45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

Anesthesia

regionel anesthesia levobupivacaine ceserean section

null

3

arm 1: Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. Injection Surgical anaesthesia Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T arm 2: Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain. Indications: Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response. Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL arm 3: Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg. Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx

[ 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: this used in intratechal area and for spinal anesthesia in ceserean section intervention 2: this used in intratechal area and for spinal anesthesia in ceserean section intervention 3: this used in intratechal area and for spinal anesthesia in ceserean section intervention 4: this used in intratechal area and for spinal anesthesia in ceserean section intervention 5: this used in intratechal area and for spinal anesthesia in ceserean section

intervention 1: Levobupivacaine intervention 2: Fentanyl intervention 3: Sufentanil intervention 4: Levobupivacaine intervention 5: Levobupivacaine

0

null

0

NCT02430090

[ 4 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.

null

Anesthesia, General

null

2

arm 1: After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. arm 2: After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.

[ 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium intervention 2: Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium intervention 3: Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization. intervention 4: Propofol IV administered for induction and maintenance of anesthesia, based on randomization.

intervention 1: Sugammadex intervention 2: Rocuronium intervention 3: Sevoflurane intervention 4: Propofol

0

null

0

NCT00559468

[ 4 ]

593

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information. Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Schizophrenia

Schizophrenia Atypical antipsychotic Psychosis

null

3

arm 1: Oral iloperidone arm 2: Oral ziprasidone arm 3: Oral placebo

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Iloperidone intervention 2: Ziprasidone intervention 3: Placebo

42

0

NCT00254202

[ 4 ]

326

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

null

Bipolar Disorder

null

2

arm 1: Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (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. arm 2: Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1. intervention 2: Placebo fast dissolving SL tablets, BID

intervention 1: Asenapine intervention 2: Placebo

0

null

1

NCT00145470

[ 4 ]

149

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

null

Diabetes Mellitus, Type 2

rosiglitazone Avandia type 2 diabetes mellitus diabetes

null

1

arm 1: study drug

[ 0 ]

1

[ 0 ]

intervention 1: study drug

intervention 1: Rosiglitazone (BRL49653C)

4

Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Ōita | N/A | Japan | 131.6 | 33.23333 N/A | N/A | N/A | N/A | N/A

0

NCT00432679

[ 3 ]

200

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.

null

Anemia

null

1

arm 1: Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.

intervention 1: Epoetin Beta

27

Arezzo | N/A | Italy | 11.88068 | 43.46276 Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351 Bussolengo VR | N/A | Italy | N/A | N/A Busto Arsizio | N/A | Italy | 8.84914 | 45.61128 Casale Monferrato | N/A | Italy | 8.4525 | 45.13338 Catania | N/A | Italy | 15.07041 | 37.49223 Catanzaro | N/A | Italy | 16.60086 | 38.88247 Chieti | N/A | Italy | 14.16494 | 42.34827 Cuneo | N/A | Italy | 7.54828 | 44.39071 Fano | N/A | Italy | 13.01665 | 43.84052 Florence | N/A | Italy | 11.24626 | 43.77925 Frosinone | N/A | Italy | 13.34109 | 41.63976 Genova | N/A | Italy | 11.87211 | 45.21604 Macerata | N/A | Italy | 13.45293 | 43.29789 Messina | N/A | Italy | 15.55256 | 38.19394 Monza | N/A | Italy | 9.27246 | 45.58005 Napoli | N/A | Italy | 14.5195 | 40.87618 Nocera Inferiore | N/A | Italy | 14.64542 | 40.7454 Pavia | N/A | Italy | 9.15917 | 45.19205 Pisa | N/A | Italy | 10.4036 | 43.70853 Pordenone | N/A | Italy | 12.66051 | 45.95689 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Sassari | N/A | Italy | 8.55552 | 40.72586 Torino | N/A | Italy | 11.99138 | 44.88856 Vecchiazzano | N/A | Italy | N/A | N/A Vittorio Veneto | N/A | Italy | 12.30065 | 45.98026

0

NCT02761642

[ 3 ]

227

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

null

Rheumatoid Arthritis

arthritis joint pain Methotrexate

null

3

arm 1: Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 2: Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 3: Participants received placebo subcutaneous injections on Day 1 and at Month 6.

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: placebo subcutaneous injection intervention 2: For subcutaneous injection

intervention 1: placebo intervention 2: denosumab

0

null

0

NCT00095498

[ 4 ]

166

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow® electronic nebulizer, in CF patients with PA. In this study, participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit (Day 0). Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI TID or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow-up visit 14 days after the last dose of study drug (Day 42).

Cystic Fibrosis

Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: AZLI 75 mg three times a day (TID) intervention 2: Placebo three times a day (TID)

53

0

NCT00112359

[ 4 ]

218

NON_RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

null

Bipolar Disorder

null

2

arm 1: Asenapine 5-10 mg twice daily for 40 weeks arm 2: Olanzapine 5-20 mg once daily for 40 weeks

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Asenapine, 40 weeks intervention 2: Olanzapine, 40 weeks

intervention 1: asenapine intervention 2: Olanzapine

0

null

0

NCT00159783

[ 4 ]

169

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Superficial Basal Cell Carcinoma

Superficial Basal Cell Carcinoma Aldara

null

1

arm 1: Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks

[ 0 ]

1

[ 0 ]

intervention 1: Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks

intervention 1: Imiquimod 5% cream

18

0

NCT00189306

[ 4 ]

661

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance. All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Benign Prostatic Hyperplasia

benign prostatic hyperplasia, alpha blocker

null

1

arm 1: Silodosin 8 mg per day with food

[ 0 ]

1

[ 0 ]

intervention 1: 8 mg daily

intervention 1: Silodosin

79

0

NCT00224133

[ 0 ]

13

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro studies performed by us have shows that genistein reduces release of inflammatory compounds by human blood eosinophils. The purpose of this pilot study is to determine whether dietary supplementation with soy isoflavones has effects in patients with asthma. 20 patients with asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for airway inflammation), collect exhaled breath condensate to measure levels of inflammatory mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of soy isoflavones on their function. We hypothesize that dietary supplementation with soy isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will provide a justification for further clinical studies.

This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures: 1. Completion of a questionnaire that asks for information about asthma including symptoms, medications, and ability to participate in activities. 2. Measurement of exhaled nitric oxide (NO) in which subjects will breathe slowly into a tube. This test takes about 5 minutes. 3. Collection of the air exhaled from the lungs and condensing it into a liquid form. This is called an exhaled breath condensate. This procedure involves breathing slowing into a tube for a period of 15 minutes. The measurements determined by this method are exclusively for research purposes and not used in routine clinical settings. 4. Measurement of lung function with a spirometer. This involves breathing in and out forcefully through a mouthpiece. 5. Collection of 60 ml (4 tablespoons) of blood to measure genistein (the major component of the soy isoflavone) levels and eosinophil function. These measurements are also for research purposes and not routinely used clinically. Each of the above measurements will be made before and after the 4 week period of dietary supplementation with soy isoflavones.

Asthma

Asthma Soy isoflavones Eosinophils Exhaled nitric oxide

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Soy isoflavones

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00277446

[ 3 ]

254

NA

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, CF101 4 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for \>=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, duration of morning stiffness, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, 12, and 14.

Rheumatoid Arthritis

Rheumatoid Arthritis RA

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: CF101

35

Peoria | Arizona | United States | -112.23738 | 33.5806 Albany | New York | United States | -73.75623 | 42.65258 Cleveland | Ohio | United States | -81.69541 | 41.4995 Perrysburg | Ohio | United States | -83.62716 | 41.557 Sugar Land | Texas | United States | -95.63495 | 29.61968 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278 Afula | N/A | Israel | 35.2892 | 32.60907 Ashkelon | N/A | Israel | 34.57149 | 31.66926 Beer Yaakov | N/A | Israel | N/A | N/A Haifa | N/A | Israel | 34.99928 | 32.81303 Haifa | N/A | Israel | 34.99928 | 32.81303 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Kfar Saba | N/A | Israel | 34.90694 | 32.175 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Bialystok | N/A | Poland | 23.16433 | 53.13333 Lublin | N/A | Poland | 22.56667 | 51.25 Sopot | N/A | Poland | 18.56003 | 54.4418 Szczecin | N/A | Poland | 14.55302 | 53.42894 Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Iași | N/A | Romania | 27.6 | 47.16667 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Zemun | N/A | Serbia | 20.40116 | 44.8458 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466

0

NCT00280917

[ 4 ]

152

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes. Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial. They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.

Pain Cancer

Breakthrough Pain in Patients with Cancer

null

2

arm 1: Placebo arm 2: BioErodible MucoAdhesive (BEMA) Fentanyl

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application. intervention 2: None

intervention 1: BEMA™ intervention 2: Placebo

1

Wilmington | North Carolina | United States | -77.94604 | 34.23556

0

NCT00293033

[ 5 ]

88

RANDOMIZED

FACTORIAL

0TREATMENT

1SINGLE

true

0ALL

true

The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.

In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups: Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™ The specific aims of the pilot are: 1. In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training. 2. In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group. 3. Assess the feasibility of the recruitment, assessment and intervention strategies 4. To estimate adherence to the weight loss, exercise training, and drug interventions; 5. In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study. 6. To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.

Obesity Overweight With Indications for Weight Loss

Body Composition Sarcopenia Weight loss trials Intervention studies Elderly

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 1, 1, 1 ]

4

[ 0, 5, 5, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: Pioglitazone intervention 2: Resistance exercise training to maximize muscle power intervention 3: Hypocaloric diet intervention 4: Placebo

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00315146

[ 3 ]

12

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

true

The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.

null

Diabetes Mellitus, Type 2

Type 2 diabetes mellitus Glucose dependent insulinotropic polypeptide Sulfonylurea compounds insulin secretion Sulfonylurea receptor subunit-SUR1 Impaired incretin effect

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Sulfonylurea

1

Hellerup, Copenhagen | N/A | Denmark | N/A | N/A

0

NCT00321321

[ 0 ]

21

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease. Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.

* Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease * Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment) * Changes in markers of inflammation in the sputum samples will be assessed * Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed

Cystic Fibrosis

Prescription drugs Administration, oral Durable medical equipment Kinetics

null

1

arm 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda

[ 0 ]

1

[ 0 ]

intervention 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

intervention 1: pioglitazone

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00322868

[ 3 ]

311

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

false

This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.

null

Asthma Common Cold Picornavirus Infection Rhinovirus

null

2

arm 1: Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. arm 2: Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. intervention 2: Placebo nasal suspension

intervention 1: Pleconaril intervention 2: Placebo to Pleconaril

0

null

0

NCT00394914

[ 4 ]

147

RANDOMIZED

PARALLEL

2DIAGNOSTIC

1SINGLE

false

0ALL

false

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Central Nervous System Diseases

Gadovist Gadavist Contrast agent Brain Spine disease Magnetic Resonance Imaging

null

2

arm 1: Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) arm 2: Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW) intervention 2: 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Magnevist

4

Nanjing | Jiangsu | China | 118.77778 | 32.06167 Xi'an | Shaanxi | China | 108.92861 | 34.25833 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222

0

NCT00395460

[ 4 ]

36

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).

This is a Phase III, multicenter, randomized, double-blind, two-period cross-over, placebo-controlled study designed to compare the efficacy and safety of Ultrase® MT20 to placebo in participants with CF and pancreatic insufficiency. The study consists of a screening period (up to 11 days) and two treatment periods (6-7 days). During screening period participants will be treated with open-label Ultrase® MT18 or MT20. Each treatment period will be preceded by a stabilization period (4 days) and the two treatment periods are separated by a break period (3-6 days). A safety follow-up visit will be performed 7-10 days after discharge from the last treatment period.

Cystic Fibrosis Exocrine Pancreatic Insufficiency

Cystic Fibrosis Exocrine Pancreatic Insufficiency Ultrase® MT20

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period. intervention 2: Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.

intervention 1: Ultrase® MT20 intervention 2: Placebo

4

0

NCT00408317

[ 5 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic) triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR) techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac structure and function.

Cardiovascular disease (CVD), including congestive heart failure (CHF), accounts for over 75% of deaths among patients with diabetes. Thus, it is imperative to rigorously evaluate existing and emerging hypoglycemic therapies with regard to their cardiovascular consequences. The thiazolidinedione (TZD) class of drugs, alone or in combination with other oral hypoglycemic medications or with insulin, has emerged as a safe and effective treatment of hyperglycemia in type 2 diabetes. Both in vitro and in vivo studies have revealed favorable pleiotropic effects of TZD on myocyte and ventricular structure and function. However, approximately 10% of patients taking TZDs develop peripheral edema and some patients have developed heart failure decompensation on the drug. These observations have led to a Food and Drug Administration (FDA) warning regarding the use of TZDs in patients with or at high risk of developing congestive heart failure (CHF). The exact effects of TZDs on integrated cardiovascular performance remain unclear. The primary hypothesis of this study is that TZD treatment improves integrated cardiovascular performance in patients at risk for CHF by improving both central (i.e. cardiac output) and peripheral (i.e. vascular resistance) function. Recently, we have developed a sensitive, reproducible noninvasive assay to measure intra-cardiomyocyte fat, which varies widely in amount between individuals. The relationship between the amount of cardiomyocyte triglyceride accumulation and LV mass and function remains unclear. TZDs have been previously shown to be associated with decreases in the TG content of the liver and muscle. The secondary hypothesis being tested in this study is that TZD treatment improves cardiac function by decreasing intra-cardiac myocyte triglyceride content. Comparisons: * Peak oxygen uptake (VO2) during cardiopulmonary exercise testing in individuals randomized to rosiglitazone, compared to those on placebo. * Amount of intra-myocardial triglycerides using NMR techniques in in individuals randomized to rosiglitazone, compared to those on placebo.

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 2 Congestive Heart Failure Cardiopulmonary exercise testing intracellular cardiomyocyte triglycerides thiazolidinedione rosiglitazone nuclear magnetic resonance

null

2

arm 1: 4mg titrated to 8mg daily arm 2: blinded matching placebo treatment

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 6 months of treatment of blinded study drug intervention 2: blinded treatment with matching placebo

intervention 1: rosiglitazone intervention 2: placebo

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00424762

[ 5 ]

26

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

null

Asthma

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks intervention 2: Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks

intervention 1: Asmanex twisthaler intervention 2: Placebo for Asmanex twisthaler

0

null

0

NCT00442351

[ 5 ]

38

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 \& 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia. Specific aims: 1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo. 2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo. 3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo. 4. Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group. 5. Assess effects of weekly D-cycloserine dosing on positive \& negative symptoms at week 8 compared to placebo. 6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo. 7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo. 8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Schizophrenia

schizophrenia cognition d-cycloserine memory

null

2

arm 1: 50 mg d-cycloserine arm 2: 50 mg placebo

[ 0, 2 ]

1

[ 0 ]

intervention 1: 50mg dose d-cycloserine v placebo

intervention 1: d-cycloserine

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00455702

[ 2, 3 ]

21

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC \< 2x10\^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (\<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Lupus Nephritis

Lupus nephritis Deoxyspergualin Immunosuppression

null

1

arm 1: NKT-01

[ 0 ]

1

[ 0 ]

intervention 1: SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.

intervention 1: NKT-01

6

Prague | N/A | Czechia | 14.42076 | 50.08804 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Mannheim | N/A | Germany | 8.46694 | 49.4891 Regensburg | N/A | Germany | 12.10161 | 49.01513

0

NCT00709722

[ 4 ]

210

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

true

0ALL

false

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Diarrhea

TD traveller's diarrhea campylobacter shigella salmonella E. coli diarrhea

null

2

arm 1: Rifaximin arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Rifaximin intervention 2: Placebo

1

Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738

0

NCT00742469

[ 2 ]

26

RANDOMIZED

CROSSOVER

5SCREENING

0NONE

true

0ALL

null

* Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions. * Clinical Design: * Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.

null

Healthy

null

2

arm 1: tablet containing 25 mg of topiramate (Torrent Pharmaceuticals) arm 2: tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)

[ 0, 1 ]

1

[ 0 ]

intervention 1: Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

intervention 1: Topiramate

1

Saint Charles | Missouri | United States | -90.48123 | 38.78394

0

NCT00939692

[ 3 ]

47

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.

null

Acute Low Back Pain

Back Pain

null

1

arm 1: 1 Tramadol Contramid® OAD 200mg tablet daily.

[ 0 ]

1

[ 0 ]

intervention 1: 1 Tramadol Contramid® OAD 200mg tablet daily.

intervention 1: Tramadol Contramid® OAD 200mg

0

null

0

NCT00952068

[ 2 ]

36

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Healthy

Healthy Bioequivalence Post-Menopausal

null

2

arm 1: Estradiol/Norethindrone acetate 1/0.5 mg Tablets arm 2: Activella® 1/0.5 mg Tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1/0.5 mg Tablets intervention 2: 1/0.5 mg Tablets

intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT01157182

[ 4 ]

83

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Randomized subjects treated for a qualifying attack were eligible to receive rescue dosing with 1,000 U of C1INH-nf if they did not achieve beginning of substantial relief of the defining symptom within 4 hours after initial treatment with blinded study drug, or if at any time the attack progressed to include airway compromise. A second 1,000 U rescue dose was permitted 60 minutes after the initial rescue dose, if necessary. The study design also allowed for administration of open-label C1INH-nf for laryngeal angioedema attacks, which were non-randomizable events due to the presence of or potential for airway compromise (immediate 1,000 U dose of C1INH-nf, repeated after 60 minutes, if necessary). In addition, subjects were eligible to receive open-label C1INH-nf (1,000 U single dose) prior to emergency surgical (non-cosmetic) procedures. A total of 83 subjects were enrolled in the study. Seventy-one (71) subjects experienced qualifying attacks and were randomized to blinded study drug (36 C1INH-nf, 35 placebo); only the 71 randomized subjects were analyzed for efficacy. An additional 12 subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. Of the 35 subjects randomized to placebo, 23 also received C1INH-nf (eg, rescue, open-label). In total, 83 subjects received at least 1 dose of study drug and were analyzed for safety; 71 subjects were exposed to C1INH-nf (59 randomized, 12 open-label only) and 12 subjects were exposed only to placebo.

Hereditary Angioedema

Hereditary angioedema HAE C1 esterase inhibitor (human) C1INH-nf

null

2

arm 1: 1,000 Units (U) of C1INH-nf administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. arm 2: Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.

[ 0, 2 ]

2

[ 2, 0 ]

intervention 1: None intervention 2: None

intervention 1: C1 esterase inhibitor [human] (C1INH-nf) intervention 2: Placebo (saline)

37

0

NCT00289211

[ 3 ]

1,415

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

false

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

null

Sepsis

severe sepsis septic shock Gram-negative infection phospholipid emulsion

null

0

null

2

[ 0, 10 ]

intervention 1: None intervention 2: None

intervention 1: Intravenous GR270773- Phospholipid Emulsion intervention 2: Placebo

390

0

NCT00089986

[ 5 ]

116

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.

Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms. Participants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. After 11/2005, no additional patients will be assigned to olanzapine treatment. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.

Schizophrenia

Psychotic Disorders Schizophreniform Disorder

null

3

arm 1: oral olanzapine 5-20mg per day for up to 52 weeks arm 2: oral risperidone 0.5mg to 6mg daily for up to 52 weeks arm 3: oral molindone from 10-140mg/daily for up to 52 weeks

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: oral risperidone 0.5mg to 6mg daily for up to 52 weeks intervention 2: oral olanzapine 5-20mg per day for up to 52 weeks intervention 3: oral molindone from 10-140mg/daily for up to 52 weeks

intervention 1: Risperidone intervention 2: Olanzapine (enrollment closed in this treatment) intervention 3: Molindone

4

0

NCT00053703

[ 4 ]

1,172

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

The duration of treatment is 104 weeks.

Diabetes Mellitus, Type 2

null

2

arm 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. arm 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. intervention 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

intervention 1: sitagliptin (MK0431) intervention 2: Comparator: glipizide

0

null

0

NCT00094770

[ 4 ]

312

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.

null

Major Depressive Disorder

Major Depressive Disorder Depression Adolescents Escitalopram Pediatrics

null

2

arm 1: Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks arm 2: Placebo once daily for up to 8 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks intervention 2: Placebo once daily for up to 8 weeks

intervention 1: Escitalopram intervention 2: Placebo

28

0

NCT00107120

[ 5 ]

551

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States. This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Keratosis

actinic keratosis lesions large head torso extremities actinic keratosis

null

1

arm 1: Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.

[ 0 ]

1

[ 0 ]

intervention 1: imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles

intervention 1: imiquimod cream

32

0

NCT00116649

[ 4 ]

771

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

null

Bacterial Pneumonia

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Telavancin 10 mg/kg/day IV for up to 21 days intervention 2: Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days

intervention 1: Telavancin intervention 2: Vancomycin

1

Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096

0

NCT00124020

[ 3 ]

142

NA

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

false

The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using \[123I\]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.

All subjects will be imaged at the Institute for Neurodegenerative Disorders. Subjects will be evaluated sequentially with \[123I\]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had \[123I\]ß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study. Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer. On the first day participants are injected with \[123I\]ß-CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions. Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Parkinson Disease

parkinson brain imaging

null

1

arm 1: To assess\[123I\]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed.

[ 0 ]

1

[ 0 ]

intervention 1: To assess \[123I\]B-CIT SPECT imaging

intervention 1: [123I]B-CIT SPECT imaging

0

null

0

NCT00134784

[ 3 ]

81

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the brain. NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models, as well as lessen conditioned cocaine cues. The purpose of this study is to determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine dependent individuals. In addition, this study will determine whether memantine produces better results than a placebo in decreasing cocaine craving, psychological symptoms, functional impairment, and discontinuation of treatment in cocaine dependent individuals.

Memantine is a non-competitive NMDA receptor antagonist that works by decreasing normal excitement in the brain. Dopamine plays a role in the rewarding and addictive properties of cocaine, however, past clinical studies have not been successful in using dopamine agonists in treating cocaine dependent individuals. Non-competitive NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models and lessen conditioned cocaine cues. This study will evaluate memantine in treating cocaine dependent individuals and its ability to prevent relapse to cocaine use. Specifically, the aim of this study is to determine if memantine is superior to placebo in decreasing cocaine craving, psychological symptoms, functional impairment, and discontinuation of treatment for cocaine abuse. Participants will enter a 2-week, single-blind, placebo lead-in phase, during which they will visit the clinic three times each week. At each study visit, urine samples and other rating assessments will be collected. In addition, participants will attend weekly therapy sessions. In order to continue in the trial, participants are required to attend at least four out of the first six study visits and both therapy sessions. Eligible participants will then be randomly assigned to receive either memantine or placebo for the duration of the 12-week, double-blind phase of the trial. Study visits will continue to occur three times each week; participants will also receive weekly therapy. Memantine will be taken twice each day. Participants who complete the 12-week trial will enter a 2-week lead-out phase, during which they will be tapered back to a placebo in a single-blind manner. Weekly psychotherapy sessions will continue until the end of Week 14.

Cocaine-Related Disorders

Cocaine dependence treatment memantine

null

2

arm 1: Memantine arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Memantine intervention 2: placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00134901

[ 5 ]

548

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

0ALL

true

Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, \> 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.

Diabetes incidence is increasing rapidly in the United States. Diabetes increases the risk for CVD, the major cause of death in diabetic individuals. The conventional cardiovascular risk factors of hyperlipidemia and hypertension add to the progression of diabetic vascular disease. Appropriate treatment targets for LDL-C and blood pressure in diabetic individuals are currently being debated. The Stop Atherosclerosis in Native Diabetics Study is a randomized, open label, 3-year, clinical trial to examine the effects of aggressive LDL-C (goal \< 70 mg/dL) and BP (goal \< 115/75 mm Hg) reduction versus the standard goals of \< 100 mg/dL for LDL-C and \< 130/85 mmHg for BP. Five hundred forty-nine American Indian men and women \> age 40 with type 2 diabetes were randomized to one of two groups. Lipids and BP are managed using FDA-approved medications in an algorithmic approach. The presence and progression of atherosclerosis are evaluated by carotid ultrasonography; echocardiography assesses cardiac function. The primary endpoint is the composite outcome of change in carotid artery intimal medial thickness and fatal/nonfatal cardiovascular events. These outcomes are combined by using a ranked analysis for carotid thickness and assigning a "worst rank" for a cardiovascular event. Secondary endpoints include carotid plaque score, left ventricular geometry and function, serum CRP, and safety measures. Unique aspects of the study design and analysis plan involve changes during the trial of LDL-C treatment goals for participants with baseline or incident CVD in the conventional group, because of changes in the standard of care, and the use of a composite outcome. Study results will be valuable in understanding the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all U.S. populations and will provide evidence for determining optimal LDL-C and BP treatment goals for diabetic patients.

Cardiovascular Disease Hypertension Hyperlipidemia Diabetes Carotid Atherosclerosis

lowering LDL and BP below current targets LDL cholesterol treatment blood pressure treatment carotid intimal medial thickness prevent progression of CVD

null

2

arm 1: Standard Treatment for blood pressure and cholesterol arm 2: FDA approved drugs to treat blood pressure and cholesterol

[ 4, 1 ]

1

[ 0 ]

intervention 1: None

intervention 1: FDA approved drugs to treat blood pressure and cholesterol

4

0

NCT00147251

[ 0 ]

31

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.

Study Procedures: This study will be a double-blind placebo-controlled 5-week trial. Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (including the SCID-Mini, HAM-D, BPRS, and CGI-S), a physical exam, and blood and urine analyses. Clinical laboratory assessments include a serum pregnancy test (for all females), comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, urine toxicology, and electrocardiogram. If subjects are found to be eligible, they will be asked return within two weeks of their eligibility screening visit to begin the study. Additionally, they will be asked to keep a diary of their sleep pattern for 1 week prior to entering the study and for the entire 5 week duration of the study. On the day before beginning study medication (Study Day 0), patients will be administered the HAM-D, BPRS, CGI-S, CGI-I and neuropsychological tests, and vitals will be obtained. Patients will also undergo an afternoon blood draw, with a blood sample taken each hour beginning at 1:00PM and ending at 4:00PM, in order to assess baseline cortisol levels. Patients will then be given a 4-day supply of double-blind study medication (either 24 100mg mifepristone tablets or 24 placebo tablets) with instructions to self-administer 6 tablets each morning. Patients will return on Day 4 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will then receive an additional 3-day supply of double-blind study medication (either 18 100mg mifepristone tablets or 18 placebo tablets with instructions to orally self-administer 3 tablets each morning. Patients will return on Day 7 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will also repeat clinical laboratory assessments (including a serum pregnancy test for all females, comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, and urinary analysis) and ECG, and repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels. They will also be administered the HAM-D, BPRS, CGI-S, and CGI-I. Patients will return after one week (Day 14) for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. Patients will also repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels. Patients will also return on Day 28 and Day 35 for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. All female patients will undergo serum pregnancy testing on Day 35. In addition, all patients will be asked turn in their sleep diary to the research staff and will receive a neuropsychological test on day 35. During the study, patients will be monitored for adrenal insufficiency and signs of Cushingnoid effects by monitoring blood pressure, pre-treatment (eligibility) and post-treatment (Day 7) metabolic panels (including measures of glucose and potassium), and monitoring of any changes that occur during the study. Women with child-bearing potential are required to use a double-barrier method to prevent pregnancy during the study and for 30 days after the study. The double-barrier method includes 2 of the following methods of contraception: spermicidal foam, condom diaphragm, or IUD. Women of child-bearing potential are defined as women, 18 years of age or older, who have not been diagnosed by their primary care physician or gynecologist with menopause, and who have an intact uterus. Women not of child-bearing potential are defined as women, 18 years of age or older, who are status post hysterectomy or have been diagnosed by their primary care physician or gynecologist with menopause (as clinically defined by examination and results of FSH/LH blood work). After the study, subjects will be referred for follow-up care as needed. Subjects will not be paid for their participation in this protocol.

Depression

null

2

arm 1: Patients received mifepristone for 6 days arm 2: Patients received placebo for 6 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Glucocorticoid antagonist intervention 2: Inactive placebo tab

intervention 1: Mifepristone intervention 2: Placebo Oral Tablet

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00186056

[ 2, 3 ]

38

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The aims of this protocol are: 1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer: 2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.

Rationale: The standard treatment for pancreatic cancer is gemcitabine. This study combines gemcitabine with etanercept, a drug that binds with tumor necrosis factor (TNF) molecules and blocks their activity through inhibiting their interaction with cell surface TNF receptors. TNF is the name for a protein in the body that often helps fight foreign substances. However, research suggests that pancreatic tumors develop resistance to TNF and then use it to support cancer growth. Combining etanercept, a TNF inhibitor, with gemcitabine is a novel approach to advanced pancreatic cancer. Because etanercept has not been tested in combination with gemcitabine, a Phase I study will be conducted first to identify the safest dosage of etanercept, and then a Phase II study will evaluate the efficacy of this combination. Purpose: This study is evaluating the safety of etanercept and gemcitabine for advanced pancreatic cancer in Phase I, and the efficacy of etanercept and gemcitabine for this condition in Phase II. TNF and other inflammatory markers will also be measured in the study. Treatment: Patients in this study will receive gemcitabine and etanercept. Gemcitabine will be administered through an intravenous infusion weekly for seven weeks followed by one week of rest. Additional treatments with gemcitabine will be given for three weeks followed by one week of rest. Patients will administer etanercept to themselves through a small injection underneath the skin twice each week. Six patients will initially be enrolled in Phase I. If severe side effects appear in at least two patients in Phase I, then additional patients will be enrolled and treated with lower dosages of gemcitabine. When the treatments do not produce unacceptable side effects, the Phase I portion of the study will end and Phase II will begin enrolling patients. Patients in the Phase II portion of the study will also receive gemcitabine and etanercept at the safest dosages identified in Phase I. Several tests and exams will be given throughout both portions of the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Pancreatic Neoplasms Adenocarcinoma

Advanced Stage Chemotherapy Naive

null

2

arm 1: Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine. arm 2: Patients with pancreatic cancer for which treatment with gemcitabine as a single agent is planned will be asked to participate in this trial as a control group.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment. intervention 2: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.

intervention 1: Gemcitabine intervention 2: Etanercept

1

Columbus | Ohio | United States | -82.99879 | 39.96118

0

NCT00201838

[ 4 ]

390

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Takeda is developing alogliptin (SYR-322) for patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. The aim of the current study is to evaluate the efficacy of alogliptin in combination with insulin in subjects who are inadequately controlled on insulin alone (with or without metformin). Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Diabetes Mellitus

Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.

intervention 1: Alogliptin and insulin intervention 2: Alogliptin and insulin intervention 3: Insulin

60

0

NCT00286429

[ 2 ]

9

NON_RANDOMIZED

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

false

This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium \[111-In\]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.

Subjects received a single infusion of 111-In-CMD-193 on Day 1. Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. Subjects were evaluated for safety for 3 hours post-infusion on Day 1 of each cycle, with subsequent safety assessments performed on Days 8 and 15. Blood for human anti-human antibody (HAHA) response was collected pre-infusion, prior to each subsequent cycle (every 3 weeks) and at study discontinuation. CMD-193 was administered on Day 1 of each subsequent 21-day cycle as a 60 (± 5) minute intravenous (IV) infusion at a dose of 1.0 mg/m\^2 in Cohort 1 and 2.6 mg/m\^2 in Cohort 2. Each subject received up to 6 cycles of CMD-193 (including the initial infusion of 111-In-CMD-193) until disease progression, unacceptable toxicity, or withdrawal of consent. Up to 6 additional cycles of CMD-193 were permitted if approved by the Sponsor in subjects who tolerated CMD-193 treatment and had evidence of response. Pretreatment medications (e.g., paracetamol, promethazine hydrochloride) were to be administered to reduce the incidence and severity of an anticipated infusion syndrome characterized by fever and chills, and less commonly hypotension. Restaging by computed tomography (CT) scan was performed at the end of Cycles 2, 4, and 6. Assessment of tumor metabolism was performed by positron emission tomography with 18F-labeled fluorodeoxyglucose (18F-FDG-PET) prior to Cycle 1 and at the time of restaging at the end of Cycles 2 and 4.

Neoplasms

null

2

arm 1: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m\^2 on Day 1 of subsequent 21-day cycles. arm 2: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m\^2 on Day 1 of subsequent 21-day cycles.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes. intervention 2: CMD-193 was administered as an IV infusion over 60 (± 5) minutes.

intervention 1: 111-Indium-CMD-193 intervention 2: CMD-193

2

0

NCT00293215

[ 3 ]

1,737

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

0ALL

null

The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV). This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1. This protocol posting deals with objectives \& outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

null

Malaria

null

8

arm 1: Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. arm 2: Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. arm 3: Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. arm 4: Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. arm 5: Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. arm 6: Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. arm 7: Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. arm 8: Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.

[ 0, 0, 0, 0, 1, 1, 1, 1 ]

6

[ 2, 2, 2, 2, 0, 0 ]

intervention 1: IM injection in the deltoid muscle intervention 2: IM injection in the deltoid muscle intervention 3: IM injection in the deltoid muscle intervention 4: IM injection in the deltoid muscle intervention 5: 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance intervention 6: 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

intervention 1: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 intervention 2: Engerix™-B intervention 3: Hiberix® intervention 4: Prevnar™ intervention 5: sulfadoxine-pyrimethamine intervention 6: amodiaquine

1

Maputo | N/A | Mozambique | 32.58322 | -25.96553

0

NCT00323622

[ 5 ]

142

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

null

HIV Infections

null

1

arm 1: Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: As prescribed intervention 2: As prescribed intervention 3: 90mg sc bid

intervention 1: Background ARVs intervention 2: PI intervention 3: enfuvirtide [Fuzeon]

38

0

NCT00326963

[ 3 ]

71

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 \[NCT00245765\] and Week 12 of re-treatment in this study.

null

Psoriasis

Moderate to severe chronic plaque psoriasis anti TNF α CDP 870 Cimzia® certolizumab pegol retreatment

null

2

arm 1: Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. arm 2: Subcutaneous injections of 400 mg every 2 weeks.

[ 0, 0 ]

1

[ 0 ]

intervention 1: * Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use * Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by * 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10 * 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10

intervention 1: Certolizumab Pegol (Cimzia®)

14

Besançon | N/A | France | 6.01815 | 47.24878 Créteil | N/A | France | 2.46569 | 48.79266 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Pierre-Bénite | N/A | France | 4.82424 | 45.70359 Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Essen | N/A | Germany | 7.01228 | 51.45657 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Hamburg | N/A | Germany | 9.99302 | 53.55073 Kiel | N/A | Germany | 10.13489 | 54.32133 Mahlow | N/A | Germany | 13.40954 | 52.36017 Mainz | N/A | Germany | 8.2791 | 49.98419 Münster | N/A | Germany | 7.62571 | 51.96236

0

NCT00329303

[ 4 ]

522

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare the efficacy and safety of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).

Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

Pneumonia

Pneumonia Respiratory Infection Infectious Advanced Life Sciences Lung Pulmonary Cethromycin Clarithromycin Biaxin

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Cethromycin 300 mg once per day (QD) for 7 days, administered orally intervention 2: Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

intervention 1: Cethromycin intervention 2: Clarithromycin

13

0

NCT00336544

[ 4 ]

789

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

null

Overactive Bladder

OAB, anticholineric, oxybutynin, urge urinary incontinence

null

2

arm 1: Oxybutynin topical gel arm 2: placebo topical gel

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: 1 application daily to skin for 12 weeks intervention 2: 1 application daily to skin for 12 weeks

intervention 1: Oxybutynin topical gel intervention 2: Placebo topical gel

63

0

NCT00350636

[ 4 ]

158

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

null

Epilepsy

Epilepsy Keppra® XR Levetiracetam XR Extended release

null

2

arm 1: Keppra® extended release formulation -XR arm 2: placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 500mg extended release oral tablet, 2 tablets once daily intervention 2: oral tablets, 2 tablets once daily

intervention 1: Keppra® extended release formulation - XR intervention 2: Placebo

34

Curitiba | N/A | Brazil | -49.27306 | -25.42778 Kuopio | N/A | Finland | 27.67703 | 62.89238 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Chennai | N/A | India | 80.27847 | 13.08784 Chennai | N/A | India | 80.27847 | 13.08784 Gandhinagar | N/A | India | 72.68333 | 23.21667 Hyderabad | N/A | India | 78.45636 | 17.38405 Hyderabad | N/A | India | 78.45636 | 17.38405 Lucknow | N/A | India | 80.92313 | 26.83928 Madurai | N/A | India | 78.11953 | 9.919 Mumbai | N/A | India | 72.88261 | 19.07283 Mumbai | N/A | India | 72.88261 | 19.07283 Visakhapatnam | N/A | India | 83.20161 | 17.68009 Aguascalientes | N/A | Mexico | -102.2843 | 21.88262 Distrio Federal | N/A | Mexico | N/A | N/A Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Puebla City | N/A | Mexico | -98.20723 | 19.04778 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Umhlanga | N/A | South Africa | 31.08583 | -29.72528 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Poltava | N/A | Ukraine | 34.55367 | 49.58925

0

NCT00368069

[ 3 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Multiple Myeloma

Multiple Myeloma Stem cell mobilization apheresis

null

1

arm 1: Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.

[ 0 ]

1

[ 0 ]

intervention 1: Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected.

intervention 1: plerixafor

2

0

NCT00396383

[ 0 ]

12

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

0ALL

false

The main purpose of this study is to examine the effect of tipranavir combined with ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks before study entry.

A large number of people with HIV-infection obtained HIV through injection drug use. Some of these people are currently being treated with buprenorphine/naloxone (BUP) for their addiction and with medications for HIV infection. Tipranavir is a medication that was recently approved by the Food and Drug Administration (FDA) for the treatment of HIV-infection. Tipranavir is given in combination with another HIV medication, ritonavir. Tipranavir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system. Ritonavir acts by increasing the amount of tipranavir available to fight HIV. Earlier studies looking at the combination of BUP and HIV medications have shown that BUP and some HIV medications act differently when taken together. It is important to learn if taking BUP and HIV medications together results in changes in the blood level of either medication. If the HIV medication decreases the level of BUP in the blood, an individual taking BUP and HIV medications may experience symptoms of withdrawal ("dope sickness"), even while taking their usual dose of BUP. On the other hand, if BUP decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if tipranavir/ritonavir and BUP will affect each other when taken together. In order to learn about the effects of BUP on tipranavir/ritonavir, we will need to measure the amount of BUP in your blood for 24 hours after you have taken tipranavir/ritonavir and BUP together and then compare that to the amount of BUP in your blood when you are not taking tipranavir/ritonavir.

HIV Infections

HIV Pharmacokinetics Buprenorphine Tipranavir HIV Seronegativity

null

1

arm 1: None

[ 5 ]

1

[ 0 ]

intervention 1: After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days.

intervention 1: Buprenorphine, Tipranavir and ritonavir

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00486330

[ 4 ]

285

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

null

Other Osteoporosis

null

2

arm 1: Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years arm 2: 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: one placebo once a week for two years followed by one 35 mg risedronate once a week for two years intervention 2: one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years

intervention 1: Placebo tablet intervention 2: Risedronate

23

Palm Desert | California | United States | -116.37697 | 33.72255 Lakewood | Colorado | United States | -105.08137 | 39.70471 Stuart | Florida | United States | -80.25283 | 27.19755 St Louis | Missouri | United States | -90.19789 | 38.62727 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Portland | Oregon | United States | -122.67621 | 45.52345 Wyomissing | Pennsylvania | United States | -75.96521 | 40.32954 Concord | N/A | Australia | 151.10381 | -33.84722 Heidelburg | N/A | Australia | N/A | N/A Leuven | N/A | Belgium | 4.70093 | 50.87959 Prague | N/A | Czechia | 14.42076 | 50.08804 Angers | N/A | France | -0.55202 | 47.47156 Lyon | N/A | France | 4.84671 | 45.74846 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Beirut | N/A | Lebanon | 35.50157 | 33.89332 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Bialystok | N/A | Poland | 23.16433 | 53.13333 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 London | N/A | United Kingdom | -0.12574 | 51.50853 Newcastle | N/A | United Kingdom | -5.88979 | 54.21804 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297

0

NCT00619957

[ 4 ]

327

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.

null

Rheumatoid Arthritis

Rheumatoid Arthritis RA Infliximab TA-650 Remicade

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. intervention 2: 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. intervention 3: 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

intervention 1: TA-650 3 mg/kg intervention 2: TA-650 6 mg/kg intervention 3: TA-650 10 mg/kg

0

null

0

NCT00691028

[ 3 ]

176

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.

null

Psoriasis

null

4

arm 1: Talarozole 0.5 mg arm 2: Talarozole 1.0 mg arm 3: Talarozole 2.0 mg arm 4: Talarozole matching Placebo

[ 1, 1, 1, 2 ]

1

[ 0 ]

intervention 1: Oral Capsule Once Daily

intervention 1: Talarozole

22

Augsburg | N/A | Germany | 10.89851 | 48.37154 Berlin | N/A | Germany | 13.41053 | 52.52437 Dresden | N/A | Germany | 13.73832 | 51.05089 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Hamburg | N/A | Germany | 9.99302 | 53.55073 Salzwedel | N/A | Germany | 11.1525 | 52.85435 Cork | N/A | Ireland | -8.47061 | 51.89797 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Korolyov | N/A | Russia | 37.82556 | 55.91417 Lipetsk | N/A | Russia | 39.57076 | 52.60311 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Veliky Novgorod | N/A | Russia | 31.27104 | 58.52131 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Amersham | N/A | United Kingdom | -0.61667 | 51.66667 Coventry | N/A | United Kingdom | -1.51217 | 52.40656 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Norwich | N/A | United Kingdom | 1.29834 | 52.62783

0

NCT00716144

[ 4 ]

221

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.

Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain. Objective: To examine the efficacy and safety of HDC medication vs. placebo in the treatment of chronic low back pain considering constitution and diathesism in a double-blind, randomized controlled clinical trial.

Low Back Pain

low-back pain chronic constitution diathesism homoeopathy fixed combination herbal preparation chronic low back pain lasting more than 6 months

null

2

arm 1: HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. arm 2: 10 drops t.i.d. for 15 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks. intervention 2: 10 drops, t.i.d, 15 weeks

intervention 1: HDC intervention 2: Placebo solution

1

Hattingen | N/A | Germany | 7.18557 | 51.39894

0

NCT01049373

[ 3 ]

18

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).

This is a pilot study to determine if oral administration of low doses of Interferon alpha might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that damages the lungs leading to marked decreases in the quality of life and death within 3-5 years after diagnosis. The cause is unknown. The standard treatment has for some time been steroids such as prednisone or prednisolone because of their anti-inflammatory actions, but there is little evidence that steroids either improve the condition, prevent further deterioration or improve life expectancy. Additionally, they have many side effects. In this disease, normal cells are damaged for unknown reasons and replaced by a type of scar. This scar tissue prevents the easy movement of oxygen from the lungs into the blood, making it difficult for the patient to perform normal activities. With progression, which usually occurs rapidly, patients require supplemental oxygen to perform even simple tasks. Interferons are chemicals normally produced in the body and the rate of their production has been shown to be reduced in the lungs of patients with IPF. They are involved in regulating the activity of the immune system which may play a role in initiating the damage to the lungs in IPF and they also can inhibit the activity of the cells that form the scar tissue. Our hypothesis is that treating patients with interferon might prevent damage to additional normal tissue and prevent the formation of additional scar tissue. This would prevent progression, improve the quality of life and extend the expected life span if successful. Another study has been ongoing in which IPF patients have been given injections of large doses of another type of interferon. This treatment regimen is expensive and side effects have been fairly frequent. In contrast, we are treating IPF patients with low doses of interferon administered orally. The interferon is taken three times per day by letting a lozenge dissolve in the mouth. These low doses have been shown to produce effects in patients with other diseases and they produce very few side effects. If side effects occur, they usually are not severe and go away quickly. Those reported most commonly by other subjects have been headaches, nausea, rashes, respiratory infections, sore throat or diarrhea. No one has had to stop taking the medicine because of the side effects. The medicine is provided free of charge. This study has been going on for about 5 years. The subjects are given the same tests that they receive as part of their standard of care. These include chest x-rays, High Resolution CT scans, pulmonary function tests and some blood tests. They are done before starting interferon alpha, and, depending on the test, are repeated at 3-, 6-, 9- or 12 month intervals. In addition subjects are asked to complete questionnaires on the quality of life, cough history and a dyspnea index at each visit.

Respiratory Tract Diseases Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Interferon alpha

null

0

null

1

[ 0 ]

intervention 1: dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year

intervention 1: Interferon alpha oral lozenge

1

Lubbock | Texas | United States | -101.85517 | 33.57786

0

NCT01442779

[ 2 ]

50

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under Fed Condition.

Healthy

null

2

arm 1: Torrent's Zolpidem TartrateTablets 10 mg arm 2: Sanofi-Synthelabo Inc's Ambient® Tablets 10 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Zolpidem Tartrate Tablets 10 mg intervention 2: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg

1

Mumbai | Maharashtra | India | 72.88261 | 19.07283

0

NCT00939367

[ 2 ]

15

NON_RANDOMIZED

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

false

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned. Patients, with advanced or metastatic solid tumor previously treated with a non cumulative dose of doxorubicin (\<300 mg/sqm in order to allow an adequate number of cycles) or chemotherapy naïve will be enrolled.

Cancer

NGR-hTNF doxorubicin solid tumors

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: 0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks intervention 2: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)

intervention 1: NGR-hTNF intervention 2: Doxorubicin

4

Rozzano | Milan | Italy | 9.1559 | 45.38193 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 9.18951 | 45.46427 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425

0

NCT00305084

[ 3 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.

Pulmonary Disease, Chronic Obstructive

Chronic Obstructive Pulmonary Disease (COPD) COPD

null

4

arm 1: Twice daily in the morning. arm 2: Twice daily in the morning. arm 3: Twice daily. arm 4: Twice daily

[ 1, 1, 1, 2 ]

2

[ 0, 10 ]

intervention 1: GW642444H intervention 2: Placebo administered twice daily

intervention 1: GW642444 intervention 2: Placebo

14

Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Nedlands | Western Australia | Australia | 115.8073 | -31.98184 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Weinheim | Baden-Wurttemberg | Germany | 8.66697 | 49.54887 Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 Geesthacht | Schleswig-Holstein | Germany | 10.3779 | 53.43575 Breda | N/A | Netherlands | 4.77596 | 51.58656 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Tauranga | N/A | New Zealand | 176.16667 | -37.68611 Bucharest | N/A | Romania | 26.10626 | 44.43225 Iași | N/A | Romania | 27.6 | 47.16667

0

NCT00372112

[ 3 ]

33

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Objectives: The primary objective of this trial was to evaluate the patients response rate at the end of the study. Patients were considered responder if one of the following conditions occurs: * Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. Secondary objectives: * to evaluate the endogenous cortisole production after receiving the study treatment * to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment * to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis * to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.

This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) . Once the patient was deemed eligible for the study, the treatment plan was selected as follows In the Dexamethasone arm (DEX 21-P): * steroid-dependant patients: one treatment procedure every 30 days up to a total of 6 procedures * mesalazine refractory active UC patients: one treatment procedure every 15 days up to a total of 3 procedures. In the placebo arm: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P. The planned duration of individual patient participation in the study was a maximum of 6 or 28 weeks, depending from the assigned treatment scheme.

Ulcerative Colitis

Ulcerative colitis Steroid-dependency Steroid adverse events Erythrocytes

null

2

arm 1: In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously loaded with Dex 21-P. arm 2: In this arm placebo solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively. Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo a total of 3 procedures at 15 days interval. Every procedure implies the collection and re-infusion of autologous erythrocytes previously NOT loaded with Dex21-P.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter. intervention 2: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P

intervention 1: Dex 21-P intervention 2: Placebo

1

San Giovanni Rotondo | N/A | Italy | 15.7277 | 41.70643

0

NCT01171807

[ 3 ]

32

RANDOMIZED

CROSSOVER

0TREATMENT

null

false

0ALL

false

This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic range.

null

Rhinitis, Allergic, Seasonal

Seasonal allergic rhinitis, hayfever

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: GSK256066

1

Berlin | N/A | Germany | 13.41053 | 52.52437

0

NCT00464568

[ 2 ]

24

RANDOMIZED

CROSSOVER

4SUPPORTIVE_CARE

0NONE

true

0ALL

false

Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects.

null

Healthy Subjects

null

3

arm 1: Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions. arm 2: Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state. arm 3: Hydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state.

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Humibid® 1200 mg (single extended release) tablet intervention 2: Hydrocodone Bitartrate (3.33 mg q4h X 3) intervention 3: Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)

intervention 1: Humibid® intervention 2: Hydrocodone Bitartrate intervention 3: Humibid® and Hydrocodone Bitartrate tablet

0

null

0

NCT03642873

[ 3 ]

234

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

null

Depressive Disorder

MDD

null

0

null

1

[ 0 ]

intervention 1: Study drug

intervention 1: bupropion hydrochloride

7

Fukuoka | N/A | Japan | 130.41667 | 33.6 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Saitama | N/A | Japan | 139.65657 | 35.90807 Tokyo | N/A | Japan | 139.69171 | 35.6895 N/A | N/A | N/A | N/A | N/A

0

NCT00135512

[ 4 ]

66

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

null

Epilepsy, Tonic-clonic

Monotherapy Epilepsy Keppra Levetiracetam

null

1

arm 1: Subjects received open-label Levetiracetam.

[ 0 ]

1

[ 0 ]

intervention 1: Pharmaceutical form: oral tablets Route of administration: Oral use

intervention 1: Levetiracetam

21

Beroun | N/A | Czechia | 14.072 | 49.96382 Brno | N/A | Czechia | 16.60796 | 49.19522 České Budějovice | N/A | Czechia | 14.47434 | 48.97447 Prague | N/A | Czechia | 14.42076 | 50.08804 Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Pécs | N/A | Hungary | 18.23083 | 46.0725 Szeged | N/A | Hungary | 20.14824 | 46.253 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gdansk | N/A | Poland | 18.64912 | 54.35227 Katowice | N/A | Poland | 19.02754 | 50.25841 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Szczecin | N/A | Poland | 14.55302 | 53.42894 Warsaw | N/A | Poland | 21.01178 | 52.22977 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Helsingborg | N/A | Sweden | 12.69437 | 56.04673 Huddinge | N/A | Sweden | 17.98192 | 59.23705 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00150813

[ 4 ]

248

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.

This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups. In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1. In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.

Hypercholesterolemia

cholesterol drugs hypercholesterolemia adolescent randomized controlled trials

null

2

arm 1: Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg arm 2: Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks intervention 2: Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks

intervention 1: ezetimibe with simvastatin intervention 2: simvastatin

0

null

1

NCT00129402

[ 4 ]

2,235

NA

SINGLE_GROUP

1PREVENTION

0NONE

true

1FEMALE

false

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

null

Contraception

pregnancy prevention oral contraceptives

null

1

arm 1: Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.

[ 0 ]

1

[ 0 ]

intervention 1: Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).

intervention 1: DR-1011

55

0

NCT00196326

[ 3 ]

412

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

null

To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

null

Low Bone Mineral Density

bone loss osteoporosis

null

9

arm 1: Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42. arm 2: Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 3: Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 4: Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42. arm 5: Participants received denosumab 14 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 6: Participants received denosumab 60 mg SC every 6 months until Month 42. arm 7: Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42. arm 8: Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42. arm 9: Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.

[ 2, 0, 0, 0, 0, 0, 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Placebo subcutaneous injection intervention 2: Denosumab for subcutaneous injection intervention 3: Alendronate 70 mg tablets

intervention 1: Placebo intervention 2: Denosumab intervention 3: Alendronate

0

null

0

NCT00043186

[ 4 ]

211

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or etanercept during the initial double-blind period. Participants could enter an escape group and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area and Severity Index (PASI) score either increased by more than 50% over baseline and by a minimum of 4 points at one visit or increased by more than 25% and by a minimum of 4 points at each of two consecutive visits. During the open-label treatment period, all patients (including those who entered the escape group) received open-label etanercept. Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 could discontinue the study or add topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) and continue to receive open-label etanercept until week 48. At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were randomly assigned to placebo or etanercept for 12 weeks in the withdrawal period. Participants in whom PASI 75 was lost resumed open-label etanercept through week 48 in the re-treatment period.

Psoriasis

Pediatric Psoriasis

null

2

arm 1: Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12. Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36). At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48). arm 2: Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12. Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36). At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48).

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week intervention 2: Placebo matching to etanercept administered by subcutaneous injection once a week

intervention 1: Etanercept intervention 2: Placebo

0

null

0

NCT00078819

[ 3 ]

512

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

null

Arthroplasty, Replacement, Knee Venous Thrombosis

null

4

arm 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration arm 3: Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration arm 4: matching placebo capsule, once a day, oral administration

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration intervention 3: Dabigatran etexilate 220 mg capsule, once a day, oral administration intervention 4: matching placebo capsule, once a day, oral administration

intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran Etexilate intervention 4: placebo

38

Eniwa, Hokkaido | N/A | Japan | 141.576 | 42.89357 Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Hachioji, Tokyo | N/A | Japan | N/A | N/A Hirosaki, Aomori | N/A | Japan | N/A | N/A Hiroshima, Hiroshima | N/A | Japan | N/A | N/A Iida, Nagano | N/A | Japan | N/A | N/A Izumisano, Osaka | N/A | Japan | N/A | N/A Izunokuni,Shizuoka | N/A | Japan | N/A | N/A Kagoshima, Kagoshima | N/A | Japan | N/A | N/A Kawasaki, Kanagawa | N/A | Japan | N/A | N/A Kawasaki, Kanagawa | N/A | Japan | N/A | N/A Kitakyusyu, Fukuoka | N/A | Japan | N/A | N/A Koshigaya,Saitama | N/A | Japan | N/A | N/A Kurume ,Fukuoka | N/A | Japan | N/A | N/A Kurume ,Fukuoka | N/A | Japan | N/A | N/A Kyoto, Kyoto | N/A | Japan | N/A | N/A Matsue, Shimane | N/A | Japan | N/A | N/A Miyazaki, Miyazaki | N/A | Japan | N/A | N/A Musashimurayama, Tokyo | N/A | Japan | N/A | N/A Obihiro, Hokkaido | N/A | Japan | 143.20444 | 42.91722 Okayama, Okayama | N/A | Japan | N/A | N/A Omura, Nagasaki | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Saga, Saga | N/A | Japan | N/A | N/A Sagamihara, Kanagawa | N/A | Japan | N/A | N/A Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sasebo, Nagasaki | N/A | Japan | N/A | N/A Sasebo, Nagasaki | N/A | Japan | N/A | N/A Sendai, Miyagi | N/A | Japan | N/A | N/A Shinjuku-ku,Tokyo | N/A | Japan | 139.69171 | 35.6895 Shizuoka, Shizuoka | N/A | Japan | N/A | N/A Sumida-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Tomigusuku, Okinawa | N/A | Japan | N/A | N/A Tsukuba , Ibaraki | N/A | Japan | N/A | N/A

0

NCT00246025

[ 5 ]

104

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Myocardial Infarction Reperfusion Injury

Edaravone Randomized Control Trial ST-Elevation Myocardial Infarction Coronary Angioplasty

null

2

arm 1: Edaravone Group arm 2: Placebo Group

[ 1, 4 ]

1

[ 0 ]

intervention 1: intravenous administration of 30mg Edaravone just before reperfusion therapy

intervention 1: edaravone

1

Kumamoto | N/A | Japan | 130.69181 | 32.80589

0

NCT00265239

[ 4 ]

527

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. The aim of the current study is to evaluate the effectiveness of alogliptin in combination with metformin in individually who are inadequately controlled on metformin alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Diabetes Mellitus

Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.

intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin

56

0

NCT00286442

[ 4 ]

500

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Diabetes Mellitus

Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.

intervention 1: Alogliptin and glyburide intervention 2: Alogliptin and glyburide intervention 3: Glyburide

68

0

NCT00286468

[ 5 ]

44

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

false

This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows: * Hypothesis 1: the subjective feelings of detection and likeability will be greater for periods of IR-MPH administration than after OROS-MPH administration irregardless of sequence; * Hypothesis 2: the greater ratings of feelings of detection and likeability will be associated with the periods of most rapid change in plasma d-MPH and not with the magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in which they coincide), and * Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions in which IR-MPH is the second condition.

The main goal of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release. To this end, the investigators will compare repeated administration of orally administered, therapeutic doses of a short (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) in the following areas: 1. pharmacokinetic profile of MPH assessing rate of onset of MPH action (indexed through change in plasma level) and 2. abuse liability (indexed through detection and likeability). The investigators will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; OROS-MPH to OROS-MPH, and placebo to placebo.

Healthy

healthy volunteers

null

5

arm 1: OROS-Methylphenidate Will be administered during the first part of the day, and again during the separate part of the day. arm 2: Immediate release methylphenidate will be administered in the first part of the day followed by Immediate release methylphenidate in the second part of the day. arm 3: Placebo will be administered during the first part of the day, and again during the second part of the day. arm 4: Concerta will be administered in the first part of the day, followed by Immediate Release Methylphenidate in the second part of the day. arm 5: Immediate release Methylphenidate will be administered in the first part of the day, followed by Concerta in the second part of the day

[ 0, 0, 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules intervention 2: Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules intervention 3: Placebo will be administered during the first part of the day, and again during the second part of the day.

intervention 1: OROS-Methylphenidate intervention 2: Immediate Release Methylphenidate intervention 3: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00302458

[ 5 ]

67

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

null

This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.

null

Post Menopausal Osteoporosis

null

2

arm 1: Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months. arm 2: Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: po monthly for 6 months intervention 2: As prescribed intervention 3: 150mg po monthly for 6 months

intervention 1: Placebo intervention 2: Vitamin D and calcium supplementation intervention 3: ibandronate [Bonviva/Boniva]

10

0

NCT00303485

[ 5 ]

137

NON_RANDOMIZED

PARALLEL

null

1SINGLE

false

0ALL

null

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

null

Bacterial Conjunctivitis

null

2

arm 1: Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. arm 2: Healthy Subjects receiving no treatment

[ 0, 4 ]

1

[ 0 ]

intervention 1: 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days

intervention 1: VIGAMOX

1

Fort Worth | Texas | United States | -97.32085 | 32.72541

0

NCT00312338

[ 3 ]

201

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).

null

Coronary Artery Disease

null

2

arm 1: One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days. arm 2: One time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days. Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

intervention 1: Prasugrel intervention 2: Clopidogrel intervention 3: Placebo for Prasugrel intervention 4: Placebo for Clopidogrel

16

Jacksonville | Florida | United States | -81.65565 | 30.33218 Worcester | Massachusetts | United States | -71.80229 | 42.26259 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Rapid City | South Dakota | United States | -103.23101 | 44.08054 Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Tours | N/A | France | 0.70398 | 47.39484 Bad Krozingen | N/A | Germany | 7.7 | 47.91667 Berlin | N/A | Germany | 13.41053 | 52.52437 Giessen | N/A | Germany | 8.67554 | 50.58727 München | N/A | Germany | 13.31243 | 51.60698 Tübingen | N/A | Germany | 9.05222 | 48.52266 Haifa | N/A | Israel | 34.99928 | 32.81303 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096

0

NCT00357968

[ 2, 3 ]

27

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of bortezomib when given together with pemetrexed disodium and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.

OBJECTIVES: Primary * Determine the safety, including dose-limiting toxicities, and feasibility of combining bortezomib with pemetrexed disodium in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors. (Phase I) * Determine the response rate in patients with advanced NSCLC treated with this regimen. (Phase II) Secondary * Compare the toxicity of 2 different schedules of bortezomib and pemetrexed disodium in patients with advanced solid tumors. (Phase I) * Determine the maximum tolerated dose (MTD) of bortezomib when administered with pemetrexed disodium in 2 different treatment schedules in these patients. (Phase I) * Determine, preliminarily, the efficacy of the combination of bortezomib and pemetrexed disodium in patients with advanced solid tumors. (Phase I) * Assess the overall survival and progression-free survival of these patients. (Phase II) * Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II) Tertiary * Perform laboratory correlative studies on tumor tissue and blood samples to investigate potential predictors of response. (Phase II) OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II, open-label study. * Phase I: Patients will be accrued, in an alternating fashion, to 1 of 2 treatment groups. * Group I: Patients receive pemetrexed disodium IV on day 1 and bortezomib IV on days 1, 4, 8, and 11. * Group II: Patients receive pemetrexed disodium IV on day 1 and bortezomib IV on days 1 and 8. In both groups, treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients per group receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive pemetrexed disodium bortezomib (at the MTD) as in either group I or group II of the phase I portion of the study. Selection of the treatment schedule is based upon observed toxicity, safety, tolerability, efficacy, and clinical practicality. Blood is drawn at baseline and prior to courses 2 and 3 for correlative and molecular studies. Tumor tissue and blood samples from patients enrolled in the phase II portion of the study are examined for various biological markers. Immunohistochemistry is used to measure BCL-2 gene, BCL-xL gene, BAX gene, and p27. Reverse transcriptase-polymerase chain reaction is used to assay the expression of thymidylate synthase, folsyl-polyglutamate synthase, and reduced folate carrier. Levels of plasminogen-activator inhibitor 1 gene, vascular endothelial growth factor, and osteopontin are measured by immunoenzyme techniques. The nuclear expression of NF-kB and p27 in blood is compared before and after study treatment by flow cytometry. After completion of study treatment, patients in phase I are followed for 30 days and patients in phase II are followed periodically.

Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific

recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific

null

0

null

9

[ 0, 0, 6, 6, 6, 6, 10, 10, 10 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None

intervention 1: bortezomib intervention 2: pemetrexed disodium intervention 3: gene expression analysis intervention 4: mutation analysis intervention 5: protein expression analysis intervention 6: reverse transcriptase-polymerase chain reaction intervention 7: flow cytometry intervention 8: immunoenzyme technique intervention 9: immunohistochemistry staining method

1

Sacramento | California | United States | -121.4944 | 38.58157

0

NCT00389805

[ 3 ]

903

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

null

Thrombosis Hip Replacement

Anti-coagulant hip replacement hip replacement surgery unilateral hip replacement surgery DeepVein Thrombosis Venous Thromboembolism pulmonary embolism Prevention of Blood Clots

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor

29

Hartford | Connecticut | United States | -72.68509 | 41.76371 Sarasota | Florida | United States | -82.53065 | 27.33643 Austin | Texas | United States | -97.74306 | 30.26715 Ajax | Ontario | Canada | -79.03288 | 43.85012 Cambridge | Ontario | Canada | -80.31269 | 43.3601 Guelph | Ontario | Canada | -80.25599 | 43.54594 Kitchner | Ontario | Canada | N/A | N/A Toronto | Ontario | Canada | -79.39864 | 43.70643 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Herlev | N/A | Denmark | 12.43998 | 55.72366 Hørsholm | N/A | Denmark | 12.50111 | 55.88098 Gyula | N/A | Hungary | 21.28333 | 46.65 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Riga | N/A | Latvia | 24.10589 | 56.946 Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saratov | N/A | Russia | 46.00861 | 51.54056 Veliky Novgorod | N/A | Russia | 31.27104 | 58.52131 Volgograd | N/A | Russia | 44.50183 | 48.71939 Chernivtsy | N/A | Ukraine | N/A | N/A Dnipro | N/A | Ukraine | 35.04066 | 48.46664 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lutsk | N/A | Ukraine | 25.35024 | 50.75784 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572

0

NCT00398216

[ 4 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Spinal Puncture

Lumbar Puncture Pediatrics Propofol Remifentanil sedation Oncology

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus. intervention 2: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

intervention 1: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg intervention 2: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

1

Toronto | Ontario | Canada | -79.39864 | 43.70643

0

NCT00405522

[ 4 ]

426

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.

null

Seasonal Allergic Rhinitis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning intervention 2: Two sprays in each nostril once daily in the morning

intervention 1: mometasone furoate intervention 2: Placebo

0

null

0

NCT00453063

[ 2, 3 ]

48

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics

Treatment: High-dose melphalan followed by a transplant of autologous stem cells is thought to be one of the most effective ways to treat multiple myeloma. However, the number one cause of treatment failure in these patients is the disease coming back. High-dose melphalan has been used in multiple myeloma for more than two decades and is considered the standard of care for this disease. Recent research in the laboratory and clinical trials has shown that Arsenic trioxide is an effective treatment against multiple myeloma. It leads to tumor cell death in myeloma cell lines and in myeloma patients. Arsenic trioxide can also make melphalan a more effective antimyeloma agent. This research has also shown that vitamin C enhances the anti-myeloma activity of arsenic trioxide by making it more toxic to myeloma cells. The purpose of this study is to learn if a combination of arsenic trioxide, vitamin C, and melphalan will be safe, well-tolerated and effective in myeloma patients. Before treatment begins, you will have several tests performed to study the status of the disease before you begin taking the study medication. You will have a bone marrow aspirate and biopsies. An aspirate is the drawing of liquid marrow with a syringe, while a biopsy is the removal of a small core of bone with a hollow needle. Aspirate can be done from the hip bone or chest, while biopsy is always from the hip bone. You will have cytogenic tests, to see if there are any genetic abnormalities in your DNA. You will have a bone survey done, where the doctor will look at X-rays of your bones for any myeloma-related bone changes. You will have routine and specialized blood tests done (about 2 tablespoons), to measure blood counts, platelets, blood clotting, kidney function, electrolyte counts, and levels of disease in your blood. You will also have a urine test to measure level of myeloma in your urine. You will have a pulmonary function test, to check if your lungs is strong enough to withstand high-dose chemotherapy. You will have an initial electrocardiogram (EKG) and also a MUGA scan that will measure how strong your heart functions are. Women who are able to have children must have a negative blood pregnancy test before participating in this study. If you agree and are eligible, you will be assigned to receive one of 3 arms. In the first arm only melphalan and vitamin C, but no Arsenic trioxide will be given. In the second and third arms, doses of arsenic trioxide together with Vitamin C and melphalan will be given. Not all patients in this study will get the same dose of arsenic. Your dose assignment will depend on the experience of other patients with this combination. The first 3 patients on this study will get the lowest dose of arsenic trioxide. Arsenic trioxide will be given through a needle in the vein over a period of 2 hours, once a day for 7 days. At the same time, vitamin C will be given once a day through the vein for 7 days. On the last 2 days of arsenic trioxide treatment, melphalan will be given through the vein over one hour after the arsenic. You will have your stem cells reinfused 2 days after the last dose of melphalan. Some patients agreeing to the optional procedure will receive one of the doses of melphalan before starting the arsenic. You will receive standard inpatient and outpatient transplant care and testing. This involves blood and bone marrow tests, heart tests, lung tests and x-rays before the study drug treatment and the transplant. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Blood tests (about two tablespoons) will be drawn at least once a week for the first month after the transplant, and then once every month for the next 3 months. Bone marrow biopsies and tests to check the level of myeloma protein in the urine and the blood are also performed at 3, 6 and 12 months after the transplant. You will be taken off study one year after transplant, if your disease does not come back. Patients off study will still return for their routine post-transplant follow up visits as decided by their transplant physician. If your disease comes back or intolerable side effects occur, you will be taken off study. This is an investigational study. Both arsenic trioxide and melphalan are commercially available and have been approved for use in patients with myeloma, though their use together with vitamin C is investigational. About 32 patients are expected to participate in this study. All will be enrolled at UTMDACC.

Multiple Myeloma Stem Cell Transplantation

Multiple Myeloma Ascorbic Acid Vitamin C Arsenic Trioxide Trisenox Melphalan Autologous Stem Cell Transplant Stem Cell Transplantation

null

1

arm 1: Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3. intervention 2: Dose Levels 1, 2, \& 3: 100 mg/m2 IV Days -4, -3. intervention 3: Dose Levels 1, 2, \& 3: 1000 mg IV Days -9 to -3.

intervention 1: Arsenic Trioxide intervention 2: Melphalan intervention 3: Ascorbic Acid

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00661544

[ 4 ]

380

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

0ALL

false

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.

This was a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. The study provided continued availability of Sativex® to subjects who completed the preceding double-blind neuropathic pain studies. Consenting, eligible subjects who had participated in previous GW Pharma Ltd (GW) randomised, placebo-controlled clinical studies entered the study (Visit 1, Day 0) and commenced dosing. Study visits took place at Week 2 (Visit 2, Day 14), Week 14 (Visit 3, Day 98), and Week 26 (Visit 4, Day 182). Subjects returned to the centre for an end of treatment visit at week 38 (Visit 5, Day 266). All subjects received Sativex®. This was followed by a five week randomised-withdrawal phase (Part B) for a subset of subjects. An end of study visit took place 28 days after Visit 5 (or 5b or 5c) or withdrawal from the study.

Pain Peripheral Neuropathy

null

1

arm 1: Active treatment

[ 0 ]

1

[ 0 ]

intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

intervention 1: Sativex®

1

Solihull | West Midlands | United Kingdom | -1.78094 | 52.41426

0

NCT00713323