ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00790205
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-10; Completion date: 2015-03-30
Enrollment: 14671 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.

Detailed description:

Arms: arm 1: Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years. arm 2: Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily. intervention 2: Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Protocol documents:
Clinical trial NCT00436852
Conditions: Disseminated Neuroblastoma Recurrent Neuroblastoma
Sponsor: Children's Oncology Group
Start date: 2007-01-01; Completion date: 2015-03-30
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well ABT-751 works in treating children with neuroblastoma that has relapsed or not responded to previous treatment. Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the time to disease progression in children with refractory or relapsed neuroblastoma treated with ABT-751 vs historical controls.

SECONDARY OBJECTIVES:

I. Determine the objective response rate in patients with measurable disease treatment with this drug.

II. Determine whether ABT-751 improves quality of life of these patients. III. Determine the toxicity of ABT-751. IV. Determine the pharmacokinetic profile of ABT-751 in these patients.

OUTLINE:

Patients receive oral ABT-751 once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during course 1 for pharmacokinetic studies. Quality of life is assessed at baseline and prior to each course of treatment.

After completion of study treatment, patients are followed up for up to 5.1 years.

Arms: arm 1: Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined. arm 2: Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
Interventions: intervention 1: ABT-751 intervention 2: quality-of-life assessment
Intervention descriptions: intervention 1: Given orally intervention 2: Ancillary studies

Protocol documents:
Clinical trial NCT01903720
Conditions: Macular Edema Retinal Vein Occlusion
Sponsor: Allergan
Start date: 2013-07-16; Completion date: 2015-03-30
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.

Detailed description:

Arms: arm 1: OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Interventions: intervention 1: dexamethasone implant
Intervention descriptions: intervention 1: OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.

Protocol documents:
Clinical trial NCT01194154
Conditions: Kidney Disease, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2010-09-30; Completion date: 2015-03-31
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera in participants with chronic kidney disease on renal disease progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated time on study treatment is 24 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta intervention 2: Placebo
Intervention descriptions: intervention 1: Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL). intervention 2: Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.

Protocol documents:
Clinical trial NCT01842633
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2013-04-01; Completion date: 2015-03-31
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).

Detailed description:

Arms: arm 1: Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered arm 2: Two ibuprofen caplets plus two placebo caplets to be administered arm 3: Four placebo caplets to be administered
Interventions: intervention 1: Paracetamol and Caffeine intervention 2: Ibuprofen intervention 3: Placebo
Intervention descriptions: intervention 1: Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine intervention 2: Caplets containing 200 mg of ibuprofen intervention 3: Matching placebo caplets

Protocol documents:
Clinical trial NCT02021773
Conditions: Chronic Migraine
Keywords: Headache Migraine Chronic Migraine
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2014-01-31; Completion date: 2015-03-31
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Detailed description:
Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.

Arms: arm 1: Subcutaneous High Dose LBR-101 Administered Monthly x 3 arm 2: Subcutaneous Low Dose LBR-101 Administered Monthly x 3 arm 3: Subcutaneous Placebo Administered Monthly x 3
Interventions: intervention 1: LBR-101 High Dose intervention 2: LBR-101 Low Dose intervention 3: Placebo
Intervention descriptions: intervention 1: Subcutaneously Administered LBR-101 Monthly x 3 intervention 2: Subcutaneously Administered LBR-101 Monthly x 3 intervention 3: Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Protocol documents:
Clinical trial NCT02025556
Conditions: Episodic Migraine Headache
Keywords: High Frequency Episodic Migraine Headache Episodic Migraine Headache Migraine Headache
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2014-01-31; Completion date: 2015-03-31
Enrollment: 297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in subjects with high frequency episodic migraine.

Detailed description:

Arms: arm 1: Subcutaneous High Dose LBR-101 Administered Monthly x 3 arm 2: Subcutaneous Low Dose LBR-101 Administered Monthly x 3 arm 3: Subcutaneous Placebo Administered Monthly x 3
Interventions: intervention 1: LBR-101 High Dose intervention 2: LBR-101 Low Dose intervention 3: Placebo
Intervention descriptions: intervention 1: Subcutaneously Administered High Dose LBR-101 Monthly x 3 intervention 2: Subcutaneously Administered Low Dose LBR-101 Monthly x 3 intervention 3: Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Protocol documents:
Clinical trial NCT02341482
Conditions: Healthy
Keywords: Itraconazole Healthy Volunteers Drug-drug interaction PF-04958242
Sponsor: Biogen
Start date: 2015-02-05; Completion date: 2015-03-31
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.

Detailed description:
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Arms: arm 1: PF-04958242 will be provided in a capsule. Participants will receive a 0.10 mg loading dose of PF-04958242 twice daily (BID) on Day 1 then 0.025 mg BID on Day 2-Day 16, with the last dose occurring in the morning on Day 17.

Itraconazole will be provided as a solution starting on Day 4. On Day 4, a 200 mg dose of itraconazole will be administered approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4-Day 17).
Interventions: intervention 1: PF-04958242 intervention 2: Itraconazole
Intervention descriptions: intervention 1: Administered as specified in the treatment arm intervention 2: Administered as specified in the treatment arm

Protocol documents:
Clinical trial NCT00256750
Conditions: Kidney Transplantation Chronic Kidney Failure
Sponsor: Bristol-Myers Squibb
Start date: 2005-03-01; Completion date: 2015-04-01
Enrollment: 738 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cyclosporine (CsA) intervention 2: Belatacept LI (less intensive) intervention 3: Belatacept MI (more intensive)
Intervention descriptions: intervention 1: tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT) intervention 2: solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT) intervention 3: solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Protocol documents:
Clinical trial NCT01108510
Conditions: HIV HIV Infections
Keywords: Treatment Naive HIV 1 Infected
Sponsor: Gilead Sciences
Start date: 2010-04-01; Completion date: 2015-04-01
Enrollment: 698 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.

Detailed description:

Arms: arm 1: COBI + RTV placebo + ATV + FTC/TDF once daily arm 2: RTV + COBI placebo + ATV + FTC/TDF once daily
Interventions: intervention 1: COBI intervention 2: RTV intervention 3: ATV intervention 4: FTC/TDF intervention 5: COBI placebo intervention 6: RTV placebo
Intervention descriptions: intervention 1: Cobicistat (COBI) 150 mg tablet administered orally once daily intervention 2: Ritonavir (RTV) 100 mg tablet administered orally once daily intervention 3: Atazanavir (ATV) 300 mg capsule administered orally once daily intervention 4: Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily intervention 5: Placebo to match COBI administered orally once daily intervention 6: Placebo to match RTV administered orally once daily

Protocol documents:
Clinical trial NCT01131676
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2015-04-01
Enrollment: 7064 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Detailed description:

Arms: arm 1: BI 10773 tablets once daily arm 2: BI 10773 tablets once daily arm 3: Placebo tablets matching BI 10773
Interventions: intervention 1: BI 10773 low dose intervention 2: Placebo BI 10773 high dose intervention 3: BI 10773 high dose intervention 4: Placebo BI 10773 low dose intervention 5: Placebo BI 10773 low dose intervention 6: Placebo BI 10773 high dose
Intervention descriptions: intervention 1: BI 10773 tablets once daily intervention 2: Placebo tablets identical to BI 10773 intervention 3: BI 10773 tablets once daily intervention 4: Placebo tablets identical to BI 10773 intervention 5: Placebo tablets identical to BI 10773 intervention 6: Placebo tablets identical to BI 10773

Protocol documents:
Clinical trial NCT01390818
Conditions: Locally Advanced Solid Tumor Metastatic Solid Tumor Breast Cancer Non Small Cell Lung Cancer Melanoma Colorectal Cancer
Keywords: MEK inhibitor (Pimasertib) PI3K/mTOR Inhibitor Solid Tumor Phase I
Sponsor: EMD Serono
Start date: 2011-05-01; Completion date: 2015-04-01
Enrollment: 146 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MSC1936369B (pimasertib) intervention 2: SAR245409 (PI3K and mTOR inhibitor) intervention 3: MSC1936369B (pimasertib) intervention 4: SAR245409 (PI3K and mTOR inhibitor)
Intervention descriptions: intervention 1: MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer. intervention 2: SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer. intervention 3: MSC1936369B (pimasertib) capsule was administered twice daily orally at a dose of 60 mg and 45 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of MSC1936369B (pimasertib) was combined with a lower dose of SAR245409 (PI3K and mTOR inhibitor). intervention 4: SAR245409 (PI3K and mTOR inhibitor) was administered twice daily orally at a dose of 30 mg and 50 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of SAR245409 (PI3K and mTOR inhibitor) was combined with a lower dose of MSC1936369B (pimasertib).

Protocol documents:
Clinical trial NCT01816295
Conditions: Hypogonadism
Sponsor: Eli Lilly and Company
Start date: 2013-05-01; Completion date: 2015-04-01
Enrollment: 715 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

Detailed description:

Arms: arm 1: Placebo Solution applied topically once daily for 12 weeks. arm 2: Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.
Interventions: intervention 1: Testosterone Solution intervention 2: Placebo Solution
Intervention descriptions: intervention 1: Administered topically to axillae. intervention 2: Administered topically to axillae.

Protocol documents:
Clinical trial NCT01926782
Conditions: Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2013-09-01; Completion date: 2015-04-01
Enrollment: 803 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Detailed description:

Arms: arm 1: Two subcutaneous (SC) injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks. arm 2: One SC injection of each Alirocumab 75 mg and placebo Q2W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8. arm 3: Two SC injections of Alirocumab 150 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
Interventions: intervention 1: Placebo (for alirocumab) intervention 2: Alirocumab intervention 3: Statin
Intervention descriptions: intervention 1: Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 2: Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 3: Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy

Protocol documents:
Clinical trial NCT00046891
Conditions: Breast Cancer Neurotoxicity
Keywords: neurotoxicity stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2002-12-01; Completion date: 2015-04-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make it difficult for patients to think clearly. EGb761 may help maintain mental clarity in patients undergoing chemotherapy.

PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.

Detailed description:
OBJECTIVES:

* Determine the effectiveness of EGb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer.
* Determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients.
* Assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients.
* Assess the quality of life and cognitive role functioning of patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (doxorubicin/cyclophosphamide vs doxorubicin/cyclophosphamide with taxane vs other anthracycline-based chemotherapy vs other non-anthracycline-based chemotherapy), age (18 to 49 vs 50 and over), menopausal status at start of therapy (premenopausal vs postmenopausal vs unknown for surgical reasons), and lymph node involvement (0-3 vs 4 or more). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral EGb761 twice daily.
* Arm II: Patients receive oral placebo twice daily. Patients in both arms receive treatment beginning no later than the start of the second course of chemotherapy and continuing until 1 month after the completion of chemotherapy.

Quality of life and cognitive function are assessed at baseline, monthly during chemotherapy, and then at 1, 6, 12, 18, and 24 months.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 11 months.

Arms: arm 1: 120 mg per day (60 mg BID) arm 2: 1 tablet BID
Interventions: intervention 1: Ginkgo Biloba intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will take 120 mg per day (60 mg BID) intervention 2: Patients will take 1 tablet BID

Protocol documents: