ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00743366
Conditions: Marijuana Smoking
Keywords: quetiapine smoked marijuana marijuana use
Sponsor: New York State Psychiatric Institute
Start date: 2008-08-01; Completion date: 2009-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

Detailed description:
The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. While inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. Our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.

Arms: arm 1: Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours).

Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. arm 2: Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
Interventions: intervention 1: Marijuana intervention 2: Quetiapine intervention 3: Placebo oral capsule
Intervention descriptions: intervention 1: 0,6.2% THC intervention 2: 200 mg/day intervention 3: None

Protocol documents:
Clinical trial NCT00754650
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.

Detailed description:

Arms: arm 1: Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Bevacizumab was supplied as a sterile liquid in single-use vials.

Protocol documents:
Clinical trial NCT00758459
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD1236 intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablet, 75 mg, twice daily during 6 weeks intervention 2: Dosing to match AZD1236

Protocol documents:
Clinical trial NCT00761007
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome Bowel disease
Sponsor: Menarini Group
Start date: 2008-07-01; Completion date: 2009-03-01
Enrollment: 554 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.

Detailed description:
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Ibodutant intervention 2: Ibodutant intervention 3: Ibodutant intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablet, dose level 1 (10 mg), once daily intervention 2: Oral tablet, dose level 2 (30 mg), once daily intervention 3: Oral tablet, dose level 3 (60 mg), once daily intervention 4: Oral tablet matching the three dose levels of ibodutant, once daily

Protocol documents:
Clinical trial NCT00761150
Conditions: Chronic Low Back Pain
Keywords: Effect on sleep interference by pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

Detailed description:
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Arms: arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Interventions: intervention 1: ABT-712 intervention 2: Placebo
Intervention descriptions: intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet

Protocol documents:
Clinical trial NCT00763555
Conditions: Psoriasis
Keywords: psoriasis spray calcitriol
Sponsor: Galderma R&D
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CD 2027 intervention 2: Calcitriol Vehicle
Intervention descriptions: intervention 1: Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. intervention 2: Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Protocol documents:
Clinical trial NCT00766090
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2008-10-01; Completion date: 2009-03-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare once and twice daily GW685698 in asthma

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GW685698X
Intervention descriptions: intervention 1: Inhaled Corticosteroid

Protocol documents:
Clinical trial NCT00766363
Conditions: Alzheimer's Disease Central Nervous System Diseases
Keywords: Alzheimer's Disease Central Nervous System Diseases Pharmacokinetics Cognition
Sponsor: FORUM Pharmaceuticals Inc
Start date: 2008-10-01; Completion date: 2009-03-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

Detailed description:
This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medication (donepezil or rivastigmine).

Study drug will be supplied as capsules and will be orally administered once daily for a total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2 (two days before the first dose of study drug is administered) and will remain confined to the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety assessments, PK sampling, and cognitive testing will be performed inpatient and at each study visit.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: EVP-6124 (0.1 mg/day) intervention 2: EVP-6124 (0.3 mg/day) intervention 3: EVP-6124 (1.0 mg/day) intervention 4: Comparator: Placebo intervention 5: Donepezil intervention 6: Rivastigmine
Intervention descriptions: intervention 1: EVP-6124 was administered as one 0.1 mg capsule per day for 28 days. intervention 2: EVP-6124 was administered as one 0.3 mg capsule every day for 28 days. intervention 3: EVP-6124 was administered as one 1.0 mg capsule every day for 28 days. intervention 4: Matching placebo was administered as one capsule per day for 28 days. intervention 5: Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study. intervention 6: Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.

Protocol documents:
Clinical trial NCT00772577
Conditions: Hypertension
Keywords: Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2
Sponsor: Novartis
Start date: 2008-08-01; Completion date: 2009-03-01
Enrollment: 386 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension

Detailed description:

Arms: arm 1: Aliskiren Hydrochlorothiazide(HCTZ) arm 2: Ramipril
Interventions: intervention 1: Aliskiren Hydrochlorothiazide intervention 2: Ramipril
Intervention descriptions: intervention 1: Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks intervention 2: Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks

Protocol documents:
Clinical trial NCT00774800
Conditions: Type 1 Diabetes Mellitus
Keywords: Recombinant Hyaluronidase Type 1 Diabetes Mellitus Humalog Humulin R rHuPH20 Hylenex
Sponsor: Halozyme Therapeutics
Start date: 2008-10-01; Completion date: 2009-03-01
Enrollment: 22 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin-R in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.

Detailed description:
Participants received all 4 interventions in the same order.

Dose-finding visits were conducted to identify the appropriate dose of Humalog and Humulin-R. For each Humalog dose-finding visit, a total of 24 U of rHuPH20 was injected SC per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog). For each Humulin-R dose-finding visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass concentration of 20.0 μg/mL rHuPH20 (at final concentration of 100 U/mL of Humulin-R).

Arms: arm 1: Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.

Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.

Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.

Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.

Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was \<160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.

All dose finding visits and interventions were separated by 3-10 days.
Interventions: intervention 1: Humalog intervention 2: Humulin-R intervention 3: Recombinant human hyaluronidase PH20 (rHuPH20) intervention 4: Liquid meal
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00777855
Conditions: Healthy
Keywords: warfarin pharmacokinetics drug transporter healthy volunteer drug interaction rifampin
Sponsor: University of California, San Francisco
Start date: 2008-11-01; Completion date: 2009-03-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the importance of uptake drug transporters in the drug disposition of warfarin. We predict that the elimination of warfarin will be decreased when co-dosed with an inhibitor of uptake drug transporters.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: warfarin plus rifampin intervention 2: warfarin
Intervention descriptions: intervention 1: warfarin 7.5mg po x 1; rifampin 600mg IV x 1 intervention 2: warfarin 7.5mg po x 1

Protocol documents:
Clinical trial NCT00782418
Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.

Detailed description:

Arms: arm 1: exenatide 5mcg arm 2: exenatide 1.5mcg arm 3: Placebo
Interventions: intervention 1: Comparator: exenatide intervention 2: Comparator: exenatide intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI. intervention 2: exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI. intervention 3: 5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

Protocol documents:
Clinical trial NCT00791661
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-01; Completion date: 2009-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.

Detailed description:

Arms: arm 1: Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. arm 2: Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. arm 3: Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Interventions: intervention 1: MK-1006 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. intervention 2: Matching placebo to MK-1006 in a single oral dose

Protocol documents:
Clinical trial NCT00795145
Conditions: Bacterial Infections
Keywords: Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2009-03-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: Placebo intervention 2: Linezolid 900 mg intervention 3: Linezolid 1200 mg intervention 4: Placebo intervention 5: Linezolid 600 mg intervention 6: Linezolid 1200 mg intervention 7: Moxifloxacin 400 mg
Intervention descriptions: intervention 1: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 2: Intravenous, 900 mg linezolid, single dose intervention 3: Intravenous, 1200 mg linezolid, single dose intervention 4: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 5: Intravenous, 600 mg linezolid, single dose intervention 6: Intravenous, 1200 mg linezolid, single dose intervention 7: Oral, 400 mg moxifloxacin, single dose

Protocol documents:
Clinical trial NCT00803270
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence, Mixed, Urge
Sponsor: Carelon Research
Start date: 2008-10-01; Completion date: 2009-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Detailed description:
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Arms: arm 1: Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. arm 2: The non-surgical treatment will include two components:

1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
2. Behavioral therapy.
Interventions: intervention 1: Non-Surgical Intervention intervention 2: Surgical
Intervention descriptions: intervention 1: Both oral urge incontinence medication and behavioral treatment intervention 2: Initial surgical (stress incontinence surgery) treatment approach.

Protocol documents: