ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02711202
Conditions: Kidney Transplantation
Sponsor: Institute for Clinical and Experimental Medicine
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.

Detailed description:

Arms: arm 1: Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy. arm 2: Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at POD 14, they were randomized to tacrolimus monotherapy.
Interventions: intervention 1: MabCampath, intervention 2: Remicade intervention 3: Sirolimus intervention 4: Tacrolimus
Intervention descriptions: intervention 1: Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively. intervention 2: Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively. intervention 3: Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively. intervention 4: Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.

Protocol documents:
Clinical trial NCT02732847
Conditions: Acute Upper Respiratory Tract Infections
Keywords: Respiratory infections Primary care Antibiotics Delayed prescriptions
Sponsor: Memorial University of Newfoundland
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).

This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.

Detailed description:
6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when.

It is hypothesised that post-dating the prescription will result in a reduced cashing rate.

Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.

Arms: arm 1: a delayed prescription dated 2 days after clinical office visit arm 2: usual date
Interventions: intervention 1: A delayed prescription dated 2 days after clinical office visit intervention 2: Usual Dated
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00810732
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Sitaxsentan
Sponsor: Pfizer
Start date: 2007-05-09; Completion date: 2009-03-06
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.

Detailed description:

Arms: arm 1: Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) arm 2: Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm) arm 3: Placebo for sitaxsentan, orally administered once daily (double blind arm)
Interventions: intervention 1: Open intervention 2: Nifedipine intervention 3: Placebo
Intervention descriptions: intervention 1: Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) intervention 2: Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm) intervention 3: Placebo for sitaxsentan, orally administered once daily (double blind arm)

Protocol documents:
Clinical trial NCT00610441
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: randomized double blind placebo controlled
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-04-01; Completion date: 2009-03-09
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH 900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or placebo will be administered in a crossover fashion for two 3-week treatment periods. The two 3-week treatment periods will be separated by a 2-week placebo washout period.

The primary objective is to compare the efficacy of various doses of MK-8777 to that of placebo in the treatment of ADHD symptoms in adults.

Detailed description:

Arms: arm 1: Participants receive a fixed dose (FD) of MK-8777 100 mg twice each day (BID) for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo (PBO) BID for 3 weeks (Treatment Period 2). arm 2: Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2). arm 3: Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2). arm 4: Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
Interventions: intervention 1: MK-8777 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00434304
Conditions: Parkinson Disease
Keywords: Parkinson's Disease PD
Sponsor: GlaxoSmithKline
Start date: 2007-04-09; Completion date: 2009-03-10
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ropinirole prolonged release/extended release(PR/XR)
Intervention descriptions: intervention 1: Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).

Protocol documents:
Clinical trial NCT01272908
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-07-18; Completion date: 2009-03-12
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: 1000 mg intravenously on Days 1 and 15

Protocol documents:
Clinical trial NCT01294709
Conditions: Angina Pectoris Coronary Heart Disease Calcitonin Gene-related Peptide Receptor
Keywords: angina pectoris coronary artery disease calcitonin gene-related peptide exercise tolerance,
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-02-12; Completion date: 2009-03-13
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the safety of telcagepant in coronary artery disease (CAD) participants with stable angina during exercise treadmill testing and evaluate whether calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise tolerance in these participants. Primary hypothesis is that telcagepant does not significantly decrease exercise duration compared to placebo, as measured by a treadmill exercise test; that is, the true treatment difference in exercise duration (MK-0974 - Placebo) \>= -60 seconds.

Detailed description:
Amendment 3 of the protocol reduced the dose of telcagepant to be administered from a single dose of 900 mg to a single dose of 600 mg. Pooled data from both the 600-mg and the 900-mg group wiil be utilized in the analyses. Also due to supply issues regarding the 300 mg telcagepant capsules, 280 mg telcagepant tablets with demonstrated bioequivalence to the 300 mg telcagepant capsules, could be administered to participants enrolled after the implementation of Amendment 3.

Arms: arm 1: Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours. arm 2: Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
Interventions: intervention 1: telcagepant intervention 2: Placebo to telcagepant
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00348140
Conditions: Alzheimer's Disease
Keywords: adjunctive therapy moderate Alzheimer's disease apolipoprotein E mild rosiglitazone cognition
Sponsor: GlaxoSmithKline
Start date: 2006-07-12; Completion date: 2009-03-20
Enrollment: 1468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

Detailed description:
A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-3)

Arms: arm 1: Rosiglitazone Extended Release 2mg OD arm 2: Rosiglitazone Extended Release 8mg OD arm 3: Placebo
Interventions: intervention 1: Rosiglitazone Extended Release 2mg intervention 2: Rosiglitazone Extended Release 8mg intervention 3: Placebo
Intervention descriptions: intervention 1: Rosiglitazone Extended Release 2mg OD intervention 2: Rosiglitazone Extended Release 8mg OD intervention 3: Placebo

Protocol documents:
Clinical trial NCT00689104
Conditions: Urinary Bladder, Overactive
Keywords: Micturition Urinary incontinence Urinary urge incontinence Overactive bladder (OAB) Urgency YM178 Frequency
Sponsor: Astellas Pharma Inc
Start date: 2008-04-28; Completion date: 2009-03-24
Enrollment: 2336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Detailed description:

Arms: arm 1: Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks. arm 2: Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. arm 3: Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. arm 4: Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Interventions: intervention 1: Mirabegron intervention 2: Tolterodine intervention 3: Placebo to Mirabegron intervention 4: Placebo to Tolterodine
Intervention descriptions: intervention 1: Tablets intervention 2: Capsules intervention 3: Matching mirabegron placebo tablets. intervention 4: Matching tolterodine placebo capsules.

Protocol documents:
Clinical trial NCT00483704
Conditions: Migraines
Keywords: multiple attacks of moderate to severe migraine headaches
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-08-14; Completion date: 2009-03-25
Enrollment: 1935 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.

Detailed description:

Arms: arm 1: Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. arm 2: Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. arm 3: Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. arm 4: Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
Interventions: intervention 1: Telcagepant 140 mg intervention 2: Talcagepant 280 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Telcagepant 140 mg tablets intervention 2: Telcagepant 280 mg tablets intervention 3: Placebo tablets

Protocol documents:
Clinical trial NCT00395694
Conditions: Epilepsy
Keywords: epilepsy Incidence of rash safety evaluation for initial dose patients with Valproic acid
Sponsor: GlaxoSmithKline
Start date: 2006-08-07; Completion date: 2009-03-26
Enrollment: 102 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: lamictal
Intervention descriptions: intervention 1: anti-epileptic drug

Protocol documents:
Clinical trial NCT00776555
Conditions: Healthy
Keywords: Not required
Sponsor: Shire
Start date: 2008-11-21; Completion date: 2009-03-31
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.

Hypothesis: DRQ-S, question 2 will show no difference between the two drugs

Detailed description:
Not required

Arms: arm 1: 50mg capsule that has been emptied and made into solution arm 2: 20mg capsule that has been emptied, crushed, and made into solution
Interventions: intervention 1: Lisdexamfetamine Dimesylate intervention 2: Racemic mixture of dextroamphetamine and lisdexamfetamine
Intervention descriptions: intervention 1: Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit. intervention 2: Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.

Protocol documents:
Clinical trial NCT00056407
Conditions: Neoplasms, Prostate
Keywords: Prostate cancer prevention prostate BPH enlarged prostate PSA prostate cancer
Sponsor: GlaxoSmithKline
Start date: 2003-03-01; Completion date: 2009-04-01
Enrollment: 8231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Detailed description:

Arms: arm 1: Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio. arm 2: Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years. intervention 2: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.

Protocol documents: