ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00619957
Conditions: Other Osteoporosis
Sponsor: Warner Chilcott
Start date: 2002-06-01; Completion date: 2007-05-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: Placebo tablet intervention 2: Risedronate
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00691028
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA Infliximab TA-650 Remicade
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2005-09-01; Completion date: 2007-05-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TA-650 3 mg/kg intervention 2: TA-650 6 mg/kg intervention 3: TA-650 10 mg/kg
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT00716144
Conditions: Psoriasis
Keywords: Psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2006-06-01; Completion date: 2007-05-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: Talarozole 0.5 mg arm 2: Talarozole 1.0 mg arm 3: Talarozole 2.0 mg arm 4: Talarozole matching Placebo
Interventions: intervention 1: Talarozole
Intervention descriptions: intervention 1: Oral Capsule Once Daily

Protocol documents:
Clinical trial NCT01049373
Conditions: Low Back Pain
Keywords: low-back pain chronic constitution diathesism homoeopathy fixed combination herbal preparation chronic low back pain lasting more than 6 months
Sponsor: Pascoe Pharmazeutische Praeparate GmbH
Start date: 2003-12-01; Completion date: 2007-05-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: 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
Interventions: intervention 1: HDC intervention 2: Placebo solution
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00939367
Conditions: Healthy
Sponsor: Torrent Pharmaceuticals Limited
Start date: 2007-02-24; Completion date: 2007-05-02
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

Detailed description:
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.

Arms: arm 1: Torrent's Zolpidem TartrateTablets 10 mg arm 2: Sanofi-Synthelabo Inc's Ambient® Tablets 10 mg
Interventions: intervention 1: Zolpidem Tartrate Tablets 10 mg intervention 2: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00305084
Conditions: Cancer
Keywords: NGR-hTNF doxorubicin solid tumors
Sponsor: AGC Biologics S.p.A.
Start date: 2006-02-28; Completion date: 2007-05-08
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
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 ).

Detailed description:
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.

Arms: arm 1: None
Interventions: intervention 1: NGR-hTNF intervention 2: Doxorubicin
Intervention descriptions: 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)

Protocol documents:
Clinical trial NCT00372112
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD) COPD
Sponsor: GlaxoSmithKline
Start date: 2006-11-03; Completion date: 2007-05-10
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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

Detailed description:
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.

Arms: arm 1: Twice daily in the morning. arm 2: Twice daily in the morning. arm 3: Twice daily. arm 4: Twice daily
Interventions: intervention 1: GW642444 intervention 2: Placebo
Intervention descriptions: intervention 1: GW642444H intervention 2: Placebo administered twice daily

Protocol documents:
Clinical trial NCT00464568
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Seasonal allergic rhinitis, hayfever
Sponsor: GlaxoSmithKline
Start date: 2007-03-28; Completion date: 2007-05-16
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Interventions: intervention 1: GSK256066
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03642873
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser LLC
Start date: 2007-05-05; Completion date: 2007-05-21
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: 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.
Interventions: intervention 1: Humibid® intervention 2: Hydrocodone Bitartrate intervention 3: Humibid® and Hydrocodone Bitartrate tablet
Intervention descriptions: 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)

Protocol documents:
Clinical trial NCT00135512
Conditions: Depressive Disorder
Keywords: MDD
Sponsor: GlaxoSmithKline
Start date: 2004-12-01; Completion date: 2007-05-28
Enrollment: 234 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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

Detailed description:

Interventions: intervention 1: bupropion hydrochloride
Intervention descriptions: intervention 1: Study drug

Protocol documents:
Clinical trial NCT00150813
Conditions: Epilepsy, Tonic-clonic
Keywords: Monotherapy Epilepsy Keppra Levetiracetam
Sponsor: UCB Pharma SA
Start date: 2005-08-10; Completion date: 2007-05-29
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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

Detailed description:

Arms: arm 1: Subjects received open-label Levetiracetam.
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: Pharmaceutical form: oral tablets Route of administration: Oral use

Protocol documents:
Clinical trial NCT00129402
Conditions: Hypercholesterolemia
Keywords: cholesterol drugs hypercholesterolemia adolescent randomized controlled trials
Sponsor: Organon and Co
Start date: 2005-08-01; Completion date: 2007-06-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: 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
Interventions: intervention 1: ezetimibe with simvastatin intervention 2: simvastatin
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00196326
Conditions: Contraception
Keywords: pregnancy prevention oral contraceptives
Sponsor: Duramed Research
Start date: 2005-06-01; Completion date: 2007-06-01
Enrollment: 2235 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:

Arms: arm 1: Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
Interventions: intervention 1: DR-1011
Intervention descriptions: 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).

Protocol documents:
Clinical trial NCT00043186
Conditions: Low Bone Mineral Density
Keywords: bone loss osteoporosis
Sponsor: Amgen
Start date: 2002-05-01; Completion date: 2007-06-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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.
Interventions: intervention 1: Placebo intervention 2: Denosumab intervention 3: Alendronate
Intervention descriptions: intervention 1: Placebo subcutaneous injection intervention 2: Denosumab for subcutaneous injection intervention 3: Alendronate 70 mg tablets

Protocol documents:
Clinical trial NCT00246025
Conditions: Arthroplasty, Replacement, Knee Venous Thrombosis
Sponsor: Boehringer Ingelheim
Start date: 2005-10-01; Completion date: 2007-06-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran Etexilate intervention 4: placebo
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00265239
Conditions: Myocardial Infarction Reperfusion Injury
Keywords: Edaravone Randomized Control Trial ST-Elevation Myocardial Infarction Coronary Angioplasty
Sponsor: Kumamoto University
Start date: 2001-04-01; Completion date: 2007-06-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Edaravone Group arm 2: Placebo Group
Interventions: intervention 1: edaravone
Intervention descriptions: intervention 1: intravenous administration of 30mg Edaravone just before reperfusion therapy

Protocol documents:
Clinical trial NCT00286442
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2006-03-01; Completion date: 2007-06-01
Enrollment: 527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin
Intervention descriptions: 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.

Protocol documents: