ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01177813
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2012-03-01
Enrollment: 986 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Detailed description:

Arms: arm 1: Patients receive BI 10773 low dose tablets once daily arm 2: Patients receive BI 10773 high dose tablets once daily arm 3: Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin arm 4: Patients receive Sitagliptin 100 mg tablets once daily arm 5: Patients receive BI 10773 high dose tablets open label once daily
Interventions: intervention 1: Placebo identical to BI10773 high dose intervention 2: BI 10773 intervention 3: BI 10773 open label intervention 4: Placebo identical to BI10773 low dose intervention 5: Placebo identical to BI10773 low dose intervention 6: Placebo identical to BI10773 high dose intervention 7: Placebo identical to Sitagliptin 100mg intervention 8: Placebo identical to Sitagliptin 100mg intervention 9: BI10773 intervention 10: Sitagliptin intervention 11: Placebo identical to Sitagliptin 100mg intervention 12: Placebo identical to BI10773 low dose intervention 13: Placebo identical to BI10773 high dose
Intervention descriptions: intervention 1: placebo tablets once daily intervention 2: BI 10773 low dose tablet once daily intervention 3: Patients receive BI 10773 high dose tablets open label once daily intervention 4: placebo tablets once daily intervention 5: placebo tablets once daily intervention 6: placebo tablets once daily intervention 7: placebo tablets once daily intervention 8: placebo tablets once daily intervention 9: BI 10773 high dose tablets once daily intervention 10: Sitagliptin tablets 100 mg once daily intervention 11: placebo tablets once daily intervention 12: placebo tablets once daily intervention 13: placebo tablets once daily

Protocol documents:
Clinical trial NCT01179347
Conditions: Cystic Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

Detailed description:

Arms: arm 1: 2 inhalations once daily delivered with Respimat® inhaler arm 2: 2 inhalations once daily delivered with Respimat® inhaler
Interventions: intervention 1: tiotropium Respimat® inhaler intervention 2: Placebo Respimat® inhaler
Intervention descriptions: intervention 1: to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo. intervention 2: patient to receive placebo matching active drug once daily

Protocol documents:
Clinical trial NCT01182610
Conditions: Gastroesophageal Adenocarcinoma Adenocarcinoma of the Distal Esophagus Adenocarcinomas of the Gastroesophageal Junction Adenocarcinoma of the Proximal Stomach
Sponsor: Accelerated Community Oncology Research Network
Start date: 2011-04-01; Completion date: 2012-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

Detailed description:

Arms: arm 1: Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36
Interventions: intervention 1: Panitumumab intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: 5FU
Intervention descriptions: intervention 1: Panitumumab 9mg/kg on Days 1, 22, and 43 intervention 2: Paclitaxel 200mg/m2 on Days 1 and 22 intervention 3: Carboplatin AUC=6 on Days 1 and 22 intervention 4: 5FU 225mg/m2/day on Days 1-15 and 22-36

Protocol documents:
Clinical trial NCT01184053
Conditions: Endometrial Carcinoma
Keywords: endometrial carcinoma recurrent metastatic Trisenox arsenic trioxide Phase II VEGF gynecology Lineberger UNC vascular endothelial growth factor University of North Carolina at Chapel Hill
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2010-03-01; Completion date: 2012-03-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to see whether women who have already received chemotherapy for their endometrial cancer, or who have disease that has spread outside of the uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their tumor.

Detailed description:
This is an open-label, single arm, single institution, phase II trial designed to assess the response rate and safety of Trisenox® in women with recurrent endometrial carcinoma. Trisenox® will be administered at a dose of 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks. A 4-week period will be defined as a cycle of treatment. Marker and non-marker lesions will be assessed every 2 cycles (every 8 weeks) and the response assigned according to Gynecologic Oncology Group (GOG) RECIST guidelines. Safety will be assessed by routine physical, laboratory and ECG evaluations. Up to 10 patients will be enrolled into the study. Patients are expected (excluding any unforeseen toxicities) to receive a minimum of 2 and a maximum of 6 cycles of Trisenox®. (Patients with at least documented stable disease may be eligible for \>6 cycles). Patients will be followed for 6 months after their last dose of Trisenox®.

For this trial we would allow one prior cytotoxic regimen since the time of recurrence and patients may have had one prior regimen as part of their induction chemotherapy. Patients will be treated with 0.25 mg/kg/day for days 1-5 every 28 days and patients may remain on trial until progression of disease.

Arms: arm 1: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Interventions: intervention 1: Arsenic trioxide
Intervention descriptions: intervention 1: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.

Protocol documents:
Clinical trial NCT01187043
Conditions: Amenorrhea
Keywords: Liver Function Steady State Exposure
Sponsor: Repros Therapeutics Inc.
Start date: 2010-08-01; Completion date: 2012-03-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.

Detailed description:
A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo in healthy adult female subjects of reproductive age. Exposure to study drug will be for up to 10 weeks. In-clinic pharmacokinetic (PK) assessments will be made on the first day of dosing and on the last day (week 10). Office visits will occur every week to assess liver function and trough blood concentrations for Proellex and primary metabolite. Daily vaginal bleeding diaries will be maintained during the course of the study. A single blind run-in period of up to 56 days will begin the study to assess baseline menstrual patterns will be utilized. Twelve subjects per treatment group (total 60 subjects) will be assigned to each dose. New groups will not begin dosing until the previous dose group has completed. Daily treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex. A single blind run-in period using placebo will be incorporated to establish baseline parameters.

Arms: arm 1: 1 mg Proellex arm 2: 3 mg Proellex arm 3: 6 mg Proellex arm 4: 9 mg Proellex arm 5: 12 mg proellex
Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

Protocol documents:
Clinical trial NCT01190020
Conditions: Chronic Constipation, Methanogenesis
Sponsor: Augusta University
Start date: 2009-02-01; Completion date: 2012-03-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether Lubiprostone has effects on colonic methanogenesis is not known. The investigators hypothesize that the effects of Lubiprostone may in part be due to its effects on altering colonic flora, particularly methanogenic flora.

By altering the colonic stasis of stool and through more efficient clearance of digestive residue, the investigators anticipate that Lubiprostone may either inhibit or promote better excretion of methanogenic flora, and thereby decrease the gut load of methane producing bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an increased rate of spontaneous bowel movements and reduction of constipation symptoms.

The aim is to investigate the effects of Lubiprostone on intestinal methane production and bowel symptoms in patients with chronic constipation, by performing a randomized, double blind, placebo controlled study.

Detailed description:

Arms: arm 1: 24mcg BID for 4 weeks, oral medication arm 2: 24mcg BID for 4 weeks (placebo), oral medication
Interventions: intervention 1: Lubiprostone intervention 2: Lubiprostone Control
Intervention descriptions: intervention 1: Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed. intervention 2: Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed.

Protocol documents:
Clinical trial NCT01195272
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-08-01; Completion date: 2012-03-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks, 52 weeks

Protocol documents:
Clinical trial NCT01196104
Conditions: Type 2 Diabetes
Sponsor: Mannkind Corporation
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Detailed description:
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.

Arms: arm 1: Insulin Glargine and Technosphere® Insulin Inhalation Powder arm 2: Insulin Glargine and Insulin Aspart
Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Insulin Aspart intervention 3: Insulin Glargine
Intervention descriptions: intervention 1: None intervention 2: Usual Care intervention 3: None

Protocol documents:
Clinical trial NCT01202188
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide
Sponsor: Novartis Pharmaceuticals
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 2144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 2: NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 3: QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 4: Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 5: Matching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Interventions: intervention 1: indacaterol and glycopyrronium (QVA149) intervention 2: glycopyrronium (NVA237) intervention 3: indacaterol (QAB149) intervention 4: tiotropium intervention 5: placebo
Intervention descriptions: intervention 1: Capsules for inhalation delivered via SDDPI. intervention 2: Capsules for inhalation delivered via SDDPI. intervention 3: Capsules for inhalation delivered via SDDPI. intervention 4: Capsules for inhalation delivered via HandiHaler® device. intervention 5: Placebo to match capsules for inhalation delivered via SDDPI.

Protocol documents:
Clinical trial NCT01202227
Conditions: Spinal Cord Diseases Spinal Cord Injuries Neuralgia Pain
Keywords: Central Nervous System Diseases Therapeutic Uses Wounds and Injuries Trauma Nervous System pregabalin
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 104 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).

Detailed description:

Arms: arm 1: Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: Pregabalin capsules taken twice a daily (150-600mg/day)

Protocol documents:
Clinical trial NCT01205451
Conditions: Spasticity, Post-Stroke
Keywords: GSK1358820 upper limb spasticity post-stroke
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2012-03-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 "200U or 240U (if thumb spasticity is present)". The subjects will be observed until 12 weeks post injection. Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale. Safety parameters will be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).

Detailed description:
This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for the treatment of patients with focal wrist, finger and in some cases, thumb spasticity post-stroke. Qualified patients will be eligible for enrollment upon completion of double-blind study 112958. Patients will receive a single treatment session with intramuscular injections of GSK1358820 "200U or 240U (if thumb spasticity is present)".The subjects will be observed for 12 weeks post injection.

Each completed subject will attend 4 clinic visits. The maximum study duration is 13 weeks. The study includes a 1 week pretreatment period, during which the screening visit (visit 1 could be the last visit of previous double-blind study 112958 or any time within 3 months after completion of previous study) is to take place. Only one upper limb (meeting inclusion/exclusion criteria) will be evaluated and treated in the study. Subjects will receive a single intramuscular treatment with investigated drug at day 0 (visit 2). There will be two post-injection follow-up visits at week 6 and 12 (visits 3 to 4).

Arms: arm 1: Botulinum toxin type A
Interventions: intervention 1: Botulinum toxin type A
Intervention descriptions: intervention 1: Botulinum toxin type A

Protocol documents:
Clinical trial NCT01209143
Conditions: Solid Cancers
Sponsor: Genentech, Inc.
Start date: 2010-11-01; Completion date: 2012-03-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-arm, multicenter, Phase Ib study designed to describe the effect of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists.

Detailed description:

Arms: arm 1: Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent. arm 2: Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.
Interventions: intervention 1: Vismodegib intervention 2: Rosiglitazone intervention 3: Norethindrone/ethinyl estradiol
Intervention descriptions: intervention 1: Vismodegib was supplied in hard gelatin capsules. intervention 2: Rosiglitazone was supplied in tablets. intervention 3: Norethindrone/ethinyl estradiol was supplied in tablets.

Protocol documents:
Clinical trial NCT01231750
Conditions: Stable Angina
Sponsor: Neal Weintraub
Start date: 2010-10-01; Completion date: 2012-03-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.

Detailed description:
Patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ECG for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and hemodynamic responses.

Arms: arm 1: 0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise arm 2: Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
Interventions: intervention 1: Capsaicin intervention 2: Placebo cream
Intervention descriptions: intervention 1: 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise intervention 2: cream, 4cm spread over 8cm x 15cm area of skin

Protocol documents: