ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01013753
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-02-01; Completion date: 2011-01-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: Very low dose inhaled orally once daily from the Respimat inhaler arm 3: Medium dose inhaled orally once daily from the Respimat inhaler arm 4: High dose inhaled orally once daily from the Respimat inhaler arm 5: 12mcg inhaled twice daily from the Aerolizer inhaler arm 6: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Interventions: intervention 1: Placebo intervention 2: Olodaterol (BI 1744) high intervention 3: Olodaterol (BI 1744) medium intervention 4: Olodaterol (BI 1744) very low intervention 5: Formoterol 12 mcg intervention 6: Olodaterol (BI 1744) low
Intervention descriptions: intervention 1: Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler intervention 2: Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 3: Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 4: Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 5: Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups intervention 6: Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Protocol documents:
Clinical trial NCT01018953
Conditions: Carcinoid Syndrome
Sponsor: Ipsen
Start date: 2010-02-01; Completion date: 2011-01-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.

Detailed description:

Arms: arm 1: This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
Interventions: intervention 1: BIM 23A760
Intervention descriptions: intervention 1: BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.

Protocol documents:
Clinical trial NCT01019928
Conditions: Sensitivity in Esophagus
Keywords: GERD patient esophagus pain
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2011-01-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD1386 intervention 2: Placebo to AZD1386
Intervention descriptions: intervention 1: 95 mg, oral solution, single dose intervention 2: Placebo, oral solution, single dose

Protocol documents:
Clinical trial NCT01027871
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.

Detailed description:
Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.

Arms: arm 1: Participants took both LY2605541 and their pre-study insulin for first several days arm 2: Participants took only LY2605541 with first dose doubled arm 3: None
Interventions: intervention 1: LY2605541 intervention 2: insulin glargine
Intervention descriptions: intervention 1: subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks intervention 2: subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks

Protocol documents:
Clinical trial NCT01028820
Conditions: Autism Spectrum Disorder
Keywords: autism asperger's repetitive restricted compulsions
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-08-01; Completion date: 2011-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (functional magnetic resonance imaging scans) where we will take pictures of your brain while performing simple tasks.

Detailed description:

Arms: arm 1: This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Protocol documents:
Clinical trial NCT01032291
Conditions: Colorectal Cancer
Keywords: Colorectal cancer Revlimid Lenalidomide Cetuximab Erbitux KRAS
Sponsor: Celgene Corporation
Start date: 2009-12-01; Completion date: 2011-01-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.

Detailed description:

Arms: arm 1: Combination therapy of lenalidomide plus cetuximab arm 2: Single agent therapy of lenalidomide
Interventions: intervention 1: cetuximab intervention 2: lenalidomide
Intervention descriptions: intervention 1: Intravenous infusions of cetuximab (400 mg/m\^2 Cycle 1 Day 1, thereafter 250 mg/m\^2), administered on days 1, 8, 15 and 22 of each 28 day cycle. intervention 2: Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle

Protocol documents:
Clinical trial NCT01040208
Conditions: Sexual Dysfunctions, Psychological Depression
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

Detailed description:

Arms: arm 1: Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs arm 2: Patient to receive 2 flibanserin tablets of 50 mg qhs arm 3: Patient to receive 2 placebo tablets of 50 mg qhs
Interventions: intervention 1: flibanserin 50 mg to 100 mg qhs intervention 2: flibanserin 100 mg qhs intervention 3: placebo 2 tablets qhs
Intervention descriptions: intervention 1: 50 to 100mg qhs intervention 2: 100mg qhs intervention 3: 50 mg placebo

Protocol documents:
Clinical trial NCT01040689
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Detailed description:

Arms: arm 1: olodaterol placebo and/or Tiotropium placebo inhaled once daily arm 2: Low dose inhaled orally once daily from Respimat inhaler arm 3: High dose inhaled orally once daily from Respimat inhaler arm 4: 18mcg inhaled once daily from Handihaler
Interventions: intervention 1: Olodaterol (BI1744) Low intervention 2: Placebo (for olodaterol BI1744) intervention 3: Placebo (for Tiotropium) intervention 4: Olodaterol (BI1744) High intervention 5: Tiotropium 18 mcg
Intervention descriptions: intervention 1: Low dose inhaled orally once daily from Respimat inhaler intervention 2: Placebo (olodaterol low and high dose)delivered by Respimat intervention 3: Placebo (Tiotropium 18 mcg) delivered by HandiHaler intervention 4: High dose inhaled orally once daily from Respimat inhaler intervention 5: 18mcg inhaled once daily from Handihaler

Protocol documents:
Clinical trial NCT01040728
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from Respimat inhaler arm 2: High dose inhaled orally once daily from Respimat inhaler arm 3: 18 mcg inhaled once daily from HandiHaler arm 4: Olodaterol placebo and/or Tiotropium placebo inhaled once daily
Interventions: intervention 1: Olodaterol (BI1744) Low intervention 2: Olodaterol (BI1744) High intervention 3: Tiotropium 18 mcg intervention 4: Placebo (for Olodaterol (BI1744)l) intervention 5: Placebo (for Tiotropium)
Intervention descriptions: intervention 1: Low dose inhaled orally once daily from Respimat inhaler intervention 2: High dose inhaled orally once daily from Respimat inhaler intervention 3: 18 mcg inhaled once daily from HandiHaler intervention 4: Placebo (olodaterol low and high dose) delivered by Respimat intervention 5: Placebo (Tiotropium 18 mcg) delivered by HandiHaler

Protocol documents:
Clinical trial NCT01042392
Conditions: Essential Hypertension
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril
Sponsor: Novartis
Start date: 2009-11-01; Completion date: 2011-01-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Detailed description:

Arms: arm 1: In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 2: In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 3: In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 4: In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).
Interventions: intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Matching placebo to Aliskiren intervention 4: Matching placebo to Ramipril
Intervention descriptions: intervention 1: 150 mg Aliskiren as film-coated tablet intervention 2: Ramipril 5 mg was given in capsule form. intervention 3: The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm. intervention 4: The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Protocol documents:
Clinical trial NCT01049412
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine

Detailed description:
Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.

Arms: arm 1: Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks. arm 2: Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.
Interventions: intervention 1: LY2605541 intervention 2: Insulin glargine
Intervention descriptions: intervention 1: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods. intervention 2: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.

Protocol documents:
Clinical trial NCT01051960
Conditions: Systemic Sclerosis Shortness of Breath Pulmonary Hypertension
Keywords: Systemic Sclerosis connective tissue disease Shortness of breath Pulmonary Hypertension
Sponsor: University of California, Los Angeles
Start date: 2009-03-01; Completion date: 2011-01-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma

Detailed description:
The current literature addresses therapies for patients with resting PAH only, diagnosed by right heart catheterization. However, the World Health Organization (WHO) also recognizes and defines exercise induced pulmonary arterial hypertension (ex-PAH), which may precede the development of resting PAH. The natural progression of PAH, especially during exercise, has not been well delineated. An exercise hemodynamic study previously showed that in normal healthy subjects the mean pulmonary pressure does not exceed 30mmHg even at maximal cardiac outputs. A prior study evaluated exercise Doppler echocardiography systemic sclerosis patients with normal resting echocardiograms, finding an abnormal response which was defined as an estimated right ventricular systolic pressure greater than 40 mmHg. In the same study, 6.6% of the patients progressed to resting PAH over the followup period of 12 months. Limited data is available regarding the prevalence of ex-PAH in systemic sclerosis using right heart catheterization.

Arms: arm 1: ambrisentan dosed at either 5mg or 10mg orally once per day
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: Ambrisentan 5mg or 10mg once daily

Protocol documents:
Clinical trial NCT01056315
Conditions: Painful Diabetic Neuropathy
Keywords: Analgesia Diabetic Neuropathy Neuropathic pain Painful Chronic pain
Sponsor: Grünenthal GmbH
Start date: 2009-11-01; Completion date: 2011-01-01
Enrollment: 553 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Detailed description:

Arms: arm 1: Participants randomly assigned to receive GRT3983Y. arm 2: Participants randomly assigned to placebo.
Interventions: intervention 1: GRT3938Y intervention 2: Placebo
Intervention descriptions: intervention 1: Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment. intervention 2: Overencapsulated tablets of placebo, 16 weeks treatment.

Protocol documents:
Clinical trial NCT01057251
Conditions: Hypertension
Keywords: Nebivolol Bystolic TM Hypertension Stage 2 Hypertension
Sponsor: Forest Laboratories
Start date: 2010-03-01; Completion date: 2011-01-01
Enrollment: 433 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nebivolol intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg, titrated to 20 mg, once daily oral administration intervention 2: 5 mg or 20 mg once daily, oral administration

Protocol documents:
Clinical trial NCT01057901
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2010-01-01; Completion date: 2011-01-01
Enrollment: 748 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Detailed description:

Arms: arm 1: Flibanserin 100 mg administered at bedtime arm 2: This is the matched placebo which will be administered two tablets daily at bedtime.
Interventions: intervention 1: Flibanserin intervention 2: Placebo
Intervention descriptions: intervention 1: Flibanserin 100mg administered at bedtime for 24 weeks intervention 2: This is the matched placebo which will be administered two tablets daily at bedtime.

Protocol documents:
Clinical trial NCT01065051
Conditions: Hypertension, Pulmonary Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension Left ventricular dysfunction
Sponsor: Bayer
Start date: 2010-11-01; Completion date: 2011-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Detailed description:
Adverse event data will be covered in Adverse events section.

Arms: arm 1: Participants received a single oral dose of 1 mg riociguat. arm 2: Participants received a single oral dose of 1 mg placebo.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg single oral dose intervention 2: Single oral dose

Protocol documents:
Clinical trial NCT01077375
Conditions: Fibromyalgia
Keywords: Milnacipran Duloxetine Switch Forest Research Institute
Sponsor: Forest Laboratories
Start date: 2010-02-01; Completion date: 2011-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Detailed description:
* Two weeks Duloxetine 60 mg Open-Label Period
* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period

Arms: arm 1: Placebo tablets, twice a day, oral administration arm 2: Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
Interventions: intervention 1: Placebo intervention 2: Milnacipran
Intervention descriptions: intervention 1: * Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period. intervention 2: * Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Protocol documents:
Clinical trial NCT01093846
Conditions: Uveitis
Keywords: uveitis
Sponsor: Novartis Pharmaceuticals
Start date: 2010-03-01; Completion date: 2011-01-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AIN457 intervention 2: AIN457 intervention 3: Placebo AIN457
Intervention descriptions: intervention 1: 300mg every 4 weeks intervention 2: 300mg every 2 weeks intervention 3: Placebo to AIN457

Protocol documents: