ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01349491
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Ranolazine
Sponsor: University of Oklahoma
Start date: 2012-03-01; Completion date: 2014-06-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.

Detailed description:
Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.

Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.

Arms: arm 1: Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. arm 2: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Interventions: intervention 1: Ranolazine intervention 2: Matching placebo
Intervention descriptions: intervention 1: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months. intervention 2: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.

Protocol documents:
Clinical trial NCT01355484
Conditions: Muscle Wasting Non Small Cell Lung Cancer
Sponsor: GTx
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".

Detailed description:
This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer (NSCLC). Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total lean body mass and physical function.

Arms: arm 1: subject will receive GTx-024 treatment for the duration of the trial arm 2: subject will receive placebo for the duration of the trial
Interventions: intervention 1: GTx-024 intervention 2: placebo
Intervention descriptions: intervention 1: subjects will be randomized to receive GTx-024 for the full duration of the trial. intervention 2: subject will receive placebo for the duration of the trial

Protocol documents:
Clinical trial NCT01355497
Conditions: Muscle Wasting Non-Small Cell Lung Cancer
Sponsor: GTx
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.

Detailed description:
This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer. Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total Lean Body Mass (LBM) and physical function.

Arms: arm 1: subjects will be randomized to receive GTx-024 3mg sofgel capsule once daily for the duration of the trial arm 2: subjects will be randomized to receive matching placebo once daily for the duration of the trial
Interventions: intervention 1: GTx-024 intervention 2: placebo
Intervention descriptions: intervention 1: subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial. intervention 2: subject will receive matching placebo for the duration of the trial

Protocol documents:
Clinical trial NCT01395797
Conditions: Heroin Dependence Nicotine Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2011-03-01; Completion date: 2014-06-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Detailed description:
Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.

Arms: arm 1: Participants will be maintained on 0 mg of Pioglitazone (PIO) prior to sessions assessing the abuse liability of heroin. arm 2: Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of heroin. arm 3: Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of heroin. arm 4: Participants will be maintained on 0 mg of PIO prior to sessions assessing the abuse liability of nicotine. arm 5: Participants will be maintained on 15 mg of PIO prior to sessions assessing the abuse liability of nicotine arm 6: Participants will be maintained on 45 mg of PIO prior to sessions assessing the abuse liability of nicotine
Interventions: intervention 1: PIO intervention 2: Placebo
Intervention descriptions: intervention 1: 0, 15, and 45 mg per day. intervention 2: Placebo

Protocol documents:
Clinical trial NCT01395966
Conditions: Acute Otitis Media
Keywords: with tubes
Sponsor: Salvat
Start date: 2011-06-01; Completion date: 2014-06-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.

Detailed description:

Arms: arm 1: Ear drops arm 2: Ear drops arm 3: Ear drops
Interventions: intervention 1: DF289 intervention 2: DF277 intervention 3: DF289 plus DF277
Intervention descriptions: intervention 1: Ear drops intervention 2: Ear drops intervention 3: Ear drops

Protocol documents:
Clinical trial NCT01401062
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer TGF-beta fresolimumab monoclonal antibody radiation therapy abscopal response
Sponsor: Weill Medical College of Cornell University
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

Detailed description:

Arms: arm 1: Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2). arm 2: Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Interventions: intervention 1: Fresolimumab intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01406223
Conditions: Nicotine Dependence
Keywords: Nicotine addiction Cigarette smoking Smoking cessation Zyban Chantix Nicotine patches varenicline bupropion fMRI
Sponsor: Duke University
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.

Detailed description:

Arms: arm 1: For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. arm 2: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. arm 3: For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. arm 4: Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.
Interventions: intervention 1: Varenicline intervention 2: Bupropion intervention 3: Nicotine patches intervention 4: Placebo varenicline intervention 5: Placebo bupropion intervention 6: Placebo patch
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01421472
Conditions: ER Positive, Her2 Negative Breast Cancer Patients Triple Negative Breast Cancer Patients
Keywords: Breast Cancer Neoadjuvant Her2 negative Her2 non-overexpressing Estrogen Receptor Positive Triple Negative MM-121 Paclitaxel
Sponsor: Merrimack Pharmaceuticals
Start date: 2011-08-01; Completion date: 2014-06-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.

Detailed description:
This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.

Arms: arm 1: 2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery. arm 2: Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Interventions: intervention 1: MM-121 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses intervention 2: Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Protocol documents:
Clinical trial NCT01427933
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2011-11-01; Completion date: 2014-06-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin together versus eribulin alone, in participants with locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: Ramucirumab 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle

Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle arm 2: Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Interventions: intervention 1: Ramucirumab (IMC-1121B) intervention 2: Eribulin
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously

Protocol documents:
Clinical trial NCT01431170
Conditions: Congenital Nasolacrimal Duct Obstruction
Sponsor: Rutgers, The State University of New Jersey
Start date: 2011-09-01; Completion date: 2014-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The hypothesis of the study is that Besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.

Detailed description:
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.

Arms: arm 1: Besivance™ ophthalmic suspension, 0.6% arm 2: Polytrim ophthalmic solution
Interventions: intervention 1: Besivance Treatment Group intervention 2: Polytrim Treatment Group
Intervention descriptions: intervention 1: Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. intervention 2: Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.

Protocol documents:
Clinical trial NCT01433250
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, demyelinating autoimmune diseases, interleukin-17, monoclonal human antibody
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2014-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.

Detailed description:

Arms: arm 1: (10mg/kg i.v.). AIN 457 core study /AIN 457 Extension arm 2: (10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension
Interventions: intervention 1: AIN457 intervention 2: AIN457
Intervention descriptions: intervention 1: (10mg/kg i.v.). intervention 2: (10mg/kg i.v.).

Protocol documents:
Clinical trial NCT01451632
Conditions: Colorectal Cancer Squamous Cell Head and Neck Cancer Non-small Cell Lung Cancer Triple Negative Breast Cancer Other Tumors With EGFR Dependence
Keywords: Metastatic Colorectal cancer Kras wild-type Squamous cell head and neck cancer Non-small cell lung cancer Triple negative breast cancer EGFR ErbB3 MM-121 Cetuximab Irinotecan
Sponsor: Merrimack Pharmaceuticals
Start date: 2011-10-01; Completion date: 2014-06-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Detailed description:
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.

Arms: arm 1: increasing doses of weekly MM-121 + weekly cetuximab arm 2: increasing doses of irinotecan + the Recommended Phase 2 Dose/Maximum Tolerated Dose (RP2D/MTD) of MM121 + cetuximab as determined in Part 1
Interventions: intervention 1: MM-121 intervention 2: Irinotecan intervention 3: Cetuximab
Intervention descriptions: intervention 1: escalating doses MM-121 IV QW intervention 2: 180 mg/m2 IV Q2W intervention 3: escalating doses cetuximab IV QW

Protocol documents:
Clinical trial NCT01459718
Conditions: Transfusion-dependent β-thalassemia Patients Cardiac Iron Overload
Keywords: Severe cardiac iron overload deferasirox β-thalassaemia cardiac dysfunction
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2014-06-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary efficacy endpoint of this interventional study was to evaluate the number of patients achieving a complete response (CR), defined as patients switching from intensive deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2\* value to \>10ms, and continue to maintain their MRI T2\* to values \>10 msec.

Detailed description:
This study was planned to recruit 52 transfusion-dependent β-thalassemia patients with severe cardiac iron overload. However only 13 patients participated in the study during a 3 year and 5 month timeframe. The study was terminated due to the slow enrollment rate due to scarcity of the patient population with severe cardiac iron overload.

Arms: arm 1: During Phase A, the induction treatment at entry, participants received Deferasirox -DFO combination. During Phase B, when participants transitioned to less intensive chelation therapy, participants received Deferasirox monotherapy.
Interventions: intervention 1: Deferasirox intervention 2: Deferoxamine (DFO)
Intervention descriptions: intervention 1: 20-40 mg/kg/day orally, once daily intervention 2: 40 mg/kg/day subcutaneous (sc) infusion, 3-4 days per week

Protocol documents:
Clinical trial NCT01474434
Conditions: Coronary Artery Disease Hypertriglyceridemia
Keywords: coronary artery disease, LCQ908, hyperlipidemia, hypertriglyceridemia, pradigastat
Sponsor: Novartis Pharmaceuticals
Start date: 2011-12-01; Completion date: 2014-06-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact cardiovascular risk.

Detailed description:
This study had 2 parts. Part A was a multicenter, double-blind, randomized, placebo-controlled, non-confirmatory crossover study assessing response to a high-fat meal challenge in the setting of pradigastat versus placebo. Part A had 2 cohorts i.e. Cohort 1 patients with stable coronary artery disease and hypertriglyceridemia and Cohort 2 patients with asymptomatic non-obstructive coronary artery disease or elevated coronary heart disease risk and hypertriglyceridemia.

Part B was a double blinded phase designed to assess response to three months of chronic treatment with pradigastat versus placebo on a normal diet.

The trial was terminated after the interim analysis of Part A, Cohort 1. The interim analysis results indicated that the high-fat meal challenge did not induce any impairment on either myocardial perfusion reserve index (MPRi) or exercise treadmill performance. Part B was never started.

Arms: arm 1: Pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment arm 2: Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by p20 mg (2 x 10-mg tablets) daily for two days
Interventions: intervention 1: pradigastat (LCQ908) intervention 2: Placebo
Intervention descriptions: intervention 1: pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs. intervention 2: matching placebo tablets

Protocol documents: