ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01419197
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-09-01; Completion date: 2015-08-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

Detailed description:

Arms: arm 1: Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity. arm 2: Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
Interventions: intervention 1: Trastuzumab emtansine intervention 2: Treatment of physician's choice
Intervention descriptions: intervention 1: The dose was calculated based on the patient's Baseline weight on Day 1 of each 3-week treatment cycle. The same dose was administered in subsequent cycles if the patient's weight stayed within 10% of the Baseline weight. If there was a weight change \> 10%, the dose was adjusted accordingly and the recorded weight became the new Baseline weight. Trastuzumab emtansine was provided as a single-use lyophilized formulation. intervention 2: The treatment of physician's choice (TPC) was a protocol-specified approved or standard of care therapy or combination of therapies, based on frequently used regimens for late-line HER2-positive metastatic breast cancer treatment after receipt of both trastuzumab- and lapatinib-containing regimens. The therapies included single-agent chemotherapy, single-agent (e.g., tamoxifen or aromatase inhibitor) or dual-agent (e.g., aromatase inhibitor with luteinizing hormone releasing hormone \[LHRH\] agonist) hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.

Participants who had documented progressive disease (PD) were eligible to switch treatment to receive trastuzumab emtansine 3.6 mg/kg. Participants who switched treatment remained on trastuzumab emtansine treatment until another PD event or unmanageable toxicity.

The formulation, storage, and preparation of all TPC were as per the appropriate package insert or national prescribing information.

Protocol documents:
Clinical trial NCT01445028
Conditions: Proliferative Vitreoretinopathy
Sponsor: Wills Eye
Start date: 2011-09-01; Completion date: 2015-08-01
Enrollment: 109 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. The purpose of this study is to evaluate the effect of oral isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.

Detailed description:
Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR. This is a prospective study to evaluate a low dose of oral isotretinoin in this regard. There are two arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes with primary detachment and features associated with a high risk of PVR formation. Eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.

Arms: arm 1: Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy arm 2: Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Interventions: intervention 1: Isotretinoin
Intervention descriptions: intervention 1: Isotretinoin 20mg daily for 12 weeks

Protocol documents:
Clinical trial NCT01448057
Conditions: Upper Respiratory Tract Infection Nasal Congestion Rhinorrhea Sneezing
Keywords: Paracetamol dimethindene maleate phenylephrine hydrochloride cold and flu symptoms
Sponsor: Novartis
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).

Detailed description:

Arms: arm 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets arm 2: Paracetamol (500 mg) tablets
Interventions: intervention 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets intervention 2: Paracetamol (500 mg) tablets
Intervention descriptions: intervention 1: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets intervention 2: Paracetamol (500 mg) tablets

Protocol documents:
Clinical trial NCT01450696
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-12-01; Completion date: 2015-08-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m\^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m\^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.

Detailed description:

Arms: arm 1: Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as a standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m\^2 intravenously q3w plus capecitabine 800 mg/m\^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6). arm 2: Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m\^2 intravenously q3w plus capecitabine 800 mg/m\^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Interventions: intervention 1: Capecitabine intervention 2: Cisplatin intervention 3: Herceptin
Intervention descriptions: intervention 1: Capecitabine will be administered at a dose of 800 mg/m\^2 orally twice daily for 14 days q3w for up to 6 cycles (Cycles 1 to 6). intervention 2: Cisplatin will be administered at a dose of 80 mg/m\^2 intravenously q3w on Day 1 of each 3-week cycle for up to 6 cycles (Cycles 1 to 6). intervention 3: Herceptin will be administered at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 or 10 mg/kg (depending upon treatment assignment) q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Protocol documents:
Clinical trial NCT01488448
Conditions: Bronchiolitis
Keywords: Hypertonic saline Bronchiolitis Infants Wheezing Nebulized Bronchodilator
Sponsor: Montefiore Medical Center
Start date: 2011-11-01; Completion date: 2015-08-01
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Detailed description:
Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Arms: arm 1: 4mL nebulized 3% sodium chloride every 4 hours until discharge arm 2: 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Interventions: intervention 1: 3% sodium chloride intervention 2: 0.9% sodium chloride
Intervention descriptions: intervention 1: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge intervention 2: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Protocol documents:
Clinical trial NCT01532869
Conditions: Sclerosis, Systemic
Sponsor: Hoffmann-La Roche
Start date: 2012-03-01; Completion date: 2015-08-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: Subcutaneously weekly, Weeks 0-48 intervention 2: 162 mg subcutaneously weekly, Weeks 0-48 intervention 3: 162 mg subcutaneously weekly, Week 48-96

Protocol documents:
Clinical trial NCT01556438
Conditions: Multiple Myeloma
Sponsor: Eli Lilly and Company
Start date: 2012-07-01; Completion date: 2015-08-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effect on the body of Tabalumab (LY2127399) in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma (MM).

Detailed description:
The study has 3 cohorts. Cohort 2 and cohort 2-SC will be conducted in parallel with some data presented combined.

Cohort 1 - Participants will receive 100 mg Tabalumab (LY2127399) intravenously (IV), 1.3 milligram per square meter (mg/m\^2) bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2 - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m\^2 bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2-SC - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m\^2 bortezomib subcutaneously (SC), and 20 mg dexamethasone orally.

Cohort 2-SC was added per protocol amendment in February 2013.

Arms: arm 1: Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle, each cyle is 21 days. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ. arm 2: Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle, each cycle is 21 days. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ. arm 3: Cohort 2-SC. 300 mg tabalumab (LY2127399)IV on day 1 of each cycle, each cycle is 21 days. BTZ, 1.3 mg/m\^2, subcutaneously (SC) on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ. Cohort 2-SC was added per protocol amendment in February 2013.
Interventions: intervention 1: Tabalumab intervention 2: Bortezomib IV intervention 3: Bortezomib SC intervention 4: Dexamethasone
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV intervention 3: Administered SC intervention 4: Administered orally

Protocol documents:
Clinical trial NCT01601704
Conditions: Obesity Overweight
Keywords: Body Weight Bupropion Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Narcotic Antagonists Naltrexone Nutrition Disorders Obesity Overnutrition Overweight
Sponsor: Orexigen Therapeutics, Inc
Start date: 2012-06-01; Completion date: 2015-08-01
Enrollment: 8910 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NB32 intervention 2: PBO intervention 3: Weight Management Program
Intervention descriptions: intervention 1: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program. intervention 2: Placebo. Administered in addition to the weight management program. intervention 3: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Protocol documents:
Clinical trial NCT01611857
Conditions: Malignant Solid Tumour Gastroesophageal Cancer
Keywords: Advanced solid tumors First-Line Metastatic GE cancer c-Met Inhibitor Tivantinib FOLFOX
Sponsor: SCRI Development Innovations, LLC
Start date: 2012-07-01; Completion date: 2015-08-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.

Detailed description:
This is a Phase I, open-label, non-randomized, dose-escalation study with a Phase II portion planned upon reaching the Maximum Tolerated Dose or recommended Phase II dose (RP2D). Phase I: The first cycle of the Phase I portion of the trial will be considered the Dose Limiting Toxicity evaluation period. Patients with advanced solid tumors will be treated with Tivantinib on Days 1 to 14 and with FOLFOX on Day 1. Following evaluation of the Dose Limiting Toxicities, doses will be escalated/reduced according to the protocol with 3 to 6 patients treated per dose level until the Maximum Tolerated Dose is determined.

Arms: arm 1: Phase I trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors followed by a Phase II portion for patients with first-line metastatic GE cancer.
Interventions: intervention 1: Tivantinib intervention 2: FOLFOX
Intervention descriptions: intervention 1: Patients with advanced solid tumors will be treated with oral Tivantinib (120, 240, or 360 mg BID) daily for 14 days in cycles of 14 days. intervention 2: The FOLFOX treatment regimen is started on Day 1 of each cycle and consists of 5-Fluorouracil (5-FU) 400 mg/m\^2, 5-FU continuous IV 2400 mg/m\^2 over 46 hours, leucovorin 400 mg/m\^2 IV, and oxaliplatin 85 mg/m\^2.

Protocol documents:
Clinical trial NCT01652534
Conditions: Parkinson's Disease
Keywords: Freezing of gait gait dysfunction
Sponsor: Northwestern University
Start date: 2011-06-01; Completion date: 2015-08-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.

Detailed description:
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.

Arms: arm 1: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day arm 2: Sugar Pill
Interventions: intervention 1: Amantadine intervention 2: Placebo
Intervention descriptions: intervention 1: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN). intervention 2: Sugar Pill

Protocol documents:
Clinical trial NCT01656759
Conditions: Osteoarthritis Intraoperative Bleeding
Keywords: Blood Loss Hemoglobin Hematocrit Blood Transfusions
Sponsor: Rush University Medical Center
Start date: 2012-05-01; Completion date: 2015-08-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Detailed description:
Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.

Treatment group:

The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population:

The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

Arms: arm 1: Control group. Will not receive the fibrin spray. arm 2: Patient will receive the fibrin spray after implantation of device but before the wound is closed.

Patients will be randomized to receive spray or not and postop parameters measured.
Interventions: intervention 1: Evicel Fibrin Spray
Intervention descriptions: intervention 1: 10cc syringe dose, once at the end of TKA

Protocol documents:
Clinical trial NCT01675661
Conditions: Cannabis Dependence
Sponsor: Medical University of South Carolina
Start date: 2014-01-01; Completion date: 2015-08-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).

Detailed description:
The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and inclusion into the study, participants will be randomized to receive a 12-week course of NAC 1200 mg or matched placebo twice daily. All participants will concurrently participate in a twice-weekly contingency management (CM) intervention. Medication management will be conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing will occur at all visits, and will be used as the primary determinant of cannabis use. Participants will return approximately four weeks after treatment conclusion for evaluation of adverse events with medication discontinuation and sustained treatment effects.

Arms: arm 1: N-acetylcysteine (NAC) plus Contingency Management (CM) arm 2: Placebo plus Contingency Management (CM)
Interventions: intervention 1: N-Acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions. intervention 2: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Protocol documents: