ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01508325
Conditions: Hypertension
Keywords: Bisoprolol Hypertension Blood pressure Heart rate
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-12-01; Completion date: 2014-04-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.

Detailed description:
Primary objectives:

To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week active treatment in subjects with mild to moderate essential hypertension (EH).

Secondary objectives:

1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (Example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate EH
2. To evaluate safety of the two drugs
3. To evaluate the treatment compliance of the two drugs

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bisoprolol intervention 2: Metoprolol
Intervention descriptions: intervention 1: Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (\>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was \>=90 mmHg measured every 4 weeks. intervention 2: Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was \>=140 mmHg and/or DBP was \>=90 mmHg measured every 4 weeks.

Protocol documents:
Clinical trial NCT01529515
Conditions: Schizophrenia
Keywords: Schizophrenia R092670 Paliperidone Palmitate Paliperidone palmitate 3 month formulation (PP3M)
Sponsor: Janssen Research & Development, LLC
Start date: 2012-05-01; Completion date: 2014-04-01
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Detailed description:
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PP3M 175 mg eq. intervention 2: PP3M 263 mg eq. intervention 3: PP3M 350 mg eq. intervention 4: PP3M 525 mg eq. intervention 5: Placebo (20% Intralipid emulsion)
Intervention descriptions: intervention 1: Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. intervention 2: Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. intervention 3: Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. intervention 4: Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. intervention 5: Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

Protocol documents:
Clinical trial NCT01536067
Conditions: Waldenström Macroglobulinemia
Sponsor: Roswell Park Cancer Institute
Start date: 2012-04-01; Completion date: 2014-04-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving ofatumumab together with bortezomib may be a better way to block cancer growth

Detailed description:
PRIMARY OBJECTIVES:

I. Determine overall response rate (complete response \[CR\] + partial response \[PR\] + minor response \[MR\]) of ofatumumab in combination with bortezomib.

SECONDARY OBJECTIVES:

I. Determine complete remission (CR) rate, near (n)CR rate, very good partial response (VGPR) rate and PR rate per new criteria.

II. Determine 5 year progression free survival (PFS). III. Determine time to progression and duration of response of ofatumumab in conjunction with bortezomib.

IV. Determine safety of ofatumumab in combination with bortezomib. V. Conduct laboratory correlates.

OUTLINE:

INDUCTION PHASE: Patients receive ofatumumab intravenously (IV) on days 1, 8, and 15 and bortezomib subcutaneously (SC) on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 5 years.

Arms: arm 1: INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ofatumumab intervention 2: bortezomib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given SC intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01539512
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL CAL-101 GS 1101 PI3K GS-US-312-0117 idelalisib
Sponsor: Gilead Sciences
Start date: 2012-04-01; Completion date: 2014-04-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Detailed description:

Arms: arm 1: Participants will receive idelalisib plus rituximab arm 2: Participants will receive placebo to match idelalisib plus rituximab
Interventions: intervention 1: Idelalisib intervention 2: Rituximab intervention 3: Placebo to match idelalisib
Intervention descriptions: intervention 1: Idelalisib 150 mg tablet administered orally twice daily intervention 2: Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter intervention 3: Placebo to match idelalisib administered orally twice daily

Protocol documents:
Clinical trial NCT01546519
Conditions: Cancer
Sponsor: Genentech, Inc.
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard therapy exists.

Detailed description:

Arms: arm 1: Control cohort with normal renal and normal hepatic function arm 2: Severe renal impairment and normal hepatic function arm 3: Mild hepatic impairment and normal renal function arm 4: Moderate hepatic impairment and normal renal function arm 5: Severe hepatic impairment and normal renal function
Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: oral repeating dose of 150 mg once daily

Protocol documents:
Clinical trial NCT01546623
Conditions: Prostate Cancer
Sponsor: Takeda
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.

Detailed description:

Arms: arm 1: TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. arm 2: TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
Interventions: intervention 1: TAP-144-SR(6M) intervention 2: TAP-144-SR(3M)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01573767
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-04-01; Completion date: 2014-04-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.

Detailed description:

Arms: arm 1: Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 2: Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 3: Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler arm 4: Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler
Interventions: intervention 1: Fluticasone propionate 100mcg intervention 2: Placebo intervention 3: Vilanterol
Intervention descriptions: intervention 1: all subjects recieve open-label Flovent twice daily duirng the run in and treatment period intervention 2: Placebo inhalation powder during treatment period intervention 3: subjects will recieve 4 weeks via NDPI during treament period

Protocol documents:
Clinical trial NCT01573910
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial conjunctivitis Anti-infective Antibiotics
Sponsor: Alcon Research
Start date: 2012-05-01; Completion date: 2014-04-01
Enrollment: 985 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.

Detailed description:

Arms: arm 1: Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 arm 2: Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Interventions: intervention 1: Moxifloxacin ophthalmic solution, 0.5% intervention 2: Ofloxacin ophthalmic solution, 0.3%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01613417
Conditions: Brain Disease
Keywords: Have confirmed or are highly suspected of brain disease
Sponsor: Bracco Diagnostics, Inc
Start date: 2012-08-01; Completion date: 2014-04-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Detailed description:
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

Arms: arm 1: MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences. arm 2: MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
Interventions: intervention 1: gadoteridol intervention 2: gadobutrol
Intervention descriptions: intervention 1: ProHance 0.1 mmol/kg intervention 2: Gadovist/Gadavist 0.1 mmol/kg

Protocol documents:
Clinical trial NCT01652729
Conditions: Diabetes Type 2
Keywords: Diabetes, Type 2, exenatide, Sitagliptin
Sponsor: AstraZeneca
Start date: 2013-02-01; Completion date: 2014-04-01
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Exenatide once weekly suspension 2mg subcutaneous injection arm 2: Overencapsulated Sitagliptin 100mg oral tablet once daily arm 3: Placebo oral capsule once daily
Interventions: intervention 1: Exenatide once weekly suspension intervention 2: Sitagliptin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Placebo oral capsule once daily

Protocol documents:
Clinical trial NCT01659554
Conditions: Recurrent Ovarian Cancer Fallopian Tube Cancer
Keywords: Primary peritoneal
Sponsor: Columbia University
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.

Detailed description:
This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.

Arms: arm 1: Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 \& 8 during a 3 week cycle.
Interventions: intervention 1: Cisplatin intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Cisplatin (75 mg/m2) prepared in 2L normal saline. intervention 2: Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).

Protocol documents:
Clinical trial NCT01662986
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-08-01; Completion date: 2014-04-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)

Detailed description:

Arms: arm 1: Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler arm 2: Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler
Interventions: intervention 1: tiotropium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: 18 mcg once a day (QD) intervention 2: Once a day (QD)

Protocol documents:
Clinical trial NCT01685801
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-09-01; Completion date: 2014-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.

Detailed description:
CFTR Mutations associated with residual function or defective messenger ribonucleic acid (mRNA) splicing include the following:

R117H, E56K, P67L, D110E, D110H, R117C, R347H, R352Q, A455E, D579G, S945L, L206W, R1070W, F1074L, D1152H, S1235R, D1270N, 2789+5G-\>A, 3849+10kbC-\>T, 3272-26A-\>G, 711+5G-\>A, 3120G-\>A, 1811+1.6kbA-\>G, 711+3A-\>G, 1898+3A-\>G, 1898+1G-\>A, 1717-1G-\>A, 1717-8G-\>A, 1342-2A-\>C, 405+3A-\>C, 1716G/A 1811+1G-\>C, 1898+5G-\>T, 3850-3T-\>G, IVS14b+5G-\>A, 1898+1G-\>T, 4005+2T-\>C, 621+3A-\>G, 621+1G-\>T.

Arms: arm 1: During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and Cycle 2 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor. arm 2: During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and Cycle 2 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor. arm 3: During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and Cycle 2 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor. arm 4: During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and Cycle 2 \[(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)\] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo-matched-to-ivacaftor tablet
Intervention descriptions: intervention 1: 150 milligram (mg) tablet orally every 12 hours up to 12 weeks. intervention 2: Orally every 12 hours up to 4 weeks.

Protocol documents:
Clinical trial NCT01693692
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Sponsor: Theravance Biopharma
Start date: 2012-11-01; Completion date: 2014-04-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.

Detailed description:

Arms: arm 1: Group 1 to be dosed with TD-9855 arm 2: Group 2 to be dosed with TD-9855 arm 3: Group to be dosed with Placebo
Interventions: intervention 1: TD-9855 Group 1 intervention 2: TD-9855 Group 2 intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: