ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01772134
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2013-01-01; Completion date: 2013-07-22
Enrollment: 617 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Detailed description:
This is a mutlicenter, randomized, double-blind, parallell-group study. Subejcts who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 4 week run-in period will enter a 12 week treatment period. There will be a 7 day follow-up period after the treatment period.

Arms: arm 1: Long-acting muscarinic antagonist (LAMA), 62.5mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg arm 2: Long-acting muscarinic antagonist (LAMA), 125mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg arm 3: Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Interventions: intervention 1: Umeclidinium bromide 62.5mcg intervention 2: Umeclidinium bromide 125mcg intervention 3: Fluticasone propionate 250mcg/Salmeterol 50mcg intervention 4: Placebo
Intervention descriptions: intervention 1: Inhalation Powder, LAMA 62.5mcg intervention 2: Inhalation Powder, LAMA 125mcg intervention 3: Inhalation Powder, ICS/LABA intervention 4: Inhalation Powder, Placebo

Protocol documents:
Clinical trial NCT01120600
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-09; Completion date: 2013-07-22
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Detailed description:
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Arms: arm 1: Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. arm 2: Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
Interventions: intervention 1: Odanacatib intervention 2: Placebo for Odanacatib intervention 3: Vitamin D3 intervention 4: Calcium carbonate
Intervention descriptions: intervention 1: One 50 mg tablet once weekly intervention 2: One 50 mg tablet once weekly intervention 3: 5600 IU of open-label Vitamin D3 once weekly intervention 4: Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

Protocol documents:
Clinical trial NCT01560403
Conditions: Short Bowel Syndrome
Keywords: Parenteral nutrition TPN HPN PN SBS Short bowel syndrome
Sponsor: Shire
Start date: 2012-05-21; Completion date: 2013-07-23
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Detailed description:
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Arms: arm 1: 0.05 mg/kg/day
Interventions: intervention 1: Teduglutide
Intervention descriptions: intervention 1: 0.05 mg/kg/day subcutaneously taken once per day for 12 months

Protocol documents:
Clinical trial NCT01745094
Conditions: Overactive Bladder
Keywords: mirabegron solifenacin
Sponsor: Astellas Pharma Inc
Start date: 2012-10-01; Completion date: 2013-07-23
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.

Detailed description:
The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.

Arms: arm 1: concomitant administration of mirabegron to solifenacin treated patients
Interventions: intervention 1: mirabegron intervention 2: solifenacin
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT03809182
Conditions: Bariatric Surgery Candidate Glucose Intolerance Insulin Resistance
Keywords: Impaired Glucose Tolerance Obese patients Dexmedetomidine
Sponsor: Pontificia Universidad Catolica de Chile
Start date: 2012-09-27; Completion date: 2013-07-25
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.

Detailed description:
A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.

Arms: arm 1: After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered. arm 2: After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
Interventions: intervention 1: Dexmedetomidine intervention 2: 0.9% Sodium-chloride intervention 3: Fentanyl intervention 4: Morphine Sulfate
Intervention descriptions: intervention 1: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. intervention 2: The same infusion rate used in the dexmedetomidine group. intervention 3: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction). intervention 4: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.

Protocol documents:
Clinical trial NCT01513473
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2012-01-16; Completion date: 2013-07-30
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily. Dose individually adjusted. intervention 2: Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted. intervention 3: Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Protocol documents:
Clinical trial NCT01777620
Conditions: Facial Rhytides
Sponsor: Allergan
Start date: 2013-01-31; Completion date: 2013-07-31
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).

Detailed description:

Arms: arm 1: BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1. arm 2: Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1. intervention 2: Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Protocol documents:
Clinical trial NCT00667810
Conditions: Alzheimer Disease
Keywords: antibody immunotherapy
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2013-08-01
Enrollment: 901 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: bapineuzumab intervention 2: bapineuzumab intervention 3: placebo
Intervention descriptions: intervention 1: Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65. intervention 2: Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65. intervention 3: Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Protocol documents:
Clinical trial NCT00689221
Conditions: Glioblastoma
Keywords: newly diagnosed Glioblastoma (WHO Grade IV) Cilengitide Temozolomide Radiotherapy
Sponsor: EMD Serono
Start date: 2008-09-01; Completion date: 2013-08-01
Enrollment: 545 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.

The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cilengitide intervention 2: Temozolomide intervention 3: Radiotherapy
Intervention descriptions: intervention 1: Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. intervention 2: Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression. intervention 3: Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy.

Protocol documents:
Clinical trial NCT00723450
Conditions: Bipolar Disorder
Keywords: Bipolar I pediatric lamictal adolescent
Sponsor: GlaxoSmithKline
Start date: 2008-07-01; Completion date: 2013-08-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).

Detailed description:

Arms: arm 1: Placebo Controlled arm 2: Flexible Dosing
Interventions: intervention 1: lamictal
Intervention descriptions: intervention 1: Flexible Dosing

Protocol documents:
Clinical trial NCT01391507
Conditions: Cardiomyopathy, Dilated
Keywords: Anti-beta1-receptor autoantibodies COR-1 Heart failure
Sponsor: Corimmun GmbH
Start date: 2011-10-01; Completion date: 2013-08-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.

Detailed description:
In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 0.9 % sodium chloride intervention 2: COR-1 intervention 3: Standard therapy for heart failure
Intervention descriptions: intervention 1: Monthly intravenous injection for 6 months intervention 2: Monthly intravenous injection for 6 months intervention 3: All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.

Protocol documents:
Clinical trial NCT01435928
Conditions: Schizophrenia
Keywords: Schizophrenia Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-09-01; Completion date: 2013-08-01
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

Detailed description:

Arms: arm 1: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating arm 2: Matching placebo once daily in the evening with a meal or 30 minutes after eating
Interventions: intervention 1: Lurasidone intervention 2: Matching Placebo
Intervention descriptions: intervention 1: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating intervention 2: Matching placebo once daily in the evening with a meal or 30 minutes after eating

Protocol documents:
Clinical trial NCT01561430
Conditions: Alzheimer's Disease
Keywords: beta-secretase inhibitor
Sponsor: Eli Lilly and Company
Start date: 2012-03-01; Completion date: 2013-08-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 1/Phase 2 study is to evaluate how the body handles the drug and the drug's effect on the body of participants with mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD and who test positive for amyloid plaque.

Detailed description:

Arms: arm 1: LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks. arm 2: LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks. arm 3: LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks. arm 4: Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Interventions: intervention 1: LY2886721 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00126594
Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2013-08-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC.

II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC.

SECONDARY OBJECTIVES:

I. Progression free survival. II. Duration of response. III. Overall Survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral sorafenib twice daily on days 1-28.

Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.

In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.

Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Arm I: Oral Sorafenib 400 mg twice daily on days 1-28. arm 2: Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Interventions: intervention 1: Sorafenib Tosylate intervention 2: Recombinant Interferon Alfa-2b intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given orally 400 mg orally (PO) every 12 hours intervention 2: Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10\^6 international units twice daily intervention 3: Correlative studies

Protocol documents: