ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01253668
Conditions: Renal Cell Carcinoma
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2011-11-01; Completion date: 2013-09-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of an investigational agent, brivanib, in patients with refractory metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of brivanib in renal cell carcinoma, and explore the activity of this drug in this population to determine whether imaging and molecular features of the tumors can be used to predict response. Approximately 30 people with advanced kidney cancer will be enrolled on this study at the University of Pennsylvania.

Detailed description:
The primary objective of this clinical trial is to determine the efficacy of brivanib in the treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) in patients who have progressed on treatment with sunitinib, sorafenib, bevacizumab, or pazopanib. The primary endpoint of the trial will be PFS at 16 weeks. The secondary objectives are to further examine the safety and tolerability profile of brivanib, to examine the efficacy of brivanib in this population in terms of best overall response, response rate, progression-free survival, and overall survival, to describe baseline and changes in I-cG250 PET/CT in relation to observed therapeutic effects, to describe novel baseline histologic features of these tumors in relation to observed therapeutic effects. Modalities will include Von Hippel-Lindau gene (VHL) and hypoxia-inducible factor 1 gene (HIF-1) expression assessment and a novel histo-cytometric assessment of the tumor microenvironment in terms of p-STAT3, p-ERK, Ki67, VEGFR2, FGFR1 expression, to describe changes in circulating collagen IV on brivanib in relation to therapeutic effects, to explore the relationship between single nucleotide polymorphisms in angiogenesis-related genes and the activity of brivanib in the treatment of these patients.

Arms: arm 1: Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Brivanib alaninate intervention 2: Polymerase chain reaction intervention 3: Iodine I 124 chimeric monoclonal antibody G250 intervention 4: Positron emission tomography/computed tomography intervention 5: Protein expression analysis intervention 6: Immunohistochemistry
Intervention descriptions: intervention 1: Brivanib by mouth daily at a dose of 800mg. intervention 2: Undergo 1241-cG250 PET/CT imaging (correlative studies) intervention 3: Undergo 124I-cG250 PET/CT imaging (correlative studies) intervention 4: Undergo 1241-cG250 PET/CT imaging (correlative studies) intervention 5: Correlative studies intervention 6: correlative studies

Protocol documents:
Clinical trial NCT01270464
Conditions: Eosinophilic Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-02-01; Completion date: 2013-09-01
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

Detailed description:

Arms: arm 1: Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses. arm 2: 0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses arm 3: 3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
Interventions: intervention 1: Reslizumab intervention 2: Placebo
Intervention descriptions: intervention 1: 3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses. intervention 2: Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.

Protocol documents:
Clinical trial NCT01273896
Conditions: Breast Cancer
Keywords: STA-9090 advanced breast cancer 10-145
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-01-01; Completion date: 2013-09-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer.

STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.

Detailed description:

Arms: arm 1: This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.
Interventions: intervention 1: STA-9090
Intervention descriptions: intervention 1: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.

Protocol documents:
Clinical trial NCT01290913
Conditions: Peanut Allergy
Keywords: peanut allergy Xolair
Sponsor: Lynda Schneider
Start date: 2011-02-01; Completion date: 2013-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.

Detailed description:
We hypothesize that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to peanut and will enhance the development of oral tolerance in patients with severe peanut allergy.

We will follow the patients for 5 years following study completion.

Arms: arm 1: Patients receive omalizumab along with oral peanut desensitization.
Interventions: intervention 1: Omalizumab
Intervention descriptions: intervention 1: Omalizumab is an antibody that helps decrease allergic responses in the body

Protocol documents:
Clinical trial NCT01313299
Conditions: Nervous System Disorders
Sponsor: Ipsen
Start date: 2011-08-01; Completion date: 2013-09-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Botulinum toxin type A intervention 2: Botulinum toxin type A intervention 3: Placebo
Intervention descriptions: intervention 1: 500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. intervention 2: 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. intervention 3: I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Protocol documents:
Clinical trial NCT01347710
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease. Positron Emission Tomography Myocardial Perfusion Imaging. Single Positron Emission Computed Tomography. Flurpiridaz F18 Injection.
Sponsor: Lantheus Medical Imaging
Start date: 2011-06-01; Completion date: 2013-09-01
Enrollment: 795 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Detailed description:
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Arms: arm 1: Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Interventions: intervention 1: Flurpiridaz F18 intervention 2: 99mTechnicium (sestamibi or tetrofosmin)
Intervention descriptions: intervention 1: Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis intervention 2: Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Protocol documents:
Clinical trial NCT01360632
Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-06-01; Completion date: 2013-09-01
Enrollment: 1539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Detailed description:

Arms: arm 1: Drug: OPC-34712 + ADT

Drug: Placebo + ADT arm 2: Drug: Placebo + ADT
Interventions: intervention 1: OPC-34712 + ADT intervention 2: Placebo + ADT intervention 3: Placebo + ADT
Intervention descriptions: intervention 1: Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT) intervention 2: Placebo + FDA Approved Antidepressant (ADT) intervention 3: Placebo + FDA Approved Antidepressant (ADT)

Protocol documents:
Clinical trial NCT01362296
Conditions: Lung Cancer, Non-Small Cell
Keywords: NRAS docetaxel NSCLC GSK1120212 MEK inhibitor targeted therapy KRAS BRAF
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2013-09-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

Detailed description:

Arms: arm 1: Oral once daily arm 2: IV once every 3 weeks
Interventions: intervention 1: GSK1120212 intervention 2: docetaxel
Intervention descriptions: intervention 1: Oral once daily intervention 2: IV once every 3 weeks

Protocol documents:
Clinical trial NCT01399723
Conditions: Pneumonia
Keywords: Severe pneumonia
Sponsor: KEMRI-Wellcome Trust Collaborative Research Program
Start date: 2011-09-01; Completion date: 2013-09-01
Enrollment: 561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.

Detailed description:
Case management for the treatment of childhood acute respiratory infections has been widely promoted in many developing countries for over 20 years. Despite this, pneumonia continues to claim over 1.5 million lives of children under five annually. The use of affordable, easily-administered, safe, effective treatments can potentially reduce the burden of childhood pneumonia. The WHO recommends the use of a single antibiotic for the treatment of severe pneumonia. Whereas in Asia, evidence from large randomized clinical trials has changed policy recommendations for treatment of severe pneumonia from parenteral penicillin to oral amoxicillin, there is little evidence to inform a similar move in African children where pneumonia is associated with poorer outcomes. In this study the investigators will investigate effectiveness of oral amoxicillin versus the current standard treatment, benzyl penicillin in severe childhood pneumonia using a randomized controlled non-inferiority design preceded by a pilot pre-intervention phase. The investigators will also collect observational data HIV-exposed / infected children with severe pneumonia. 594 children aged 2 - 59 months admitted with clinical signs of severe pneumonia to up to 7 hospitals in Kenya will be randomly assigned to receive either oral amoxicillin or injectable benzyl penicillin. They will then be followed up for the primary outcome of pre-defined treatment failure at 48 hours. The results of this trial will provide valuable data on the effectiveness of oral amoxicillin in the treatment of severe pneumonia in a population of Kenyan children and determine the practicability of conducting large pragmatic trials on pneumonia in Africa similar to those done in Asia.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Amoxicillin intervention 2: Benzyl penicillin
Intervention descriptions: intervention 1: Oral 45mg/kg 12 hourly intervention 2: Intravenous 50,000IU/kg 6 hourly

Protocol documents:
Clinical trial NCT01412710
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Cholecalciferol Vitamin D Insulin resistance Cardiovascular disease risk Minorities
Sponsor: Florida International University
Start date: 2011-07-01; Completion date: 2013-09-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.

Detailed description:
Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population.

Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke.

These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD.

Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.

Arms: arm 1: This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months. arm 2: This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.
Interventions: intervention 1: Cholecalciferol
Intervention descriptions: intervention 1: 4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.

Protocol documents:
Clinical trial NCT01416389
Conditions: Metastatic Breast Cancer
Keywords: Locally Recurrent Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2011-08-01; Completion date: 2013-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.

Detailed description:

Arms: arm 1: LY2523355: Five milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met. arm 2: Forty milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
Interventions: intervention 1: LY2523355 intervention 2: ixabepilone intervention 3: pegfilgrastim intervention 4: filgrastim
Intervention descriptions: intervention 1: Administered intravenously as a one hour infusion intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol documents:
Clinical trial NCT01422720
Conditions: Epilepsy
Keywords: Epilepsy ESL Eslicarbazepine Acetate BIAL BIA Partial-onset Seizures
Sponsor: Bial - Portela C S.A.
Start date: 2010-04-01; Completion date: 2013-09-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

Detailed description:
Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.

Arms: arm 1: None
Interventions: intervention 1: Eslicarbazepine Acetate
Intervention descriptions: intervention 1: ESL tablets (800 mg) QD

Protocol documents:
Clinical trial NCT01422876
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-08-01; Completion date: 2013-09-01
Enrollment: 1405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Detailed description:

Arms: arm 1: Patients receive BI 10773/linagliptin FDC (high dose) once daily arm 2: Patients receive BI 10773/linagliptin FDC (low dose) once daily arm 3: Patients receive BI 10773 (high dose) once daily arm 4: Patients receive BI 10773 (low dose) once daily arm 5: Patients receive linagliptin once daily
Interventions: intervention 1: high dose FDC intervention 2: BI 10773 high dose intervention 3: high dose FDC placebo intervention 4: low dose FDC placebo intervention 5: high dose FDC placebo intervention 6: high dose FDC placebo intervention 7: low dose FDC placebo intervention 8: low dose FDC placebo intervention 9: high dose BI 10773 placebo intervention 10: low dose FDC intervention 11: high dose FDC placebo intervention 12: BI 10773 low dose intervention 13: high dose BI 10773 placebo intervention 14: high dose BI 10773 placebo intervention 15: linagliptin intervention 16: low dose FDC placebo intervention 17: linagliptin placebo intervention 18: BI 10773 low dose placebo intervention 19: linagliptin placebo intervention 20: low dose BI 10773 placebo intervention 21: linagliptin placebo intervention 22: high dose BI 10773 placebo intervention 23: BI 10773 low dose placebo intervention 24: low dose BI 10773 placebo intervention 25: linagliptin placebo
Intervention descriptions: intervention 1: once daily intervention 2: once daily intervention 3: once daily intervention 4: once daily intervention 5: once daily intervention 6: once daily intervention 7: once daily intervention 8: once daily intervention 9: once daily intervention 10: once daily intervention 11: once daily intervention 12: low dose once daily intervention 13: once daily intervention 14: once daily intervention 15: once daily intervention 16: once daily intervention 17: once daily intervention 18: once daily intervention 19: once daily intervention 20: once daily intervention 21: once daily intervention 22: once daily intervention 23: once daily intervention 24: once daily intervention 25: once daily

Protocol documents:
Clinical trial NCT01431274
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2011-09-01; Completion date: 2013-09-01
Enrollment: 2624 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: Once daily 2 puffs solution for inhalation Respimat arm 2: Once daily 2 puffs solution for inhalation Respimat arm 3: Once daily 2 puffs solution for inhalation Respimat arm 4: Once daily 2 puffs solution for inhalation Respimat arm 5: Once daily 2 puffs solution for inhalation Respimat
Interventions: intervention 1: tiotropium + olodaterol intervention 2: tiotropium intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium + olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: fixed dose combination intervention 2: low dose intervention 3: one dose only intervention 4: high dose intervention 5: fixed dose combination intervention 6: Respimat inhaler

Protocol documents: