ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01056718
Conditions: Hypertension
Keywords: Diastolic Function Nebivolol
Sponsor: Mercy Research
Start date: 2009-11-01; Completion date: 2014-05-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this pilot study is to effectively treat hypertension in subjects with either known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due to the unique properties of nebivolol, it is hypothesized that there will be improvements in left ventricular (LV) systolic and diastolic function manifesting as increase exercise capacity in this patient population with primarily LV diastolic dysfunction. The present study was performed to determine the effects of nebivolol on blood pressure, exercise tolerance and parameters of left ventricular systolic and diastolic function in a group of hypertensive patients with echocardiographic evidence diastolic dysfunction.

Detailed description:
Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health at baseline and at conclusion of the 10 week trial period.

Arms: arm 1: 10 week open label nebivolol treatment.
Interventions: intervention 1: Nebivolol
Intervention descriptions: intervention 1: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.

Protocol documents:
Clinical trial NCT01098487
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: Immune (idiopathic) thrombocytopenic purpura (ITP) bone marrow fibers eltrombopag olamine thrombopoietin receptor agonist
Sponsor: GlaxoSmithKline
Start date: 2010-05-01; Completion date: 2014-05-01
Enrollment: 167 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.

Detailed description:
This is a phase IV, open-label safety study, designed to determine baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP)and to evaluate the long-term effect of eltrombopag on bone marrow reticulin and/or collagen fibers.

The duration of the screening period is up to 8 weeks. Eltrombopag will be administered for at least 2-years followed by a 4-week follow-up period. Bone marrow biopsies will be performed at screening, after 1-year and 2-years of eltrombopag treatment, and at early withdrawal of treatment. The screening bone marrow biopsy should be performed within 8 weeks of planned start of study medication and the bone marrow biopsy block must be available for central laboratory processing.

Arms: arm 1: Oral eltrombopag once daily, starting dose 50 mg (or 25 mg for subjects of East Asian ancestry).
Interventions: intervention 1: Eltrombopag olamine
Intervention descriptions: intervention 1: Thrombopoietin receptor agonist

Protocol documents:
Clinical trial NCT01105377
Conditions: Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-04-01; Completion date: 2014-05-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving azacitidine together with entinostat works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the preliminary efficacy via Response Evaluation Criteria In Solid Tumors (RECIST) response rate of the combination of azacitidine and entinostat in patients with metastatic colorectal cancer.

SECONDARY OBJECTIVES:

I. Explore the effects of azacitidine and entinostat on time to progression in patients with metastatic colorectal cancer.

II. To assess the toxicity for combination azacitidine and entinostat therapy.

TERTIARY OBJECTIVES:

I. Evaluate changes in promoter methylation of selected genes from DNA in circulating serum samples.

II. To determine changes in histone deacetylase activity and acetylation of H3 and H4 histones in pre- and post-treatment tumor biopsies.

III. To evaluate correlations between these molecular effects and clinical outcomes (response, time to progression).

IV. To correlate response rates by RECIST criteria versus response rates determined be EASL (change in tumor enhancement).

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5 and 8-10 and oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected at baseline and periodically during courses 1-3 for DNA methylation, histone deacetylation activity, and acetylation of H3 and H4 histones analysis by PCR, western blot, and RT-PCR assays. Pharmacogenomic studies may also be conducted.

After completion of study therapy, patients are followed up every 3-6 months for up to 3 years.

Arms: arm 1: Patients receive azacitidine subcutaneously on days 1-5 and 8-10 and oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: entinostat intervention 2: azacitidine intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given SC intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01117012
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2010-07-01; Completion date: 2014-05-01
Enrollment: 192 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.

Detailed description:
This open-label, rollover study of orally administered VX-770 was conducted in participants with CF to evaluate the safety and efficacy of long-term VX-770 treatment. Participants who were previously enrolled in Study 102 (VX08-770-102/NCT00909532) and Study 103 (VX08-770-103/NCT00909727), and met certain criteria were eligible to enroll in this study (Study 105/VX08-770-105/NCT01117012).

Arms: arm 1: VX-770 (ivacaftor) 150 milligram (mg) tablet orally twice daily (q12h).
Interventions: intervention 1: Ivacaftor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01145638
Conditions: Non-myeloid Malignancies Chemotherapy Induced Anaemia
Keywords: cancer chemotherapy induced anaemia iron Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA) CIA
Sponsor: Pharmacosmos A/S
Start date: 2010-10-01; Completion date: 2014-05-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

Detailed description:

Arms: arm 1: Iron isomaltoside intravenously as bolus or infusion arm 2: oral iron sulphate twice a day
Interventions: intervention 1: iron isomaltoside 1000 intervention 2: iron sulphate
Intervention descriptions: intervention 1: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose intervention 2: oral, 200 mg per day (100 mg bid),12 weeks

Protocol documents:
Clinical trial NCT01171183
Conditions: Cocaine Dependence Cocaine Withdrawal
Keywords: cocaine dependence cocaine withdrawal
Sponsor: University of Arkansas
Start date: 2010-08-01; Completion date: 2014-05-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.

Detailed description:

Arms: arm 1: None arm 2: controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
Interventions: intervention 1: controlled release carvedilol intervention 2: Placebo
Intervention descriptions: intervention 1: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper intervention 2: Placebo

Protocol documents:
Clinical trial NCT01186003
Conditions: Diabetes
Keywords: Diabetes
Sponsor: University of Colorado, Denver
Start date: 2010-08-01; Completion date: 2014-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.

Detailed description:

Arms: arm 1: None arm 2: Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Interventions: intervention 1: Detemir
Intervention descriptions: intervention 1: Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Protocol documents:
Clinical trial NCT01191086
Conditions: Epilepsy
Keywords: Epilepsy partial onset seizure adjunctive therapy
Sponsor: Upsher-Smith Laboratories
Start date: 2010-10-01; Completion date: 2014-05-01
Enrollment: 210 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Detailed description:

Arms: arm 1: Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
Interventions: intervention 1: USL255
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01217749
Conditions: B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Prolymphocyctic Leukemia Richter's Transformation
Sponsor: Pharmacyclics LLC.
Start date: 2010-12-01; Completion date: 2014-05-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases

Detailed description:

Arms: arm 1: In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing arm 2: In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1) arm 3: In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
Interventions: intervention 1: PCI-32765 intervention 2: ofatumumab
Intervention descriptions: intervention 1: 420 mg PO daily intervention 2: per package insert as an IV infusion

Protocol documents:
Clinical trial NCT01218802
Conditions: HIV Infections Heart Disease
Keywords: HIV Heart Disease Bone Density
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2011-02-01; Completion date: 2014-05-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.

Detailed description:
While the use of antiretroviral therapy (ART) in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, nevertheless, cardiovascular disease is a major concern impacting morbidity and mortality in this population.

This study will assess if a potent statin, rosuvastatin, could improve endothelial dysfunction, slow carotid intima media thickness (IMT) progression and bone loss, and decrease inflammation and oxidative stress in HIV-infected ART-treated subjects with good HIV virologic control. The investigators will also see if rosuvastatin will induce beneficial changes in the prevalence of metabolic syndrome and lipid metabolism as well as improve bone turnover markers.

Arms: arm 1: Participants will take Rosuvastatin 10 mg. daily for 96 weeks arm 2: Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Interventions: intervention 1: Rosuvastatin 10 mg. daily for 96 weeks intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will take Rosuvastatin 10 mg. daily for 96 weeks. intervention 2: participants will take a sugar pill daily for 96 weeks

Protocol documents:
Clinical trial NCT01228747
Conditions: Epilepsy Generalized Tonic-Clonic Seizures
Keywords: Levetiracetam epilepsy generalized tonic-clonic
Sponsor: UCB Japan Co. Ltd.
Start date: 2010-10-01; Completion date: 2014-05-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Detailed description:

Arms: arm 1: Matching placebo for 28 weeks arm 2: Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Interventions: intervention 1: Levetiracetam intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks intervention 2: Matching oral placebo tablets twice daily for 28 weeks

Protocol documents:
Clinical trial NCT01232829
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2014-05-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) works in treating patients with previously treated metastatic pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the 6-month survival of patients with previously treated metastatic pancreas cancer treated with gamma secretase RO4929097.

II. To determine the adverse events of RO4929097 in this patient population. III. To correlate changes in tumor markers with RO4929097 exposure.

SECONDARY OBJECTIVES:

I. To evaluate the response rate and overall survival of this population treated with RO4929097.

II. To correlate clinical outcome with tumor markers (including stem cell markers) obtained from pre- and post- treatment biopsies. (exploratory) III. To assess variants in genes involved in RO4929097 disposition and their relation to RO4929097 exposure.

OUTLINE: This is a multicenter study.

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients may undergo tumor biopsy at baseline and on days 16 or 17 of course one for biomarker and other correlative studies. Blood samples may also collected at baseline and periodically during study for pharmacokinetic and angiogenesis marker studies.

After completion of study therapy, patients are followed up periodically for 2 years.

Arms: arm 1: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients may undergo tumor biopsy at baseline and on days 16 or 17 of course one for biomarker and other correlative studies. Blood samples may also collected at baseline and periodically during study for pharmacokinetic and angiogenesis marker studies.
Interventions: intervention 1: gamma-secretase/Notch signalling pathway inhibitor RO4929097
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT01245595
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury (AKI) Cardiopulmonary bypass (CPB)
Sponsor: Stanford University
Start date: 2010-11-01; Completion date: 2014-05-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.

Detailed description:
Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.

Arms: arm 1: Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours arm 2: Normal Saline Placebo
Interventions: intervention 1: Aminophylline intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours intervention 2: Normal Saline

Protocol documents:
Clinical trial NCT01246960
Conditions: Stomach Cancer Esophageal Cancer
Keywords: cancer stomach esophagus gastroesophageal
Sponsor: Eli Lilly and Company
Start date: 2011-04-01; Completion date: 2014-05-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.

Detailed description:

Arms: arm 1: * Oxaliplatin 85 milligrams per square meter (mg/m\^2) given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m\^2 given on Day 1 of a 2-week cycle
* 5-Fluorouracil (5-FU) 400 mg/m\^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met arm 2: * Oxaliplatin 85 mg/m\^2 given on Day 1 of a 2-week cycle
* Leucovorin 400 mg/m\^2 given on Day 1 of a 2-week cycle
* 5-FU 400 mg/m\^2 bolus given on Day 1 of a 2-week cycle
* 5-FU 2400 mg/m\^2 continuously given over 46-48 hours on Day 1 of a 2-week cycle
* Placebo given on Day 1 of a 2-week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Interventions: intervention 1: Ramucirumab intervention 2: Placebo intervention 3: Oxaliplatin intervention 4: Leucovorin intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously intervention 5: Administered intravenously

Protocol documents:
Clinical trial NCT01249404
Conditions: Leg Spasticity
Sponsor: Ipsen
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 388 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 lower limb spasticity due to stroke or traumatic brain injury.

Detailed description:

Arms: arm 1: 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle) arm 2: 1500 U, I.M., on day 1 (single treatment cycle) arm 3: I.M., on day 1 (single treatment cycle)
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: I.M. injection on day 1 (single treatment cycle) intervention 2: I.M. injection on day 1 (single treatment cycle)

Protocol documents:
Clinical trial NCT01250119
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2014-05-01
Enrollment: 688 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 150 mg daily, orally

Protocol documents: