ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01241903
Conditions: Acute Coronary Syndrome Angioplasty, Transluminal, Percutaneous Coronary Hydroxymethylglutaryl-CoA Reductase Inhibitors Blood Platelets
Keywords: Platelet activation platelet leukocyte aggregates
Sponsor: Susan Smyth
Start date: 2011-06-01; Completion date: 2014-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rosuvastatin intervention 2: placebo
Intervention descriptions: intervention 1: Patients (n = 54) presenting acute coronary syndrome/non-ST elevation myocardial infarction who present within 8 hours of symptom-onset will be randomized to two groups to receive rosuvastatin (40 mg oral dose) or placebo at the time of presentation, in addition to standard of care (aspirin, clopidogrel, low molecular weight heparin). Blood will be collected at baseline (time of enrollment, immediately prior to drug or placebo), at 6 - 8 hours, at 18 - 24 hours, and at 30 days for analysis of platelet - leukocyte co-aggregate formation, biomarkers of platelet - leukocyte interactions, and biomarkers of myocardial necrosis. Additional samples may be collected just after revascularization, in patients undergoing PCI. The group of patients treated with rosuvastatin will be maintained on rosuvastatin 20 mg daily and the group randomized to placebo will be given rosuvastatin (20 mg oral once daily) within 48 hoursof enrollment and after planned PCI, but before hospital discharge. intervention 2: frequency and duration

Protocol documents:
Clinical trial NCT01260688
Conditions: Hormone Refractory Prostate Cancer Recurrent Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2014-02-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying the side effects and how well giving cediranib maleate together with or without dasatinib works in treating patients with hormone-resistant prostate cancer resistant to treatment with docetaxel. Cediranib maleate and dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known whether giving cediranib maleate together with dasatinib or alone is an effective treatment for prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the progression-free survival of patients with docetaxel-resistant and castration-resistant prostate cancer treated with cediranib maleate with versus without dasatinib.

SECONDARY OBJECTIVES:

I. To confirm the safety and tolerability of cediranib maleate with versus without dasatinib in these patients.

II. To calculate objective response rates of cediranib maleate with versus without dasatinib, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in patients with measurable disease at baseline.

III. To perform symptom assessment using the FACT-P questionnaire and the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire.

IV. To explore bone resorption markers (e.g., c-telopeptide and bone alkaline phosphatase), and to correlate these biomarkers with clinical outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to the presence of soft tissue (visceral or nodal) vs bone-only disease. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: dasatinib
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01263717
Conditions: HIV HIV Lipodystrophy
Keywords: HIV lipodystrophy tesamorelin Egrifta growth hormone releasing hormone
Sponsor: Massachusetts General Hospital
Start date: 2010-12-01; Completion date: 2014-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness \[cIMT\]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.

Detailed description:

Arms: arm 1: Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose arm 2: Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Interventions: intervention 1: tesamorelin intervention 2: placebo
Intervention descriptions: intervention 1: Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose intervention 2: Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection

Protocol documents:
Clinical trial NCT01264965
Conditions: Arthritis Pain Cognitive Impairment
Keywords: Pain Analgesia Cognitive impairment Randomized controlled trial Physical function
Sponsor: University of Chicago
Start date: 2011-01-01; Completion date: 2014-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: long acting oxycodone intervention 2: extra strength acetaminophen
Intervention descriptions: intervention 1: 10mg twice daily intervention 2: 1,000 mg twice daily

Protocol documents:
Clinical trial NCT01273805
Conditions: Pancreatic Cancer
Keywords: metastatic pancreatic cancer hydroxychloroquine
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-01-01; Completion date: 2014-02-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Hydroxychloroquine is approved for the treatment of non-cancerous illnesses such as rheumatoid arthritis and systemic lupus erythematous. Researchers in the laboratory have tested tumors from patients with pancreatic cancer and have discovered that they have certain pathways inside the cells that promote growth and survival of the tumor. Hydroxychloroquine may inactivate these pathways and results in the death of pancreatic cancer cells.

Detailed description:
Primary Objective

* To determine the efficacy of single-agent hydroxychloroquine in patients with metastatic pancreatic cancer previously treated with one or two prior chemotherapy regimens as measured by progression-free survival at two months

Secondary Objectives

* To assess tumor response rate, biochemical response rate (i.e. decrease in serum CA19-9 by \> 30%), and overall survival

Translational/Exploratory Objectives

* To investigate predictors of response to anti-autophagy therapy with hydroxychloroquine
* To explore the kinetics of in vivo autophagy inhibition using peripheral blood WBCs to monitor autophagic activity among patients receiving hydroxychloroquine

Arms: arm 1: Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision. arm 2: Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01308736
Conditions: Tobacco Use Disorder
Keywords: tobacco nicotine cigarette smoking
Sponsor: Rutgers, The State University of New Jersey
Start date: 2011-01-01; Completion date: 2014-02-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Placebo pill
Intervention descriptions: intervention 1: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. intervention 2: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.

Protocol documents:
Clinical trial NCT01309243
Conditions: HIV-1 Infection
Keywords: HIV HIV-1 Antiretroviral Treatment-Naïve
Sponsor: Gilead Sciences
Start date: 2011-02-01; Completion date: 2014-02-01
Enrollment: 799 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: FTC/RPV/TDF intervention 2: EFV/FTC/TDF
Intervention descriptions: intervention 1: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal intervention 2: Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime

Protocol documents:
Clinical trial NCT01322347
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: End Stage Renal Disease Hemodialysis SFP Hemodialysis-dependent chronic renal failure
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2011-04-01; Completion date: 2014-02-01
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Detailed description:
Screening: 2-3 weeks prior to enrollment in Stage 1.

Stage 1 (Run-In): 1-4weeks depending on qualification for Stage 2.

Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.

Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.

Arms: arm 1: 11 micrograms (µg) of iron / deciliter (dL) of dialysate. arm 2: 0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Interventions: intervention 1: Soluble Ferric Pyrophosphate (SFP) intervention 2: Standard dialysate
Intervention descriptions: intervention 1: Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months. intervention 2: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Protocol documents:
Clinical trial NCT01366209
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pirfenidone ASCEND IPF FVC
Sponsor: Genentech, Inc.
Start date: 2011-06-01; Completion date: 2014-02-01
Enrollment: 555 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pirfenidone intervention 2: Placebo
Intervention descriptions: intervention 1: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. intervention 2: Placebo equivalent given as 3 divided doses 3 times per day.

Protocol documents:
Clinical trial NCT01392300
Conditions: Post-stroke Spasticity of the Upper Limb
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2011-09-01; Completion date: 2014-02-01
Enrollment: 317 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Detailed description:
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Arms: arm 1: IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment arm 2: Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
Interventions: intervention 1: IncobotulinumtoxinA (400 Units) intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection intervention 2: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Protocol documents:
Clinical trial NCT01393613
Conditions: Acute Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-01; Completion date: 2014-02-01
Enrollment: 674 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.

Detailed description:
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Arms: arm 1: Higher dose, tablet, once daily, for six weeks arm 2: Middle dose, tablet, once daily, for six weeks arm 3: Lower dose, tablet, once daily, for six weeks arm 4: Placebo, once daily, for six weeks
Interventions: intervention 1: OPC-34712 intervention 2: OPC-34712 intervention 3: OPC-34712 intervention 4: Placebo
Intervention descriptions: intervention 1: Higher dose tablet, once daily, for six weeks, intervention 2: Middle dose tablet, once daily, for six weeks intervention 3: Lower dose tablet, once daily, for six weeks intervention 4: Placebo, once daily, for six weeks

Protocol documents:
Clinical trial NCT01398410
Conditions: Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole proton pump inhibitor Acetylsalicylic Acid Aspirin Gastric Ulcer Duodenal Ulcer
Sponsor: Eisai Co., Ltd.
Start date: 2011-12-01; Completion date: 2014-02-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Detailed description:
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rabeprazole intervention 2: Rabeprazole
Intervention descriptions: intervention 1: Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily intervention 2: Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Protocol documents:
Clinical trial NCT01410227
Conditions: Von Willebrand Disease
Sponsor: Baxalta now part of Shire
Start date: 2011-11-01; Completion date: 2014-02-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).

Detailed description:

Arms: arm 1: PK assessment (80 IU/kg rVWF) + 12-month treatment period arm 2: Two single-blinded PK assessments (50 IU/kg rVWF + rFVIII/placebo) + 12-month treatment period arm 3: PK assessment (50 IU/kg rVWF) only, no treatment of bleeding episodes arm 4: Treatment of bleeding episodes for a total of 12 months
Interventions: intervention 1: Recombinant von Willebrand factor (rVWF) intervention 2: Placebo intervention 3: Recombinant factor VIIII (rFVIII)
Intervention descriptions: intervention 1: Intravenous administration intervention 2: Syringe supplied with physiologic saline solution for infusion intervention 3: Intravenous administration

Protocol documents:
Clinical trial NCT01426789
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis IgG1K monoclonal antibody Interleukin-17A neutralizing
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2014-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.

Detailed description:

Arms: arm 1: 10 mg/kg intravenous (I.V.) arm 2: Placebo I.V.
Interventions: intervention 1: Placebo intervention 2: Secukinumab
Intervention descriptions: intervention 1: Matching placebo to secukinumab I.V. intervention 2: In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.

Protocol documents: