ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01474200
Conditions: Heart Failure Cardiac Failure Acute Decompensated Heart Failure (ADHF)
Keywords: Ultrafiltration Aquapheresis Diuretics Loop Diuretics Aquadex Flexflow System Gambro UF Solutions
Sponsor: Nuwellis, Inc.
Start date: 2012-01-01; Completion date: 2014-07-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.

Detailed description:
The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.

Arms: arm 1: Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System arm 2: Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment
Interventions: intervention 1: Isolated veno-venous ultrafiltration (AQ) intervention 2: IV Loop Diuretics (LD)
Intervention descriptions: intervention 1: Aquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR) intervention 2: IV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of the"Diuretic strategies in patients wth acute decompensated heart failure" (DOSE) trial.

Protocol documents:
Clinical trial NCT01478373
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Dovitinib
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2014-07-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib

Detailed description:

Arms: arm 1: Patients will receive Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
Interventions: intervention 1: Dovitinib (TKI258)
Intervention descriptions: intervention 1: Oral Dovitinib (TKI258) as a gelatin capsule of 100 mg strength and dosed on a flat scale of 500 mg on a 5 days on /2 days off dosing schedule.

Protocol documents:
Clinical trial NCT01491022
Conditions: Parkinson's Disease
Keywords: parkinson's gait dysfunction ampyra 4-aminopyridine
Sponsor: University of Miami
Start date: 2012-07-01; Completion date: 2014-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).

Detailed description:
Subjects with Parkinson's disease will be randomly assigned to two groups. One group will receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then Ampyra.

Arms: arm 1: Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks arm 2: placebo 4 weeks followed by Ampyra 10 mg po BID
Interventions: intervention 1: Ampyra first, then Placebo intervention 2: placebo first, then Ampyra
Intervention descriptions: intervention 1: 10 mg po bid for 4 weeks followed by placebo 4 weeks. intervention 2: placebo

Protocol documents:
Clinical trial NCT01493557
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim
Start date: 2011-12-01; Completion date: 2014-07-01
Enrollment: 1067 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.

Detailed description:

Arms: arm 1: Patients with non valvular atrial fibrillation for whom Pradaxa is indicated in accordance with the current local label, not previously treated with Pradaxa, will be provided 3 months of treatment for the prevention of stroke and systemic embolism. Patients who report gastrointestinal symptoms (GIS) will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected. arm 2: Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal arm 3: Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal
Interventions: intervention 1: pantoprazole intervention 2: Pradaxa (dabigatran etexilate) intervention 3: Pradaxa, within 30 minutes after a meal intervention 4: Pradaxa (dabigatran etexilate)
Intervention descriptions: intervention 1: 40 mg q.a.m, p.o. intervention 2: 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada) intervention 3: Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal intervention 4: 150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Protocol documents:
Clinical trial NCT01495481
Conditions: Supraventricular Tachycardia
Keywords: Supraventricular Tachycardia SVT Reentrant Tachycardia Dexmedetomidine Adenosine
Sponsor: University of Pittsburgh
Start date: 2012-01-01; Completion date: 2014-07-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).

Detailed description:
In 2006 the investigator found that dexmedetomidine, an alpha-2 adrenergic agonist with primarily sedative properties, possesses additional anti-arrhythmic properties. So far the investigator has found that dexmedetomidine has the ability to prevent or terminate arrhythmias like atrial ectopic tachycardia (85% success) and junctional ectopic tachycardia (75% success). The most dramatic effect however was observed in the acute termination of reentrant SVT with a success rate of \> 96%. More importantly we found that dexmedetomidine terminates SVT without causing any sinus pause or asystole (frequently seen with adenosine) and thus avoiding the feeling of "impending doom". In this study adenosine is being compared head to head with dexmedetomidine in a cross over study, for both safety and efficacy when given for the termination of SVT in the electrophysiology (EP) lab. Additional EP parameters will be measured to elucidate the exact site of dexmedetomidine's mechanism of action.

Arms: arm 1: Patients will receive adenosine and then dexmedetomidine for the termination of SVT
Interventions: intervention 1: Dexmedetomidine intervention 2: Adenosine
Intervention descriptions: intervention 1: Dexmedetomidine 2 mcg/kg, Intravenous push intervention 2: Stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful

Protocol documents:
Clinical trial NCT01498822
Conditions: Epilepsy
Keywords: Levetiracetam Oxcarbazepine treatment failure partial epilepsy
Sponsor: Korea UCB Co., Ltd.
Start date: 2011-06-01; Completion date: 2014-07-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

Detailed description:
The study duration consists of the following periods:

* Baseline period of one week: Week -1
* Titration period of two weeks: Week 0 to Week 1
* Treatment period of 48 weeks: Week 2 to Week 50

Arms: arm 1: Levetiracetam twice a day treatment group arm 2: Oxcarbazepine twice a day treatment group
Interventions: intervention 1: Levetiracetam intervention 2: Oxcarbazepine
Intervention descriptions: intervention 1: 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks intervention 2: 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)

Protocol documents:
Clinical trial NCT01511068
Conditions: Hereditary Pulmonary Alveolar Proteinosis
Keywords: PAP
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2012-08-01; Completion date: 2014-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to partial dysfunction of the GM-CSF receptor.

Detailed description:

Arms: arm 1: Inhaled recombinant human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (hPAP) due to partial dysfunction of the GM-CSF receptor
Interventions: intervention 1: Leukine
Intervention descriptions: intervention 1: Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy.

Protocol documents:
Clinical trial NCT01514357
Conditions: Hypertension
Sponsor: John C Burnett
Start date: 2012-04-01; Completion date: 2014-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: If the use of B-type natriuretic peptide (BNP) is proven to be effective in controlling high blood pressure, it may lead to a reduction of standard therapy and improved cardiovascular and kidney protection.

Detailed description:
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure. Its myocardial complications result from increased mechanical load on the heart. Under physiological conditions of increased myocardial load and resulting myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis. However, studies indicate that in subjects with cardiovascular diseases the biological structure of these hormones may be altered, thus reducing their favorable protective activities. New studies indicate that early and moderate hypertension is associated with a derangement of the natriuretic peptide system which is characterized by the lack of activation of biologically active ANP and BNP, while severe hypertension is characterized by cardiac release of altered molecular forms of ANP and BNP that have reduced biological properties and/or enhanced degradation.

The broad objective of proposal is to advance the biology and therapeutics of the natriuretic peptides (NPs) with a special focus on the cardiac peptide BNP in human hypertension. The investigators' proposal is based upon the biological properties of BNP (i.e., natriuretic, renin-angiotensin-aldosterone suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its mechanistic role in human hypertension, and thus its potential as an innovative chronic protein therapeutic to enhance the treatment of patients with uncontrolled and or resistant hypertension. Importantly, BNP is an endocrine hormone normally produced by the human heart, and its use as therapeutic agent has been approved in USA for more than a decade and has been proven to be safe.

Arms: arm 1: Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg. arm 2: Subjects will receive SQ placebo bid for seven consecutive days.
Interventions: intervention 1: Nesiritide (BNP) intervention 2: Placebo
Intervention descriptions: intervention 1: NATRECOR® (nesiritide) is a sterile, purified preparation of human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Each 1.5 mg vial contains a white- to off-white lyophilized powder for intravenous (IV) administration after reconstitution. intervention 2: Placebo will be administered subcutaneously instead of active drug (nesiritide) in a blind fashion in the second arm of the study.

Protocol documents:
Clinical trial NCT01530334
Conditions: Lung Cancer
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2014-07-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
the primary objective is to characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC

Detailed description:
A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA�) as 3rd line treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and who responded to gefitinib in 1st line and progressed after 2nd line chemotherapy

Arms: arm 1: Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal
Interventions: intervention 1: Gefitinib 250mg
Intervention descriptions: intervention 1: Gefitinib 250mg once daily

Protocol documents:
Clinical trial NCT01534663
Conditions: Heart Failure
Keywords: Heart Failure Skeletal Muscle Function Metabolism Inflammation Glutamine Fish oil Muscle Function
Sponsor: Columbia University
Start date: 2011-11-01; Completion date: 2014-07-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.

Detailed description:

Arms: arm 1: The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. arm 2: 3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d).
Interventions: intervention 1: Glutamine and Fish Oil Supplementation intervention 2: Placebo
Intervention descriptions: intervention 1: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. intervention 2: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.

Protocol documents:
Clinical trial NCT01537133
Conditions: Asthma Atopy
Sponsor: Milton S. Hershey Medical Center
Start date: 2012-10-01; Completion date: 2014-07-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease).

The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.

Detailed description:
Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in asthmatics.

Arms: arm 1: Fluticasone (250 mcg/puff, one puff, twice a day) arm 2: Placebo fluticasone (one puff, twice a day) arm 3: None arm 4: None
Interventions: intervention 1: fluticasone intervention 2: Placebo
Intervention descriptions: intervention 1: Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day intervention 2: Dry Powder Inhaler: Placebo

Protocol documents:
Clinical trial NCT01588548
Conditions: Advanced Solid Malignancies Malignant Lymphoma
Keywords: Advanced solid malignancies Malignant lymphoma
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2014-07-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

Detailed description:
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Arms: arm 1: None
Interventions: intervention 1: AZD1208
Intervention descriptions: intervention 1: Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

Protocol documents: