ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00881569
Conditions: Advanced Cancer
Keywords: CS-7017 Advanced Cancer
Sponsor: Daiichi Sankyo
Start date: 2009-03-01; Completion date: 2011-09-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.

Detailed description:
This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.

Arms: arm 1: CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg
Interventions: intervention 1: CS-7017
Intervention descriptions: intervention 1: CS-7017 administered orally, twice daily continuously for 6 weeks

Protocol documents:
Clinical trial NCT00889863
Conditions: Systemic Juvenile Idiopathic Arthritis With Active Flare
Keywords: Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis Juvenile rheumatoid
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2011-09-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

Detailed description:

Arms: arm 1: In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. arm 2: Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
Interventions: intervention 1: canakinumab intervention 2: placebo
Intervention descriptions: intervention 1: Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake. intervention 2: Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.

Protocol documents:
Clinical trial NCT00908050
Conditions: Bruxism
Keywords: bruxism, botulinum toxin, sleep study
Sponsor: Baylor College of Medicine
Start date: 2009-04-01; Completion date: 2011-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.

Detailed description:
Bruxism represents involuntary movements of the jaw muscles, resulting in tooth grinding and clenching. Generally it occurs during sleep, but occasionally can be present during the day, so called awake bruxism. Bruxism is a common condition, affecting approximately 8% of all people. It is not known what causes bruxism but it may result in tooth damage, jaw pain, headaches, poor quality sleep and may bother your partner's sleep at night due to the tooth grinding noise. There is no generally accepted treatment for bruxism. Mouth guards and several medications have been tried, but they generally did not work or caused side effects.

Botulinum toxin "Botox" is a natural toxin, which weakens the muscles when injected in very small amounts. It is currently approved and used for the treatment of various conditions involving abnormal muscle spasms, such as neck twisting (torticollis), twitching of the face (hemifacial spasm) or eyes (blepharospasm), headaches, muscles stiffness following strokes, and it has also been used cosmetically for wrinkle removal.

Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been tried, initial results showing that it is safe and effective. The injections generally take one week to start working and 2 weeks for a full effect, which lasts on average 12-16 weeks, and slowly wear off. The injections are generally repeated every 3-4 months.

Arms: arm 1: Placebo arm arm 2: Active arm
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo arm
Intervention descriptions: intervention 1: Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally. intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT00911300
Conditions: Fibrillation, Atrial
Keywords: Cardioversion, Electric Pathological Conditions, Sings and Symptoms Cardiovascular Diseases Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac Pathologic Processes Anticoagulants
Sponsor: GlaxoSmithKline
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: fondaparinux intervention 2: unfractionated heparin intervention 3: Vitamin-K-Antagonist
Intervention descriptions: intervention 1: Comparison of different drugs intervention 2: Comparison of different drugs intervention 3: Comparison of different drugs

Protocol documents:
Clinical trial NCT00911937
Conditions: Overactive Bladder
Keywords: incontinence OAB urgency nocturia
Sponsor: Pfizer
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 963 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fesoterodine intervention 2: Placebo
Intervention descriptions: intervention 1: Fesoterodine 4mg and 8 mg tablets taken daily. intervention 2: Placebo sham 4mg and 8 mg tables taken daily.

Protocol documents:
Clinical trial NCT00928070
Conditions: Overactive Bladder
Keywords: Urgency Urinary Incontinence OAB
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 566 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fesoterodine intervention 2: Placebo
Intervention descriptions: intervention 1: Fesoterodine 4 mg and 8 mg intervention 2: Placebo sham 4 mg and 8 mg

Protocol documents:
Clinical trial NCT00931164
Conditions: Alternating Hemiplegia of Childhood
Keywords: phase I/II study effects of sodium oxybate cohort of 6 children and young adults AHC
Sponsor: University of Utah
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
WHO: The investigators are recruiting children and young adults to participate in a research study who:

1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC)
2. Are between the ages of 6 months - 25 years old
3. Have at least three 10-minute-long AHC episodes during a typical week
4. Can commit to 12 weeks of completing of a daily log describing AHC episodes and to a multi-night hospital stay at the University of Utah Center for Clinical and Translational Science (CCTS)

WHY: The goal of this study is to evaluate whether the study drug can safely and effectively decrease AHC episodes and improve the quality of life of individuals with AHC.

WHAT and WHERE: This study involves at least 12 weeks of completing and submitting daily AHC Episode Logs and a five-day hospital stay at the University of Utah CCTS.

There are 4 phases of the study, and they include:

1. Six weeks of daily log completion prior to starting study drug
2. Five day stay at the University of Utah CCTS
3. Six additional weeks of daily log completion while using study drug at home
4. One day clinic visit to the University of Utah for follow up

COMPENSATION:

There is no fee to participate. All procedures performed specifically for this study will be covered by the study and will not be billed to you or your insurance company.

The study drug will be dispensed to you free of charge. Meals and lodging at the study site will be provided free of charge for the study participant and one care provider. Additionally, the research team will assist subjects with booking and obtaining free transportation, such as an airline tickets, to and from the study site.

Detailed description:

Arms: arm 1: * The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.
* Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.
Interventions: intervention 1: Sodium Oxybate
Intervention descriptions: intervention 1: dosage is by weight

Protocol documents:
Clinical trial NCT00933608
Conditions: Alzheimer's Disease
Keywords: subjective memory complaints cognitively healthy family history AD
Sponsor: NYU Langone Health
Start date: 2009-07-01; Completion date: 2011-09-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's disease (AD). Hence, targeting populations at risk with pharmacological interventions is a possible strategy to lessen the burden of the disease. Cognitively normal individuals with subjective memory complaints (SMC) manifest biological characteristics consistent with early AD and are at risk for future cognitive decline. Family history of AD also constitutes a risk. In a previous study the investigators showed that memantine slows down the accumulation of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity. In this new project the investigators propose to treat a sample of 12 presymptomatic individuals at risk (SMC and family history of AD) with memantine. This will be a double blind, placebo controlled study with a control group (12 non-treated subjects). The investigators will determine whether the effects of memantine as assessed by cognitive performance and MRS are present after 4 months of treatment and persist 2 months after discontinuation. MRS will be used to evaluate the effect of memantine on levels of the neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the hippocampus. The investigators will test the following hypotheses:

1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal integrity).
2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be measured 2 months after discontinuation of the treatment.

Detailed description:

Arms: arm 1: after a period of gradual dose increase from 5 mg/day, participants will be asked to take memantine (20mg/day) for 16 weeks 10 mg in the morning, 10 mg at night arm 2: dose increase to match active drug, after that 1 tablet in the morning, 1 tablet at night, to match active drug
Interventions: intervention 1: memantine intervention 2: Placebo
Intervention descriptions: intervention 1: participants will be asked to take memantine (20mg/day) for 16 weeks intervention 2: participants will be asked to take 2 tablets per day to match active drug

Protocol documents:
Clinical trial NCT00940875
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-06-01; Completion date: 2011-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: erlotinib [Tarceva] intervention 2: gemcitabine intervention 3: gemcitabine
Intervention descriptions: intervention 1: 150mg po on days 15-28 of each 4 week cycle intervention 2: 1250mg/m2/day on days 1 and 8 of each 4 week cycle intervention 3: 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle

Protocol documents:
Clinical trial NCT00954447
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 1263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: patient receives a tablet with intended final marketed dose arm 2: patient receives a tablet identical to those containing Linagliptin
Interventions: intervention 1: Placebo intervention 2: Linagliptin
Intervention descriptions: intervention 1: Placebo, identical to Linagliptin tablet intervention 2: intended final marketed dose

Protocol documents:
Clinical trial NCT00969553
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.

Detailed description:

Arms: arm 1: Schedule A
Interventions: intervention 1: BI 6727
Intervention descriptions: intervention 1: Dose level 1

Protocol documents:
Clinical trial NCT00970684
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer
Sponsor: Nathan Pennell, MD, PhD
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.

Secondary

* Evaluate the median time to progression in patients treated with this regimen.
* Estimate the response rate in patients treated with this regimen.
* Determine the median overall survival of patients treated with this regimen.
* Determine the incidence of adverse events associated with this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.

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

Arms: arm 1: Treatment repeats every 21 days for up to 6 courses.
Interventions: intervention 1: bevacizumab intervention 2: docetaxel intervention 3: gemcitabine hydrochloride
Intervention descriptions: intervention 1: 15 mg/kg on day 1 of a 21-day cycle intervention 2: 75 mg/m2 on day 1 intervention 3: 900 mg/m2 on days 1, and 8,

Protocol documents:
Clinical trial NCT00980980
Conditions: Methicillin-resistant Staphylococcus Aureus
Keywords: MRSA infection
Sponsor: Harvard Pilgrim Health Care
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 74256 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:

* screening on admission followed by isolation of MRSA+ patients
* screening on admission followed by isolation and decolonization of MRSA+ patients
* universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.

The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Detailed description:
Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level.

Eligibility survey was conducted to determine exclusion criteria.

As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.

Arms: arm 1: Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ arm 2: Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ arm 3: Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Interventions: intervention 1: Chlorhexidine bath and nasal mupirocin
Intervention descriptions: intervention 1: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)

Protocol documents:
Clinical trial NCT00984867
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin DPP IV inhibitor add on study Inadequate control
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2011-09-01
Enrollment: 833 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.

Detailed description:

Arms: arm 1: Dapagliflozin 10 mg tablet arm 2: Matching placebo tablet
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablet, oral, once daily, 48 weeks intervention 2: Matching placebo tablet

Protocol documents: