ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01233284
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-11-01; Completion date: 2012-01-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25 µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with moderate persistent asthma who are still symptomatic despite regular maintenance therapy with inhaled corticosteroids (ICS).

The data collected in the present trial will provide useful information to health care providers and patients regarding the efficacy and safety of a once daily inhalation of three different doses of tiotropium solution delivered by the Respimat® inhaler in addition to inhaled corticosteroids in the treatment of not fully controlled moderate asthma in comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD patients. However, there is currently no PK data available for the 3 doses of tiotropium being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients. Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of moderate persistent asthma.

Detailed description:

Arms: arm 1: once daily, delivered by the Respimat® inhaler arm 2: once daily, delivered by the Respimat® inhaler arm 3: once daily, delivered by the Respimat® inhaler arm 4: once daily, delivered by the Respimat® inhaler
Interventions: intervention 1: tiotropium bromide 2.5µg once daily intervention 2: Tiotropium matching Placebo once daily intervention 3: tiotropium bromide high dose once daily intervention 4: tiotropium bromide 1.25µg once daily
Intervention descriptions: intervention 1: Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo intervention 2: Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo intervention 3: Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo intervention 4: IMP

Protocol documents:
Clinical trial NCT01234870
Conditions: Heart Disease, Ischemic Atherosclerosis, Coronary
Keywords: Myocardial Perfusion Imaging Magnetic Resonance Imaging
Sponsor: Northwestern University
Start date: 2010-06-01; Completion date: 2012-01-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.

Detailed description:
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.

With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac Magnetic Resonance Imaging.

Arms: arm 1: Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
Interventions: intervention 1: Gadolinium intervention 2: Adenosine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01244984
Conditions: Asthma
Keywords: asthma Fluticasone furoate GW642444
Sponsor: GlaxoSmithKline
Start date: 2010-07-01; Completion date: 2012-01-01
Enrollment: 243 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.

Detailed description:

Arms: arm 1: Combination inhaled corticosteroid and long-acting beta2-agonist arm 2: Inhaled corticosteroid
Interventions: intervention 1: Fluticasone Furoate/GW642444 Inhalation Powder intervention 2: Fluticasone Furoate Inhalation Powder
Intervention descriptions: intervention 1: Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks intervention 2: Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks

Protocol documents:
Clinical trial NCT01257750
Conditions: Corneal Neovascularization
Keywords: corneal neovascularization pazopanib votrient rosacea
Sponsor: Reza Dana, MD
Start date: 2010-11-01; Completion date: 2012-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and efficacy of a drug \[Pazopanib (Votrient)\] as a treatment for corneal neovascularization. The cornea is the clear, central portion of the eye and neovascularization means blood vessel growth. The cornea is typically avascular, or without blood vessels. Corneal neovascularization in the cornea and can put vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell deficiency can lead to corneal neovascularization. This major ocular complication can lead to corneal scarring, edema (swelling), lipid deposits, and inflammation that may significantly alter your vision. In addition, it worsens the outcome of potential future treatments, such as a corneal transplant. A corneal transplant is a treatment that many patients with severe corneal disease may ultimately need.

Detailed description:
Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. In previous studies, inhibition of new blood or lymphatic vessels has been achieved by neutralization of vascular endothelial growth factor A (VEGF-A). It has also been shown that platelet-derived growth factor-B (PDGF-B) plays a role in corneal and choroidal neovascularization by regulating mural cell recruitment. Inhibition of PDGF-B and VEGF-A signaling pathways has shown to more effectively promote vessel regression than solely inhibiting VEGF-A. Pazopanib is a drug designed to block these pathways, stop new growth, and regress old vessel growth.

Arms: arm 1: This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Interventions: intervention 1: Pazopanib (5mg/ml)
Intervention descriptions: intervention 1: Topical pazopanib, 4 times per day for 3 weeks

Protocol documents:
Clinical trial NCT01262092
Conditions: Opioid Dependence Opioid Withdrawal Opioid Detoxification
Keywords: opioid dependent detoxification buprenorphine suboxone opiate
Sponsor: University of Arkansas
Start date: 2010-10-01; Completion date: 2012-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.

Detailed description:

Arms: arm 1: Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. arm 2: Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
Interventions: intervention 1: Buprenorphine
Intervention descriptions: intervention 1: Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.

Protocol documents:
Clinical trial NCT01262456
Conditions: Nocturia
Sponsor: Ferring Pharmaceuticals
Start date: 2011-02-01; Completion date: 2012-01-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.

Detailed description:

Arms: arm 1: Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. arm 2: Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. arm 3: Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Interventions: intervention 1: Desmopressin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01275300
Conditions: Hyperlipidemia
Sponsor: University of Pennsylvania
Start date: 2007-07-01; Completion date: 2012-01-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin.

Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis

Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis

Detailed description:
The purpose of this study is to look at the roles of various blood cells and their contributions of different prostaglandins. The intention is that by better understanding these prostaglandins and various metabolites, it will provide insights into their roles in the cardiovascular system.

Prostaglandins and metabolites are naturally occurring substances found in the blood and urine which can act as markers which can be quantified and studied as we will be doing in this study. Flushing response to niacin will also be assessed by laser doppler measuring blood flow of the facial skin.

Untransformed and transformed data will be subjected to exploratory analysis of variance appropriated for a three factor design with one two period crossover factor and two non-repeated factors. Additionally, volunteer's test(s) for paired observations will characterize the magnitude of the niacin effect on the response variables within selected time points.

Arms: arm 1: Subjects were given 5 days of placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of placebo. Urine was collected sequentially for analysis. The same subjects came back for cross-over study and were assigned to Aspirin group. There was a 2-week washout period between each treatment. arm 2: Subjects were given 5 days of 81 mg aspirin. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. Urine was collected sequentially for analysis. arm 3: In phase II study, subjects were given 5 days of 81 mg aspirin. On day 6, they were given a single dose of niacin (600 mg) administered 24 hours after the last dose of aspirin. Urine was collected sequentially for analysis
Interventions: intervention 1: Aspirin intervention 2: Placebo intervention 3: Niacin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01276223
Conditions: Dry Eye Disease
Keywords: Dry eye ocular discomfort
Sponsor: Alcon Research
Start date: 2011-02-01; Completion date: 2012-01-01
Enrollment: 722 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Detailed description:
Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Arms: arm 1: Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure. arm 2: Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
Interventions: intervention 1: Difluprednate 0.05% ophthalmic emulsion intervention 2: Difluprednate vehicle
Intervention descriptions: intervention 1: Topical ocular steroid intervention 2: Inactive ingredients used as Run-In and placebo comparator

Protocol documents:
Clinical trial NCT01287832
Conditions: Bacteremia
Keywords: Methicillin-resistant Staphylococcus aureus
Sponsor: St. John Health System, Michigan
Start date: 2011-06-01; Completion date: 2012-01-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.

Detailed description:

Arms: arm 1: Vancomycin dosed to achieve a trough of 15-20 microgram/mL. arm 2: Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Interventions: intervention 1: Vancomycin intervention 2: Daptomycin
Intervention descriptions: intervention 1: Vancomycin dosed to achieve a trough of 15-20 microgram/mL. intervention 2: None

Protocol documents:
Clinical trial NCT01289015
Conditions: Tinea Pedis
Keywords: fungal infection athlete foot
Sponsor: Merz North America, Inc.
Start date: 2011-02-01; Completion date: 2012-01-01
Enrollment: 855 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NAFT-600 ( naftin 2 % gel ) intervention 2: Placebo
Intervention descriptions: intervention 1: Topical; applied once daily for two weeks intervention 2: Topical; applied once daily for two weeks

Protocol documents:
Clinical trial NCT01289080
Conditions: Schizophrenia Psychiatric Disorders
Keywords: Schizophrenia psychiatric disorders renal failure
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-01-01; Completion date: 2012-01-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.

Detailed description:

Arms: arm 1: subjects with normal renal function arm 2: severely renally impaired subjects
Interventions: intervention 1: OPC-34712
Intervention descriptions: intervention 1: administered orally

Protocol documents:
Clinical trial NCT01298063
Conditions: Liver Diseases Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2012-01-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.

Detailed description:

Arms: arm 1: healthy subjects, mild and moderate liver impaired subjects to receive one single dose treatment containing the highest dose afatinib arm 2: healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the medium dose of afatinib arm 3: healthy subjects, moderate liver impaired subjects to receive one single dose treatment containing the low dose of afatinib
Interventions: intervention 1: Afatinib intervention 2: Afatinib intervention 3: Afatinib
Intervention descriptions: intervention 1: 1 tablet, once qd in the morning intervention 2: 1 tablet, once qd in the morning intervention 3: 1 tablet, once qd in the morning

Protocol documents:
Clinical trial NCT01305577
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2010-12-01; Completion date: 2012-01-01
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Detailed description:

Arms: arm 1: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Interventions: intervention 1: Deoxycholic acid injection intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT01310803
Conditions: Carcinoma in Situ Transitional Cell Carcinoma Non-muscle Invasive Bladder Cancer
Keywords: Urinary Bladder Neoplasms Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases TURBT Valstar
Sponsor: Endo Pharmaceuticals
Start date: 2011-05-01; Completion date: 2012-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (\>1 year vs. \<1 year).

Detailed description:

Arms: arm 1: Chemotherapeutic: EN3329-301 (VALSTAR) arm 2: Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Interventions: intervention 1: VALSTAR - Maintenance Therapy intervention 2: No Maintenance treatment ( Standard of Care)
Intervention descriptions: intervention 1: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase intervention 2: Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

Protocol documents: