ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00745030
Conditions: REM Behavior Disorder Parkinsonism
Keywords: Parkinson's disease Multiple Systems Atrophy Lewy Body Dementia
Sponsor: Northwestern University
Start date: 2008-06-01; Completion date: 2009-12-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD patients experience a variety of sleep disorders including parasomnias, specifically REM behavior disorder (RBD) that can precede the onset of motor manifestations of PD. RBD has negative consequences on patients' and their bed partners' quality of life mainly due to its impact on the sleep quality and day time alertness. RBD also predisposes affected individuals and their bed partners to physical injuries.

There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment but carries risks of daytime sedation, tolerance, and withdrawal symptoms. More recently, melatonin has been demonstrated to be effective in several small studies. Ramelteon, a selective melatonin receptor agonist with favorable safety profile, could potentially be effective for the treatment of RBD.

This pilot protocol will investigate safety and efficacy of ramelteon for the treatment of RBD in subjects with parkinsonism. We plan to recruit 20 subjects with RBD diagnosed based on the clinical interview and confirmed by the polysomnographic (PSG) data. The study is designed as a prospective randomized placebo controlled 12-week study. Primary outcome measure will be change in frequency of RBD events based on the daily sleep diaries. Secondary outcome measure will be change in the amount of tonic muscle activity based on the results of the baseline and final PSG. A number of other secondary and exploratory outcome measures will be collected

Detailed description:
See above.

Arms: arm 1: Ramelteon (TAK-375) 8mg tablets arm 2: Placebo 8 mg tablets
Interventions: intervention 1: Rozerem intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects take 1 8mg tablet 30 minutes before bedtime everyday for 8 weeks. intervention 2: Placebo 8 mg tablets

Protocol documents:
Clinical trial NCT00745251
Conditions: Sleep Apnea
Keywords: Sleep apnea; obesity
Sponsor: VIVUS LLC
Start date: 2008-08-01; Completion date: 2009-12-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.

Detailed description:

Arms: arm 1: 15 mg Phentermine and 92 mg Topiramate arm 2: None
Interventions: intervention 1: VI-0521 intervention 2: placebo
Intervention descriptions: intervention 1: 15 mg Phentermine and 92 mg Topiramate intervention 2: placebo

Protocol documents:
Clinical trial NCT00750139
Conditions: Tinea Pedis Athlete's Foot
Keywords: Tinea Pedis Athlete's foot
Sponsor: Merz North America, Inc.
Start date: 2008-08-01; Completion date: 2009-12-01
Enrollment: 707 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).

Detailed description:
To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.

Arms: arm 1: Naftin 2% cream applied daily for 2 weeks arm 2: Placebo cream applied daily for two weeks arm 3: Active comparator applied daily for 4 weeks arm 4: placebo cream applied daily for 4 weeks
Interventions: intervention 1: NAFT-500 intervention 2: Placebo 2-weeks intervention 3: Naftin 1% intervention 4: Placebo 4-weeks
Intervention descriptions: intervention 1: topical cream 1 application every day up to 4 weeks weeks intervention 2: placebo cream 1 application every day for up to 4 weeks intervention 3: topical allylamine cream applied once a day for up to 4 weeks intervention 4: topical placebo cream applied once a day for up to 4 weeks

Protocol documents:
Clinical trial NCT00750555
Conditions: Head and Neck Cancer
Keywords: squamous cell cancer of head and neck SCCHN
Sponsor: Geisinger Clinic
Start date: 2008-09-01; Completion date: 2009-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months

Protocol documents:
Clinical trial NCT00751179
Conditions: Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-01; Completion date: 2009-12-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.

Detailed description:

Arms: arm 1: Rocuronium - Sugammadex 4.0 mg/kg arm 2: Succinylcholine 1.0 mg/kg
Interventions: intervention 1: rocuronium intervention 2: sugammadex intervention 3: succinylcholine
Intervention descriptions: intervention 1: A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block. intervention 2: At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered. intervention 3: A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Protocol documents:
Clinical trial NCT00753142
Conditions: Diabetes Mellitus, Type 2
Keywords: Hyperglycemia
Sponsor: Emory University
Start date: 2004-03-01; Completion date: 2009-12-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA patients with DKA have type 2 diabetes. In such patients, previous studies reveal that: a) at presentation, obese AA patients with DKA have markedly decreased pancreatic insulin secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but significantly greater than in lean patients with DKA; b) aggressive diabetic management results in significant improvement in beta-cell function and insulin sensitivity sufficient to allow discontinuation of insulin therapy within 3 months of follow-up. Based on these observations the researchers conclude that similar to obese patients with hyperglycemia, most obese AA with DKA have type 2 diabetes, and that although defects in both insulin secretion and insulin action are present, transient b-cell failure is the primary defect in the development of ketoacidosis.

Detailed description:
Obese AA patients with a history of DKA who later experience near-normoglycemia remission represent an ideal population in which to define the sequence of events that lead to b-cell dysfunction in type 2 diabetes. The researchers hypothesize that obese AA with DKA will prove particularly susceptible to beta-cells dysfunction due to sustained elevations of plasma glucose (glucose toxicity) and/or free fatty acid levels (lipotoxicity). This study will test beta-cell response by administering a glucose infusion to diabetic African Americans with a history of DKA, diabetic African Americans without a history of DKA, and non-diabetic African Americans.

Arms: arm 1: Obese African Americans with type 2 diabetes with history of diabetic ketoacidosis (DKA) receiving Intralipid 20% and a glucose infusion. arm 2: Obese African American with type 2 diabetes with hyperglycemia without ketosis receiving Intralipid 20% and a glucose infusion. arm 3: Obese African Americans without diabetes receiving a glucose infusion.
Interventions: intervention 1: Intralipid 20% intervention 2: Glucose infusion
Intervention descriptions: intervention 1: Participants receive a 48-hour infusion with Intralipid at 40 milliliters per hour (mL/hr). intervention 2: Participants receive a glucose infusion consisting of 10% dextrose infused intravenously at a rate of 200 mg/m\^2/min for 20 hours.

Protocol documents:
Clinical trial NCT00758667
Conditions: Implant Capsular Contracture
Keywords: capsular contracture capsulectomy mesna Capsular contracture after breast implant placement
Sponsor: Vanderbilt University
Start date: 2005-01-01; Completion date: 2009-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Detailed description:
Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Arms: arm 1: Standard treatment arm 2: Standard surgical procedure with Mesna
Interventions: intervention 1: Mesna
Intervention descriptions: intervention 1: B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed

Protocol documents:
Clinical trial NCT00759707
Conditions: Peripheral Arterial Disease
Keywords: saphenous vein bypass grafts flow-mediated vasodilation
Sponsor: Brigham and Women's Hospital
Start date: 2006-04-01; Completion date: 2009-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether or not saphenous vein \[arterial\] bypass grafts in the leg relax in response to increases in blood flow.

Detailed description:
Subjects who have undergone saphenous vein \[arterial\] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. Following 10 minutes of rest, subjects will be given intravenous L-NMMA, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.

Arms: arm 1: ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
Interventions: intervention 1: L-N^G monomethyl arginine (L-NMMA)
Intervention descriptions: intervention 1: L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein \[arterial\] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA.

Protocol documents:
Clinical trial NCT00773175
Conditions: Dehydration
Keywords: pediatric hylenex subcutaneous infusion hyaluronidase rHuPH20 recombinant human hyaluronidase
Sponsor: Halozyme Therapeutics
Start date: 2008-10-01; Completion date: 2009-12-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.

Detailed description:
This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

Arms: arm 1: Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL) arm 2: Isotonic fluid rehydration by IV
Interventions: intervention 1: recombinant human hyaluronidase
Intervention descriptions: intervention 1: 150 Units in 1 mL

Protocol documents:
Clinical trial NCT00784550
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Spirometry COPD
Sponsor: GlaxoSmithKline
Start date: 2008-12-01; Completion date: 2009-12-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Detailed description:

Arms: arm 1: Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD arm 2: Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID
Interventions: intervention 1: Tiotropium Bromide intervention 2: Fluticasone Propionate/Salmeterol
Intervention descriptions: intervention 1: Long-acting muscarinic antagonist intervention 2: Inhaled corticosteroid plus long-acting bronchodilator

Protocol documents:
Clinical trial NCT00787332
Conditions: Suspected Heparin-Induced Thrombocytopenia
Keywords: Suspected Heparin Induced Thrombocytopenia (HIT)
Sponsor: Canyon Pharmaceuticals, Inc.
Start date: 2008-09-01; Completion date: 2009-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare Clinical Success and Costs in two Arms

Detailed description:
Demonstrate clinical and economic utility between the study Arms.

Arms: arm 1: Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin arm 2: Patients randomized to IV Argatroban®
Interventions: intervention 1: Desirudin or Argatroban®
Intervention descriptions: intervention 1: Desirudin 15mg SC Argatroban® IV dosing per Package Insert

Protocol documents:
Clinical trial NCT00789672
Conditions: Amblyopia
Keywords: Amblyopia Patching Levodopa
Sponsor: Jaeb Center for Health Research
Start date: 2009-01-01; Completion date: 2009-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide limited data on it's efficiency, and to provide data to assist in selecting a dose to use in a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.

Detailed description:
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study (ATS3) where children 7 to 13 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Arms: arm 1: Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. arm 2: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication.
Interventions: intervention 1: levodopa/carbidopa intervention 2: patching intervention 3: levodopa/carbidopa
Intervention descriptions: intervention 1: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) intervention 2: 2 hours daily patching intervention 3: Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)

Protocol documents:
Clinical trial NCT00789880
Conditions: Atopic Dermatitis Psoriasis
Keywords: Vitamin D3 Atopic Dermatitis Antimicrobial Peptide Expression
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2008-12-01; Completion date: 2009-12-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether administration of oral Vitamin D3 given over 21 days will change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic Dermatitis (AD). This study will help researchers determine if the lack of the expression of antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema vaccinatum (EV).

Detailed description:
Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from a combination of immunological, genetic, and environmental factors. Individuals with AD are at risk for developing a severe and widely disseminated infection called eczema vaccinatum (EV). EV is caused when the live attenuated vaccinia virus in the vaccine reproduces and spreads throughout the body. Individuals with AD lack certain antimicrobial peptides, specifically cathelicidins.

This trial also includes a sub-study with individuals who have psoriasis. Psoriasis is also an immune-mediated skin disease, and is characterized by scaling skin and inflammation (pain, swelling, heat, and redness). Most psoriasis cause patches of thick, red skin with silvery scales. These patches can itch or feel sore. This sub-study will provide additional information on psoriatic responses to oral vitamin D. (Originally listed separately as ADVN-CATH-03-01).

Arms: arm 1: Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] arm 2: Subjects received a 21-day course of oral vitamin D3-placebo
Interventions: intervention 1: Vitamin D3 intervention 2: Placebo
Intervention descriptions: intervention 1: Administration of oral vitamin D3 at 4000IU intervention 2: Administration of oral Vitamin D3 placebo

Protocol documents:
Clinical trial NCT00797316
Conditions: Hypertension
Keywords: Hypertension Metabolic Syndrome aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure stage 2
Sponsor: Novartis
Start date: 2008-11-01; Completion date: 2009-12-01
Enrollment: 532 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).

Detailed description:

Arms: arm 1: Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form. arm 2: Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Interventions: intervention 1: Aliskiren intervention 2: Hydrochlorothiazide
Intervention descriptions: intervention 1: Aliskiren 150 mg or 300 mg taken once daily in oral form intervention 2: Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Protocol documents:
Clinical trial NCT00799227
Conditions: Diabetic Macular Edema Vitrectomy
Sponsor: Allergan
Start date: 2009-01-01; Completion date: 2009-12-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Detailed description:

Arms: arm 1: 700 µg dexamethasone implant in the study eye at Day 1
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Protocol documents:
Clinical trial NCT00811850
Conditions: Glaucoma
Sponsor: Allergan
Start date: 2008-12-01; Completion date: 2009-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.

Detailed description:

Arms: arm 1: Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks. arm 2: Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Interventions: intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution intervention 2: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
Intervention descriptions: intervention 1: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks intervention 2: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Protocol documents: