ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00667225
Conditions: Molluscum Contagiosum, Skin Disease
Sponsor: University of North Carolina, Chapel Hill
Start date: 2008-01-01; Completion date: 2009-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.

Detailed description:

Arms: arm 1: Subjects in this group will have topical application of cantharidin's vehicle at each visit. arm 2: Subjects in this group will have topical application of cantharidin at each visit.
Interventions: intervention 1: cantharidin's vehicle intervention 2: Cantharidin 0.7%
Intervention descriptions: intervention 1: Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits. intervention 2: Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.

Protocol documents:
Clinical trial NCT00670267
Conditions: Asthma
Keywords: Asthma hyperresponsiveness
Sponsor: Invion, Inc.
Start date: 2007-01-01; Completion date: 2009-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.

Detailed description:

Arms: arm 1: Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
Interventions: intervention 1: nadolol
Intervention descriptions: intervention 1: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.

Protocol documents:
Clinical trial NCT00677365
Conditions: Cystic Fibrosis (CF)
Sponsor: Amgen
Start date: 2008-06-01; Completion date: 2009-06-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

Detailed description:
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days arm 2: MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days arm 3: MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days arm 4: MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days
Interventions: intervention 1: MP-376 intervention 2: Placebo
Intervention descriptions: intervention 1: 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days intervention 2: same frequency as study drug using the same nebulizer

Protocol documents:
Clinical trial NCT00678288
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer Interferon
Sponsor: Bayer
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

Detailed description:

Arms: arm 1: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. arm 2: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Sorafenib (Nexavar, BAY43-9006) + Interferon
Intervention descriptions: intervention 1: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously intervention 2: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

Protocol documents:
Clinical trial NCT00685698
Conditions: Diabetic Foot Infections
Keywords: Diabetic Foot Infections, DFI, Nemonoxacin
Sponsor: TaiGen Biotechnology Co., Ltd.
Start date: 2008-06-01; Completion date: 2009-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections

Detailed description:
This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be conducted in a subgroup of eight consenting patients.

Arms: arm 1: Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
Interventions: intervention 1: TG-873870 (Nemonoxacin)
Intervention descriptions: intervention 1: 750 mg

Protocol documents:
Clinical trial NCT00687609
Conditions: Attention Deficit Hyperactivity Disorder Cannabis Abuse
Keywords: Attention Deficit Hyperactivity Disorder with Cannabis Abuse Marihuana Abuse Comorbid Cannabis Abuse
Sponsor: Eli Lilly and Company
Start date: 2008-09-01; Completion date: 2009-06-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse.

Detailed description:
In the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for ADHD symptoms was studied. In this study the efficacy of atomoxetine on symptoms of ADHD in adolescents with ADHD and comorbid cannabis abuse will be studied.

Arms: arm 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.

Protocol documents:
Clinical trial NCT00688909
Conditions: Breast Cancer
Keywords: breast cancer adjuvant treatment in post menopausal women letrozole arthralgia-myalgia
Sponsor: Novartis Pharmaceuticals
Start date: 2008-03-01; Completion date: 2009-06-01
Enrollment: 261 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole

Detailed description:
This is a multi-center prospective non-randomized single arm, open label trial in postmenopausal HR positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a patient has breast cancer recurrence or is intolerant to letrozole during the 24 week period, the drug will be discontinued.

Arms: arm 1: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks.
Interventions: intervention 1: letrozole
Intervention descriptions: intervention 1: 2.5 mg daily by mouth for 6 months

Protocol documents:
Clinical trial NCT00698646
Conditions: Hypertension
Keywords: Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide
Sponsor: Novartis Pharmaceuticals
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Detailed description:

Arms: arm 1: (patients initiated on valsartan) arm 2: (patients initiated on HCTZ) arm 3: (patients initiated on Valsartan+HCTZ)
Interventions: intervention 1: Valsartan + HCTZ intervention 2: Valsartan intervention 3: HCTZ
Intervention descriptions: intervention 1: At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. intervention 2: At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. intervention 3: At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

Protocol documents:
Clinical trial NCT00699153
Conditions: Ocular Inflammation
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-06-01; Completion date: 2009-06-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

Detailed description:

Arms: arm 1: Loteprednol Etabonate 0.5% arm 2: Vehicle of Ophthalmic Loteprednol Etabonate
Interventions: intervention 1: Loteprednol Etabonate intervention 2: Vehicle of Ophthalmic Loteprednol Etabonate
Intervention descriptions: intervention 1: Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. intervention 2: Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.

Protocol documents:
Clinical trial NCT00718328
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage Edema Statins
Sponsor: Johns Hopkins University
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).

Detailed description:
Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.

The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.

The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.

Arms: arm 1: Simvastatin Group arm 2: Placebo Group
Interventions: intervention 1: Simvastatin 80 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge. intervention 2: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Protocol documents:
Clinical trial NCT00734929
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV nausea emesis antiemetics aprepitant ondansetron dexamethasone
Sponsor: Duke University
Start date: 2007-09-01; Completion date: 2009-06-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Detailed description:

Arms: arm 1: Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia arm 2: Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
Interventions: intervention 1: Aprepitant + Dexamethasone intervention 2: Ondansetron + Dexamethasone
Intervention descriptions: intervention 1: Aprepitant 40 mg + Dexamethasone 10 mg intervention 2: Ondansetron 4 mg + Dexamethasone 10 mg

Protocol documents:
Clinical trial NCT00737633
Conditions: Diabetes
Keywords: Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control
Sponsor: VIVUS LLC
Start date: 2008-08-01; Completion date: 2009-06-01
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Detailed description:

Arms: arm 1: Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) arm 2: Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Interventions: intervention 1: VI-0521
Intervention descriptions: intervention 1: Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Protocol documents:
Clinical trial NCT00739882
Conditions: Chronic Plaque Psoriasis
Keywords: Efalizumab, Chronic plaque psoriasis moderate to severe involving hands feet
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody intervention 2: Placebo
Intervention descriptions: intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. intervention 2: Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)

Protocol documents:
Clinical trial NCT00741273
Conditions: Impaired Liver Function
Sponsor: Repros Therapeutics Inc.
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.

Detailed description:
16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.

Arms: arm 1: Proellex 25 mg in healthy females arm 2: Proellex 50 mg in hepatically impaired females
Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: Proellex 25 mg capsule, single dose

Protocol documents:
Clinical trial NCT00743483
Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: cystic fibrosis pancreatic insufficiency bucelipase alfa bile salt stimulating lipase BSSL coefficient of fat absorption
Sponsor: Swedish Orphan Biovitrum
Start date: 2008-08-01; Completion date: 2009-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

Detailed description:
In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Arms: arm 1: 170 mg rhBSSL three times daily for 5 to 6 consecutive days
Interventions: intervention 1: rhBSSL
Intervention descriptions: intervention 1: oral suspension, 170 mg BSSL, 3 times daily for 5-6 days

Protocol documents:
Clinical trial NCT00758485
Conditions: Anesthesia Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.

Detailed description:

Arms: arm 1: Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium arm 2: Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Interventions: intervention 1: Sugammadex intervention 2: 0.9% sodium chloride (NaCl)
Intervention descriptions: intervention 1: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. intervention 2: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion.

Protocol documents:
Clinical trial NCT00766415
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Moderate to severe COPD
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD1981 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet, twice daily, 4 weeks treatment intervention 2: Placebo

Protocol documents: