ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00876343
Conditions: Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-03-01; Completion date: 2012-07-01
Enrollment: 586 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.

Detailed description:

Arms: arm 1: Fixed dose arm 2: Titration dose arm 3: Placebo
Interventions: intervention 1: Aripiprazole (Fixed dose) intervention 2: Aripiprazole (Titrated dose) intervention 3: Placebo
Intervention descriptions: intervention 1: administered orally once daily, 3 mg daily, 6 weeks intervention 2: administered orally once daily, 3 to 15 mg daily, 6 weeks intervention 3: administered orally once daily, 6 weeks

Protocol documents:
Clinical trial NCT00882362
Conditions: Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-03-01; Completion date: 2012-07-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major depressive disorder.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-14597 (Aripiprazole)
Intervention descriptions: intervention 1: administered orally once daily, 3 to 15 mg daily, 52 weeks

Protocol documents:
Clinical trial NCT00887562
Conditions: MELAS Syndrome
Sponsor: Michio Hirano
Start date: 2009-05-01; Completion date: 2012-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of two (2) different doses of idebenone with that of a placebo over a one month period on cerebral lactate concentration as measured by magnetic resonance spectroscopy.

Detailed description:
MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-Like Episodes), a progressive and often devastating multisystem disorder, is most commonly associated with mitochondrial Deoxyribonucleic acid (mtDNA) point mutation at nucleotide 3243. Seizures, cognitive deterioration, and neurobehavioral abnormalities are frequent features of this disease which typically shortens life expectancy. Idebenone, an ATP production modulator and antioxidant, improves neurological function in Friedreich's ataxia, a disease also associated with mitochondrial dysfunction.

Given that there is no effective treatment for MELAS, the investigators propose a Phase II proof of concept trial of idebenone to study its preliminary efficacy in patients with MELAS and the A3243G mtDNA mutation, and to study its safety and tolerability in this patient group.

The investigators propose to evaluate 21 patients with the A3243G mitochondrial DNA mutation and MELAS (defined by a history of either seizures or stroke). Patients will receive idebenone (900 mg/day or 2250 mg/day) or matching placebo for one month. The primary outcome measure is cerebral lactate levels measured by Magnetic Resonance Spectroscopy (MRS), a biomarker associated with disease worsening. This study will help the investigators to determine if there is sufficient signal to proceed to efficacy studies. Also it will provide additional information on the safety and tolerability of two different doses of idebenone in MELAS.

Arms: arm 1: Idebenone 900 mg/day arm 2: Idebenone 2250 mg/day arm 3: Placebo
Interventions: intervention 1: Idebenone intervention 2: Idebenone intervention 3: Placebo
Intervention descriptions: intervention 1: 900 mg/day for 1 month intervention 2: 2250 mg/day for 1 month intervention 3: Placebo - No idebenone

Protocol documents:
Clinical trial NCT00899678
Conditions: Crohn's Disease
Keywords: Certolizumab Pegol Cimzia ® Crohn's Disease
Sponsor: UCB Celltech
Start date: 2009-04-01; Completion date: 2012-07-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.

Detailed description:

Arms: arm 1: Maintenance High-Dose group: 400 mg Certolizumab Pegol for subjects ≥ 40 kg or 200 mg Certolizumab Pegol for subjects 20 to \< 40 kg arm 2: Maintenance Low-Dose group: 200 mg Certolizumab Pegol for subjects ≥ 40 kg or 100 mg Certolizumab Pegol for subjects 20 to \< 40 kg
Interventions: intervention 1: Certolizumab Pegol intervention 2: Certolizumab Pegol
Intervention descriptions: intervention 1: 400 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg

\*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg intervention 2: 200 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg

\*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg

Protocol documents:
Clinical trial NCT00905437
Conditions: Pain, Perioperative
Keywords: perioperative pregabalin total hip replacement post-operative pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-11-01; Completion date: 2012-07-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.

Detailed description:

Arms: arm 1: Placebo as an adjunct to standard of care arm 2: Pregabalin as an adjunct to standard of care
Interventions: intervention 1: Placebo intervention 2: Pregabalin
Intervention descriptions: intervention 1: Placebo as an adjunct to standard of care intervention 2: 75 mg BD for 14 days

Protocol documents:
Clinical trial NCT00917553
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy diabetes diabetic eye studies
Sponsor: Thomas Gardner
Start date: 2009-07-01; Completion date: 2012-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 24 month randomized research study will evaluate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate non-proliferative diabetic retinopathy.

Detailed description:
The objective of this proof-of-concept study is to investigate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate NPDR (with abnormal retinal function defined as a foveal sensitivity \< 30.91 dB on Matrix frequency doubling perimetry \[FDP\]). Based on results of the END DR Study, the primary visual function endpoint in the POC 2 Study will be performance on the Matrix Frequency Doubling Technology Perimeter. This test was the most sensitive to NPDR of the visual function endpoints the investigators evaluated in the END DR Study. This selection is aggressive because the investigators lack natural history data to estimate the 2-year rate of change in the endpoint; in fact, a major output of this POC 2 Study will be 2-year natural history data using several visual function endpoints. The investigators are enrolling patients who have moderate dysfunction; that is, patients who fall outside the 95% confidence interval of normal performance on FDP. These patients will have the opportunity to improve their FDP performance to "normal" levels as well as progress to more severe FDP impairment associated with more advanced disease. Secondary endpoints include visual acuity, contrast sensitivity, visual field, and dark adaptation. The tests will be performed in the Ophthalmology Department of the Penn State College of Medicine. The 24-month proof-of-concept clinical study will involve a prospective, randomized, double-masked clinical trial including 60 adult patients with type 1 or type 2 diabetes who have mild to moderate NPDR (ETDRS levels 20 to 43), and in whom retinal photocoagulation is not anticipated (by the investigator) within the subsequent 2 years. Participants will be randomized to receive either doxycycline monohydrate 50mg or an identical placebo once daily for 24 months.

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: doxycycline monohydrate intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg intervention 2: Cellulose Placebo Capsule

Protocol documents:
Clinical trial NCT00919633
Conditions: Hepatitis C
Keywords: hepatitis C HCV genotype sustained virological response rapid virological response interferon
Sponsor: Medtronic Corporate Technologies and New Ventures
Start date: 2009-06-01; Completion date: 2012-07-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.

Detailed description:
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.

Arms: arm 1: continuous subcutaneous infusion for 48 weeks arm 2: continuous subcutaneous infusion for 48 weeks arm 3: continuous subcutaneous infusion for 48 weeks arm 4: subcutaneous weekly for 48 weeks
Interventions: intervention 1: interferon alfa-2b intervention 2: peginterferon alfa-2b intervention 3: ribavirin, USP intervention 4: external drug infusion pump
Intervention descriptions: intervention 1: subcutaneous continuous infusion at one of three doses for 48 weeks intervention 2: 1.5 μg/kg subcutaneous weekly for 48 weeks intervention 3: All patients will receive oral ribavirin intervention 4: pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

Protocol documents:
Clinical trial NCT00920582
Conditions: Type 1 Diabetes Mellitus
Sponsor: MacroGenics
Start date: 2009-09-01; Completion date: 2012-07-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Detailed description:

Arms: arm 1: 14-day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-14. Repeat at Week 26 arm 2: Subjects received a 14-day cycle of teplizumab consisting of daily IV doses of 17 µg/m2, 34 µg/m2, 68 µg/m2, and 136 µg/m2 on Study Days 1-4, respectively, and one dose of 273 µg/m2 on each of Study Days 5-14. Repeat at Week 26 arm 3: Subjects received a 6 day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-6, followed by 8 days of IV placebo (Study Days 7-14). Repeat at Week 26 arm 4: 14-day cycle of placebo consisting of daily IV doses. Repeat at Week 26
Interventions: intervention 1: Teplizumab Herold Regimen intervention 2: Placebo intervention 3: Teplizumab 33.3% Herold Regimen intervention 4: Teplizumab Curtailed Herold Regimen
Intervention descriptions: intervention 1: Full dose of teplizumab IV for 14 days, repeated at Week 26 intervention 2: IV dosing daily for 14 days repeated at Week 26 intervention 3: One third full dose of teplizumab IV for 14 days, repeated at Week 26 intervention 4: Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Protocol documents:
Clinical trial NCT00924508
Conditions: Eczema
Keywords: eczema at least 3 patches of eczema
Sponsor: University of California, San Francisco
Start date: 2008-07-01; Completion date: 2012-07-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone, without TAC.

Detailed description:
This will be a 6-week, open label, bilaterally-controlled single center study involving 30 subjects age 13 and older with eczema. The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone. All subjects will have 3 target lesions of similar severity followed throughout the study. Patients will apply hydrogel patch alone to the first lesion, TAC 0.1% cream to the second lesion, and TAC 0.1% cream occluded by hydrogel patch to the third lesion. All treatments are twice a day for a maximum of 4 weeks or until lesions are cleared. The modified Eczema Area and Severity Index (EASI) score will be used to evaluate each lesion.

Arms: arm 1: This is a single arm study. Each subject will have 3 target lesions; one treated with TAC 0.1% cream and hydrogel patch (occlusion), the second treated with cream alone, and the third treated with occlusion alone.
Interventions: intervention 1: hydrogel patch intervention 2: Triamcinolone (TAC) 0.1% cream
Intervention descriptions: intervention 1: occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface. intervention 2: Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.

Protocol documents:
Clinical trial NCT00927563
Conditions: Pathological Gambling
Keywords: Gambling Addiction
Sponsor: University of Chicago
Start date: 2009-06-01; Completion date: 2012-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.

Detailed description:
The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: Tolcapone 100-300mg/day
Interventions: intervention 1: Tolcapone
Intervention descriptions: intervention 1: pill, 100-300mg/day for 8 weeks

Protocol documents:
Clinical trial NCT00996736
Conditions: Corneal Ulcer Eye Infections, Fungal
Keywords: Fungal Infections Eye Disease Fungal Keratitis Visual Acuity
Sponsor: University of California, San Francisco
Start date: 2010-04-01; Completion date: 2012-07-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

Detailed description:
Fungal corneal ulcers tend to have very poor outcomes with commonly used treatments. There has only been a single randomized trial of anti-fungal therapy for mycotic keratitis, and no new ocular anti-fungal medications have been approved by the FDA since the 1960s. The triazole voriconazole has recently become the treatment of choice for systemic fungal infections such as pulmonary aspergillosis. The use of topical ophthalmic preparations of voriconazole has been described in numerous case reports, however there has been no systematic attempt to determine whether it is more or less clinically effective than natamycin. Additionally, there have been many case reports of the use of oral voriconazole in the treatment of fungal corneal ulcers, however there has been no systematic attempt to determine if it improves outcomes in severe ulcers.

This study is a randomized, double-masked, placebo-controlled trial to determine if the use natamycin or voriconazole results in better outcomes for fungal corneal ulcers. 368 fungal corneal ulcers with baseline visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3) presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation will be randomized to receive either topical natamycin or topical voriconazole. The primary outcome is best spectacle-corrected logMAR visual acuity three months after enrollment, using best spectacle-corrected enrollment visual acuity as a co-variate.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Natamycin intervention 2: Voriconazole
Intervention descriptions: intervention 1: 5% natamycin plus 0.02% preservative, one drop to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until 3 weeks after enrollment. intervention 2: 1% voriconazole plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.

Protocol documents:
Clinical trial NCT01001702
Conditions: Schizophrenia
Keywords: Open Label Aripiprazole
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2006-04-01; Completion date: 2012-07-01
Enrollment: 85 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.

Detailed description:

Arms: arm 1: Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Flexible dose between 5 mg and 30 mg Aripiprazole tablets.

Protocol documents:
Clinical trial NCT01011075
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer, Non-small cell lung cancer NSCLC Metastatic Gleevec elderly
Sponsor: New Mexico Cancer Research Alliance
Start date: 2009-08-01; Completion date: 2012-07-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.

Detailed description:
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6

Arms: arm 1: Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
Interventions: intervention 1: Imatinib mesylate intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6 intervention 2: Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6

Protocol documents:
Clinical trial NCT01018394
Conditions: Tobacco Dependence
Keywords: tobacco dependence tobacco reduction chewing tobacco snuff moist snuff
Sponsor: Mayo Clinic
Start date: 2009-01-01; Completion date: 2012-07-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Detailed description:
In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.

Arms: arm 1: 40 subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. arm 2: 41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.
Interventions: intervention 1: nicotine lozenges intervention 2: tobacco-free snuff
Intervention descriptions: intervention 1: 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day. intervention 2: Tobacco-free snuff used ad lib for a maximum of 12 weeks

Protocol documents: