ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00123123
Conditions: Pneumonia
Keywords: Ventilator-associated pneumonia
Sponsor: State University of New York at Buffalo
Start date: 2004-03-01; Completion date: 2007-11-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).

The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.

Detailed description:
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque.

This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.

Arms: arm 1: Delivered Twice a day arm 2: Delivered twice a day arm 3: Delivered once a day, placebo once a day
Interventions: intervention 1: chlorhexidine gluconate oral rinse (0.12%) intervention 2: placebo
Intervention descriptions: intervention 1: chlorhexidine gluconate oral rinse intervention 2: None

Protocol documents:
Clinical trial NCT00141817
Conditions: Gastroesophageal Reflux
Keywords: Gastrointestinal Reflux Disease
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2005-08-01; Completion date: 2007-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Detailed description:

Interventions: intervention 1: pantoprazole for approximately 9 weeks.
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00145041
Conditions: Malignant Melanoma
Sponsor: Acrotech Biopharma Inc.
Start date: 2005-02-01; Completion date: 2007-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment, and who have relapsed after previous therapies.

Detailed description:
OBJECTIVES:

Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.

Secondary: To assess the safety and antitumor activity of VSLI in this population.

Arms: arm 1: Single armed study; all subjects received VSLI
Interventions: intervention 1: Vincristine Sulfate Liposomes Injection
Intervention descriptions: intervention 1: Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.

Protocol documents:
Clinical trial NCT00192075
Conditions: Colorectal Cancer
Sponsor: Eli Lilly and Company
Start date: 2003-06-01; Completion date: 2007-11-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.

Detailed description:

Arms: arm 1: Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid arm 2: Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid
Interventions: intervention 1: Gemcitabine intervention 2: avastin intervention 3: 5FU/folinic acid intervention 4: oxaliplatin
Intervention descriptions: intervention 1: 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression. intervention 2: 5 milligrams per kilogram (mg/kg) intervention 3: Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).

Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).

5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). intervention 4: 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.

Protocol documents:
Clinical trial NCT00249002
Conditions: Hemodialysis Graft Dysfunction
Keywords: Vascular Access Graft Failure Venous Neointimal Hyperplasia(VNH) Hemodialysis
Sponsor: Celgene
Start date: 2005-11-01; Completion date: 2007-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.

Detailed description:
This is an open-label, pilot, phase II study to assess the feasibility of administering ABI-007 intravenously \[IV\] over 3-5 minutes to patients with hemodialysis graft dysfunction (i.e., either a thrombosed polytetrafluoroethylene (PTFE) graft, or a patent but dysfunctional PTFE graft). Patients with graft dysfunction who are successfully treated with angioplasty will start treatment after angioplasty or during their first dialysis through the graft following intervention, and will receive 3 subsequent treatments of ABI-007 at 35 mg/m\^2 on weeks 5, 13 and 21.

Arms: arm 1: ABI-007 35 mg/m\^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
Interventions: intervention 1: ABI-007
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00306189
Conditions: Osteoporosis
Keywords: RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density Japanese
Sponsor: Amgen
Start date: 2006-01-01; Completion date: 2007-11-01
Enrollment: 212 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 100 mg AMG 162 intervention 2: 60 mg AMG 162 intervention 3: 14 mg AMG 162 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg AMG 162 (denosumab) SC every 6 months intervention 2: 60 mg AMG 162 (denosumab) SC every 6 months intervention 3: 14 mg AMG 162 (denosumab) SC every 6 months intervention 4: Placebo SC every 6 months

Protocol documents:
Clinical trial NCT00311363
Conditions: Restless Legs Syndrome
Sponsor: XenoPort, Inc.
Start date: 2006-04-01; Completion date: 2007-11-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description:
This study was a multicenter, blinded, randomized withdrawal study in subjects with primary Restless Legs Syndrome (RLS). Eligible subjects were initially enrolled in a 24-week single blind (SB) treatment period during which they received XP13512. Subjects who completed the initial treatment period and met the responder criteria were then randomized 1:1 to receive either XP13512 or placebo during the 12-week double-blind (DB) treatment period. The primary study objective was to assess the maintenance of efficacy of XP13512 1200 mg taken once daily in the long-term treatment of subjects with primary RLS. The secondary study objectives were to assess maintenance of improvements in sleep outcomes and quality of life, and to assess the safety and tolerability of XP13512 in the treatment of primary RLS subjects.

Arms: arm 1: GEn (XP13512) 1200 mg arm 2: Placebo
Interventions: intervention 1: GEn (XP13512) intervention 2: GEn (XP13512) intervention 3: Placebo
Intervention descriptions: intervention 1: 1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks intervention 2: 1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks intervention 3: Placebo, orally, once daily for 12 weeks following single blind 24-week phase

Protocol documents:
Clinical trial NCT00325780
Conditions: Hypercholesterolemia Dyslipidemia
Keywords: Kowa Hypercholesterolemia dyslipidemia pitavastatin NK-104 Hypercholesterolemia or combined dyslipidemia
Sponsor: Kowa Research Europe
Start date: 2006-07-01; Completion date: 2007-11-01
Enrollment: 1355 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Detailed description:
Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Arms: arm 1: Pitavastatin 4 mg once daily
Interventions: intervention 1: Pitavastatin
Intervention descriptions: intervention 1: Pitavastatin 4 mg once daily

Protocol documents:
Clinical trial NCT00333866
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-07-01; Completion date: 2007-11-01
Enrollment: 747 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: pregabalin intervention 2: pregabalin intervention 3: pregabalin intervention 4: placebo
Intervention descriptions: intervention 1: 600mg/day intervention 2: 450mg/day intervention 3: 300mg/day intervention 4: placebo

Protocol documents:
Clinical trial NCT00352911
Conditions: HIV Infections
Keywords: HIV-1
Sponsor: VGX Pharmaceuticals, LLC
Start date: 2006-07-01; Completion date: 2007-11-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level.

Detailed description:
VT004 is a double-blind, randomized, placebo-controlled Phase II study of two doses of orally administered mifepristone (VGX-410) (300 and 600 mg) taken as a twice daily (BID) dosage (150mg BID and 300mg BID) in a dose-escalating fashion for 14 days at each dose level to determine antiviral activity and safety in HIV-1-infected participants. At entry, 18 subjects will be randomized in a 5:1 fashion (15 on active drug: 3 on placebo) to receive escalating doses of VGX-410 or matching placebo. Patients will be randomized to receive 300 mg (as 150 mg BID dose) of VGX-410 or matching placebo for 14 days. In patients that complete this dose without significant safety concerns or side effects, the dose will be increased to 600 mg (as 300 mg BID dose) or matching placebo for 14 days. Patients must meet all inclusion/exclusion criteria listed below and be seen on a weekly basis by study personnel while on study drug. Patients must return \~ one month after finishing the study therapy for examination and safety labs.

Arms: arm 1: 150mg twice daily of VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of VGX-410 for 14 days arm 2: 150mg twice daily of placebo for VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of placebo for VGX-410 for 14 days
Interventions: intervention 1: VGX-410 (Mifepristone) intervention 2: Placebo for VGX-410 (Mifepristone)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00379288
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-06-01; Completion date: 2007-11-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: mometasone furoate combination MDI 200/10 mcg BID intervention 2: mometasone furoate combination MDI 400/10 mcg BID intervention 3: Fluticasone/Salmeterol 250/50 mcg BID intervention 4: Fluticasone/Salmeterol 500/50 mcg BID
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 2: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 3: F/SC 250/50 twice daily for 1 year intervention 4: F/SC 500/50 twice daily for 1 year

Protocol documents:
Clinical trial NCT00382993
Conditions: Migraine Disorders
Keywords: migraine with or without aura naproxen sodium combination product sumatriptan succinate poor response short acting triptan migraine, acute
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2007-11-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 2 of 2\]

Detailed description:
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks.

Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit.

The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).

Arms: arm 1: Combination Product (sumatriptan and naproxen sodium) \[Attack 1\] followed by Placebo \[Attack 2\] arm 2: Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\]
Interventions: intervention 1: Placebo intervention 2: Combination Product (sumatriptan succinate/naproxen sodium)
Intervention descriptions: intervention 1: Matching placebo tablet intervention 2: Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.

Protocol documents:
Clinical trial NCT00389519
Conditions: Hypertension
Keywords: Hypertension/*etiology Blood Pressure Pediatric Adolescent Child
Sponsor: Pfizer
Start date: 2006-10-01; Completion date: 2007-11-01
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.

Detailed description:
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.

Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.

Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.

A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.

Arms: arm 1: once per day arm 2: 0.3125, 0.625, or 1.25 mg once a day, based on subject weight arm 3: 1.25, 2.5, or 5 mg once a day, based on subject weight arm 4: 5, 10, or 20 mg once a day, based on subject weight
Interventions: intervention 1: ramipril intervention 2: placebo
Intervention descriptions: intervention 1: once a day oral ramipril capsules given for 4 weeks intervention 2: once a day oral placebo capsule for 4 weeks

Protocol documents:
Clinical trial NCT00394901
Conditions: Neuralgia, Postherpetic
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-09-01; Completion date: 2007-11-01
Enrollment: 372 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin
Intervention descriptions: intervention 1: placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose). intervention 2: Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose). intervention 3: Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose). intervention 4: Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

Protocol documents: