ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00788372
Conditions: Chronic Pain
Keywords: Chronic pain Fentanyl Patch
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-11-01; Completion date: 2010-11-01
Enrollment: 142 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering period (0-6 weeks) and Follow-up period (1 week). Treatment will be initiated at 12.5 microgram per hour (mcg/hr). In both Treatment period 1 and 2, the dose will be increased as per the Investigator's discretion, ranging from 12.5 mcg/hr to 100 mcg/hr and the maximum application dose will be 300 mcg/hr. However, in Treatment period 2, the dose will be increased on 7th day before the day of medical examination (only if the participant used rescue treatment for minimum of 3 times per day for minimum of 4 days). The patch will be applied on areas including the chest, abdomen, upper arm and femoral region and replaced daily. Efficacy will primarily be evaluated by visual analog scale (VAS) score. The total duration of the study treatment will be 52 weeks. Participants' safety will be monitored throughout the study.

Arms: arm 1: Fentanyl transdermal patch will be applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose will be increased as per Investigators' discretion in both treatment periods and the maximum applied dose will be 300 mcg/hr. Total duration of treatment is 52 weeks.
Interventions: intervention 1: Fentanyl
Intervention descriptions: intervention 1: Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion.

Protocol documents:
Clinical trial NCT00793780
Conditions: Obesity Schizophrenia Schizoaffective Disorder
Keywords: obesity schizophrenia schizoaffective disorder weight loss
Sponsor: Yale University
Start date: 2008-12-01; Completion date: 2010-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Naltrexone 25mg intervention 2: Placebo
Intervention descriptions: intervention 1: Naltrexone 25mg caplets taken orally once a day for 8 weeks intervention 2: Placebo caplet (inactive substance) taken orally once a day for 8 weeks

Protocol documents:
Clinical trial NCT00796926
Conditions: Xerophthalmia Blepharitis
Sponsor: Louis Tong
Start date: 2009-07-01; Completion date: 2010-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes

Detailed description:
Comparison of efficacy of Systane Ultra and Refresh Tears

Arms: arm 1: Used four times a day topically to each eye arm 2: Used four times a day topically to each eye
Interventions: intervention 1: Systane Ultra eyedrops intervention 2: Refresh eye drops
Intervention descriptions: intervention 1: Four times a day intervention 2: Four times a day

Protocol documents:
Clinical trial NCT00801138
Conditions: Anesthesia, Local Shoulder Surgery
Keywords: ropivacaine bupivacaine glucocorticoid
Sponsor: The Cleveland Clinic
Start date: 2008-11-01; Completion date: 2010-11-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.

Detailed description:
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:

* Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
* Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
* Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
* Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.

The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.

Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.

Arms: arm 1: Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block arm 2: Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline arm 3: Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) arm 4: Group 4 Bupivacaine and steroid: 30 ml 0.5% bupivacaine mixed with dexamethasone 8 mg (2 ml).
Interventions: intervention 1: saline intervention 2: Dexamethasone intervention 3: ropivacaine intervention 4: Bupivacaine
Intervention descriptions: intervention 1: 2 ml 0.9% saline (placebo) intervention 2: dexamethasone 8 mg (2 ml) intervention 3: 30 ml 0.5% ropivacaine intervention 4: 30 ml 0.5% bupivacaine

Protocol documents:
Clinical trial NCT00811434
Conditions: Minimal Hepatic Encephalopathy
Keywords: encephalopathy pediatric liver disease pediatric cirrhosis serum ammonia levels
Sponsor: Indiana University
Start date: 2009-01-01; Completion date: 2010-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.

Detailed description:
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.

Arms: arm 1: 3 months of Lactulose therapy based on pt. weight arm 2: 1.5 ml/kg day po of sugar water placebo for three months
Interventions: intervention 1: Lactulose intervention 2: placebo
Intervention descriptions: intervention 1: 1.5cc/kg/day po for three months intervention 2: 1.5 ml sugar water/kg day for three months

Protocol documents:
Clinical trial NCT00811720
Conditions: Alcohol Dependence
Keywords: Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents
Sponsor: H. Lundbeck A/S
Start date: 2008-12-01; Completion date: 2010-11-01
Enrollment: 598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Detailed description:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as-needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 6 months in adult patients with alcohol dependence.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Nalmefene
Intervention descriptions: intervention 1: as-needed use, tablets, orally, 6 months intervention 2: 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Protocol documents:
Clinical trial NCT00821821
Conditions: Acute Ischemic Stroke (AIS)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-02-01; Completion date: 2010-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-186 intervention 2: Placebo
Intervention descriptions: intervention 1: Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion

Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion intervention 2: Cohort1:circa 1000mg / 72-hour infusion matching placebo

Cohort2:circa 2000mg / 72-hour infusion matching placebo

Protocol documents:
Clinical trial NCT00825565
Conditions: Epidermolysis Bullosa
Keywords: Epidermolysis bullosa
Sponsor: Northwestern University
Start date: 2009-02-01; Completion date: 2010-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily.

Detailed description:
Potential subjects came to the for a screening visit. Eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. Subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. Subjects returned every 4 weeks for a total of 12 weeks for repeat assessments.

Arms: arm 1: 8 subjects enrolled in this single study arm. All 8 subjects completed the study.
Interventions: intervention 1: Alwextin cream
Intervention descriptions: intervention 1: Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.

Protocol documents:
Clinical trial NCT00836719
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis safety open label Polyphenon E EGCG NAA N-acetyl-aspartate MRI
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Start date: 2009-02-01; Completion date: 2010-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.

Detailed description:
Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.

Arms: arm 1: Standarized green tea extract containing 50% EGCG
Interventions: intervention 1: Polyphenon E
Intervention descriptions: intervention 1: Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.

Protocol documents:
Clinical trial NCT00841568
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: ADPKD Tolvaptan
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-04-01; Completion date: 2010-11-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Detailed description:
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Arms: arm 1: None
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Protocol documents:
Clinical trial NCT00849810
Conditions: Hypertension
Keywords: Hypertension Beta-blockers Ambulatory blood pressure Basal metabolic rate Quality of life
Sponsor: University of Mississippi Medical Center
Start date: 2009-01-01; Completion date: 2010-11-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.

Detailed description:

Arms: arm 1: metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 4 -5 weeks.
Interventions: intervention 1: Metoprolol intervention 2: Nebivolol
Intervention descriptions: intervention 1: Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks intervention 2: 5 - 20 mg daily, at a stable dose for 4 to 5 weeks

Protocol documents:
Clinical trial NCT00871494
Conditions: Pelvic Inflammatory Disease
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2010-11-01
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

Protocol documents:
Clinical trial NCT00905307
Conditions: Schizophrenia
Keywords: Schizophrenia Relapsed
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-07-01; Completion date: 2010-11-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.

Detailed description:

Arms: arm 1: OPC-34712 0.25 mg arm arm 2: OPC-34712 low-dose arm arm 3: OPC-34712 mid-dose arm arm 4: OPC-34712 high-dose arm arm 5: None arm 6: Aripiprazole arm
Interventions: intervention 1: OPC-34712 intervention 2: Placebo intervention 3: Aripiprazole
Intervention descriptions: intervention 1: oral, once daily intervention 2: Placebo intervention 3: oral, once daily

Protocol documents:
Clinical trial NCT00909181
Conditions: Urge Urinary Incontinence Urinary Frequency
Sponsor: Antares Pharma Inc.
Start date: 2009-03-01; Completion date: 2010-11-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.

The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Oxybutynin intervention 2: Placebo
Intervention descriptions: intervention 1: Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.

Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo intervention 2: Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment.

Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo

Protocol documents:
Clinical trial NCT00909857
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea Oral Contraception
Sponsor: Bayer
Start date: 2009-04-01; Completion date: 2010-11-01
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Detailed description:

Arms: arm 1: Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles arm 2: Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Interventions: intervention 1: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Ethinyl estradiol, Levonorgestrel (Miranova) intervention 3: Placebo Match to SH T00658ID intervention 4: Placebo Match to SH D593B
Intervention descriptions: intervention 1: Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 2: Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 3: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. intervention 4: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Protocol documents:
Clinical trial NCT00910715
Conditions: Erythema Chronicum Migrans
Keywords: erythema migrans Lyme borreliosis doxycycline treatment outcome subjective symptoms
Sponsor: University Medical Centre Ljubljana
Start date: 2009-06-01; Completion date: 2010-11-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: doxycycline intervention 2: doxycycline intervention 3: placebo
Intervention descriptions: intervention 1: doxycycline 100 mg bid, 10 days intervention 2: doxycycline 100 mg bid, 15 days intervention 3: control subjects without a history of Lyme borreliosis

Protocol documents:
Clinical trial NCT00918255
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa Adalimumab Nodule Abscess Fistula Physicians Global Assessment Hurley Stage Sartorius Scale
Sponsor: Abbott
Start date: 2009-04-01; Completion date: 2010-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

Detailed description:
This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I \[abscess formation without scarring and sinus tracts\], II \[widely separated recurrent abscesses with scarring and sinus tracts\], and III \[multiple interconnected abscesses and sinus tracts across entire area\]. Randomization in this study was performed using stratification by Hurley Stage \[III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.

Arms: arm 1: Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. arm 2: Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. arm 3: Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Interventions: intervention 1: adalimumab intervention 2: Placebo
Intervention descriptions: intervention 1: Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters intervention 2: Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Protocol documents: