ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00321321
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus Glucose dependent insulinotropic polypeptide Sulfonylurea compounds insulin secretion Sulfonylurea receptor subunit-SUR1 Impaired incretin effect
Sponsor: University Hospital, Gentofte, Copenhagen
Start date: 2006-05-01; Completion date: 2007-04-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.

Detailed description:

Interventions: intervention 1: Sulfonylurea
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00322868
Conditions: Cystic Fibrosis
Keywords: Prescription drugs Administration, oral Durable medical equipment Kinetics
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2006-04-01; Completion date: 2007-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.

Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.

Detailed description:
* Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease
* Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment)
* Changes in markers of inflammation in the sputum samples will be assessed
* Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed

Arms: arm 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda
Interventions: intervention 1: pioglitazone
Intervention descriptions: intervention 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Protocol documents:
Clinical trial NCT00394914
Conditions: Asthma Common Cold Picornavirus Infection Rhinovirus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-08-01; Completion date: 2007-04-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.

Detailed description:

Arms: arm 1: Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. arm 2: Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
Interventions: intervention 1: Pleconaril intervention 2: Placebo to Pleconaril
Intervention descriptions: intervention 1: Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. intervention 2: Placebo nasal suspension

Protocol documents:
Clinical trial NCT00395460
Conditions: Central Nervous System Diseases
Keywords: Gadovist Gadavist Contrast agent Brain Spine disease Magnetic Resonance Imaging
Sponsor: Bayer
Start date: 2006-09-01; Completion date: 2007-04-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms: arm 1: Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) arm 2: Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Magnevist
Intervention descriptions: intervention 1: 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW) intervention 2: 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

Protocol documents:
Clinical trial NCT00408317
Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: Cystic Fibrosis Exocrine Pancreatic Insufficiency Ultrase® MT20
Sponsor: Forest Laboratories
Start date: 2006-11-01; Completion date: 2007-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Detailed description:
This is a Phase III, multicenter, randomized, double-blind, two-period cross-over, placebo-controlled study designed to compare the efficacy and safety of Ultrase® MT20 to placebo in participants with CF and pancreatic insufficiency. The study consists of a screening period (up to 11 days) and two treatment periods (6-7 days). During screening period participants will be treated with open-label Ultrase® MT18 or MT20. Each treatment period will be preceded by a stabilization period (4 days) and the two treatment periods are separated by a break period (3-6 days). A safety follow-up visit will be performed 7-10 days after discharge from the last treatment period.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ultrase® MT20 intervention 2: Placebo
Intervention descriptions: intervention 1: Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period. intervention 2: Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.

Protocol documents:
Clinical trial NCT00442351
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2007-04-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Asmanex twisthaler intervention 2: Placebo for Asmanex twisthaler
Intervention descriptions: intervention 1: Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks intervention 2: Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks

Protocol documents:
Clinical trial NCT00455702
Conditions: Schizophrenia
Keywords: schizophrenia cognition d-cycloserine memory
Sponsor: Massachusetts General Hospital
Start date: 2004-07-01; Completion date: 2007-04-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

Detailed description:
This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 \& 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.

Specific aims:

1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
4. Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group.
5. Assess effects of weekly D-cycloserine dosing on positive \& negative symptoms at week 8 compared to placebo.
6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Arms: arm 1: 50 mg d-cycloserine arm 2: 50 mg placebo
Interventions: intervention 1: d-cycloserine
Intervention descriptions: intervention 1: 50mg dose d-cycloserine v placebo

Protocol documents:
Clinical trial NCT00709722
Conditions: Lupus Nephritis
Keywords: Lupus nephritis Deoxyspergualin Immunosuppression
Sponsor: Nippon Kayaku Co., Ltd.
Start date: 2003-10-01; Completion date: 2007-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Detailed description:
The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC \< 2x10\^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (\<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Arms: arm 1: NKT-01
Interventions: intervention 1: NKT-01
Intervention descriptions: intervention 1: SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.

Protocol documents:
Clinical trial NCT00742469
Conditions: Diarrhea
Keywords: TD traveller's diarrhea campylobacter shigella salmonella E. coli diarrhea
Sponsor: Bausch Health Americas, Inc.
Start date: 2005-06-01; Completion date: 2007-04-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Detailed description:
To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Arms: arm 1: Rifaximin arm 2: Placebo
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00939692
Conditions: Healthy
Sponsor: Torrent Pharmaceuticals Limited
Start date: 2007-01-01; Completion date: 2007-04-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
* Objective:

  * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.
* Clinical Design:

  * Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.

Detailed description:

Arms: arm 1: tablet containing 25 mg of topiramate (Torrent Pharmaceuticals) arm 2: tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
Interventions: intervention 1: Topiramate
Intervention descriptions: intervention 1: Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

Protocol documents:
Clinical trial NCT00952068
Conditions: Acute Low Back Pain
Keywords: Back Pain
Sponsor: Labopharm Inc.
Start date: 2007-01-01; Completion date: 2007-04-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.

Detailed description:

Arms: arm 1: 1 Tramadol Contramid® OAD 200mg tablet daily.
Interventions: intervention 1: Tramadol Contramid® OAD 200mg
Intervention descriptions: intervention 1: 1 Tramadol Contramid® OAD 200mg tablet daily.

Protocol documents:
Clinical trial NCT01157182
Conditions: Healthy
Keywords: Healthy Bioequivalence Post-Menopausal
Sponsor: Teva Pharmaceuticals USA
Start date: 2007-02-01; Completion date: 2007-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Estradiol/Norethindrone acetate 1/0.5 mg Tablets arm 2: Activella® 1/0.5 mg Tablets
Interventions: intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®
Intervention descriptions: intervention 1: 1/0.5 mg Tablets intervention 2: 1/0.5 mg Tablets

Protocol documents:
Clinical trial NCT00289211
Conditions: Hereditary Angioedema
Keywords: Hereditary angioedema HAE C1 esterase inhibitor (human) C1INH-nf
Sponsor: Shire
Start date: 2005-03-14; Completion date: 2007-04-13
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Detailed description:
Randomized subjects treated for a qualifying attack were eligible to receive rescue dosing with 1,000 U of C1INH-nf if they did not achieve beginning of substantial relief of the defining symptom within 4 hours after initial treatment with blinded study drug, or if at any time the attack progressed to include airway compromise. A second 1,000 U rescue dose was permitted 60 minutes after the initial rescue dose, if necessary.

The study design also allowed for administration of open-label C1INH-nf for laryngeal angioedema attacks, which were non-randomizable events due to the presence of or potential for airway compromise (immediate 1,000 U dose of C1INH-nf, repeated after 60 minutes, if necessary). In addition, subjects were eligible to receive open-label C1INH-nf (1,000 U single dose) prior to emergency surgical (non-cosmetic) procedures.

A total of 83 subjects were enrolled in the study. Seventy-one (71) subjects experienced qualifying attacks and were randomized to blinded study drug (36 C1INH-nf, 35 placebo); only the 71 randomized subjects were analyzed for efficacy. An additional 12 subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. Of the 35 subjects randomized to placebo, 23 also received C1INH-nf (eg, rescue, open-label). In total, 83 subjects received at least 1 dose of study drug and were analyzed for safety; 71 subjects were exposed to C1INH-nf (59 randomized, 12 open-label only) and 12 subjects were exposed only to placebo.

Arms: arm 1: 1,000 Units (U) of C1INH-nf administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. arm 2: Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
Interventions: intervention 1: C1 esterase inhibitor [human] (C1INH-nf) intervention 2: Placebo (saline)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00089986
Conditions: Sepsis
Keywords: severe sepsis septic shock Gram-negative infection phospholipid emulsion
Sponsor: GlaxoSmithKline
Start date: 2004-09-01; Completion date: 2007-04-15
Enrollment: 1415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

Detailed description:

Interventions: intervention 1: Intravenous GR270773- Phospholipid Emulsion intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00053703
Conditions: Schizophrenia
Keywords: Psychotic Disorders Schizophreniform Disorder
Sponsor: University of North Carolina, Chapel Hill
Start date: 2002-02-01; Completion date: 2007-05-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.

Detailed description:
Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms.

Participants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. After 11/2005, no additional patients will be assigned to olanzapine treatment. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.

Arms: arm 1: oral olanzapine 5-20mg per day for up to 52 weeks arm 2: oral risperidone 0.5mg to 6mg daily for up to 52 weeks arm 3: oral molindone from 10-140mg/daily for up to 52 weeks
Interventions: intervention 1: Risperidone intervention 2: Olanzapine (enrollment closed in this treatment) intervention 3: Molindone
Intervention descriptions: intervention 1: oral risperidone 0.5mg to 6mg daily for up to 52 weeks intervention 2: oral olanzapine 5-20mg per day for up to 52 weeks intervention 3: oral molindone from 10-140mg/daily for up to 52 weeks

Protocol documents:
Clinical trial NCT00094770
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-09-01; Completion date: 2007-05-01
Enrollment: 1172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Detailed description:
The duration of treatment is 104 weeks.

Arms: arm 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. arm 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Interventions: intervention 1: sitagliptin (MK0431) intervention 2: Comparator: glipizide
Intervention descriptions: intervention 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. intervention 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

Protocol documents:
Clinical trial NCT00107120
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Adolescents Escitalopram Pediatrics
Sponsor: Forest Laboratories
Start date: 2005-03-01; Completion date: 2007-05-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.

Detailed description:

Arms: arm 1: Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks arm 2: Placebo once daily for up to 8 weeks
Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks intervention 2: Placebo once daily for up to 8 weeks

Protocol documents: