ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00209560
Conditions: Arthroscopy Bunionectomy Osteotomy Carpal Tunnel
Keywords: AQUAVAN® Injection Midazolam Minor surgical procedures Sedation
Sponsor: Eisai Inc.
Start date: 2004-10-01; Completion date: 2005-03-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.

Detailed description:
Randomized, open label, multi-center,midazolam adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing minor surgical and/or therapeutic procedures. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in majority of patients who are pre-medicated with fentanyl citrate injection.

Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice.

\[new paragraph\] All patients were pre-medicated with fentanyl citrate as an analgesic.

The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation. In outpatient minor surgical procedures, sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management. Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia. This injection is used following pretreatment with fentanyl citrate for pain management.

Interventions: intervention 1: fospropofol disodium
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00227994
Conditions: Cerebrovascular Accident
Keywords: Cholinesterase Inhibitors Elderly Stroke Cognition
Sponsor: University of Pittsburgh
Start date: 2003-04-01; Completion date: 2005-03-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Detailed description:
Cognitive impairment is a common result of a stroke and can be detrimental to recovery. It can negatively affect both mental and physical functioning, thereby complicating the rehabilitation process. Although much research has targeted the effects of long-term cognitive impairment after a stroke, very little research has been done to examine the incidence and course of cognitive impairment during the first three months following a stroke. These first three months are the most important in terms of regaining function. Acetylcholinesterase inhibitors have been beneficial to both sufferers of vascular dementia and Alzheimer's disease. They may also be a useful pharmacologic intervention to enhance post-stroke rehabilitation. This study will compare the effectiveness of two acetylcholinesterase inhibitors, galantamine and donepezil, in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks. Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks. Functional independence will be measured at baseline and Weeks 2 and 12. In addition, a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families. Participants will also be monitored for signs of depression and medication side effects throughout the study.

Arms: arm 1: Galantamine for 12 weeks arm 2: Donepezil for 12 weeks
Interventions: intervention 1: Galantamine intervention 2: Donepezil
Intervention descriptions: intervention 1: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. intervention 2: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.

Protocol documents:
Clinical trial NCT00315458
Conditions: Osteoarthritis
Keywords: osteoarthritis opioid transdermal
Sponsor: Purdue Pharma LP
Start date: 2003-12-01; Completion date: 2005-03-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patches 10 or 20 mcg/h arm 2: Placebo to match buprenorphine transdermal patch 10 or 20
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Placebo transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch 10 or 20.

Protocol documents:
Clinical trial NCT00320216
Conditions: Psoriasis
Keywords: Psoriasis CNTO 1275 Ustekinumab Stelara Interleukin-12 IL-12 Interleukin-23 IL-23
Sponsor: Centocor, Inc.
Start date: 2003-11-01; Completion date: 2005-03-01
Enrollment: 320 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Detailed description:
This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Arms: arm 1: Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg. arm 2: Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. arm 3: Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. arm 4: Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. arm 5: Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.
Interventions: intervention 1: Ustekinumab intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg). intervention 2: Patients in the placebo group will receive placebo medication.

Protocol documents:
Clinical trial NCT00320801
Conditions: Osteoarthritis
Keywords: Chronic pain osteoarthritis transdermal
Sponsor: Purdue Pharma LP
Start date: 2004-01-01; Completion date: 2005-03-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Protocol documents:
Clinical trial NCT00490945
Conditions: Circadian Rhythm Sleep Disorders
Sponsor: Vanda Pharmaceuticals
Start date: 2004-07-01; Completion date: 2005-03-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Detailed description:

Interventions: intervention 1: VEC-162
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00685139
Conditions: Healthy
Keywords: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2005-01-01; Completion date: 2005-03-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.

Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, after an overnight fast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Arms: arm 1: A single dose of zonisamide 100 mg administered after an overnight fast. arm 2: A single dose of Zonegran® 100 mg administered after an overnight fast.
Interventions: intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule
Intervention descriptions: intervention 1: 100 mg capsule administered after an overnight fast. intervention 2: 100 mg capsule administered after an overnight fast.

Protocol documents:
Clinical trial NCT00687167
Conditions: Healthy
Keywords: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2005-01-01; Completion date: 2005-03-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

Detailed description:
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Arms: arm 1: A single dose of zonisamide 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast. arm 2: A single dose of Zonegran® 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.
Interventions: intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule
Intervention descriptions: intervention 1: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast. intervention 2: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Protocol documents:
Clinical trial NCT00801099
Conditions: Surgical Site Infection
Keywords: Postoperative wound infection surgical site infection antimicrobial prophylaxis developing countries Sub-Saharan Africa reduction of SSI using preoperative antibiotics
Sponsor: Swiss Tropical & Public Health Institute
Start date: 2004-12-01; Completion date: 2005-03-01
Enrollment: 276 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%. Inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. After implementation of a standardized procedure with a single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI dropped by 80% in spite of procedural risk factors like poor hygiene etc.

Detailed description:
Surgical Site Infections (SSIs) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. Patients with SSIs are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without SSI. In non-industrialized countries, the incidence of SSIs is higher and the consequences of SSI are even more severe: Many hospitals lack appropriate facilities for early diagnosis and treatment. In addition, microbiological identification of pathogens and susceptibility testing are rarely available, a prerequisite for targeted treatment of SSIs. Overcrowding and understaffing are additional risk factors for SSIs, common in these countries.

A study conducted at the local surgeons' suggestion in an 82-bed department of general surgery, obstetrics and gynecology, urology and orthopedics at the St. Francis Designated District Hospital (SFDDH) in Ifakara (Southern Tanzania) showed an SSI-rate of 21.6%.

The analyses of this study identified two major risk factors for SSI in clean and clean-contaminated surgical procedures: Inadequate timing of administration of routine antimicrobial prophylaxis (AMP) and inappropriate selection of antibiotics not covering the most commonly observed pathogens.

Therefore, an intervention study was discussed with the local surgeon in charge to improve selection and timing of routine AMP and thereby reduce the rate of SSIs.

The study design and objective were presented to all the staff during a general meeting and special duties and responsibilities discussed with the individual colleagues. Furthermore we distributed pocket flow sheets to the involved staff and hung up some laminated flow sheets in theatre.

Arms: arm 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Interventions: intervention 1: Amoxicillin/Clavulanic Acid
Intervention descriptions: intervention 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Protocol documents:
Clinical trial NCT00834366
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: Labopharm Inc.
Start date: 2005-02-01; Completion date: 2005-03-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated tablets, are bioequivalent.

Detailed description:

Arms: arm 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. arm 2: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Interventions: intervention 1: Tramadol HCl
Intervention descriptions: intervention 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.

Protocol documents:
Clinical trial NCT00986856
Conditions: Impetigo
Sponsor: LEO Pharma
Start date: 2004-05-01; Completion date: 2005-03-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.

To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.

To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fucidin® cream
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01074450
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2005-02-01; Completion date: 2005-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets
Interventions: intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride
Intervention descriptions: intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet

Protocol documents:
Clinical trial NCT01074463
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2005-02-01; Completion date: 2005-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under non-fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets
Interventions: intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride
Intervention descriptions: intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet

Protocol documents: