ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00746889
Conditions: Osteoarthritis
Keywords: osteoarthritis knee corticosteroids ultrasound
Sponsor: University of California, San Diego
Start date: 2004-03-01; Completion date: 2008-09-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

Detailed description:

Arms: arm 1: 40 mg of intraarticular triamcinolone acetonide arm 2: Intraarticular injection of 0.9% saline
Interventions: intervention 1: triamcinolone acetonide intervention 2: saline
Intervention descriptions: intervention 1: single intraarticular injection of 40 mg of triamcinolone acetonide intervention 2: Single intraarticular injection of 1 ml of 0.9% saline

Protocol documents:
Clinical trial NCT00754338
Conditions: Ametropia
Keywords: comfort wetability protein deposit lipid deposit
Sponsor: University of Waterloo
Start date: 2008-01-01; Completion date: 2008-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Detailed description:
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Alcon Opti-Free® RepleniSH® with Supraclens® intervention 2: Alcon Opti-Free® RepleniSH® intervention 3: B&L ReNu MultiPlus™
Intervention descriptions: intervention 1: Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover intervention 2: Marketed Multipurpose Disinfecting Care System intervention 3: Marketed Multipurpose Disinfecting Care Systems

Protocol documents:
Clinical trial NCT00762177
Conditions: Oral Bacteria
Sponsor: Colgate Palmolive
Start date: 2008-05-01; Completion date: 2008-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the antimicrobial efficacy of three dentifrices on oral bacteria

Detailed description:

Arms: arm 1: fluoride toothpaste arm 2: Stannous fluoride toothpaste arm 3: fluoride/triclosan/copolymer toothpaste
Interventions: intervention 1: Fluoride intervention 2: Fluoride, Triclosan intervention 3: Stannous Fluoride
Intervention descriptions: intervention 1: Brush twice a day for 14 days intervention 2: Brush twice daily for 14 days intervention 3: Brush twice daily for 14 days

Protocol documents:
Clinical trial NCT00762229
Conditions: Hypercholesterolemia
Keywords: Cholesterol Ezetimibe
Sponsor: Bronx VA Medical Center
Start date: 2007-07-01; Completion date: 2008-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.

Detailed description:

Arms: arm 1: A whole ezetimibe 10 mg tablet arm 2: Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half
Interventions: intervention 1: Ezetimibe 10 mg intervention 2: Ezetimibe 5 mg
Intervention descriptions: intervention 1: Ezetimibe 10 mg daily for 4 weeks intervention 2: Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

Protocol documents:
Clinical trial NCT00779038
Conditions: Pain, Postoperative
Keywords: IONSYS Fentanyl Iontophoretic Transdermal System Postoperative pain
Sponsor: Janssen Cilag N.V./S.A.
Start date: 2008-08-01; Completion date: 2008-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

Detailed description:
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids \[morphine like medications\] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.

Arms: arm 1: 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours.
Interventions: intervention 1: Fentanyl ITS
Intervention descriptions: intervention 1: 40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.

Protocol documents:
Clinical trial NCT00811187
Conditions: Paracervical Block
Keywords: Hysteroscopy Pain medication Lidocaine Office Procedures
Sponsor: Montefiore Medical Center
Start date: 2007-03-01; Completion date: 2008-09-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.

Detailed description:

Arms: arm 1: 5cc 1% lidocaine injection in each paracervical region arm 2: 5cc Normal Saline injection in each paracervical region
Interventions: intervention 1: Lidocaine paracervical block intervention 2: Normal Saline
Intervention descriptions: intervention 1: 5cc 1% lidocaine injection in each paracervical region intervention 2: 5cc Normal Saline injection in each paracervical region

Protocol documents:
Clinical trial NCT00812214
Conditions: Insomnia Migraine
Keywords: insomnia migraine eszopiclone insomnia in migraineurs
Sponsor: MedVadis Research Corporation
Start date: 2007-04-01; Completion date: 2008-09-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

Detailed description:
The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.

Arms: arm 1: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit. arm 2: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
Interventions: intervention 1: eszopiclone intervention 2: placebo
Intervention descriptions: intervention 1: 3 mg tablet every night at bedtime intervention 2: 1 tablet every night at bedtime

Protocol documents:
Clinical trial NCT00812604
Conditions: Temporomandibular Disorders
Sponsor: The University of Hong Kong
Start date: 2007-04-01; Completion date: 2008-09-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.

Detailed description:
Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.

Arms: arm 1: Ping On Ointment arm 2: Vaseline with minor trace of Ping On ointment to give medicinal smell
Interventions: intervention 1: Ping On Ointment intervention 2: Vaseline
Intervention descriptions: intervention 1: Ping On Ointment intervention 2: Placebo

Protocol documents:
Clinical trial NCT00814801
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Cognitive dysfunction Dementia Galantamine R113675
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2007-02-01; Completion date: 2008-09-01
Enrollment: 580 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

Detailed description:
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease. Study drug taken orally twice a day.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Galantamine 16 mg/day intervention 3: Galantamine 24 mg/day
Intervention descriptions: intervention 1: Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks. intervention 2: Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks. intervention 3: Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.

Protocol documents:
Clinical trial NCT00821184
Conditions: Overactive Bladder
Keywords: urinary incontinence overactive bladder urinary frequency
Sponsor: Lahey Clinic
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Detailed description:
Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Arms: arm 1: Vesicare alone arm 2: Vesicare plus behavioral modification
Interventions: intervention 1: Vesicare (solifenacin) intervention 2: Vesicare (solifenacin) plus behavioral modification
Intervention descriptions: intervention 1: 5mg po qd intervention 2: 5 mg dose po once daily plus behavioral modification

Protocol documents:
Clinical trial NCT00829933
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation Factor Xa inhibition
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2007-03-01; Completion date: 2008-09-01
Enrollment: 536 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Detailed description:

Arms: arm 1: DU-176b low dose arm 2: DU-176b intermediate dose arm 3: DU-176b high dose arm 4: Warfarin
Interventions: intervention 1: DU-176b tablets intervention 2: Warfarin potassium tablets
Intervention descriptions: intervention 1: DU-176b tablets taken once daily for up to 12 weeks intervention 2: Warfarin potassium tablets taken once daily for up to 12 weeks

Protocol documents:
Clinical trial NCT00846521
Conditions: Pediatric Obesity Insulin Resistance Impaired Glucose Tolerance Cardiovascular Disease
Keywords: Pediatric Obesity Insulin Resistance Glucose Tolerance Adolescents Acarbose Continuous Glucose Monitoring (CGMS) Endothelial Dysfunction
Sponsor: Yale University
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of \>130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.

Detailed description:
We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.

Arms: arm 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
Interventions: intervention 1: Acarbose
Intervention descriptions: intervention 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.

Protocol documents:
Clinical trial NCT00917644
Conditions: Hypercholesterolemia
Keywords: Bioqeuivalence, Pharmacokinetics, Atorvastatin
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-07-01; Completion date: 2008-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).

Detailed description:

Arms: arm 1: 80 mg atorvastatin tablets arm 2: New 80 mg atorvastatin tablets
Interventions: intervention 1: Atorvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: A single 80 mg dose of marketed 80 mg atorvastatin tablets intervention 2: A single dose of new formulation of 80 mg atorvastatin tablets

Protocol documents:
Clinical trial NCT00971295
Conditions: Neuropathic Pain
Keywords: eslicarbazepine acetate zebinix metformin
Sponsor: Bial - Portela C S.A.
Start date: 2007-10-01; Completion date: 2008-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

Detailed description:

Arms: arm 1: Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period arm 2: Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period
Interventions: intervention 1: Metformin intervention 2: Eslicarbazepine acetate
Intervention descriptions: intervention 1: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days intervention 2: None

Protocol documents:
Clinical trial NCT00978731
Conditions: Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2005-12-01; Completion date: 2008-09-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules:

* 5 days on, 2 days off
* 6 days on, 1 day off
* Continuous daily dosing

Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study

Protocol documents:
Clinical trial NCT01107353
Conditions: Depression
Sponsor: Roxane Laboratories
Start date: 2008-08-01; Completion date: 2008-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

Detailed description:

Arms: arm 1: First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) arm 2: First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Interventions: intervention 1: Imipramine Pamoate
Intervention descriptions: intervention 1: 75 mg capsule

Protocol documents:
Clinical trial NCT01135368
Conditions: Gastroesophageal Reflux
Keywords: GERD Gastroesophageal Reflux Disease Drug Therapy
Sponsor: Takeda
Start date: 2002-06-01; Completion date: 2008-09-01
Enrollment: 506 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Detailed description:
Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Arms: arm 1: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
Interventions: intervention 1: Lansoprazole
Intervention descriptions: intervention 1: Lansoprazole capsules

Protocol documents: