ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00145574
Conditions: Hypercholesterolemia
Keywords: Pediatric hypercholesterolemia colesevelam
Sponsor: Daiichi Sankyo
Start date: 2005-11-01; Completion date: 2007-12-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

Detailed description:

Arms: arm 1: colesevelam HCl 3.750 g arm 2: Low dose colesevelam 1.875 g arm 3: placebo comparator
Interventions: intervention 1: colesevelam HCl intervention 2: placebo
Intervention descriptions: intervention 1: Tablets intervention 2: Matching Tablets

Protocol documents:
Clinical trial NCT00149994
Conditions: Liver Transplant
Keywords: Liver transplant, adults, C2 monitoring
Sponsor: Novartis Pharmaceuticals
Start date: 2002-12-01; Completion date: 2007-12-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.

Detailed description:

Arms: arm 1: Cyclosporine A was given in a twice-daily schedule at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses, as close as possible to 15mg/kg/day. After the first oral administration, the dose of Cyclosporine A was adjusted to bring the sample taken 2 hours after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. C-2h target ranges post-transplantation: 0-3 months: range of 800-1200 ng/ml with midpoint of 1000 ng/ml; 4-6 months: range of 700-900 ng/ml with midpoint of 800 ng/ml; \> 6 months: range of 500-700 ng/ml with midpoint of 600 ng/ml is recommended. During the course of the study, the dose of Cyclosporine A was adjusted as necessary to achieve and maintain the C-2h blood Cyclosporine A (CsA) concentrations within the target ranges. arm 2: Tacrolimus was given on a twice-daily schedule at 12-hour intervals which had to be maintained throughout the study period. Tacrolimus was administered within the first 24 hrs postoperatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the patient can swallow. The initial dosing level was determined by the patient's overall post-operative condition. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the pre-dose blood concentration (C-0h) (trough) tacrolimus concentrations. C-0h target ranges post-transplantation: 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml; \> 6 months: range of 5-10 ng/ml is recommended.
Interventions: intervention 1: Cyclosporine A intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Methylprednisolone intervention 5: Prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. intervention 4: Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery intervention 5: Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.

Protocol documents:
Clinical trial NCT00159588
Conditions: Headache
Keywords: Medication-overuse headache preventative medication controls follow-up randomized abrupt withdrawal
Sponsor: Norwegian University of Science and Technology
Start date: 2004-01-01; Completion date: 2007-12-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

Detailed description:
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.

The included patients were randomized to one out of three possible options:

1. Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
2. Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
3. No specific treatment (controls), 5 month follow-up.

Arms: arm 1: Use of preventive drugs from the start without abrupt withdrawal arm 2: Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week arm 3: Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment
Interventions: intervention 1: Betablockers or other preventive drugs based on primary headache type
Intervention descriptions: intervention 1: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)

Protocol documents:
Clinical trial NCT00191906
Conditions: Attention Deficit Hyperactivity Disorder Reading Disorder
Sponsor: Eli Lilly and Company
Start date: 2005-04-01; Completion date: 2007-12-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Detailed description:

Arms: arm 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks arm 2: Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks arm 3: Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population. arm 4: The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.
Interventions: intervention 1: Atomoxetine Hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) intervention 2: Placebo, every day (QD), by mouth (PO)

Protocol documents:
Clinical trial NCT00231478
Conditions: Post-Operative Nausea and Vomiting
Sponsor: Hoffmann-La Roche
Start date: 2007-04-01; Completion date: 2007-12-01
Enrollment: 171 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: granisetron intervention 2: granisetron
Intervention descriptions: intervention 1: 20 micrograms intravenously (iv) 15 min prior to end of surgery intervention 2: 40 micrograms intravenously (iv) 15 min prior to end of surgery

Protocol documents:
Clinical trial NCT00244881
Conditions: Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2007-12-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171.

II. Estimation of the objective response rate (ORR = CR + PR) among patients with refractory breast cancer receiving AZD2171.

SECONDARY OBJECTIVES:

I. Estimation of the response/stable disease rate (RSDR = CR + PR + SD). II. Characterization of the toxicity associated with AZD2171 in this cohort of patients.

III. Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP.

IV. Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Arms: arm 1: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00255008
Conditions: Hepatitis C, Chronic
Keywords: chronic hepatitis C pegylated interferon alfa-2b ribavirin Asia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-03-01; Completion date: 2007-12-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

Detailed description:

Arms: arm 1: Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy arm 2: Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy arm 3: Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy arm 4: Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Interventions: intervention 1: peginterferon alfa-2b intervention 2: ribavirin intervention 3: peginterferon alfa-2b intervention 4: ribavirin
Intervention descriptions: intervention 1: Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks intervention 3: Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 4: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks

Protocol documents:
Clinical trial NCT00257010
Conditions: Migraine
Keywords: Migraine Almotriptan Malate Headache Triptan
Sponsor: Janssen-Ortho LLC
Start date: 2005-12-01; Completion date: 2007-12-01
Enrollment: 447 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

Detailed description:
Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Arms: arm 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Interventions: intervention 1: Almotriptan Malate
Intervention descriptions: intervention 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Protocol documents:
Clinical trial NCT00276094
Conditions: Atrophy Vaginal Diseases
Keywords: Urogenital atrophy Vaginal atrophy Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms
Sponsor: Shionogi
Start date: 2006-01-01; Completion date: 2007-12-01
Enrollment: 826 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Detailed description:

Arms: arm 1: Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 2: Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 3: Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Interventions: intervention 1: Ospemifene 30 mg intervention 2: Ospemifene 60 mg intervention 3: Placebo intervention 4: Nonhormonal vaginal lubricant
Intervention descriptions: intervention 1: 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 2: 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 3: 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 4: Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Protocol documents:
Clinical trial NCT00321672
Conditions: Pain HIV Infections Peripheral Nervous System Diseases
Keywords: Analgesics Capsaicin Neuropathic pain Neuropathy Distal sensory polyneuropathy Peripheral neuropathy Dermal assessment Pain measurement
Sponsor: NeurogesX
Start date: 2006-06-01; Completion date: 2007-12-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Detailed description:
Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study. Subjects were randomly assigned to receive active NGX-4010 patches (8% capsaicin) or low-concentration control patches (0.04% capsaicin) identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2:1:2:1 allocation scheme.

Subjects could be on stable chronic oral pain medication regimens, but could not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours were recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects continued to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study treatment.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: NGX-4010, 8% capsaicin patch intervention 2: 0.04% capsaicin patch intervention 3: NGX-4010, 8% capsaicin patch intervention 4: 0.04% capsaicin patch
Intervention descriptions: intervention 1: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 2: Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 3: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes. intervention 4: Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.

Protocol documents:
Clinical trial NCT00324038
Conditions: Osteoarthritis
Keywords: OA Elderly Pain OA of the hips and/or knees
Sponsor: Napp Pharmaceuticals Limited
Start date: 2006-03-01; Completion date: 2007-12-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).

Detailed description:

Arms: arm 1: Buprenorphine transdermal 7 day analgesic patch arm 2: codeine paracetamol combination tablets
Interventions: intervention 1: Buprenorphine intervention 2: Codeine paracetamol
Intervention descriptions: intervention 1: buprenorphine transdermal system 5, 10 and 20 mg intervention 2: combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500

Protocol documents:
Clinical trial NCT00327392
Conditions: Procedural Sedation
Keywords: Arthroscopy AV Shunt Bunion Dilatation and Curettage Esophagogastroduodenoscopy Hysteroscopy Lithotripsy Rotator Cuff/ Shoulder Transesophageal Echocardiography Ureteroscopy AQUAVAN Sedation
Sponsor: Eisai Inc.
Start date: 2006-05-01; Completion date: 2007-12-01
Enrollment: 123 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.

Detailed description:
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

Interventions: intervention 1: AQUAVAN® (fospropofol disodium) Injection
Intervention descriptions: intervention 1: None

Protocol documents: