ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00452348
Conditions: Asthma
Keywords: FLOVENT fluticasone 12 month salmeterol asthma ADVAIR
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2009-04-01
Enrollment: 628 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Detailed description:

Arms: arm 1: Fluticasone propionate 250 mcg BID arm 2: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
Interventions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID
Intervention descriptions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID

Protocol documents:
Clinical trial NCT00481676
Conditions: Chronic Urticaria
Keywords: Chronic urticaria, omalizumab, thyroperoxidase, IgE
Sponsor: Novartis
Start date: 2007-05-01; Completion date: 2009-04-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

Detailed description:

Arms: arm 1: Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. arm 2: Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Interventions: intervention 1: Omalizumab 75-375 mg intervention 2: Placebo to omalizumab intervention 3: Loratadine intervention 4: Clemastine
Intervention descriptions: intervention 1: Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection. intervention 2: Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection. intervention 3: All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. intervention 4: All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.

Protocol documents:
Clinical trial NCT00498186
Conditions: Restless Legs Syndrome
Keywords: Rotigotine Neupro®
Sponsor: UCB Pharma
Start date: 2003-07-01; Completion date: 2009-04-01
Enrollment: 295 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).

Detailed description:

Arms: arm 1: Rotigotine trans-dermal patch
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patches once daily:

2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)

Protocol documents:
Clinical trial NCT00501592
Conditions: Diabetes Mellitus, Type II Fatty Liver
Keywords: Farnesoid X receptor agonist Metabolic Disorder Diabetes NAFLD
Sponsor: Intercept Pharmaceuticals
Start date: 2007-07-01; Completion date: 2009-04-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

* The safety and tolerability of multiple doses of INT 747;
* The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
* Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
* Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.

Detailed description:
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.

The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: INT-747 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg by mouth once daily, 50 mg by mouth once daily intervention 2: Placebo

Protocol documents:
Clinical trial NCT00504166
Conditions: Osteopenia Osteoporosis
Sponsor: University of California, San Francisco
Start date: 2006-02-01; Completion date: 2009-04-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate, 70 mg once a week as compared to placebo

Detailed description:
This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age range of 45-65 years, with low bone density will be recruited, with half of the subjects receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo + 2800 IU of vitamin D once weekly. All study subjects will receive supplemental calcium 1000 mg/day + Vitamin D 400 IU/day. Measurements of microarchitecture will be made in the wrist, ankle, and hip, and the changes in trabecular bone will be assessed at 0, 12 and 24 months. Markers of bone turnover and bone mineral density (BMD) will be used to characterize the cohort and postmenopausal changes in bone turnover and density.

Arms: arm 1: alendronate sodium 70 mg tablet once a week for 24 months arm 2: placebo to match alendronate sodium
Interventions: intervention 1: alendronate sodium intervention 2: placebo comparator
Intervention descriptions: intervention 1: alendronate sodium 70 mg tablet once week for 24 months intervention 2: placebo to match alendronate sodium one tablet once a week for 24 months

Protocol documents:
Clinical trial NCT00509600
Conditions: Leukemia
Keywords: Juvenile Myelomonocytic Leukemia JMML Leukemia Etanercept Enbrel
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-09-01; Completion date: 2009-04-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML.

1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) \[mutations in NF1, Ras, SHP2\] or levels of TNFa.

1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts.

1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.

Detailed description:
Etanercept blocks a hormone called Tumor Necrosis Factor (TNF), which has been shown to play a role in helping the growth of leukemic cells in JMML.

Before participants can start treatment on this study, they will have what are called "screening tests". These tests will help the doctor decide if patients are eligible to take part in the study. You will have a complete medical history and physical exam. About two tablespoons of blood and urine will be collected for routine tests as well as to test for the liver and kidney function. You will have a bone marrow biopsy performed to monitor disease activity. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. You will have cells from inside of the mouth tested for genetic changes by swabbing the side of the cheeks.

If you are found to be eligible, etanercept will be given as an injection under the skin once a week for up to 90 days.

During the study, you will have weekly follow-up tests that will include physical exam and lab tests. About 2 tablespoons of blood will be collected each time. Urine will also be collected for testing at least every 3 weeks while on the study.

If the disease gets worse or intolerable side effects occur, you will be taken off study and alternative treatment options will be discussed.

This is an investigational study. The FDA has approved etanercept for use in adults and children with rheumatoid arthritis and juvenile rheumatoid arthritis. Its use in this study is experimental. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 0.8 mg/kg subcutaneously weekly for 90 days
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: 0.8 mg/kg Subcutaneously Once A Week for 90 Days

Protocol documents:
Clinical trial NCT00518882
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-08-01; Completion date: 2009-04-01
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Detailed description:

Arms: arm 1: Liraglutide 1.8 mg once daily + subject's own OAD treatment arm 2: Exenatide 10 mcg twice daily + subject's own OAD treatment
Interventions: intervention 1: liraglutide intervention 2: exenatide
Intervention descriptions: intervention 1: 1.8 mg once daily for s.c. (under the skin) injection. intervention 2: 10 mcg twice daily for s.c. (under the skin) injection.

Protocol documents:
Clinical trial NCT00532480
Conditions: Major Depression
Keywords: Depression Duloxetine fMRI pictures
Sponsor: Indiana University School of Medicine
Start date: 2007-09-01; Completion date: 2009-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

Detailed description:
This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called duloxetine.

Arms: arm 1: Open-label duloxetine 30 - 60 mg oral administration
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: 60 mg capsules

Protocol documents:
Clinical trial NCT00536380
Conditions: Chronic Idiopathic Urticaria
Sponsor: Organon and Co
Start date: 2007-09-01; Completion date: 2009-04-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

Detailed description:

Arms: arm 1: 5-mg Desloratadine once daily arm 2: 10-mg Desloratadine once daily arm 3: 20-mg Desloratadine once daily
Interventions: intervention 1: 5-mg Desloratadine intervention 2: 10-mg Desloratadine intervention 3: 20-mg Desloratadine
Intervention descriptions: intervention 1: 5-mg desloratadine tablets, once daily for four weeks. intervention 2: 10-mg desloratadine tablets, once daily for four weeks. intervention 3: 20-mg desloratadine tablets, once daily for four weeks.

Protocol documents:
Clinical trial NCT00537680
Conditions: Friedreich's Ataxia
Keywords: Friedreich's Ataxia Idebenone ICARS
Sponsor: Santhera Pharmaceuticals
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

Detailed description:
The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone.

Arms: arm 1: mid dose Idebenone arm 2: high dose Idebenone arm 3: Placebo
Interventions: intervention 1: Idebenone intervention 2: Idebenone intervention 3: Placebo
Intervention descriptions: intervention 1: Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day intervention 2: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day intervention 3: Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.

Protocol documents:
Clinical trial NCT00549328
Conditions: Lung Cancer, Non-Small Cell
Keywords: anti-angiogenesis Non-small cell lung cancer, pazopanib (GW786034)
Sponsor: GlaxoSmithKline
Start date: 2008-02-01; Completion date: 2009-04-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.

Detailed description:
Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.

Arms: arm 1: Single-arm, non-randomised, single-stage pazopanib monotherapy.
Interventions: intervention 1: Pazopanib (GW786034)
Intervention descriptions: intervention 1: Pazopanib monotherapy

Protocol documents:
Clinical trial NCT00549601
Conditions: Alzheimer's Disease
Keywords: Alzheimer's rivastigmine transdermal safety randomized switch patch
Sponsor: Novartis
Start date: 2007-09-01; Completion date: 2009-04-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) intervention 2: Rivastigmine patch (9.5 mg/day) intervention 3: Rivastigmine capsules (6 mg to 12 mg/day)
Intervention descriptions: intervention 1: Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). intervention 2: Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). intervention 3: Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.

Protocol documents:
Clinical trial NCT00550290
Conditions: Wound Infection
Keywords: vulvectomy wound infection wound complication prophylactic antibiotic Post-operative wound complications following vulvectomy
Sponsor: Aultman Health Foundation
Start date: 2007-10-01; Completion date: 2009-04-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Detailed description:
Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. This proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy. This same regimen has been described by a leader in the field of gynecology in his text - TeLinde's Operative Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

Arms: arm 1: Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision arm 2: Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op
Interventions: intervention 1: Cefazolin PostOperatively intervention 2: Cefazolin Preoperatively
Intervention descriptions: intervention 1: Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used. intervention 2: Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.

Protocol documents:
Clinical trial NCT00551616
Conditions: Contraception
Sponsor: HRA Pharma
Start date: 2007-04-01; Completion date: 2009-04-01
Enrollment: 2221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CDB-2914 intervention 2: Levonorgestrel
Intervention descriptions: intervention 1: Single dose intervention 2: Single dose

Protocol documents: