ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01037985
Conditions: Scar Prevention
Keywords: Scarring Cicatrix Fibrosis Pathologic Process
Sponsor: Pfizer
Start date: 2009-12-03; Completion date: 2010-09-22
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EXC 001 intervention 2: Placebo
Intervention descriptions: intervention 1: Multiple intradermal injections of EXC 001 and placebo intervention 2: Multiple intradermal injections of EXC 001 and placebo

Protocol documents:
Clinical trial NCT01153971
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2005-07-20; Completion date: 2010-09-24
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: 1

Protocol documents:
Clinical trial NCT04707573
Conditions: Chronic Kidney Disease
Keywords: CKD CKD, Stage 3 CKD, Stage 4 Vadadustat pharmacokinetics
Sponsor: Akebia Therapeutics
Start date: 2010-07-08; Completion date: 2010-09-24
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.

Detailed description:

Arms: arm 1: Participants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate \[eGFR\] 30 - 59 milliliters \[mL\]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. arm 2: Participants with Stage 4 CKD (eGFR \<30 mL/minute and not yet on dialysis) received a single 500 mg oral dose of Vadadustat after fasting for at least 4 hours.
Interventions: intervention 1: Vadadustat
Intervention descriptions: intervention 1: oral capsules

Protocol documents:
Clinical trial NCT00097370
Conditions: Hypereosinophilic Syndrome
Keywords: Mepolizumab Open-label Anti-IL-5 Hypereosinophilic Syndrome Hypereosinophilia
Sponsor: GlaxoSmithKline
Start date: 2004-09-30; Completion date: 2010-09-29
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

Detailed description:

Arms: arm 1: 750mg Intravenous, monthly and individual dosing schedule
Interventions: intervention 1: mepolizumab
Intervention descriptions: intervention 1: Study Drug

Protocol documents:
Clinical trial NCT00120523
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, children, infants, pimecrolimus
Sponsor: MEDA Pharma GmbH & Co. KG
Start date: 2004-04-01; Completion date: 2010-10-01
Enrollment: 2418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).

Detailed description:

Arms: arm 1: Pimecrolimus arm 2: Topical corticosteroids
Interventions: intervention 1: Pimecrolimus intervention 2: Topical corticosteroids
Intervention descriptions: intervention 1: Pimecrolimus cream 1 % intervention 2: TCS

Protocol documents:
Clinical trial NCT00130442
Conditions: Melanoma
Keywords: phase II metastatic melanoma dacarbazine combination PI-88
Sponsor: Cellxpert Biotechnology Corp.
Start date: 2005-06-01; Completion date: 2010-10-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma.

PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.

Detailed description:
Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma. However, it is associated with low response rates (10-20%) and median survival of less than 12 months (6-11 months in most studies). PI-88 is an antiangiogenic and antimetastatic drug that has already shown some evidence of efficacy when used alone in an intermittent dosage regimen (4 consecutive days per week) in the treatment of patients with advanced melanoma. The FDA has designated PI-88 as an Orphan Drug for this indication, as well as for Stage III and high-risk stage II disease. The aim of this randomised pilot phase II trial is to determine whether PI-88 in combination with a standard regimen of dacarbazine (1000 mg/m2 every 3 weeks) should be considered for further investigation in a larger-scale trial.

Arms: arm 1: PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle arm 2: dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion
Interventions: intervention 1: PI-88 and dacarbazine intervention 2: dacarbazine or DTIC
Intervention descriptions: intervention 1: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion intervention 2: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle

Protocol documents:
Clinical trial NCT00329238
Conditions: Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2006-05-01; Completion date: 2010-10-01
Enrollment: 2867 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Detailed description:

Arms: arm 1: Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements arm 2: Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Interventions: intervention 1: Dabigatran intervention 2: Warfarin
Intervention descriptions: intervention 1: Dabigatran 150 mg BID (twice daily) intervention 2: Warfarin dosed individually to maintain INR 2.0-3.0

Protocol documents:
Clinical trial NCT00662831
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcers Neuroischaemic
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2010-10-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.

Detailed description:

Arms: arm 1: Active study treatment arm 2: Placebo
Interventions: intervention 1: Fragmin/ Dalteparin Sodium intervention 2: Placebo for Fragmin/ Dalteparin Sodium
Intervention descriptions: intervention 1: Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium. intervention 2: Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.

Protocol documents:
Clinical trial NCT00664521
Conditions: Rheumatoid Arthritis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-03-01; Completion date: 2010-10-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

Detailed description:

Arms: arm 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. arm 2: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
Interventions: intervention 1: Rituximab intervention 2: Atacicept intervention 3: Placebo matched to atacicept
Intervention descriptions: intervention 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3. intervention 2: Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32. intervention 3: Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.

Protocol documents:
Clinical trial NCT00761605
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Paliperidone extended-release Antipsychotics Agents
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-04-01; Completion date: 2010-10-01
Enrollment: 387 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.

Detailed description:
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER. The total study duration will be approximately of 24 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks). Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Interventions: intervention 1: Paliperidone
Intervention descriptions: intervention 1: Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.

Protocol documents:
Clinical trial NCT00804843
Conditions: Carotid Atherosclerosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-01; Completion date: 2010-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers

Detailed description:

Arms: arm 1: Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin. arm 2: Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
Interventions: intervention 1: Atorvastatin/niacin extended-release intervention 2: Atorvastatin intervention 3: Simvastatin intervention 4: Simvastatin
Intervention descriptions: intervention 1: 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. intervention 2: 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. intervention 3: (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. intervention 4: (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Protocol documents:
Clinical trial NCT00970268
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2009-08-01; Completion date: 2010-10-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Detailed description:

Arms: arm 1: Aclidinium bromide dose, inhaled, for 52 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Interventions: intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment intervention 2: Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Protocol documents:
Clinical trial NCT01032837
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2009-11-01; Completion date: 2010-10-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

Detailed description:

Arms: arm 1: Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment. arm 2: Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days. arm 3: Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment. arm 4: Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
Interventions: intervention 1: Oseltamivir intervention 2: Oseltamivir intervention 3: Placebo
Intervention descriptions: intervention 1: Oseltamivir capsules for participants ≥ 13 years. intervention 2: Pediatric suspension for participants aged ≤ 12 years. intervention 3: Matching placebo provided as capsules and as a suspension.

Protocol documents:
Clinical trial NCT01095250
Conditions: Uveitis
Keywords: Active uveitis intermediate uveitis panuveitis posterior uveitis uveitis
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2010-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

Detailed description:

Arms: arm 1: AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks. arm 2: AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks. arm 3: AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks arm 4: Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
Interventions: intervention 1: AIN457 intervention 2: AIN457 intervention 3: AIN457 intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00070941
Conditions: Parkinson's Disease Depression
Keywords: Parkinsons Disease Depression SAM-e
Sponsor: NYU Langone Health
Start date: 2003-07-01; Completion date: 2010-10-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).

Detailed description:
PD is commonly associated with depression, but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer. SAM-e improves dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good alternative to the currently-used antidepressants in patients with PD. This study will investigate whether SAM-e is safe and effective in the treatment of depression associated with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective serotonin reuptake inhibitor commonly used for the treatment of depression in PD.

Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12 weeks (for a total of 24 weeks on study medication). Participants will have study visits at entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation, psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone interview will be conducted at Week 10.

Arms: arm 1: 40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram. arm 2: 40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e. arm 3: 20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
Interventions: intervention 1: SAM-e intervention 2: oral escitalopram intervention 3: placebo
Intervention descriptions: intervention 1: oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram. intervention 2: 20mg or 30mg daily in two divided doses, along with placebo SAM-e. intervention 3: oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.

Protocol documents:
Clinical trial NCT00079326
Conditions: HER2-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-01-01; Completion date: 2010-10-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Examine the response rate of HER2-positive metastatic breast cancer to combination therapy with trastuzumab and BMS-247550 in two cohorts of women: a. women who have received no prior chemotherapy or trastuzumab for their metastatic breast cancer; b. women who have received prior trastuzumab therapy (either for metastatic disease or prior adjuvant trastuzumab if \< 1 year since completion of adjuvant trastuzumab therapy) and up to 2 prior chemotherapeutic regimens in the metastatic setting.

SECONDARY OBJECTIVES:

I. To characterize the safety and toxicity profile of trastuzumab in combination with BMS-247550.

II. To determine the time-to-disease-progression (TTP) and time-to-treatment-failure (TTF) for patients receiving trastuzumab in combination with BMS-247550 in each cohort.

III. Analyze various tissue biomarkers (e.g. HER2/phospho-HER2, EGFR/phospho-EGFR, IGRF-I, phospho-MAPK, phospho-P13K, bcl-2, bcl-xL, MDR-1, MRP and β-tubulin) and blood biomarkers (HER2-extracellular domain \[ECD\], circulating tumor cells) to correlate them with response to treatment.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior trastuzumab (Herceptin®) therapy (with or without chemotherapy) for metastatic breast cancer (yes vs no).

Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: trastuzumab intervention 2: ixabepilone intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents: