ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00634920
Conditions: Renal Function
Keywords: De novo renal transplantation
Sponsor: Novartis Pharmaceuticals
Start date: 2008-03-01; Completion date: 2013-05-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy

Detailed description:

Arms: arm 1: Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart. arm 2: Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.
Interventions: intervention 1: everolimus intervention 2: cyclosporine A intervention 3: Enteric Coated Mycophenolate Sodium (EC-MPS) intervention 4: corticosteroids intervention 5: Basiliximab
Intervention descriptions: intervention 1: Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2. intervention 2: CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method intervention 3: Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate) intervention 4: For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion. intervention 5: Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.

Protocol documents:
Clinical trial NCT00781391
Conditions: Stroke Atrial Fibrillation Embolism
Keywords: Systemic embolic events
Sponsor: Daiichi Sankyo
Start date: 2008-11-01; Completion date: 2013-05-01
Enrollment: 21105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.

Detailed description:

Arms: arm 1: Warfarin tablets plus placebo Edoxaban tablets arm 2: Edoxaban tablets (60mg) plus warfarin placebo tablets arm 3: Edoxaban tablets (30mg) plus warfarin placebo tablets
Interventions: intervention 1: warfarin tablets intervention 2: Edoxaban tablets (high dose regimen-60mg) intervention 3: Edoxaban tablets (low dose regimen-30mg) intervention 4: placebo warfarin intervention 5: placebo edoxaban
Intervention descriptions: intervention 1: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months intervention 2: Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months intervention 3: Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months intervention 4: placebo warfarin intervention 5: placebo edoxaban

Protocol documents:
Clinical trial NCT00836875
Conditions: Invasive Aspergillosis
Keywords: Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2013-05-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.

Detailed description:

Arms: arm 1: Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).
Interventions: intervention 1: Voriconazole
Intervention descriptions: intervention 1: All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.

Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.

Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \<50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.

Protocol documents:
Clinical trial NCT01107886
Conditions: Type 2 Diabetes Mellitus
Keywords: Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus
Sponsor: AstraZeneca
Start date: 2010-05-01; Completion date: 2013-05-01
Enrollment: 18206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

Detailed description:
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg or 2.5 mg once daily intervention 2: None

Protocol documents:
Clinical trial NCT01126437
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2013-05-01
Enrollment: 17183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

Detailed description:

Arms: arm 1: Patients receive one of the active tiotropium arms daily arm 2: Patients receive one of the active tiotropium arms daily arm 3: Patients receive one of the active tiotropium arms daily
Interventions: intervention 1: tiotropium 18 mcg intervention 2: tiotropium 1.25 mcg (2 actuations/day) intervention 3: tiotropium 2.5 mcg (2 actuations/day)
Intervention descriptions: intervention 1: HandiHaler intervention 2: soft mist inhaler 2 actuations=2 puffs/day intervention 3: soft mist inhaler (2 actuations=2 puffs/day)

Protocol documents:
Clinical trial NCT01152996
Conditions: Depressive Disorder, Major
Keywords: Depression Melancholia Paraphrenia Drug Therapy
Sponsor: Takeda
Start date: 2010-09-01; Completion date: 2013-05-01
Enrollment: 1075 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.

Detailed description:
Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.

This is a multicenter extension study designed to allow eligible patients who have completed short-term efficacy and safety studies LuAA21004\_315 (NCT01153009), LuAA21004\_316 (NCT01163266) and LuAA21004\_317 (NCT01179516) to receive the 52-week treatment with vortioxetine in this open-label extension study. Participants are expected to return to the site for approximately 13 visits.

A safety follow-up call will be made 4 weeks after completion of the 52-week treatment period.

Arms: arm 1: Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
Interventions: intervention 1: Vortioxetine
Intervention descriptions: intervention 1: Vortioxetine tablets

Protocol documents:
Clinical trial NCT01399125
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Rivastigmine Patch Dementia
Sponsor: Novartis Pharmaceuticals
Start date: 2011-07-01; Completion date: 2013-05-01
Enrollment: 501 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).

Detailed description:

Arms: arm 1: Once-daily target patch size 10 cm² arm 2: Twice-daily target dose of 6 mg oral capsule
Interventions: intervention 1: Rivastigmine Patch intervention 2: Rivastigmine Capsules intervention 3: Placebo to Rivastigmine patch intervention 4: Placebo to Rivastigmine capsules
Intervention descriptions: intervention 1: Once-daily target patch size 10 cm² intervention 2: Twice-daily target dose of 6 mg oral capsule intervention 3: Matching placebo to Rivastigmine patch intervention 4: matching Placebo to Rivastigmine capsules

Protocol documents:
Clinical trial NCT01551173
Conditions: Lipid Metabolism Disorders
Keywords: Dyslipidemias Fluvastatin sodium Chinese
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.

Detailed description:

Arms: arm 1: Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks arm 2: Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Interventions: intervention 1: Fluvastatin sodium
Intervention descriptions: intervention 1: Fluvastatin sodium Extended Release Tablets 80mg

Protocol documents:
Clinical trial NCT01604850
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Treatment Experienced GS-7977 Ribavirin
Sponsor: Gilead Sciences
Start date: 2012-06-01; Completion date: 2013-05-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Detailed description:

Arms: arm 1: Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks. arm 2: Participants were randomized to receive SOF+RBV for 16 weeks.
Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Placebo to match SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet was administered orally once daily. intervention 2: Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). intervention 3: Placebo to match SOF was administered orally once daily. intervention 4: Placebo to match RBV was administered orally twice daily.

Protocol documents:
Clinical trial NCT01964547
Conditions: Multiple Sclerosis Spasticity
Keywords: Cognition Mood
Sponsor: Jazz Pharmaceuticals
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.

Detailed description:
Eligible patients entered this 50 week multicenter, double-blind, randomised, placebo-controlled, parallel group study which evaluated the effect of Sativex on cognitive performance. At each scheduled clinic visit, patients were assessed for cognitive performance, mood, severity of spasticity, use of investigational medicinal products and number of visits to a healthcare professional. Primary efficacy comparisons were made between scores recorded during baseline and scores recorded at the end of treatment.

Arms: arm 1: Contains delta-9-tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.

Dose: 100 µL oromucosal spray to be administered up to a maximum of 12 sprays per day. There was an initial dose-titration period during which patients gradually increased their dose of study drug according to individual response and tolerability. arm 2: Oromucosal spray, containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Dose: 100 µL oromucosal spray to be administered up to a maximum of 12 sprays per day. There was an initial dose-titration period during which patients gradually increased their dose of study drug according to individual response and tolerability.
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period). intervention 2: Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).

Protocol documents:
Clinical trial NCT00093808
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer male breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2004-08-01; Completion date: 2013-05-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the overall response rate in patients with HER2/neu-overexpressing metastatic breast cancer treated with first- or second-line therapy comprising capecitabine, vinorelbine, and trastuzumab (Herceptin\^®).

Secondary

* Determine the time to disease progression, duration of response, and overall survival of patients treated with this regimen.
* Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab (Herceptin\^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Arms: arm 1: Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab (Herceptin\^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Interventions: intervention 1: trastuzumab intervention 2: capecitabine intervention 3: vinorelbine tartrate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00201851
Conditions: Breast Cancer
Keywords: Asian Premenopausal Women Oophorectomy
Sponsor: International Breast Cancer Research Foundation
Start date: 2004-01-01; Completion date: 2013-05-01
Enrollment: 740 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.

Detailed description:

Arms: arm 1: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen arm 2: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen arm 3: Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Interventions: intervention 1: Tamoxifen intervention 2: Surgery: Oophorectomy
Intervention descriptions: intervention 1: 20 mg po daily x 5 years intervention 2: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

Protocol documents:
Clinical trial NCT00227760
Conditions: Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-12-01; Completion date: 2013-05-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well cediranib maleate works in treating patients with recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the clinical benefit rate (objective response rate and rate of stable disease for at least 4 months) of AZD2171 (cediranib maleate) given to patients with progressive unresectable or, recurrent or metastatic renal cell carcinoma (RCC).

II. To assess the duration of response or stable disease, progression free, median and overall survival rates, and safety and tolerability of AZD2171.

III. To measure baseline and post treatment levels of soluble markers of angiogenic growth factors and receptors as well as levels of circulating endothelial cells, and correlate these with clinical outcome.

IV. To assess changes in blood flow and vessel permeability using dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) pre and post treatment and to correlate these changes with clinical outcome.

OUTLINE:

Patients receive cediranib maleate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cediranib Maleate intervention 2: Dynamic Contrast-Enhanced Magnetic Resonance Imaging intervention 3: Laboratory Biomarker Analysis intervention 4: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents: