ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00113568
Conditions: Menorrhagia Heavy Menstrual Bleeding
Keywords: Menorrhagia Heavy Menstrual Bleeding
Sponsor: Ferring Pharmaceuticals
Start date: 2005-06-01; Completion date: 2009-05-01
Enrollment: 784 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tranexamic acid tablets (XP12B)
Intervention descriptions: intervention 1: Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation

Protocol documents:
Clinical trial NCT00115765
Conditions: Colorectal Cancer
Keywords: Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study) Colorectal, Colon, Rectal Cancer, Metastatic Colorectal Cancer EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Oncology
Sponsor: Amgen
Start date: 2005-06-01; Completion date: 2009-05-01
Enrollment: 1053 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.

Detailed description:

Arms: arm 1: Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. arm 2: Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W arm 3: Irinotecan-based chemotherapy and Bevacizumab Q2W alone arm 4: Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W
Interventions: intervention 1: Oxaliplatin Based Chemotherapy intervention 2: Panitumumab intervention 3: Irinotecan Based Chemotherapy intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 2: PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. intervention 3: Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 4: Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .

Protocol documents:
Clinical trial NCT00132028
Conditions: Adult Favorable Prognosis Hodgkin Lymphoma Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Lymphocyte Predominant Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Adult Unfavorable Prognosis Hodgkin Lymphoma Recurrent Adult Hodgkin Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2009-05-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma.

II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA.

III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Arms: arm 1: Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.
Interventions: intervention 1: vorinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00141102
Conditions: Osteoarthritis Arthritis, Rheumatoid
Keywords: GI events in high risk GI arthritis patients
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2005-10-01; Completion date: 2009-05-01
Enrollment: 4484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Celecoxib intervention 2: Diclofenac + Omeprazole
Intervention descriptions: intervention 1: Participants are assigned to one of two groups in parallel for the duration of the study intervention 2: Participants are assigned to one of two groups in parallel for the duration of the study

Protocol documents:
Clinical trial NCT00174265
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2005-07-01; Completion date: 2009-05-01
Enrollment: 196 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an extension study of A7501013 (P05771/NCT00145496) to further test

the efficacy and safety of Asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: asenapine intervention 2: olanzapine
Intervention descriptions: intervention 1: 5-10 mg sublingually twice daily for 26 weeks intervention 2: 5-20 mg by mouth once daily for 26 weeks

Protocol documents:
Clinical trial NCT00180713
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension Simvastatin Statins
Sponsor: Imperial College London
Start date: 2005-10-01; Completion date: 2009-05-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.

Detailed description:
Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure.

The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. In addition there is evidence of inflammation of the vessels and what is known as oxidative stress. The disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and HIV infection.

Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. Alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymeA, or HMG-CoA, reductase inhibitor). Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.

Arms: arm 1: Placebo tablet once daily arm 2: Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Simvastatin 40mg od for 1 month, then 80mg od for 11 months intervention 2: Placebo tablet once daily.

Protocol documents:
Clinical trial NCT00184093
Conditions: Uterine Cervical Cancer
Keywords: Cervical Carcinoma
Sponsor: University of Southern California
Start date: 1999-06-01; Completion date: 2009-05-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.

Detailed description:

Arms: arm 1: Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Interventions: intervention 1: Gemcitabine
Intervention descriptions: intervention 1: Gemcitabine weekly x 6 wks with concurrent external radiation

Protocol documents:
Clinical trial NCT00193206
Conditions: Breast Cancer
Keywords: Locally Advanced Breast Cancer Inflammatory Breast Cancer Breast Cancer Abraxane nab Paclitaxel Epirubicin Gemcitabine Gemzar
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-09-01; Completion date: 2009-05-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Detailed description:
Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Arms: arm 1: Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.
Interventions: intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Albumin-bound Paclitaxel
Intervention descriptions: intervention 1: Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles intervention 2: Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles intervention 3: ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Protocol documents:
Clinical trial NCT00203047
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis brain atrophy Glatiramer Acetate Copaxone Steroids Prednisone
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2005-01-01; Completion date: 2009-05-01
Enrollment: 414 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

Detailed description:
One interim analysis was planned for possible early termination due to proven efficacy when 75% of the preplanned 500 (approx. 375 patients) recruited patients completed the entire study duration or early discontinued.

In addition to the stopping rule already given for proven efficacy, the sponsor was also interested in examining the data for futility (i.e., absence of the desired treatment effect) with the view to terminating the trial if an "insufficient" effect of the treatment is seen. The reasons why the need for futility arose were:

1. Recruitment difficulties
2. Increasing dropout rate
3. Budgetary constraints

The primary efficacy measure is defined as the percent change from baseline to termination (Month 36 or Early Termination) in normalized brain volume (Brain Atrophy) measured according to the SIENA (Structural Imaging Evaluation using Normalization of Atrophy) method. However, since not many patients had completed the entire study at the time of futility analysis, it was the sponsor's decision that the futility analysis be performed on patients with MRI scans at months 24 or 36 or at early termination visits - the latest available.

Based on the recalculation of study power (probability is unconditioned on the interim result and provide the real power of the study if designed anew), conditional power (based on the interim results) and risk assessment of a false negative, the Data Monitoring Committee agreed that the study should be terminated early.

Arms: arm 1: Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily. arm 2: Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Interventions: intervention 1: Glatiramer Acetate intervention 2: Placebo intervention 3: Prednisone
Intervention descriptions: intervention 1: 20mg glatiramer acetate (GA) administered by daily subcutaneous injections intervention 2: Placebo for prednisone given daily intervention 3: Prednisone 1250 mg taken daily

Protocol documents:
Clinical trial NCT00214201
Conditions: Primary Renal Transplant
Sponsor: University of Wisconsin, Madison
Start date: 2003-05-01; Completion date: 2009-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.

Detailed description:

Arms: arm 1: Standard of Care CNI immunosuppression arm 2: Calcineurin inhibitor withdrawal
Interventions: intervention 1: Calcineurin inhibitor withdrawal
Intervention descriptions: intervention 1: stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

Protocol documents:
Clinical trial NCT00227344
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster EMEA
Start date: 2004-12-01; Completion date: 2009-05-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.

Detailed description:

Arms: arm 1: Catheter ablation arm 2: Antiarrhythmic drugs
Interventions: intervention 1: RF ablation intervention 2: Antiarrhythmic drugs
Intervention descriptions: intervention 1: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System intervention 2: Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study

Protocol documents:
Clinical trial NCT00245583
Conditions: Pathological Gambling
Keywords: Pathological Gambling Compulsive Gambling Gambling topiramate
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2005-10-01; Completion date: 2009-05-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy of topiramate in the treatment of pathological gambling. Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal, familial, financial, social, and occupational impairments. In PG, the patient experiences a progressive inability to resist impulses to gamble, and gambling significantly disrupt the patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has shown preliminary evidence of efficacy in some impulse control disorders.

Detailed description:
This is a 14-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in subjects with pathological gambling. After giving informed consent, subjects who meet all the inclusion and exclusion criteria may be enrolled. The study will consist of three phases:

* Washout/Screening Phase (up to 28 days prior to randomization or longer for those medications requiring a longer washout period;
* Double-Blind Phase (Titration: up to 6 weeks; Maintenance: 8 weeks); and
* Taper Phase (approximately 1 week).

The study medication will be titrated to 300 mg/day or the subject's maximum tolerated dose (MTD). Subjects must reach a minimum dose of 50 mg/day by Week 2. The taper phase will last approximately one week where subjects gradually reduce their medication until they are no longer taking study medication.

Patient may also give an optional blood sample for pharmacogenomic testing

Arms: arm 1: 25mg to 300mg daily dose arm 2: placebo equivalent tablets
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: minimum does of 50mg/day intervention 2: matching tablet

Protocol documents:
Clinical trial NCT00266630
Conditions: Manic or Mixed Episode Associated With Bipolar I Disorder
Sponsor: Eli Lilly and Company
Start date: 2005-11-01; Completion date: 2009-05-01
Enrollment: 139 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC \[Study BMAC\]) will be examined.

Detailed description:

Arms: arm 1: Olanzapine extension for Study BMAC patients who completed Visit 8.

Patients received olanzapine 5-20 mg for 18 weeks. arm 2: Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.

Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.

Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Interventions: intervention 1: olanzapine intervention 2: lithium intervention 3: valproate intervention 4: carbamazepine
Intervention descriptions: intervention 1: oral, daily intervention 2: Dose adjusted according to local package insert intervention 3: Dose adjusted according to local package insert intervention 4: Dose adjusted according to local package insert

Protocol documents:
Clinical trial NCT00276419
Conditions: Breast Pain Non-cyclical Mastalgia Surgical Scar-Related Breast Pain
Sponsor: Mayo Clinic
Start date: 2005-06-01; Completion date: 2009-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

Detailed description:
A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.

Arms: arm 1: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. arm 2: Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
Interventions: intervention 1: Diclofenac intervention 2: Placebo
Intervention descriptions: intervention 1: Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks intervention 2: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks

Protocol documents: