ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00376675
Conditions: Fatigue Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue unspecified adult solid tumor, protocol specific
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-02-01; Completion date: 2010-06-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer.

PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.

Detailed description:
OBJECTIVES:

Primary

* Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory.

Secondary

* Evaluate the tolerability and adverse events associated with this drug in these patients.
* Study the effect of this drug on quality of life (QOL)-related variables (vitality, sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived treatment efficacy) in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (0, I, or II vs III or IV), level of fatigue at baseline (4-7 vs 8-10), concurrent biological therapy (yes vs no), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral methylphenidate daily on days 1-28.
* Arm II: Patients receive oral placebo daily on days 1-28.

Patients in both arms complete questionnaires to assess their symptoms of fatigue, overall mood, quality of life, sleep quality, and adverse effects from treatment at baseline and once weekly for 4 weeks. Patients also complete a Symptom Experience Diary.

McNeil Consumer \& Specialty Pharmaceuticals provided medication support for NCCTG N05C7.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Arms: arm 1: Patients receive oral methylphenidate hydrochloride daily on days 1-28. arm 2: Patients receive oral placebo daily on days 1-28.
Interventions: intervention 1: methylphenidate hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00383266
Conditions: Esophageal Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2006-10-01; Completion date: 2010-06-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.

Detailed description:

Arms: arm 1: * Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00385138
Conditions: Atherosclerosis Acute Coronary Syndrome (ACS)
Keywords: Percutaneous Coronary Intervention (PCI) ACS
Sponsor: The Medicines Company
Start date: 2006-09-01; Completion date: 2010-06-01
Enrollment: 5364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR).

Detailed description:

Arms: arm 1: cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion arm 2: placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Interventions: intervention 1: Cangrelor intervention 2: clopidogrel intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of PCI intervention 5: Placebo capsules - end of infusion
Intervention descriptions: intervention 1: cangrelor bolus (30 mcg/kg) \& cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) intervention 2: clopidogrel capsules (600 mg) at end of PCI intervention 3: placebo bolus (30 mcg/kg) \& placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) intervention 4: Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing intervention 5: Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Protocol documents:
Clinical trial NCT00391274
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-10-01; Completion date: 2010-06-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pemetrexed intervention 2: docetaxel
Intervention descriptions: intervention 1: 500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment

Protocol documents:
Clinical trial NCT00413777
Conditions: Polycystic Kidney, Autosomal Dominant
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2005-12-01; Completion date: 2010-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Detailed description:
Autosomal Dominant Polycystic Kidney Disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts causes the kidneys to enlarge several times the normal size and leads to the eventual loss of renal function and ultimately results in renal failure in end-stage patients. This is a disease with life-threatening implications to those who have it, and their family members who may also be affected. Aside from early anti-hypertensive control and dietary protein restriction, which are presumed to offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality.

A rationale for use of tolvaptan in these genetic disorders has been proven, in principle, through use of a variety of animal models. In these models, tolvaptan is effective in halting or reversing the progression of this renal disease.

The current study is being undertaken in order to evaluate whether tolvaptan, an oral vasopressin V2 receptor inhibitor, will maintain an adequate safety profile and show a potential clinical benefit by reducing total renal volume in the hopes of making an impact upon disease progression.

Arms: arm 1: Participants received tolvaptan 45 mg orally in the morning and 15 mg orally 8 hours later for up to 4 years. arm 2: Participants received tolvaptan 60 mg orally in the morning and 30 mg orally 8 hours later for up to 4 years.
Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.

Protocol documents:
Clinical trial NCT00422942
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-01-01; Completion date: 2010-06-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreatment will also be investigated. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg po weekly

Protocol documents:
Clinical trial NCT00462462
Conditions: Congenital Venous Malformation
Sponsor: Orfagen
Start date: 2007-05-01; Completion date: 2010-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in order to minimize systemic and local diffusion capacities of ethanol. Therefore, the pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel 96% and absolute ethanol need to be carried out.

FDA Office of Orphan Products Development (FDA OOPD) : Funding source.

Detailed description:

Arms: arm 1: Ethanol gel arm 2: Ethanol solution
Interventions: intervention 1: Ethanol 96% Gel intervention 2: Ethanol 98% Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00466440
Conditions: Prostate Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-06-01; Completion date: 2010-06-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.

Detailed description:

Arms: arm 1: Regimen A: docetaxel 75 milligrams per square meter (mg/m\^2), intravenous (IV) is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 milligrams (mg) oral (po), twice daily (BID) every day. In Cycle 1, enzastaurin is given as a loading dose of 1125 mg on the day prior to docetaxel and prednisone therapy, followed by enzastaurin 500 mg po, daily (QD) for the remaining Period 2 (chemotherapy) and Period 3 (maintenance). arm 2: Regimen B: docetaxel 75 mg/m\^2, IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by po, QD placebo for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding. arm 3: Modified Regimen A, including pharmacokinetic (PK) characterization: Participants were treated with a modified investigational regimen with no dose escalation: docetaxel 75 mg/m2, IV was administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, enzastaurin was given as a loading dose of 1125 mg starting on Day 4, followed by enzastaurin 500 mg po, QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance).
Interventions: intervention 1: enzastaurin intervention 2: placebo intervention 3: docetaxel intervention 4: prednisone
Intervention descriptions: intervention 1: 1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years intervention 2: Loading dose, then po QD until unblinding intervention 3: 75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles intervention 4: 5 mg po BID, six 21-day cycles

Protocol documents:
Clinical trial NCT00467558
Conditions: Compulsive Sexual Behavior
Keywords: Impulse Control Disorder Compulsive Sexual Behavior
Sponsor: University of Minnesota
Start date: 2007-05-01; Completion date: 2010-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed description:
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Arms: arm 1: Naltrexone 50mg-150mg by mouth per day. arm 2: Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Interventions: intervention 1: Naltrexone intervention 2: Sugar pill
Intervention descriptions: intervention 1: daily intervention 2: daily

Protocol documents:
Clinical trial NCT00471276
Conditions: Breast Neoplasms
Keywords: Metastatic Breast Cancer
Sponsor: Pfizer
Start date: 2007-08-01; Completion date: 2010-06-01
Enrollment: 83 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: sunitinib
Intervention descriptions: intervention 1: sunitinib (Sutent), 37.5 mg, daily dosing

Protocol documents:
Clinical trial NCT00495716
Conditions: Genital Herpes
Sponsor: University of Washington
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners.

Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.

Detailed description:
We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital herpes, and prospectively follow them for 1 year to assess sexual behavior, adherence to therapy, and herpes-related quality of life. These outcomes will be measured by self-report in a confidential, computer-based assessment. We plan to use data from this trial to model the effect that increasing the proportion of sexually-active HSV-2 infected persons taking suppressive therapy will have on population-level incidence and prevalence of HSV-2.

Arms: arm 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence arm 2: 400 mg acyclovir orally twice daily for 1 year
Interventions: intervention 1: acyclovir intervention 2: acyclovir
Intervention descriptions: intervention 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence intervention 2: 400 mg acyclovir orally twice daily for 1 year

Protocol documents:
Clinical trial NCT00496197
Conditions: Candidiasis
Keywords: candidemia invasive candidiasis fungal bloodstream infection
Sponsor: Pfizer
Start date: 2007-07-01; Completion date: 2010-06-01
Enrollment: 282 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Detailed description:

Arms: arm 1: Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
Interventions: intervention 1: Eraxis (anidulafungin) intervention 2: Diflucan (fluconazole) intervention 3: Vfend (voriconazole)
Intervention descriptions: intervention 1: Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species. intervention 2: Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis. intervention 3: Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Protocol documents:
Clinical trial NCT00512252
Conditions: Leukemia, Myeloid, Acute
Keywords: Plerixafor CXCR4 Chemosensitization
Sponsor: Washington University School of Medicine
Start date: 2007-07-01; Completion date: 2010-06-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML.

We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.

Detailed description:
The interaction of leukemic blasts with the bone marrow microenvironment is postulated to be an important mediator of chemoresistance in AML. Although a number of receptor / ligand pairs have been implicated, the CXCR4 / SDF-1 axis functions as the principal regulator of homing and retention of both normal and malignant hematopoietic cells in the marrow. AMD3100 is a bicyclam molecule which reversibly blocks CXCR4 binding to SDF-1 and is being developed clinically as a mobilization agent for hematopoietic stem cell transplantation. Preclinical data from our group has demonstrated that in murine models, plerixafor can disrupt the interaction of leukemic cells with the marrow microenvironment and sensitize blasts to the effect of chemotherapy. Based on these data, we have initiated a phase I/II study in patients with relapsed or refractory AML in which plerixafor is administered prior to salvage chemotherapy.

Arms: arm 1: * AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5

Dose Level 1 AMD3100 dose = 80 mcg/kg/d

Dose Level 2 AMD3100 dose = 160 mcg/kg/d arm 2: * AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5

Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)
Interventions: intervention 1: AMD3100 intervention 2: Mitoxantrone intervention 3: Etoposide intervention 4: Cytarabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00514683
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2007-08-01; Completion date: 2010-06-01
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Detailed description:

Arms: arm 1: low dose BIBF1120 once daily arm 2: low dose BIBF 1120 twice daily arm 3: intermediate dose BIBF 1120 twice daily arm 4: high dose BIBF 1120 twice daily arm 5: placebo
Interventions: intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo
Intervention descriptions: intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo

Protocol documents: