ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00241358
Conditions: Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic Leukemia, Lymphoblastic, Acute Lymphocytic Leukemia, Chronic Myelodysplastic Syndromes Multiple Myeloma Lymphoma, Non-Hodgkin Hodgkin Disease
Keywords: Plerixafor Stem cell transplantation Stem cells Mobilization
Sponsor: Washington University School of Medicine
Start date: 2004-05-01; Completion date: 2010-02-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Detailed description:
This study will determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Arms: arm 1: * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3. arm 2: * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
* Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
* If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3. arm 3: * Conditioning Regimen

  * Cyclophosphamide 60mg/kg/day on Days -3 and -2
  * TBI 550cGy on Day -1
* GVHD prophylaxis

  \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
* PBSC transplant on Day 0
Interventions: intervention 1: AMD3100 intervention 2: Stem Cell Transplant
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00255086
Conditions: Alzheimer Disease
Sponsor: Stanford University
Start date: 2005-05-01; Completion date: 2010-02-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In secondary analyses, we will determine if measures of clinical stabilization produced by memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS measures of brain NAA and MRI volumetric measures of hippocampal volume.

Detailed description:
Alzheimer's disease (AD) is the most common form of dementia. Currently, there are more than 4 million individuals with dementia in the United States with at least 400,000 deaths annually. AD is a progressive, neurodegenerative disorder, characterized neuropathologically by widespread neuronal loss, presence of neurofibrillary tangles, and deposits of beta amyloid in cerebral blood vessels and neuritic plaques. Since the medial-temporal lobes, hippocampus, and association cortex are significantly impacted it is not surprising that the primary symptom of AD is a decline in cognitive functioning that leads to marked impairment in daily functioning. In particular, memory impairments, visuospatial decline, language difficulties, and loss of executive function are central cognitive symptoms of this illness. Behavioral disturbances such as agitation and hallucinations often accompany disease progression. The illness lasts approximately 7 to 10 years, with patients requiring total care in the latter stages. Thus, AD places a tremendous emotional and economic burden on both patients and their caregivers. Beyond a cure, therapeutic approaches which would alleviate the symptoms or delay progression could be of substantial psychological and economic benefit. Recent placebo controlled clinical trials have shown memantine to be efficacious in the treatment of patients with moderate to severe AD.

The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In secondary analyses, we will determine if measures of clinical stabilization produced by memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS measures of brain NAA and MRI volumetric measures of hippocampal volume.

Arms: arm 1: 10mg Memantine arm 2: 10 mg Placebo pill
Interventions: intervention 1: Memantine intervention 2: Placebo pill
Intervention descriptions: intervention 1: 10mg Memantine intervention 2: 10mg placebo pill

Protocol documents:
Clinical trial NCT00278395
Conditions: Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2010-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vorinostat works in treating patients with advanced kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the antitumor activity of vorinostat (SAHA), in terms of objective response and progression rate, in patients with advanced renal cell carcinoma.

SECONDARY OBJECTIVES:

I. Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in these patients.

II. Evaluate overall survival, progression-free survival, and survival rate at 12 months in patients treated with this drug.

III. Correlate changes in biologic measurements with outcomes of patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.

After completion of study treatment, patients are followed within 1 month and then approximately every 2 months thereafter.

Arms: arm 1: Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.
Interventions: intervention 1: Vorinostat
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00375427
Conditions: Breast Cancer With Bone Metastasis
Keywords: Breast cancer Zoledronic acid Skeletal related events (SRE)
Sponsor: Novartis Pharmaceuticals
Start date: 2006-02-01; Completion date: 2010-02-01
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.

Detailed description:

Arms: arm 1: Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every three months. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized patients will receive a maximum of 4 infusions in this group. arm 2: Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every 4 weeks. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Patients randomized to this group will receive up to 12 infusions.
Interventions: intervention 1: Zoledronic acid
Intervention descriptions: intervention 1: Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.

Protocol documents:
Clinical trial NCT00377962
Conditions: Disorder Related to Cardiac Transplantation
Keywords: thoracic transplant recipients everolimus immunosuppressants
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-01; Completion date: 2010-02-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.

Detailed description:

Arms: arm 1: Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level \< 75 ng/mL or a tacrolimus trough level \< 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice. arm 2: CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
Interventions: intervention 1: Everolimus intervention 2: Mycophenolic acid (MPA)/azathioprine (AZA) intervention 3: Calcineurin inhibitors (CNI) intervention 4: Steroids
Intervention descriptions: intervention 1: 0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL. intervention 2: In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice. intervention 3: Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus. intervention 4: Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Protocol documents:
Clinical trial NCT00391716
Conditions: Alcoholism Alcohol Dependence
Keywords: Alcohol Alcohol treatment Alcoholism Alcohol Dependence
Sponsor: The Scripps Research Institute
Start date: 2004-02-01; Completion date: 2010-02-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gabapentin treatment for alcohol dependence

Detailed description:
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Arms: arm 1: 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. arm 2: 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks arm 3: placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Interventions: intervention 1: Gabapentin 900mg intervention 2: behavioral counseling intervention 3: placebo intervention 4: gabapentin 1800mg
Intervention descriptions: intervention 1: 900 mg gabapentin daily for 12 weeks intervention 2: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info. intervention 3: lactose capsule compounded to mimic gabapentin capsules intervention 4: 1800 mg gabapentin daily for 12 weeks

Protocol documents:
Clinical trial NCT00397891
Conditions: Alzheimer Disease
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2006-10-01; Completion date: 2010-02-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.

Detailed description:

Arms: arm 1: bapineuzumab 0.15 mg/kg or placebo arm 2: bapineuzumab 0.5 mg/kg or placebo arm 3: bapineuzumab 1.0 mg/kg or placebo
Interventions: intervention 1: bapineuzumab intervention 2: bapineuzumab intervention 3: bapineuzumab
Intervention descriptions: intervention 1: The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour. intervention 2: The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour. intervention 3: The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.

Protocol documents:
Clinical trial NCT00408434
Conditions: Neoplasm
Keywords: PPARγ agonist advanced or metastatic malignancies Tumor Cancer
Sponsor: Daiichi Sankyo
Start date: 2006-11-01; Completion date: 2010-02-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.

Detailed description:

Arms: arm 1: CS-7017 from 0.05 to 3.2 mg bid
Interventions: intervention 1: CS-7017
Intervention descriptions: intervention 1: CS-7017 0.05mg and 1.0mg tablets

Protocol documents:
Clinical trial NCT00437073
Conditions: Neoplasms, Breast
Keywords: brain metastases ErbB2 lapatinib Breast Cancer HYCAMTIN topotecan capecitabine metastatic breast cancer TYKERB XELODA
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2010-02-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

Detailed description:

Arms: arm 1: A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm. arm 2: A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm.
Interventions: intervention 1: capecitabine intervention 2: topotecan intervention 3: lapatinib
Intervention descriptions: intervention 1: capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days intervention 2: topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days intervention 3: lapatinib administered 1250mg once daily orally

Protocol documents:
Clinical trial NCT00466661
Conditions: Alcohol Dependence Bipolar Disorder
Keywords: Acamprosate Alcoholism Bipolar disorder Comorbidity Craving Depression GABA Glutamate Mania Pharmacotherapy Withdrawal
Sponsor: Medical University of South Carolina
Start date: 2007-04-01; Completion date: 2010-02-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.

The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.

Detailed description:

Arms: arm 1: 666 mg p.o. TID arm 2: Matching placebo
Interventions: intervention 1: Acamprosate intervention 2: Placebo
Intervention descriptions: intervention 1: 666 mg po TID intervention 2: 2 tabs po TID

Protocol documents:
Clinical trial NCT00489359
Conditions: Ovarian Cancer Primary Peritoneal Cancer
Sponsor: Eli Lilly and Company
Start date: 2005-07-01; Completion date: 2010-02-01
Enrollment: 86 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.

Detailed description:

Arms: arm 1: Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. arm 2: Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Interventions: intervention 1: Pemetrexed - Phase 1 intervention 2: Carboplatin - Phase 1 intervention 3: Pemetrexed - Phase 2 intervention 4: Carboplatin - Phase 2
Intervention descriptions: intervention 1: 500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD) intervention 2: area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD) intervention 3: Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles intervention 4: Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles

Protocol documents:
Clinical trial NCT00490451
Conditions: Sarcoma, Soft Tissue
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2010-02-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.

Detailed description:
Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Arms: arm 1: None
Interventions: intervention 1: LY573636-sodium
Intervention descriptions: intervention 1: LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.

Protocol documents:
Clinical trial NCT00495391
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C, Chronic
Sponsor: Romark Laboratories L.C.
Start date: 2007-07-01; Completion date: 2010-02-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.

Detailed description:

Arms: arm 1: Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks. arm 2: Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Interventions: intervention 1: Nitazoxanide intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: One oral 500 mg nitazoxanide tablet twice daily for 52 weeks. intervention 2: One oral placebo tablet twice daily for 52 weeks. intervention 3: Weekly injections of 180µg peginterferon alfa-2a for 48 weeks. intervention 4: 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Protocol documents:
Clinical trial NCT00520936
Conditions: Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2010-02-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: 1910 milligrams per meter squared (mg/m\^2) (or 60 milligrams per kilogram \[mg/kg\] if patient \<12 months old), intravenous (IV), for 21 days x 17 cycles

Protocol documents: