ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00074308
Conditions: Recurrent Melanoma Stage III Melanoma Stage IV Melanoma Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: National Cancer Institute (NCI)
Start date: 2003-10-01; Completion date: 2009-07-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells

Detailed description:
OBJECTIVES:

I. Determine the tolerability, maximum tolerated dose, and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancers.

II. Determine the response rate, time to progression, and survival of patients treated with this regimen.

III. Correlate clinical activity with inhibition of platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor, flt-1, and markers of angiogenesis in patients treated with this regimen.

IV. Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen.

V. Correlate toxicity, clinical activity, and correlative endpoints with the steady-stage plasma concentration of imatinib mesylate in patients treated with this regimen.

OUTLINE: This is a dose-escalation, open-label study.

PHASE I (closed to accrual as of 8/23/04): Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD.

Arms: arm 1: Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: imatinib mesylate intervention 2: bevacizumab intervention 3: pharmacological study intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00086138
Conditions: Alzheimer's Disease Depression
Keywords: Alzheimer's disease Depression
Sponsor: Johns Hopkins University
Start date: 2004-07-01; Completion date: 2009-07-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

Detailed description:
Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.

Arms: arm 1: Participants will receive sertraline at a target dose of 100mg daily. arm 2: Participants will receive placebo matched to sertraline
Interventions: intervention 1: Sertraline (Zoloft) intervention 2: Placebo
Intervention descriptions: intervention 1: Sertraline: range of 25 to 125 mg per day for 24 weeks intervention 2: Placebo designed to mimic sertraline taken daily for 24 weeks

Protocol documents:
Clinical trial NCT00088972
Conditions: Breast Cancer
Keywords: breast cancer breast cancer in situ lobular breast carcinoma in situ ductal breast carcinoma
Sponsor: SWOG Cancer Research Network
Start date: 2004-11-01; Completion date: 2009-07-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.

PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.

Detailed description:
OBJECTIVES:

* Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
* Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
* Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
* Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E\_2 in patients treated with these drugs.
* Compare the toxicity of these drugs in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but \< 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Celocoxib: Patients receive oral celecoxib twice daily.
* Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Arms: arm 1: Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. arm 2: Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Interventions: intervention 1: celecoxib intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00095979
Conditions: Endometrial Adenocarcinoma Recurrent Endometrial Carcinoma Stage IV Endometrial Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-05-01; Completion date: 2009-07-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Arms: arm 1: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00127933
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-08-01; Completion date: 2009-07-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: capecitabine [Xeloda] intervention 2: Taxotere intervention 3: Herceptin (HER2-neu positive patients only) intervention 4: capecitabine [Xeloda] intervention 5: Taxotere
Intervention descriptions: intervention 1: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly intervention 4: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 5: 75mg/m2 iv on day 1 of each 3 week cycle

Protocol documents:
Clinical trial NCT00153985
Conditions: Hemoglobinopathies Sickle Cell Disease Thalassemia
Keywords: Hemoglobinopathies Sickle cell anemia sickle cell-hemoglobin C disease sickle cell-B-thalassemia transfusion-dependant thalassemia allogeneic transplant nonmyeloablative transplant Stem cell transfusion graft vs. host disease
Sponsor: Dana-Farber Cancer Institute
Start date: 2004-03-01; Completion date: 2009-07-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

Detailed description:
* In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days.
* To prepare patient's bone marrow to accept donor stem cells, they will receive fludarabine and busulfex. Fludarabine will be given intravenously once daily for 4 days. Busulfex will be given once daily for the same 4 days.
* One day before patients receive busulfex and fludarabine, they will also be given alemtuzumab intravenously once daily for 5 days.
* Three days after the end of chemotherapy, patients will receive the infusion of donor stem cells.
* If patients have thalassemia, they will receive subcutaneous injections of filgrastim starting on day one after the donor stem cell transfusion and will continue receiving filgrastim every day until it appears that the donor stem cells have been accepted. If the patient has sickle cell disease, filgrastim will not be given,
* Additional drugs will be given to help prevent infection (i.e. antibiotics).
* After stem cell infusion patients will be examined and have blood tests weekly for 1 month. Bone marrow biopsies, and blood work will also be performed 1 month, 3 months, 6 months and 1 year after stem cell infusion.
* Patients will be on the study for about 12 months. After study is completed progress will be monitored on an annual basis.

Interventions: intervention 1: Busulfex intervention 2: Fludarabine intervention 3: Alemtuzumab intervention 4: Stem Cell Transfusion
Intervention descriptions: intervention 1: Given once daily for 4 days intervention 2: Given intravenously once daily for 4 days intervention 3: One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days. intervention 4: Performed three days after the end of chemotherapy

Protocol documents:
Clinical trial NCT00215150
Conditions: Social Anxiety Disorder
Keywords: anxiety disorder SAD ziprasidone sertraline antidepressant antipsychotic
Sponsor: Duke University
Start date: 2004-11-01; Completion date: 2009-07-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

Detailed description:
This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Arms: arm 1: 8 weeks of open label treatment with sertraline arm 2: 8 weeks of treatment with sertraline augmented with ziprasidone arm 3: 8 weeks of treatment with sertraline augmented by placebo
Interventions: intervention 1: Ziprasidone intervention 2: Sertraline
Intervention descriptions: intervention 1: Sertraline augmentation with ziprasidone intervention 2: Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase

Protocol documents:
Clinical trial NCT00222105
Conditions: Multiple Myeloma
Sponsor: University of Kansas Medical Center
Start date: 2002-11-01; Completion date: 2009-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.

Detailed description:
Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.

This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.

Arms: arm 1: Doxil, Thalidomide, Dexamethasone
Interventions: intervention 1: Doxil intervention 2: Thalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Doxil 40 mg/m2 IV day 1 intervention 2: 50-100 mg day 1-28 intervention 3: Dexamethasone 40 mg day 1-4 and 15-18

Protocol documents:
Clinical trial NCT00228423
Conditions: Atherosclerosis
Keywords: Saphenous vein Intimal hyperplasia Coronary artery bypass graft surgery Antiplatelet therapy Clopidogrel Saphenous vein graft disease
Sponsor: Ottawa Heart Institute Research Corporation
Start date: 2006-05-01; Completion date: 2009-07-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.

Detailed description:
Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.

Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.

Arms: arm 1: 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. arm 2: Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
Interventions: intervention 1: Clopidogrel 75 mg daily intervention 2: water pill daily
Intervention descriptions: intervention 1: Daily dose of 75 mg Clopidogrel intervention 2: Daily dose of water pill (placebo)

Protocol documents:
Clinical trial NCT00243347
Conditions: Carcinoma Non-Small-Cell Lung Carcinoma Head and Neck Neoplasms
Keywords: RECENTIN
Sponsor: AstraZeneca
Start date: 2005-12-01; Completion date: 2009-07-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Detailed description:

Interventions: intervention 1: AZD2171
Intervention descriptions: intervention 1: oral tablet

Protocol documents:
Clinical trial NCT00259298
Conditions: Osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2005-11-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.

Detailed description:

Arms: arm 1: Participants receive teriparatide 20 microgram once daily by subcutaneous injection for 18 months followed by 6 months off therapy
Interventions: intervention 1: teriparatide
Intervention descriptions: intervention 1: Subcutaneous, 20 microgram (mcg)/day, 18 months

Protocol documents:
Clinical trial NCT00271011
Conditions: Colorectal Cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2005-12-01; Completion date: 2009-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.

Detailed description:
We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.

Arms: arm 1: Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.

Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.

Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.
Interventions: intervention 1: Mitomycin C intervention 2: Cetuximab intervention 3: Irinotecan.
Intervention descriptions: intervention 1: Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. intervention 2: Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. intervention 3: Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2.

Protocol documents:
Clinical trial NCT00274651
Conditions: Cutaneous T-Cell Lymphoma Peripheral T-Cell Lymphoma Non-Hodgkin's Lymphoma
Keywords: CTCL PTCL lymphoma Non-Hodgkin's Lymphoma Cutaneous T-Cell Lymphomas (CTCL) Peripheral T-Cell Lymphomas (PTCL) Other Types of Non-Hodgkin's Lymphoma belinostat
Sponsor: Valerio Therapeutics
Start date: 2006-01-01; Completion date: 2009-07-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

Detailed description:

Arms: arm 1: PXD101 1000 mg/m2 once daily for 5 days every 21 days arm 2: PXD101 1000 mg/m2 once daily for 5 days every 21 days
Interventions: intervention 1: belinostat
Intervention descriptions: intervention 1: None

Protocol documents: