ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00083122
Conditions: Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Ovarian Epithelial Cancer Stage IIIC Primary Peritoneal Cavity Cancer Stage IV Ovarian Epithelial Cancer Stage IV Primary Peritoneal Cavity Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-04-01; Completion date: 2012-05-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed description:
OBJECTIVES:

I. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.

II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2 closed to accrual as of 3/10/06) .

GROUP 1: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years.

Arms: arm 1: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cisplatin intervention 2: alvocidib intervention 3: cisplatin/flavopiridol
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV

Protocol documents:
Clinical trial NCT00096018
Conditions: Leukemia
Keywords: stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia
Sponsor: Roswell Park Cancer Institute
Start date: 2002-05-01; Completion date: 2012-05-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.

Detailed description:
OBJECTIVES:

* Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia.
* Determine the overall response rate (complete and partial) in patients treated with this regimen.
* Determine the duration of response in patients treated with this regimen.

OUTLINE: This is an open-label, phase I, dose-escalation study of thalidomide followed by a phase II study.

* Phase I: Beginning on day 1, patients receive oral thalidomide once daily for up to 6 months. Beginning on day 7, patients also receive fludarabine IV over 30 minutes daily for 5 days. Treatment with fludarabine repeats every 28-35 days for up to 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of thalidomide 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 fludarabine and thalidomide as in phase I at the MTD.

Patients are followed at 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years.

PROJECTED ACCRUAL: Up to 45 patients (≥ 9 for the phase I portion and ≤ 36 for the phase II portion) will be accrued for this study within 8 years.

Arms: arm 1: Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days
Interventions: intervention 1: fludarabine phosphate intervention 2: thalidomide
Intervention descriptions: intervention 1: Given IV intervention 2: Orally

Protocol documents:
Clinical trial NCT00096109
Conditions: Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2012-05-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (tanespimycin) in patients with refractory/resistant metastatic breast cancer.

II. To determine the progression free survival (PFS) of patients with refractory/resistant metastatic breast cancer when treated with 17-AAG.

III. To correlate patients' her2/neu status with response to 17-AAG treatment.

OUTLINE: This is a multicenter study.

Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter.

Arms: arm 1: Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: tanespimycin intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00106171
Conditions: HIV Infections
Keywords: HIV Acute/Early Seroconverters Acute Infection Treatment Naive Primary HIV Infection
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2005-05-01; Completion date: 2012-05-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV.

Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.

Detailed description:
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in slower progression of HIV disease. This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy (HAART) with those who receive no treatment. This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion (acute seroconverters) with patients who enroll within 3 to 12 months of seroconversion (early seroconverters).

This study will last at least 3 years. Participants will be randomly assigned to one of two groups. Group 1 will receive HAART for 1 year; Group 2 will receive no treatment. There will be at least 20 study visits over the 3-year study period. Blood collection will occur at all study visits. A physical exam, medical and medication history, and risk behavior assessment will occur at most visits; participants will also be asked to complete an adherence questionnaire at most visits.

Arms: arm 1: Participants will receive immediate HAART for 1 year; then HAART will stopped until clinically indicated. arm 2: Participants will receive no immediate HAART, but will receive HAART when HAART is clinically indicated.
Interventions: intervention 1: Highly active antiretroviral therapy (HAART)
Intervention descriptions: intervention 1: Regimens will be assigned by investigators

Protocol documents:
Clinical trial NCT00167661
Conditions: Disorder Related to Renal Transplantation
Keywords: living or deceased donor renal transplant recipient
Sponsor: University of Wisconsin, Madison
Start date: 2004-06-01; Completion date: 2012-05-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.

Detailed description:

Arms: arm 1: Campath 1-H
Interventions: intervention 1: Campath-1H
Intervention descriptions: intervention 1: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

Protocol documents:
Clinical trial NCT00198133
Conditions: Thymoma Thymic Carcinoma
Keywords: Thymoma Thymic Carcinoma
Sponsor: Patrick Joseph Loehrer Sr.
Start date: 2005-01-01; Completion date: 2012-05-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To study the efficacy of Alimta as a single agent in thymic cancers

Detailed description:
The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.

Arms: arm 1: Pemetrexed infusion once every 21 days (one cycle).
Interventions: intervention 1: Premetrexed (Alimta)
Intervention descriptions: intervention 1: Pemetrexed will be 500 mg/m2 IV every 3 weeks

Protocol documents:
Clinical trial NCT00208949
Conditions: Hematologic Diseases
Keywords: Hematologic Diseases
Sponsor: Emory University
Start date: 2002-09-01; Completion date: 2012-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study involving patients who are undergoing allogeneic peripheral blood stem cell transplantation. Both donors and recipients are being sought for this study.

Detailed description:
Patients with leukemia will receive a stem cell transplant, prior to which they will receive medication and/or radiation to destroy all leukemia cells as well as other blood cells. In order to survive this treatment, patients will need to be given the stem cells from another person to replace the blood cells killed by the treatment.

The stem cells given to the recipient will be collected from a relative. To increase the number of stem cells in the relative, he/she is given a growth factor to increase the number of stem cells prior to collection. The standard growth factor used is called G-CSF(Granulocyte Colony-Stimulating Factor ). In this research study, the physician will give the relative either G-CSF or a combination of G-CSF and GM-CSF (Granulocyte Macrophage (GM)) , another type of growth factor. Whether the relative receives G-CSF or GM-CSF will be determined by chance. The donors will be randomized to one or the other. It is not known if the stem cells and white blood cells collected using one or both growth factors results in more cures for this disease and fewer side effects, such as graft-versus-host disease.

The reason for doing the study is to determine if the stem cells and other white blood cells collected are any different when different growth factors are given, and to see how well the patient does. The stem cell transplant will in every other way be the same. The only difference is that if the recipient and donor decide to be in this study, the donor will either be given only G-CSF or the combination of G-CSF and GM-CSF and the recipient will receive the stem cells collected.

Arms: arm 1: Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day arm 2: Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
Interventions: intervention 1: G-CSF intervention 2: GM-CSF
Intervention descriptions: intervention 1: G-CSF, solution given subcutaneously twice per day, total dosage varies by weight. intervention 2: GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Protocol documents:
Clinical trial NCT00223236
Conditions: Mania Hypomania Cocaine Abuse Cocaine Dependence
Sponsor: University of Texas Southwestern Medical Center
Start date: 2010-07-01; Completion date: 2012-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.

Detailed description:
Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.

Arms: arm 1: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. arm 2: Inactive ingredient matching the active medication in appearance
Interventions: intervention 1: Citicoline intervention 2: Placebo
Intervention descriptions: intervention 1: Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects. intervention 2: Placebo matching active medication in all other aspects.

Protocol documents:
Clinical trial NCT00268853
Conditions: Diffuse Large-Cell Lymphoma
Keywords: lymphoma NHL large cell phase II CHOP R CPOP R non Hodgkins
Sponsor: CTI BioPharma
Start date: 2005-11-01; Completion date: 2012-05-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

Detailed description:
In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CPOP-R intervention 2: CHOP-R
Intervention descriptions: intervention 1: Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles intervention 2: Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

Protocol documents:
Clinical trial NCT00295334
Conditions: Type 2 Diabetes
Keywords: adherence glycemic control
Sponsor: Iris Shai
Start date: 2010-06-01; Completion date: 2012-05-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

Detailed description:
Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: alcohol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00357552
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2008-01-01; Completion date: 2012-05-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Most anti-HIV regimens include a non-nucleoside reverse transcriptase inhibitor (NNRTI); however, some individuals fail on these regimens. The purpose of this study is to evaluate the safety and effectiveness of the protease inhibitor (PI) lopinavir/ritonavir (LPV/r) in HIV infected individuals who are failing an anti-HIV regimen that includes an NNRTI.

Detailed description:
Standard effective antiretroviral therapy for HIV infected individuals includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a PI or an NNRTI. However, three-drug regimens may not be ideal in resource-limited settings, where viral load and resistance testing may not be readily available. The purpose of this study is to evaluate the safety and efficacy of the PI LPV/r alone in treatment-experienced, PI-naive HIV infected individuals who are experiencing virologic failure on three-drug regimens.

This study will last 104 weeks. All participants will receive LPV/r twice daily for up to 104 weeks. Participants who experience virologic failure will receive emtricitabine/tenofovir disoproxil fumarate once daily in addition to LPV/r twice daily for the remainder of the study.

There will be 16 study visits for participants on LPV/r monotherapy and 12 study visits for participants who have intensified LPV/r with emtricitabine/tenofovir disoproxil fumarate. Blood collection and clinical assessment will occur at all visits; urine collection and resistance testing will occur at selected visits.

Arms: arm 1: Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.
Interventions: intervention 1: Emtricitabine/Tenofovir disoproxil fumarate intervention 2: Lopinavir/Ritonavir
Intervention descriptions: intervention 1: Once daily intervention 2: Twice daily

Protocol documents: