ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00433966
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction Angioplasty Myocardial Ischemia Myocardial Reperfusion Stents Heart Disease
Sponsor: Cardiovascular Research Foundation, New York
Start date: 2005-03-01; Completion date: 2010-11-01
Enrollment: 3602 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary objectives of the trial are:

1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy.
2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.

Detailed description:
Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).

Arms: arm 1: To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:

1. reduced rates of major bleeding events at 30 days
2. similar rates of major adverse ischemic cardiac events at 30 days
3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days. arm 2: To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:

1. reduced rates of target lesion revascularization for ischemia at 1 year
2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
3. lower rates of analysis segment binary angiographic restenosis at 13 months
Interventions: intervention 1: Bivalirudin intervention 2: Unfractionated heparin intervention 3: Bare metal stent intervention 4: Paclitaxel-eluting stent
Intervention descriptions: intervention 1: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room). intervention 2: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). intervention 3: Uncoated bare metal stent intervention 4: slow rate-release paclitaxel-eluting stent

Protocol documents:
Clinical trial NCT00436605
Conditions: Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-12-01; Completion date: 2010-11-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.

II. Determine the progression-free survival of patients treated with this drug.

SECONDARY OBJECTIVES:

I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections.

II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1.

III. To assess toxicity.

OUTLINE:

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00439231
Conditions: Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma
Keywords: Monoclonal Antibody Therapy Biologic Response Modifier Therapy CLL SLL chemo-care (CC) 5013- Revlimid Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia
Sponsor: Georg Aue, M.D.
Start date: 2007-02-01; Completion date: 2010-11-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment.

Patients 21 years of age and older with CLL or SLL who have previously received standard treatment may be eligible for this study.

Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety.

...

Detailed description:
There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a majority of patients. However, there was also remarkable efficacy and evidence for an immune stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Subjects with at least partial response (PR) may go on to receive 4 additional cycles.

The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme of lenalidomide.

Arms: arm 1: Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects

Protocol documents:
Clinical trial NCT00459875
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer stage IV renal cell cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-03-01; Completion date: 2010-11-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and every 2 months thereafter.

Arms: arm 1: The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00461708
Conditions: Pancreatic Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-05-01; Completion date: 2010-11-01
Enrollment: 153 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants with a rash graded less than (\<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m\^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. arm 2: Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m\^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Interventions: intervention 1: Erlotinib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 100 mg, PO, once per day intervention 2: 1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles

Protocol documents:
Clinical trial NCT00464087
Conditions: Acute Coronary Syndromes
Sponsor: Medstar Health Research Institute
Start date: 2007-06-01; Completion date: 2010-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.

Detailed description:
This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Arms: arm 1: Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI arm 2: Patients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI.
Interventions: intervention 1: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00494299
Conditions: Carcinoma, Hepatocellular
Keywords: HCC Cancer Liver Cancer TACE
Sponsor: Bayer
Start date: 2006-04-01; Completion date: 2010-11-01
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Detailed description:

Arms: arm 1: Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. arm 2: Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib intervention 2: Placebo: matching placebo

Protocol documents:
Clinical trial NCT00496808
Conditions: Ductal Carcinoma In Situ
Keywords: Ductal Carcinoma In Situ Breast Cancer Herceptin Trastuzumab DCIS
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-03-01; Completion date: 2010-11-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

* To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)
* To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS

Detailed description:
Herceptin (Trastuzumab) stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow.

As part of your standard care for DCIS, you will have a complete routine physical exam, a mammogram of both breasts, and blood (about 2 tablespoons) will be drawn for routine tests. Some of your leftover breast biopsy tissue will be tested for Her-2/neu expression. Blood will be drawn (about 2-6 teaspoons) to check if your bone marrow (red blood cells), kidney, and liver are functioning well enough to have this treatment. Women who are able to have children must have a negative blood pregnancy test before starting treatment.

If you are eligible to take part in this study, you will receive one dose of trastuzumab at least 2 weeks before your surgery. The dose of trastuzumab will be given intravenously (through a needle in a vein in your arm) as a steady infusion over 90 minutes, on an outpatient basis. You will be checked during the infusion and for 1 hour after it is completed.

You will have routine surgery for DCIS (either segmental mastectomy, mastectomy with or without reconstruction, and possible sentinel lymph node biopsy) approximately 14 to 28 days after being given Herceptin. If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery. After your surgery, patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed.

Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers (substances which indicate the severity or spread of cancer), cancer growth rate, and apoptotic index (cell death rate).

This is an investigational study. The FDA has approved trastuzumab for the treatment of breast cancer. Up to 71 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 8 mg/kg intravenously (IV) Over 90 Minutes
Interventions: intervention 1: Herceptin (Trastuzumab)
Intervention descriptions: intervention 1: 8 mg/kg IV Over 90 Minutes

Protocol documents:
Clinical trial NCT00502203
Conditions: Mixed Tumor, Mullerian
Keywords: Uterine Neoplasms Endometrial Cancer Paclitaxel Taxol Carboplatin Paraplatin Malignant Mixed Mullerian Tumors MMMT Immunohistochemical markers
Sponsor: M.D. Anderson Cancer Center
Start date: 2001-08-01; Completion date: 2010-11-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to find out if the combination of paclitaxel and carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of the uterus.

Detailed description:
Before treatment starts, patients will have a complete check-up, blood tests, a chest x-ray, and a CT scan. Other scans or tests will be done as needed. Women able to have children must have a negative urine pregnancy test. A blood sample will be taken for routine testing once a week during treatment and a month after treatment ends.

Patients will also be asked to complete two questionnaires before they start treatment, before Courses 3 and 5, and at the end of treatment. These questionnaires will help researchers understand how this drug affects patients' daily lives and also identify the side effects caused by this treatment. Each questionnaire will take about 10 minutes to complete.

Patients in this study will be given paclitaxel and carboplatin through a catheter (tube) placed in a vein. Paclitaxel is given first (over 3 hours) followed by carboplatin (over 1 hour). All treatment is given in the outpatient department at M.D. Anderson Cancer Center.

Patients may receive up to 6 courses of treatment. If the disease gets worse or intolerable side effects occur, patients will be taken off study.

-Before each course of treatment, patients will have a checkup. At each checkup, patients will have a physical exam and blood tests. Another CT scan will be done after the third course of treatment. A complete physical exam and a CT scan will also be done at the end of treatment.

This is an investigational study. Both of the study drugs are FDA approved. Their use together in this study is experimental. A total of 50 patients will take part in this multicenter study. About 35 will be enrolled at M. D. Anderson.

Arms: arm 1: Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel
Intervention descriptions: intervention 1: AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses intervention 2: 175 mg/m\^2 By Vein Over 3 Hours Every 21 Days for 6 Courses

Protocol documents:
Clinical trial NCT00507442
Conditions: Multiple Myeloma
Keywords: Treatment for patients with multiple myeloma who have received no prior treatment
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2007-08-01; Completion date: 2010-11-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.

Detailed description:

Arms: arm 1: VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) arm 2: VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) arm 3: VELCADE (bortezomib), dexamethasone, cyclophosphamide arm 4: Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
Interventions: intervention 1: VELCADE (bortezomib) intervention 2: dexamethasone intervention 3: cyclophosphamide intervention 4: Revlimid (lenalidomide)
Intervention descriptions: intervention 1: bortezomib 1.3 mg/m\^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance). intervention 2: dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop intervention 3: cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop intervention 4: lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm)

lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)

Protocol documents:
Clinical trial NCT00556712
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-01-01; Completion date: 2010-11-01
Enrollment: 889 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. arm 2: Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.
Interventions: intervention 1: erlotinib [Tarceva] intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg po daily intervention 2: po daily

Protocol documents: