ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00121199
Conditions: Contiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2010-12-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the 1-year progression-free survival rate in patients with advanced stage diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab.

II. To estimate the response rate (complete, complete unconfirmed, and partial) and 2-year progression-free survival of this regimen in patients with advanced stage diffuse large B-cell NHL.

III. To evaluate the toxicities associated with this regimen. IV. To correlate angiogenic biomarkers with patient outcome.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 6 months for 2 years and then annually for 3 years.

Arms: arm 1: Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: rituximab intervention 2: bevacizumab intervention 3: cyclophosphamide intervention 4: doxorubicin hydrochloride intervention 5: vincristine sulfate intervention 6: prednisone intervention 7: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Given PO intervention 7: Correlative studies

Protocol documents:
Clinical trial NCT00127036
Conditions: Adenocarcinoma Colon Cancer
Keywords: colon adenocarcinoma adenocarcinoma-colon adenocarcinoma-rectum
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2003-10-01; Completion date: 2010-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents.

Detailed description:
Colorectal cancer is the third largest cause of cancer mortality in the United States. The treatment of metastatic colorectal cancer is undergoing rapid improvement. Currently, there are two major chemotherapy regimens, which can both be combined with anti-angiogenesis treatment. These regimens are 5-Fluorouracil (5-FU) + irinotecan and 5-FU + oxaliplatin. Each therapy has roughly similar rates of response, but it is unclear which specific therapy would benefit which patients. The advent of genome wide expression analysis provides a tool to analyze these differences. In the microarray analysis of colon cancer outcome trial, sponsored by the National Institutes of Health (NIH) and Moffitt Cancer Center, patients with newly diagnosed metastatic colon cancer are biopsied and samples are preserved in ribonucleic acid (RNA) later. Patients are then randomized to either one of two state of the art regimens: capecitabine + irinotecan + avastin (bevacizumab) or capecitabine + oxaliplatin + avastin. Response to chemotherapy, time to progression, and overall survival are end points of this trial. Once accrual of patients has been met, the investigators will compare genome wide expression patterns for each group.

Arms: arm 1: Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression arm 2: Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Interventions: intervention 1: XELOX intervention 2: XELIRI intervention 3: Bevacizumab
Intervention descriptions: intervention 1: XELOX: Oxaliplatin 130 mg/m\^2 intravenously (IV); Capecitabine 825 mg/m\^2 by mouth (po) intervention 2: XELIRI: Irinotecan 240 mg/m\^2 IV; Capecitabine 825 mg/m\^2 by mouth (po) intervention 3: 7.5 mg/kg intravenously (IV)

Protocol documents:
Clinical trial NCT00131456
Conditions: Depression Marijuana Abuse
Keywords: cannabis dependence depression treatment venlafaxine
Sponsor: New York State Psychiatric Institute
Start date: 2004-03-01; Completion date: 2010-12-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.

Detailed description:
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.

During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.

Arms: arm 1: Venlafaxine arm 2: Placebo
Interventions: intervention 1: Venlafaxine intervention 2: Placebo
Intervention descriptions: intervention 1: 375mg/day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00143390
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2005-04-01; Completion date: 2010-12-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exemestane intervention 2: anastrozole
Intervention descriptions: intervention 1: take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal intervention 2: take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Protocol documents:
Clinical trial NCT00144391
Conditions: Panhypopituitarism
Sponsor: Charles Drew University of Medicine and Science
Start date: 2003-07-01; Completion date: 2010-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.

Detailed description:
Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women.

Arms: arm 1: Transdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months arm 2: Placebo 2 pumps per day for 6 months
Interventions: intervention 1: Transdermal Testosterone gel
Intervention descriptions: intervention 1: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.

Protocol documents:
Clinical trial NCT00181155
Conditions: Congestive Heart Failure
Keywords: metabolism congestive heart failure allopurinol Adenosine triphosphate (ATP)
Sponsor: Johns Hopkins University
Start date: 2004-11-01; Completion date: 2010-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Detailed description:
Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.

The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.

Arms: arm 1: One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes. arm 2: One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
Interventions: intervention 1: Allopurinol intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous infusion of allopurinol (300mg) intervention 2: intravenous infusion of 50 ml dose of 5% dextrose

Protocol documents:
Clinical trial NCT00186628
Conditions: Leukemia, Mast-Cell Mantle-cell Lymphoma
Sponsor: Stanford University
Start date: 2005-06-01; Completion date: 2010-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

Detailed description:
To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).

Arms: arm 1: Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)
Interventions: intervention 1: Total lymphoid irradiation intervention 2: Rituximab intervention 3: Anti-thymoglobulin, rabbit (ATG, rabbit ATG) intervention 4: Cyclosporine intervention 5: Mycophenylate mofetil intervention 6: Filgrastim intervention 7: Granisetron intervention 8: Solumedrol intervention 9: Acetaminophen intervention 10: Diphenhydramine intervention 11: Hydrocortisone
Intervention descriptions: intervention 1: Total lymphoid irradiation (TLI) administered at 80cGy for 10 days intervention 2: Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses. intervention 3: Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg. intervention 4: Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates \> 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week). intervention 5: Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete intervention 6: Filgrastim provided as needed for neutrophil support intervention 7: Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI intervention 8: Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG) intervention 9: Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC intervention 10: Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC intervention 11: Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

Protocol documents:
Clinical trial NCT00191308
Conditions: Non-Small Cell Lung Cancer Carcinoma
Sponsor: Eli Lilly and Company
Start date: 2005-05-01; Completion date: 2010-12-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.

Detailed description:

Arms: arm 1: Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs

Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Intervention descriptions: intervention 1: 500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs intervention 2: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs intervention 3: All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.

Protocol documents:
Clinical trial NCT00194675
Conditions: Hypogonadism Benign Prostatic Hyperplasia
Keywords: androgen deficiency testosterone Benign Prostatic Hyperplasia hypogonadism prostate BPH
Sponsor: University of Washington
Start date: 2005-03-01; Completion date: 2010-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).

Detailed description:
The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone.

We will also determine the effects of changes in serum T and dihydrotestosterone (DHT) on both the hormonal milieu and genetic program within the prostate gland itself. The technology employed will allow us to determine which genes are androgen responsive within each prostate tissue compartment. Together, these data may determine whether the combination of testosterone and dutasteride safely corrects the symptoms of BPH and hypogonadism and minimizes growth stimulus to the prostate at the genetic level. We will also assess the effects of the combination of T and dutasteride on cognitive function.

This is a six-month, double-blind, randomized, placebo-controlled, single-site study of older hypogonadal men with mild to moderate BPH.

Within each treatment group, a sub-group of subjects will undergo additional procedures as part of a Prostate Biopsy sub-study to obtain prostate tissue for hormonal and genetic analyses. Selection of subjects will be based on clinical indication and/or willingness to undergo prostate biopsies.

Arms: arm 1: Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily arm 2: Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily
Interventions: intervention 1: Dutasteride intervention 2: Testosterone gel intervention 3: Placebo dutasteride
Intervention descriptions: intervention 1: Dutasteride 0.5 mg orally daily intervention 2: Testosterone gel 7.5 g daily topical intervention 3: placebo dutasteride orally daily

Protocol documents:
Clinical trial NCT00204373
Conditions: Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia
Sponsor: Charles Mel Wilcox, MD
Start date: 2003-03-01; Completion date: 2010-12-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.

Detailed description:
The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.

Arms: arm 1: This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Interventions: intervention 1: Lansoprazole (Prevacid)
Intervention descriptions: intervention 1: Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.

Protocol documents:
Clinical trial NCT00227591
Conditions: Essential Thrombocythemia Polycythemia Vera Primary Myelofibrosis
Sponsor: National Cancer Institute (NCI)
Start date: 2005-12-01; Completion date: 2010-12-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the rate of complete or partial remission from treatment with a combination of lenalidomide and prednisone in patients with myelofibrosis with myeloid metaplasia.

SECONDARY OBJECTIVES:

I. To examine drug toxicity. II. To examine duration of response. III. To examine the effect of treatment on bone marrow fibrosis, angiogenesis, and cytogenetics.

OUTLINE:

For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28 and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Patients with stable or responding disease after course 3 receive oral lenalidomide alone once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years from study entry.

Arms: arm 1: For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28 and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Patients with stable or responding disease after course 3 receive oral lenalidomide alone once daily on days 1-28 for courses 4-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lenalidomide intervention 2: prednisone intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally (PO) intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00260832
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia Dacogen Decitabine Poor or intermediate-risk cytogenetics
Sponsor: Eisai Inc.
Start date: 2005-11-01; Completion date: 2010-12-01
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Detailed description:

Arms: arm 1: Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) arm 2: None
Interventions: intervention 1: Cytarabine or Supportive Care intervention 2: Dacogen (decitabine) only
Intervention descriptions: intervention 1: Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.) intervention 2: 20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.

Protocol documents: