ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00381550
Conditions: Accelerated Phase Chronic Myelogenous Leukemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Essential Thrombocythemia Philadelphia Chromosome Negative Chronic Myelogenous Leukemia Polycythemia Vera Primary Myelofibrosis Relapsing Chronic Myelogenous Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-01; Completion date: 2011-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving 3-AP together with fludarabine works in treating patients with myeloproliferative disorders (MPD), chronic myelomonocytic leukemia (CMML), or accelerated phase or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as 3-AP and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 3-AP may help fludarabine work better by making cancer cells more sensitive to the drug. 3-AP and fludarabine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving 3-AP together with fludarabine may kill more cancer cells.

Detailed description:
OBJECTIVES:

I. Determine the efficacy of 3-AP (Triapine®) followed by fludarabine phosphate in patients with myeloproliferative disorders or chronic myelomonocytic leukemia in aggressive phase or transformation or chronic myelogenous leukemia in accelerated phase or blast crisis.

II. Determine the toxicity of this regimen in these patients. III. Determine, preliminarily, the effect of this regimen on circulating leukemic cell genetics in these patients.

Outline: This is an open-label study.

Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow and/or peripheral blood collection at baseline and periodically during study treatment for molecular analysis of Janus kinase 2 (JAK2) mutations, GATA-1 mutations, and expression of the death-inducer-obliterator (Dido) genes on chromosome 20q.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: fludarabine phosphate intervention 2: triapine intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative study

Protocol documents:
Clinical trial NCT00382733
Conditions: Tumors
Keywords: Solid Tumors
Sponsor: Accelerated Community Oncology Research Network
Start date: 2006-11-01; Completion date: 2011-03-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the chemotherapy is tolerated (any side effects) when it is given in different dose levels. The study will also collect information on how the medication is being broken down and absorbed in the body and how quality of life is affected during treatment.

Detailed description:

Interventions: intervention 1: Oral Topotecan
Intervention descriptions: intervention 1: Topotecan will be received in one of the five dose levels:0.25mg/day,0.5mg/day, 0.75mg/day, 1.0mg/day, and 1.25mg/day.

Protocol documents:
Clinical trial NCT00404066
Conditions: Breast Cancer Metastatic Breast Cancer
Sponsor: George Albert Fisher
Start date: 2006-10-01; Completion date: 2011-03-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.

Detailed description:
Lapatinib acts as a dual inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2 (Her2/neu) tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed or altered in human cancers including breast cancer. This study plans to determine the antitumor activity of this regimen and its effectiveness preventing tumor growth and spread.

Neoadjuvant chemotherapy which achieves pathologic complete responses (pCR) has been shown to predict improved long-term survival and serves as a surrogate for clinical outcome. By using this primary endpoint we can obtain statistical data with smaller patient numbers and at a lower overall cost. Additionally, we hope to correlate clinical and radiologic outcomes with gene expression data.

Arms: arm 1: Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
Interventions: intervention 1: Lapatinib intervention 2: Doxorubicin intervention 3: Cyclophosphamide intervention 4: Docetaxel intervention 5: Pegfilgrastim intervention 6: Filgrastim intervention 7: Dexamethasone intervention 8: Trastuzumab
Intervention descriptions: intervention 1: 1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles) intervention 2: 60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide. intervention 3: 600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin. intervention 4: 100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide intervention 5: 6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments. intervention 6: 300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies. intervention 7: 8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel intervention 8: Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year

Protocol documents:
Clinical trial NCT00414167
Conditions: Binge Eating Disorder Obesity
Keywords: Binge eating Obesity Medication Craving Emotional eating
Sponsor: Yale University
Start date: 2005-12-01; Completion date: 2011-03-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. Participants in the study will receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for eight weeks. In addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. This treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost.

It is expected that compared to placebo, bupropion will produce greater reductions in binge eating.

Detailed description:
The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge eating episodes, bupropion is a promising psychopharmacological agent in treating binge eating and reducing weight. It is hypothesized that compared to placebo, bupropion will produce significantly greater reductions in the frequency of binge eating. Secondary goals are to explore interrelationships between treatment and changes in cravings, frequency of binge episodes, emotional eating, and weight loss. Following the medication phase of the trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered by doctoral-level psychologists specializing in eating disorders and weight management.

Arms: arm 1: Bupropion arm 2: Placebo
Interventions: intervention 1: bupropion intervention 2: Placebo
Intervention descriptions: intervention 1: 300 mg per day for 8 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT00415506
Conditions: Scleritis Orbital Disease
Sponsor: Oregon Health and Science University
Start date: 2007-01-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of Rituximab in refractory scleritis and non-infectious orbital inflammation.

Detailed description:

Arms: arm 1: Subjects with Scleritis arm 2: Subjects with Orbital Inflammation
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Two 500 or 1000mg infusions over 2 weeks with the option of retreating after 6 months if initial improvement was seen.

Protocol documents:
Clinical trial NCT00431184
Conditions: Bipolar Disorder Schizoaffective Disorder Manic Disorder Mania Manic State
Keywords: bipolar disorder bipolar mania schizoaffective disorder schizoaffective mania mania kappa opiates opiates
Sponsor: Mclean Hospital
Start date: 2007-01-01; Completion date: 2011-03-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.

Detailed description:
Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target this system particularly promising as a treatment modality, with relatively low risk of addictive properties. Pentazocine is an approved drug for pain relief with a good side effect profile. It is predominantly a kappa opioid agonist with weaker side effects at mu opioid receptors, at which it is an antagonist. Data from our open-label pilot study of pentazocine had promising results. We will follow up on these findings with a double-blind, active-control study of individuals with bipolar disorder or schizoaffective disorder who are currently hospitalized with acute mania. The antimanic effects of pentazocine will be compared with an active control (ativan).

Arms: arm 1: In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. arm 2: In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
Interventions: intervention 1: Pentazocine intervention 2: Lorazepam
Intervention descriptions: intervention 1: see arms description intervention 2: see arms description

Protocol documents:
Clinical trial NCT00438490
Conditions: Healthy
Keywords: galactorrhea prolactin bone turnover menstrual cycle Control Groups Women
Sponsor: Massachusetts General Hospital
Start date: 2002-04-01; Completion date: 2011-03-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

Detailed description:
There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Arms: arm 1: Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection arm 2: Normal saline placebo subcutaneous injection
Interventions: intervention 1: Recombinant Human Prolactin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00448669
Conditions: HIV Infections
Keywords: HIV incidence HIV prevention Tenofovir Emtricitabine Botswana HIV seronegativity
Sponsor: Centers for Disease Control and Prevention
Start date: 2007-03-01; Completion date: 2011-03-01
Enrollment: 1219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

Detailed description:
Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board

Arms: arm 1: Eligible participants were randomized to oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet. The ratio of randomization was 1:1. Participants randomized to the active arm received male and female condoms, risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. arm 2: Eligible participants were randomized to the placebo arm and received placebo oral tablets that were visually identical to the TDF-FTC tablet and taken once daily. The placebo tablets contained no active ingredients. The ratio of randomization was 1:1. Participants randomized to the placebo arm received male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Interventions: intervention 1: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00450723
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer male breast cancer
Sponsor: University of Miami
Start date: 2004-05-01; Completion date: 2011-03-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

Detailed description:
OBJECTIVES:

* Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
* Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
* Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.

OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.

All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: Isosulfan blue intervention 2: Axillary Lymph Node Dissection intervention 3: Surgery intervention 4: Sentinel Lymph Node Biopsy intervention 5: Thoracoscopic Surgery intervention 6: Technetium Tc 99m Sulfur Colloid
Intervention descriptions: intervention 1: Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure. intervention 2: Axillary Lymph Node Dissection intervention 3: The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest. intervention 4: Sentinel Lymph Node Biopsy intervention 5: Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy. intervention 6: Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots

Protocol documents:
Clinical trial NCT00467077
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer
Sponsor: California Cancer Consortium
Start date: 2004-09-01; Completion date: 2011-03-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib together with PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the 6-month progression-free survival of patients with unresectable or metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.

Secondary

* Determine the response rate (by RECIST criteria), duration of response, time to treatment failure, and overall survival of patients treated with this regimen.
* Assess toxicity and tolerability of this regimen in these patients.
* Determine the pre-treatment expression of the von Hippel-Lindau (VHL) protein, the epidermal growth factor receptor (EGFR), and p27, and correlate with response to treatment.
* Determine post-treatment alteration of EGFR and p27 expression in patients with tumors accessible for serial biopsy.
* Assess changes in EGFR levels in buccal epithelial cells in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily and PEG-interferon alfa-2b subcutaneously once weekly in weeks 1-6. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response or stable disease after completion of course 2 continue to receive gefitinib alone as above in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Arms: arm 1: Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Interventions: intervention 1: PEG-interferon alfa-2b intervention 2: gefitinib
Intervention descriptions: intervention 1: PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks intervention 2: ZD1839 will be administered at a dose of 250 mg orally once daily,

Protocol documents: