ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00499655
Conditions: Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: City of Hope Medical Center
Start date: 2007-11-01; Completion date: 2016-12-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib vs. erlotinib + placebo for advanced NSCLC.

SECONDARY OBJECTIVES:

I. Objective tumor response rate as defined by RECIST Criteria for subjects receiving erlotinib/celecoxib treatment arms.

II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of subjects.

III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate with clinical response.

V. Measurement of change in urinary PGE-M and correlation with response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.

ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.

In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. arm 2: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: celecoxib intervention 3: placebo intervention 4: laboratory biomarker analysis intervention 5: immunohistochemistry staining method intervention 6: fluorescence in situ hybridization intervention 7: mutation analysis intervention 8: protein expression analysis intervention 9: gene expression analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies intervention 9: Correlative studies

Protocol documents:
Clinical trial NCT00551525
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2008-04-01; Completion date: 2016-12-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer.

PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional conformal radiation therapy or intensity-modulated radiation therapy in patients with rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate cancer.

Secondary

* To assess the proportion of patients completing protocol treatment.
* To evaluate hematological toxicity at 12 weeks.
* To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
* To evaluate the "acute" and "late" radiation therapy-related events having occurred up to 24 weeks from the end of radiation therapy.
* To compare the freedom from progression rate at 2 years to that predicted by the Kattan Nomograms.

OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients may receive hormonal therapy (after radiation therapy) at the discretion of their physician.

Treatment continues in the absence of disease progression (defined as a PSA doubling time less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000 cells/mm³ or less), or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter.

Arms: arm 1: Samarium 153 infusion followed by radiotherapy 12 weeks later
Interventions: intervention 1: Radiotherapy intervention 2: Samarium 153
Intervention descriptions: intervention 1: 3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks. intervention 2: Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.

Protocol documents:
Clinical trial NCT00557492
Conditions: Pancreatic Cancer
Keywords: pancreas pancreatic cancer resectable
Sponsor: Amer Zureikat
Start date: 2006-12-01; Completion date: 2016-12-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.

Detailed description:
This is a 2 stage phase II study of bevacizumab (10 mg/kg) and fixed dose rate (FDR) gemcitabine (1500 mg/m2 at 10 mg/kg/min) in combination with sequential rapid fractionation radiotherapy (30 Gy total) in the preoperative treatment of potentially-resectable subjects with adenocarcinoma of the pancreas. The purpose of this study is to determine the rate of margin negative surgical resection (R0 resection rate) and the rate of complete pathological response in patients with resected pancreas cancer. The overall goal of this study is to determine the merit of this novel regimen for further study in a Phase III trial examining time to progression and overall survival. Based on the need for 48 evaluable subjects to evaluate the primary endpoints, the study will be opened with a target accrual of 60 subjects given an expected 20% rate of attrition observed in prior studies of subjects with pancreas cancer at UPCI.

Arms: arm 1: Intervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43

Intervention: Drug: Gemzar (Gemcitabine) On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).

Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
Interventions: intervention 1: Avastin (bevacizumab) intervention 2: Gemzar (Gemcitabine) intervention 3: external beam radiotherapy
Intervention descriptions: intervention 1: 10 mg/kg, days 1, 15, 29 and 43 intervention 2: On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min). intervention 3: 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Protocol documents:
Clinical trial NCT00655980
Conditions: Major Surgery Coronary Artery Disease
Sponsor: Washington University School of Medicine
Start date: 2008-02-01; Completion date: 2016-12-01
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of cardiac complications after surgery in patients with a specific genetic profile (mutations in the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate during surgery.

Detailed description:
Background and significance: Recent studies have shown that nitrous oxide (N2O) anesthesia may be associated with an increased risk of adverse cardiovascular outcomes. It is well-known that N2O inhibits vitamin B12-dependent enzymes and as a result increases plasma homocysteine concentrations. Homocysteine has been identified as risk factor for cardiovascular disease. Therefore elevations in homocysteine after N2O may be a causative factor in N2O toxicity. In a previous investigation, we found that patients who carry a homozygous mutation in the MTHFR gene develop higher homocysteine levels after N2O anesthesia than non-carriers. These patients might be at higher risk for adverse cardiac outcomes from N2O. Thus, there may be a pharmacogenetic mechanism to account for the adverse cardiac outcomes from N2O. Moreover, prevention of N2O-increased homocysteine concentrations in these high risk patients by perioperative vitamin B12 and folate supplementation might decrease the incidence of adverse cardiac outcomes.

Hypothesis: Patients carrying a homozygous MTHFR 677C\>T or 1298 A\>C variant allele will have a higher incidence rate of postoperative myocardial ischemia after N2O anesthesia \[detected by serial TnI measurements\] due to elevated homocysteine levels than normal "wild-type" non-carriers, and that the incidence rate will be reduced if they receive perioperative vitamin B12/folate supplementation.

Primary outcome: Myocardial ischemia in the first 72 hours after surgery (measured by serial troponin and ECGs).

Secondary outcome: Composite endpoint of 30-day mortality and major cardiac morbidity (non-fatal MI)

Design: Randomized controlled trial. 500 patients will receive N2O during surgery and will be randomized to receive B-vitamins or placebo. 125 patients will receive no N2O and no B-vitamins (control arm). Mendelian randomization of MTHFR genotype.

Intervention: IV vitamin B12 (1 mg) and folate (5 mg) pre- and postoperatively

Study setting: Barnes-Jewish-Hospital, St. Louis, MO

Patients: Patients scheduled for major surgery with or at risk for coronary artery disease

Arms: arm 1: Vitamin B12 and folic acid arm 2: Nitrous oxide and placebo arm 3: standard of care
Interventions: intervention 1: Vitamin B12 and folic acid intervention 2: Nitrous oxide and placebo intervention 3: standard of care
Intervention descriptions: intervention 1: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00709202
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Bipolar I Disorder Bipolar II Bipolar NOS(Not Otherwise Specified) Psychotic Disorder Not Otherwise Specified Autism Spectrum Disorder
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2008-07-01; Completion date: 2016-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.

Hypothesis to be tested:

A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.

B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.

C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation

Detailed description:
Subjects for this study were adolescents and adults from age 12 to age 59. Subjects were individuals who have been psychiatrically stabilized on first or second generation antipsychotic medication, and have gained substantial weight during their treatment. Subjects were excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog) or are prescribed medications known to affect body composition or metabolism other than those currently being studied. Subjects were randomized to receive either betahistine or placebo at a 1:1 ratio.

Arms: arm 1: Subjects assigned to this arm will receive Betahistine. arm 2: Subjects in this group will received placebo.
Interventions: intervention 1: Betahistine intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day).. intervention 2: None

Protocol documents:
Clinical trial NCT00828308
Conditions: Prostate Cancer
Keywords: localized high risk prostate cancer neoadjuvant treatment
Sponsor: Brown University
Start date: 2009-02-01; Completion date: 2016-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

Detailed description:
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

Arms: arm 1: Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion \*\*\*this was standard of care and not a part of the study\*\*\*
Interventions: intervention 1: Ixabepilone intervention 2: Prostatectomy
Intervention descriptions: intervention 1: Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. intervention 2: Prostatectomy 2-8 weeks after completion \*\*\*this was standard of care and not a part of the study\*\*

Protocol documents:
Clinical trial NCT00869323
Conditions: Lymphoproliferative Disorder
Keywords: post-transplant lymphoproliferative disorder
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2009-03-01; Completion date: 2016-12-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell 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. Giving bortezomib together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.

Detailed description:
OBJECTIVES:

Primary

* To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.

Secondary

* To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
* To characterize the quantitative and qualitative toxicities of this regimen.

OUTLINE:

* Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22.

Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest.

* Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).
Interventions: intervention 1: rituximab intervention 2: bortezomib
Intervention descriptions: intervention 1: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 intervention 2: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22

Protocol documents:
Clinical trial NCT00925132
Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma Epigenetic Temozolomide Decitabine Panobinostat LBH589
Sponsor: University of Iowa
Start date: 2009-12-01; Completion date: 2016-12-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat. This combination is proposed to unlock genes that may contribute to mechanisms that cause tumor growth.

The primary objectives of this study are:

* To evaluate the safety and tolerability of the proposed schedule of decitabine, temozolomide and panobinostat in the treatment of metastatic melanoma.
* To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the combination of decitabine, temozolomide and panobinostat.

Detailed description:
Most chemotherapeutics target rapidly proliferating cells, leaving quiescent cells and those with extended cell cycles unaffected. The investigators propose that this combination of decitabine, temozolomide, and panobinostat will target both melanoma stem cells and rapidly proliferating melanoma cells. The use of two drugs that regulate gene expression epigenetically (panobinostat and decitabine) in combination with a chemotherapeutic agent (temozolomide) is hypothesized to:

* induce expression genes (e.g., Apaf-1) that increase chemosensitivity of tumor cells and enhance apoptosis
* potentiate the cytotoxic effect of temozolomide by epigenetic modulation, and
* induce proliferation and differentiation of tumor stem cells, thus enabling senescence and apoptosis.

Secondary objectives:

* To measure overall survival
* To measure the time to progression of patients treated with this combination in comparison to patients treated historically with DTIC (the current standard of care).
* To evaluate treatment response with FDG PET and compare FDG PET with conventional imaging for treatment response assessment.

Arms: arm 1: Temozolomide - given each cycle.

Decitabine - 6 cohorts with dose escalation.

Panobinostat - 6 cohorts with dose escalation.
Interventions: intervention 1: Temozolomide, Decitabine, Panobinostat
Intervention descriptions: intervention 1: Temozolomide - given each cycle.

Decitabine - 6 cohorts with dose escalation.

Panobinostat - 6 cohorts with dose escalation.

Protocol documents:
Clinical trial NCT00926380
Conditions: Osteoporosis
Keywords: osteoporosis postmenopausal denosumab teriparatide Forteo® DXA Bone Mineral Density pQCT
Sponsor: Massachusetts General Hospital
Start date: 2009-06-01; Completion date: 2016-12-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: denosumab intervention 2: teriparatide
Intervention descriptions: intervention 1: denosumab: 60 mg SC every 6 months intervention 2: teriparatide: 20 mcg SC QD

Protocol documents: