ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00198081
Conditions: Pancreas Neoplasms
Keywords: celecoxib for pancreas lesions
Sponsor: Indiana University School of Medicine
Start date: 2005-09-01; Completion date: 2012-04-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.

Detailed description:
Efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing. Some patients are at increased risk of pancreatic cancer or may have pre-malignant pancreatic lesions which predispose them to later pancreatic cancer development. In these individuals, chemopreventative measures may block future development of pancreatic cancer. Human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests that cyclooxygenase-2 (COX-2) may be a successful target for chemoprevention. COX-2 is overexpressed in human pancreatic cancers. Elevated COX-2 expression correlates with progression of premalignant precursors of pancreatic cancer in development models of hamster pancreatic cancer. Human tissue studies confirm increases in COX-2 expression with progression of premalignant precursors called intraductal papillary mucinous neoplasms (IPMNs) and pancreatic intraepithelial neoplasms (PanINs). Moreover, COX-2 inhibitors appear to have chemopreventative efficacy in the PC-1 homograft model of hamster pancreatic cancer. Demographic studies have suggested COX-2 inhibitors may confer protection from pancreatic cancer. We propose to conduct a pilot/phase II trial to determine the chemopreventative effects of the COX-2 inhibitor celecoxib in patients with premalignant pancreatic lesions.

Patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to surgery (if patient decides to have surgery for his/her condition). If subject is not a surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.

Arms: arm 1: COX-2 Inhibitor 6-8 weeks prior to surgery arm 2: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
Interventions: intervention 1: COX-2 Inhibitor 6-8 weeks prior to surgery intervention 2: COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
Intervention descriptions: intervention 1: 400 mg BID 6-8 weeks prior to surgery intervention 2: 400 mg BID for 6 months prior to follow-up EUS or ERCP

Protocol documents:
Clinical trial NCT00245635
Conditions: Body Dysmorphic Disorder
Keywords: Body Dysmorphic Disorder BDD BDD treatment delusionality variant OCD
Sponsor: Montefiore Medical Center
Start date: 2004-11-01; Completion date: 2012-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

Detailed description:
BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.

Arms: arm 1: Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. arm 2: Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.
Interventions: intervention 1: Fluoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. intervention 2: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.

Protocol documents:
Clinical trial NCT00268450
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder stage III bladder cancer stage II bladder cancer recurrent bladder cancer
Sponsor: Medical University of South Carolina
Start date: 2005-09-21; Completion date: 2012-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.

Detailed description:

Arms: arm 1: Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.
Interventions: intervention 1: bevacizumab intervention 2: cisplatin intervention 3: gemcitabine hydrochloride intervention 4: paclitaxel intervention 5: cysectomy
Intervention descriptions: intervention 1: Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles

After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles intervention 2: Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles intervention 3: Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles intervention 4: After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles intervention 5: None

Protocol documents:
Clinical trial NCT00314808
Conditions: Brain Neoplasms Nausea Vomiting
Keywords: primary gliomas brain tumors vomiting appetite suppression appetite
Sponsor: Duke University
Start date: 2006-04-01; Completion date: 2012-04-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study seeks to define the tolerability and safety associated with the administration of Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients with primary gliomas who are undergoing chemotherapy treatment. The study will also describe the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in this patient group.

Detailed description:
Symptoms identified as impacting quality of life include nausea and vomiting, appetite changes, pain, fatigue, mobility, insomnia, mood, bowel patterns, concentration and appearance (Donaldson and Fields, 1998). There has been little information published on the impact of these symptoms in the glioblastoma multiforme (GBM) population. More specifically, to date, there has not been an investigation that demonstrates the efficacy of an intervention on improving appetite, and decreasing nausea and vomiting in patients with GBM. This need serves as the basis for the current proposed investigation utilizing Dronabinol, a cannabinoid known to decrease incidence of nausea and vomiting, as well as controlling appetite changes for terminally ill patients receiving chemotherapy. In addition, there is no published research on the use of Dronabinol and dose limited toxicity for the brain tumor population.

In this study, patients will receive daily Dronabinol therapy through their chemotherapy cycle. Patients will complete daily appetite and nausea/vomiting logs, as well as receive telephone follow-up from the research coordinator to assess impact of treatment. This will be assessed through two consecutive cycles of chemotherapy.

Arms: arm 1: None
Interventions: intervention 1: Dronabinol
Intervention descriptions: intervention 1: Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy

Protocol documents:
Clinical trial NCT00438464
Conditions: Adenocarcinoma of the Prostate Stage II Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-02-01; Completion date: 2012-04-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo.

SECONDARY OBJECTIVES:

I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients.

II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients.

III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo.

IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

V. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy.

Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy.

Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. arm 2: Placebo once daily for 4-6 weeks, then undergo prostatectomy.
Interventions: intervention 1: Finasteride intervention 2: Placebo intervention 3: Prostatectomy intervention 4: Laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Undergo prostatectomy intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00459342
Conditions: Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-03-01; Completion date: 2012-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.

III. Determine the toxicity of this drug.

OUTLINE:

Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.

Arms: arm 1: Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00517361
Conditions: Metastatic Breast Cancer
Sponsor: University of Chicago
Start date: 2007-08-01; Completion date: 2012-04-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: carboplatin intervention 2: bevacizumab
Intervention descriptions: intervention 1: AUC 6 in 250mL saline IV over 30 minutes intervention 2: 15mg/kg in 100mL saline IV over 60 - 90 minutes

Protocol documents:
Clinical trial NCT00517829
Conditions: Gastric Cancer Adenocarcinoma Metastatic
Keywords: metastatic gastric or adenocarcinoma of the GE junction
Sponsor: US Oncology Research
Start date: 2007-07-01; Completion date: 2012-04-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.

Detailed description:
This is a Phase II, open- label, randomized, noncomparative study. Patients will be stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS.

Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 - Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle.

Treatment will continue until disease progression or intolerable toxicity. Patients who achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to 24 months of participation, counted from the date of the first dose of study drug.

Arms: arm 1: Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours arm 2: Docetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
Interventions: intervention 1: Docetaxel intervention 2: cetuximab intervention 3: oxaliplatin
Intervention descriptions: intervention 1: Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour intervention 2: ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. intervention 3: Eloxatin 130 mg/m2 IV over 2 hours

Protocol documents:
Clinical trial NCT00519285
Conditions: Prostatic Neoplasms Neoplasm Metastasis
Keywords: metastatic prostate cancer
Sponsor: Sanofi
Start date: 2007-08-01; Completion date: 2012-04-01
Enrollment: 1224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).

The secondary objectives were:

* To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
* To assess the overall safety in both treatment arms;
* To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
* to determine immunogenicity of IV aflibercept.

Detailed description:
The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first.

The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.

Arms: arm 1: Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone arm 2: Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone
Interventions: intervention 1: Aflibercept intervention 2: Placebo (for aflibercept) intervention 3: Docetaxel intervention 4: Prednisone or Prednisolone
Intervention descriptions: intervention 1: 25 mg/ml solution

6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle intervention 2: Sterile aqueous buffered solution identical to aflibercept

1-hour IV on Day 1 of each 3-Week cycle intervention 3: Marketed formulation

75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo) intervention 4: Marketed formulation

5 mg twice daily PO from day 1 continuously

Protocol documents:
Clinical trial NCT00532129
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-11-01; Completion date: 2012-04-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m\^2) intravenously (IV) in Cycle 1, and 500 mg/m\^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m\^2/day per oral (PO).

Detailed description:

Arms: arm 1: Participants will receive combination therapy of rituximab plus chlorambucil for first 6 cycles and then chlorambucil alone for a maximum of 6 additional cycles.
Interventions: intervention 1: Rituximab intervention 2: Chlorambucil
Intervention descriptions: intervention 1: 375mg/m\^2 IV on Day 1 of Cycle 1; 500mg/m\^2 on Day 1 of Cycles 2-6. intervention 2: 10 mg/m\^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

Protocol documents:
Clinical trial NCT00537056
Conditions: Kidney Neoplasms Carcinoma, Renal Cell Kidney (Renal Cell) Cancer
Sponsor: Stanford University
Start date: 2007-10-01; Completion date: 2012-04-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).

Detailed description:
This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.

The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.

Arms: arm 1: FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Interventions: intervention 1: FDG PET CT intervention 2: DCE MRI intervention 3: F-18 Fluoro-deoxi-glucose intervention 4: Gadolinium-DTPA intervention 5: Sunitinib
Intervention descriptions: intervention 1: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body intervention 2: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg). intervention 3: 15 mCi iv intervention 4: 0.1 mmol/kg iv intervention 5: 50 mg/day po

Protocol documents: