ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00580853
Conditions: Smoking Lapse Behavior
Keywords: smoking lapse behavior smoking cessation varenicline bupropion medication effect on smoking lapse behavior
Sponsor: Yale University
Start date: 2007-04-01; Completion date: 2016-10-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.

Detailed description:

Arms: arm 1: varenicline 2mg/day arm 2: Bupropion 300mg/day arm 3: Placebo Control
Interventions: intervention 1: varenicline intervention 2: bupropion intervention 3: Placebo
Intervention descriptions: intervention 1: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8). intervention 2: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8). intervention 3: Placebo

Protocol documents:
Clinical trial NCT00622466
Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer HER2-negative breast cancer
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-04-23; Completion date: 2016-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib 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. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.

Secondary

* To evaluate time to disease progression in patients treated with this regimen.
* To evaluate six-month progression-free survival of patients treated with this regimen.
* To evaluate time to treatment failure in patients treated with this regimen.
* To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
* To evaluate duration of response in patients treated with this regimen.
* To evaluate the tolerability of this regimen in these patients.
* To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
Interventions: intervention 1: paclitaxel intervention 2: sorafenib tosylate
Intervention descriptions: intervention 1: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma intervention 2: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma

Protocol documents:
Clinical trial NCT00742560
Conditions: Hematologic Cancer
Keywords: Multiple Myeloma
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-08-01; Completion date: 2016-10-01
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and dexamethasone in subjects with relapsed multiple myeloma.

Detailed description:

Arms: arm 1: Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. arm 2: Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. arm 3: Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. arm 4: Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. arm 5: Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Interventions: intervention 1: elotuzumab intervention 2: lenalidomide intervention 3: dexamethasone oral intervention 4: dexamethasone injection
Intervention descriptions: intervention 1: Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3. intervention 2: Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle intervention 3: Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) intervention 4: Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Protocol documents:
Clinical trial NCT01023477
Conditions: Carcinoma, Intraductal, Noninfiltrating DCIS Ductal Carcinoma In Situ
Keywords: Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma In Situ DCIS Carcinoma, Intraductal Breast Cancer Breast Tumors chloroquine autophagy Autophagic Cell Death Autophagocytosis Programmed Cell Death, Type II Autophagy, Cellular Autophagic Programmed Cell Death
Sponsor: Inova Health Care Services
Start date: 2009-12-01; Completion date: 2016-10-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the hypothesis that chloroquine will reduce the ability of ductal carcinoma in situ (DCIS) to survive and spread. Participants will receive either chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior to surgical removal of the tumor.

Detailed description:
The purpose of this study is to test the hypothesis that inhibiting the autophagy pathway in DCIS will reduce the capacity of DCIS to survive and invade. The study will examine the safety and effectiveness of neoadjuvant chloroquine administration for a one month period to patients with low, intermediate grade, or high grade DCIS. We will evaluate whether this treatment will reduce the capacity of DCIS neoplastic cells, existing within the duct, to survive, induce lesion regression, and kill the invasive DCIS progenitor cells.

Arms: arm 1: Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week). arm 2: Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).
Interventions: intervention 1: Chloroquine Standard Dose (500mg/week) intervention 2: Chloroquine Low Dose (250mg/week) intervention 3: Breast Biopsy
Intervention descriptions: intervention 1: Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion. intervention 2: Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion. intervention 3: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery.

Protocol documents:
Clinical trial NCT01128387
Conditions: Cancer
Keywords: esophageal cancer Locally advanced esophageal cancer
Sponsor: University of Wisconsin, Madison
Start date: 2010-05-01; Completion date: 2016-10-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).

Detailed description:

Arms: arm 1: Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU (Fluorouracil) arm 2: Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)
Interventions: intervention 1: Panitumumab
Intervention descriptions: intervention 1: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

Protocol documents:
Clinical trial NCT01164098
Conditions: FSGS Proteinuria
Sponsor: George W. Burke
Start date: 2012-02-01; Completion date: 2016-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.

Detailed description:
A total of 60 patients will be enrolled in the study.

Arms: arm 1: Participants will receive Rituximab post within 24 of Kidney Transplant arm 2: Participants will not receive Rituximab within 24 hours of Kidney Transplant
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Induction therapy

Protocol documents:
Clinical trial NCT01254552
Conditions: Type 2 Diabetes Mellitus Coronary Atherosclerosis
Sponsor: Guerbet
Start date: 2010-08-01; Completion date: 2016-10-01
Enrollment: 351 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).

Detailed description:
Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.

Arms: arm 1: None
Interventions: intervention 1: iobitridol intervention 2: gadoterate meglumine
Intervention descriptions: intervention 1: Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration. intervention 2: Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Protocol documents:
Clinical trial NCT01275586
Conditions: Neurofibromatosis NF1 Neurofibromas
Keywords: NF1 plexiform neurofibromas nilotinib Tasigna
Sponsor: Indiana University
Start date: 2011-01-01; Completion date: 2016-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas treated with Tasgina® respond to therapy.

Detailed description:
This is an open-label Pilot Study to determine the efficacy of Tasigna® in adults with neurofibromatosis (NF1) and plexiform neurofibromas with the secondary goals of determining the toxicity, and tumor markers in this genetically defined population. The rationale for this study arises from the response of human and murine NF1 cells to Tasigna® in vitro and the clinical response in NF1 patients with plexiform neurofibromas using the similar drug, Gleevec®. Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated. Subjects will have his/her dose increased as tolerated dose during the first three months of therapy. The maximum targeted dose is 400mg twice daily.

Arms: arm 1: Following enrollment each subject will initially receive the drug Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated. Subjects will have his/her dose increased as tolerated dose during the first three months of therapy. The maximum targeted dose is 400mg twice daily.
Interventions: intervention 1: Tasigna
Intervention descriptions: intervention 1: Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.

Protocol documents:
Clinical trial NCT01313897
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2011-01-01; Completion date: 2016-10-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy in research participants with relapsed high risk MM \[defined as gene expression profile (GEP) 70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L\] by establishing the (near) complete response rate. Response rate will be compared to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM defined as above). Disease-free survival and overall survival will be captured but are not primary or secondary endpoints.

Detailed description:
The use of auto-exp-NK cells in this protocol makes therapy available to all refractory high risk MM patients, 2/3 of whom would otherwise not have a suitable haploidentical donor. We have shown that NK cells can be expanded both from newly diagnosed high risk MM patients and from refractory, previously heavily treated patients, the very individuals in need of novel therapies such as exp-NK cell infusions. Furthermore, we observed that exp-NK cells have the ability to kill auto-MM cells in vitro compared to no killing with resting auto-NK cells. This may be due to the elevated activation state of exp-NK cells, which allows them to overcome otherwise dominant inhibitory signaling. The incorporation of the proteasome inhibitor bortezomib, which down regulates the principal NK cell inhibitory ligands on MM cells should further increase the efficacy of auto-exp-NK cells. Because there is no risk for GvHD, CD3+ T cell depletion will not be necessary for auto-exp-NK cell products.

Arms: arm 1: Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.

Protocol documents:
Clinical trial NCT01349569
Conditions: Multiple Myeloma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-01-01; Completion date: 2016-10-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.

Detailed description:
This is a single institution, single arm, Phase II study examining the clinical efficacy of an allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide. Fifteen (15) patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation) per criteria for response in a 6 month period. Patients will continue on the dose of lenalidomide they were on prior to being enrolled but will need to discontinue steroids for at least 4 weeks. Patients will receive 4 vaccinations on day 14(+/-3 days) of cycles 1, 2, 3 and 6 from enrollment that will include both the myeloma vaccine as well as Prevnar.

Arms: arm 1: Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.
Interventions: intervention 1: Lenalidomide intervention 2: Allogeneic Myeloma Vaccine intervention 3: Prevnar-13
Intervention descriptions: intervention 1: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). intervention 2: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. intervention 3: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.

Protocol documents:
Clinical trial NCT01407107
Conditions: Rectal Cancer
Keywords: nitroglycerin 5-flourouracil radiation therapy neo-adjuvant treatment
Sponsor: University of Texas Southwestern Medical Center
Start date: 2011-01-01; Completion date: 2016-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether topical nitroglycerin in addition to 5-flourouracil and radiation therapy are effective in the treatment of operable rectal cancer.

Detailed description:
This is an open label, non-randomized, multi-cohort, dose escalation trial to evaluate the safety, tolerability, feasibility and maximum tolerated dose (MTD) of topical nitroglycerin in addition to 5-flourouracil and radiation therapy for neo-adjuvant treatment of, T3-T4 or clinically node positive, operable rectal cancer.

Patients that would otherwise be eligible for concurrent neo-adjuvant chemotherapy with continuous infusion 5-FU, for locally advanced operable rectal cancer, will be assigned to 4 sequential cohorts of 3 different dose levels of nitro glycerin patches (0.2; 0.4; and 0.6 mg/hr). Each cohort will consist of 3 patients. All patients will receive radiation therapy, 45-50 Gy in 25-28 fractions to the pelvis along with continuous infusion 5-FU 225mg/M2 for the duration of the radiation therapy. The radiation therapy will be planned and delivered as per institutional standard of care for the Dallas VAMC radiation oncology department.

Arms: arm 1: Dose escalation trial of Nitroglycerin
Interventions: intervention 1: Nitroglycerin 0.2 MG/HR intervention 2: Nitroglycerin 0.4 MG/HR intervention 3: Nitroglycerin 0.6 MG/HR
Intervention descriptions: intervention 1: 0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr). intervention 2: 0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients. intervention 3: 0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.

Protocol documents: