ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00893464
Conditions: Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-08-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with lymphoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: IXAZOMIB
Intervention descriptions: intervention 1: Patients will be administered IXAZOMIB by IV on Days 1, 8, and 15 of a 28-day cycle. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Protocol documents:
Clinical trial NCT00929344
Conditions: Alcohol Dependence
Keywords: Alcohol Alcohol treatment Alcoholism Alcohol Abuse Alcohol Dependence
Sponsor: The Scripps Research Institute
Start date: 2009-07-01; Completion date: 2014-10-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pregabalin intervention 2: Duloxetine intervention 3: Standardized behavioral therapy intervention 4: Standardized behavioral therapy intervention 5: Placebo intervention 6: Standardized behavioral therapy
Intervention descriptions: intervention 1: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. intervention 2: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. intervention 3: Standardized behavioral therapy 1 time per week for 12 week duration. intervention 4: Standardized behavioral therapy 1 time per week for 12 week duration. intervention 5: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. intervention 6: Standardized behavioral therapy 1 time per week for 12 week duration.

Protocol documents:
Clinical trial NCT00952393
Conditions: Schizophrenia
Keywords: receptors nicotinic
Sponsor: VA Office of Research and Development
Start date: 2010-01-01; Completion date: 2014-10-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Detailed description:
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.

Arms: arm 1: This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Interventions: intervention 1: Pharmacokinetic
Intervention descriptions: intervention 1: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined

Protocol documents:
Clinical trial NCT00976456
Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: lung cancer NSCLC elderly non-squamous Elderly patients at least 65 years old first line therapy non-squamous non-small cell lung cancer stage IIIb or IV
Sponsor: PD Dr. med. Wolfgang Schuette
Start date: 2009-09-01; Completion date: 2014-10-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multi-center, open, randomized (parallel) and comparative phase III.

Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

Arm A: Bevacizumab + pemetrexed

Arm B: Bevacizumab + pemetrexed + carboplatin

Detailed description:
Primary:

* Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(\> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival

Secondary:

* To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
* To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
* To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
* To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
* To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score

Arms: arm 1: Bevacizumab + Pemetrexed arm 2: Bevacizumab + Pemetrexed + Carboplatin
Interventions: intervention 1: Bevacizumab + Pemetrexed intervention 2: Bevacizumab + Pemetrexed + Carboplatin
Intervention descriptions: intervention 1: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks intervention 2: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Protocol documents:
Clinical trial NCT00996333
Conditions: Metastatic Pancreatic Cancer
Keywords: Stage IVB
Sponsor: Columbia University
Start date: 2003-06-01; Completion date: 2014-10-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.

Detailed description:
This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer.

Arms: arm 1: Gemcitabine, Docetaxel, Capecitabine:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Interventions: intervention 1: Gemcitabine, Docetaxel, Capecitabine
Intervention descriptions: intervention 1: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.

Protocol documents:
Clinical trial NCT01010867
Conditions: Hematopoietic Organs; Disorder
Keywords: Probiotics Hematopoietic Stem Cell Transplantation Pediatrics
Sponsor: Columbia University
Start date: 2010-02-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

1\. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and 299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by incidence of Lactobacillus plantarum bacteremia.

Secondary Objectives:

1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to children and adolescents undergoing HSCT.
2. To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum.
3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT patients who have been administered Lactobacillus plantarum.

Detailed description:
Myeloablative regimens are the backbone of hematopoietic stem cell transplantation (HSCT) and are associated with prolonged periods of cachexia/anorexia, nausea/vomiting, mucositis, and compromised gut integrity (CGI). The toxicities associated with HSCT often lead to prolonged periods of poor oral intake and may result in overt malnutrition. CGI decreases oral tolerance to foods, reduces Quality of Life (QOL) and functional status, delays the transition from the hospital to home setting, and increases the risk of the development of gut-derived infections. Probiotics are nutritional supplements that contain a defined amount of viable microorganisms and upon administration confer a benefit to the host. Clinical trials in adults receiving organ transplants have found probiotics decrease the incidence of infection, the duration of antibiotic use, the incidence of multiorgan failure and systemic inflammation. Children and adolescents undergoing HSCT, experience similar clinical challenges suggesting probiotics may have a therapeutic value in the setting of HSCT. This study is to evaluate the safety and feasibility of administering probiotics to children and adolescents undergoing HSCT.

Arms: arm 1: There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Interventions: intervention 1: Lactobacillus plantarum strains 299 and 299v
Intervention descriptions: intervention 1: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10\^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.

Colony forming units (CFU)

Protocol documents:
Clinical trial NCT01016600
Conditions: Leukemia, Myeloid, Acute
Sponsor: Washington University School of Medicine
Start date: 2010-04-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia

Detailed description:
Primary:

Phase 1:

To determine the toxicity and feasibility of combining lenalidomide and azacitidine in patients with relapsed/ refractory AML ≥ 18 years or untreated AML ≥60 years.

Phase 2:

To assess the complete remission (CRm plus CRi) rate after lenalidomide + azacitidine therapy in untreated AML ≥60 years.

Secondary:

1. To assess the response rate (RR), morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetic CR (CRc) rate, CR with incomplete blood counts 14 rate, and partial remission 15 rate (PR).
2. To assess overall survival (OS) and event free survival (EFS).
3. To assess time to progression (TTP) in untreated AML ≥60 years.
4. To assess relapse free survival (RFS) and duration of CR for complete responders.
5. To determine the incidence and severity of other toxicities of lenalidomide in combination with azacitidine.
6. Assay the expression levels of cytokines/chemokines in the bone marrow plasma, expression of chemokine receptors/ligands on leukemic blasts important for the AML microenvironment and study the direct cytotoxic effects of lenalidomide, azacitidine and combination of both drugs on cryopreserved AML blast cells.

Arms: arm 1: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 2: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 3: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 4: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5
Interventions: intervention 1: Lenalidomide intervention 2: Azacitidine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01026324
Conditions: Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-09-01; Completion date: 2014-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the recommended phase 2 dose of SCH727965 administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I) II. To determine the 1-year overall survival of patients with malignant melanoma treated with SCH727965 at the dose and schedule derived in the phase 1 part of the study. (Phase II)

SECONDARY OBJECTIVES:

I. To characterize the safety profile and toxicities of SCH727965 administered as a 4-hour infusion every other week.

II. To determine the pharmacokinetics of SCH727965 administered as a 4-hour infusion every other week.

III. To determine the proportion of patients with malignant melanoma who are alive without progression of disease 6 months after beginning treatment with SCH727965 at the dose and schedule derived in the phase 1 part of the study.

IV. To determine the objective response rate to SCH727965 of patients with malignant melanoma enrolled to part 2 of the study.

V. To document cdk2, combined cdk2/1 and cdk9 inhibition in surrogate tissues and tumor.

VI. To correlate the degree of change of pharmacodynamic parameters in post-treatment compared to pre-treatment samples with clinical outcome.

VII. To correlate the degree of change of parameters defining cdk2, cdk2/1 and cdk9 inhibition with pharmacokinetic parameters.

VIII. To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition.

IX. To correlate pre-treatment cdk2 levels with clinical outcome. X. To correlate tumor p53 status with clinical outcome.

OUTLINE: This is a phase I dose-escalation study followed by a phase II study.

Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

Arms: arm 1: Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Interventions: intervention 1: dinaciclib intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01033032
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Amrubicin
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-12-01; Completion date: 2014-10-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.

Detailed description:
This will be a phase I/II study where phase I will evaluate the maximum tolerated dose of amrubicin, and phase II will assess the progression free survival of patients with HER2-negative metastatic breast cancer using the dose established in the phase I portion.

Arms: arm 1: Systemic therapy with amrubicin
Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: Phase I: dose-escalating portion with the starting dose of amrubicin at 90mg/m\^2 IV q21 days. Dose escalations are as follows:

DL2 - 100mg/m\^2; DL3 - 110mg/m\^2; and DL4 - 120mg/m\^2. All cycles are q21 days

Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days

Protocol documents:
Clinical trial NCT01074216
Conditions: Colorectal Cancer
Keywords: Vitamin D Vitamin D3 colon cancer rectum cancer Cholecalciferol 09-143
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-02-01; Completion date: 2014-10-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.

Detailed description:

Arms: arm 1: This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.
Interventions: intervention 1: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Intervention descriptions: intervention 1: Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.

Protocol documents:
Clinical trial NCT01083368
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate hormone-resistant prostate cancer recurrent prostate cancer stage IV prostate cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2009-01-01; Completion date: 2014-10-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may be a better way to block tumor growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with bevacizumab and to see how well it works in treating patients with hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.

Detailed description:
PRIMARY OBJECTIVES:

I. The primary objective of the Phase I portion of this study is to determine the maximum tolerated dose (MTD) of temsirolimus in combination with AVASTIN in subjects with chemotherapy refractory metastatic CRPC.

II. The primary objective for the Phase II portion of this study is to evaluate the objective response frequency (PSA and RECIST-Response Evaluation Criteria in Solid Tumors-defined) of the combination of temsirolimus and AVASTIN in patients with chemotherapy refractory metastatic CRPC.

SECONDARY OBJECTIVES:

I. To evaluate the effect of the combination of temsirolimus and AVASTIN on time to clinical progression and overall survival in patients with chemotherapy refractory metastatic CRPC.

II. To further evaluate the safety of temsirolimus given in combination with AVASTIN in chemotherapy refractory metastatic CRPC patients at the dose established in our phase I safety phase.

III. To determine the presence of circulating tumor cells (CTCs) and status of single nucleotide polymorphism (SNPs) in CRPC patients. (Exploratory)

OUTLINE: Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28 days.

Arms: arm 1: Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: temsirolimus intervention 2: bevacizumab intervention 3: polymorphism analysis intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01103284
Conditions: Type 1 Diabetes Mellitus
Keywords: beta-cells autoimmune Diabetes immunomodulation
Sponsor: Andromeda Biotech Ltd.
Start date: 2010-04-01; Completion date: 2014-10-01
Enrollment: 475 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Detailed description:

Arms: arm 1: Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. arm 2: Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Interventions: intervention 1: DiaPep277 intervention 2: Placebo
Intervention descriptions: intervention 1: 1.0 mg dose in 0.5 mL of solution intervention 2: 40 mg mannitol in 0.5 mL of solution.

Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Protocol documents: