ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00521144
Conditions: Recurrent Small Cell Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: National Cancer Institute (NCI)
Start date: 2007-08-01; Completion date: 2010-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose, recommended phase II dose, and toxicity profile of obatoclax mesylate when administered with topotecan hydrochloride in patients with advanced solid tumors. (Phase I) II. Determine the response rate in patients with relapsed or refractory small cell lung cancer treated with obatoclax mesylate and topotecan hydrochloride. (Phase II)

SECONDARY OBJECTIVES:

I. Evaluate the expression of pro- and anti-apoptotic proteins which may correlate with obatoclax mesylate sensitivity or resistance.

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

PHASE I (solid tumor): Patients receive obatoclax mesylate IV over 3 hours on day 1 OR days 1 and 3 and topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II (small cell lung cancer): Patients receive obatoclax mesylate and topotecan hydrochloride at the recommended phase II dose (RPTD) determined in phase I. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples from patients with small cell lung cancer may be collected at baseline for correlative studies. Tissue samples are analyzed for biomarkers and protein expression of Bcl-2, Bcl-Xl, MCL-1, Bax, Bad, c-Myc, L-Myc, and N-Myc by immunohistochemistry.

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

Arms: arm 1: Patients receive obatoclax mesylate IV over 3 hours on day 1 OR days 1 and 3 and topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: obatoclax mesylate intervention 2: topotecan hydrochloride intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00526799
Conditions: Ovarian Cancer
Sponsor: Daniela Matei, MD
Start date: 2007-09-01; Completion date: 2010-08-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).

Detailed description:
OUTLINE: This is a multi-center study.

* Topotecan: 4mg/m2 weekly, 3 weeks on and one week off.
* Sorafenib: Assigned cohort dose for phase I (up to 12 patients) Maximum tolerated dose for phase II (21 total patients)

Cycles will consist of 4 weeks (28 days) with disease evaluations every 8 weeks.

Non-PD and acceptable toxicity: Patients will continue protocol therapy PD or unacceptable toxicity: Patients will discontinue protocol therapy

ECOG performance status 0-1

Life expectancy: Three (3) months

Hematopoietic:

* White blood cell count (WBC) \> 3 K/mm3
* Hemoglobin (Hgb) \> 9 g/dL
* Platelets \> 100 K/mm3
* Absolute neutrophil count (ANC) \> 1.5 K/mm3
* INR \< 1.5 or a PTT within normal limits. NOTE: Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
* No evidence or history of bleeding diathesis or coagulopathy.

Hepatic:

* Bilirubin \< 1.5 x ULN
* Aspartate aminotransferase (AST, SGOT) \< 2.5 x ULN
* Alanine aminotransferase (ALT, SGPT) \< 2.5 x ULN
* Alkaline phosphate \< 2.5 x ULN

Renal:

* Creatinine \< 1.5 x ULN

Cardiovascular:

* No history of myocardial infarction or angina pectoris or angina equivalent within 6 months prior to registration for protocol therapy (the patient may not be on anti-anginal or anti-arrhythmic medications), or have uncontrolled hypertension or congestive heart failure \> class II NYHA

Pulmonary:

* No thrombolic or embolic events such as a cerebrovascular accident, including transient ischemic attacks within the past 6 months.
* No pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 28 days prior to registration for protocol therapy.
* No non-pulmonary hemorrhage/bleeding event \> CTCAE Grade 3 within 28 days prior to registration for protocol therapy.

Arms: arm 1: Topotecan 3.5 mg/m\^2 + Sorafenib dose escalation: arm 2: Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.
Interventions: intervention 1: Sorafenib intervention 2: Topotecan
Intervention descriptions: intervention 1: Phase I: Dose Escalation, Phase II: MTD

Dose level -1: 200mg po daily Dose level 1: 400mg po daily (MTD) Dose level 2: 400mg po bid intervention 2: 3.5mg/m2 weekly, 3 weeks on and one week off.

Protocol documents:
Clinical trial NCT00529542
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Sponsor: Milton S. Hershey Medical Center
Start date: 2004-12-01; Completion date: 2010-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

Detailed description:
The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lipitor intervention 2: Placebo
Intervention descriptions: intervention 1: 40mg caplets per day for six weeks intervention 2: 1 placebo caplet per day for six weeks.

Protocol documents:
Clinical trial NCT00532441
Conditions: Hepatocellular Carcinoma
Sponsor: Gabi Chiorean, MD
Start date: 2007-09-01; Completion date: 2010-08-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.

Detailed description:
Outline: This is a multi-center study.

Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities:

* Erlotinib 150 mg p.o. daily on days 2-7, 9-14, 16-28
* Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8, 15

Treatment cycle = 28 days

Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Life expectancy: At least 12 weeks

Hematopoietic:

* Absolute neutrophil count (ANC) \> 1000 mm3
* Platelet count \> 75,000 mm3
* Hemoglobin \> 8 g/dL

Hepatic:

* Bilirubin \< 2.0 x upper limit of normal (ULN)
* Transaminases (AST, ALT) \< 5.0 x ULN if alkaline phosphatase is \< 2.5 x ULN, or alkaline phosphatase \< 5 x ULN if transaminases are \< 1.5 x ULN.
* If not on anticoagulation: PT \< 4 seconds above ULN; INR \< 1.5; PTT \< 1.3 x ULN.
* If on therapeutic anticoagulation, patients may have an INR \> 1.5 and PTT within therapeutic range; INR will be monitored weekly until stable.
* Serum Albumin \> 3.0

Renal:

* Creatinine clearance of \> 60 ml/ min (by Cockcroft-Gault)

Pulmonary:

* Not specified

Arms: arm 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 arm 2: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
Interventions: intervention 1: Erlotinib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 intervention 2: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Protocol documents:
Clinical trial NCT00538590
Conditions: Open Angle Glaucoma
Keywords: ologen collagen matrix glaucoma trabeculectomy Mitomycin-C
Sponsor: Pro Top & Mediking Company Limited
Start date: 2007-07-01; Completion date: 2010-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Detailed description:
To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Arms: arm 1: Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C. arm 2: 20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Interventions: intervention 1: Collagen Matrix in Glaucoma Filtering Surgery intervention 2: Mitomycin-C(MMC) and glaucoma filtering surgery
Intervention descriptions: intervention 1: Collagen Matrix implantation in Glaucoma Filtering Surgery intervention 2: If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Protocol documents:
Clinical trial NCT00542815
Conditions: Chronic Kidney Disease Dialysis Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-11-01; Completion date: 2010-08-01
Enrollment: 632 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Detailed description:
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-196 intervention 2: Another Phosphate binder (Sevelamer)
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose intervention 2: Current approved dosing recommendations for 12 weeks

Protocol documents:
Clinical trial NCT00555672
Conditions: Stomach Neoplasms
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2010-08-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 5-fluorouracil intervention 2: cisplatin intervention 3: sunitinib malate
Intervention descriptions: intervention 1: 5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 2: Cisplatin is given 80 mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 3: sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

Protocol documents:
Clinical trial NCT00575042
Conditions: Primary Biliary Cirrhosis
Keywords: PBC Primary Biliary Cirrhosis Fenofibrate Triglide
Sponsor: University of Florida
Start date: 2007-08-01; Completion date: 2010-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

Detailed description:
This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.

Arms: arm 1: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year
Interventions: intervention 1: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Intervention descriptions: intervention 1: 160 mg per day for 1 year

Protocol documents:
Clinical trial NCT00584740
Conditions: Crohn's Disease
Keywords: Crohn's disease, moderate, severe, active, AIN457
Sponsor: Novartis Pharmaceuticals
Start date: 2008-08-01; Completion date: 2010-08-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.

Detailed description:

Arms: arm 1: AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22. arm 2: Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg/kg intervention 2: Matching placebo to AIN457

Protocol documents:
Clinical trial NCT00593827
Conditions: Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2008-05-01; Completion date: 2010-08-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.

Detailed description:

Arms: arm 1: ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest arm 2: ixabepilone 40 mg/m\^2 every 3 weeks
Interventions: intervention 1: Ixabepilone intervention 2: Ixabepilone
Intervention descriptions: intervention 1: Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity. intervention 2: Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.

Protocol documents:
Clinical trial NCT00594646
Conditions: HIV Infections
Keywords: HIV Prevention Non-occupational post-exposure prophylaxis HIV seronegativity
Sponsor: Fenway Community Health
Start date: 2008-02-01; Completion date: 2010-08-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Detailed description:
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Arms: arm 1: TRUVADA
Interventions: intervention 1: TRUVADA + Raltegravir
Intervention descriptions: intervention 1: TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg

Protocol documents:
Clinical trial NCT00645658
Conditions: Kidney Failure Kidney Diseases
Sponsor: Palo Alto Veterans Institute for Research
Start date: 2007-08-01; Completion date: 2010-08-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.

Detailed description:
All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after the hormone treatment is started, the blood testosterone (TT) level will be measured 6 hours after administration. Our goal will be the attainment of serum total TT levels in the mid- to upper normal young adult range. If the serum TT is not at goal, the dose of gel will be increased or decreased repeat testing will be performed within one week. All subjects will be tested for serum TT levels every 4 weeks to assure that the serum total TT remains at goal level. Measurements will be repeated at 8 and 16 weeks.

Arms: arm 1: Patients with chronic kidney disease between the ages of 55 and 75 years. arm 2: Control participants with baseline data collection only (for baseline comparator).
Interventions: intervention 1: Testim, 1% testosterone gel
Intervention descriptions: intervention 1: Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.

Protocol documents:
Clinical trial NCT00650546
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Non-alcoholic steatohepatitis NASH
Sponsor: Indiana University
Start date: 2006-08-01; Completion date: 2010-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.

Detailed description:
Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in NAS by 2 or more points spread across at least two of the three NAS components, or (b) post-treatment NAS equal or greater than 3.

Arms: arm 1: liver biopsy score pre treatment with exenatide 5 micrograms SQ (sub-cutaneous) twice a day titrated to 10 mcg SQ twice a day as tolerated
Interventions: intervention 1: Exenatide
Intervention descriptions: intervention 1: 5 mcg twice a day titrated to 10 mcg twice a day

Protocol documents:
Clinical trial NCT00656851
Conditions: HIV Infections Cardiovascular Disease Insulin Resistance HIV Lipodystrophy The Metabolic Syndrome
Keywords: HIV/AIDS Heart disease Diabetes Cardiovascular disease risk Dyslipidemia Visceral adiposity treatment experienced
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2005-09-01; Completion date: 2010-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize fats and sugars inappropriately, and that this may impair the heart's ability to pump blood. We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of exercise training and pioglitazone for improving insulin resistance, heart metabolism and heart function in this at risk population.

Detailed description:
We hypothesize that myocardial free fatty acid and glucose utilization and oxidation rates are dysregulated in HIV+ people with The Metabolic Syndrome in comparison to HIV+ people without The Metabolic Syndrome, and in comparison to HIV-seronegative people with and without The Metabolic Syndrome. We hypothesize that dysregulated myocardial fatty acid and glucose metabolism is associated with impaired heart function (diastolic dysfunction) in HIV+ people with The Metabolic Syndrome. We will use myocardial positron emission tomography, radioactive isotope tracers of palmitate and glucose, and echocardiography to evaluate myocardial metabolism and function. HIV+ people with The Metabolic Syndrome will receive 16wks of exercise training or pioglitazone (Actos), and we will evaluate their potential beneficial effects on myocardial metabolism and function.

Arms: arm 1: Pioglitazone (Actos, 30mg/day for 16 weeks) arm 2: Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Interventions: intervention 1: Pioglitazone intervention 2: Exercise Training
Intervention descriptions: intervention 1: 30mg/day for 16 weeks intervention 2: Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks

Protocol documents: