ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01207726
Conditions: Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-09-01; Completion date: 2013-05-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor, 5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung cancer (NCSLC).

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the effect of 5-azacitidine and entinostat on the hazard of 3 year progression-free survival in patients with resected stage I non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To assess the safety, tolerability and toxicity of entinostat and 5-azacitidine in patients with resected stage I non-small cell lung cancer.

II. To explore the effect of entinostat and 5-azacitidine on median disease-free and overall survival in patients with resected stage I non-small cell lung cancer.

III. To assess the pharmacodynamic effects of 5-azacitidine and entinostat on DNA methylation and gene re-expression in patients with resected stage I NSCLC through analysis of sputum.

IV. To estimate the effect of entinostat and 5-azacitidine on progression free survival comparing patients with N2 lymph nodes categorized as methylated pre-treatment with those who are categorized as unmethylated.

V. To establish factors that predict clinical outcome in patients treated with combination epigenetic therapy by performing genome-wide analyses on pre-treatment tumor DNA.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive azacitidine subcutaneously (SC) on days 1-5 and 8-10 and entinostat orally (PO) once daily (QD) on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive standard of care.

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

Arms: arm 1: Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive standard of care.
Interventions: intervention 1: Azacitidine intervention 2: Entinostat intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given SC intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01214616
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2013-05-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);
* To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.

Detailed description:

Arms: arm 1: patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
Interventions: intervention 1: afatinib 20mg intervention 2: afatinib 40mg intervention 3: vinorelbine IV 25 or 20mg/m2
Intervention descriptions: intervention 1: patient to receive afatinib low dose po daily in combination with vinorelbine iv intervention 2: patient to receive afatinib high dose po daily in combination with vinorelbine iv intervention 3: patient to receive standard dose vinorelbine once a week for four times per cycle

Protocol documents:
Clinical trial NCT01215721
Conditions: Urinary Incontinence
Keywords: Incontinence Robotic Prostatectomy Prostate Cancer
Sponsor: University of California, Irvine
Start date: 2010-10-01; Completion date: 2013-05-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods.

Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine.

By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery.

\*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.

Detailed description:

Arms: arm 1: Vesicare 5mg daily for 90 days was prescribed for men presenting with post-Robotic Assisted Radical Prostatectomy (RARP) severe incontinence.
Interventions: intervention 1: Vesicare
Intervention descriptions: intervention 1: 5 mg daily

Protocol documents:
Clinical trial NCT01216332
Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
Sponsor: Vanderbilt University
Start date: 2010-10-01; Completion date: 2013-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.

Detailed description:

Arms: arm 1: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. arm 2: 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
Interventions: intervention 1: High-dose trivalent inactivated influenza vaccine intervention 2: Standard dose trivalent inactivated influenza vaccine
Intervention descriptions: intervention 1: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. intervention 2: 0.5 mL standard dose trivalent inactivated influenza vaccine

Protocol documents:
Clinical trial NCT01227018
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2010-12-01; Completion date: 2013-05-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the treatment of patients with metastatic pancreatic cancer.

Detailed description:
PRIMARY OBJECTIVES: I. To measure the 8-week disease control (CR + PR + SD) rate of therapy with STA-9090 in patients with metastatic pancreas cancer who have failed (either progressed or did not tolerate) one or two lines of prior therapy. SECONDARY OBJECTIVES: I. To determine response rate (by RECIST criteria v1.1). II. To determine overall survival. III. To evaluate the safety and toxicity profile in this patient population. TERTIARY OBJECTIVES: I. We will obtain from all patients blood samples pre and post therapy (after 1 week of therapy) and isolate serum for interrogation for a variety of biomarkers (eg AKT, Stat3, Caspase 3). OUTLINE: Patients receive Hsp90 inhibitor STA-9090 intravenous (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks.

Arms: arm 1: Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: STA-9090 intervention 2: Radiologic imaging intervention 3: blood draw
Intervention descriptions: intervention 1: Given IV intervention 2: radiologic modalities used to evaluate response to treatment intervention 3: Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response

Protocol documents:
Clinical trial NCT01227512
Conditions: Hyponatremia Dilutional Hyponatremia Inappropriate ADH Syndrome
Keywords: Hyponatremia Dilutional Hyponatremia Euvolemic Hyponatremia Hypervolemic Hyponatremia Fluid Restriction Tolvaptan
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-10-01; Completion date: 2013-05-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.

Detailed description:

Arms: arm 1: Oral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response. arm 2: Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response.
Interventions: intervention 1: tolvaptan intervention 2: Fluid Restriction
Intervention descriptions: intervention 1: 15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response. intervention 2: Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.

Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"

Protocol documents:
Clinical trial NCT01228084
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer
Keywords: sulforaphane broccoli sprout extract (BSE) prostate cancer recurrent prostate cancer phase II
Sponsor: OHSU Knight Cancer Institute
Start date: 2010-11-01; Completion date: 2013-05-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the proportion of patients who achieve a 50% decline in prostate-specific antigen (PSA) levels within 20 weeks of sulforaphane treatment.

SECONDARY OBJECTIVES:

I. To determine the percentage change in PSA from baseline to the final measured value at the end of study as well as the maximal PSA decline that occurs while on study for each subject.

II. To determine the proportion of patients whose PSA has not doubled after full 20 weeks of sulforaphane treatment.

III. To determine the safety profile of sulforaphane. IV. To determine the pharmacokinetics (PK) of sulforaphane and its metabolites in blood.

V. To determine the effect of sulforaphane supplementation on target pharmacodynamic (PD) modulation in peripheral blood cells.

VI. To assess the effect of Glutathione-S-Transferase Mu 1 (GSTM1) genotype on sulforaphane PK, PD.

VII. To collect frozen serum for future analysis of correlative biomarkers.

OUTLINE:

Patients receive sulforaphane orally (PO) once daily for 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 14-30 days and every 6 months for 12 months.

Arms: arm 1: Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
Interventions: intervention 1: Sulforaphane intervention 2: Laboratory biomarker analysis intervention 3: Pharmacological study
Intervention descriptions: intervention 1: Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic. intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01232738
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Yunxia Wang, MD
Start date: 2011-12-01; Completion date: 2013-05-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.

Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.

Detailed description:
The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression

Arms: arm 1: Treated for 12 months with rasagiline 2mg orally, once daily.
Interventions: intervention 1: rasagiline
Intervention descriptions: intervention 1: rasagiline 2 mg daily for 12 months

Protocol documents:
Clinical trial NCT01234116
Conditions: Human Immunodeficiency Virus
Keywords: Post exposure prophylaxis Health Care Workers
Sponsor: Henry Ford Health System
Start date: 2011-02-01; Completion date: 2013-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital.

Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.

Detailed description:
Health Care Workers that have occupational exposure to blood are at risk for HIV infection. Prevention of blood exposure, through safer practices, barrier precautions, safer needle devices, and other innovations, is the best way to prevent infection with HIV and other bloodborne pathogens.

Though these strategies have been successful in reducing the frequency of blood exposure and needlestick injuries in the past decade, the hazard has not been eliminated. As of December 2001, the CDC had received voluntary reports of 57 documented cases of HIV seroconversion temporally associated with occupational exposure to HIV among U.S. health care personnel. An additional 138 infections among health care personnel were considered possible cases of occupational transmission. Because there is no cure or effective vaccine for HIV, optimal post exposure care, including the administration of antiretroviral drugs to prevent HIV infection, remains a high priority in protecting health care workers.

Arms: arm 1: Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. arm 2: Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
Interventions: intervention 1: emtricitabine/tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: Each health care worker will receive one of the Treatment Arms for 28 days.

Protocol documents:
Clinical trial NCT01244490
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2011-01-17; Completion date: 2013-05-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: None arm 2: Active Reference arm 3: None
Interventions: intervention 1: Extended-release Guanfacine Hydrochloride intervention 2: Atomoxetine Hydrochloride intervention 3: Placebo Comparator
Intervention descriptions: intervention 1: Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose. intervention 2: Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose intervention 3: Placebo

Protocol documents:
Clinical trial NCT01251952
Conditions: Multiple Myeloma
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2010-11-01; Completion date: 2013-05-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days).

The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.

Detailed description:

Arms: arm 1: Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Interventions: intervention 1: Denileukin Diftitox (Ontak)
Intervention descriptions: intervention 1: After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.

Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.

Protocol documents:
Clinical trial NCT01252290
Conditions: Breast Cancer
Sponsor: Carol Fabian, MD
Start date: 2010-11-01; Completion date: 2013-05-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides.

Detailed description:
The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid esters \[eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg\] daily in the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice daily) will have a favorable side effect profile and potential efficacy as demonstrated by favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer in postmenopausal women.

Arms: arm 1: Lovaza™ (two 1 gram capsules twice daily) for six months
Interventions: intervention 1: Lovaza™
Intervention descriptions: intervention 1: 4 capsules daily for 6 months

Protocol documents:
Clinical trial NCT01264380
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2011-01-01; Completion date: 2013-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: RO5185426 intervention 2: RO5185426 intervention 3: RO5185426
Intervention descriptions: intervention 1: Single oral dose, fasted intervention 2: Single oral dose, with high fat meal intervention 3: Continuous administration, orally twice daily

Protocol documents: