ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00578721
Conditions: Colorectal Cancer
Keywords: Colorectal cancer aspirin
Sponsor: University of California, Irvine
Start date: 2008-09-24; Completion date: 2013-11-26
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence and for development of secondary colorectal cancers in the future. Specific chemicals (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help understand a person's risk for developing colorectal cancer. Specific biomarkers associated with colorectal cancer have been identified in prior laboratory studies. By measuring these predefined biomarkers before and after the study intervention, we can assess how they are affected by the intervention, and gain knowledge about their usefulness in colorectal cancer patients on clinical trial.

This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.

Detailed description:

Arms: arm 1: 325 mg aspirin po qd with arginine-restricted diet
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: 325 mg taken daily with an arginine-restricted diet

Protocol documents:
Clinical trial NCT01168232
Conditions: Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-09-07; Completion date: 2013-11-26
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.

II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

II. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.

OUTLINE:

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Ixabepilone intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01707667
Conditions: Chronic Constipation
Sponsor: Shire
Start date: 2013-02-27; Completion date: 2013-11-27
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: prucalopride intervention 2: PEG 3350
Intervention descriptions: intervention 1: One 2 mg tablet orally administered on Day 1 intervention 2: 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).

Protocol documents:
Clinical trial NCT02101008
Conditions: Melanoma
Sponsor: University of Utah
Start date: 2010-03-01; Completion date: 2013-11-27
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives Determine the response rate associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.

Secondary Objectives Determine the progression-free survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.

Determine the overall survival associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc.

Determine the toxicity associated with treatment of refractory disseminated malignant melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated zinc on in vivo protein S-glutathionylation.

Detailed description:

Arms: arm 1: There is only one arm. All patients are treated wtih disulfiram and chelated zinc.
Interventions: intervention 1: disulfiram and chelated zinc
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01544166
Conditions: Magnetic Resonance Imaging
Keywords: Gadolinium, Pediatrics, MRI, contrast
Sponsor: Bayer
Start date: 2012-05-16; Completion date: 2013-11-28
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.

A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.

Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.

The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gadobutrol (Gadavist, BAY86-4875)
Intervention descriptions: intervention 1: Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.

Protocol documents:
Clinical trial NCT00792571
Conditions: Pulmonary Arterial Hypertension
Sponsor: Lung Biotechnology PBC
Start date: 2009-02-28; Completion date: 2013-11-30
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.

Detailed description:
This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.

Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.

Arms: arm 1: Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing) arm 2: Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)
Interventions: intervention 1: Beraprost Sodium Modified Release
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00990314
Conditions: Pulmonary Arterial Hypertension
Sponsor: Lung Biotechnology PBC
Start date: 2009-11-30; Completion date: 2013-11-30
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.

Detailed description:
Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving study drug in an open-label extension.Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment. Patients will be called by study personnel to assess adverse events and concomitant medications at Month 9, and at 3 month intervals following the annual visit.

At the End of Study visit, patients discontinuing study drug will be down-titrated off of BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg) b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise, patients who withdraw early from the study will be down-titrated off of BPS-MR in the same manner. Upon completion of down-titration, patients will return to the clinic for a final Closeout visit.

Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-204 main study.

Arms: arm 1: Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing) arm 2: Beraprost Sodium Modified Release Tablet, 60mcg, q.i.d (four times a day dosing)
Interventions: intervention 1: Beraprost Sodium Modified Release
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01547299
Conditions: Prostate Cancer
Keywords: prostate cancer prostatectomy neoadjuvant
Sponsor: Pfizer
Start date: 2012-03-31; Completion date: 2013-11-30
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Detailed description:

Arms: arm 1: Enzalutamide 160 mg, orally, once daily arm 2: Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
Interventions: intervention 1: Enzalutamide intervention 2: Leuprolide intervention 3: Dutasteride
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00528268
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy SMA Sodium Phenylbutyrate
Sponsor: University of Utah
Start date: 2007-07-01; Completion date: 2013-12-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A variety of outcome measures will be performed at each study visit to follow the course of the disease. Total duration of the study for type I infants will be 18 months, for type II infants, 24 months.

Detailed description:
Perform a phase I/II study to evaluate effects of sodium phenylbutyrate (NaPB) in a cohort of presymptomatic infants, predicted to develop either SMA type 1 or SMA type 2 given genotype and family history of an older sibling with the respective SMA type. Primary outcomes: 1) to collect additional safety and pharmacokinetic data in neonates and young infants administered NaPB within the dosing guidelines already in use for urea cycle disorder therapy, and 2) to determine possible benefit of early treatment intervention with regard to status of denervation and functional motor status at specific time points for which we have matched natural history data to perform a comparison between cohorts and between each cohort and participants from our natural history database matched for age, SMN2 dosage and gender.

Arms: arm 1: Treatment with sodium phenylbutyrate; age \< 3 months; history of sibling(s) with type I SMA; SMN2 dosage \< 3 copies arm 2: Treatment with sodium phenylbutyrate; age \< 6 months; history of sibling(s) with type II SMA; SMN2 dosage \< 4 copies
Interventions: intervention 1: Sodium phenylbutyrate
Intervention descriptions: intervention 1: Sodium phenylbutyrate is dispensed as a powder, 450-600 mg/kg/day, divided into four doses. For cohort 1, treatment and monitoring continues for 18 months. For cohort 2, treatment and monitoring continues for 24 months.

Protocol documents:
Clinical trial NCT01111604
Conditions: Colon Cancer Rectal Cancer
Keywords: Colonic Neoplasms Rectal Neoplasms Adenocarcinoma Antibodies, Monoclonal
Sponsor: Eli Lilly and Company
Start date: 2010-08-01; Completion date: 2013-12-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Detailed description:
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \[FA\] + fluorouracil \[5-FU\] + oxaliplatin \[mFOLFOX-6\])-based regimens, as second-line therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

Arms: arm 1: mFOLFOX-6 arm 2: mFOLFOX-6 + Ramucirumab arm 3: mFOLFOX-6 + Icrucumab
Interventions: intervention 1: Ramucirumab intervention 2: Icrucumab intervention 3: mFOLFOX-6
Intervention descriptions: intervention 1: 8 mg/kg IV Q2W intervention 2: 15 mg/kg IV Q2W intervention 3: Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Protocol documents:
Clinical trial NCT01432444
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-09-01; Completion date: 2013-12-01
Enrollment: 493 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.

Detailed description:
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.

Arms: arm 1: Aripiprazole IM depot injection 300 mg or 400 mg.
Interventions: intervention 1: Aripiprazole (Abilify®) IM Depot Injection
Intervention descriptions: intervention 1: 400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.

Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.

Protocol documents:
Clinical trial NCT01513460
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, NVA 237, glycopyrronium, COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-01; Completion date: 2013-12-01
Enrollment: 773 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. arm 2: Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. arm 3: Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Interventions: intervention 1: NVA237 50µg once daily intervention 2: Tiotropium 18µg once daily intervention 3: Flu/Sal intervention 4: NVA237 placebo + Tiotropium placebo.
Intervention descriptions: intervention 1: NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Tiotropium 18 μg o.d. delivered via a proprietary inhalation device intervention 3: Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device intervention 4: Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Protocol documents:
Clinical trial NCT01556165
Conditions: Parkinson's Disease
Keywords: Rasagiline Azilect Parkinson´s Disease Motor fluctuations
Sponsor: H. Lundbeck A/S
Start date: 2012-04-01; Completion date: 2013-12-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rasagiline intervention 2: placebo
Intervention descriptions: intervention 1: 1 mg/day, tablets, once daily, orally intervention 2: tablets, once daily, orally

Protocol documents:
Clinical trial NCT01715298
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Anticholinergic Antimuscarinic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease Chronic Obstructive Pulmonary Disease COPD LAMA Lung Disease Lung Diseases, Obstructive Lung Function Muscarinic receptor antagonist Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-12-01
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Detailed description:

Arms: arm 1: NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks arm 2: Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules intervention 2: Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Protocol documents: