ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00927485
Conditions: Familial Adenomatous Polyposis
Keywords: Familial Adenomatous Polyposis (FAP) Curcumin Colorectal polyps Duodenal polyps
Sponsor: University of Puerto Rico
Start date: 2007-11-01; Completion date: 2016-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.

Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Detailed description:
Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

Arms: arm 1: Curcumin arm 2: Placebo (sugar pills)
Interventions: intervention 1: Calcumin (Curcumin) intervention 2: Risk Factor Questionnaire intervention 3: Blood samples intervention 4: Biopsies (Sigmoidoscopy) intervention 5: Biopsies (Upper endoscopy)
Intervention descriptions: intervention 1: Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months). intervention 2: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes. intervention 3: Three tubes of blood at visits 0, 4 and 12 months. intervention 4: Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy. intervention 5: Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Protocol documents:
Clinical trial NCT00974142
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Cyclosporine Oral Immunotherapy Advanced stage
Sponsor: Michael Donahoe
Start date: 2009-09-01; Completion date: 2016-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA) in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).

Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD, not responsive to conventional inhaler therapy, who meet all the study requirements, will be enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cyclosporine intervention 2: Placebo
Intervention descriptions: intervention 1: Fifteen patients will receive cyclosporine at an initial dosing of 3.0 mg/kg/day. intervention 2: Fifteen patients will receive will receive placebo.

Protocol documents:
Clinical trial NCT01016561
Conditions: Cervical Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2009-07-01; Completion date: 2016-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy.

Detailed description:
PURPOSE: This clinical trial is studying magnetic resonance imaging-based radiation therapy and cisplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.Detailed DescriptionPRIMARY OBJECTIVES:

I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.

II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.

III. To evaluate local, regional, and distant recurrence rates. IV. To evaluate disease-free and overall survival rates. OUTLINE: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.

After completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.

Arms: arm 1: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
Interventions: intervention 1: intracavitary balloon brachytherapy intervention 2: external beam radiation therapy intervention 3: intensity-modulated radiation therapy intervention 4: radiation therapy treatment planning/simulation intervention 5: 3-dimensional conformal radiation therapy intervention 6: Cisplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01034631
Conditions: Renal Cell Carcinoma
Keywords: Metastatic Kidney Cancer BNC105P
Sponsor: Hoosier Cancer Research Network
Start date: 2010-01-01; Completion date: 2016-12-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.

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

Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle

* Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2
* Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2
* Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2
* Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2

Phase II: Patients will be randomized 1:1 to Arm A or Arm B

Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle

Sequential Arm B: Everolimus 10 mg 21 day cycle

* Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.

Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy.

Life Expectancy: Not specified

Hematopoietic:

* White blood cell count (WBC) \> 3.5 K/mm3
* Hemoglobin (Hgb) \> 8.5 g/dL
* Platelets \> 100 K/mm3
* Absolute neutrophil count (ANC) \> 1.5 K/mm3

Hepatic:

* Total Bilirubin \< 1.25 x ULN
* Aminotransferase (AST and ALT) \< 2.5 x ULN

Renal:

* Serum Creatinine \< 2.5 x ULN (upper limit normal)

Cardiovascular:

* No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
* No history of clinical CHF or LVEF \<50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.

Arms: arm 1: Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle arm 2: Sequential Arm B: Everolimus 10 mg, 21 day cycle

Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Interventions: intervention 1: Everolimus intervention 2: BNC105P
Intervention descriptions: intervention 1: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals intervention 2: BNC105P, up to 16 mg/m\^2

Protocol documents:
Clinical trial NCT01140360
Conditions: Neurofibromatosis Neurofibromas
Keywords: Neurofibromas
Sponsor: Kent Robertson
Start date: 2012-02-01; Completion date: 2016-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a second Pilot Study to determine the efficacy of Gleevec® in neurofibromatosis (NF1) patients with plexiform neurofibromas using new response assessment modalities with the secondary goals of assessing Gleevec toxicity, and characterizing markers of response. The rationale for this study arises from the response of human and murine NF1 cells to Gleevec® in vitro, the response of a NF1 patient treated with Gleevec® for airway compression by a plexiform neurofibroma with a dramatic response not previously seen in NF1 therapy, and the experience in 37 NF1 patients treated with Gleevec® in the initial pilot study. Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA \> 1.8 m2 or 55 mg/m2 twice daily for patients with BSA \< 1.8 m2. For patients with a BSA \> 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA \< 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid. Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.

Detailed description:

Arms: arm 1: Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA \> 1.8 m2 or 55 mg/m2 twice daily for patients with BSA \< 1.8 m2. For patients with a BSA \> 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA \< 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
Interventions: intervention 1: Gleevec
Intervention descriptions: intervention 1: Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA \> 1.8 m2 or 55 mg/m2 twice daily for patients with BSA \< 1.8 m2. For patients with a BSA \> 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA \< 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.

Protocol documents:
Clinical trial NCT01302379
Conditions: Breast Neoplasms
Keywords: Obesity Survival Weight loss Metformin Biological markers
Sponsor: University of California, San Diego
Start date: 2011-08-01; Completion date: 2016-12-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Metformin intervention 2: Placebo intervention 3: Lifestyle intervention intervention 4: Standard printed dietary guidelines
Intervention descriptions: intervention 1: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time intervention 2: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time intervention 3: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss. intervention 4: Set of standard health education materials provided to participants at single time point (immediately after randomization)

Protocol documents:
Clinical trial NCT01302743
Conditions: Diabetes
Keywords: Diabetes Metformin Cinnamon
Sponsor: Mike O'Callaghan Military Hospital
Start date: 2010-11-01; Completion date: 2016-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.

Detailed description:
We are studying whether or not cinnamon bark or water-soluble cinnamon could be an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of metformin 1000 mg (extended-release). This study will enroll 309 subjects type 2 diabetics (using American Diabetes Association criteria) on no hypoglycemic medications. Subjects will be randomized into one of three groups, group 1 will receive oral extended-release Metformin 1000mg, group 2 will receive Cinnamon Bark 1000mg, group 3 will receive cinnulin PF 500mg. Subjects will be instructed to take their study pills once a day for 90 days.After 90 days of treatment, each subject will again have hemoglobin A1C, lipid panel, height, weight, blood pressure and waist circumference measured. Analysis described above using intention-to-treat principles for any missing data will be used (we will use the carry-forward method to impute missing data). Subjects will bring in any remaining medication to determine adherence rates to the study protocol.

Arms: arm 1: oral extended-release Metformin 1000 mg once a day for 90 days arm 2: Cinnamon Bark 1000 mg once a day for 90 days arm 3: Cinnulin PF 500 mg once a day for 90 days
Interventions: intervention 1: Group 1: Metformin intervention 2: Group 2: Cinnamon Bark intervention 3: Group 3: Cinnulin PF
Intervention descriptions: intervention 1: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days intervention 2: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days intervention 3: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Protocol documents:
Clinical trial NCT01322048
Conditions: Brain Injuries Craniocerebral Trauma Trauma, Nervous System Traumatic Brain Injury
Keywords: Sympathetic Hyperactivity Traumatic Brain Injury Agitation Severe TBI TBI Catecholamines Heart rate variability Adrenergic alpha-Agonists Adrenergic beta-Antagonists Cognitive Impairment
Sponsor: Vanderbilt University
Start date: 2011-08-01; Completion date: 2016-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe Traumatic Brain Injury (TBI).

The primary hypothesis is that adrenergic blockade after severe TBI will be associated with increased ventilator-free days.

Detailed description:
Severe traumatic brain injury (TBI) is associated with sympathetic hyperactivity resulting in catecholamine excess, abnormal heart rate variability, agitation and sympathetic storms, deep white matter changes, and poor neuropsychological outcomes. Notably, persistent sympathetic hyperactivity after TBI results in higher days of mechanical ventilation and longer intensive care unit (ICU) length of stay (LOS). While there are data describing limited portions of this response, the full spectrum of sympathetic hyperactivity after severe TBI has not been systemically described or methodically intervened upon.

We will perform a double-blinded, randomized, placebo-controlled pilot trial in a 100 patient cohort in which one group will receive centrally acting sympatholytic drugs, propranolol and clonidine, and the other group, placebo, within 48 hours of severe TBI. The length of therapy will be 7 days.

The primary question studied is whether ventilator-free days will be increased after therapy.

Secondary endpoints include plasma and urine catecholamine levels, heart rate and blood pressure variability, responses to autonomic cold pressor testing, assessments of coma, sedation, and agitation, sedative requirements, analgesic use, antipsychotic medication use, coma-free days, ventilator-free days, Intensive Care Unit (ICU) length of stay, and survival. Also, neuropsychological outcomes will be measured at ICU discharge, 3 months, and 12 months.

Interim Analysis: At approximately 50% targeted accrual, n=46 randomized subjects, an interim analysis will be performed with A Priori (planned) futility and efficacy rules, which are DSMB and IRB approved.

Arms: arm 1: Propranolol and Clonidine arm 2: Placebo
Interventions: intervention 1: IV Propranolol and Per Tube Clonidine intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days intervention 2: Placebo IV q6h and Per Tube q12, both for 7 days

Protocol documents:
Clinical trial NCT01358266
Conditions: Uveitis; Posterior, Disorder
Sponsor: Santen Inc.
Start date: 2011-05-01; Completion date: 2016-12-01
Enrollment: 592 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: DE-109 44 ug intervention 2: DE-109 440 ug intervention 3: DE-109 880 ug
Intervention descriptions: intervention 1: Low dose intervention 2: Medium dose intervention 3: High dose

Protocol documents:
Clinical trial NCT01373164
Conditions: Neoplasms Neoplasm Metastasis Pancreatic Cancer
Keywords: Neoplasms Neoplasm Metastasis Pancreatic Cancer
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2016-12-01
Enrollment: 170 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy

Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

Detailed description:

Arms: arm 1: Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. arm 2: Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. arm 3: Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. arm 4: Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. arm 5: Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Interventions: intervention 1: Galunisertib intervention 2: Gemcitabine intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered intravenously intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01377987
Conditions: Heart Failures
Sponsor: David Andrew Wellman
Start date: 2011-08-01; Completion date: 2016-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The ultimate goal is to improve our understanding of the pathophysiology and resistance to effective treatment of sleep disordered breathing in patients with heart failure, with a focus on selecting patients that will benefit specifically from acetazolamide treatment.

The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the most severe ventilatory control instability (strongest chemoreflex response to carbon dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary congestion, and cardiac function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Acetazolamide intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg/kg, once daily before bed, for 7 days intervention 2: 4 mg/kg, once daily before bed, for 7 days

Protocol documents: