ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00946309
Conditions: Prostate Cancer
Sponsor: Fred Hutchinson Cancer Center
Start date: 2010-07-01; Completion date: 2015-05-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.

The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: High Sulforaphane Extract (Broccoli Sprout Extract) intervention 2: Microcrystalline Cellulose NF (placebo)
Intervention descriptions: intervention 1: 100 umol sulforaphane, every other day for 5 weeks intervention 2: 250 mg every other day for 6 weeks

Protocol documents:
Clinical trial NCT01000064
Conditions: Traumatic Brain Injury Attention Deficit Disorder
Keywords: Traumatic Brain Injury Attention Deficit TBI
Sponsor: Vanderbilt University
Start date: 2009-10-01; Completion date: 2015-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.

Detailed description:
Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.

Arms: arm 1: Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

Placebo capsule each morning for 6 weeks.

Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit. arm 2: Vyvanse capsule, 30-70 mg, each morning for 6 weeks.

Placebo capsule each morning for 6 weeks.

Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit.
Interventions: intervention 1: Vyvanse intervention 2: fMRI intervention 3: Placebo
Intervention descriptions: intervention 1: 30 mg - 70 mg capsules taken every morning for 6 weeks. intervention 2: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit. intervention 3: Placebo capsules taken every morning for 6 weeks.

Protocol documents:
Clinical trial NCT01007552
Conditions: Cholangiocarcinoma
Keywords: Biliary Duct Cancer Cancer of the Gallbladder Adenocarcinoma of the Gall Bladder Adenocarcinoma of the Biliary Ducts Cholangiocarcinoma Extrahepatic cholangiocarcinoma
Sponsor: Roswell Park Cancer Institute
Start date: 2009-12-01; Completion date: 2015-05-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.

Detailed description:
The primary objective of this study is to assess progression free survival with proposed therapy for patients with locally advanced or metastatic adenocarcinoma of the gallbladder or biliary ducts.

Arms: arm 1: Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Interventions: intervention 1: Gemcitabine, Capecitabine and Bevacizumab
Intervention descriptions: intervention 1: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days.

Protocol documents:
Clinical trial NCT01053637
Conditions: Children Lacerations Procedures Child Pain
Keywords: lacerations sutures pediatrics child pain Anxiety
Sponsor: Baylor College of Medicine
Start date: 2009-02-01; Completion date: 2015-05-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment
* To evaluate for a statistical difference in pain scores in children during laceration repair
* To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair

Detailed description:
A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.

Arms: arm 1: Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. arm 2: Placebo
Interventions: intervention 1: hydrocodone/acetaminophen intervention 2: Sugar water
Intervention descriptions: intervention 1: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered. intervention 2: An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug

Protocol documents:
Clinical trial NCT01059071
Conditions: Neuroblastoma
Keywords: Refractory Neuroblastoma Relapsed neuroblastoma
Sponsor: Giselle Sholler
Start date: 2010-02-01; Completion date: 2015-05-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate a new investigational drug to treat neuroblastoma. This study drug is called DFMO. The objectives of this study will be to monitor for safety and to find a maximum tolerated dose in this population. A secondary objective will be to look at efficacy of DFMO.

The safety of the proposed dosing regimen in this trial will be tested by an on-going risk/benefit assessment during the study. A patient benefiting from treatment, not progressing on therapy, and in the absence of any safety issues associated with DFMO and/or etoposide may continue on treatment with the expectation that there will be an overall clinical benefit.

The procedures involved in this study include Medical history, Physical exam, Vital signs (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are considered standard of care for this population. Drug administration is also part of this protocol, including an investigational new drug called DFMO, and later combined with an already approved drug, etoposide.

The proposed dosing regimen is an oral dose of DFMO two times a day for each day while on study. There will be 5 cycles. Each cycle will be 21 days in length. The first cycle will be DFMO alone. In the second cycle etoposide will be added in and will be given orally once a day for the first 14 days of each cycle (cycles 2-5).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: DFMO intervention 2: Etoposide
Intervention descriptions: intervention 1: Escalating doses of DFMO in a 3 +3 cohort design.

DFMO at current cohort Dose Level orally each day for 21 day cycles

Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID intervention 2: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg.

Protocol documents:
Clinical trial NCT01064284
Conditions: Hemophilia A
Keywords: Hemophilia A Factor VIII inhibitors vWF/FVIII rFVIII
Sponsor: Fondazione Angelo Bianchi Bonomi
Start date: 2010-01-01; Completion date: 2015-05-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII concentrates by determining the frequency of inhibitor development in previously untreated patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the first 3 years from enrollment, whichever occurs first.

.

Detailed description:
Patients meeting the enrollment criteria will be consecutively enrolled at each participating centre, randomized to be treated exclusively with a single FVIII product either plasma-derived or recombinant, and followed up until inhibitor development or until 50 exposure days (EDs) or 3 years from enrolment have elapsed, whichever comes first. Study products, belonging to the class of rFVIII concentrates and to the class of plasma-derived VWF/FVIII concentrates, will be provided for free to the patients for all the duration of the study

Arms: arm 1: Plasma-derived vWF/FVIII arm 2: Recombinant FVIII
Interventions: intervention 1: PLASMA DERIVED Factor VIII intervention 2: Recombinant FVIII
Intervention descriptions: intervention 1: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding intervention 2: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding

Protocol documents:
Clinical trial NCT01088997
Conditions: Persistent Fetal Circulation Syndrome
Keywords: Persistent pulmonary hypertension of newborn PPHN Persistent pulmonary hypertension Pulmonary hypertension Pulmonary hypertension of newborn
Sponsor: Children's Hospital of Philadelphia
Start date: 2010-06-01; Completion date: 2015-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger study of babies with persistent pulmonary hypertension of the newborn (PPHN).

Detailed description:
Persistent pulmonary hypertension of the newborn (PPHN) is a condition in which the pulmonary vasculature fails to relax after birth resulting in severe hypoxemia. This condition has a high rate of mortality and morbidity. The current standard of care is treatment with inhaled nitric oxide (iNO). However, for many babies this treatment does not provide sufficient improvement in oxygenation.

In this study, subjects already receiving nitric oxide will be randomized to one of two dosing regimens of milrinone. They will receive milrinone IV for 24 hours and will be monitored for 24 hours afterwards. During this time, milrinone assays will be performed by blood sampling. Echocardiograms will also be performed to explore the pharmacodynamics of milrinone. Safety monitoring will be performed.

Arms: arm 1: Subjects will receive a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours. arm 2: Subjects will receive a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours.
Interventions: intervention 1: Milrinone Lactate
Intervention descriptions: intervention 1: Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.

Protocol documents:
Clinical trial NCT01091259
Conditions: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma
Keywords: antibody therapy chemotherapy biologic therapy combination therapy
Sponsor: NYU Langone Health
Start date: 2010-03-01; Completion date: 2015-05-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab.

Detailed description:
Accumulating data suggests that angiogenesis plays a critical role in the formation and development of a number of solid tumors including ovarian cancer. For women with ovarian cancer, a direct relationship between vascular endothelial growth factor (VEGF) expression and tumor vascularity has been documented. In vivo and in vitro data has demonstrated that increased angiogenesis and microvessel density are negative prognostic factors for women with ovarian cancer. These observations have fueled interest in incorporating anti-angiogenic agents into ovarian cancer treatment regimens.

Several phase II trials of irinotecan in patients with epithelial ovarian cancer showed that the drug had efficacy in both chemotherapy-naïve patients and in those who had been previously treated with standard therapies, including platinum-based compounds, radiation, or both. Combination of bevacizumab, an antibody against VEGF, and irinotecan was studied in colorectal cancer and malignant brain neoplasms. In these trials, the combination was shown to be safe and effective.

The purpose of this study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab. In this phase II open-label study patients will be treated with bevacizumab 15 mg/kg and irinotecan 175mg/m\^2 every 3 weeks. Patients will undergo pre-treatment evaluation within 4 weeks of enrolling into the study. Clinical and laboratory evaluation will be performed every 3 weeks. Imaging studies and CA-125 measurements will be used to assess response to treatment.

Arms: arm 1: Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
Interventions: intervention 1: Irinotecan intervention 2: Bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01117428
Conditions: Metastatic Colorectal Cancer
Keywords: Advanced solid tumors Metastatic colorectal Cancer
Sponsor: Symphogen A/S
Start date: 2010-03-01; Completion date: 2015-05-01
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

Detailed description:
Part A investigates the safety and pharmacokinetics (PK) of escalating weekly dosing of Sym004 in patients with recurrent advanced solid tumors.

Part B and C validates the safety, PK and efficacy of weekly dosing of Sym004 at the maximum tolerated dose (MTD) in a homogenous patient population with advanced metastatic colorectal cancer (mCRC) and wild-type Kirsten rat sarcoma (KRAS). Part B will be initiated when a safe dose has been established in Part A.

If MTD equals 12 mg/kg, then part C will explore the 9 mg/kg level.

Part D and E is to validate the safety, PK and efficacy when administered every 2 weeks at doses of 12 mg/kg and 18 mg/kg, respectively.

Part F is to validate safety, PK and efficacy when administered with a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg.

Arms: arm 1: None
Interventions: intervention 1: Sym004
Intervention descriptions: intervention 1: In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression.

In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression.

In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression.

In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression.

In Part F, patients will receive a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg.

Protocol documents:
Clinical trial NCT01123161
Conditions: Stroke, Acute
Keywords: Hypothermia Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Body Temperature Changes Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Signs and Symptoms Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Plasminogen cooling tPA thrombolysis
Sponsor: University of California, San Diego
Start date: 2010-06-01; Completion date: 2015-05-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.

Detailed description:
A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)-a naturally occurring protein that opens blocked arteries by dissolving blood clots - activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.

The Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset.

Researchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging.

Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.

There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

Arms: arm 1: IV tpa and normothermia arm 2: IV tpa and hypothermia and anti-shivering treatment
Interventions: intervention 1: hypothermia and anti-shivering treatment intervention 2: Group1: IV t-PA and normothermia
Intervention descriptions: intervention 1: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming intervention 2: Group 1 will t-PA as standard of care and normothermia

Protocol documents:
Clinical trial NCT01124838
Conditions: Uveitis
Keywords: Uveitis
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-08-01; Completion date: 2015-05-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19. arm 2: Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
Interventions: intervention 1: Adalimumab intervention 2: Prednisone intervention 3: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1. intervention 2: Administered orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all subjects continuing in the study were to discontinue prednisone no later than Week 19. intervention 3: Administered by subcutaneous injection

Protocol documents: