ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01024387
Conditions: Neuroendocrine Tumor Carcinoid Tumor Pancreatic Neuroendocrine Tumor
Keywords: AMG 479
Sponsor: Dana-Farber Cancer Institute
Start date: 2010-03-01; Completion date: 2017-01-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the effectiveness of AMG 479 against carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the laboratory. Antibodies are highly specific proteins produced by the body's immune system that recognize foreign substances in the body. AMG 479 has been used in other research studies and information from those other research studies suggests that AMG 479 may help to prevent the growth of some neuroendocrine tumors. The observed antitumor activity of AMG 479, together with the current limited treatment options available for patients with neuroendocrine tumors, warrant further investigation of AMG 479 in this patient population.

Detailed description:
Neuroendocrine tumors (NETs) comprise a heterogeneous spectrum of neoplasms. NETs are commonly subclassified into two broad subgroups according to their site of origin: pancreatic NETs are thought to arise from the endocrine cells of the pancreas, whereas NETs of other sites such as the lungs or gastrointestinal tract are often referred to as carcinoid tumors. While histologically similar, carcinoid tumors and pancreatic neuroendocrine tumors have demonstrated different response rates in prior phase II studies of antitumor agents. Because of these differences, we will perform the current study using two cohorts of patients (30 with carcinoid and 30 with pancreatic neuroendocrine tumors). The statistical design, however, is the same for both cohorts. With 30 patients in each cohort, this study has 80% power assuming type I error of 6% to differentiate a \>/=17% objective response rate from a \</=5% objective response rate using a single stage design. The proposed regimen would be promising in either cohort if at least 4 of 30 patients achieve an objective response.

Arms: arm 1: Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Interventions: intervention 1: AMG 479
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01275053
Conditions: Lean Obese Obese Diabetics
Keywords: Leptin In Vivo Diabetic Obese Lean
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2002-07-01; Completion date: 2017-01-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to help us to better understand how leptin regulates blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells. Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an investigational drug and has not yet been approved by the Food and Drug Administration (FDA), will be administered to participants in this study. The expected duration of your participation is 3 study visits, which will be spread over 3-4 weeks.

This study involves having fat and muscle biopsies after receiving leptin under local anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or Endocrinology exam room at the Beth Israel Deaconess Medical Center.

Detailed description:
Screening Visit During this visit, you will have a complete medical history taken and have a physical examination performed by one of the study physicians. You will also have your height and weight measured. You will have a blood drawn (approximately 2 tablespoons)and will have an electrocardiogram (EKG). At the screening visit you will also meet with a dietician who will review your food preferences with you in order to design the meals that you will receive as part of the study.

Study Day #1: You will pick up your meals designed with the dietician. You will be provided with meals for 48 hours prior to your fat biopsy. These meals will be designed by the dietician based upon what you like to eat. You will also have your Resting Metabolic Rate Measured.

Study Day #2: A nurse will will insert two intravenous catheters (IV) into a medium size vein in each of your forearms. You will then have two fat and muscle thigh biopsy. One before and one after leptin is given. You will stay in the hospital for three hours of observation. During this time you will have your Resting Metabolic Rate measured and then you will be provided with a meal.

Study Day #3: Seven to ten days after the biopsy, you will be asked to return to the hospital so that the surgeon can inspect the wound.

Your participation in this study will involve 3 study visits, which will be spread out over 3-4 weeks.

Arms: arm 1: None
Interventions: intervention 1: leptin
Intervention descriptions: intervention 1: 0.01mg/kg

Protocol documents:
Clinical trial NCT01296672
Conditions: Prostate Cancer
Keywords: Finasteride Placebo Prostate cancer Prostate Specific Antigen (PSA) Men at intermediate risk of prostate cancer Men scheduled for prostate biopsy
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2011-02-01; Completion date: 2017-01-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

Detailed description:
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.

Arms: arm 1: Finasteride 5mg tablets every day by mouth for 3 months arm 2: Placebo 5mg tablet every day by mouth for 3 months
Interventions: intervention 1: Finasteride intervention 2: Placebo
Intervention descriptions: intervention 1: Finasteride 5mg every day by mouth for 3 months intervention 2: Placebo every day by mouth for 3 months

Protocol documents:
Clinical trial NCT01352182
Conditions: Severe Sepsis Septic Shock
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2011-10-01; Completion date: 2017-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to determine the effect on inflammatory biomarkers for pioglitazone in patients with severe sepsis and septic shock.

Detailed description:
Severe sepsis is a major cause of morbidity and mortality among adults and children. Few clinical trials have demonstrated clinical benefit in sepsis. Severe sepsis is a systemic inflammatory syndrome in response to infection that is associated with acute organ dysfunction. The nuclear receptor peroxisome proliferator-activated receptor-gamma (PPARg) is involved in the regulation of the sepsis-induced inflammatory response. The central hypothesis is that pioglitazone reduces the inflammatory responses in children with severe sepsis and septic shock.

Arms: arm 1: Pioglitazone hydrochloride treatment group arm 2: Normal standard care control group
Interventions: intervention 1: Pioglitazone hydrochloride
Intervention descriptions: intervention 1: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.

Protocol documents:
Clinical trial NCT01354444
Conditions: Alzheimer's Disease
Keywords: Memory problems Alzheimer's Disease
Sponsor: Johns Hopkins University
Start date: 2011-06-01; Completion date: 2017-01-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with the primary objective being to determine whether carvedilol treatment is associated with improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this dose will be safe and well-tolerated in AD patients. Clinical assessments will be performed at baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be obtained at baseline and 6 months.

Detailed description:
The purpose of the study is to measure decline in episodic memory in participants with early AD taking carvedilol compared to placebo treatment as evidenced by the Hopkins Verbal Learning Test (HVLT). cerebrospinal fluid levels of Aβ oligomers in early AD, will be measured in participants receiving carvedilol treatment when compared to placebo treatment. Adverse effects will be monitored in participants receiving carvedilol when compared to placebo.

To assess adverse events, routine chemistry and hematology studies, vital signs, and electrocardiographic parameters before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing 25 early AD participants taking carvedilol vs. 25 early AD participants taking placebo.

Arms: arm 1: Carvedilol is a is a beta-blocker. Beta-blockers are generally used to reduce the workload on the heart and help it to beat more regularly. arm 2: Non active substance
Interventions: intervention 1: Carvedilol intervention 2: Placebo
Intervention descriptions: intervention 1: target dose of 25 mg daily which is half the maximum dose used in clinical practice intervention 2: a pill that will look like the active drug but will not contain any carvedilol

Protocol documents:
Clinical trial NCT01609348
Conditions: Alzheimer's Disease Depression
Keywords: Depression Alzheimer's Disease
Sponsor: Johns Hopkins University
Start date: 2012-04-01; Completion date: 2017-01-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease. Venlafaxine works by increasing natural substances in the brain (serotonin and norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest neurodegenerative disease of aging and the cause of major financial and emotional burden to patients, families and caregivers, and society. Depression is a very common symptom of AD, affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's disease) contributes greatly to patient disability and caregiver distress. Neither psychosocial interventions nor psychotropic medications have proven effective to date for the treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depression but it is not known whether or not it can help depression in Alzheimer's Disease.

Detailed description:

Arms: arm 1: 225 mg daily over 12 weeks arm 2: None
Interventions: intervention 1: Placebo intervention 2: Venlafaxine
Intervention descriptions: intervention 1: Capsule matching active drug to be taken once a day for 12 weeks intervention 2: 225 mg daily for 12 weeks

Protocol documents:
Clinical trial NCT01683565
Conditions: Preterm Birth Child Development Child Behavior
Sponsor: Sarah Keim
Start date: 2012-09-01; Completion date: 2017-01-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help development and behavior of children born preterm.

Detailed description:

Arms: arm 1: EPA + DHA + GLA + OA oil supplement arm 2: None
Interventions: intervention 1: LCPUFA oil supplement intervention 2: Canola Oil Placebo
Intervention descriptions: intervention 1: 2.5mL per day for 90 days

Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg) intervention 2: 2.5mL per day for 90 days

Protocol documents:
Clinical trial NCT01827930
Conditions: Leukemia, Myeloid, Chronic-Phase
Keywords: chronic myeloid leukemia in chronic phase residual plasma IM concentration adapted strategy
Sponsor: Institut Bergonié
Start date: 2009-07-01; Completion date: 2017-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

Detailed description:
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.

Arms: arm 1: Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po arm 2: Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po arm 3: Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Interventions: intervention 1: Imatinib Mesylate 600 MG Oral Tablet intervention 2: Imatinib Mesylate 400 MG Oral Tablet intervention 3: Imatinib Mesylate
Intervention descriptions: intervention 1: Imatinib Mesylate for CP CML intervention 2: Imatinib Mesylate for CP CML intervention 3: Imatinib Mesylate for CP CML

Protocol documents:
Clinical trial NCT01849588
Conditions: Hepatocellular Cancer
Keywords: Hepatitis C positive
Sponsor: Massachusetts General Hospital
Start date: 2013-05-01; Completion date: 2017-01-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.

The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.

Detailed description:
This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.

Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood

During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.

Arms: arm 1: Sorafenib taken orally twice per day
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01860287
Conditions: Basic Science
Keywords: opioid subjective stress buprenorphine
Sponsor: University of Chicago
Start date: 2013-09-01; Completion date: 2017-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.

Detailed description:

Arms: arm 1: Healthy volunteers receive placebo during session (within-subjects design). arm 2: Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design). arm 3: Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).
Interventions: intervention 1: Buprenorphine 0.2 MG Sublingual Tablet intervention 2: Placebo intervention 3: Buprenorphine 0.4 MG Sublingual Tablet
Intervention descriptions: intervention 1: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2) intervention 2: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo intervention 3: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)

Protocol documents:
Clinical trial NCT01861665
Conditions: Post-operative Pain
Sponsor: Weill Medical College of Cornell University
Start date: 2010-06-01; Completion date: 2017-01-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.

Detailed description:
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

Arms: arm 1: Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. arm 2: Marcaine 0.25% administered post-incision, total amount 5cc per incision.
Interventions: intervention 1: Marcaine- 0.25% intervention 2: Marcaine 0.25%.
Intervention descriptions: intervention 1: Marcaine 0.25% administered pre-incision. intervention 2: Marcaine 0.25% administered post-incision.

Protocol documents:
Clinical trial NCT01895959
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis (OA) hyaluronic acid injection
Sponsor: University of California, San Francisco
Start date: 2013-08-01; Completion date: 2017-01-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to identify novel imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.

We hypothesize that:

1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of glutamate will predict patient response of pain relief after HA injection;
3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and T2 will decrease in patients who respond to the treatment, indicating potential beneficial effects of HA injection to cartilage preservation.

Detailed description:

Arms: arm 1: EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Interventions: intervention 1: Euflexxa intervention 2: Magnetic Resonance Imaging (MRI)
Intervention descriptions: intervention 1: Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint. intervention 2: MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).

Protocol documents:
Clinical trial NCT01905683
Conditions: Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2013-08-01; Completion date: 2017-01-01
Enrollment: 370 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: IncobotulinumtoxinA (16-20 Units per kg body weight)
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.

Protocol documents: