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NCT ID: NCT01172717 Withdrawn - Carcinoid Syndrome Clinical Trials

Study of Panitumumab in the Treatment of Carcinoid Syndrome

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who fail or do not adequately respond to octreotide or other supportive therapies.

NCT ID: NCT01171456 Withdrawn - Clinical trials for Gestational Diabetes Mellitus

Early Intervention for Gestational Diabetes

Start date: April 2010
Phase: N/A
Study type: Interventional

Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk of neonatal complications as well as an increased prevalence of a number of chronic diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective. Additional studies demonstrated that metformin is able to decrease the incidence of type 2 diabetes among individuals at risk for this disease. Based upon these findings, the investigators propose to test the hypothesis that metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM. The investigators intend to conduct a prospective, randomized, double-blind placebo controlled range-finding study to measure the effects of early metabolic intervention with metformin in women at risk for GDM before the commencement of pregnancy or prior to completion of the first trimester. The target sample size for this pilot study is 100 women. The effect size observed will provide preliminary data for a subsequent study which will be sufficiently powered to detect small or moderate effects from early metabolic intervention in women at risk for GDM. The specific aims of the proposed research consist of the following: 1. Determine whether treating women at risk for GDM with metformin prior to conception and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks' gestation. 2. Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin in women at risk for GDM. 3. Use these pilot study results to: 1. identify specific demographic characteristics associated with an intervention effect 2. calculate effect size for specific outcomes 3. provide range-finding data for a subsequent study design Metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.

NCT ID: NCT01171352 Withdrawn - Clinical trials for Peridialytic Hypotension

Predicting Hypotension During Dialysis in the ICU

Start date: July 19, 2010
Phase:
Study type: Observational

Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the Crit-Lineā„¢ III, and central venous pressures. However, these tools perform poorly in predicting the circulatory system's overall response to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently encountered. Better techniques to predict the circulatory system's response to dialysis are much needed. The intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. This is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. The investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.

NCT ID: NCT01170871 Withdrawn - Clinical trials for Advanced Solid Tumors

Ixabepilone and Pemetrexed/Solid Tumors

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the activity of this combination. This research study is for research participants who have confirmed metastatic or unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate) for which standard curative or palliative measures do not exist or no longer effective.

NCT ID: NCT01170325 Withdrawn - Autism Clinical Trials

A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG

Start date: June 30, 2010
Phase: Phase 2
Study type: Interventional

Background: - Electroencephalography (EEG) records electric patterns produced by the brain, and can detect conditions such as epilepsy or other l abnormalities that may affect brain function. In EEG studies, electric patterns that resemble epileptic seizures are known as epileptiform pattern. These patterns are associated with an increased risk of seizures, even in people who have not been diagnosed with epilepsy. Epileptiform patterns also appear on the EEGs of some children who have autism spectrum disorders but do not have epilepsy. It is unclear if these discharges are related in any way to the symptoms of autism (behavior, language or intellectual abilities). - Divalproex sodium (Depakote) is a drug that has been used for many years to treat epilepsy and other brain disorders in children and adults. Researchers are interested determining whether treatment with divalproex sodium can reduce epileptiform patterns in children with autism spectrum disorders, and in doing so study whether this treatment can improve behavior, language or cognition in children with autism spectrum disorders. Objectives: - To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges in children with autism spectrum disorders. Eligibility: - Children between 3 and 10 years of age who have an autism spectrum disorder and show frequent epileptiform discharges on an overnight EEG. Design: - This study will last for a total of 9 months, with 6 months of treatment with either divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium only. - Potential participants will be screened with a physical examination and medical history, blood samples, and psychological tests, and will spend the night in the NIH Clinical Center to have an overnight EEG. Children with frequent epileptiform abnormalities on the EEG will continue with the study; all others will be considered ineligible. - Eligible participants will receive either divalproex sodium or a placebo to be taken twice daily for 24 weeks. Neither the investigators nor the participants will know which they are taking. - Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects and to test for possible behavioral improvement, and will also have overnight EEG testing at 12 and 24 weeks. - At the end of the 24-week study period, participants will have the option to have an additional 12 weeks of treatment with divalproex sodium. - A final evaluation (including EEG) will be conducted at the end of the final treatment period.

NCT ID: NCT01169922 Withdrawn - Health Behavior Clinical Trials

HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

SHARP
Start date: October 2007
Phase: N/A
Study type: Interventional

This research is examining how genetic and brain factors play a role in adolescents' health risk behavior as well as studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

NCT ID: NCT01169857 Withdrawn - Lupus Nephritis Clinical Trials

Velcade for Proliferative Lupus Nephritis

Start date: August 2010
Phase: Phase 4
Study type: Interventional

The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.

NCT ID: NCT01169025 Withdrawn - Pain Clinical Trials

Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients

Start date: September 2012
Phase: N/A
Study type: Interventional

Often, patients transported by aeromedical systems do not receive enough medication to control and relieve their pain. The purpose of this study is to determine if pain treatment with intravenous (IV) ketamine is a better way to treat aeromedical patients' pain than the current treatment practices.

NCT ID: NCT01167335 Withdrawn - Clinical trials for Partial Onset Seizures

Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

NCT ID: NCT01166828 Withdrawn - Spinal Cord Injury Clinical Trials

Pressure Ulcer Prevention for SCI Using a Tele Home Program

TELEPUPPS
Start date: January 2011
Phase: N/A
Study type: Interventional

NRI research focuses on nursing interventions that are patient-centered, culturally congruent, cost-effective and outcome-driven. High priority populations of interest are veterans with Spinal Cord Injuries (SCI). The development of innovative tele home techniques for preventing pressure ulcers in veterans with SCI is of high importance in the VA. Our findings may provide clinicians with improved methods for skin and wound assessment and more effective and efficient PUP strategies for Hispanic and non Hispanic veterans. The new model for primary care, the patient-centered Medical Home provides an exciting change in the VA that can benefit from the proposed project.