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NCT ID: NCT02265146 Withdrawn - Clinical trials for Coronary Atherosclerosis

ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study

ORACLE-NIRS
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).

NCT ID: NCT02264236 Withdrawn - Lung Neoplasms Clinical Trials

Vaccination of Advanced-Stage Lung Cancer Patients

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

NCT ID: NCT02263898 Withdrawn - Stage IV Melanoma Clinical Trials

Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.

NCT ID: NCT02263677 Withdrawn - Type 2 Diabetes Clinical Trials

Evaluation of the DPP-4 Inhibitor Sitagliptin in the Treatment of Non-Alcoholic Fatty Liver Disease Using MRI

Start date: March 2014
Phase: Phase 4
Study type: Interventional

Participants will be persons with type 2 diabetes who are likely to have fatty liver disease. The investigators think that this medication will reduce fatty liver. The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat before and after subjects take a diabetes medication. The investigators will also collect a small amount of blood to measure liver, kidney and hormone functions. This will be done 4 times. Also, at the time of the subject gets their first dose of medication they will have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and body composition). The goal of all of these studies is to determine whether the study drug lowers liver fat.

NCT ID: NCT02263222 Withdrawn - Post-operation Pain Clinical Trials

A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty

Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.

NCT ID: NCT02261844 Withdrawn - Liver Cancer Clinical Trials

Resveratrol and Human Hepatocyte Function in Cancer

Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.

NCT ID: NCT02260765 Withdrawn - Depression Clinical Trials

Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual

Start date: October 2014
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the different in resource utilization of treating depression with Deep TMS compare to the TAU. The current study is a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or could not tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. The study designed as double arm study of which patient will have 50% chance to be randomized to one of the study groups. The study includes two arms. The dTMS study group will be treated according to the cleared FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient clinical status

NCT ID: NCT02259140 Withdrawn - Cerebral Palsy Clinical Trials

A Randomized Control Trial of Hip Dislocation Techniques for Pediatric Patients With Cerebral Palsy

Start date: October 2015
Phase: N/A
Study type: Interventional

This randomized controlled trial will compare proximal femoral resection-interposition arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary outcome is quality of life and care giver burden measured by The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function (mobility questions), complications and surgical parameters such as OR time and fluoroscopy time. A cost-effectiveness analysis will follow completion of the randomized controlled trial (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the cost of the plate, longer operative time, longer length of stay, and blood loss, but Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better functional and quality of life outcomes.The results of this study are expected to improve outcomes for children with cerebral palsy with painful irreducible dislocated hips.

NCT ID: NCT02259023 Withdrawn - Over All Health Clinical Trials

Discretionary Food Sources and Stress Perception

Start date: February 2014
Phase: N/A
Study type: Interventional

Purpose: The objective of this study is to determine the effect different sources and forms of discretionary foods have on stress perception in healthy adults in a free living, real world setting. Rationale: The rationale for conducting this study is to test the effects of sugar-sweetened beverages and grain-based desserts have on perceived health and stress perception, since the evidence for this topic is limited.

NCT ID: NCT02258880 Withdrawn - Stroke Clinical Trials

Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.