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NCT ID: NCT02673697 Terminated - Aortic Stenosis Clinical Trials

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

PERSIST-AVR
Start date: March 22, 2016
Phase: N/A
Study type: Interventional

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

NCT ID: NCT02673684 Terminated - Clinical trials for Pain (Visceral, Somatic, or Neuropathic)

Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use

NSS
Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.

NCT ID: NCT02673541 Terminated - Pancreatic Necrosis Clinical Trials

Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents

Start date: February 2016
Phase: N/A
Study type: Interventional

The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic necrosis.

NCT ID: NCT02673021 Terminated - Lung Cancer Clinical Trials

MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s)

MARK 1A
Start date: June 8, 2016
Phase: N/A
Study type: Interventional

Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?

NCT ID: NCT02672033 Terminated - Clinical trials for Pleural Malignant Mesothelioma

Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.

NCT ID: NCT02671955 Terminated - Advanced Cancer Clinical Trials

A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.

NCT ID: NCT02671331 Terminated - Obesity Clinical Trials

Loop Duodenal Switch Surgery in Morbidly Obese Patients

Start date: January 2016
Phase: N/A
Study type: Observational

The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.

NCT ID: NCT02671136 Terminated - Diabetes Clinical Trials

Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes

Start date: August 18, 2016
Phase: N/A
Study type: Interventional

Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans. Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated inflammation can increase insulin resistance in Diabetics and worsens the condition. Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome between 2 main diabetic type 2 patient groups receiving medical care treatment: either Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at LLU Health. 24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical needs. For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use history, BMI, current medication list) and oral health habits will be obtained. Blood samples for HbA1c determinations, clinical periodontal measurements (plaque index, probing measurements including pocket depth, attachment levels, gingival index and bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites and analyzed for detection of about 300 of the most prevalent oral bacterial species. Differences in periodontal clinical outcomes and bacterial profiles will be identified utilizing ANCOVA (Analysis of Covariance).

NCT ID: NCT02671045 Terminated - Clinical trials for Carcinoma, Non-small Cell Lung

Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer

Start date: April 2015
Phase:
Study type: Observational

Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver mutations, which when targeted with specific therapies, experience improved outcomes. Unfortunately, identification of these mutations, although recommended in national guidelines, has been limited for a variety of factors including small biopsy samples. The broad application of a sensitive genomic profiling test, which simultaneously examines for multiple genomic alterations on limited biopsy material, could increase the identification of patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne test meets these requirements. A recent study using the FoundationOne assay identified a significant number of actionable mutations among NSCLC patients who were previously thought to be negative for mutations when tested using other approaches. This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status. Survival and cost information will be compared based on different use of genomic profiling.

NCT ID: NCT02670941 Terminated - Clinical trials for Chemotherapy Symptoms

Aromatherapy for Chemotherapy-induced Symptoms

Start date: January 2016
Phase: Early Phase 1
Study type: Interventional

The rationale behind the proposed study is to determine the initial effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy.