Clinical Trials Logo

Filter by:
NCT ID: NCT05343260 Active, not recruiting - Neoplasms Clinical Trials

Impact of Anesthesia Maintenance Methods on 5-year Survival After Surgery

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

Surgery is one of the major treatment methods for patients with solid organ cancer. And, alone with the ageing process, more and more elderly patients undergo surgery for cancer. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From the point of view of immune function after surgery and invasiveness of malignant tumor cells, propofol intravenous anesthesia may be superior to inhalational anesthesia. However, the clinical significance of these effects remains unclear. Retrospective studies indicated that use of propofol intravenous anesthesia was associated higher long-term survival rate. Prospective studies exploring the effect of anesthetic choice on long-term survival in cancer surgery patients are urgently needed.

NCT ID: NCT02442297 Active, not recruiting - Clinical trials for Brain Tumor, Recurrent

T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors

iCAR
Start date: April 1, 2016
Phase: Phase 1
Study type: Interventional

This study is for patients that have brain cancer. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting immune cells present in the blood that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to tumor cells because of a substance on the outside of these cells called HER2. Many types of brain tumors are positive for HER2 . HER2 antibodies have been used to treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric antigen receptor (CAR). These CAR-T cells seem to be able to kill tumors like the one these patients have, but they don't last very long and so their chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of these T cells should help them fight cancer. These HER2-CAR T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the largest safe dose of HER2-CAR T cells, to learn what the side effects are, and to see whether this experimental intervention might help patients with brain tumors who volunteer to test this new agent.

NCT ID: NCT02715648 Active, not recruiting - Cystoscopy Clinical Trials

Using Phenazopyridine for In-office Cystoscopy

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

NCT ID: NCT02724371 Active, not recruiting - Clinical trials for Breast Reconstruction, Revision Breast Reconstruction

A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

Athena
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.

NCT ID: NCT02737098 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

TOP Implementation Project

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved access to first class primary care services, it has been more challenging to deliver specialty mental health care to rural Veterans. Evidence based specialty mental care practices developed for large VA Medical Centers are often not feasible to deploy in small CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel barriers prevent most rural Veterans from receiving trauma-focused evidence-based psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a technology-facilitated virtual care clinical intervention that is designed to enhance access to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and Office of Connected Health and Telehealth Services intend to deploy the TOP intervention nationally. This project will lay the ground work for this national implementation initiative. The goal of this implementation project is to support the national deployment of the TOP intervention and evaluate its clinical effectiveness in routine care. The specific aims are to compare the cost and effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes. The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size will be 600. The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider, and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The telephone care managers will coordinates care. The telepsychologists will deliver of trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric consultation. The standard VA implementation strategy will follow standard procedures for deploy clinical practices in the VA include disseminating support materials, providing technical assistance and transfer funds to hire clinical personnel. The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, local staff will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart. The project will compare the standard VA implementation strategy to the enhanced implementation strategy. All VAMCs will receive the enhanced implementation strategy if they need it, but the time period during which they will receive the enhanced implementation strategy will be randomized. This will allow us to determine whether more patients are reached by the TOP intervention during standard implementation compared to enhanced implementation. This design will also allow us to document improvements in perceived access and PTSD outcomes for patients at sites that successfully implement the TOP intervention. Data will be collected from patient survey and chart review for all patients sampled for the evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys. The reach implementation outcome measure will be specified as the proportion of sampled patients who received the TOP intervention. PTSD outcomes will be specified as a continuous change in patient self-reported symptom severity between baseline and follow-up. Perceived access will be measured using items specifically developed for the project. Provider adoption will be assessed with qualitative interviews of all CBOC clinicians treating a sampled patient as well as members of the TOP intervention team. Costs - The investigators will measure the cost of both implementation strategies both prospectively and retrospectively. The investigators will collect data on implementation activities during both the standard VA and enhanced implementation strategies.

NCT ID: NCT02746276 Active, not recruiting - Malnutrition Clinical Trials

Optimising Antibiotic Treatment for Sick Malnourished Children

FLACSAM-PK
Start date: April 1, 2016
Phase: Phase 2
Study type: Interventional

Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, policymakers are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. Finding this out will need a large trial comparing different antibiotics. To prepare for such a trial the investigators first want to make sure that the doses given are correct for malnourished children. The investigators also want to check whether malnourished children more commonly carry resistant bacteria in their feces than well-nourished children. The study is important because the types of antibiotics and the doses needed to fight infection may be different in malnourished children because of the changes in their body due to malnutrition and the types of bacteria present.

NCT ID: NCT02746458 Active, not recruiting - Clinical trials for Closed Femur Fracture

Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

REPAIR
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.

NCT ID: NCT02759614 Active, not recruiting - NSCLC Clinical Trials

Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations

Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).

NCT ID: NCT02823938 Active, not recruiting - Clinical trials for Affiliated to the General Scheme

DRUG EXPOSURE AND RISK OF DEMENTIA

EXMEDEM
Start date: April 1, 2016
Phase:
Study type: Observational

In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among these substances, some, not prescribed in an indication related to cognitive function, however, will influence thereon. Several drug candidates with potential preventive effects have already been explored with little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other studies have suggested the existence of deleterious cognitive effects of certain substances (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of a limited number of drugs were analyzed, and most drugs have not been specific study in epidemiology. The study of this research theme has often been restricted by the limited size of the cohort of staff, not allowing the study of sometimes rare drug exposures, and poverty of the information collected on drug exposures. Thus, most studies focuses on families of molecules among the most prescribed. In addition, we now know that the pathophysiological process underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10 years before the diagnosis of dementia. It is therefore essential to have a setback of several years between drug exposure and diagnosis of dementia to assess their role in the genesis and evolution of the disease. The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance and those of medicalization program of information systems (PMSI) for a sample of 550 000 subjects enrolled in the general scheme of the insurance since 2004 and followed for a period of 20 years.

NCT ID: NCT02907424 Active, not recruiting - Malnutrition Clinical Trials

Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM

FLNS_SAM
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.