Active clinical trials for "Wounds and Injuries"

Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of face transplantation. Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries/ defects by minimizing maintenance immunosuppression therapy in face transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 15 full or partial human face transplants employing this novel protocol. Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term, high-dose, multi-drug immunosuppression. Significance of Research: Face transplantation could help injured individuals recover functionality, self-esteem, and the ability to reintegrate into family and social life as "whole" individuals. This protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this life-enhancing procedure and enabling a wider clinical application of face transplantation.

One of the main objectives in spinal cord injury rehabilitation programs is the improvement of trunk control in order to achieve independence, to prevent complications and, in specific cases to walk. Research question: What is the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury? Purpose: To determine the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury. Methods: Randomized clinical trial, blinded to evaluator and to the person that will analyze data. Population: Spinal cord injured individuals treated at the National Institute of Rehabilitation, with a spinal cord injury of any ethiology, with a neurologic level of C8 and below, with time since injury from three months to one year. Proceeding: The subjects will be randomly assigned to : a control group with neuro propioceptive facilitation exercises focused in trunk control or an experimental group with kayak ergometer training. Both groups will recieve 5 sessions a week during 6 weeks.

This is a multi-center randomized clinical trial study. The purpose of this study is to examine safety, feasibility and efficacy of automated peritoneal dialysis as compared with intermittent hemodialysis for AKI patients with indications for dialysis.

Non-suicidal self-injuries (NSSI) is a deliberate harm a person causes directly to their body, resulting in structural or functional damage, without suicidal ideation. This behavior is related to unbearable internal stress, thoughts, or mental pain, which NSSI assists in dismantling. To date, there is no generally approved therapy that assists in lowering NSSI. Ketamine is a sedative drug, presently at the focus of psychopharmacologic research, which was found to improve depression, when taken orally, and lower suicidal ideation, when given intravenously. Our aim is to assess the efficiency of intravenous ketamine in decreasing NSSI symptomology in women with a history of childhood sexual abuse presenting with such behavior. Participants will be recruited among hospitalized patients from the Tel-Aviv Medical Central psychiatric ward, who will present with either NSSI urges or behavior. The study design is a randomized control, double blind trial. Each patient will be assessed before, during, and after the trial by physical examination, blood tests and questionnaires. The patients will be randomized into research group (treated by ketamine and midazolam intravenously) or control group (treated intravenously via midazolam only). Our hypothesis is that treatment by intravenous ketamine will lower NSSI symptomology, and enable optimal treatment while being hospitalized.

The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration. As secondary objectives, the study aims to: demonstrate improvement of specific neuropsychological tests of working memory; demonstrate improvement of non-specific tasks involving working memory; assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect; demonstrate improvement of social integration ability and quality of life; demonstrate persistence of effects at 3 months and 6 months after the end of treatment; demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.

An investigator initiated pilot study: two arm, double blind, placebo controlled, randomized, group of approximately 60 patients with spinal cord injury, and who have evidence of neurogenic bladder. Patients will be treated with human milk oligosaccharide (HMO) versus placebo over 12 weeks from start of the investigational medication date (approximately 3 months) to test whether HMO can improve bowel motility in neurogenic bowel and bladder patients. Patients in the placebo arm of the study will be offered participation in the open label portion of the study immediately after their part in the control group is completed, they will receive HMO for 12 weeks. HMO sachets will be administered to determine the safety and efficacy of HMO relative to placebo in improving quality of life of neurogenic bowel and bladder patients by improving bowel motility and function.

The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.

The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.

Calcified lesions related to coronary artery are a type of atherosclerosis, accompanied by severe calcified lesions of the stenosis, which is a difficult point for PCI interventional therapy. Calcified lesions have poor response to balloon dilatation and the device can not be successfully placed, which reduce the success rate of operation. Furthermore, the stent is under-expanded and the adherence is poor, which significantly increases the incidence of major adverse cardiovascular events (MACEs). Intracoronary rotational atherectomy (RA) was developed by David Auth in the early 1980s. In 1988, Bertrand has completed the first case of coronary RA. RA was recommended for treatment of severe calcified lesions in ACC/AHA Guidelines for Coronary Interventional Therapy in 2011 (IIa, C). However, many studies have found that the incidence of RA-related myocardial injury is relatively high, and affect the efficacy of RA and prognosis in patients with severe calcified lesions. It has been reported that 58 consecutive patients with stable angina requiring PCI with RA to a calcified coronary lesion have 68% 5-fold increase in high sensitivity troponin after RA. The objective of this randomized control trial is to gain a clinical insight on the use of low temperature rota-flush solution for the treatment of RA-related myocardial injury in patients with heavy calcified lesions. The primary objective is assess efficacy and safety of low temperature rota-flush solution for the treatment of RA-related myocardial injury in patients with severe calcified lesions.