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Wounds and Injuries clinical trials

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NCT ID: NCT03602014 Completed - Clinical trials for Spinal Cord Injuries

Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury

Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

The goal of this study is to determine the efficacy of the drug Droxidopa (Northera) in increasing blood pressure in subject with hypotension, low blood pressure, which is classified as blood pressure less than 110/70 in males and 100/70 in females. The first aim is to determine the proportion of subject with Spinal Cord Injury (SCI) who have a normotensive response to Droxidopa. The second is to determine the proportion of subject with SCI who express a hypertensive response to Droxidopa. A Normal blood pressure ranges from 111-139 in males and 101-139 in females and a hypertensive blood pressure is anything higher than 140 in males and females. The study would take place in James J. Peters VA Medical Center (JJPVAMC) and The Icahn School of Medicine at Mount Sinai (ISMMS) in Manhattan, New York.

NCT ID: NCT03597763 Completed - Clinical trials for Traumatic Brain Injury

Fatigue Following Moderate and Severe TBI

Start date: March 1, 2018
Phase:
Study type: Observational

The subjective feeling of being periodically fatigued, tired, even exhausted is common in the general population, as well as in a large number of medical conditions, including neurological illness, such as traumatic brain injury (TBI), cerebrovascular accidents (CVA), multiple sclerosis (MS), and poliomyelitis. Fatigue typically results in compensatory behaviors such as spending extended time in bed, daytime napping, and restricted participation in activities of daily living, which in turn can have a profound negative impact on mental and physical health. Although fatigue is common and debilitating, there is a scarcity of knowledge concerning underlying biological, psychological and psychosocial mechanisms in the development and maintenance of persisting fatigue. There is also a general lack of theoretical accounts of potentially shared and etiology-specific mechanisms across conditions. The existence of clinical subgroups and diverse clinical trajectories is not well documented, resulting in a lack of evidence-based treatment opportunities. Diagnosis and management of fatigue is further challenged by difficulties in conceptualizing and defining the phenomenon itself, since fatigue is subjectively experienced and multifaceted. Thus, as fatigue often poses a chronic problem, health professionals in community based rehabilitation settings are faced with helping patients cope with this symptom without a clear understanding of causes or treatment options. The current project aims to map the occurrence of fatigue following moderate to severe TBI and achieve a better theoretical and clinical understanding of the mechanisms which may cause, exacerbate or protect against persisting fatigue following TBI. The study approach acknowledges that fatigue after neurological illness is the result of complex interplays between general individual predispositions and etiology-specific factors. A better understanding of these mechanisms is a prerequisite for personalized treatment and development of empirically based randomized controlled intervention studies. This approach has relevance to other clinical conditions as well. The long-term aim is to ensure accurate diagnosis, improve treatment and rehabilitation, and to contribute to knowledge based clinical decision-making both within specialized and community based rehabilitation settings.

NCT ID: NCT03597074 Completed - Sepsis Clinical Trials

Doppler Ultrasound for Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients

Start date: March 2, 2017
Phase:
Study type: Observational

Purpose: The aim of this study was to assess the ability of early discrimination between transient and persistent Acute Kidney Injury (AKI) using the color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization in septic patients in an Intensive Care Unit (ICU). Methods: Prospective observational cohort study with unselected, with 32 adult consecutive septic patients. Patients were divided into 3 groups: Group 1: patients without progression to AKI, Group 2: transient AKI, Group 3: persistent AKI.

NCT ID: NCT03596112 Completed - Wound Heal Clinical Trials

The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care

wound-size
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Chronic wounds (CW) such as leg or foot ulcers are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. The signs and symptoms of a chronic wounds are not only a burden on those who are affected by it but also on the health care system and society in general. With a prevalence of 1% in the general population, the prevalence rises to 3% in the over 80-age group. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. Advanced wound dressings, especially super absorbent dressings are an important part of the wound care. Heavy wound exudate, if unabsorbed, may damage surrounding healthy skin and thus delay wound healing and contribute to maceration and excoriation regimen as CW may deliver excessive amounts of exudate followed by maldour. Maldodourous wounds can have a profoundly negative impact on the quality of life of the patient and of their carers causing feelings of guilt repulsion and leading to social isolation and depression. Therefore, it is important to use effective advanced wound dressings that are capable of managing wound exudate and with that promote wound healing. Currently the standard approches to managing exudate and wound odour are the use of hydrocellular foam dressing with silver or absorbent dressings like of a sterile polyacrylate wound pad with activated carbon cloth treatment. However, there is no evidence demonstrating whether there is adifference in wound size as an indicator of wound healing when comparing the application of a sterile polyacrylate wound pad with activated carbon clothtreatment to a standard non-adhesive hydrocellular foam dressing with silver treatment in a randomised controlled trail. A randomized controlled trail with 90 participants in one wound care outpatient clinic is proposed. Data will be analysed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution. This research project is designed to compare two wound dressings in everyday care. Since the cost of leg ulcers to individuals, the economy, and society is high, the evaluation of wound care dressings that leads to a reduction of wound size and promote wound healing are important for the individuals affected, their families, society at large and the health care system.

NCT ID: NCT03594669 Completed - Athletic Injuries Clinical Trials

Training for Injury Prevention in Collegiate Soccer Players

Start date: August 11, 2018
Phase: N/A
Study type: Interventional

The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.

NCT ID: NCT03581461 Completed - Trauma Clinical Trials

Trauma-Informed Mindfulness-Based Yoga

TIMBY
Start date: January 14, 2019
Phase: N/A
Study type: Interventional

The proposed study aims to gather the multiple types of preliminary data needed to design a large and rigorous pragmatic, cluster randomized trial on the impact of a trauma-informed mindfulness-based yoga program on enhancing self-regulation (in the short-term) and reducing recidivism (in the long-term) among juvenile justice-involved youth. Such a study will ultimately provide more definitive outcomes related to the effectiveness of these programs this population. If effective, the assimilation of such programs into the treatment plans of youth in juvenile justice facilities and in other residential settings could have a significant impact on a range of health, educational, vocational, and interpersonal outcomes relevant to this population.

NCT ID: NCT03581006 Completed - Lung Injury Clinical Trials

Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial

Start date: November 12, 2018
Phase:
Study type: Observational [Patient Registry]

This is a randomized-controlled unblinded clinical trial to investigate dietary intervention on metabolic biomarker assessment in World Trade Center (WTC) Lung Injury (LI) in firefighters. The purpose of this study is to evaluate biomarkers of metabolic dysregulation that have previously been found to predict WTC-LI in a case cohort study selected from the entire exposed firefighter cohort, and attempt to alter these metabolites using dietary intervention and a technology-supported behavioral modification program. Investigators will measure Pre/Post global metabolic expression in WTC-exposed, symptomatic firefighter serum sampled after 6-month intervention, as well as clinical outcomes of WTC-LI in the study group vs controls.

NCT ID: NCT03575169 Completed - Clinical trials for Traumatic Brain Injury

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

BIS-TBI
Start date: July 1, 2019
Phase:
Study type: Observational

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

NCT ID: NCT03574896 Completed - Critical Illness Clinical Trials

Acute Kidney Injury Predictor Validation Study

AKIpredValid
Start date: May 2, 2018
Phase:
Study type: Observational

Purpose: To evaluate the performance of AKIpredictor, a computer-based algorithm that predicts the development of AKI in the 7 days following ICU admission, by comparing it with similar predictions made by attending physicians. Primary objective: To compare the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission Secondary objective(s): To investigate the influence of the level of seniority of the physician on the accuracy of the predictions; feasibility of making predictions within a 3 hour window for physicians Trial Design: Monocentric, prospective, longitudinal, non-interventional Endpoints: Primary: comparing the area under the ROC curves of the AKIpredictor and physicians. Secondary: estimation of PPV, NPV, sensitivity and specificity of both predictors at different thresholds; evaluation of alternative negative endpoints (ICU readmission after discharge, death); subgroup analyses. Sample Size: This is a pilot study. Sample size calculations to obtain sufficient power are not feasible due to lack of previous studies. The investigation will be conducted with a preset end time on June 30th. The investigators expect to include approximately 150 patients. Summary of eligibility criteria: All adult patients admitted to UZ Leuven's surgical ICU in the period of the study, with the exclusion of those with end-stage renal disease or AKI already present at the time of admission

NCT ID: NCT03574090 Completed - Clinical trials for Surgical Wound Infection

Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

PROTOP
Start date: October 20, 2020
Phase: Phase 4
Study type: Interventional

The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery