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Wounds and Injuries clinical trials

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NCT ID: NCT02869737 Completed - Severe Trauma Clinical Trials

Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Coaguchek
Start date: January 2015
Phase: N/A
Study type: Observational

Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.

NCT ID: NCT02868684 Completed - Clinical trials for Posttraumatic Stress Disorder

Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study

Start date: August 2016
Phase:
Study type: Observational

This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.

NCT ID: NCT02868671 Completed - Clinical trials for Mild Traumatic Brain Injury

Acupuncture for Mild Traumatic Brain Injury:A Functional Magnetic Resonance Imaging Study

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

The overall goal of this study is to examine if acupuncture intervention can reduce the post-concussion symptom (PCS), and affective and cognitive complaints among mild traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham acupuncture and waiting list control groups, patients in the real acupuncture group will have fewer symptoms of depression, sleep problems and post-concussion symptoms.

NCT ID: NCT02866708 Completed - Clinical trials for Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation

The Effects of Intermittent Negative Pressure on Wound Healing and Peripheral Circulation in Spinal Cord Injured Subjects

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

This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot study will look at the effects of intermittent negative pressure (INP) therapy wound healing and the peripheral macro- and microcirculation in spinal cord injured patients with chronic leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized clinical trial with single-subject multiple baseline design. We will perform convenience sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment by the end of december 2016.To ensure equal distribution of participants in each study arm, we will perform block randomization. A statistician will randomized patients to either intervention arm or control arm before start of the study: At baseline, each participants will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in the the control group (A) will be re-examined, and start 8-week INP therapy. Also the intervention (INP) will be subjected to the same lower limb in each individual throughout the study period. The other leg will act as a intra-individual control. At baseline (week 0), and during the course of the study (every 4th week), the participants' wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after intervention the following measures will be performed: Demographic data (weight, height, ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before and after the study period will be: wound healing (primary endpoint), quality of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy applied to a limited part of the lower limb on clinically relevant measures related to wound healing and peripheral macro- and microcirculation in patients with spinal cord injury. The hypotheses of the study are: - Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve wound healing in the foot compared to before treatment (baseline) and compared to standard wound care alone. - Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the foot compared to before treatment (baseline) and compared to standard wound care alone in patients with spinal cord injury. - Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the intervention foot compared to the control foot and compared to standard wound care alone in patients with spinal cord injury.

NCT ID: NCT02865902 Completed - Wounds Clinical Trials

Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness

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

Objective: The aim of this study was to determine the effects of Low Level Laser Therapy (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS). Materials and Methods: Forty patients requiring FGG were selected for this randomized controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency, colour match (CM), and H2O2 bubbling test for the evaluation of complete wound epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue thickness (TT) was measured at baseline and at the 1st month.

NCT ID: NCT02865343 Completed - Spinal Cord Injury Clinical Trials

Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury

NIV-Ex
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

The investigators have an existing exercise program (N>70) with a unique population of individuals with spinal cord injury (SCI) who have been enrolled in FES-RT for at least 6 months. Roughly half have high level SCI. Thirty individuals with high level SCI who have FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 3 months with either NIV or sham NIV. Before and after training, the investigators will assess maximal aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference. Based on the investigators current data, it is hypothesized that only those randomized to NIV will experience further increases in aerobic capacity and that these increases will relate to increases in cardiac output and arterio-venous oxygen difference. This Exploratory/Developmental Research project will lay the groundwork for a larger study of the impact of FES-RT+NIV to improve health and function in those with high level SCI.

NCT ID: NCT02860689 Completed - Spinal Cord Injury Clinical Trials

Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury

Start date: March 2015
Phase: N/A
Study type: Observational [Patient Registry]

Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.

NCT ID: NCT02860637 Completed - Spinal Cord Injury Clinical Trials

Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function

Start date: March 2015
Phase: N/A
Study type: Observational

In addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation. Objective: To assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

NCT ID: NCT02859233 Completed - Clinical trials for Postdural Puncture Headache

Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache

PROPHYDRA
Start date: November 8, 2016
Phase: N/A
Study type: Interventional

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying. For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care. The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.

NCT ID: NCT02858544 Completed - Brain Injuries Clinical Trials

Concussion in Motor Vehicle Accidents: The Concussion Identification Index

CIDI
Start date: November 2013
Phase: N/A
Study type: Observational

The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment for concussion.