Active clinical trials for "Wounds and Injuries"

Graves' orbitopathy (GO) is a characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis. The most frequent cause is Graves' disease. The classification is comprised based on the severity of orbital changes ranging from mild, moderate-to-severe GO and sight-threatening GO, which includes dysthyroid optic neuropathy (DON). Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON. This therapy is more effective and better tolerated than oral glucocorticoids (GCs). The current recommendation of the European Group of Graves' Orbitopathy (EUGOGO) is that cumulative doses of IVMP should not exceed 8.0g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON. According to EUGOGO recommendations patients with moderate-to-severe GO are treated with IVMP cumulative dose 4.5g during a 12-week period (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week). According to EUGOGO recommendations patients with DON should receive 3.0g IVMP (1.0g/day for 3 consecutive days) as the basic treatment. This limitation in doses are due to the necessity of the prevention of severe side effects that are rare but may be fatal. One of the most severe adverse events is acute liver injury (ALI), in some cases irreversible and/or fatal. The estimated morbidity and mortality of ALI was found to be 1-4 % and 0.01-0.3%, respectively. Since 2000, there were 5 reported fatal cases. Mechanisms causing an IVMP-induced ALI remains incompletely elucidated. There are some possible hypotheses that may explain the occurrence of ALI. Firstly, GCs can lead to reactivation of autoimmune hepatitis: an immune "rebound phenomenon" following GCs withdrawal. The second mechanism of ALI is reactivation of viral hepatitis. Finally, there is well known direct toxic effect of GCs on hepatocytes, probably dose-dependent. This study was performed to evaluate the influence of two different, routinely used schemes of therapy with IVMP in patients with moderate-to-severe GO (first scheme) and DON (second scheme) on biochemical liver parameters. Patients included into the study were treated according to EUGOGO recommendations with routine doses of IVMP and routine scheme of administration for moderate-to-severe GO and DON. No additional treatment was performed during the study protocol.

Individuals with a spinal cord injury need to exercise regularly to prevent the decline of health that results from a sedentary lifestyle. The purpose of this investigation is to examine the effects of a pre-existing exercise program and respiratory training on measures of health and quality of life in individuals who elect to participate in an existing 8-week supervised exercise program.

The purposes of this study were to understand the effects of mhealth App on wound care knowledge, wound care skills, and anxiety related to dressing change when compared to traditional health education before patients discharged from hospital.

The study is aimed to explore female patients' experience of the Survive & Thrive course that has been designed for survivors of interpersonal trauma (e.g. childhood sexual abuse, domestic abuse, rape, physical abuse, neglect, harassment, stalking and similar). The course aims to help attendees develop an understanding of the normal range of reactions to trauma and introduce new ways of coping. It is a 10 week course that is structured to utilise cognitive behavioural skills training while delivering psychoeducation on how a history of victimisation can impacts on the survivors life. Female adult participants who attended the Survive & Thrive course will be invited to take part in a 30-45 minutes semi-structured interview exploring their experience of the course. The aim is to interview 12 participants; those individuals attended 6 or more sessions. Access to some demographic information will be gained through the Survive & Thrive team to gain additional insight to the participant's course experience. The rationale for this study is to evaluate the effectiveness of the Survive & Thrive course as a treatment option within the Stepped Care Approach for survivors of interpersonal trauma. There is an increasing number of individuals being exposed to traumatic life events. Most research has concentrated on the individual psychological input for patients with trauma history. Courtois and Ford (2009) argued that at a service level, group therapy is more efficient than individual as it can be offered more broadly. There is however limited research on the effectiveness of manualised approaches for the mental health and behavioural problems. Research shows that safety and stabilisation in trauma survivors can be achieved through psychoeducational approaches which emphasise present-time, coping strategies/skills, elimination of self-harming behaviour, control over acute symptoms, and increased self-care (Lubin & Johnson, 1997). Findings from this study will be published.

The purpose of the present study is to evaluate the influence of the post-surgical chlorhexidine indication in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues. The main hypothesis is that the post-surgical use of chlorhexidine affects the gene expression and the celular behavior in the early wound healing process of the soft oral tissues.

This study evaluates the effectiveness of The Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills in supporting a child with TBI experiencing cognitive, behavioral, and social challenges. The application provides training in evidence-based support strategies with the goal of improving outcomes for children with TBI and their families. Half the participants will receive access to the TIPS program, while the other half will receive access to a different TBI related website.

The purpose of the study is to determine if opiates are required to achieve adequate analgesia after knee arthroscopy and ACL reconstruction in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic.

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients. However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients. In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

Abstract: Background: Circumferential negative pressure wound therapy (CNPWT) is commonly used to manage wounds and enhance the healing process. A theoretical concern was recently raised that CNPWT may have a negative effect on perfusion distally. Objectives: We aim to evaluate the effect of circumferential negative pressure therapy (CNPT) on distal O2 saturation in healthy volunteers. Design: Randomized controlled non-inferiority study. Methods: Fourteen healthy adult volunteers with O2 saturation ≥95% (by index finger pulse oximetry) will be invited to participate in the study. After obtaining a written informed consent, CNPWT foam/dressing will be applied in a sandwich-like manner on the middle third of each arm and a negative intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for 9 hours. Individual's participation will be terminated if O2 saturation drops below 92% at any study time. The outcome measure is index finger O2 saturation and will be checked every 30 minutes using a pulse oximetry. The area under the curve (AUC) of O2 saturation in the 2 arms will be compared using ANCOVA. Sample size was calculated to have 90% power, assuming a type one error of 5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop out of 2 participants. Importance: The study is expected to provide conclusive evidence on the effect of intermittent CNPT on distal O2 saturation. The results would have direct implications for CNPWT.

Most people with moderate or severe TBI have difficulty returning to their usual social roles and activities. The OBIA has developed a program where peers (other individuals living with TBI) coach or mentor those with more recent brain injury. The objective of this project is to evaluate the feasibility of measuring the impact of the OBIA Peer Program on social participation and mood compared to a control group who have not received peer support yet. The proposed study will involve three phases. It will begin with a qualitative component (stakeholder interviews), then a pilot RCT, and end with more interviews to explore the success of the study intervention. A qualitative descriptive approach will be used at these first and last phases of the study. In Phase 1, interviews will be conducted with approximately 15 participants including individuals with moderate to severe TBI, caregivers, Mentors, OBIA staff members, and health researchers. The proposed Phase 2 will be a clinical trial, conducted with 60 participants. These participants will be randomized to one of three groups: a twice a week Program (n=20), a once a week Program (n=20), or the wait list control group (n=20). For Phase 3, a sub group of approximately 25 participants from Phase 2 who participated in the OBIA Peer Support Program will be asked to participate in a one-on-one, telephone/Skype interview. A sub-group of Mentors will also be asked to participate in a one-on-one, telephone/Skype interview. This research project will address the highest priority areas of "strategies to enhance social participation and community life (personal relationships)" and "psychological strategies to improve mood, depression, and irritability", as identified in the ONF's Request for Proposals on "Addressing Evidence Gaps in Moderate to Severe TBI Rehabilitation". The study will provide important results to inform a RCT (of appropriate size) on the impact of peer support on the social participation and mood of individuals with moderate to severe TBI. This study will then provide the best evidence to support the recommendation on "a peer-supported relationship model of intervention", and inform future versions of the INESSS-ONF Guideline.