Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury...
Brain InjuriesIn severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature. The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature. Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling). Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site. The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature). No medical device will be put in place specifically for the need of the study.
Ketogenic Diet for Traumatic Brain Injury
Traumatic Brain InjuryKetogenic DietingTraumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.
High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
WoundUlcerThe purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects.
Mild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord...
Spinal Cord InjuriesAutonomic DysreflexiaThe prevalence of autonomic dysfunction and sleep disordered breathing (SDB) is increased in individuals with spinal cord injury (SCI). The loss of autonomic control results in autonomic dysreflexia (AD) and orthostatic hypotension (OH) which explains the increase in cardiovascular related mortality in these Veterans. There is no effective prophylaxis for autonomic dysfunction. The lack of prophylactic treatment for autonomic dysfunction, and no best clinical practices for SDB in SCI, are significant health concerns for Veterans with SCI. Therefore, the investigators will investigate the effectiveness of mild intermittent hypoxia (MIH) as a prophylactic for autonomic dysfunction in patients with SCI. The investigators propose that MIH targets several mechanisms associated with autonomic control and the co-morbidities associated with SDB. Specifically, exposure to MIH will promote restoration of homeostatic BP control, which would be beneficial to participation in daily activities and independence in those with SCI.
Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury...
Spinal Cord InjuriesThe purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Wound HealingDiabetic Foot2 moreStudy will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds
Skin WoundScar1 moreThe goal of this clinical trial is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cell (hUCMSC) therapy in patients undergoing medium-thickness skin grafts for donor site wounds. The study aims to answer the following main questions: Question 1: Does hUCMSC therapy improve the healing quality and speed of donor site wounds in comparison to standard treatment? Question 2: Does hUCMSC therapy reduce scar formation in the donor site wounds? Participants in this study will undergo medium-thickness skin grafts, and those in the treatment group will receive hUCMSC therapy. The main tasks for participants will involve regular follow-up visits, monitoring of wound healing progress, and assessment of any potential side effects or complications associated with the therapy. In order to evaluate the effectiveness of hUCMSC therapy, researchers will compare the treatment group receiving hUCMSC therapy with a control group that receives standard treatment alone. The aim is to determine if the use of hUCMSC therapy leads to improved healing outcomes and reduced scar formation compared to the standard treatment group.
Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine...
Sports Medicine InjuriesPatients experiencing sports medicine related injuries are particularly vulnerable to developing both chronic pain and experiencing prolonged opioid use. This multiarmed randomized controlled trial will quantify the impact of integrating Life Care Specialists, pain management focused paraprofessionals, have on increasing access to multimodal pain management approaches and subsequently optimizing both patient-reported pain-related outcomes and objective measures of activity. Life Care Specialists work with patients and clinicians on implementing non-pharmacological pain management approaches, specifically teaching participants how to implement mindfulness based skills into their recovery, systematically conducting standardized biopsychosocial pain assessments, and coordinate care. By developing a toolbox of pain management approaches with the support of the Life Care Specialist, patients are well positioned to incorporate evidence-based pain management approaches into their recovery that result in improved psychosocial functioning and reduced opioid medication utilization. In total, 150 individuals with sports medicine injuries will be randomized to one of two interventions arms where they will work with a Life Care Specialists in person or over telehealth, or receive standard of care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist based watches, and opioid utilization captured using medication event monitoring system (MEMS) caps will be evaluated over 3-months postoperatively for a total of 4 study visits.
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained...
DepressionSpinal Cord InjuriesThis randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.
Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing
Wound HealScar; Previous Cesarean Sectioncaesarean section rate in Egypt has reached about 60% between primgravidae. Wound complications are of the most common morbidities following cesarean section. The prevalence of wound infection and disruption after cesarean has been reported as 3-15%, averagely speaking 6% and 2-42% in various studies. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery