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Wounds and Injuries clinical trials

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NCT ID: NCT04901858 Recruiting - ACL Injury Clinical Trials

Knee Aspiration and High Definition MRI for ACL Injury

Start date: November 22, 2019
Phase: N/A
Study type: Interventional

The aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (ACL). This will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. The study will look at inflammatory and healing responses using DNA, RNA and protein analysis. This, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of ACL injury.

NCT ID: NCT04900168 Recruiting - Clinical trials for Moderate Traumatic Brain Injury

Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

IPMMTBI
Start date: June 1, 2021
Phase:
Study type: Observational

Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China. Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months. Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension. Each patient will be evaluated at 6 months post injury on neurological outcomes. Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.

NCT ID: NCT04899778 Recruiting - Ligament Injury Clinical Trials

Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

OC
Start date: September 29, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.

NCT ID: NCT04898595 Recruiting - Acute Kidney Injury Clinical Trials

Discontinuing CRRT in Patients With Acute Kidney Injury

DC-CRRT
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

In this study, investigators are going to test whether a standardize approach to discontinuation of Continuous Renal Replacement Therapy (CRRT) using a set of criteria improves outcomes. These criteria are based on the best available evidence. In a systematic review, aside from urine output, there was no one factor that predicted successful weaning of RRT in patients with AKI. Urine output prior to discontinuation of RRT was the most commonly described and robust predictor. The pooled analysis found a sensitivity of 66.2% and specificity of 73.6% for urine output to predict successful RRT discontinuation. Patients with AKI on CRRT recruited during the first half of the study will be controls (usual process of care). After accrual, patients recruited for the second half will receive the intervention where discontinuation of CRRT will be guided by a set of criteria based on the patient's hemodynamic status and other factors.

NCT ID: NCT04898010 Recruiting - Acute Kidney Injury Clinical Trials

The Selective Cytopheretic Device (SCD) for Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I

Start date: June 9, 2022
Phase: N/A
Study type: Interventional

This research study is being done to learn what effect 7 days of treatment with the Selective Cytopheretic Device (SCD) will have on these white blood cells in the bloodstream of patients with hepatorenal syndrome and to learn whether it has any effect on the blood circulation and kidney function.

NCT ID: NCT04894734 Recruiting - Clinical trials for Spinal Cord Injury at T1-T12 Level

Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)

Start date: December 30, 2021
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 12 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be randomly assigned to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 12 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.

NCT ID: NCT04893837 Recruiting - Clinical trials for Brain Injuries, Traumatic

Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

MOBI-1
Start date: April 18, 2022
Phase:
Study type: Observational

MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.

NCT ID: NCT04890639 Recruiting - Clinical trials for Brain Injuries, Traumatic

Acute Intermittent Hypoxia in Traumatic Brain Injury

AIH
Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This study is designed to answer questions related to safety and preliminary efficacy of Acute Intermittent Hypoxia (AIH) in Traumatic Brain Injury (TBI) survivors. First, we aim to establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in TBI survivors. Second, we aim to establish whether there are any effects of AIH on memory, cognition, and motor control. Participants will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.

NCT ID: NCT04887688 Recruiting - Diabetes Clinical Trials

Exciflex for Chronic Wound Therapy

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds. Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use. Methodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy. Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.

NCT ID: NCT04883463 Recruiting - Clinical trials for Spinal Cord Injuries

Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.