Clinical Research Directory

Treatment and Outcome of Patients With Mild Head Injury

The study aims to assess the incidence of complications, such as intracranial haemorrhages and neurological deficits, in patients with head trauma treated in the emergency departments of the Emilia-Romagna Region and to compare the prognostic accuracy of the Canadian CT Head Rule and NEXUS Head CT Instrument in predicting post-traumatic complications. This is a retrospective multicentre cohort study that includes patients aged 18 years or older with isolated head trauma who underwent brain CT within 24 hours of the trauma. The data, sourced from hospital databases, will include medical history, prognostic scores, instrumental examinations, pharmacotherapy and adverse events. The primary objective is to determine the incidence of complications in patients who require surgery or who die, while the secondary objectives aim to compare the prognostic effectiveness of the two instruments in predicting complications. In addition, the study will examine the management strategies adopted and seek to identify any predictors of complications not included in current prognostic models. The results will contribute to improving the management of head trauma in emergency departments and optimising the use of available prognostic tools.

Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?

At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner. However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature. This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

Screening Emotions in Adolescents at the Hospital for mTBI

The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions. The main aims the study wish to answer are: * Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury? * Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires? Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.

Osteopathic Manipulative Treatment RCT and Computational Modeling for Head Injuries in Mixed Martial Artists

The purpose is to test how osteopathic medicine (OMM) improves recovery after a hit to the head during Mixed Martials Arts (MMA). The small changes in the bone, joints, and fluids during head injuries may lead to traumatic brain injury (TBI). The OMM is adjusting the body with the doctors' hands. The goal is to restore alignment and release tension. The head is treated with the doctors' hands placed gently on the head or face. It was previously found to improve symptoms and recovery of memory after head injuries in college athletes. There haven't been clinical trials of this procedure in MMA fighters. Yet, they often get injuries to the part of the brain that releases hormones. Referrals for tests for the hormones are available. Individuals who participate in MMA fighting or sparring matches may join this study. Those who don't get hit in the head or a concussion will contribute to our understanding the osteopathic structural physical exam and fluid dynamics of the head in relation to brain function tests. Those who get hit in the head may be put in the treatment procedure or sham-placebo group. Participants will not be told which group they are in. We anticipate that 100 individuals of any gender will enroll in this study at NYIT Academic Health Care Center (AHCC). To be in this study, the participant must: Part 1 - Before the fight: 1. Plan to participate in an MMA fight or sparring match, 2. 18 to 50 years of age, 3. Be able to do online cognitive neuropsychology tests for memory, reaction time, and symptoms. Part-2-After the fight: (1) Have been hit in the head, or had a head injury, during a fight The participant cannot be in this study if they have: Part 1- Before the fight: 1. a current or previous spinal cord injury, 2. a traumatic brain injury within the past six months, 3. inability to tolerate the sports physical, 4. a diagnosis of brain degeneration, 5. low hormones levels from the brain, 6. Pregnancy Participants won't get referred for hormone testing if they don't have any clinical signs of this injury. They also won't get referred for it if they've had heart disease, disease of the blood vessels in their brain, or seizures. Participants cannot be in Part-2-After the fight if they: 1. cannot tolerate OMM (For example, you have a skull fracture, cervical spine fracture, bleeding or increased pressure in the head, tearing of tissues in the neck, space-occupying lesion, or stroke). 2. were knocked out for more than 2 minutes, had seizures, persistent vomiting, or paralysis when your head was hit. Participation involves 2 or 4 visits, which will take place over one week. * The first visit takes 30 mins. in-person and 70 mins. of online testing from home. * The second visit takes 30-60 mins. in-person and 70 mins. of online testing from home. * The third \& fourth visits will each be 30 mins. in-person and 70 mins. online testing from home. If participants agree to be in this study, they will be asked to do the following: Visit #1: Before the Fight * Get screened and review the consent form * Take the neuropsychology tests (ImPACT and Inquisit Web) online from home * Get a non-invasive sports physical exam of head, neck, back, arms, and legs. * Urine sample for the hormone from the brain called oxytocin (optional) * Have blood sugar checked by a lancet after pricking the finger (optional) Fight video: The study-doctors will record the participants' fights to make a computational model of the head. Visit 2: After the Fight * Get a sports physical of head, neck, back, arms, and legs. * IF the participant was hit in the head, the study-doctors or participants private doctor will examine them. * Take the ImPACT and Inquisit Web tests online from home * If the participant had an injury to their brain, they may get the OMM procedure or sham placebo-control (non-therapeutic light touch). * Urine sample for the hormone from the brain called oxytocin (optional) * Have your blood sugar checked by a lancet after pricking your finger (optional) * Referral to your doctor to test the levels of other brain hormone (optional) Visit 3 \& 4: * Sports physical of head, neck, back, arms, and legs * Take the ImPACT and Inquisit Web tests online from home * If you had an injury to your brain, you may get the OMM procedure or sham placebo-control (nontherapeutic light touch). You will not be told which one you are getting. * Urine sample for oxytocin (optional) * Have blood sugar checked by a lancet after pricking your finger (optional) * Referral to test the levels of other brain hormone (optional) Any significant new findings that develop during research that may relate to the participants health or willingness to continue will be provided to them by phone call. The results will help us understand head injuries, how well OMM works to treat them, and may improve future care for fighters.

Pre-post Evaluation of the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Repeated Blast Exposure

A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.