Active clinical trials for "Fractures, Stress"

Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults presenting with COVID-19 -induced stress reactions including one or more of the following: anxiety, depression, anger, substance use, or sleep disturbance.

Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients. Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.

The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are: [whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.] [whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.

A clinical trial comparing healing of unilateral or bilateral spondylolysis in children treated with a Boston thoracolumbar orthosis (brace) or with a soft spinal brace (Porostrap lumbar support) for four months. Inclusion criteria will be a child or adolescent aged between 8 and 20 years with an early uni- or bilateral defect (fracture line) in the pars interarticularis in the CT-scan with no signs of bony sclerosis. Additionally, bone marrow edema has to be confirmed in MR images (T2 sagittal) as a sign of an early lesion. Exclusion criteria will be spondylolisthesis on standing spinal radiograph, systemic skeletal disorder or lack of interest. Patient's preference defines the treatment method. Minimum follow-up time will be 2 years for all patients. According to statistical power analysis a total of 60 patients will be needed to provide evidence for the effectiveness or no effectiveness of rigid thoracolumbar orthosis on the natural history of early spondylolysis. Measured outcome parameters are 1) Bony healing on CT-scan, 2) SRS-24-score at the beginning of the treatment and during the 2-year follow-up, 3) Back and lower extremity pain at the beginning of the treatment and during the 2-year follow-up (Pain drawing including VAS-score in children under 16 years old, Oswestry disability index including VAS-score in patients over 16 years old), 4) Thoracolumbar radiographs at 2-year follow-up: Evidence of spondylolisthesis, 5) Trunk strength and spinal mobility at follow-up visits. As part of this study, the investigators will also evaluate patients with spondylolysis treated in their hospitals before this clinical trial begun. In this retrospective study they will evaluate all patients between 8 and 20 years of age with spondylolysis, which have been treated with thoracolumbar orthosis after year 2009 and are not participating in to prospective study. Main focus will be in bony healing in CT-scans after brace treatment.

The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).

Service members and/or recently separated veterans with post traumatic stress symptoms and mild traumatic brain injury may participate in 8 sessions including 2 sessions including interviews and questionnaires as well as 6 sessions of art therapy. In the art therapy, participants will be provided with a blank paper mache mask template and invited to alter the mask however they wish using a variety of art materials. The therapist will use the art-making process and culminating product to aid in self-reflection, reframe negative thoughts and feelings, and work through traumatic content. Prior to the session start participants will get set up with a mobile qEEG (worn like a hat and backpack). The qEEG will measure brain activity in a non-invasive way throughout the art therapy session to improve understanding of brain activity during the art therapy process.

The project goals are to improve combat readiness of U.S. Soldiers and sustain the availability of the military to deploy by, 1) decreasing the number of days not physically ready for duty after diagnosis of a diaphyseal tibial stress fracture, 2) decreasing the need for a physical profile or medical discharge board after bone stress injury, and 3) decreasing the recurrence rates of bone stress injuries.

The study will comprise of an original investigation that will take the form of a prospective intervention (two matched groups) study. Condition-1 will be a vitamin D supplementation group (50.000 IU every two months), and Condition-2 will be a placebo supplementation group. The primary research aim of this project is to evaluate the effectiveness of vitamin D supplementation to reduce stress fracture risk and susceptibility to skin, soft tissue infection (SSTI) and respiratory infection in Royal Marine recruits undertaking arduous physical training in a randomised control trial (RCT). The secondary research aims are: To investigate whether supplementation of vitamin D3 at a dose of 50.000 IU every two months (equivalent to 800 IU per day) is effective in reducing the risk of stress fracture and susceptibility to skin, soft tissue and respiratory infection. To examine changes in vitamin D status (relative to baseline serum 25(OH)D concentration), serum PTH concentration, and markers of bone turnover in response to vitamin D3 supplementation during the winter and summer months. To identify interactions between dietary intakes, physical fitness, physical characteristics (body mass, BMI, thigh girth), smoking habit, alcohol consumption, and stress fracture prevalence with serum 25(OH)D status, serum PTH concentration and markers of bone turnover in the vitamin D3 supplemented group vs. the placebo supplemented group.

The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.

Breaking bad news (e.g., telling patients that they have cancer) is not only very stressful for the patients concerned, but also for the physicians delivering the diagnosis. It is unclear how this burden and the associated communication performance can be optimized. The project contributes to this goal. The main goal of the project is to scientifically analyze to what extent the stress reaction and communication performance of medical students can be optimized when breaking bad news. Two strategies will be employed and tested for their effectiveness: First, "stress arousal reappraisal", which consists in reinterpreting physiological arousal (e.g., increased heart rate) as adaptive and beneficial for task performance. Second, medical students can be well prepared for breaking bad news by learning from worked examples (step-by-step demonstrations of how to break bad news). The investigators hypothesize that both strategies will shift the interpretation of breaking bad news from a threat to a challenge state. This will lead to better communication performance during the task. To test the hypothesis, about 200 medical students' communication performance, cardiovascular activity, stress hormone release, and subjective stress perception when communicating a serious cancer diagnosis to a simulated patient (actor) will be measured. The results of the study provide a first comprehensive picture of the psychophysiological stress patterns of medical students who are entrusted with a stressful communication task. Ultimately, this may promote stress management and communication skills in future physicians.