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Fractures, Stress clinical trials

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NCT ID: NCT06423378 Not yet recruiting - Clinical trials for Subchondral Insufficiency Fracture

Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

Start date: July 3, 2024
Phase: Phase 2
Study type: Interventional

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. The OSSIOfiber® Trimmable Fixation Nails used in this study will be considered on-label.

NCT ID: NCT06390267 Not yet recruiting - Clinical trials for Cognitive Performance

Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

ASR
Start date: August 2024
Phase: N/A
Study type: Interventional

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.

NCT ID: NCT06256952 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use

ReCoDe
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study: Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.

NCT ID: NCT06138548 Not yet recruiting - Clinical trials for Subchondral Insufficiency Fracture

Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

Start date: May 2024
Phase: N/A
Study type: Interventional

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.

NCT ID: NCT06037785 Not yet recruiting - Ptsd Clinical Trials

Self-Management Interventions After an ICD Shock

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.

NCT ID: NCT05912998 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Knee arthroscopy using standard portals will be performed in three groups. Complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. The cartilage lesion grading according to the International Cartilage Repair Society system (ICRS). The patients assigned for the first group will have Liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). Autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. The graft will be mixed with fibrin glue and left to solidify a little. After obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. During the graft preparation, a high tibial osteotomy will be performed. Patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. Patients assigned for the third group will have open wedge high tibial osteotomy. Standard titanium T locked plate will be used to fix the open wedge osteotomy in the three groups.

NCT ID: NCT05798052 Not yet recruiting - Clinical trials for Stress, Psychological

Effects of Stress on Team Coordination and Performance

Start date: April 2023
Phase: N/A
Study type: Interventional

Healthcare teams often encounter challenging circumstances where they must deliver high-quality care. For a team to function effectively, its members must not only be individually competent, but they also need to collaborate and cooperate using their respective expertise. Such teams often work under high stress situations, where they need to make high stakes decisions under conditions of uncertainty, time-sensitivity and variable levels of control. Research shows that such emergency situations provoke stress responses in individuals, which can impair attention, memory, reasoning, and decision-making. However, it remains unclear how individual-level stress responses influence team communication, coordination, and performance. The aims of this study are to a) compare team coordination, communication, and performance in low stress versus high stress simulated emergency situations; and b) characterize the relationship between teams' stress profiles and the teams' performance and coordination. The study will be a within-subject experimental design, with teams serving as their own controls. Teams of emergency medicine residents and nurses will participate in two simulation scenarios: one in a low stress condition, and the other in a high stress condition (counterbalanced across the teams).

NCT ID: NCT05694585 Not yet recruiting - Airway Obstruction Clinical Trials

Effect of Esmolol on Perioperative Stress Reaction

Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention .

NCT ID: NCT04686968 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

Start date: July 2021
Phase: N/A
Study type: Interventional

Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

NCT ID: NCT04533984 Not yet recruiting - Stress Fracture Clinical Trials

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Start date: October 1, 2020
Phase: Phase 4
Study type: Interventional

FORTEO (teriparatide [rDNA origin]; Eli-Lilly, Indiana, USA) is an injectable synthetic recombinant human parathyroid hormone analog that is commonly used to treat people with osteoporosis. In the current investigation this drug will be tested to evaluate its efficacy to accelerate bone healing and decrease the convalescence time of US Army Basic Trainees who have sustained a diaphyseal tibial stress fracture (DTSF). Investigators from the University of South Carolina will collaborate with military personnel to perform a prospective, randomized, double-blind, placebo-controlled study at Fort Jackson, SC.