Trauma encompasses physical injuries often resulting from accidents or violence, requiring comprehensive approaches to care and recovery. Clinical trials related to trauma explore various treatment evaluations aimed at improving healing processes and...
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Found 2002 Actively Recruiting clinical trials
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Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.
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This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.
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Researchers are evaluating the quality of 3D hand modelization using the EOS imaging system compared to the standard computed tomography (CT) scans. The study focuses on patients who require CT imaging of the hand or wrist to assess the accuracy and potential benefits of the EOS imaging device. Participants will undergo EOS hand imaging, and these images will be compared directly with their standard CT images. The primary goal is to collect and analyze data from both imaging methods at 60 days to determine how well the EOS system performs in creating 3D models of the hand. During the study, participants will have imaging procedures and data collection focused on the hand or wrist area. Researchers will monitor and compare the imaging outcomes from both EOS and CT methods. The total participation duration includes data evaluation at day 60, with no additional treatment or long-term follow-up specified.
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Many people experience wounds that do not heal well or take a long time to heal, including both chronic and acute wounds. This research aims to study the effects of 4-aminopyridine (4-AP), a drug currently used in neurological conditions, to see if it can help speed up wound healing in healthy adults. Previous animal studies showed promising results with faster healing and no adverse effects, making it important to evaluate 4-AP's role in human wound repair. Participants in this study will be randomly assigned to receive either 4-aminopyridine capsules or placebo capsules taken every 12 hours. The treatment period lasts for 6 weeks, during which researchers will monitor wound healing progress. The study includes a phase where participants receive either the active drug or placebo to compare effects on skin integrity and wound closure. During the study, participants will have a skin punch biopsy wound that will be monitored for healing over 6 weeks. Researchers will assess the return of skin integrity, wound closure, and hair growth at the biopsy site. Participants must attend scheduled follow-up visits and may be asked to provide wound photographs. The study also tracks safety and tolerability, ensuring participants are able to report any sensory or motor changes. Total participation is about 6 weeks with regular evaluations.
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Many patients suffer from traumatic burns, and current treatments mainly focus on infection prevention and fluid management without improving the skin's ability to regenerate. This research aims to evaluate the role of 4-aminopyridine (4-AP), a promising agent with a good safety profile, in accelerating burn wound healing in patients with second-degree burns. The study addresses the need for new regenerative treatments that can speed up recovery while allowing existing protocols to continue. Participants will be randomly assigned to receive either 4-aminopyridine capsules (10 mg every 12 hours) or a placebo capsule on the same schedule. This phase 2 study will compare these two groups over a 12-month period to assess the treatment's effect on the healing process. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for healing rate, skin graft requirements, scar formation, and scar sensitivity over 12 months. They will provide informed consent and attend scheduled follow-up visits where researchers will evaluate wound healing through sensory and motor assessments and calibrated wound photographs. Safety and adherence will be closely tracked to evaluate the treatment's impact and patient outcomes throughout the study period.
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Researchers are evaluating the role of a single dose of 4-aminopyridine (4-AP) to help diagnose whether nerve injuries from peripheral nerve traction or crush are complete or incomplete. The study aims to speed up the identification of nerve continuity compared to standard electrodiagnostic and clinical assessments. This is a phase 2, randomized, double-blind crossover trial conducted at a single center. Participants will be randomized to receive either a 10 mg dose of 4-aminopyridine followed by a placebo, or placebo followed by the drug, with the order determined randomly. Each participant undergoes baseline sensory and motor testing, blood sampling, and then hourly testing for three hours after each dose to assess sensory and motor function, electrodiagnostic results, and serum 4-AP levels. After completing both treatment arms, testing concludes. Following initial testing, participants will be monitored for 20 weeks with follow-up visits at 2, 6, 12, 18, and 20 weeks, including physical exams and phone interviews at 9 and 15 weeks to assess subjective motor and sensory function. The main outcome measured is the subjective return of sensation during dosing and at various post-injury time points. Each visit or call lasts about 30 minutes.
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Researchers are investigating how the antidepressant citalopram affects the brain's response to emotional information, focusing on the amygdala, a key brain area involved in depression. This study explores how different parts of the amygdala react to positive and negative emotional stimuli, using advanced brain scanning technology to understand the underlying brain mechanisms. Participants will receive a single oral dose of either 20 mg citalopram or a placebo in a randomized, double-blind design. After dosing, participants will undergo high-strength 7T fMRI brain scans while viewing emotional faces. This precise imaging allows researchers to observe how citalopram influences specific subfields of the amygdala during emotional processing. Participants will be screened for medical and psychiatric health before joining. During the study, brain activity and behavioral responses such as accuracy and reaction time during a gender discrimination task will be measured about three hours after dosing. The study includes safety monitoring and lasts for a few hours on the study day, focusing on neural and behavioral outcomes related to emotional processing.
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Burn injuries can cause long-lasting physical and mental effects due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the depth of the burn, followed by surgery for deeper burns. Assessing burn depth is difficult, and surgical removal of damaged tissue may remove some healthy tissue. New methods like hydro-dissection devices and enzymatic treatments like Bromolein have been explored but lack clear proof of benefit and may sometimes cause harm. This research compares PluroGel®, a special gel that helps soften and remove dead tissue while keeping the wound moist, to the standard antibiotic ointment and gauze dressings. PluroGel® is applied in a 0.5 cm layer with moist gauze twice daily, alongside the standard dressing applied three times a week. The study will assess if PluroGel® improves wound healing and reduces the need for surgery. Participants will receive either the standard dressing or PluroGel® treatment and will be followed for up to 14 days. Researchers will monitor wound healing, pain levels, satisfaction of patients and caregivers, and whether surgery is needed. The study uses a randomized, double-blind design and aims to provide evidence on the effectiveness of PluroGel® in burn care.
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Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.
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Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits: a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.
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