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NCT ID: NCT06139666 Enrolling by invitation - Postoperative Pain Clinical Trials

The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery

Start date: July 11, 2019
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.

NCT ID: NCT06139627 Recruiting - Clinical trials for Stage III Lung Cancer AJCC v8

Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

Start date: June 16, 2024
Phase: N/A
Study type: Interventional

This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.

NCT ID: NCT06139614 Completed - Clinical trials for Well-Being, Psychological

Personal Resilience Skills to Improve Surgery Training

PERSIST
Start date: August 16, 2023
Phase: N/A
Study type: Interventional

The objective of the current study (PERSIST) is to 1) determine acceptability of an 8-session (16 week) group curriculum on personal resilience skills for residents in the Duke General Surgery Program, and 2) examine changes in professional fulfillment, depression symptomatology, anxiety symptomatology, and self-valuation, and positive wellbeing (flourishing) at the end of the program and 3-month follow-up compared to baseline, 3) examine performance on surgery training metrics compared to the mean performance of non-participants. Participants will be residents active in the Duke General Surgery Program. There will be one group of Junior Assistant Residents (JAR, N = 10) and one group of Senior Assistant Residents (SAR, N =10), which will be conducted separately. At baseline, all participants will complete questionnaires related personal resilience, including professional fulfillment (professional fulfillment, work exhaustion, interpersonal disengagement), depression symptoms, anxiety, symptoms, self-valuation, flourishing, and psychosocial working conditions. At post-treatment (end of session 8), participants will complete the baseline questionnaires (with the exception of psychosocial working conditions), as well as a questionnaire assessing acceptability of the group experience and content. The post-treatment questionnaires will be repeated as a 3-month follow-up. All study activities are considered low risk, and there the training is expected to have the benefit of teaching lasting skills to promote professional and personal resilience. To protect participant confidentiality, surgery staff and faculty will not have access linkage between study variables and participant identity.

NCT ID: NCT06139601 Recruiting - Body Image Clinical Trials

A Single Session Community-Based Body Empowerment Session

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

This present study will examine the effectiveness of a single session, virtually delivered body empowerment program for decreasing participants thin ideal internalization. The intervention asks participants to identify cultural norms surrounding appearance and attractiveness, then challenge these ideals. Participants will answer questions about thin ideal internalization before and after the program.

NCT ID: NCT06139549 Recruiting - Clinical trials for Gross Motor Development Delay

The Effects of Playful Pathways

Start date: September 20, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program. The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.

NCT ID: NCT06139523 Recruiting - Glaucoma Clinical Trials

Optimize Pediatric OCT Imaging

Start date: January 24, 2024
Phase:
Study type: Observational

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

NCT ID: NCT06139458 Recruiting - Gynecologic Cancer Clinical Trials

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.

NCT ID: NCT06139289 Active, not recruiting - Clinical trials for External Ventricular Drain

A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

Start date: September 19, 2022
Phase:
Study type: Observational

External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.

NCT ID: NCT06139224 Recruiting - Clinical trials for Alcohol Use Disorder

Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 20 HIV+ ART+ (10 AUD- and 10 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept observational study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will have two study visits, where stool collection and blood draw will be collected, as well as questionnaires. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. We will recruit the following groups of participants: HIV+ ART+ AUD-; HIV+ ART+ AUD+; HIV- AUD- ; HIV- AUD+. Blood, urine, stool, and intestinal biopsies will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois. Second, lleal/colonic organoids from HIV- and HIV ART+ individuals will be generated to examine their resilience to alcohol-induced intestinal barrier disruption.

NCT ID: NCT06139172 Enrolling by invitation - Fragile X Syndrome Clinical Trials

Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities

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

The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral strategies in individuals with syndromic intellectual and developmental disorders. Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.