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NCT ID: NCT06132477 Recruiting - Hypertension Clinical Trials

Impact GLP-1 Agonists Following Bariatric

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.

NCT ID: NCT06132464 Recruiting - Aphasia Clinical Trials

ECoLoGiC Speech Therapy for Everyday Communication in Aphasia

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The primary goal of this clinical trial study is to evaluate the effect of a new therapy to improve talking in people with the language disability 'aphasia' after a stroke. The therapy is called: 'Expanding Communication and Language Generated in Conversation Treatment' (ECoLoGiC Treatment), and helps improve language skills for talking to other people in conversation. The second goal is to develop training materials to teach families of people with aphasia about the therapy and how to practice at home. This part of the study will be completed with help from two people with aphasia and a family member who have completed the program. The study asks: 1. How do people with aphasia improve their language skills following this therapy? Results will be determined by using tests of language and by testing language in conversation and other types of talking tasks, like describing a picture. 2. After completing the family training, do family members use the ideas they learned when talking to the person with aphasia? And, what do family members and people with aphasia think of the family training? The first question will be answered with a checklist to see if the family members followed the ideas they learned. The second question will be answered by talking with the people with aphasia and the family members to find out what they thought. The people with aphasia will complete language testing before and after therapy, and 6 weeks later (to see if improvements are maintained). Therapy is twice a week for one hour, for 10 weeks with a speech-language pathologist. During therapy, the person will have casual conversations with the speech-language pathologist, who will help the person communicate by giving small amounts of help at a time. The speech-language pathologist will tell the person what they are doing that does and does not help with communication. This process helps the person use more language and learn how to communicate better. The family members will have training with the speech-language pathologists to learn about the therapy and how to continue with the ideas at home. Training will take place over 3 sessions, scheduled in addition to therapy sessions. After therapy ends, the family members will have conversations with the person with aphasia, to show what they have learned. Each family member and person with aphasia will also have a 10-20 minute conversation with a researcher to share their thoughts about the training program.

NCT ID: NCT06132425 Completed - Anxiety Disorders Clinical Trials

Reward Processes and Rehearsal in Exposure Therapy

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to 1) examine the importance of self-reported relief following exposure and 2) test whether positive-focused rehearsal following exposure can improve treatment outcomes for participants who endorse fear of public speaking. Exposure therapy is an extinction-based behavioral technique, often employed in the context of cognitive behavioral therapy. It involves strategically exposing an individual to a feared stimulus in an effort to generate new non-fear associations with that stimulus. Relief refers to the positive, rewarding emotions associated with the absence of an expected aversive outcome following exposure to a feared stimulus. In the current study, participants will engage in a series of short public speaking exposures that take place over two sessions. After every two exposures, participants will be asked to complete either a positive or neutral rehearsal exercise, consisting of recalling either positive or neutral aspects of the speech exposures. At multiple points throughout the study, participants will complete ratings of reward sensitivity, positive affect, relief, and expectancy of the aversive outcome. The investigators will test the following: 1) the relationship of reward sensitivity and positive affect with relief following exposures, 2) the relationship between relief after exposure and learning rate (i.e., learning that the feared stimulus does not predict an aversive outcome), 3) potential differences in exposure outcomes between the positive and neutral rehearsal groups.

NCT ID: NCT06132386 Completed - HIV Infections Clinical Trials

Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue

Start date: August 7, 2023
Phase:
Study type: Observational

The goal of this clinical study is to learn about the effect of aging on certain enzymes, or proteins, in the blood and colon. The study involves collection of blood and colon tissue biopsies using a flexible sigmoidoscope or colonoscope. This study is also investigating how medications tenofovir and emtricitabine interact with certain enzymes. The investigators will compare the difference in enzyme activity between people taking tenofovir and emtricitabine, to those who are not taking tenofovir and emtricitabine.

NCT ID: NCT06132282 Completed - Clinical trials for Substance Use Disorders

The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth

SUHRI
Start date: June 21, 2022
Phase: N/A
Study type: Interventional

This investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for Juvenile Justice (JJ) youth that will ultimately be (after full testing through a subsequent large-scale RCT) a sustainable intervention implemented within a JJ supervision/case management context to teach and facilitate positive, pro-social, and expected behaviors. The intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices. Existing evidence-based intervention materials will be incorporated and delivered through a web-based application. Sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics. Research activities will be carried out in two pilot studies: (1) Intervention Adaptation and Feasibility and (2) Protocol Feasibility and Preliminary Efficacy Trial. In Pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (N = 30; 20 youth, 10 JJ staff). Pilot 2 will test a scaled-down version of an intervention efficacy randomized control trial (RCT), comparing the web-based intervention to a time-matched, information-only group using a 2-arm, randomized design whereby 120 enrolled youth (who meet eligibility requirements) from one juvenile probation department are randomly assigned to condition.

NCT ID: NCT06132178 Not yet recruiting - Depression Clinical Trials

Psilocybin rTMS for Treatment Resistant Depression

PSILOBSD
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

NCT ID: NCT06132165 Recruiting - Neurofibromatosis 1 Clinical Trials

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Start date: March 1, 2024
Phase: Phase 1
Study type: Interventional

This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site..

NCT ID: NCT06132126 Recruiting - Healthy Clinical Trials

A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.

NCT ID: NCT06132113 Recruiting - Clinical trials for Neuroendocrine Neoplasms

DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers

Start date: December 20, 2023
Phase: Phase 1
Study type: Interventional

This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3. The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has 2 parts. Part A of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC. Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it. Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.

NCT ID: NCT06132087 Recruiting - Clinical trials for Locally Advanced Pancreatic Adenocarcinoma

PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy

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

This clinical trial tests how well surgical resection after chemotherapy given before surgery to make the tumor smaller (neoadjuvant) works to treat pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and that cannot be removed by surgery (unresectable). In general, surgery is considered the most effective treatment for pancreatic cancer, especially when the cancer is localized and has not spread to other organs. However, most patients with pancreatic cancer are not candidates for surgical removal because the cancer has grown into or close to nearby arteries, veins, or organs and there is a concern of damaging these nearby structures. Researchers want to find out if surgery after neoadjuvant chemotherapy can be done safely to completely remove the tumor in patients with locally advanced and unresectable pancreatic cancer.