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NCT ID: NCT06348238 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Strategies to Improve Well-Being and Diabetes Management

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are: - Will self-affirmation reduce feelings of stigmatization? - Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors. - Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it. After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention.

NCT ID: NCT06348160 Recruiting - Type 1 Diabetes Clinical Trials

iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes

Start date: May 14, 2024
Phase: N/A
Study type: Interventional

This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.

NCT ID: NCT06348147 Not yet recruiting - Multiple Myeloma Clinical Trials

Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists. This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

NCT ID: NCT06348134 Not yet recruiting - Breast Cancer Clinical Trials

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

NCT ID: NCT06348108 Not yet recruiting - Multiple Myeloma Clinical Trials

Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

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

This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM

NCT ID: NCT06348082 Not yet recruiting - Insomnia Clinical Trials

Project Women's Insomnia Sleep Health Equity Study (WISHES)

Project WISHES
Start date: September 2025
Phase: N/A
Study type: Interventional

The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.

NCT ID: NCT06348056 Recruiting - Clinical trials for Response of Fatty Acid Desaturation to Zinc Intake

A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate

Start date: January 22, 2024
Phase: N/A
Study type: Interventional

Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate. The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state. The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex.

NCT ID: NCT06347978 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Personalized DBS for OCD Guided by Stereoencephalography Mapping

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

This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

NCT ID: NCT06347861 Recruiting - Healthy Clinical Trials

A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults

Start date: April 2, 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food. This study looks at how the medicine is changed and removed from the body after a participant takes it. This study is seeking for participant who: - are healthy males, and healthy females who do not have the possibility to have children. - are 18 years of age or older. - weigh more than 45 Kilograms (99 pounds). The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks.

NCT ID: NCT06347822 Not yet recruiting - Psychotherapy Clinical Trials

Increasing Access to Evidence-Based Care in Integrated Behavioral Health

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

The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future.