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NCT ID: NCT06418971 Not yet recruiting - Dementia Clinical Trials

The Caregiver Resource Room (CRR): Using Technology to Enhance Support for Dementia Family Caregivers

CRR
Start date: March 1, 2025
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and test CarePair, a web-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being. The main aims of this study are: - To evaluate the feasibility and acceptability of the CarePair web application. - To explore the potential for the CarePair web-application to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy. Caregiver participants will be asked to log in and test the CarePair web application and complete study activities for a three-month duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.

NCT ID: NCT06418880 Not yet recruiting - Type 2 Diabetes Clinical Trials

Automated Insulin Delivery for Inpatients With Dysglycemia

AIDING
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors. The main objectives of this study are: - To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting - To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics. Participants will be: - Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group) - Followed for a total of 10 days or until hospital discharge (if less than 10 days).

NCT ID: NCT06418711 Not yet recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

ICoN-1
Start date: June 2024
Phase: Phase 3
Study type: Interventional

This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to Guideline-based therapy (GBT).

NCT ID: NCT06418308 Not yet recruiting - Cesarean Section Clinical Trials

Intrathecal Dexmedetomidine vs Epinephrine

Start date: May 2024
Phase: Phase 4
Study type: Interventional

Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.

NCT ID: NCT06417229 Not yet recruiting - Clinical trials for Healthy Participants

Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

Start date: May 16, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.

NCT ID: NCT06417190 Not yet recruiting - Tumor Clinical Trials

Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

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

This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.

NCT ID: NCT06416982 Not yet recruiting - Pain Clinical Trials

Perineal Massage for Pessary Examinations

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

Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.

NCT ID: NCT06416969 Not yet recruiting - Obesity Clinical Trials

Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

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

Adults who gain most of their excess weight in the abdominal area typically do not respond to factors that "turn on" fat cells the same way as people who don't have excessive weight. Researchers are trying to understand why fat tissue responds differently in people with different body types.

NCT ID: NCT06416436 Not yet recruiting - Solid Tumor Clinical Trials

Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients

Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options.

NCT ID: NCT06416150 Not yet recruiting - Cervical Cancer Clinical Trials

Reducing Urban Cervical Cancer Disparities

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

This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment.