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NCT ID: NCT06321484 Not yet recruiting - Ovarian Cancer Clinical Trials

Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer

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

The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer (HGOC). Names of the study therapies involved in this study are: - CIML NK (cellular therapy) - N-803 (a novel immune-cell stimulator)

NCT ID: NCT06321471 Not yet recruiting - Asthma Clinical Trials

AeviceMD for Pediatric Asthma Management

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

A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations.

NCT ID: NCT06321302 Recruiting - Clinical trials for Diabetic Retinopathy

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Start date: May 7, 2024
Phase: Phase 2
Study type: Interventional

This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study. The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy. Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06321055 Completed - Clinical trials for Advanced Gastrointestinal Stromal Tumor

An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States

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

This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied. In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment. Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body. The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world. The participants in this study had started treatment with regorafenib as part of their regular care from their doctors. The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on: Duration of treatment with regorafenib (also known as duration of therapy) The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy) The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023. Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days. In this study, only available data are collected. No visits or tests are required as part of this study.

NCT ID: NCT06321029 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Electronic Diabetes Tune-Up Group (eDTU) for African Americans

Start date: October 19, 2023
Phase: N/A
Study type: Interventional

The primary aims of this study are: 1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates). 2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control. Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 & T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 & T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c.

NCT ID: NCT06320990 Not yet recruiting - Pancreatic Cyst Clinical Trials

Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

MCN_Tam
Start date: September 2024
Phase: Phase 1
Study type: Interventional

This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic mucinous cystic neoplasms (MCN) who will not undergo immediate resection. Up to 15 participants will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks.

NCT ID: NCT06320951 Not yet recruiting - Obesity Clinical Trials

VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway

VITAL-IMPACT
Start date: May 1, 2025
Phase: Phase 2
Study type: Interventional

This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals.

NCT ID: NCT06320925 Recruiting - Knee Injuries Clinical Trials

SportsPro: Post-Market Clinical Follow Up Study

Start date: December 5, 2023
Phase:
Study type: Observational

Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

NCT ID: NCT06320860 Enrolling by invitation - Kidney Calculi Clinical Trials

FlexStone Enabled Kidney Stone Retrieval

Start date: March 8, 2024
Phase: N/A
Study type: Interventional

This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

NCT ID: NCT06320808 Active, not recruiting - Knowledge Clinical Trials

Evaluating FDA's Proposed Patient Medication Information Handout

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

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users. The main questions it aims to answer are: How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension? and How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information? Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.