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NCT ID: NCT06297993 Recruiting - PSC Clinical Trials

Adult Patients With Primary Sclerosing Cholangitis

WIND-PSC
Start date: May 6, 2024
Phase:
Study type: Observational

Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.

NCT ID: NCT06297980 Recruiting - Type 1 Diabetes Clinical Trials

Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes

MERIT
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

NCT ID: NCT06297941 Recruiting - Clinical trials for Acute Myeloid Leukemia

Study of REM-422 in Patients With AML or Higher Risk MDS

Start date: April 26, 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML

NCT ID: NCT06297876 Recruiting - Vaccine Hesitancy Clinical Trials

COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color

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

Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts

NCT ID: NCT06297629 Not yet recruiting - Clinical trials for Allogeneic Stem Cell Transplantation

A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

Start date: July 31, 2024
Phase: Phase 2
Study type: Interventional

To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.

NCT ID: NCT06297603 Recruiting - Type 2 Diabetes Clinical Trials

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

Start date: March 15, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

NCT ID: NCT06297590 Not yet recruiting - Alzheimer Disease Clinical Trials

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

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

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A. If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks.

NCT ID: NCT06297551 Recruiting - Clinical trials for Acute Myeloid Leukemia

Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)

Start date: March 5, 2024
Phase:
Study type: Observational

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.

NCT ID: NCT06297499 Not yet recruiting - Clinical trials for Pruritus Caused by Drug

Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section

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

Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.

NCT ID: NCT06297486 Recruiting - Hemophilia A Clinical Trials

Study of a Gene Therapy Treatment for Hemophilia A

KEYSTONE 1
Start date: March 13, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.