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NCT ID: NCT06275386 Not yet recruiting - Clinical trials for Coronary Artery Disease

Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention

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

The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.

NCT ID: NCT06274788 Not yet recruiting - Malnutrition Clinical Trials

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

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

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

NCT ID: NCT06273241 Not yet recruiting - Clinical trials for Pharmacokinetic Study in Healthy Volunteers

Impact of Food Intake on Berberine Kinetics

BERKI-3
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed. In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon. As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively. 24 heathy volunteers with an equal ratio of man and women will be enrolled.

NCT ID: NCT06272513 Not yet recruiting - Clinical trials for Advanced Head and Neck Squamous Cell Carcinoma

Influencing Factors for Physical Activity in People With Head and Neck Cancer

ProAct-HNC
Start date: March 2024
Phase:
Study type: Observational

The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others. Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions: - What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience? - What motivates people with advanced head and neck cancer to be physically active? - How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer? The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

NCT ID: NCT06272162 Not yet recruiting - Clinical trials for Locally Advanced Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy

LAPSTAR
Start date: February 2024
Phase: N/A
Study type: Interventional

A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).

NCT ID: NCT06271616 Not yet recruiting - Clinical trials for Chronic Graft Versus Host Disease

Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

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

This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD.

NCT ID: NCT06271057 Not yet recruiting - Clinical trials for Refractory High Grade B-Cell Lymphoma

Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

Start date: April 22, 2024
Phase: Phase 2
Study type: Interventional

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.

NCT ID: NCT06269874 Not yet recruiting - Clinical trials for Microvascular Coronary Artery Disease

Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

ASPERA-ANOCA
Start date: March 2, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. Goals of this study are: 1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value. 2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow). 3. Time required for IMR measurements

NCT ID: NCT06268808 Not yet recruiting - Clinical trials for Type 2 Diabetes Treated With Insulin

Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy

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

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

NCT ID: NCT06267508 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

LIFE2Scale
Start date: March 2024
Phase:
Study type: Observational

This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.