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NCT ID: NCT05912517 Recruiting - Clinical trials for Hemolytic Disease of the Fetus and Newborn

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

AZALEA
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

NCT ID: NCT05909748 Recruiting - Clinical trials for Aortic Valve Stenosis

FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis

Start date: May 21, 2023
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation

NCT ID: NCT05909618 Recruiting - Clinical trials for MGMT-Unmethylated Glioblastoma

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases

14
Start date: July 11, 2023
Phase: Phase 2
Study type: Interventional

A single-center, open-label, non-randomized phase I/II study to evaluate the efficacy, safety and tolerance of crizanlizumab monotherapy and in combination with nivolumab in patients with advanced glioblastoma (GB) who exhausted standard of care (SOC) therapy, patients with metastatic brain melanoma (MBM) and patients with newly diagnosed unmethylated GB. Subjects will be screened for up to 28 days prior to treatment initiation. Eligible subjects will be allocated to one of 3 cohorts: Cohort 1: Patients with metastatic melanoma with primarily diagnosed or newly progressing brain metastases who failed immunotherapy. Cohort 2: Patients with recurrent or progressing GB following primary radiation therapy and temozolomide. Patients may have failed up to 2 prior systemic treatment lines (including temozolomide as adjuvant therapy) and are candidates for further treatment. Cohort 3: Patients with newly diagnosed GB who were evaluated for methylguanine-DNA methyltransferase(MGMT) methylation status and have un-methylated MGMT promotor-therefore, they are not candidates for maintenance temozolomide therapy.

NCT ID: NCT05908708 Recruiting - Type 1 Diabetes Clinical Trials

Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes

Start date: June 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, and six months after the connection.

NCT ID: NCT05904808 Completed - Clinical trials for Congestive Heart Failure

The Heart Failure Diuresis Efficacy Comparison (DEA-HF) Study

DEA-HF
Start date: April 19, 2023
Phase: Phase 4
Study type: Interventional

To investigate the effectiveness of three (3) IV diuretic regimens to increase natriuresis in volume-overloaded HF patients, allowing for better decongestion and potentially resulting in improved clinical and biochemical parameters outcome.

NCT ID: NCT05902832 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Autism spectrum condition (ASC) is a neurodevelopmental disorder characterized fundamentally by social deficits. Emotional competence - the ability to express, recognize, understand, and regulate emotions - is a key aspect of social communication. Evidence suggests that the developmental trajectories of autistic children differ from that of neuro-typical children regarding their ability to process and recognize emotions from paralinguistic emotional facial, body language, and voice tone cues. They also have difficulty integrating these cues in context and lack in emotional language. Numerous approaches to teaching people with autism how to recognize and understand emotions have been tried, with recent increased interest in computer-based interventions (CBI). However, most of the research focused only on facial expressions, were limited to autistic children with no intellectual disabilities (ID); and showed limited generalization to real social settings. EmotiPlay, a computer-based intervention program, designed to enhance emotion recognition (ER) by addressing multiple modalities of emotional cues (facial expressions, tone of voice, body language), has shown good outcome when used at home by autistic children and no ID . However, the examination of generalization was partial and depended only on parental reports. The present study main goals are to: (1) Examine the adaptation and the integration of EmotiPlay into special education classrooms in regular schools. (2) Assess EmotiPlay's effect on emotional competence among autistic children at different functioning levels.

NCT ID: NCT05896163 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.

Start date: August 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of two study medicines (maplirpacept [PF-07901801] and glofitamab) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means has returned after last treatment. Refractory means that it has not responded to last treatment. The two study medicines are given after a single dose of obinutuzumab which is the third study medicine. DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking adult participants who: - Have histologically confirmed diagnosis of DLBCL - Have received at least one first line of treatment for NHL. - Are unable or unwilling to undergo a stem cell transplant or CAR-T cell therapy. Stem cell transplant is a procedure in which a patient receives healthy blood-forming cells to replace their own stem cells that have been destroyed by treatment. A CAR-T therapy is a type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells. Everyone in this study will receive all three medicines at the study site by intravenous (IV) infusion which is given directly into a vein. The two study medicines (maplirpacept [PF-07901801] and glofitamab) will be given in 21-day cycles. At Cycle 0, participants will receive a single dose of obinutuzumab pre-treatment followed by two step-up doses of glofitamab. The combination of maplirpacept (PF-07901801) with glofitamab full dose will be administered for the first time at Cycle 1 Day 1. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every three weeks. Glofitamab will be given every 3 weeks for approximately 9 months. Thereafter participants will continue to receive maplirpacept alone. Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive the same fixed doses of glofitamab and obinutuzumab studied in patients with DLBCL. The study will compare the experiences of people receiving different doses of maplirpacept (PF-07901801). This will help to determine what dose is safe and effective when given with the other 2 study medicines.

NCT ID: NCT05894785 Recruiting - Clinical trials for Twin Pregnancy With Antenatal Problem

External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin

Start date: February 27, 2022
Phase: N/A
Study type: Interventional

In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.

NCT ID: NCT05893641 Recruiting - Exercise Clinical Trials

Investigate the Relationship Between Exercise Training and Recovery Ratio to Improve Physical Performance and Health Status

MOD_2
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

This study aims to investigate the effectiveness of various recovery strategies (such as longer recovery periods or reduced exercise intensity) in optimizing both physical performance and overall health status. Furthermore, the study will explore the potential of using changes in blood and urinary markers as indicators for assessing recovery status. This study will assess whether extending recovery periods between exercise sessions and reducing the volume of exercise training can enhance the recovery process and enhance performance and health-related markers, relative to a control group. One hundred-fifth young males will be recruited to participate in a single-center, parallel-group, randomized, well-controlled, superiority trial for 8 weeks of high-volume exercise training. A single-center, parallel-group, randomized, well-controlled, superiority trial will be conducted among 150 physically active young males. Participants will undergo an 8-week high-volume exercise during base training program, which they will be randomly assigned to one of three groups: (1) a control group, which will follow the standard exercise regimen of 35 hours/week (n = 50); (2) a less exercise volume group, which will reduce exercise volume by 15% to 30 hours/week (n = 50); and (3) an extended recovery group, which will perform the same volume of exercise as the control group (35 hours/week), but with longer recovery intervals between exercises (n = 50). The intervention will take place at the Ministry of Defense training platform. All study measurements will be taken at baseline and throughout the study. Body composition will be assessed using multichannel bioelectrical impedance (Seca). Continuously monitor (Garmin) will be used to evaluate heart rate and heart rate variability. Fasting blood samples will be used to examine inflammatory, lipid, glycemic, and endocrine markers. Physical performance will be assessed by several validated assessments, including handgrip, maximal voluntary contraction, Wingate test, Isometric Mid-Thigh Pull (IMTP), counter movement jump (CMJ) and maximal oxygen consumption (VO2max).

NCT ID: NCT05893498 Recruiting - Clinical trials for Percutaneous Coronary Intervention

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

ALL-RISE
Start date: June 21, 2023
Phase: N/A
Study type: Interventional

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.