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NCT ID: NCT06038864 Not yet recruiting - Clinical trials for Lower Limb Lymphedema

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4

EvaLymph-Leg4
Start date: April 1, 2024
Phase:
Study type: Observational

Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?

NCT ID: NCT06039293 Not yet recruiting - Depression Clinical Trials

Program AACTIVE: African American's Coming Together to Increase Vital Exercise

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

Program AACTIVE will enroll 80 African American/Black men with type 2 diabetes and depression. Participants will be randomized to either the intervention arm or the control arm. Participants in the intervention arm will receive talk therapy and physical activity sessions over 12 weeks. Talk therapy and physical activity sessions will take place via a video conferencing platform. There will also be 3 in-person health assessments including baseline, at 12-weeks and 3-month follow up. The investigators are interested in seeing if physical activity and talk therapy improve A1C outcomes and depression symptoms for participants.

NCT ID: NCT06041763 Not yet recruiting - Meniscus Tear Clinical Trials

Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

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

The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.

NCT ID: NCT06049615 Not yet recruiting - Atrial Fibrillation Clinical Trials

Conscious Sedation Study

CSS
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.

NCT ID: NCT06066502 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

PREVENT VILI
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.

NCT ID: NCT06070103 Not yet recruiting - Diabetes Mellitus Clinical Trials

Depression ,Anxiety and Stress Disorders Among Diabetic Patients in Assuit University Hospitals

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

1. Assessment the prevalence of psychiatric disorders in diabetic patient in Assuit University Hospital. 2. Determine the associated factors with the psychiatric disorders.

NCT ID: NCT06094088 Not yet recruiting - Depression Clinical Trials

Examining the Impact of Heated Yoga on Mindfulness and Rumination

RHYME
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study will examine how doing heated yoga or non-heated yoga affects depression.

NCT ID: NCT06096519 Not yet recruiting - HIV Clinical Trials

Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens

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

This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).

NCT ID: NCT06097195 Not yet recruiting - Epilepsy Clinical Trials

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

CITADEL
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.

NCT ID: NCT06100614 Not yet recruiting - Clinical trials for Early-Onset Neonatal Sepsis

Presepsin to Safely Reduce Antibiotics in Preterm Infants

PRESAFE
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

In the Netherlands, more than 85% of the preterm infants born <32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of these preterm babies actually has a bacterial infection. The use of antibiotics after birth can lead to problems on short term (bowel infection, infection with a bacteria later on or death) or long term (asthma, allergy, obesity). The goal of the PRESAFE trial is to investigate whether addition of a biomarker (presepsin) to the Dutch early-onset neonatal sepsis (EOS) guideline safely reduces unnecessary empirical antibiotic exposure after birth in preterm infants born before 32 weeks gestational age. In this 874-subject multicenter, randomized clinical trial with a concurrent observational cohort, the hypothesis to be tested is that by adding presepsin to the national guideline the amount of unnecessary empirical antibiotic exposure after birth will be reduced with at least 30% without increase in infants with untreated sepsis. The study targets a population of clinical stable very preterm infants with risk factors for eary-onset neonatal sepsis. Antibiotic administration after birth is started to pre-emptively treat EOS. By adding a presepsin-guided step to the Dutch EOS guideline for those infants qualifying for antibiotic treatment, it is assumed that the rate of antibiotic administration can be reduced. However, it is imperative that this reduction in antibiotics is not outweighed by an increase in (culture proven) EOS. Therefore, the co-primary outcomes of the study are: 1) the incidence of culture-proven EOS (non-inferiority) and 2) unnecessary antibiotics prescription i.e. antibiotic administration for ≤ 3 days when started within the first 72 hours after birth (superiority). Secondary outcomes include sepsis-related severity of illness, total number of antibiotic days when started < 72 hours after birth, and the composite outcome of necrotizing enterocolitis (NEC), late-onset sepsis (LOS), or death until discharge from the initial hospital.