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NCT ID: NCT06411405 Recruiting - Neonatal Sepsis Clinical Trials

Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe

NeoRisk
Start date: April 11, 2024
Phase:
Study type: Observational

The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe. The main questions it aims to answer are: - What are the risk factors for early-onset neonatal sepsis in low-resource settings? - How can these be combined into a risk prediction model? Mother-baby pairs will be recruited in Uganda. They will have extensive data taken on their medical and obstetric histories and lifestyles, and their newborns will have a blood sample taken just after birth for culture. Machine learning techniques will be used to create the risk prediction model, which will then be validated in a second population in Zimbabwe.

NCT ID: NCT06377878 Recruiting - Preeclampsia Clinical Trials

The Preeclampsia Registry

TPR
Start date: September 1, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves.

NCT ID: NCT06362356 Recruiting - Clinical trials for Hypertensive Disorder of Pregnancy

Microbial Metabolites and Outcomes of Pregnancy Study

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

Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction. Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants. Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes.

NCT ID: NCT06344819 Recruiting - Sepsis Clinical Trials

An Acupuncture Study for People At High Risk for Sepsis

Start date: March 20, 2024
Phase: Phase 2
Study type: Interventional

Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture.

NCT ID: NCT06323226 Recruiting - Sepsis Clinical Trials

The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis

Start date: January 1, 2019
Phase:
Study type: Observational

This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life.

NCT ID: NCT06312488 Recruiting - Sepsis Clinical Trials

Point of Care Evaluation of Fibrinolysis in Sepsis

POCEFIS
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers.

NCT ID: NCT06295393 Recruiting - Sepsis Clinical Trials

Renin Angiotensin Aldosterone System In Septic Kids

RISK
Start date: January 24, 2024
Phase:
Study type: Observational

Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI. Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients. Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.

NCT ID: NCT06287684 Recruiting - Sepsis Clinical Trials

Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

MENDSEP
Start date: September 13, 2023
Phase:
Study type: Observational [Patient Registry]

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.

NCT ID: NCT06281665 Recruiting - Hypertension Clinical Trials

Treatment With Aspirin After Preeclampsia: TAP Trial

TAP
Start date: May 29, 2024
Phase: Phase 4
Study type: Interventional

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

NCT ID: NCT06267742 Recruiting - Sepsis Clinical Trials

Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Start date: June 23, 2022
Phase:
Study type: Observational

This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.