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NCT ID: NCT06285630 Enrolling by invitation - Healthy Clinical Trials

The Development and Health of the Intestinal Flora During the First Year of Life

PREVENT
Start date: February 26, 2024
Phase:
Study type: Observational

In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark). The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection. From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden.

NCT ID: NCT06263218 Enrolling by invitation - CMV Infection Clinical Trials

Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable.

NCT ID: NCT06262282 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

POSTSTAMP
Start date: February 5, 2024
Phase:
Study type: Observational

About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year.

NCT ID: NCT06216639 Enrolling by invitation - Clinical trials for Helicobacter Pylori Infection

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

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

This prospective non-interventional study is being conducted as part of the EU4Health project Eurohelican. The main goal of this pilot study is to evaluate the feasibility and acceptability of implementing the proposed "test-and-treat" screening program on a population-based sample. Participants will be randomly selected from a younger population registered at the primary level of care and tested for the presence of active infection with Helicobacter pylori (H. pylori). Infected participants will undergo a bismuth-based quadruple treatment with antibiotics and a proton pump inhibitor, and will be controlled for eradication success by taking the urea breath test (UBT). A number of other participant outcomes will be also measured to provide additional pro et contra argumentation for the potential future implementation of a population-based test-and-treat screening program in Slovenia. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.

NCT ID: NCT06200545 Enrolling by invitation - HIV Infection Clinical Trials

Improving HIV Prevention Among Heterosexual Cisgender Men Seeking STI Services in Malawi

NJIRA
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual cisgender men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.

NCT ID: NCT06188988 Enrolling by invitation - Clinical trials for Respiratory Viral Infection

Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure. CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated. A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival. The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF. About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.

NCT ID: NCT06160349 Enrolling by invitation - Infections Clinical Trials

EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Start date: July 20, 2023
Phase:
Study type: Observational

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary observational study is to establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

NCT ID: NCT06156202 Enrolling by invitation - Clinical trials for Cognitive Impairment

Evaluating a Comprehensive Multimodal Outpatient Rehabilitation Program for PASC Program to Improve Functioning of Persons Suffering From Post-COVID-19 Syndrome: A Randomized Controlled Trial

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARSCoV-2 infection (referred here as PASC). While treatments offered at emerging outpatient COVID recovery clinics are being informed by previous similar diseases, the need is great for a better understanding of the unique needs of this growing population and for tested, efficacious rehabilitation programs to address them. We provide both here.The targeted six-week program will be comprised of a core set of therapies, including individually titrated stretching and flexibility, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation tailored to patients' needs.

NCT ID: NCT06148532 Enrolling by invitation - Infections Clinical Trials

EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Start date: April 26, 2023
Phase:
Study type: Observational

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary observational study is to optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

NCT ID: NCT06145724 Enrolling by invitation - Infections Clinical Trials

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.