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NCT ID: NCT05820594 Recruiting - Tuberculosis Clinical Trials

Using BCG Vaccine to Understand Tuberculosis Infection

Pilot BCG CHIM
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is a disease that usually causes an infection in the lungs. The only vaccine to prevent TB is called BCG (Bacillus Calmette-Guérin). BCG contains a live germ similar to Mycobacterium tuberculosis, the germ that causes TB. BCG does not work very well, and TB remains the most common cause of death by infection worldwide. Human challenge models involve exposing healthy volunteers to an infectious disease in a safe and controlled way. This helps researchers understand more about an infectious disease and the body's response and can help develop new vaccines and treatments. The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this. If our human challenge model works well it may be used to help researchers develop new vaccines and tablets to treat TB in the future. This study will recruit healthy volunteers, of all genders, age 18-50 years. The first part of the study (phase A) will recruit 10 participants. Participants in phase A will receive intradermal injection with BCG into the upper arm at three times the usual dose. On day 14 after BCG the following skin samples will be taken from the BCG site with the use of local anaesthetic: skin swab, microbiopsy, skin scrape and punch biopsy. Participants in this phase of the study will also have blood tests to ensure they are safe to take part and to monitor the immune response to BCG. The overall aim of this part of the study will be to ensure BCG can be isolated (grown in culture and by molecular techniques) from participants' BCG site 14 days after the injection. The investigators aim to test whether BCG can be isolated by punch biopsy and minimally invasive techniques (microbiopsy, skin scrape and skin swab). If the investigators find that they can isolate BCG successfully using the minimally invasive methods of skin sampling and the participants have not experienced any serious adverse events, they can proceed to phase B of the study. In phase B 20 participants will be recruited. These participants will receive BCG as described for phase A. They will then have serial skin samples taken using either microbiopsy, skin scrape or skin swab on days 0, 2, 7, 14 and 28. The focus of this phase of the study is to assess immune responses to intradermal injection at the local (skin), systemic (blood) and respiratory mucosal (nose) compartments. This will involve longitudinal sampling from blood, nose and skin to measure BCG growth and the immune response over time.

NCT ID: NCT05819229 Recruiting - Clinical trials for Urinary Tract Infections in Children

Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

Start date: February 27, 2023
Phase:
Study type: Observational

The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.

NCT ID: NCT05817825 Recruiting - Opioid Use Disorder Clinical Trials

Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.

NCT ID: NCT05816135 Recruiting - Clinical trials for Surgical Site Infection

Investigation of Environmental Parameters in Operating Rooms

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Postoperative surgical site infection (SSI) is a serious and complicated healthcare-associated infection (HAI) affecting about 2% of patients undergoing orthopedic surgery. Exogenous infections, could occur from insufficient air quality in operating rooms as shown in previous studies. However, from our knowledge, no study have collect environmental parameters and cross referenced the data with recorded patient registries to see if insufficient air quality is associated with higher risk of exogenous SSI. Temperature, humidity and the difference in air pressure in relation to the operating room and the adjacent corridors are examples of environmental parameters that could affect the air quality in operating rooms. Number of persons during an operation and particle counts could also give an indication of insufficient air quality.

NCT ID: NCT05815433 Recruiting - Clinical trials for Microbial Colonization

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

PPDHM
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum antibiotic prophylaxis (IAP) therapy during labour. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

NCT ID: NCT05814250 Recruiting - Clinical trials for Urinary Tract Infections

Ultrasonography in Children With First Febrile Urinary Tract Infection

Start date: June 13, 2022
Phase:
Study type: Observational

In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. The majority of guidelines, continue to recommend a routine KUS for all children at the first fUTI. On the other hand, as this approach is not based on robust evidence, other guidelines suggest that KUS should only be performed on selected patients according to specific risks. Despite being a non-invasive and radiation-free method, KUS tests negative in 83% of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux (VUR). Since VUR is the most commonly associated renal malformation with UTI, it is evident that all the guidelines focus on the research of VUR, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (CAKUT). However, VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. To reduce the number of normal VCUGs performed, recent evidence regarding VUR suggests that the presence of pathogens different from E. coli and UTI recurrence may help to identify children who necessitate further investigations. A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of UTI exhibits a 85% sensitivity to detect pathological ultrasound. The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI

NCT ID: NCT05812612 Recruiting - COVID-19 Infection Clinical Trials

UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease

Start date: January 30, 2023
Phase:
Study type: Observational

This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021 to December 2023. After enrollment, collect the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment. After enrollment, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. To compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.

NCT ID: NCT05802732 Recruiting - Clinical trials for Helicobacter Pylori Infection

Stool Antigen In Diagnosis Of Helicobacter Pylori

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

Helicobacter pylori is among the most common bacterial infections in humans. Helicobacter pylori is a Gram-negative, S -shaped rod .The most likely mode of transmission is fecal-oral or oral-oral. Helicobacter pylori infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. The majority of children with Helicobacter pylori infection remain asymptomatic, although a percentage of the infected children do develop Helicobacter. pylori-associated diseases. Helicobacter pylori is closely associated with the development of gastritis, gastric or duodenal ulcers. Helicobacter pylori infection can manifest with abdominal pain or vomiting and, less often, refractory iron deficiency anemia or growth retardation. Helicobacter pylori can be associated, though rarely, with chronic autoimmune thrombocytopenia. Anemia, idiopathic thrombocytopenic purpura, short stature, and sudden infant death syndrome (SIDS) have also been reported as possible extra-gastric manifestations of Helicobacter pylori infection . The diagnosis of Helicobacter pylori infection is made histologically by demonstrating the organism in the biopsy specimens. 13 C-urea breath tests and stool antigen tests are reliable noninvasive methods of detecting Helicobacter pylori infection in patients who do not require endoscopic evaluation. However, some guidelines recommend that non-invasive assessment methods are reserved to determine whether Helicobacter pylori has been eradicated not for diagnosis .However Helicobacter pylori-associated gastritis may, however, be an incidental histopathologic finding during upper endoscopy performed for unrelated indications such as the diagnosis of inflammatory bowel disease, or celiac disease.

NCT ID: NCT05797649 Recruiting - Heart Failure Clinical Trials

Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis

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

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

NCT ID: NCT05797246 Recruiting - Neoplasms Clinical Trials

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Start date: August 2, 2023
Phase: Phase 2
Study type: Interventional

Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP. Eligibility: People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways. Design: Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest. Participants will have surgery to remove the growths in their airways. Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours. Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia. Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle. Follow-up will continue for 1 year after the last treatment.