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NCT ID: NCT05000723 Recruiting - Clinical trials for Prosthetic Joint Infection

Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven

PROFITH
Start date: July 14, 2022
Phase:
Study type: Observational [Patient Registry]

Prosthetic Joint Infection (PJI) of a Total Hip Replacement (THR) is a disastrous complication of an otherwise extremely successful surgical procedure. It is associated with a burdensome treatment for the patient, significant challenges for the medical team and high costs for society. As more joint replacements are being performed each year, due to an ageing population and lower thresholds for surgery, the number of PJIs is on the rise. Many of these patients will be referred to University Hospitals Leuven as the physicians have extensive experience with this particular pathology and can offer a multidisciplinary and patient-tailored treatment. Many controversies exist in the field of PJI treatment, both with regard to the surgical aspects as well as the antibiotic treatment. Setting up randomized controlled trials to answer these questions has been proven to be very difficult due to large variations in patients, implants, germs, soft and hard tissues, antibiotic resistance patterns, and so on. Also, surgery for PJIs is usually non-elective / semi-urgent and therefore time to include patients into different trials is limited. Therefore the investigators will prospectively collect data on patients with PJI treated at University Hospitals Leuven, starting 01/01/2022, in order to have knowledge of own results and inform patients about chances of success prior to treatment; perform internal audits and quality checks; answer questions in the field of PJI treatment not suitable for RCTs.

NCT ID: NCT05000307 Completed - SARS-CoV Infection Clinical Trials

Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection

Coser
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies. Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use. After the completion of the study, the samples will be stored for 30 years with consent of the participants.

NCT ID: NCT05000268 Completed - Clinical trials for COVID-19 Respiratory Infection

Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection

Start date: January 16, 2022
Phase: N/A
Study type: Interventional

In the literature, there are studies examining the effects of telerehabilitation on individuals who have had COVID-19, but studies examining the effects on healthcare workers who have experienced COVID-19 are insufficient. In this study, which is planned to be done, it is aimed to examine the effects of myofascial relaxation technique on pain and other symptoms through telerehabilitation. The aim of the study is to examine the effects of myofascial relaxation technique applied with the telerehabilitation method on pain level, anxiety, depression, sleep, fatigue and kinesiophobia in healthcare workers with and without COVID-19 infection with pain.

NCT ID: NCT04999098 Recruiting - SARS-CoV2 Infection Clinical Trials

Echinaforce COVID-19 Shedding Study

Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

Respiratory viruses pose a permanent threat to humans and society as demonstrated by the current Covid-19 pandemic. Novel drugs and vaccines provide a means for controlling illness. Infections and symptomatic presentation of illness may be reduced, but it remains to be determined to which extent viral shedding and transmission (e.g. by silent transmitters) can be controlled. Lack of such activity may result in continuing viral spread by assumed healthy but asymptomatic spreaders. Echinacea is an established and readily-accessible product with demonstrated in vitro antiviral activity (including coronaviruses). This study aims to estimate the potential of different Echinacea formulations (head-to-head) to reduce concentration infectivity and shedding of SARS-CoV-2 under in vivo conditions.

NCT ID: NCT04998318 Recruiting - HIV Infections Clinical Trials

1:1 Comparison of the Pocket Colposcope in Kenya

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

NCT ID: NCT04994509 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV Infection

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

PURPOSE 1
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.

NCT ID: NCT04994275 Active, not recruiting - Clinical trials for Postoperative Complications

Impact of Iron Deficiency on the Incidence of Postoperative Infections

CARIPO
Start date: November 3, 2021
Phase:
Study type: Observational

Iron deficiency is a common state during the perioperative period. Data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. This prospective observational study aims to assessed the postoperative infections incidence according to the preoperative iron-stock status.

NCT ID: NCT04993027 Not yet recruiting - Clinical trials for Infection of Total Knee Joint Prosthesis

Topical Vancomycin for Infection Prophylaxis in TJA

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7% undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026. Periprosthetic joint infection (PJI) remains one of the most common complications, accounting for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the incidence of PJI but its potential drawbacks include wound healing complications, reduced osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical administration of vancomycin powder for the primary prevention of PJI has been studied in observational studies, but conclusions are limited due to the low incidence of PJI and high number of patients required to detect a significant difference. Investigators therefore propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin compared to standard care on PJI rates following THA and TKA. Aim: To determine whether topical vancomycin is a safe and effective intervention for the primary prevention of PJI after THA and TKA. Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50 TKA patients. Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history or synovial aspirate Prior major operation on the affected joint Current immunosuppressive medications Vancomycin allergy or history of a vancomycin-related complication Recruitment: surgeons introduce study to the patients, research staff will conduct recruitment. Intervention: Patients will be randomized preoperatively and remain blinded to their treatment arm. Patients allocated to the control group will have all standard care infection prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the standard care measures in addition to 1g of powdered vancomycin applied to the wound. Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year visits. Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups: Reoperation on the same joint Superficial and non-infectious wound complications All complications

NCT ID: NCT04992104 Recruiting - Pregnancy Related Clinical Trials

Microbiome and Malnutrition in Pregnancy

MMIP
Start date: February 22, 2023
Phase:
Study type: Observational

This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on pregnant women, 24 years and younger living in the Toronto and greater Toronto area. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. With the hypothesis that alterations of the microbiota in the maternal gut (dysbiosis) exacerbated by nutritional status or pathogen exposure during pregnancy, impacts weight gain because of impaired nutrient absorption, leading to corresponding negative birth outcomes.

NCT ID: NCT04991818 Completed - Clinical trials for Microbial Colonization

MSC - OneBiome UX Pilot Study

OneBiome
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Evaluating the user (pregnant women and parents of young children) experience of the OneBiome consumers value journey service offered to the 1000 days and young children consumers market