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NCT ID: NCT05337072 Not yet recruiting - Subfertility Clinical Trials

The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI

FLORA
Start date: May 1, 2023
Phase:
Study type: Observational

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Today, diagnosis of chronic endometritis is not evident, since no well-validated classification scales are available. In the UZ Brussel the pathology department applies its own in-house scoring system, based on the presence and position of plasma cells within the histological images. Despite limited research so far, it recently became clear that the endometrium is colonized by micro-organisms (the microbiome). However, it is still unclear what role these microorganisms play in chronic endometritis and fertility problems. Chronic endometritis is often diagnosed in the context of fertility problems, and the patient is treated 'blindly' with broad-spectrum antibiotics such as doxycycline. Broad-spectrum antibiotics unnecessarily eradicate many microorganisms in our body, including the ones that positively influence implantation. The exact cause of chronic endometritis is unknown, so treatment remains empirical. The research and knowledge in the endometrial microbiome is constantly expanding, mainly due to the rise of research into the links between pathologies and human microbiota. It is becoming increasingly clear that the composition of the microbiome can play a vital role in health and disease. Regarding the influence of the endometrial microbiome on different pathologies, such as chronic endometritis and implantation failure or miscarriage, there is still no consensus. Despite multiple studies on the endometrial microbiome, we are not yet able to define a normal or healthy endometrial microbiome. In this project, we want to gain insight into the microorganisms that are present in the female reproductive tract based on various techniques. The analyses will performed on an endometrial biopsy and a vaginal swab. The biopsy is routinely taken at Brussels IVF for the detection of plasma cells in the anatomopathology lab for the diagnosis of chronic endometritis. In the microbiology lab we will investigate which microorganisms are present in the female reproductive tract with and without the histological diagnosis of chronic endometritis. This will be done based on the state-of-the-art analytical techniques metagenomics (sequencing) and culturomics (culture).

NCT ID: NCT05337020 Completed - Clinical trials for Cardiovascular Diseases

Survey on the Future of Telemedicine in the Daily Care of Cardiology Patients.

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

The Cardiology research group at the Jessa Hospital Hasselt and the University Hospital Antwerp (in collaboration with the University of Hasselt and the University of Antwerp) is conducting research into remote patient monitoring (telemedicine). Digital technologies such as smartphones, tablets, fitness trackers, smartwatches,… make it easier to monitor the health of cardio patients between consultations. This would allow for faster intervention when necessary, but consultations can also (partially) take place remotely. For this study, we are looking for patients who have already used such technologies to remotely monitor their health and patients who have never used it before. We would like to find out how these patients feel about telemedicine by means of a questionnaire. This will take approximately 5 to 10 minutes. In this way, we can gain a better understanding of these patients' views and expectations regarding telemedicine. In this way we can further improve healthcare and develop more options to follow up patients even better from your home environment.

NCT ID: NCT05335876 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

SPECTRUM
Start date: December 19, 2022
Phase: Phase 3
Study type: Interventional

This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 15 years from the date of OAV101 administration in the previous clinical trial.

NCT ID: NCT05334368 Recruiting - Clinical trials for Hypereosinophilic Syndrome

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

DESTINY
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

NCT ID: NCT05333042 Completed - Pulmonary Embolism Clinical Trials

External Validation of a Deep Learning Based Model for Pulmonary Embolism Detection on Chest CT Scans

Start date: April 1, 2022
Phase:
Study type: Observational

The scope of this study is the external validation of an explainable deep learning-based classifier for the diagnosis and detection of pulmonary embolism in computed tomography pulmonary angiography (CTPA) and contrast enhanced CT scans.

NCT ID: NCT05331183 Active, not recruiting - Cystic Fibrosis Clinical Trials

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Start date: November 23, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

NCT ID: NCT05330429 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

ELEVATE CRC
Start date: July 8, 2022
Phase: Phase 2
Study type: Interventional

The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

NCT ID: NCT05330325 Recruiting - Clinical trials for SGA, Turner Syndrome, Noonan Syndrome, ISS

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

REAL 8
Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

NCT ID: NCT05330260 Completed - Surgery Clinical Trials

Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery

FUNOMICS
Start date: March 25, 2022
Phase:
Study type: Observational [Patient Registry]

A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy control group. It is hypothesized that the endo-CABG group will show a stronger postoperative cognitive dysfunction compared to the PCI group and the healthy control group.

NCT ID: NCT05329922 Enrolling by invitation - Hearing Disability Clinical Trials

Assistant for LIstening and Communication Enhancement

ALICE
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

As we get older, our hearing deteriorates and an age-related hearing loss can develop. Having a hearing loss can make it more difficult for people to understand conversations. Hearing aids can help in these situations, but difficulties often remain in more challenging situations, for example, when a conversation is being held in a group or when background noise is present. These difficulties are often not only related to the hearing loss but also to how these sounds are processed in the brain. Auditory rehabilitation is believed to help persons with a hearing impairment train their listening and communication skills. Auditory rehabilitation includes sensory management to enhance auditory function; knowledge and skills to improve the outcome; perceptual training and counselling. For this reason, the ALICE app was developed. The ALICE app contains monitoring tests, listening training exercises and counselling for persons with a hearing impairment. In the current study, the ALICE app will be evaluated by persons with a hearing impairment. The experimental group will use the ALICE app in addition to the standard of care (hearing aid or cochlear implant) while the control group will receive the standard of care. Listening and communication skills will be evaluated pre and post training by a speech perception test in noise and questionnaires.