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NCT ID: NCT06256510 Completed - Clinical trials for Healthy Participants

A Study to Learn If the Study Medicine Called Vepdegestrant Changes How the Body Processes the Other Study Medicine Called Midazolam

Start date: February 8, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn if the study medicine called Vepdegestrant changes how the body processes the other study medicine called Midazolam. This study is seeking participants who: - female who cannot have children. - are 18 years or older. - are overtly healthy as decided by medical tests. - have a body mass index (BMI) of 16 to 32 kilogram per meter squared. - have a total body weight of more than 45 kilograms (99 pounds). All participants in this study will receive one dose of midazolam alone by mouth in Period 1. In Period 2, all participants will receive vepdegestrant by mouth once a day for 15 days. Participants will also receive one dose of midazolam by mouth on day 1 and day 15. The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults. The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.

NCT ID: NCT06254950 Recruiting - Ulcerative Colitis Clinical Trials

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 29, 2024
Phase: Phase 2
Study type: Interventional

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

NCT ID: NCT06252363 Recruiting - Clinical trials for Immersive Virtual Reality

Knowledge, Practices, and Acceptance of Physiotherapists About the Use of Immersive Virtual Reality in Clinical Practice.

Start date: February 28, 2024
Phase:
Study type: Observational

Objective: The aim of this online cross-sectional survey is to investigate the knowledge, practices, and acceptance of use of immersive virtual reality (VR) in clinical practice in physiotherapists. Methods: Physiotherapists from different French-speaking and Dutch-speaking countries will be recruited using non-probability sampling. The survey will be available online on LimeSurvey software for a period of 4 months. The questionnaire will include questions about: general data; knowledge about immersive VR; immersive VR usage in clinical practice; intention to use immersive VR; attitudes towards immersive VR; perceived usefulness of immersive VR; perceived ease of use of immersive VR; social influence on using immersive VR. Discussion: This study will be the first to investigate the knowledge, practices, and acceptance of use of immersive VR in clinical practice in physiotherapists from different countries around the world. This investigation could lead to a better understanding of the current (non-)implementation of this means of rehabilitation in physiotherapy, and help develop ways to better implement it in physiotherapists' clinical practice.

NCT ID: NCT06251466 Recruiting - Clinical trials for Gestational Diabetes

Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus.

TEGEDIM
Start date: December 18, 2023
Phase: N/A
Study type: Interventional

This interventional study examines the addition of telemonitoring (TM) in prenatal care for gestational diabetes mellitus (GDM). By incorporating TM into the prenatal care for GDM, it is expected to achieve faster and improved follow-up, resulting in faster reaction time in the detection of aberrant blood glucose levels. Therefore, the overarching aim is to improve maternal and newborn pregnancy outcomes through optimized monitoring strategies (TM).

NCT ID: NCT06250478 Completed - Stroke Clinical Trials

Dynamic Ultrasound of the Calf Muscles After Stroke

Stroke_DynUS
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

Muscle behaviour of calf muscles can be studied during dynamic conditions using dynamic ultrasound. In particular, the medial gastrocnemius is suitable for measurements with dynamic ultrasound due to its superficial location. With this measurement technique, the muscle behavior during walking can be observed gaining insight into the mechanism of action of this muscle during a functional task. This technique has already been used in other populations (such as children with cerebral palsy) but not yet in individuals after a stroke. Therefore, the aim of this study is to assess the muscle behavior of the medial gastrocnemius during walking in persons after stroke. There are 3 concrete objectives of the current study: 1. is the technique feasible to perform in persons after stroke? 2. does the use of the dynamic echoprobe change gait patterns? 3. can differences between persons after stroke and healthy controls be detected? This data can be used as pilot data for project applications in the future that will allow to design larger studies. Therefore, 10 stroke patients and 10 age- and gender-matched healthy controls will walk on a treadmill for 3x2 minutes after a familiarisation period of 6 minutes. During 1 x 2 minutes, subjects will walk without using the dynamic ultrasound. This recording aims to measure the normal gait pattern of the subjects. During the other 2x2 minutes, subjects will walk using the dynamic ultrasound at 2 different locations on the calf. Once with the ultrasound probe on the centre of the muscle belly to visualise muscle fibre bundles and once on the muscle tendon transition, from which muscle belly and tendon length can be derived. The use of ultrasound or not will be randomized to exclude the effect of fatigue on the outcome measures.

NCT ID: NCT06249971 Completed - Burns Clinical Trials

A Single-stage Bilayered Skin Reconstruction With Glyaderm®

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The study will explore the potential of utilizing Glyaderm® in a single-stage engrafting process, aiming for a more cost-effective approach. While the absence of the reticular dermal layer is a challenge associated with autologous split-thickness skin grafting (STSG), often leading to hypertrophic scars and contractures, various dermal substitutes with inconsistent results exist. Bilayered skin reconstruction using glycerolized acellular dermis (Glyaderm®) has shown promise in improving scar quality through a two-step procedure. However, unlike the typical two-step process required for most dermal substitutes, our investigation focuses on the cost-effective application of Glyaderm® in a single-stage engrafting. This approach, if successful, could offer advantages such as reduced costs, shorter hospitalization times, and lower infection rates-attributes preferred by many surgeons, especially when autografts are available.

NCT ID: NCT06248060 Completed - Clinical trials for Pre-anaesthetic Consultation

Comparison and Opinion on the Safety of Teleconsultation Versus Traditional Anaesthetic Consultation in a Day Hospital

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023. The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.

NCT ID: NCT06243380 Active, not recruiting - Clinical trials for Beta Lactam Adverse Reaction

B-lactam Databank Algorithm

Start date: December 11, 2023
Phase:
Study type: Observational

Background: Antibiotic allergy constitutes a major health problem with serious medical and financial consequences when under- but also overdiagnosed. About one and a half million Belgians report having an allergy to penicillin. However, in 1.35 million (90%) of these "penicillin allergies", the suspicion is wrong. The issue of false penicillin allergy is therefore seen as an important medical problem with significant implications for the individual patient but also for society. Today, therefore, there is a global consensus to contain the pandemic of false penicillin allergy as much as possible. This should ultimately lead to correct antibiotic policies for the patient and reduce antibiotic resistance and the cost to society. The problem with this is that there is no diagnostic test that one can perform on a population of one and a half million people. This is practically and financially unfeasible. So there is a need for proper risk stratification based on anamnestic data to better guide our diagnostics. Specific question: The investigators currently have a database of about 1000 patients with a possible hypersensitivity to antibiotics who have been fully diagnosed according to current guidelines. The aim of the study is to use this database to see whether a tool can be developed to reliably perform an initial "screening" to determine in whom further testing is necessary and in whom, based purely on the story, it can be decided that the likelihood of penicillin allergy is extremely low and additional diagnostics are unnecessary.

NCT ID: NCT06241729 Recruiting - Lymphoma, B-Cell Clinical Trials

Prospective Observational Study of Diffuse Large-cell B Lymphoma

LBDGCréfract
Start date: January 3, 2023
Phase:
Study type: Observational

Diffuse large B-cell lymphoma (DLBCL) represents the most common type of non-Hodgkin lymphoma and is currently a curable malignant disease for many patients with immuno-chemotherapy frontline treatment. However, around 30-40 % of patients, are unresponsive or will experience early relapse. The prognosis of primary refractory patient is poor and the management and treatment are a significant challenge due to the disease heterogeneity and the complex genetic framework. The reasons for refractoriness are various and include genetic abnormalities, alterations in tumor and tumor microenvironment. Patient related factors such as comorbidities can also influence treatment outcome. Recently the progress in Machine learning (ML) showed its usefulness in the procedures used to analyze large and complex datasets. In medicine, machine learning is used to create some predictive tools based on data-driven analytic approach and integration of various risk factors and parameters. Machine learning, as a subdomain of artificial intelligence (AI), has the capability to autonomously uncover patterns within datasets. It offers algorithms that can learn from examples to perform a task automatically.The investigators tested in a previous study five machine learning algorithms to establish a model for predicting the risk of primary refractory DLBCL using parameters obtained from a monocentric dataset. The investigators observed that NB Categorical classifier was the best alternative for building a model in order to predict primary refractory disease in DLBCL patients and the second was XGBoost.The investigators plan to extend this previous study by further exploring the two best-performing models (NBC Classifier and XGBoost), progressively incorporating a larger number of patients in a prospective way.

NCT ID: NCT06241313 Recruiting - Migraine Clinical Trials

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

ECLIPSE
Start date: March 25, 2024
Phase: Phase 3
Study type: Interventional

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.