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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: NCT06203795 Active, not recruiting - Clinical trials for Hemodialysis Complication

Dialysis Performance of the FX CorAL Membrane

PATENCY
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Second, to better estimate the impact of clotting on the overall dialysis performance, clotting kinetics during dialysis should be understood. The aim of the present project is therefore to quantify the performance of the FX CorAL dialyzer (Fresenius Medical Care, Germany) in settings with reduced anticoagulation, and compare different performance outcomes (percent open fibers, solute removal rates) to those of other commercially available dialyzers. The different outcomes are related to the dialyzer extraction ratio and reduction ratio of small and middle molecules and albumin, the visual scoring of the dialyzer post dialysis, and the anticoagulation properties as assessed by fiber blocking in the dialyzer. Performance parameters at different time steps will allow to better understand clotting kinetics during dialysis.

NCT ID: NCT06137729 Active, not recruiting - Clinical trials for Healthy Participants

A Study to Learn How Different Amounts and Forms of the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

The purposes of the study are as follows: - To understand how safe and tolerable different amounts of study medicine (PF-07899895) are. - To measure the amount of PF-07899895 in blood after the medicine is taken by mouth. The study is seeking participants who: - Are male or female of 18 to 65 years of age. - Are in good health condition. - Have not had viral infections (HIV, HBV, or HCV). HIV, human immunodeficiency virus. HBV, hepatitis B virus. HCV, hepatitis C virus. - Have tested negative for tuberculosis. Participants will receive either PF-07899895 or placebo (dummy pill) by chance. In the first part of the study (Part A): - Each participant will receive a total of up to 5 doses of the medicine or placebo with at least 5 days between each dose. - After each dose, participants will stay in study clinic for 3 to 5 days. In the second part of the study (Part B): - Each participant will need to take 10 days of dosing and will stay in the study clinic for clinical checks for 13 days. The planned duration of participation from screening to follow-up in: - Part A of the study is up to 15 to 18 weeks. - Part B of the study is up to 11 weeks. Participants will also have their blood collected by the study doctors several times.

NCT ID: NCT06134804 Active, not recruiting - Clinical trials for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

Engage
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.

NCT ID: NCT06113913 Active, not recruiting - Ulcerative Colitis Clinical Trials

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

AMARETTO
Start date: April 9, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: - Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.

NCT ID: NCT06097754 Active, not recruiting - Hypoxia Clinical Trials

Intermittent Exogenous Ketosis (IEK) at High Altitude

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

Altitude-related hypoxia decreases human functional capacity, especially during exercise. Even with prolonged acclimatization, the physiological adaptations are insufficient to preserve exercise capacity, especially at higher altitudes completely. Consequently, there has been an ongoing search for various interventions to mitigate the negative effects of hypoxia on human performance and functional capacity. Interestingly, early data in rodents and humans indicate that intermittent exogenous ketosis (IEK) by ketone ester intake improves hypoxic tolerance, i.e.by facilitating muscular and neuronal energy homeostasis and reducing oxidative stress. Furthermore, there is evidence to indicate that hypoxia elevates the contribution of ketone bodies to adenosine-triphosphate (ATP) generation, substituting glucose and becoming a priority fuel for the brain. Nevertheless, it is reasonable to postulate that ketone bodies might also facilitate long-term acclimation to hypoxia by upregulation of both hypoxia-inducible factor-1α and stimulation of erythropoietin production. The present project aims to comprehensively investigate the effects of intermittent exogenous ketosis on physiological, cognitive, and functional responses to acute and sub-acute exposure to altitude/hypoxia during rest, exercise, and sleep in healthy adults. Specifically, we aim to elucidate 1) the effects of acute exogenous ketosis during submaximal and maximal intensity exercise in hypoxia, 2) the effects of exogenous ketosis on sleep architecture and quality in hypoxia, and 3) the effects of exogenous ketosis on hypoxic tolerance and sub-acute high-altitude adaptation. For this purpose, a placebo-controlled clinical trial (CT) in hypobaric hypoxia (real high altitude) corresponding to 3375 m a.s.l. (Rifugio Torino, Courmayeur, Italy) will be performed with healthy individuals to investigate both the functional effects of the tested interventions and elucidate the exact physiological, cellular, and molecular mechanisms involved in acute and chronic adaptation to hypoxia. The generated output will not only provide novel insight into the role of ketone bodies under hypoxic conditions but will also be of applied value for mountaineers and athletes competing at altitude as well as for multiple clinical diseases associated with hypoxia.

NCT ID: NCT06087640 Active, not recruiting - Influenza, Human Clinical Trials

A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

Start date: October 23, 2023
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.

NCT ID: NCT06066515 Active, not recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

SYNCHRONIZE™-1
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have - a body mass index (BMI) of 30 kg/m² or more, or - a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06040580 Active, not recruiting - Epilepsy Clinical Trials

Can we Use Resting-state fMRI and CSD Fiber Tractography for Presurgical Mapping?

Start date: October 8, 2018
Phase:
Study type: Observational

This prospective study aims to investigate and validate the use of resting-state functional MRI (rs-fMRI) and high angular resolution diffusion imaging (HARDI), specifically constrained spherical deconvolution (CSD) tractography, for functional and structural brain mapping prior to neurosurgery. The goal is to assess the feasibility of replacing task-based fMRI (tb-fMRI) and diffusion tensor imaging (DTI) with fiber tractography (FT) using the fiber assignment by continuous tracking (FACT) algorithm. The study focuses on mapping sensory-motor, language, visual, and higher cognitive functional and structural networks in patients with brain pathology suitable for surgical intervention. The objective is to improve neurosurgical planning, navigation, and risk assessment through the utilization of rs-fMRI and CSD tractography.

NCT ID: NCT06024174 Active, not recruiting - Clinical trials for Advanced Solid Tumors

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors

Start date: November 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).