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NCT ID: NCT06057558 Active, not recruiting - Cystic Fibrosis Clinical Trials

Airway Microbiome of Cystic Fibrosis Patients

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

With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.

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).

NCT ID: NCT05938387 Active, not recruiting - Glioblastoma Clinical Trials

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

Start date: May 9, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible. After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy. The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024. Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.

NCT ID: NCT05932420 Active, not recruiting - Clinical trials for Exercise Adaptations

Role of Intermittent Exogenous Ketosis in the Physiological and Muscular Adaptive Response to Endurance Training

Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

In a recent study (Poffé et al., 2019), we demonstrated that increasing the concentration of ketone bodies in the blood through the ingestion of a ketone ester (KE) post-exercise and just before sleeping time during a 3-week overtraining period resulted in suppression of the physiological symptoms of overtraining. Consistent KE intake improved endurance performance, positively affected the autonomic regulation of the heart, suppressed the increase of nocturnal sympathetic activity, and increased spontaneous energy intake. In addition, KE intake had a positive effect on muscular adaptive response, as evidenced by the significantly increased muscular angiogenesis. Therefore, in this study, we aim to investigate whether the oral administration of ketones after exercise and just before bedtime also has a positive effect on the adaptive response during a well-dosed endurance training program. Since suppression of nocturnal sympathetic activity can positively influence sleep quality, we will also study the effect of KE and the training period on sleep quality. To investigate this, we will use a randomized, placebo-controlled parallel research design. Well-trained male cyclists will participate in a fully controlled intervention period of 8 weeks. During the intervention period, participants will follow a supervised cycling training program (5-7 training sessions per week) with a gradual buildup aimed at improving endurance capacity. Throughout the intervention period, participants will ingest 25g ketone ester or a corresponding placebo after each training session and 30 minutes before bedtime. Endurance performance will be evaluated before the start of the training period (pretest), after week 3 (midtest), after week 7 (posttest) of the training period, and at the end of the training intervention (posttest+taper). Additionally, blood samples will be taken at the pre-test and post-test to analyze markers of hormonal status and inflammation. Muscle biopsies will be taken from the vastus lateralis muscle of the right leg at pretest and posttest to analyze cross-sectional area, muscle fiber typing, angiogenesis, protein synthesis and degradation, mitochondrial function, and energy substrate concentrations. One month after the intervention period, an additional biopsy will be taken to study changes in gene expression (epigenetic modifications). Sleep will be evaluated via polysomnography (PSG) at the pretest, midtest and posttest. Finally, before and after the training period, resting and exercise echocardiography will be taken to investigate investigate structural and morphological changes of the heart.

NCT ID: NCT05923827 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults

RADIANT
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1.

NCT ID: NCT05923424 Active, not recruiting - Healthy Volunteers Clinical Trials

A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

Start date: November 28, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people. Other aims are to assess: - How much of the study drug is in the blood at different times - Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

NCT ID: NCT05879107 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults

Start date: May 26, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.

NCT ID: NCT05878938 Active, not recruiting - Haemophilia A Clinical Trials

A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

FRONTIER 5
Start date: June 26, 2023
Phase: Phase 3
Study type: Interventional

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT05865756 Active, not recruiting - Clinical trials for Head and Neck Cancer

Assessment of (Chemo)RT-related Dysphagia in HNC Patients Based on Cough-related Acoustic Features

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

To develop this objective and easily implementable assessment method of coughing based on acoustic features of voluntary and reflex coughs, there is a primary need in identifying and comparing acoustic cough features in healthy subjects and different disease-related coughs features. Cough is a common reason for seeking medical care. Chronic cough, defined as a cough that has lasted for longer that eight weeks, represents 10-38% of all referrals made to respiratory physicians [1-2]. Furthermore, between 60 and 80% of patients with chronic obstructivepulmonary disease (COPD) report cough. Following this pilot study comparing different populations, the applicability of the selected acoustic cough features should be examined in HNC patients with radiotherapy-induced dysphagia, Another frequent aspect of the clinical diagnostic examination of swallowing is perceptual analysis of voice quality immediately following deglutition. Changes in voice quality are assumed to provide information on the possible accumulation of saliva or food at the vocal folds level. It is reported that a change of voice may indicate laryngeal dysfunction or the presence of a foreign body at the laryngeal level [3] confirm that a normophonic voice after swallowing reflects a lack of aspiration-penetration. However, research shows that there is no strong correlation between aspiration and changes in perceptual voice quality (e.g. wet voice). A more reliable and easily implementable method could be detection of specific acoustic features of changes in voice quality.