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NCT ID: NCT06256588 Recruiting - Clinical trials for Neoplasms, Head and Neck

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

JADE
Start date: March 21, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)

NCT ID: NCT06255678 Recruiting - Clinical trials for Acute Coronary Syndrome

Angio-based Final Functional Effect of PCI

AFFE-PCI
Start date: July 3, 2023
Phase:
Study type: Observational [Patient Registry]

Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health. This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.

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: NCT06254391 Recruiting - Clinical trials for Myocardial Infarction

Aspirin Dose Comparison in Elderly PCI Patients: 30mg vs. 75mg in Acute Coronary Syndrome

LowASA-PCI
Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in healthy volunteers. However, ASA at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications. This randomized study will include 40 patients over 65 years undergoing PCI for acute coronary syndrome (ACS). It compares a new dual antiplatelet therapy (DAPT) strategy consisting of a P2Y12 antagonist (ticagrelor) and ASA at a very low dose of 30 mg/day (n=20) against the current standard treatment (P2Y12 antagonist and ASA at a dose of 75 mg) (n=20) in the control group.

NCT ID: NCT06251362 Recruiting - Sleep Clinical Trials

Effects of Sleep Restriction on Female Soccer Players: Physical Performance, Muscle Damage, Inflammation, and BDNF Levels.

Start date: November 25, 2023
Phase: N/A
Study type: Interventional

This research aims to investigate the interplay between menstrual cycles, sleep patterns, and athletic performance. Before experimental sessions, participants will maintain menstrual diaries for three months and complete assessments for sleep disorders and chronotype. Sleep duration will be objectively measured over five nights using actigraphy, complemented by sleep-related data from an actigraph and the Karolinska Sleep Diary. The study involves two sessions: normal sleep (based on habitual duration) and restricted sleep (reduced by 3 hours). Athletes will engage in a simulated match-play game before both sessions, followed by comprehensive performance tests the next day. Blood samples will be collected at three intervals to analyze hormonal profiles (including progesterone, and estradiol), markers of muscle damage, inflammation, stress (such as TNF-α, IL-6, CRP, myoglobin, cortisol, testosterone), and brain-derived neurotrophic factor (BDNF). On Day 1, pre- and post-training blood samples will be obtained, and participants will wear an actigraph, adhere to specified bedtime routines, and report activities (restricted sleep group). Day 2 involves completing a sleep diary, refraining from caffeine, responding to questionnaires assessing readiness to train and mood, and undergoing performance tests followed by self-reporting of pain levels and perceived exertion using established scales (VAS, RPE 6-20).

NCT ID: NCT06249802 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Beta-blockade in Unruptured Intracranial Aneurysm

BBLURAN
Start date: January 1, 2025
Phase: Phase 4
Study type: Interventional

Subarachnoid haemorrhage is a devastating type of stroke, with high mortality and morbidity rate. In approximately 85% of cases, it is caused by an intracranial aneurysm rupture. Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment, however, some patients are managed conservatively. Currently, the only recommendations for patients with conservatively managed intracranial aneurysms, are routine imaging follow-ups and minimization of rupture risk factors. There are no medications proven to decrease risk of aneurysm rupture, that might be prescribed to such patients. In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size, as well as more favorable hemodynamic parameters. No other antihypertensive drugs showed similar associations. Therefore, in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role. The investigators aim to perform a randomised, double-blind, placebo-controlled clinical trial. One hundred patients with unruptured intracranial aneurysm, , qualified to conservative management will be enrolled. Two arms (50 patients each) will be receiving nebivolol or matching placebo. Treatment in each arm will last 12 months. The following examinations will be performed at baseline and at 6 and 12 months: clinical assessment, angio-MRI with vessel wall imaging, Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery, Vertebral Artery Middle Cerebral Artery, Anterior Cerebral Artery and Posterior Cerebral Artery, as well as blood samples. Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement. The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood. Additionally, the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome. All obtained measurements will be compared at baseline and at 6 and 12 months. The investigators hypothesize that, in comparison to the placebo group, β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome, decrease wall degradation process and prevent from aneurysm growth.

NCT ID: NCT06249074 Completed - Clinical trials for Autoimmune Thyroiditis

Gluten-free Diet in Women With Autoimmune Thyroiditis

Start date: September 22, 2020
Phase: N/A
Study type: Interventional

The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition. The main questions it aimed to answer were: - Does the gluten-free diet worsen the gut microbiome composition? - Does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)? - Does the gluten-free diet improve the quality of life? Participants: - followed normocaloric gluten-free diet for 8 weeks - after first 4 weeks were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo). Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks of diet (T2) (total of 3 samples per participant). Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).

NCT ID: NCT06248814 Recruiting - Dermatitis, Atopic Clinical Trials

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis

Start date: March 21, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT06247384 Not yet recruiting - Clinical trials for Hypotension During Surgery

The Hypotension Prediction Index in Major Abdominal Surgery

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery. Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index. The main question the study aims to answer is: • will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.

NCT ID: NCT06245421 Recruiting - Dry Eye Clinical Trials

Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye Dryness

Start date: March 7, 2024
Phase: N/A
Study type: Interventional

This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of DM934 in comparison with Théalose in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment