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NCT ID: NCT06469424 Recruiting - Ulcerative Colitis Clinical Trials

An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)

PASS TOFA
Start date: January 11, 2024
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.

NCT ID: NCT06464393 Recruiting - Anesthesia Clinical Trials

Opioid-based Versus Opioid-free Endotracheal Intubation

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

The aim of this study will be to investigate the effect of opioid-free induction versus opioid-based induction on hemodynamic response and nociception level index during elective operations

NCT ID: NCT06460389 Recruiting - Cataract Clinical Trials

Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance

Start date: January 1, 2024
Phase:
Study type: Observational

The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

NCT ID: NCT06428656 Recruiting - Clinical trials for Postbiotics Supplementation

Postbiotics Supplementation, Gut Microbiota Composition, and Exercise-induced Inflammation

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

This study will investigate the effect of postbiotics supplementation on gut microbiota (GM) composition, exercise-induced oxidative stress and performance following eccentrically biased exercise. The study will be a cross-over, randomized, double-blind, controlled study that will be conducted in two cycles. Participants will be randomly assigned into one of the two trials: i) Postbiotics supplementation for 4 weeks, ii) Placebo supplementation for 4 weeks. Participants will then perform a 45-min treadmill running at (-15% slope, ~70% VO2max) followed by a time-trial (0% slope, ~95% VO2max) until exhaustion. Before, as well as 24 h, 48 h and 72 h following exercise, assessment of GM composition and metabolites (short-chain fatty acids), exercise induced muscle damage (EIMD) (delayed onset of muscle soreness, creatine kinase), complete blood count (CBC), blood inflammatory status (tumor necrosis factor alpha, interleukin 6, C-reactive protein), gut inflammatory status (lipopolysacharides-binding protein, zonulin), blood redox status (total antioxidant capacity, catalase, protein carbonyls, reduced glutathione, oxidized glutathione, and performance (knee-extensors' and knee-flexors' isometric, concentric, eccentric torque, countermovement jump) will be performed. In addition, metabolism (lactic acid) will be assessed before and 4 min following exercise. Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, CBC, blood inflammatory status, blood redox status and performance at the same time-points. At the second cycle, the participants will repeat the above procedures under the remaining condition. Between conditions, there will be a 14-day washout period. The results of the research will provide important information for coaches and physically active individuals, regarding the effectiveness of postbiotics to favorably change the gut microbiota composition and alleviate gut inflammation, exercise-induced inflammation and oxidative stress, and improve performance after intense exercise.

NCT ID: NCT06421571 Recruiting - Mycosis Fungoides Clinical Trials

The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients

GR-CTCL_CL
Start date: February 21, 2023
Phase:
Study type: Observational

Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, clinical data from the investigators' clinic confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. Based investigators' clinical and biological results , the investigators like to further investigate the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.

NCT ID: NCT06417671 Recruiting - Clinical trials for Postbiotics Supplement

The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress.

PB-EIOS
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

Scientific data on the effect of supplementation of postbiotics on exercise-induced oxidative stress are scarce. The main purpose of the research is to investigate the effect of postbiotics supplementation on exercise-induced oxidative stress and performance indicators after intense exercise. The study will be a cross-over, randomized, double-blind, controlled study that will be conducted in two cycles. Participants will be randomly assigned into one of the two trials: i) Postbiotics supplementation for 4 weeks, ii) Placebo supplementation for 4 weeks. Participants will then perform a 45-min treadmill running at (-15% slope, ~70% VO2max) followed by a time-trial (0% slope, ~95% VO2max) until exhaustion. Before, as well as 24 h, 48 h and 72 h after the exercise, participants will undergo measurements of exercise-induced muscle damage (EIMD) [delayed onset of muscle soreness (DOMS), creatine kinase], blood redox status [total antioxidant capacity, catalase, protein carbonyls, reduced glutathione, oxidized glutathione], and isokinetic performance (knee-extensors and knee-flexors isometric, concentric, eccentric torque) evaluation. In addition, metabolism (lactic acid) will be assessed before and 4 min after exercise. Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, blood redox status and performance indices at the same time-points. At the second cycle, the participants will repeat the above procedures under the remaining condition. Between conditions, there will be a 14-day washout period. The results of the research will provide important information for coaches and physically active individuals, regarding the effectiveness of postbiotics in alleviating oxidative stress and improving performance after intense exercise.

NCT ID: NCT06411249 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

BE-EARLY
Start date: June 4, 2024
Phase: Phase 4
Study type: Interventional

This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.

NCT ID: NCT06409130 Recruiting - Clinical trials for Alcohol-related Liver Disease

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease

Start date: May 20, 2024
Phase: Phase 2
Study type: Interventional

The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or "dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks.

NCT ID: NCT06405906 Recruiting - Dietary Habits Clinical Trials

A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

RADIGAL
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoing cholecystectomy for gallstone disease. The main question it aims to answer is: • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed (RADIGAL-2)? A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be administered both at baseline and during follow-up. Analysis of covariance with ordinary least squares estimation will be applied to estimate between-group differences in GIQLI scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms occurrence or hospitalizations will also be appraised (secondary endpoint). Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will: - be randomly assigned to recommending either a fat-free or a balanced WHO diet . - be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events. This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.

NCT ID: NCT06404983 Recruiting - Breast Cancer Clinical Trials

Opioid-free Anaesthesia in Breast Cancer Surgery

Start date: December 28, 2022
Phase: N/A
Study type: Interventional

Background: Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders. The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision). Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively. During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded. Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded. The investigators expect to recruit at least 100 participants per group.