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NCT04768062
This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.
NCT02483481
Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease. Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.
NCT06259760
This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.
NCT05582070
The aim of the study is to evaluate the effect of nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy) on sleep quality, assessed by the variation of the Wake after sleep onset (WASO), in patients presenting with sleep disorders and severe nasal obstruction.
NCT03845075
Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period. • The study will have two parts: * Part 1: 24 weeks double-blind treatment (DB), followed by * Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator
NCT06256211
To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.
NCT03480386
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
NCT06069817
The application of HFNC therapy in patients with airway stent, improving both humidification and clearance of the airway secretion, could potentially reduce the risk of mucoid impaction, respiratory infections and granulation. HFNC therapy could be superior to nebulization of normal saline (usual care) in order to keep the stent cleaned, reducing, by inference, the risk of complications, as defined above.
NCT05123326
Portal vein thrombosis is defined as partial or complete occlusion of the portal vein lumen by the blood clot or its replacement by multiple collateral vessels with the hepato-petal flow, known as 'portal cavernoma'. \[1,2\] Based on the published literature, 15-25% of patients with cirrhosis have portal vein thrombosis (PVT) \[3\], and 35-50% of patients with hepatocellular carcinoma (HCC) have malignant PVT \[4\] compared to 1-3.8 per 100,000 patients in the general population. \[5\] The reported cumulative incidence of PVT in patients of Child-Pugh A and B is 4.6% and 10.7% at 1 and 5 years respectively with higher incidence among those with decompensated disease or with an underlying hypercoagulable disorder. \[6\]. Similarly, the prevalence of PVT in compensated cirrhosis is around 1% which increases to 8 - 25% in liver transplant (LT) candidates and 40% in patients with hepatocellular carcinoma (HCC) \[7,8\]. Based on the published literature 7-9 % of all chronic liver disease patients have hepatic vein outflow tract obstruction (HVOTO) in the Indian population. \[9\] HVOTO is defined as obstruction to hepatic venous outflow at any site from the right atrium inlet to the small hepatic venules. The Budd-Chiari syndrome (BCS) results from occlusion of one or more hepatic veins (HV) and/or the inferior vena cava (IVC). In the West, the most common cause is HV occlusion by thrombosis. More recent Indian studies have however shown that isolated HV and combined IVC+HV obstruction are now more common. \[10\] In the post COVID-19 era, there has been great interest in the prothrombotic states associated with the SARS-Cov-2 virus infection, and the adverse effects of some vaccines. \[11\] With the availability of better molecular tests for hypercoagulable states, use of global coagulation tests (GCT) like rotational thromboelastometry (ROTEM), thromboelastography (TEG) and Sonoclot, use of therapeutic procedures like Transjugular intrahepatic portosystemic shunt (TIPS), availability of novel oral anticoagulants (NOAC), the natural course of disease can be changed with good outcomes. \[12\] Standard Coagulation tests (SCTs) like PT, aPTT, and platelet count are not predictive of bleeding or coagulation risk as they exclude the cellular elements of hemostasis and are unable to assess the effect of thrombomodulin and cannot assess the stage of the coagulation pathway which is affected. Global coagulation tests provide dynamic information on the coagulation pathway that is not available from conventional tests. \[13\]
NCT06254937
Fertility means being fertile, that is, having the ability to reproduce. Fertility awareness means that individuals know and avoid the anatomy and physiology of the reproductive system, the importance of fertility, fertility options and life habits that negatively affect fertility. Reproductive Life Plans (RLP) are personal goals related to individuals' decisions to have children, when and how to make this decision, focusing on their priorities, current situations and goals.RLP prioritizes preconception care so that individuals can achieve their reproductive goals. This study aimed to examine the effect of RLP training on university students' knowledge and attitudes about fertility and preconception health. The research was designed as a pretest-posttest randomized controlled experimental study. The population of the research will consist of 1025 senior undergraduate students studying in five faculties and 17 departments of Bartın University in the fall semester of the 2023-2024 academic year. To determine the number of participants to be included in the research sample, power analysis was performed using the G-Power 3.1.9.7 program. Accordingly, the sample of the study was planned to include a minimum of 160 participants in intervention and control groups, 80 for each group. Firstly, a Preliminary Evaluation Form will be applied to university students to collect the data of the research. Then, students who meet the inclusion criteria will be pre-tested with the Introductory Information Form, Fertility Health Information Scale and Preconceptional Health Information and Attitude Form. After the pre-test is administered, participants will be randomly assigned to intervention and control groups. Participants in the intervention group will be given group training based on the contents of the Reproductive Life Plan Training Booklet (RLPTB) created by the researcher in line with the literature. No intervention will be made to the participants in the control group. After the pre-test is applied to the participants in both groups, the data collection form will be applied again 8 weeks later and the post-test phase of the research will be completed. IBM SPSS 22.0 package program will be used for statistical analysis of the data obtained from the study. The findings will be evaluated at a 5.0% significance level within a 95.0% confidence interval.
NCT06248463
The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are: Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM). Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes. Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.
NCT06016153
Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival. There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS. The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.
NCT06252246
BACKGROUND: Primary angle closure glaucoma (PACG) is one of a leading cause of blindness worldwide including Thailand. This problem impact to the overall health of people and health care system. Treatment guidelines of each stage is differenced. Therefore, factors that affect to treatment should be explored to plan for taking care patients in the future. OBJECTIVES: The study aimed to examine the effects of cataract surgery by phaco- emulsification on intraocular pressure and to determine the factors associated with intraocular pressure among primary angle closure glaucoma patients.
NCT05610514
The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.
NCT02985918
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could reduce the need for endotracheal intubation during hospitalization in patients with an AECOPD and hypercapnia.
NCT05994716
This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring, tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD). The main study objective is to evaluate the impact of telemedicine on the quality of life in IBD. The secondary study endpoints are to determine disease activity, the number of IBD relapses, to investigate rate of leukopenia in patients taking azathioprine, to determine medication adherence, psychological well-being and satisfaction with medical care in the telemedicine group in comparison with the face-to-face follow-up group. Moreover, we aim to evaluate association between secondary outcomes and QoL. It is planned to enroll 64 patients. The study duration is 18 months (12 months - patient enrollment, 6 months - telemonitoring). The study consists of 3 stages. The first stage is selection of patients with IBD after treatment in the gastroenterology department. The second stage is face-to-face appointment and general recommendations (for the observation group); monthly completion of questionnaires on the web-platform, possibility to contact with doctor via chat or phone call, access to educational information; a monthly phone call to each patient from to answer any questions or concerns they may have and to interview them according to the checklist (for the intervention group). The third stage is the evaluation of IBD activity (re-hospitalization after 6 months), number of IBD relapses, quality of life, frequency of leukopenia in patients receiving azathioprine therapy, medication adherence, psychological well-being and satisfaction with medical care.
NCT06246825
Rationale: Obstructive sleep apnea (OSA) is a highly prevalent, often undiagnosed, modifiable risk factor for atrial fibrillation (AF), as well as AF-related complications and treatment effectiveness. It is unclear which OSA-related pathophysiological mechanism, i.e. intrathoracic pressure shifts, hypoxemia or sympathovagal imbalance, plays the most dominant role, and a better understanding of these mechanisms could provide valuable information in future diagnostic and therapeutic strategies in this population. Objective: The primary objective is to assess the role of OSA-related pathophysiological mechanisms in the initiation of AF by a multi-parametric strategy that combines the estimated parameters. The main hypothesis is that intrathoracic pressure fluctuations are the predominant mechanism. The secondary objective is to validate a nonobtrusive sensing technology based on photoplethysmography (PPG) and diaphragm electromyography (dEMG) measurements as surrogates for gold standard technology based on invasive intraoesophageal pressure (PES) measurement. Study population: Adult patients with paroxysmal AF with nocturnal onset and high risk of OSA based on the STOP-BANG questionnaire. Study design: An observational study in a selected cohort. Subjects are recruited from the AF outpatient clinic of the Catharina Hospital, and referred to Kempenhaeghe Centre for Sleep Medicine for a one-night full PSG, with the addition of dEMG and PPG. The acquired data will be analysed at the Eindhoven Technical University. Main study parameters/endpoints: Primary endpoint: Identification of prognostic factors for the initiation of AF in relation to OSA-related pathophysiological mechanisms..nl
NCT06247020
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
NCT03949491
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
NCT04310410
The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.