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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: NCT06438042 Recruiting - Pressure Ulcer Clinical Trials

Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

Start date: June 11, 2024
Phase:
Study type: Observational

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

NCT ID: NCT06421818 Recruiting - Ulcerative Colitis Clinical Trials

Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis

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

Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's invention of transendoscopic entral tubing (TET) has been used in Baitouweng Decoction for the treatment of UC across the whole colon, however, the efficacy have not been reported and the underlying mechanism is still unclear. Compared with oral and rectal enema, Baitouweng Decoction by colon TET can improve the therapeutic effect by increasing the concentration of drugs in the whole colon, which need to be verified. This project will reveal the prescription effect and drug-microbiome interaction mechanism of whole colon repeated administration of Baitouweng Decoction in the treatment of UC through clinical randomized controlled studies, deep intestinal dynamic sampling, integrated analysis of multi-omics and TCM prescription metabolomics studies, and provide key scientific basis for the establishment of a new approach of whole colon repeated administration of TCM and a new strategy for the treatment of UC.

NCT ID: NCT06403605 Recruiting - Diabetic Foot Ulcer Clinical Trials

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

BGWM
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC treatments for Diabetic Foot Wounds.

NCT ID: NCT06402565 Recruiting - Diabetic Foot Ulcer Clinical Trials

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

NTCDU
Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

The goal of this multi-center, randomized, placebo-controlled, evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo, as an adjunct to Standard of Care (SOC). The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care SOC. Each site will assign a physician (or designee) to serve as the blinded evaluator who is responsible for assessing the study endpoints. The blinded evaluator will not be involved in the clinical care of subjects.

NCT ID: NCT06398808 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.

NCT ID: NCT06393907 Recruiting - Clinical trials for Gastroduodenal Ulcer

Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

Start date: March 26, 2024
Phase: N/A
Study type: Interventional

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

NCT ID: NCT06383013 Recruiting - Diabetic Foot Ulcer Clinical Trials

Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

Start date: February 29, 2024
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.

NCT ID: NCT06372613 Recruiting - Clinical trials for Ulcerative Colitis in Histologic Remission

Association Between LRG and Histologic Remission in Ulcerative Colitis

Start date: February 25, 2024
Phase:
Study type: Observational

We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

NCT ID: NCT06359808 Recruiting - Colitis, Ulcerative Clinical Trials

Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

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

Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.