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Ulcer clinical trials

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NCT ID: NCT02330653 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis

Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) or active Crohn's colitis (CD) who have failed, are intolerant to, or have refused traditional first-line maintenance therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric UC or pediatric CD.

NCT ID: NCT02328508 Completed - Diabetes Clinical Trials

Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.

NCT ID: NCT02325388 Completed - Pressure Ulcer Clinical Trials

Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

Start date: December 2014
Phase: N/A
Study type: Interventional

Pressure ulcers are prevalent conditions that result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. This study is a parallel two-group randomized controlled trial that aims to study how the use of a pressure sensing device with continuous visual feedback of pressure imaging may potentially decrease the interface pressure of patients who are at risk of pressure ulcers in an acute hospital setting.

NCT ID: NCT02322307 Completed - Ulcerative Colitis Clinical Trials

Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life

Start date: February 2015
Phase: N/A
Study type: Interventional

HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.

NCT ID: NCT02319798 Completed - Ulcerative Colitis Clinical Trials

Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease

Start date: July 2010
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing. Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances. Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting

NCT ID: NCT02318667 Completed - Colitis, Ulcerative Clinical Trials

Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

EVOLUTION
Start date: February 27, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe UC who have failed on prior conventional therapies. The primary endpoints of this study are to correlate serum soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and histological activity (Geboes index) of disease.

NCT ID: NCT02316990 Completed - Stress Ulcers Clinical Trials

China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

SUP
Start date: January 2015
Phase: N/A
Study type: Observational

Stress ulcers or stress-related mucosal disease (SRMD) is defined as "acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands."[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients. Objectives of this Non-Interventional Study Primary 1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China. 2. Main secondary objective - To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China. - To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China. - To assess time to upper GI bleeding after a cerebral lesion. - To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients. - To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding. - To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis. - To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube. (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)

NCT ID: NCT02306785 Completed - Ulcerative Colitis Clinical Trials

TP0502-Pharmaco-Scintigraphic-Study and Amendment

Start date: October 2012
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively. Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H. In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).

NCT ID: NCT02295735 Completed - Pressure Ulcer Clinical Trials

Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention

Start date: June 2015
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

NCT ID: NCT02294175 Completed - Bacterial Infection Clinical Trials

Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm

Start date: January 2015
Phase: N/A
Study type: Interventional

This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.