Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
Gastro-Intestinal DisordersTo evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.
Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease...
BiotherapyChronic Inflammatory Disease6 moreBiological treatments (BT) are commonly prescribed to treat chronic inflammatory diseases in children. Paradoxical reactions during treatment with a biological agent can be defined as the appearance or exacerbation of a pathological condition that usually responds to this class of drug while treating a patient for another condition. Limited data are available in children treated by BT on cutaneous paradoxical reactions, or any other cutaneous adverse events occurring during treatment. On the contrary, dermatologists tend to see and manage increasing numbers of cutaneous adverse events, including paradoxical reactions. The aim of this project is to describe the incidence of cutaneous adverse events, including cutaneous paradoxical reactions, occurring in the pediatric population, during a treatment by BT given for a chronic inflammatory disease.
Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient...
Inflammatory Bowel DiseasesCrohn Disease4 moreInflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients. Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted. Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections. The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool. In the current study the investigators aim to: Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments Identify the predictors and risk factors of mild and moderate infections. Assess the relation between patient reported infections and the risk for serious infectious complications
Remote Ischemic Conditioning in Abdominal Surgery
LaparotomyLaparoscopy7 moreThis phase II randomized (1:1) controlled trial will examine the effects of remote ischemic conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be enrolled at a single institution - University Hospital - Newark. The study population are patients undergoing major abdominal surgery (anticipated to be >/= 2 hrs long with a hospital stay >/= 2 days). Subjects in the treatment group will receive lower limb ischemic conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in systemic inflammatory markers in peripheral blood and 30-day mortality.
Gastrointestinal Tract Disorders: A Prospective Multicenter Registry
Endoscopic SuturingGI Tract Disorders1 moreThe purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract for various GI tract disorders. Currently, lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.
Evaluation of People With Gastrointestinal Disease
Gastrointestinal DiseasesBackground: - Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. People who are interested in clinical trials need to be screened before they can take part in the studies. Researchers want to evaluate people with different stomach and intestine disorders to see if they are eligible for clinical trials. Objectives: - To study people who have gastrointestinal disorders and see if they are eligible for clinical trials. Eligibility: - Individuals at least 18 years of age who have or may have a gastrointestinal disorder. Design: Participants will be screened with a physical exam and medical history. Blood, urine, and stool samples will be collected. Imaging studies such as x-rays and ultrasound will check to see if the disorder has affected other organs. Participants may have tests as needed depending on their disorder. These tests include the following: Colonoscopy and endoscopy of the large intestine, esophagus, and stomach. Stomach acid analysis to look at stomach pH levels. Wireless capsule endoscopy to take pictures of the small intestine. Hydrogen breath testing to study issues like bloating, diarrhea, and constipation. Sitz Marker Study to see how fast stool moves through the colon. Participants may donate extra blood, urine, or stool samples for study. They may also donate stomach contents or tissue from the gut. Treatment will not be provided as part of this study. However, participants may be admitted to other clinical trials.
Validation of New Tests for Gastrointestinal (GI) Permeability
Gastrointestinal DiseasesIntroduction: The primary function of the gastrointestinal (GI) wall is digestion and absorption of nutrients that are important for growth and development. The second important function of the GI wall is forming an effective barrier to prevent penetration of potentially harmful components from the inside of the gut (lumen), via the GI wall, into the body. A compromised barrier function may play an important role in the development of a range of inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food allergy, but also in the pathophysiology of postoperative complications. It is important and clinically relevant to have reliable GI permeability tests, however the existing test leave room for improvement. Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both normal controls with and without raised permeability, and in patients with coeliac disease. In the current study these new permeability tests will be evaluated and compared with the golden standard permeability test, the dual sugar test.
Heart Rate Variability in Children With a Functional Gastrointestinal Disorder
Abdominal PainThe current study is designed to assess relationships between anxiety/stress, autonomic nervous system balance, and electrical activity in the stomach before and after eating/drinking in children with abdominal pain.
A Study on the Effectiveness of AI-assisted Colonoscopy in Improving the Effect of Colonoscopy Training...
ColonoscopyArtificial Intelligence1 moreIn this study,the AI-assisted system(EndoAngel)has the functions of reminding the ileocecal junction, withdrawal time, withdrawal speed, sliding lens, polyps in the field of vision, etc. These functions can improve the colonoscopy performance of novice physicians and assist the colonoscopy training。
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
Functional Gastrointestinal DisordersInfantile Colic1 moreThis observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)