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Gastrointestinal Disease clinical trials

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NCT ID: NCT04585516 Active, not recruiting - Colo-rectal Cancer Clinical Trials

Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

The number of endoscopies performed varies greatly between different countries and does not reflect variations in disease incidents. The costs of unnecessary endoscopies are significant and with a better selection of which patients need to be examined with endoscopy, resources could be saved in healthcare, and a better triage would mean that malignancies and other more serious conditions do not have to wait. An example of unnecessary endoscopy is a colonoscopy in patients with irritable bowel syndrome or gastroscopy in patients with functional dyspepsia. The purpose of the project is, among other things: - What diagnostic benefit have gastroscopy, colonoscopy, capsule endoscopy and double balloon enteroscopy for different indications in different age groups? - What are the risks of this type of examination? - Can patients be better selected based on symptoms, psychometric data or laboratory findings to reduce the number of unnecessary examinations and prioritize those that should be scooped up first? - Can changed calling methods reduce the number of late cancellations and rebookings and missed patients?

NCT ID: NCT04575649 Recruiting - Clinical trials for Gastrointestinal Disease

Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery

NOGINS
Start date: December 20, 2019
Phase:
Study type: Observational

Infants with congenital gastrointestinal anomalies (CGIA) experience multiple physiologic stressors, including neonatal surgery, early in life during an essential time of growth and development. Early physiologic stressors such as inadequate nutrition have been linked to altered growth patterns and neurodevelopmental delays later in life. In other groups of at-risk infants, early body composition measurements can be used as predictors of long-term health outcomes more so than weight and length alone. The primary objective of this study is to determine if body composition changes in early life are predictive of neurodevelopmental outcomes among infants with CGIA. The secondary objective is to determine if infants with CGIA have altered body composition over time when compared with healthy infants. The investigators propose a prospective, observational study of infants with CGIA, including detailed chart review, body composition measurements, and neurodevelopmental testing at follow-up. If a correlation between body composition measurements and neurodevelopmental outcomes is established in this population, the addition of body composition measurement to standard of care in the neonatal intensive care unit and in follow-up care could allow for further optimization of overall health and development of this vulnerable pediatric population through earlier detection of growth alterations and informed interventions.

NCT ID: NCT04565704 Enrolling by invitation - Clinical trials for Gastrointestinal Disease

Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

Start date: March 25, 2016
Phase: N/A
Study type: Interventional

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

NCT ID: NCT04549727 Not yet recruiting - Prematurity Clinical Trials

Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC

Start date: November 1, 2020
Phase:
Study type: Observational

Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged. Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients 1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells 2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants 3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology 4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions 5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens 6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants 7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC

NCT ID: NCT04519086 Suspended - Appendicitis Clinical Trials

The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30

OPTICAP>30
Start date: November 4, 2020
Phase: N/A
Study type: Interventional

This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to differentiate between uncomplicated and complicated acute appendicitis. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.

NCT ID: NCT04514042 Not yet recruiting - Dysphagia Clinical Trials

Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.

ZIPPY
Start date: October 2020
Phase: N/A
Study type: Interventional

The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Patients have a significantly reduced quality of life index and numerous complications. Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques. There is a novel technique, called the peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum. The ZIPPY trial designed as prospective, international, multicenter, double-blind, randomized study which will be carried out by experienced endoscopists. The aim of this study will be to evaluate the results of Zenker's diverticulum treatment using peroral endoscopic myotomy and to compare its efficacy and safety to flexible endoscopy septotomy. Patients at least 18 years old with symptomatic Zenker's diverticulum diagnosed on the basis of endoscopic and radiological examinations will be enrolled.

NCT ID: NCT04501380 Enrolling by invitation - Clinical trials for Gastrointestinal Disease

Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

Open label interventional randomized pilot study utilizing two dosing regimens of AEMCOLO. The goal of this study is to evaluate effectiveness of a novel antibiotic, AEMCOLO (Rifamycin SV MMX) in the treatment of Small intestinal bacterial overgrowth (SIBO).

NCT ID: NCT04498208 Completed - Surgery Clinical Trials

Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Novel interventions that improve the resolution of pain, minimize opioid exposure, and accelerate functional recovery after surgery are urgently needed. Multi-modal pre-operative optimization programs (or "prehab") integrating exercise, nutrition, and stress reduction have been shown to safely and effectively improve outcomes after surgery. However, no objective biological markers assess prehab effectiveness and are able to tailor prehab programs to individual patients. Surgery is a profound immunological perturbation, during which a complex network of innate and adaptive immune cells is mobilized to organize the recovery process of wound healing, tissue repair, and pain resolution. As such, the in-depth assessment of a patient's immune system before surgery is a promising approach to tailor prehab programs to modifiable biological markers associated with surgical recovery. The primary goal of this clinical trial is to determine the effect of a personalized prehab program on patients immunological status before surgery.

NCT ID: NCT04401124 Not yet recruiting - Colorectal Cancer Clinical Trials

Status of Management of Surgery in Beijing During COVID-19

Start date: May 25, 2020
Phase:
Study type: Observational

This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.

NCT ID: NCT04389333 Completed - Infectious Disease Clinical Trials

Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic

Start date: March 26, 2020
Phase: N/A
Study type: Interventional

In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.