Clinical Research Directory

Review of Infant Oral Feeding and Skills

This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.

Elemental 028 Extra Case Studies

Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content micronutrient profile has been developed to better meet the nutritional requirements of patients. This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.

Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients

The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.

Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year. Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2. Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED. This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information. The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.

Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

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.

Advancing Nursing Practices in Hospital Oncology Care

The purpose of this study is to find out if a new training program for nurses called PACT (Partnership, Assessment, Care, and Transition) will be effective and relevant in helping nurses gain the skills needed to provide high-quality family-centered care. Family-centered care skills include engaging family caregivers as partners in patient care, and strengthening their capacity for caregiving by assessing family support needs and facilitating access to resources when needed. The study will also look at whether the quality of nurses' family-centered care skills is associated with improved outcomes for family caregivers. Both nurses and family caregivers will be enrolled in this study. Participants will be nurses/caregivers who care for advanced GI cancer patients admitted to Memorial Sloan Kettering.

A Study to Evaluate Safety and Efficacy of PBK_M2502

This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?

This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.

Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients

The objective of this clinical trial is to assess the feasibility of the remimazolam combined with esketamine OFA (opioid-free anesthesia) protocol for painless gastroscopy and colonoscopy in elderly patients and to determine if it is non-inferior to the traditional OA (opioid-containing anesthesia) protocol. The main questions it aims to answer are: * Is the remimazolam combined with esketamine protocol feasible for painless gastroscopy and colonoscopy in elderly patients? * Is the OFA protocol superior to the OA protocol? Participants will: * During anesthesia induction, the experimental group will receive remimazolam combined with esketamine for anesthesia, while the control group will receive remimazolam combined with remifentanil. * Record respiratory and circulatory indicators and adverse reaction times.

Therapeutic EUS Registry

The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.

SGM-101 in Colorectal Brain Metastases.

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Spanish Series of Patients Treated With the Radionuclide Lutetium177

This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.

Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

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?

Collection of Anonymized Samples

This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.