Clinical Research Directory

Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.

The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity

This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.

Effect of Consuming Vitamin A-fortified Sugar on Serum Retinol Levels in Children

The increase in vitamin A deficiency (\<20 mcg/dL) among children under five in Colombia (2010-2015) is a public health problem (27.3%). The objective of this randomized, controlled, double-blind clinical trial was to determine whether daily consumption of retinol-fortified sugar (23.5 mcg ER/day) was effective in treating this deficiency in children; furthermore, to evaluate whether daily sugar consumption (13 g/day) increased excess weight (P/T: overweight and obesity) in them. The main questions were: * Does daily consumption of retinol-fortified sugar (23.5 mcg ER/g) significantly increase serum retinol levels in children in the intervention group during the study? * What is the increase in weight-for-height among study participants at the end of the intervention following daily consumption of sugar in various meals throughout the day? The researchers compared daily consumption of retinol-fortified sugar over three months with daily consumption of regular sugar or a placebo to determine whether the fortified sugar was effective in increasing serum retinol levels in children in the intervention group and, furthermore, whether the increase in weight-for-height among participants at the end of the study showed no statistically significant differences compared to baseline. Participants were required to: * Children undergo antiparasitic treatment at each school with 400 mg of albendazole before starting the sugar intervention, in the presence of a nutritionist from the team. * The nutritionist be able to assess the children's anthropometric indicators at the beginning and end of the study to evaluate changes in the presence of undernutrition or excess weight (overweight and obesity). * Caregivers must allow the collection of two 5-ml blood samples: the first to assess baseline serum levels of retinol and CRP before the intervention; and the second and final sample at the end of the intervention to measure the levels of retinol and CRP achieved during the study through the consumption of retinol-fortified sugar. * Caregivers would provide baseline information on the consumption of food groups (at baseline: semiquantitative frequency of consumption; and at baseline and at the end of the study: 24-hour dietary recalls). In addition, they would provide information at three different time points on the semiquantitative consumption of supplements and foods that are sources of vitamin A and carotenoids. * Caregivers and teachers will provide the nutritionist with information at baseline, during the intervention, and at the end of the study regarding the presence of infectious diseases, clinical signs of infection and their duration, as well as the occurrence of adverse events among participants who consumed fortified sugar (13 g/day: 23.5 mcg ER/g).

The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement

This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.

Nutritional Educational Program On Therapy in Iron Deficiency Anemia

The goal of this clinical trial is to evaluate whether a Nutritional Educational Program for caregivers can improve their knowledge and performance in managing iron deficiency anemia (IDA) in children, compared to oral iron therapy alone. The study focuses on children with IDA, particularly in \[age range 1-5 years\], and aims to determine if combining nutritional education with oral iron therapy has a greater impact on improving hemoglobin levels than iron therapy alone. The main questions it aims to answer are: 1. Does caregiver education improve children's hemoglobin levels more effectively than oral iron therapy alone? 2. Does nutritional education improve caregiver knowledge and practices regarding iron-rich diets? Researchers will compare children who receive both caregiver education and oral iron therapy to those receiving only oral iron therapy to assess differences in hemoglobin levels. Participants will: Receive oral iron supplements. Caregivers will participate in educational sessions on dietary strategies to manage IDA.

The Effect of Abdominal Massage on Gastric Problems in Pediatric Intensive Care: A Randomized Controlled Study

Many system functions differ in children dependent on mechanical ventilation support and may present with various complications. In the gastrointestinal system, gastric and duodenum-related decreased motility disorders are a very common problem in critically ill patients hospitalized in the intensive care unit, which increases mortality and morbidity. The prevalence of gastric dysmotility in pediatric intensive care is estimated to be 50%. Gastric problems such as vomiting, increase in the amount of gastric residue, decrease in bowel movements, abdominal distension, diarrhea/ constipation, etc. are observed as a result of the dysfunction of the gastrointestinal system. In addition to these problems; there are problems associated with the ventilator such as pneumonia, infection, bacterial growth, and stopping enteral feeding. Malnutrition as a result of stopping feeding prolongs the hospitalization of intensive care patients and affects mortality. Intensive care nurses play a key role in providing nutritional support to patients who receive mechanical ventilation support and whose level of consciousness is reduced. Intensive care nurses have many responsibilities such as timely initiation of nutrition, application of correct nutrition, correct placement of feeding tubes, and prevention of problems that may arise as a result of nutrition. Abdominal massage practice is a therapeutic, independent, and evidence-based nursing intervention. It has been used for many years to increase the motility of the gastrointestinal system and to treat constipation. Inexpensive and easy to apply abdominal massage compared to other methods; It increases intestinal motility, accelerates the mechanical advancement of nutrients in the digestive system, improves the blood flow of the region, and is effective in reducing intra-abdominal pressure. It has been reported in the literature that abdominal massage applied to preterm babies increases nutritional tolerance. Studies on adults have also reported that gastric residue is reduced, less vomiting is experienced, and abdominal distension is less common. However, there is no study examining the effects of abdominal massage in reducing gastrointestinal problems in children hospitalized in pediatric intensive care units and receiving ventilator support. Therefore, the aim of this study is to examine the effect of abdominal massage on gastric problems in children who are fed enterally in the pediatric intensive care unit.

Co-designed Nutritional Training Program for Oncology Nurses in Vietnam

This study evaluates a co-designed nutritional training program for oncology nurses in Vietnam. The aim is to improve nurses' knowledge, confidence, and clinical practice in providing nutritional support for patients with cancer experiencing treatment-related symptoms. The study used a single-group pre-post intervention design. Oncology nurses participated in a structured training program that included theoretical sessions and supervised clinical practice. After training, nurses delivered nutritional support to patients during routine care. The study assessed changes in nurses' knowledge, self-confidence, and practice performance before and after the intervention. In addition, the acceptability of the program was evaluated from both nurses and patients who received the nutritional support. This study provides preliminary evidence on the feasibility and potential effectiveness of a nurse-led nutritional training program and supports the integration of structured nutritional care into routine oncology practice.

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.

The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes

Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life. Enteral nutrition is superior to parenteral nutrition and should be preferred. Patients should begin enteral nutrition as soon as possible to protect the gastrointestinal mucosa and maintain normal flora. In patients unable to take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube. Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality compared to surgical gastrostomy, and is cheaper and more time-saving. It was first applied in 1980 as an alternative to surgical gastrostomy. Initially described, a line was drawn between the umblicus and the middle of the left lower costal margin, and a feeding tube was inserted under local anesthesia at the junction of the middle 2/3 and the outer 1/3, with feeding starting the next day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process. Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) are described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines note that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level. The exact placement of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally determined by endoscopic transillumination. However, its level within the gastric lumen is predictable. In our study, we aimed to measure the distance of the feeding tube from the pylorus in patients undergoing PEG surgery, to investigate how this affects post-procedure outcomes, and to determine the optimal level within the gastric lumen. Additionally, the catheter placement on the skin will be recorded for each patient. The anatomical skin localization obtained by examining the data of all patients will be defined as the 'Triangle of Çaykara'.

Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck

Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative. Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage. In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months. In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

NASCITA Italian Birth Cohort Study

The NASCITA study (NAscere e creSCere in ITAlia) was created to improve the understanding of the health status of Italian children early on and how it is affected by social and health determinants. The study will evaluate physical, cognitive, and psychological development, and health status and health resource use during the first six years of life in a group of newborns, as well as potential associated factors. The association between the well-being of children and parental adherence to the recommendations for better child care and development will also be assessed. Information on the children will be collected by paediatricians mostly during routine visits. The findings will be used in the development of specific prevention measures and interventions to improve the health of children, in particular more vulnerable ones.

Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD

Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.

In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.

Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients

Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.

Nutrition Impact on Immunotherapy of Cancer

This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Guangzhou Nutrition and Health Study (GNHS)

Purpose: The Guangzhou Nutrition and Health Study (GNHS) project aims to assess the determinants of metabolic disease in nutritional aspects, as well as other environmental and genetic factors, and explore possible mechanisms with multi-omics integration. Study design: GNHS is a community-based prospective cohort study. Participants: In this cohort, the original GNHS and another cohort study (the controls of a case-control study of hip fractures, CCFH) have been integrated into the one GNHS project. After completing the baseline examination, a total of 5118 participants were recruited during 2008-2015 in the GNHS project. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, dual-energy x-ray absorptiometry (DXA) scanning, ultrasonography evaluation, vascular endothelial function evaluation, cardiopulmonary exercise testing, magnetic resonance imaging (MRI), 14-d real-time continuous glucose monitoring tests, laboratory tests, and multi-omics data were/will be conducted. Up to December 2022, 3442 and 2895 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, muscle function and bracelet motion monitoring. 3. DXA scanning: To determine bone density, bone mineral content, bone geometry information, fat mass, and muscle mass. 4. Ultrasonography evaluations: To determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Vascular endothelial function evaluation. 6. Cardiopulmonary exercise testing: Lung function. 7. MRI: Brain and upper-abdomen MRI. 8. 14-d Real-time continuous glucose monitoring tests. 9. Specimen collections: Overnight fasting blood, early morning first-void urine, faces, and saliva samples. 10. Laboratory tests: Metabolic syndrome-related indices; Diabetes-related indices; Uric acid; Nutritional indices; Inflammatory cytokines; Index of oxidative stress; Adipocytes; Sexual hormones; Liver and renal function-related markers; Routine blood test. 11. Multi-omics data: Genotyping data; Gut microbiota; Untargeted serum and fecal proteomics; Targeted serum and fecal metabolomics. 12. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.