Effective Consumption of Oral Nutritional Supplements in Geriatrics: A Study Evaluating a Strategy...
MalnutritionGeriatric PatientsMalnutrition affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional supply with a high density of calorie and protein. The clinical efficiency of ONS is well demonstrated whether on nutritional parameters or on clinical outcomes. However, acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia, taste changes, monotony … also partly because patients dislike flavor, taste or texture. The respect of patients' preferences is essential to improve the therapeutic observance to ONS. Generally, ONS are delivered after the patient has told his preferences orally to the dietitian. To date, there is no study evaluating the effect of an alternative strategy based on a preliminary degustation of several products on the effective consumption of ONS in geriatrics. The study is designed as prospective, randomized, controlled, open study to test this strategy in older undernourished people hospitalized in geriatrics who require prescription of ONS. This study will be performed among 220 older people hospitalized in two departments of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille). The main objective is to compare the therapeutic observance to ONS when products are delivered to older people according to the usual way (preferences announced orally and/or dietitian's choice) or according to an alternative strategy based on a preliminary degustation of several products varying for flavor and texture but always in respect of the medical prescription. The secondary objective is to compare the evolution of the nutritional status estimated by routinely used clinical and biological parameters, as well as the main clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients will be reevaluated clinically 3 months after the hospital's discharge. The hypothesis is that a strategy based on a preliminary degustation, leading to an informed choice, will significantly improve the acceptability and the effective consumption of ONS during the hospital stay, and will also impact positively the nutritional status at hospital's discharge and 3 months after. The validation of this hypothesis could allow recommending the generalization of preliminary degustation of ONS at the time of their prescription to optimize the therapeutic observance in undernourished older people.
Saving Mother and Baby With Text Messaging
BleedingInfection2 moreWe plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)...
Parenteral Nutrition Associated Liver DiseaseEssential Fatty Acid Deficiency3 moreThis study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
MalnutritionThe purpose of this study is to determine whether short-term use of oral nutritional supplements as part of the diet improves nutritional and functional status of post-hospitalization malnourished elderly.
Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
Lung CancerMalnutrition1 moreRATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment. PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.
Pre-Operative Parenteral Nutrition in Malnourished Patients
MalnutritionInflammatory Bowel Disease 1Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will have fewer post-operative complications compared to malnourished patients that receive standard of care nutritional therapy.
Fortified Foods in Older Inpatients
MalnutritionDementia2 moreMalnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.
A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under...
Therapeutic EquivalencyA study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.
Nutritive Sucking Patterns in Premature Infants
PrematureLight-For-Dates Without Mention of Fetal Malnutrition2 moreIn this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions...
HealthyIn Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively. The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively. The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine is bioequivalent to the reference formulation (Cymbalta®) when administered with the same dosage and under fed conditions in healthy male research subjects.