|drug1032||Control (standard clinical practice) Wiki||0.50|
|drug4507||hospitalized children with Covid19 Wiki||0.50|
|drug1217||Dietary advice Wiki||0.50|
|D009059||Mouth Diseases NIH||0.58|
|D011502||Protein-Energy Malnutrition NIH||0.50|
There are 4 clinical trials
In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults with low protein intake.
Description: Change in walk time on a 400 meter walk testMeasure: 6-month change in walk time on a 400 meter walk test Time: 6 months
Description: SPPB consists of three tests: repeated chair stands test, 4 meter walk test, and tandem stand test. The total score ranges from 0-12. A higher score indicates better physical functioning.Measure: 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB) Time: 6 months
Description: Hand grip strength measured by a hand held dynamometerMeasure: 6-month change in hand grip strength Time: 6 months
Description: Upper leg strength measured by a measurement chairMeasure: 6-month change in leg strength Time: 6 months
Description: Body composition (fat-free mass, skeletal muscle mass and fat mass) will be assessed from bioelectrical impedance using body resistance, reactance, impedance and phase angle. In the Dutch sample only, fat-free mass and fat mass will be directly measured by using densitometry (BODPOD).Measure: 6-month change in body composition Time: 6 months
Description: Mobility limitations will be assessed by means of a questionnaire; "Because of your health, how much difficulty do you have walking 400 meter?" and "Because of your health, how much difficulty do you have climbing one flight of stairs?" Participants responded using a five level Likert scale: 'No difficulty', 'a little difficulty', 'some difficulty', 'a lot of difficulty', and 'unable to do the activity'.Measure: 3, and 6-moths self-reported mobility limitations (questionnaire) Time: 3 and 6 months
Description: Quality of life measured using the EuroQol-5D instrument. The EuroQol 5D consists of five questions on a Likert scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Answer categories range from (1) 'no problems' to (5) 'unable to'. An additional thermometer for experienced health is scored on a Visual Analogue scale (VAS), ranging from 0-100. The exact point where the line crosses the VAS is the VAS score. The scores are converted to an index value, which facilitates the calculation of quality-adjusted life years (QALYs) that is used to calculate the cost-effectiveness of the study.Measure: 3, and 6-moths self perceived quality of life Time: 3 and 6 months
Description: Frailty will be determined using the 5 criteria of the Fried Frailty Index: Self-reported unintentional weight loss: >4 kg in past 6 months. Self-reported exhaustion. Based on two self-reported questions from the Center for Epidemiologic Studies Depression scale on exhaustion in the past week at baseline and follow-up: "I felt that everything I did was an effort" and "I could not get going". Scores ranges from 1 'not at all' to 4 'most of the time'. A score of 3 or 4 on either question indicates exhaustion. Weakness: grip strength in the lowest 20% of the study population, adjusted for gender and BMI. Slow walking speed: walk time on the 400 meter walk test in the slowest 20% of the study population, adjusted for gender and height. Low physical activity: Kilocalories expended/wk based on accelerometer data in the lowest quintile of physical activity for each gender. Outcome: No components:robust 1 or 2 components:intermediate/prefrail 3 or more components:frailMeasure: Incident frailty assessed by the Fried Frailty Index Time: 6 months
Description: Incidence of sarcopenia risk will be assessed with the SARC-F questionnaire; how much effort do you experience when 1) lifting and carrying a bag of 4.5 kilo, 2) walking across a room, 3) transferring from a chair or bed, 4) climbing a flight of 10 stairs, and 5) how many times have you fallen in the past year. Answering option include no effort (0 points), a bit of effort (1 point) and a lot of effort (2 points), where a score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.Measure: Incidence of sarcopenia risk Time: 3 and 6 months
Description: BMI<22 kg/m2 and unintentional weight loss >5% over 6 monthsMeasure: Incident malnutrition Time: 6 months
Description: To measure health care costs the investigators will use a modified version of the Resource Utilization in Dementia Questionnaire WIMO. This questionnaire contains questions on hospital admissions, prescribed medicine use, care from health professionals, and use of other health care services in the past three months. These are the domains that the investigators might expect changes in due to the intervention.Measure: 3, and 6-moths health care costs assessed by questionnaire Time: 3 and 6 months
Description: Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale.Measure: 3, and 6-month change in body weight Time: 3 and 6 months
Description: Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.Measure: Body height Time: baseline
Description: Based on measured weight (measured at baseline and after 6 months) and height (measured at baseline) BMI will be calculated as body weight (kg) divided by height (m) squared.Measure: 3, and 6-month change in body mass index (BMI) Time: 3 and 6 months
Description: A 24-hour recall is a structured interview intended to capture detailed information about all foods and beverages consumed by the participant in the past 24 hours. Changes in dietary intake (based on data of the 24-hour recalls) enables to investigate compliance; i.e. higher protein intake indicates higher compliance.Measure: Dietary intake assesed by three 24-hour recalls Time: 3 and 6 months
Description: Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit.Measure: Physical activity Time: 3 and 6 months
Description: Examine the effect of persuasive technology on adherence to increasing protein intake. A subsample of the Dutch participants will receive a food storage box that can measure which protein rich food products are taken out and a small-size screen (tablet) that provides reminders and nudges. The investigators will test if there are differences in adherence to the interventions between participants who took part in this sub-study and participants who did not.Measure: Effectiveness of persuasive technology sub-study on protein intake Time: 6 months
Description: The effect of increasing protein intake to at least 1.2 g/kg body weight/d on faecal and oral microbiota compositionMeasure: Microbiota sub-study Time: 6 months
Description: To examine the effects of increasing protein intake on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging. BOLD fMRI will be used to measure neuronal activity in CNS satiety and reward circuits (including striatum, amygdala, orbitofrontal cortex, insula) in response to visual food stimuli (pictures of food items) and to the actual consumption of food (chocolate milk).Measure: Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging Time: 6 months
Prospective observational follow-up of Intensive Care Unit (ICU) survivors on the adequacy of nutritional therapy: what is the mean caloric and nitrogen intake and how does their metabolic profile evolve over time? Is supplemental nutrition, in any forms, indicated to fill the caloric and protein gap? Would IV access be a barrier for SPN, and would subcutaneous parenteral nutrition be welcomed by health care practitioners and patients? Are patient centered outcomes (physical function, quality of life, performance in activities of daily living) correlated with nutritional adequacy and metabolic profile? Overall: are ICU survivors well fed after they leave ICU until hospital discharge? What kind of nutrition would possibly be useful to optimize the intake? How do their energy and protein requirements evolve? What is the physical and mental status of ICU survivors and is this correlated with nutritional status?
Description: MorbidityMeasure: Morbidity Time: 6 months after hospital discharge
Description: MortalityMeasure: Mortality Time: 6 months after hospital discharge
Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:
Description: Body Mass Index evolution from baselineMeasure: Body Mass Index Time: 1 Month
Description: Body Mass Index evolution from baselineMeasure: Body Mass Index Time: 3 Months
Description: Usual weight at baseline vs weight before confinement (gk)Measure: Weight changes during confinement Time: 8 weeks
Description: number and type of nutritional supplements from baselineMeasure: prescription of nutritional supplements and observance Time: 3 months
The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.
Description: Respiratory infections incidence (includes LRTI, pneumonia and exacerbations of COPD): all new episodes of respiratory infections recorded in the clinical history or in the reports presented by the patient will be recorded. LRTI: presence of at least 2 of the following symptoms without other cause to explain them: fever, cough, purulent expectoration, rhonchi or wheezing. Pneumonia: performing 1 or more radiographic tests with new condensation, fever or leukopenia or leukocytosis and at least: cough, purulent expectoration, dyspnea, tachypnea, suggestive auscultation or worsening of gas exchange. COPD exacerbation: acute exacerbation of COPD is a sudden worsening of COPD symptoms (shortness of breath, quantity and color of phlegm) that typically lasts for several days. It may be triggered by an infection with bacteria or viruses or by environmental pollutants.Measure: Respiratory infections incidence. Time: From discharge to 6 months follow-up
Description: Mortality: the date and reason for death will be recorded (hospitalization, 1, 3 and 6 months).Measure: Mortality Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: General readmissions and readmissions for respiratory infections (1, 3 and 6 months): LRTI, pneumonia and exacerbations of COPD: the reason for admission will be that stated in the hospital database (CMBDAH) according to CIM-10. The information source of the readmissions will be the registration of hospital discharges that is integrated into the hospital information system and that includes the CIM-10 codes of the main and secondary diagnoses of the episode that caused the admission, the date of admission and discharge and the days of hospitalization. Readmissions from pneumonia (codes CIM-10): J13, J18.1, J15.1, J14, J15.4, J15.211, J15.5, A48.1, J15.8, J18.0, J18.8, J69.0; readmissions for LRTI (no pneumonic): J20.0 - J20.9, J10.1, J11.1, J41.8, J44.1 and J44.0. Readmissions from exacerbation of COPD: J441.Measure: General readmissions and readmissions for respiratory infections Time: Through study completion, at 1, 3 and 6 months from disharge.
Description: Mini-nutritional assessment form (MNA) (hospitalization, 1, 3 and 6 months).Measure: Nutritional status (MNA) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Heigh in cm (hospitalization, 1, 3 and 6 months).Measure: Nutritional status (Anthropometric measures) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Weight in kg (hospitalization, 1, 3 and 6 months).Measure: Nutritional status (Anthropometric measures2) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Biochemical parameters from blood analysis (hospitalization, 3 and 6 months).Measure: Nutritional status (Biochemical parameters) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Hydration status: we will register total body water and intracellular water with bioimpedance (hospitalization, 1, 3 and 6 months).Measure: Hydration status (bioimpedance) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Quality of life: EQ-5D questionnaire will be used (hospitalization, 1, 3 and 6 months).Measure: Quality of life of patients during the study period Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Functional status: we will use the Barthel Index (hospitalization, 1, 3 and 6 months).Measure: Functional status Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Oral Hygiene: the OHI-S (simplified oroal hygiene index) will be collected (hospitalization, 1, 3 and 6 months).Measure: Oral Hygiene Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Severity of dysphagia: according to the different viscosities that patients will be able to swallow and with the Functional Oral Intake Scale (V-VST/FOIS) (hospitalization, 1, 3 and 6 months).Measure: Dysphagia severity Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Sociodemographic characteristics of the study population.Measure: Sociodemographics Time: Baseline
Description: Swallowing function (V-VST) (hospitalization, 1, 3 and 6 months).Measure: Swallowing function (V-VST) Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Rate of institutionalization (1, 3 and 6 months).Measure: Institutionalization Time: Through study completion, at 1, 3 and 6 months from disharge.
Description: Drugs taken by the patient.Measure: Pharmacological treatment Time: Baseline
Description: Geriatric syndromesMeasure: Geriatric syndromes Time: Baseline
Description: Fried criteria (hospitalization, 1, 3 and 6 months).Measure: Frailty 1 Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Edmonton frail scale (hospitalization, 1, 3 and 6 months).Measure: Frailty 2 Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Smoking and alcohol consumptionMeasure: Toxic habits Time: Baseline
Description: Compliance with the recommendations of the study intervention (adaptations of fluid, prescribed diets and oral hygiene) (hospitalization, 1, 3 and 6 months).Measure: Compliance Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Palatability of the intervention products will be measured with the 5-point facial hedonic scale (hospitalization, 1, 3 and 6 months).Measure: Palatability Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Description: Acceptability of the dietes will be measured with the Food Action Rating Scale (hospitalization, 1, 3 and 6 months)Measure: Acceptability Time: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports