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Malnutrition clinical trials

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NCT ID: NCT06405412 Recruiting - Achalasia Clinical Trials

Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.

NCT ID: NCT06405360 Recruiting - Clinical trials for Fetal Growth Retardation

DEUX OEUFs: Cracking the Potential of Eggs to Improve Child Growth and Development

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

This proposed randomized controlled trial aims to investigate the effect of maternal egg consumption during pregnancy on birth length. The study hypothesizes that mothers who consume two eggs a day will have children whose birth length is significantly longer than those born to mothers who consume a typical diet. Pregnant women (n=956) from Nyagatare District in Rwanda will be randomized into one of two study arms: a treatment group (T1) or a control group (T2). Mothers in the treatment arm will receive an animal source food (ASF) supplement of two eggs per day, from enrollment during first trimester through childbirth. Mothers in the control arm will be asked to continue consuming their typical diet. Mothers in both arms will receive standard information, education, and communication about health and nutrition during pregnancy and after birth. All enrolled mothers in the study will also receive up- to-date standard care for pregnant women, as outlined by the Government of Rwanda, a fortified blended flour if they are not already receiving it from the government, a mobile phone with cellular connection, health insurance if they do not already have, and compensation for traveling to a Community Health Worker's home every day for study engagement. All women will receive ultrasound examinations three times during pregnancy, as well as blood tests for anemia. Women in the control arm will receive additional compensation at childbirth. Women will be recruited and enrolled during first trimester (9-14 weeks gestational age), as confirmed by ultrasound. At enrollment, baseline data will be collected on socio-economic factors, maternal health, maternal diet, and fetal growth. Additional markers for maternal health and child growth and development, including markers for fetal brain development, will be collected during two targeted ante-natal clinic visits (20-26 weeks and 30-34 weeks), where all women will receive ultrasound assessment in addition to their typical clinical assessment. At childbirth, maternal and child health data will be collected, including birth outcomes, child anthropometry, and indicators of neurodevelopment. Additional follow-up of maternal and child health indicators, including maternal depression, and infant and young child feeding practices, will be collected at 1 month and 6 months of child age.

NCT ID: NCT06382857 Recruiting - Malnutrition, Child Clinical Trials

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to < 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

NCT ID: NCT06337019 Recruiting - Cancer Clinical Trials

The Italian Registry of Malnutrition in Oncology

IRMO
Start date: October 25, 2022
Phase:
Study type: Observational [Patient Registry]

The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL.

NCT ID: NCT06317402 Recruiting - Malnutrition Clinical Trials

Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods)

EPIDENUT_PSL
Start date: March 9, 2024
Phase:
Study type: Observational [Patient Registry]

According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay. Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).

NCT ID: NCT06287827 Recruiting - Child Malnutrition Clinical Trials

Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research

Start date: February 14, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela. The main question it aims to answer is: What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ <-2 or mid-upper-arm circumference (MUAC) <125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery. Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

NCT ID: NCT06250686 Recruiting - Ovarian Cancer Clinical Trials

Exercise and Nutrition Intervention in Ovarian Cancer

BENITA
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients. The main question it aims to answer is: • Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer? Participants of the IG will undergo: - Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition). - Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points: - Baseline: After surgery and before starting chemotherapy - T1: After chemotherapy (week 19) - T2: After intervention (week 26) The primary outcome is: • 6-minute walk test, 6 months after enrollment (T2)

NCT ID: NCT06250166 Recruiting - Colorectal Cancer Clinical Trials

Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are: 1. What are the current eating trends in colorectal cancer patients? 2. What are the common perceptions of adopting a plant-based diet in colorectal cancer? 3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients? 4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status? Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling. The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.

NCT ID: NCT06242301 Recruiting - Physical Inactivity Clinical Trials

Is a Collective Person-centered Dialogue Intervention for Hospitalised COPD Patients Feasible?

COPE-D
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The aim of this mixed methods trial is to investigate the feasibility of a collective person-centred dialogue (COPE-D) intervention delivered by an interdisciplinary team for a population of patients hospitalised and diagnosed with COPD and their relatives. The main questions it aims to answer are: - The clinical uncertainties: What components of the COPE-D intervention are delivered to the included patients? (The data will be collected from the patient's journal record) - The clinical uncertainties: How acceptable is the COPE-D intervention for the patients, relatives, and the interdisciplinary team? (Answered by patient and relative interviews with a structured interview guide before discharge and 14 days after hospitalisation, and by the interdisciplinary team using focus-group interviews after the intervention enrolment). - The procedural uncertainties: Are the patients willing to engage in the trial? (Estimated by the inclusion rate). The interdisciplinary team will be instructed to deliver and document the COPE-D intervention. The primary focus of COPE-D intervention is to prepare and enhance the patient's and relative's ability to regain their everyday life after discharge. The COPE-D intervention includes a dialogue tool based on a needs assessment, an action plan template, and a patient guide that prepares for discharge. The interdisciplinary team will collaborate with COPD patients and their relatives to: 1. Assess the patient's need for nutrition and physical activity support, both during and after hospitalisation using the dialogue tool. 2. Develop an action plan for nutrition and physical activity support using the action plan template. 3. The interdisciplinary team will provide, adjust, and document the nutritional and physical activity support provided by the action plan. 4. Prior to discharge, patients and their relatives are given a discharge guide with pre-defined questions to ask healthcare professionals, a contact telephone number to the outpatient clinic for follow-up if needed, and information about prescriptions for oral nutritional supplementation.

NCT ID: NCT06214897 Recruiting - Clinical trials for Moderate Acute Malnutrition

Choline to Prevent SAM in Children With MAM

CHOP-MAM
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is: Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?