Clinical Trials Logo

Filter by:
NCT ID: NCT05202106 Recruiting - Child Development Clinical Trials

Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled Trial

DigitalECD
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

About 250 million children under age five are at risk of not reaching their developmental potential due to continued exposure to ill health, malnutrition and lack of appropriate learning environments. A large number of initiatives have been launched in recent years to support early childhood development, with home visiting programs increasingly being recognized as a key strategy for improving child wellbeing. However, the most effective ways to reach families in low income settings remain unclear due to the large expense associated with personal family visits. In this project, we assess the effectiveness and equity of a newly developed digital platform designed to deliver evidence-based, individualized parenting support through automated services. The Afinidata platform uses state-of-the art machine learning algorithms to allow caregivers to get answers to questions about child health and development, while also identifying and promoting age- and development-appropriate activities for parents to support their children. We will collaborate with partners in Peru to rigorously assess the reach, impact and cost effectiveness of this digital platform in a poor rural population through a randomized controlled trial. Our work will follow a mixed-methods evaluation approach with repeated feedback into the Afinidata system. A total of 2400 newborns will be enrolled in a randomized controlled trial in San Marcos, Peru, and followed up for two years. The primary study outcome will be children's healthy development at 24 months of age assessed through the Bayley Scales of Infant and Toddler Development (BSID-III). Secondary outcomes will be systems utilization, program coverage and cost-effectiveness, as well as caregiver satisfaction. If proven effective, this innovative digital platform may increase global access to low-cost parental support -a widely recognized key strategy for improving child well-being.

NCT ID: NCT05185921 Not yet recruiting - Depression Clinical Trials

CBT and Quality of Life of People With HIV, COVID-19 and Anxiety or Depression

COVIHMENT-19
Start date: January 2022
Phase: N/A
Study type: Interventional

Experimental open-label randomized clinical trial to determine the effect of virtual Cognitive Behavioral Therapy (CBT) on the quality of life of patients with HIV, COVID-19 and anxiety or depression. It will be carried out at the hospital for 6 months, where people over 18 years of age with HIV from the infectious disease service will participate. In the study, patients will be randomized 1:1 in an intervention group, who will receive eight sessions of virtual CBT by 02 psychotherapists, and a control group. Additionally, patients will be consulted about the participation of at least one adult family member or caregiver in the study, if the patient and the family member agree, the family member or caregiver will enter the study. The informed consent process will be conducted by telephone, during the call the recruiting staff will read the consent document and the participant (patient and family member or caregiver) will give their consent by answering affirmatively to the questions asked at the end of the document. The main objective will be evaluated by comparing the quality of life measurement at three months with the baseline measurement, as well as the variation of anxiety and depression scores.

NCT ID: NCT05171647 Not yet recruiting - Clinical trials for Non-Hodgkin Lymphoma

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

SUNMO
Start date: March 31, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

NCT ID: NCT05168631 Recruiting - Clinical trials for Neuroendocrine Tumors

Multicenter Retrospective Database on Prognostic and Predictive Factors in Patients With Neuroendocrine Tumors

LACOG/GTG 0119
Start date: May 16, 2020
Phase:
Study type: Observational

Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.

NCT ID: NCT05158387 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of MEDI3506 in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.

TITANIA
Start date: February 7, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of MEDI3506 Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or contraindicated) in stable doses throughout at least 3 months prior to enrolment.

NCT ID: NCT05154500 Recruiting - Potato Clinical Trials

Iron and Zinc Bioavailability From Biofortified Potatoes

Start date: August 29, 2018
Phase: N/A
Study type: Interventional

Two of the most common nutritional deficiencies are anemia and zinc deficiency. One strategy for combating nutritional deficiencies is biofortification. The primary objective of the proposed research is to determine in humans the bioavailability of iron and zinc from biofortified potatoes as compared to a non-fortified local variety. The secondary objective is to use the data obtained from the human studies to model the potential impact of the introduction of biofortified potatoes to the alleviation of iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere. Iron bioavailability studies: The investigators will compare bioavailability of iron from a non-fortified potato variety with a biofortified potato that has significantly higher iron content though the use of a randomized cross-over intervention study. Female volunteers will consume both biofortified potato extrinsically labelled with 58FeSO4 and a nonfortified potato labelled with 57FeSO4. Thirty women with marginal iron status (plasma ferritin < 25 ng/ml) will be selected from an initial screening of 180 women. Every woman will receive 2 different types of test meals in a series of 20 servings for 10 days each. Blood samples will be collected during screening and on days 1, 15, 26 and 40 and the amount of 58Fe and 57Fe incorporated into hemoglobin and serum ferritin quantified. Zinc bioavailability study: The investigators will compare bioavailability of zinc from a non-fortified potato variety with that of a biofortified potato that has significantly higher zinc content (p<0.001) with a crossover study. Forty volunteers will be randomly assigned to receive first either the biofortified or the non-fortified potato and receive the second meal 30 days later. Zinc absorption from two meals will be measured using the double stable isotope technique. Every volunteer will be given an i.v. infusion of 70zinc and two test meals of 250 g cooked potato labelled extrinsically with 67zinc separated by 3-4 hr. A spot urine sample will be collected 96 hours after each set of test meal and the ratio of the two isotopes measured to calculate absorption of zinc from the test meal. Modelling and Impact assessment: Data on bioavailability will be used in a Disability Adjusted Life Year model to assess the potential impact of biofortified potatoes to alleviate iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere.

NCT ID: NCT05138133 Not yet recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: January 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05117788 Not yet recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer Accupower Q-RFIA PCR Kit Clinical Evaluation

Start date: January 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.

NCT ID: NCT05113251 Recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

NCT ID: NCT05103709 Recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age

Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.