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NCT ID: NCT05036967 Not yet recruiting - Heart Failure Clinical Trials

A Study to Observe Treatment Patterns in Patients in Colombia Who Have Heart Failure

Start date: August 30, 2021
Study type: Observational

Researchers want to learn more about the treatments doctors choose to treat heart failure. Heart failure means the heart isn't pumping as well as it should be. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death. There are different types of treatments available for people who have heart failure, and these work in different ways. In this study, the researchers will collect information about Colombian patients who have heart failure. The main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in Columbia. To do this, the researchers will review information from the patients' medical records and from a drug-dispensing database. The study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020. There will be no required visits, treatments, or procedures in this study. The researchers will collect information about the treatments the patients have been prescribed by their own doctors.

NCT ID: NCT05013359 Enrolling by invitation - Obesity Clinical Trials

Awareness, Care & Treatment In Obesity Management - An International Observation Among Teens (ACTION Teens)

Start date: August 21, 2021
Study type: Observational

ACTION Teens is a multinational cross-sectional survey-based study. The study consists of a quantitative online survey to be conducted among three groups of respondents in ten countries worldwide. The respondent population will include Adolescents Living with Obesity (ALwO), Caregivers of ALwO, and HCPs treating adolescents who have obesity. The goal of this study is to provide insights to drive awareness around the needs of adolescents living with obesity and their caregivers, as well as to identify key areas of misalignment between adolescents, their caregivers and the HCPs involved in obesity treatment and management. ACTION Teens is designed to generate evidence to identify and address these challenges on both a global and local level, extending the insights from the previously conducted ACTION-IO study.

NCT ID: NCT05011838 Not yet recruiting - Hypertension Clinical Trials

Evaluation of the Effectiveness of an Intervention to Reduce Gaps in Hypertension Care in Low-income Medellin, Colombia

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income Communes of Medellin, Colombia, and assess the process and fidelity of the intervention's implementation.

NCT ID: NCT05011513 Recruiting - COVID-19 Clinical Trials

A Study of PF-07321332/Ritonavir in Non-hospitalized Low-Risk Adult Participants With COVID-19

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

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

NCT ID: NCT05008029 Recruiting - Clinical trials for Radius Fracture Distal

Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary. The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.

NCT ID: NCT05007444 Not yet recruiting - Breast Cancer Clinical Trials

Safety and Efficacy Evaluation of the P2Et Extract in Patients With Breast Cancer

Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

Currently, the study of many extracts in different types of cancer has allowed the validation of scientific knowledge either as a therapy that reduces the size of the tumor or that helps to improve the quality of life of the patient by reducing the associated effects of the treatment. In the Immunobiology and Cell Biology group of the Pontificia Universidad Javeriana, a standardized extract of Caesalpinia spinosa (Dividivi) called P2Et has been obtained. This extract has been shown to have cytotoxic activity in different human and murine tumor cell lines, favoring the induction of immunogenic cell death with the release of danger signals such as calreticulin, HMGB1 and ATP. Additionally, treating mice with murine melanoma and sinus tumors significantly reduces tumor size and metastases. On the other hand, induction of complete autophagic flux and synergistic effects with anthracycline-type chemotherapeutics have been shown in human cell lines and in animal models of breast cancer. With this background, and the results of the Phase I clinical study carried out in healthy volunteers that showed that the extract is safe, the investigators propose that treatment with the P2Et extract in patients with breast cancer could improve their general condition, impacting their quality of life. , and induce antitumor immune response, improving the immune infiltrate and acting as a transforming agent from a cold tumor to a warm tumor. This would lead to an improvement in the long-term survival of patients treated with the phytomedicine in conjunction with the chemotherapeutic treatment selected by the treating oncologist. In order to advance on this path, and responding to the adjustments suggested in the phase I study in healthy individuals, it is proposed to carry out a clinical study that allows determining the optimal biological dose of the P2Et extract in a design based on randomized simulations of adaptive form and considering the safety of the extract as an objective in patients with breast cancer. Additionally, those parameters that allow defining the best indicators of effectiveness of P2Et in this group of patients will be evaluated, such as modulation of the immune response, quality of life, reduction of adverse effects and progression-free survival.

NCT ID: NCT05007080 Not yet recruiting - Healthy Clinical Trials

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

Start date: September 23, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S or placebo administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents (Part 1 and Part 2); and to demonstrate non-inferiority (NI) of immune responses induced by 1 dose or 2 doses or of a lower, to be determined, dose level of Ad26.COV2.S in adolescents versus 1 or 2 doses of Ad26.COV2.S in young adults (Part 2).

NCT ID: NCT05005988 Not yet recruiting - Patient Empowerment Clinical Trials

Actions for Empowered Maternal Neonatal Care (ACUNE): A Nursing Intervention

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The quality of care premature infants receive at home after hospital discharge is critical to their health and well-being. Premature infants require special care, which is why Neonatal Intensive Care Units (NICUs) have processes in place to prepare mothers for discharge. However, this experience is very complex for mothers, who often experience high levels of stress, anxiety, sadness and uncertainty. Mothers need knowledge and skills about caring for a premature infant, but they also need to gain confidence, believe in their abilities, and become empowered to participate more actively and confidently in decisions that have to do with their child's health. Several approaches exist to prepare mothers for home-based infant care; in the present study, an intervention focused on empowerment is proposed as a way to strengthen mothers' competence to care for their preterm infants and improve infant health outcomes. The intervention is expected to have adequate acceptability and feasibility, as well as preliminary evidence that it improves mothers' competence to care for their infants and decreases readmissions, emergency department visits, improves weight gain and health outcomes of preterm infants.

NCT ID: NCT04987424 Active, not recruiting - Clinical trials for Unilateral Breast Cancer

Prevalence of Lymphedema in Valle Del Cauca, Colombia.

Start date: January 18, 2018
Study type: Observational

This is an epidemiological cross-sectional study aiming to determine the prevalence of lymphedema and the incidence of risk factors in patients diagnosed with unilateral breast cancer in a cohort from 2008 to 2020 in a specialised oncology centre in Valle del Cauca, Colombia.

NCT ID: NCT04962880 Recruiting - Clinical trials for Castration-resistant Prostate Cancer

HRR Prevalence in LatAm PROSPECT Study

Start date: April 21, 2021
Study type: Observational

Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America (LatAm) between February 2021 and January 2022.