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NCT ID: NCT04848467 Not yet recruiting - Clinical trials for SARS-CoV-2 Infection

A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older

CV-NCOV-011
Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also referred to as Coronavirus disease 2019 (COVID-19). As of January 2021, there are only few authorized vaccines available for the prevention of COVID-19. "CVnCoV" is a new SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccine which is currently being developed for the prevention of COVID-19. The vaccine contains a molecule called mRNA which serves as an instruction manual for the cells in the body to produce a piece of protein from SARS-CoV-2 which activates the body´s defense system. The "CVnCoV" vaccine is injected into the muscle. After the injection, the body recognizes the protein as something that does not belong there. In this way the natural infection with the virus is imitated. The body activates immune cells to produce antibodies against the virus and creates specific immune cells called T cells. "CVnCoV" is given in two doses separated by 28 days. In this study, the researchers will look at how well "CVnCoV" works when the first of the two doses is given together with a flu vaccine called seasonal quadrivalent influenza vaccine (QIV). They will also look at how well the flu vaccine works under these conditions. The QIV is injected into the muscle and is given as 1 dose. To see how well the participants' immune systems is activated by "CVnCoV" and QIV, the researches will measure the levels of specific antibodies against the viruses in the blood. Antibodies are proteins that allow the immune system to find and react to bacteria and viruses in the body. The researches will look into how safe the vaccination is and which type and degree of typical vaccination reactions are seen. To give "CVnCoV" and the flu vaccine together in the future when needed, e.g. during the flu season, would reduce the burden on the health system and on the patients. Participants in this study are adults aged 60 years and older. In this study, participants are assigned to one of the two parallel groups of the same size. The assignment to either group is done by chance via a computer program. Participants in group 1 (Co-ad group) will receive CVnCoV at the same visit as QIV. Participants in group 2 (control group) will receive QIV and CVnCoV at two different visits. The Co-ad group will receive the first dose of CVnCoV and a dose of QIV in opposite arms at Day 1, the second dose of CVnCoV at Day 29, and a placebo injection, i.e. an injection that looks like a vaccination injection but does not contain vaccine, at Day 57. The control group will receive QIV and placebo in opposite arms at Day 1, the first dose of CVnCoV at day 29 and the second dose of CVnCoV at Day 57. There will be five visits and four phone calls. During the study, the study team will take blood samples on four occasions to measure the antibodies against SARS-CoV-2, and nasopharyngeal swabs at 1 occasion. The physicians will do physical examinations at each visit. The participants will be asked how they are feeling and if they have any medical problems. They will, in addition, receive an electronic Diary to report medical problems.

NCT ID: NCT04829981 Enrolling by invitation - Clinical trials for Water-Related Diseases

SAFEWATER Health & Behaviour Impact Field Trials; Colombia

SAFEWATER
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Diseases related to the consumption of contaminated drinking-water place a major burden on human health. In 2017, 785 million people still lacked access to an improved drinking water source, and these are mostly the poor and marginalised. Almost a quarter of those people rely on surface water that is untreated and over 90% live in rural areas. Many people are forced to rely on sources that are microbiologically unsafe, leading to a higher risk of contracting waterborne diseases, including typhoid, hepatitis A and E, polio and cholera. The objectives of the SAFEWATER project is to develop technologies to provide clean water to economically deprived communities in rural Colombia and Mexico. These water technologies will be tested under real conditions with the cooperation of the rural communities. The SAFEWATER field trials aims to evaluate the health and behaviour impacts of implementing SAFEWATER water treatment technologies for drinking water disinfection, with a behavioral change intervention, within rural communities in Colombia and Mexico The project has three specific objectives: 1. Assess water quality improvement at household level 2. Assess behaviors and test behavioral interventions' 3. Assess child growth and related health outcomes Three communities in Colombia and one community in Mexico were recruited to take part in the study. Communities were selected based on factors such as current availability of clean water, accessibility, safety, community size and current activities within the communities. Pilot and feasibility studies were carried out prior to commencing field trials, thus the design of the trials vary across countries. Mexico field trial: The trial in Mexico will use a stepped-wedge design, randomized at household level over a 12-month period (6-12 steps dependent on adherence and feasibility). All households (max n200) willing to be involved will be recruited (separate clinicaltrials.gov registration). Colombia field trial: the trial in Colombia will use a non-randomized parallel design (2:1; intervention:control). A maximum of 84 households (54:30; intervention:control) will be recruited to take part, with families with young children (<12 years) prioritized. Outcomes for both countries will include 1) water quality, 2) water-related behaviour (e.g. frequency of system use, uses of treated / raw water), and 3) health, e.g. diarrhoea prevalence, growth (height/weight), school attendance, water insecurity status, gut integrity. Impact: The development and deployment of the SAFEWATER technology has the potential to impact on clean drinking water access for participating communities in Mexico and Colombia, and subsequently on the health and wellbeing of those individuals involved. Additionally if successful, the work will also provide an evidence based model for the provision of improved access to clean drinking water for rural communities in developing regions more widely.

NCT ID: NCT04824092 Not yet recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

frontMIND
Start date: April 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

NCT ID: NCT04820790 Not yet recruiting - Oxygen-therapy Clinical Trials

Mobile Application for Monitoring Patients With Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial.

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

The use of mobile technology has become part of the reality capable of changing the health services' paradigm. As a proof of that, nowadays, technology is seemed as a key tool in processes such as: data collection, epidemiological surveillance, health promotion, and disease prevention. Therefore, technological tools should be taken as an advantage to optimize the control or monitoring of patients with chronic diseases including those who require the use of home oxygen therapy. Objective: Determine the efficiency of a mobile application for clinical monitoring of patients who require home oxygen therapy. Methods A randomized-controlled clinical trial including individuals whose age is 18 years or older who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) under treatment with home oxygen therapy. The sample will be divided in two groups: the intervention group will be made up of those who are followed up with the mobile app, and the control group will be made up of the patients who are followed up conventionally (regular visit of the respiratory caregiver). To measure the effect of the intervention, some outcomes variables will be taken as the recognition of self-management of dyspnea, number of exacerbations associated with oxygen therapy, and the frequency of underutilization of oxygen supplies.

NCT ID: NCT04799132 Completed - Obesity Clinical Trials

Association Between Body Mass Index and HFNC Therapy Success

Start date: March 11, 2020
Phase:
Study type: Observational

Patients over 18 years of age who are admitted to the Intermediate Care Unit of the Clinica del Country and the Clinica la Colina, with symptoms suggestive of severe pneumonia secondary to COVID-19 infection and acute hypoxemic respiratory failure. The primary outcome will be to determine the relationship between body mass index and high-flow cannula therapy success defined as: No need for mechanical ventilation.

NCT ID: NCT04795583 Not yet recruiting - Covid19 Clinical Trials

Corticosteroids for COVID-19

CORE-COVID
Start date: April 2021
Phase: Phase 3
Study type: Interventional

This trial is an interventional, randomized, placebo-controlled, adaptive clinical trial in outpatients with symptomatic microbiologically-confirmed SARS-CoV-2, in stable clinical condition, and increased levels of serum C-reactive protein. The hypothesis of this study is that early administration of prednisone for 7 days in patients with evidence of increased C-reactive protein will decrease the progression of COVID-19, prevent clinical deterioration, and hospital admission. Objectives: Primary Objective: To evaluate if early administration of corticosteroids in non-hospitalized participants with proven SARS-CoV-2 infection with compatible clinical symptoms and increased C-reactive protein can prevent hospital admission or early death

NCT ID: NCT04768413 Recruiting - Clinical trials for Rheumatoid Arthritis

Evaluation of a Non-face to Face Multidisciplinary Health Care Model in a Population With Rheumatoid Arthritis

Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

This research work proposes the evaluation of the implementation of a tele-orientation program and tele-consultation to the adult population with RA attended at a specialized rheumatology center in Bogota, Colombia, over a period of three months, by means of a observational, analytical, cohort, prospective study that will include mixed methods for collecting information (quantitative and qualitative)

NCT ID: NCT04764188 Not yet recruiting - NSCLC Clinical Trials

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

ReAlec
Start date: April 2, 2021
Phase:
Study type: Observational

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

NCT ID: NCT04740918 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

KATE3
Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

NCT ID: NCT04739917 Not yet recruiting - Malaria, Vivax Clinical Trials

Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers

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

This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the CS protein of Plasmodium vivax to determine their protective efficacy. Then volunteers will be subject to an infectious challenge (Controlled Human Malaria Infection) to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.