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NCT ID: NCT04756908 Recruiting - Cataract Clinical Trials

Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

Start date: October 8, 2020
Phase: N/A
Study type: Interventional

This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

NCT ID: NCT04609904 Recruiting - Asthma Clinical Trials

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

LOGOS
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

NCT ID: NCT04352634 Recruiting - Depression Clinical Trials

The Covid-19 HEalth caRe wOrkErS (HEROES) Study

HEROES
Start date: April 26, 2020
Phase:
Study type: Observational

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

NCT ID: NCT04181970 Recruiting - Clinical trials for Gastrointestinal Stromal Tumors

Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK

(SELNET)
Start date: June 30, 2019
Phase:
Study type: Observational [Patient Registry]

Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc. Expert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis. Tumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.

NCT ID: NCT04163159 Recruiting - Clinical trials for Metastatic Breast Cancer

Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica

Start date: January 7, 2019
Phase:
Study type: Observational

The use of circulating tumor DNA (ctDNA) as a noninvasive test for breast cancer monitoring throughout the course of the disease

NCT ID: NCT03969212 Recruiting - Influenza Clinical Trials

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Start date: October 10, 2019
Phase: Phase 3
Study type: Interventional

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

NCT ID: NCT03711032 Recruiting - Clinical trials for High-risk Non-muscle Invasive Bladder Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Start date: December 24, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

NCT ID: NCT03549754 Recruiting - Hypertension Clinical Trials

iCaReMe Global Registry

iCaReMe
Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

NCT ID: NCT03178552 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

B-FAST
Start date: September 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

NCT ID: NCT03144648 Recruiting - Clinical trials for Breast Cancer Female

PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women

PRECAMA
Start date: October 12, 2012
Phase:
Study type: Observational

Breast cancer has become a major public health problem in Latin America, as it is the most common form of cancer among women. Women are more likely to develop breast cancer at younger age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty years, the mortality from breast cancer in Latin America has also been increasing very rapidly, and is currently the leading cause of cancer mortality. Little is known on specific risk factors for premenopausal breast cancer in general, and in Latin America in particular. There is a lack of specific knowledge on tumor molecular and pathological characteristics of breast cancer in Latin America premenopausal women, and this has major consequences on cancer treatment and survival. To improve our understanding on determinants of breast cancer incidence and mortality in young Latin America women and support preventive actions, we implemented an international, population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter population-based case-control study). PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major aims of the project are the following: 1. To develop a multi-centric population-based case-control study on breast cancer in premenopausal women in several countries in Latin America with structured collection of individual, clinical, pathological information and biological specimens, according to strictly controlled protocols 2. To characterize, in these populations, the subtypes of premenopausal breast cancer on the basis of their molecular and pathological phenotypes 3. To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes. 4. Provide advanced training, induce a structuring effect on the breast cancer research community in Latin America and influence the public health agenda regarding the management of breast cancer. The results of our study will be of utmost importance to understand the etiology of breast cancer in Latin America countries, and would provide important information on the role of modifiable exposures for breast cancer prevention.