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NCT ID: NCT04166162 Completed - Alcohol Drinking Clinical Trials

Businesses That Care - Zacatecas

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and implement a community-based prevention initiative to prevent youth alcohol use and abuse in Zacatecas, Mexico.

NCT ID: NCT04165460 Enrolling by invitation - Cervical Cancer Clinical Trials

Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

Cancer represents the second cause of death in general population worldwide and according to statistics, it is expected to increase in the next 20 years. Cervical cancer is the fourth cause of morbidity and mortality among women around the world. Late diagnosis and treatment indices several emotional reactions in patients leading to psychological disorders with an impact in quality of life. Anxiety and depression are the most frequent emotional reactions in cancer patients, which may vary depending on psychosocial factors such as coping and family support, mostly provided by the primary caregiver. Despite the high psychological morbidity in cancer patients, it is estimated that, among those patients needing psychological support, only 10% receive such interventions. A growing interest on psychological interventions in oncology has increased in the last 40 years, however, scarce investigations have been performed, especially in cervical cancer patients. The Cognitive-Behavioral Therapy has proven to be beneficial in general cancer population decreasing the psychological symptoms and improving the quality of life. Thus, the aim of this study is to evaluate the effect of two Cognitive-Behavioral psychological interventions on anxiety, depression, coping, therapeutic adherence, sexual satisfaction and quality of life of cervical cancer patients with locally-advanced and advanced disease attended at the National Cancer Institute from Mexico. Psychological intervention will be provided during ten weekly sessions including psychoeducation, relaxation, cognitive restructuring and problem solving with a pretest, posttest performed one week after intervention, and finally a follow up after three months after finishing the psychological intervention.

NCT ID: NCT04165356 Recruiting - Clinical trials for Pneumonia Associated With Mechanical Ventilation

Efficacy of Mouth-rinse With Chlorhexidine for the Prevention of Ventilator-associated Infections in Intensive Care Unit

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Background: Infections associated with mechanical ventilation are associated with high rates of morbidity and mortality, which results not only in an increase in hospitalization days and care costs, but also in an increase in DALYS (years of life disability adjustment) in the population. Critically ill patients have a high risk of infection as a result of underlying immunodeficiency, comorbidity and placement of invasive devices (such as endotracheal tubes and intravascular devices). Infections in these patients constitute a challenge for hospital authorities, as they are considered a social and economic problem that influences the quality of care, in a system where health services are increasingly affected by high patient care costs and the reduction of public spending. The decrease in the number of bacteria in the oral cavity reduces the presence of microorganisms available for translocation and colonization of the lower respiratory tract; Therefore, performing oral care intervention is considered an economically attractive method to reduce the risk of developing infections associated with endotracheal intubation. In our environment, oral cleaning is performed as part of the nursing care package granted to all patients of the ICU, however, there is no standardized method among nursing staff that guarantees the desired prevention. Objective: To evaluate the efficacy and safety of mouth-rinse with 0.12% chlorhexidine to prevent infections associated with mechanical ventilation in patients in the intensive care unit in a third level hospital in Mérida, Yucatán. Hypothesis: Mouth-rinse with 0.12% chlorhexidine twice daily more effective and safe than mouthwash with bicarbonated isotonic solution twice daily to prevent infections associated with mechanical ventilation in patients in the intensive care unit of a hospital third level. Methodology: Double-blind randomized controlled clinical trial with active substance for the evaluation of the non-inferiority of the efficacy and safety of mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.

NCT ID: NCT04165200 Completed - HIV Infections Clinical Trials

Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV

Start date: September 6, 2018
Phase: N/A
Study type: Interventional

Patients eligible for the study will be selected on Fridays during the HIV consultation at the Infectious Diseases Department. Patients that meet the inclusion and exclusion criteria, will be randomized and assigned in two groups 1:1. A group will start intervention with FMT (fecal matter transplant) through frozen capsules and after seven days, antiretroviral therapy (ART) will be started. Patients in the other group will be given placebo capsules and after seven days ART will be started. The frozen capsules of FMT will be ingested orally with a frequency of 15 capsules every 12 hours for 4 doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Subsequently, blood samples will be taken to monitor the immune status with CD4 T lymphocytes and HIV viral load during week 0, 4, 8, 12 and 24 after ART start. Throughout the study period, subjects can carry out a free diet, moderate alcohol intake, perform their daily activities and abstain from any of the elimination criteria. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.

NCT ID: NCT04164394 Completed - Lactose Intolerance Clinical Trials

Effect of I31 Probiotic on Lactose Intolerance

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.

NCT ID: NCT04161495 Completed - Clinical trials for Factor VIII Deficiency

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

XTEND-1
Start date: November 19, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

NCT ID: NCT04158258 Active, not recruiting - Breast Cancer Clinical Trials

A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

Start date: February 21, 2020
Phase:
Study type: Observational

A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.

NCT ID: NCT04155034 Recruiting - Clinical trials for Extensive Stage Lung Small Cell Carcinoma

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

Start date: May 4, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04151563 Withdrawn - Clinical trials for Carcinoma, Non-small Cell Lung Cancer

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

CheckMate 79X
Start date: April 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy