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NCT ID: NCT04498117 Active, not recruiting - Ovarian Cancer Clinical Trials

Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

FLORA-5
Start date: August 25, 2020
Phase: Phase 3
Study type: Interventional

Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.

NCT ID: NCT04497636 Completed - Depression Clinical Trials

Mental Health Impact of the COVID-19 Pandemic Among Migrants in Chile

STRING-COVID
Start date: July 3, 2020
Phase:
Study type: Observational

The mental health of a representative sample of immigrants residing in Santiago, Chile (STRING cohort) was assessed nine months prior to the COVID-19 pandemic (T0). Evidence suggests that social isolation affects mental health by increasing symptoms of anxiety and depression. One of the main components of the current COVID-19 pandemic is the social isolation imposed on the population. This study seeks to explore the short (T1) and long-term (T2) effects of the pandemic on the psychological wellbeing of the cohort. Specific aims are to 1. Describe the variations in the levels of mental health problems (i.e. symptoms of depression, anxiety, post-traumatic stress, sleep difficulties) and wellbeing of immigrants during the first (T1) and second follow-up (T2) 2. Calculate the short (T1) and long-term (T2) effects of social isolation on the levels of mental health problems of the immigrant population, and 3. Identify risk / protective factors associated with a short (T1) and long-term (T2) increase in mental health problems

NCT ID: NCT04496583 Recruiting - Fluid Overload Clinical Trials

Fluid unLoading On Weaning (FLOW)

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

The purpose of this study is to determine if testing preload responsiveness, the normal physiologic state that means that changes in preload determine changes in cardiac output, allows an earlier and physiologically safer weaning from mechanical ventilation in critically ill patients with fluid overload, when compared to a strategy of fluid removal aimed at obtaining a predetermined negative fluid balance.

NCT ID: NCT04493853 Active, not recruiting - Clinical trials for Hormone-Sensitive Prostate Cancer

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

CAPItello-281
Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

NCT ID: NCT04491877 Completed - Clinical trials for Respiratory Syncytial Virus Infection

Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

VAD00001
Start date: September 17, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of the study were: - To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. - To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: - To quantify the amount of vaccine virus shed by each participant by baseline serostatus. - To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. - To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. - To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. - To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.

NCT ID: NCT04491227 Enrolling by invitation - Covid19 Clinical Trials

Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

Start date: May 5, 2020
Phase:
Study type: Observational

The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.

NCT ID: NCT04489446 Completed - Covid19 Clinical Trials

Sildenafil in COVID-19

Start date: August 19, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.

NCT ID: NCT04486404 Completed - Clinical trials for Acute Stress Disorder

Needs, Perceptions and Acute Stress of Healtcare Workers Caring for COVID-19 Patients in South America

Start date: April 1, 2020
Phase:
Study type: Observational

The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility. In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume. Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised. The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.

NCT ID: NCT04478266 Terminated - Breast Cancer Clinical Trials

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

AMEERA-5
Start date: October 14, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms.

NCT ID: NCT04475965 Completed - Clinical trials for Chronic Shoulder Pain

The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.