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NCT ID: NCT04851561 Recruiting - Covid19 Clinical Trials

Post-coronavirus Disease-2019 Fatigue

Start date: March 2, 2021
Phase:
Study type: Observational

Background: COVID-19 is consistently spreading throughout the world, and the number of recovered patients is steadily increasing. Accordingly, a significant number of individuals will develop persisting post-COVID symptoms, while many of them will report on lasting fatigue. The main objective of the current study is to assess risk factors for the development of post-COVID-19 fatigue symptoms. As a secondary aim, the current study is intended to identify pathophysiology and explanatory mechanisms for the post-COVID-19 fatigue. Study design and population: a nested case-control study will be conducted at Rabin Medical Center (RMC), Beilinson Hospital. RMC runs a post-COVID-19 clinic for adult (age ≥18 years) recovered individuals (diagnosed using a polymerase chain reaction test from a nasopharyngeal sample), who are invited for a comprehensive medical evaluation. During a visit, all individuals undergo pulmonary function testing and an evaluation by an infectious diseases physician, a pulmonologist, and a social worker. The cohort of recovered COVID-19 individuals evaluated at RMC will serve as the population from which the current study participants will be consecutively sampled. The cases would be defined as such if report on lasting fatigue symptoms which appeared following COVID-19, while at least two months have elapsed since COVID-19 diagnosis and the lasting fatigue symptoms are present for at least six weeks. The controls would be defined as those that did not report on fatigue symptoms at any time point since one month following their diagnosis with COVID-19. Evaluation protocol of cases and controls: All participating individuals (cases and controls) will be assessed following the study protocol. The assessment will be conducted as follows: First assessment meeting (approximately one hour long) in which the participant will undergo physical examination and blood tests, fill the study questionnaires [demographic, clinical and post-COVID fatigue questionnaire; sleep assessment questionnaires (Epworth sleepiness score [ESS], Pittsburg sleep quality index [PSQI], Insomnia severity index (ISI)]) and depression severity questionnaire (the patient health questionnaire-9 [PHQ-9]), and conduct cognitive fatigue task. Second assessment meeting: (approximately one hour long) in which the participants will undergo a cardiopulmonary stress test (CPET). Data collection: The main dependent variable will be the presence of continuing fatigue symptoms. The independent variables included demographic and clinical characteristics. The demographic variables will include: age at diagnosis, sex, marital status and number of children, occupational status (employed, unemployed, or retired), education (number of years at school and higher education), and occupation. The clinical variables will include: smoking status, alcohol and cannabis consumption, basic physical function (independent, limited in certain activities, dependent in activities of daily living, or bedridden), background illnesses, and pharmacotherapy. The acute COVID-19 history will be also collected: disease severity according to the WHO criteria, symptoms (sore throat, nasal congestion, headache anosmia/disguesia, cough, shortness of breath, chest pain, gastrointestinal symptoms, and myalgia), need for hospitalization, hospital complications (veno-thromboembolism, super-imposed bacterial infections), for individuals who were not hospitalized - the site of isolation (home, hotel or another isolation facility) will be collected, time from onset to symptoms resolution, pharmacotherapy directed at COVID-19, and information of other household or family members who were also diagnosed. Statistical methods: Demographic and clinical variables of the patients with fatigue symptoms (cases) and control group (free from fatigue symptoms) will be compared using bivariate and multivariable conditional logistic regression models. Independent variables will be selected to be included in the multivariable model based on the bivariate analysis. Odds ratios and 95% confidence intervals will be obtained from the conditional logistic regression models. P<0.05 will be considered statistically significant. Sample size calculation: Disease severity may serve as a potential risk factor for the development of lasting fatigue symptoms. A preliminary analysis revealed that in our cohort of recovered COVID-19 patients, 20% were hospitalized due to their disease's severity. We will therefore assume that the proportions of individuals required hospitalization during the acute phase were 30% and 10% of the cases and controls, respectively. It is also likely that approximately two thirds of our sample would report on persisting fatigue. Under these assumptions, a sample size of 153 individuals (102 in the cases group and 51 in the control group) will yield a statistical power of 80% at a significance level of 5% for detecting a difference of 0.2 between two proportions.

NCT ID: NCT04850118 Not yet recruiting - Clinical trials for X-Linked Retinitis Pigmentosa

A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations

Start date: August 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501) to an untreated control group in male patients with X-linked retinitis pigmentosa caused by RPGR mutations.

NCT ID: NCT04847622 Recruiting - Covid19 Clinical Trials

Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

909REM
Start date: February 1, 2021
Phase:
Study type: Observational

This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.

NCT ID: NCT04847557 Not yet recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

SUMMIT
Start date: April 20, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

NCT ID: NCT04843748 Completed - Cataract Clinical Trials

Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL

Start date: August 18, 2018
Phase: N/A
Study type: Interventional

Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.

NCT ID: NCT04842708 Recruiting - Covid19 Clinical Trials

Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis

COVID-19
Start date: December 24, 2020
Phase: N/A
Study type: Interventional

The objective of this study will be to evaluate the effect of vaccination on breath VOC content. By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.

NCT ID: NCT04841941 Completed - Presbyopia Clinical Trials

A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use

Start date: July 17, 2018
Phase: N/A
Study type: Interventional

The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.

NCT ID: NCT04838730 Recruiting - Cataract Clinical Trials

Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery.

NCT ID: NCT04837560 Recruiting - Edema Leg Clinical Trials

Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema

Start date: April 2021
Phase: Phase 1
Study type: Interventional

Device Efficacy: The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device. Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time. The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation. The edema volume will be measured by a calf circumference measurement.

NCT ID: NCT04836910 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Microbiome and Polycystic Ovaries

Start date: March 30, 2021
Phase:
Study type: Observational

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.