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NCT ID: NCT04359966 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia

Start date: May 10, 2020
Phase: N/A
Study type: Interventional

Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.

NCT ID: NCT04356417 Not yet recruiting - Clinical trials for AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection

Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse

TRAPSAH
Start date: April 2020
Phase:
Study type: Observational

The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold. Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19. Treatments currently being investigated include: - Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS; - Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists. We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease. Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are - Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors). - Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities. This in order to: - To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD. - To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

NCT ID: NCT04353245 Not yet recruiting - COVID19 Clinical Trials

Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System

PostCOVID19
Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.

NCT ID: NCT04350554 Not yet recruiting - HIV Infections Clinical Trials

Pregnancy in Women With HIV Infection

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

Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy. Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes. There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study. The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020. Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.

NCT ID: NCT04346875 Not yet recruiting - Infection Clinical Trials

Changing of Dressing for Periprosthetic Joint Infection in Total Knee Arthroplasty

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.

NCT ID: NCT04343144 Not yet recruiting - Clinical trials for COVID19- Infection With SARS-CoV-2 Virus

Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.

CORIMUNO-NIVO
Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments. A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units. Patients will be randomly allocated 1:1 to either nivolumab or SoC.

NCT ID: NCT04341831 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection

Start date: April 15, 2020
Phase: Phase 3
Study type: Interventional

Infection after spinal surgery is one of the serious complications. Spinal surgery infection can cause high morbidity, mortality, and costs. In spite of different prophylactic methods, up to 15% of infection appears after spinal surgery. Vancomycin powder, which is one of the most applied methods, seems to be effective and inexpensive. However, vancomycin administration may be inconvenient in elderly participants with high comorbidity and especially kidney problems. The investigators aimed to reduce the rate of infection in the post-op 90-day period by adding per-op Teicoplanin powder onto the implant in participants scheduled for lumbar posterior instrumentation.

NCT ID: NCT04326114 Not yet recruiting - Safety Issues Clinical Trials

Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19

Start date: July 26, 2020
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

NCT ID: NCT04324866 Not yet recruiting - Clinical trials for Coronavirus Infection

Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

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

This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

NCT ID: NCT04318262 Not yet recruiting - Clinical trials for Staphylococcus Lugdunensis Infection

Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients

INHOSTAL
Start date: September 2020
Phase:
Study type: Observational

Staphylococcus lugdunensis is a coagulase-negative Staphylococcus (CoNS) belonging to the normal human skin flora. It is responsible for a wide variety of infections, such as skin and soft tissue infections, bone and joint infections, but also bacteraemia and endocarditis. Although the implication of S. lugdunensis in infectious diseases is proven, many questions remain both in terms of clinical and molecular epidemiology. In this context, INHOSTAL is the first prospective, bicentric study, which will comprehensively include all patients with S. lugdunensis infection (based on microbiological and clinical data) in two French university hospitals. The main objective of this study is thus to determine the incidence of S. lugdunensis infections in hospitalized patients. Moreover, the originality of this project is to compare the characteristics of S. lugdunensis infections with those of infections caused by S. aureus and other species of CoNS. Thereby, the clinical epidemiology of these infections will be compared (i.e. types of infection, mode of acquisition, host risk factors…). Finally, complete genome of all S. lugdunensis strains will be sequenced using Illumina technology and analyzed to describe the molecular epidemiology as well as the molecular mechanisms of antibiotic resistance (compared to antibiotic susceptibility evaluated by minimum inhibitory concentrations determined by Sensititre technique). This will enable to identify if predominant clones exist, and if some strains are spreading into the hospital. The duration of the study period will be 18 months, to allow the inclusion of a total of 300 patients: 100 S. lugdunensis infections, as well as 100 S. aureus infections and 100 other species of CoNS infections.