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NCT ID: NCT04625257 Recruiting - Clinical trials for Coronavirus Infectious Disease 2019 (COVID-19)

COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

Start date: October 24, 2020
Phase:
Study type: Observational

This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.

NCT ID: NCT04624997 Recruiting - COVID-19 Clinical Trials

Coagulopathy and Vasculopathy Assessment as a Predictor of the Severity of SARS-CoV-2 / COVID-19 Infection

SARCODO
Start date: June 8, 2020
Phase:
Study type: Observational

On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance. Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

NCT ID: NCT04619823 Recruiting - Dengue Clinical Trials

Virological and Immunological Determinants of Arbovirus Infection in New Caledonia

VIRIMA
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, particularly in tropical and sub-tropical countries. In New Caledonia, dengue epidemics are recurrent and may be associated with the co-circulation of other arboviruses such as Zika or chikungunya. The virological determinants which condition the occurrence of these epidemics may be linked to an increased vectorial competence of the vector mosquito Aedes aegypti for a particular viral isolate. In fact, the Aedes aegypti mosquito is infected by making a blood meal on a person infected with an arbovirus. The virus infects its digestive tract, then spreads throughout the mosquito's body until it reaches its salivary glands. The virus is then present in the saliva and will be injected into the human host during a new blood meal. Some viral variants are best transmitted by Aedes aegypti. In general, the study of this vectorial competence is carried out by experiments in the laboratory during which an artificial blood meal composed of mammalian blood (human, rabbit, etc.) is mixed with a viral stock. Carrying out deported blood meals during which blood collected from patients infected with an arbovirus is used to gorge mosquitoes makes it possible to place oneself in experimental conditions as close as possible to the natural cycle of transmission of arboviruses. In the human host, cells of the myeloid lineage present in the peripheral blood constitute preferred targets of replication for arboviruses. At the same time, the peripheral blood cells of patients are activated in response to infection and secrete many soluble factors released into the blood of patients. The study of blood samples from patients infected with arboviruses is therefore of prime importance for understanding both the replicative mechanisms of arboviruses but also the immune response they induce.

NCT ID: NCT04615065 Recruiting - Sepsis Clinical Trials

Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine

Acutelines
Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.

NCT ID: NCT04613206 Recruiting - Influenza Clinical Trials

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

Start date: January 11, 2021
Phase: Phase 2
Study type: Interventional

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

NCT ID: NCT04608851 Recruiting - Clinical trials for Secondary Prevention

Preventing Urinary Tract Infections With E. Coli Nissle:

FinNissle
Start date: January 18, 2021
Phase: Phase 4
Study type: Interventional

Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children. The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.

NCT ID: NCT04600973 Recruiting - Infection Clinical Trials

Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection

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

Surgical site infections (SSIs) are associated with increased patient morbidity, mortality, and healthcare costs. ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) pathogens are particularly pathogenic because they have increased capacity to acquire resistance and virulence traits. The investigators have proven that a multifaceted program involving improved basic perioperative preventive measures can generate substantial reductions in S. aureus transmission and significant reductions in SSIs (88% reduction as compared to usual care). In this study, the investigators aim to examine the relative effectiveness of each component of this program in controlling ESKAPE transmission and reducing SSIs and to identify an optimal implementation strategy for national dissemination. Randomization occurs at the site level, and sites adopt preventative programs. This work will improve perioperative patient safety for the 51 million patients who undergo surgery each year.

NCT ID: NCT04597008 Recruiting - Clinical trials for Post Operative Surgical Site Infection

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

Start date: May 11, 2021
Phase: Phase 3
Study type: Interventional

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

NCT ID: NCT04587050 Recruiting - HIV Infections Clinical Trials

Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV

SHiP
Start date: July 19, 2021
Phase:
Study type: Observational

This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

NCT ID: NCT04585165 Recruiting - HIV Infections Clinical Trials

User-friendly HIV Testing and Counseling Services

Start date: October 19, 2020
Phase:
Study type: Observational

Multicenter cohort study of individuals reporting behavioral risks of HIV acquisition, recruited among those presenting for testing for HIV and other sexually transmitted infections. Overarching goal: to study factors associated with uptake of HIV prevention and (re)testing services in medium-sized cities in Thailand. Primary objective: To estimate the incidence of HIV and other sexually transmitted infections (syphilis, chronic hepatitis B and C) among individuals presenting for retesting. Secondary objectives: - To evaluate the uptake of pre-exposure prophylaxis - To assess retention in the study - To evaluate client HIV knowledge - To describe HIV prevalence and characteristics of individuals newly diagnosed with HIV - To describe characteristics of individuals at risk of HIV infection - To assess the quality of the testing and referral services.