Taipei County,, Taiwan
Perpetual Observational Study - Ventilator Associated Pneumonia
Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV). Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs). RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP. These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population. Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.
Phase
N/ASpan
187 weeksSponsor
European Clinical Research Alliance for Infectious Diseases (ECRAID)Tirana
Recruiting
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Phase
1/2Span
180 weeksSponsor
ShionogiTirana
Recruiting
Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)
This is a cross-sectional study that will involve the recruitment of patients diagnosed with PCOS. The study will be conducted at a tertiary care center Koco Gliozheni Maternity, Faculty of Medicine of Tirana, Department of Obstetrics and Gynecology with expertise in gynecology and endocrinology and will then be examined with the aid of the department of Biology and Physiology of the University of Perugia. The study protocol will be approved by the institutional ethics committee, and written informed consent will be obtained from all participants.
Phase
N/ASpan
75 weeksSponsor
Albanian UniversityTirana
Recruiting
SA Versus SOI Surfaces for Single Implant-supported Crown
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
Phase
N/ASpan
108 weeksSponsor
Osstem AICTirana
Recruiting
Healthy Volunteers
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods: Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Phase
3Span
567 weeksSponsor
Immunic AGTirana
Recruiting
COVID-19 Vaccine Effectiveness in Albanian Health Workers
This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease. The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers. SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.
Phase
N/ASpan
65 weeksSponsor
Institute of Public Health, AlbaniaTirana
Recruiting
Healthy Volunteers
Predictors of Disease Severity in COVID-19 Patients
Background: Severe acute respiratory syndrome 2 (SARS-CoV-2) is etiological agent of heterogeneous corona-virus disease 19 (COVID-19), which clinical condition range from asymptomatic or mild to critically severe with high odds for fatal outcome. Since the pathophysiological pathways of COVID-19 disease development are not fully elucidated, resulting in repeated changes in treatment plans, there is an unmet need for more research into genetic, biochemical, immunological, and clinical predictive indicators of better outcomes in COVID-19 patients. Aim: The VIRIONUM project's main aim is to investigate the relation between genetic polymorphisms, inflammatory and other biochemical markers, and disease severity and mortality in COVID-19-infected hospitalized patients. Method and patients: The observational nested case-control clinical study will be conducted in at least 1019 COVID-19 patients. The genetic polymorphisms (ACE2, IFNL3/4 and TMPRSS2), serum concentration of soluble ACE2 and the pro- and anti-inflammatory cytokines, blood concentration of common inflammatory and other biomarkers, peripheral blood mononuclear leukocyte (PBMC) phenotype, demographic and clinical risk factors will be monitored as independent variables, while the dependent variables will be the outcome of the disease and the severity of the clinical condition. Genotyping will be performed by Real-Time PCR method, and serum concentrations of ACE2 and pro- and anti-inflammatory cytokines by ELISA method, and PBMC phenotype by flow cytometry. The disease severity will be assessed according to WHO criteria. Expected results: The findings of this clinical study will contribute to understanding of significant genetic, biochemical, and clinical determinants of severity and lethal outcomes in COVID-19 patients, as well as, creation of set of recommendations for individuals at higher risk - future, evidence-based, targeted and individualized approach.
Phase
N/ASpan
165 weeksSponsor
Zeljko MijailovicTirana
Recruiting
Metabolic FingerPrinting
Phase
N/ASpan
266 weeksSponsor
Arcensus GmbHTirana
Recruiting
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
Phase
N/ASpan
27 weeksSponsor
Żelazna Medical Centre, LLCTirana
Recruiting
Healthy Volunteers