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NCT ID: NCT05589909 Recruiting - Clinical trials for Neonatal Sepsis, Early-Onset

Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis

Start date: June 20, 2022
Phase:
Study type: Observational

Neonatal sepsis still considered as one of the major causes of mortality and morbidity during the neonatal period due to high vulnerability of that age group. The blood culture is considered as the gold standard for diagnosis of bacterial sepsis, however in early onset neonatal sepsis (EONS) the inability to isolate a microbial pathogen does not exclude sepsis. The reason behind the high number of culture-negative cases is not clear and might be attributed to low levels of bacteremia or small volumes of blood obtained from sick infants. Also maternal antibiotic treatment before or during delivery may theoretically mask detection of bacteremia in the newborn. In addition these cultures have a 48-72 hours delay to obtain results. Therefore, the combination of clinical assessment and laboratory biomarkers currently are the bases for diagnosis of neonatal sepsis. Recently interleukin-27 (IL-27) has been looked at as another candidate biomarker in the serum for diagnosis of sepsis in both adult and children. Interleukin-27 (IL-27), a novel member of the IL-12 family, was first discovered in 2002. IL- 27 is primarily synthesized by antigen-presenting cells, and it is widely expressed in a myriad of cells, including placental trophoblast cells. Although multiple studies have reported IL-27 as an essential regulator of immune response and inflammation, its precise role in the immune response is still disputable. Conventionally, IL-27 has been envisaged as a potent promoter of inflammation. When first discovered, it was characterized as a promoting factor in the rapid initiation of inflammatory responses, processing the ability to stimulate the rapid expansion of naïve CD4+T and then the production of IFN-?, which has been demonstrated by various subsequent studies. The aim of this study was to evaluate the usage of elevated IL-27 in cord blood as an early predictor biomarker for EONS.

NCT ID: NCT05582382 Recruiting - COVID-19 Clinical Trials

Validation of Prognostic Clinical Risk Scores in Predicting Outcome for Patients With COVID-19 at Initial Triage

Start date: January 1, 2023
Phase:
Study type: Observational

Background Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) causing Covid-19 pandemic continues to be a global health threat with a massive burden on health care systems resulting in more than six million deaths in 188 countries. Because of wide clinical spectrum of disease severity, having clinically applicable prognostic tools for early identification of patients at high risk of progression to severe / critical illness is essential to guide clinical decision making and resource allocation efforts. So far, clinical prognostic tools have focused on host factors, but more recent data indicated a significant association between SARS-CoV-2 variants and the development of complications such as long COVID. Objectives 1. Validation of the ALA & ALKA prediction tools for initial evaluation of patients diagnosed with COVID-19 infection. 2. Comparison of performance of the ALA & ALKA prediction tools with the currently clinical risk assessment scoring system used during initial evaluation of patients diagnosed with COVID-19 infection. 3. Evaluation of the clinical risk assessment scoring based on number of comorbidities in prediction of COVID-19 related complications 4. Assessment of the association between SARS-CoV-2 variants and the risk of COVID-19 severity 5. Assessment of the impact of SARS-CoV-2 variants on the performance of ALA & ALKA prediction tools Methods Data will be abstracted from electronic medical records including demographics, clinical manifestation, comorbidities, and initial laboratory data in patients with Covid 19 infection of around 2000 patients presented initially to COVID assessment centre, including SARS CoV-2 sequencing data. Furthermore, population level SARS-CoV-2 RNA sequence data will also be examined and correlated with COVID-19 severity and the performance of prediction tools.

NCT ID: NCT05565378 Recruiting - Clinical trials for Lung Cancer, Non-Small Cell

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Start date: October 14, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

NCT ID: NCT05532787 Recruiting - Clinical trials for Acute Coronary Syndrome

Comparison of Accelerated Diagnostic Pathways for Acute Chest Pain in Emergency Departments in the United Arab Emirates

Start date: February 3, 2022
Phase:
Study type: Observational

This is a prospective four-site cohort study, which will accrue adults with symptoms concerning for acute coronary syndrome over a period of 12 months. After application of inclusion and exclusion criteria, Physicians will complete HEART Pathway and EDACS risk assessments on eligible participants. Major adverse cardiac events as defined by our study will be assessed at 30 days using electronic health record, telephone contact, and national death and health events search. Outcomes for all patients will then be matched against the existing pathway of care for acute chest pain that is being used currently to compare diagnostic accuracy of both scores to diagnose low risk chest pain in this population. The objective of this study is to compare the test performance of the HEART and EDACS pathway in a large cohort of patients presenting to the Emergency department with chest pain in the United Arab Emirates and to determine if either accelerated diagnostic pathway can achieve a negative predictive value of ≥99% for 30-day MACE as well as to externally validate EDACS-ADP and the HEART pathway in the UAE population and gain further insight into the applicability of these decision-making aids in different clinical settings in order to assess which score is best suitable for the UAE population. Our third objective is to compare the effectiveness of both scores to the existing framework for chest pain work up in each hospital and have the opportunity to unify Emergency Departments in their chest pain pathways in the UAE. The investigators will be testing the null hypothesis that there is no difference in using the EDACS-ADP to safely classify patients to low-risk category and early discharge from the ED versus the HEART pathway.

NCT ID: NCT05517798 Recruiting - Clinical trials for Alveolar Ridge Preservation

Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction

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

The Global Burden of Disease Study of 2016 considered oral disease as the most common noncommunicable disease that affected half of the world population throughout their lifetime. Dental caries and periodontal diseases may cause pain and discomfort with severe forms of periodontal diseases causing tooth loss. Periodontal disease and tooth loss were estimated to be one of the ten causes of Years Lived with Disability. The dimensional changes in the alveolar ridge following tooth loss have been extensively investigated in the literature. At six months after tooth loss, a systematic review on bone remodelling showed horizontal and vertical bone loss of 29-63% and 11-22%, respectively. Such bone loss may complicate replacement of missing teeth with dental implants. Dental implant is now a common treatment modality. However, the loss of bone volume may not allow the placement of dental implant in an optimal position and may subsequently jeopardize functional and aesthetic implant outcomes. Therefore, the use of bone replacement graft following tooth extraction, as part of a procedure termed alveolar ridge preservation (ARP), has increasingly becoming a common treatment protocol to optimize dental implant placement in the future. A Cochrane review on ARP has demonstrated that there are no significant differences between the plethora of synthetic or biologically driven grafting materials used to minimize changes in width and height of the extraction sockets. Nevertheless, a regenerative agent, known as enamel matrix derivative (EMD), has gained more attention in regenerative therapy over the last 20 years. Several studies demonstrated its ability to enhance wound healing, induce new attachment and promote bone formation in recession and intrabony defects. Over the last two decades, EMD has been successfully used in the periodontal regeneration of intrabony defects. EMD has the potential to cause early vascularization and support early bone formation, hence, it can be considered as a potential regenerative agent for ARP when used with appropriate carrier material. Moreover, the majority of studies showed that bone substitutes generally performed well in small or contained defects compared with non-grafted sites, but there is lack of information regarding the efficacy of different bone substitute materials in large defects. Short-term follow-up studies of three to six months have also dominated the literature when the main aim of the ARP is to develop a site that optimise long-term implant outcomes. Such aim requires evaluating the long-term performance of dental implants placed in preserved ridges and reporting patient outcomes in well-conducted randomized controlled trial. The aim of the present clinical trial is to evaluate the adjunctive use of EMD in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes.

NCT ID: NCT05494606 Recruiting - Ulcerative Colitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

PROFUNDUS
Start date: August 15, 2022
Phase:
Study type: Observational

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05483335 Recruiting - Clinical trials for Burnout, Professional

Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates

Start date: September 28, 2022
Phase:
Study type: Observational

Burnout Syndrome is a medical condition caused by long-term job-related strain and is defined by presence of either one or more of the three states i.e. emotional exhaustion, depersonalization and lack of personal accomplishment. Burnout has been shown to cause decreased work output and mental well being of employees and increase errors at workplace. Burnout is observed in various lines of work and but has been found to be especially high among academic students undertaking professional studies as well as healthcare professionals. Medical students in their clerkship years undergo high stake exams, while adapting from classroom and simulation learning to participate in clinical care of patients in hospital care setting with no prior experience, which much them vulnerable to developing burnout during medical school. Burnout can effect medical students' well-being, which may continue into their internship and residency so greater emphasis in required on creating an awareness of burnout and identifying any factors associated to its development.

NCT ID: NCT05476926 Recruiting - Clinical trials for Diabetic Macular Edema

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

VOYAGER
Start date: November 21, 2022
Phase:
Study type: Observational

The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products (Faricimab and Port Delivery System with Ranibizumab) in approved retinal indications (neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.

NCT ID: NCT05473273 Recruiting - Infertility, Female Clinical Trials

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.

Start date: April 24, 2023
Phase:
Study type: Observational

To describe the peripheral serum levels of the anti-inflammatory cytokines IL-4 (Interleukin-4), IL-10 (Interleukin-10), TGF-ß1 (Transforming Growth Factor beta1), the pro-inflammatory cytokines IL-17 (Interleukin-17), IFγ (Interferon Gamma) and the immune mediator PIBF (Progesterone-Induced Blocking Factor) along a single frozen euploid blastocyst transfer in a natural cycle (NC) or Hormone Replacement Therapy (HRT).

NCT ID: NCT05456191 Recruiting - Clinical trials for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

ASC4START
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).