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NCT ID: NCT03768128 Recruiting - Clinical trials for Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee

Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

JII-Uni
Start date: August 10, 2018
Phase:
Study type: Observational

This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.

NCT ID: NCT03767244 Not yet recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Start date: February 15, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.

NCT ID: NCT03766425 Active, not recruiting - Eye Diseases Clinical Trials

Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

Start date: June 14, 2017
Phase: Early Phase 1
Study type: Interventional

Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.

NCT ID: NCT03764722 Recruiting - Clinical trials for Systolic Heart Failure

Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure. Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.

NCT ID: NCT03763812 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

Start date: December 2018
Phase: N/A
Study type: Interventional

Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage. This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration. Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery. Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.

NCT ID: NCT03761368 Completed - Clinical trials for Remote Ischemic Preconditioning

Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).

NCT ID: NCT03761355 Recruiting - Mindfulness Clinical Trials

Mindfulness and Executive Functions for Prediction of Non-technical Skills of Students in Pediatric Medical Simulations

MindExSim
Start date: October 1, 2018
Phase:
Study type: Observational

Medical simulation is a technique that creates a situation or environment to allow persons to experience a representation of a real event for the purpose of practice, learning, evaluation, testing or to gain understanding of systems or human actions Non-technical skills in pediatric simulation are the skills of communication, leadership, teamwork, situational awareness, decision-making, resource management, safe practice, adverse event minimization, and professionalism, also known as teamwork skills. Mindfulness is the self-regulation of attention with an attitude of curiosity, openness and acceptance. Executive functions include a collection of interrelated functions that are responsible for purposeful, goal-directed, problem-solving behavior. In this project, the investigators aim to check whether features of mindfulness and executive functions can be used to predict teamwork skills of medical students during repeated high-fidelity simulations in emergency pediatric care. The project will include simulation center in Bialystok, Poland. The investigators will conduct this project over a time of 2 years. Team project is made up of 5 persons, including psychologist, simulation instructors and pediatricians. Participants will be students of medical faculty in medical university. The investigators expect to include at least 340 students in the study which will result in 180 assessed as main or second leaders in repeated simulations. Team project will assess the students during high-fidelity pediatric emergency simulations. Methods of assessment of medical students during pediatric emergency simulations: features of mindfulness (Mindful Attention Awareness Scale), assessment of executive functions (The Behavior Rating Inventory of Executive Functions - Adult), non-technical skills (Ottawa Crisis Resource Management scale & checklist), technical skills (checklists) and stress. The researchers first will examine association between mindfulness or executive functions and demographic variables. And finally team project will assess the possibility of prediction of non-technical performance level during medical simulations with the use of mindfulness and executive functions assessment. In general the investigators anticipate that the results of the study will lead to the better understanding of mechanisms that influence non-technical skills in medical students during pediatric emergency cases.

NCT ID: NCT03759652 Completed - Neurosurgery Clinical Trials

Surgical and Non-surgical Infections of Neurosurgical Patient: Before-after Cohort Study

Start date: January 2003
Phase:
Study type: Observational

Continuous surveillance in 2003-2017 allowed to detect HAIs in patients staying in a 42-bed neurosurgery unit with 6 intensive neurosurgical supervision beds. 10,332 surgical patients were qualified for the study. The study was carried out in the framework of a national surveillance of HAI programme following methodology recommended by Healthcare-Associated Infections Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control. Intervention in this before-after study (2003-2017) comprised standardised surveillance of HAI with regular analysis and feedback.

NCT ID: NCT03758885 Not yet recruiting - Infertility Clinical Trials

Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

IMPLANT4
Start date: February 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.

NCT ID: NCT03757975 Recruiting - Fibroid Uterus Clinical Trials

Impact of Hysterectomy on Quality of Life and Urethral Length

Start date: July 1, 2018
Phase:
Study type: Observational

To establish the impact of hysterectomy on sexual function, urethral length and quality of life