Clinical Trials Logo

Filter by:
NCT ID: NCT04719624 Terminated - Clinical trials for Alveolar Ridge Preservation

Novel Porous Bioceramic Material as a Bone Substitute

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

The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction. The primary hypothesis of the study is that Adaptos®-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss®).

NCT ID: NCT04718389 Recruiting - Asthma Clinical Trials

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

NIMBLE
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

NCT ID: NCT04717232 Enrolling by invitation - Competence Clinical Trials

Effectiveness of Interprofessional Mentoring Competence Education for Dental Health Care Professionals

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

Clinical practice is an integral part of dental and dental hygiene students' education. The curriculum for a degree is guided by best academic practices for European undergraduate dental education, published by the Association for Dental Education in Europé (ADEE), and the dental hygienist education is based on a European qualifications framework. Interprofessional education has been recognized as a means to improve oral health professional training due to the linked form of education with improved health outcomes. The interprofessional mentoring education is needed for the clinical practice, which has to be implemented in interprofessional teams. Clinical practice mentors need to have completed an interprofessional mentoring education. Different types of educational approaches have been previously affecting mentors' competence development in mentoring. Dental and dental hygiene students can experience team-based, interprofessional education by participating in clinical practice sessions offered in a communal learning environment. Traditional lectures can be transformed into modern, enhanced learning experiences that correspond to the new generation of students. Online learning methods are increasingly being incorporated into dental health care education. Online learning is designed to be able to support learners with technology supporting and facilitating student learning. Those methods can be used in dental health care continuous education. This study is designed to evaluate educational intervention's effectiveness of inter-professional mentoring education on mentors' competence development of dentists and dental hygienists mentors.

NCT ID: NCT04715503 Recruiting - Inflammation Clinical Trials

PET-imaging of Unruptured Intracranial Aneurysm Inflammation

PET-IA
Start date: January 14, 2021
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.

NCT ID: NCT04714762 Active, not recruiting - Clinical trials for Gestational Diabetes

eHealth in Treatment of Gestational Diabetes (eMOMGDM)

eMOMGDM
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way. In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.

NCT ID: NCT04713319 Completed - Clinical trials for Healthy Participants

Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

RH013001
Start date: October 4, 2019
Phase: Early Phase 1
Study type: Interventional

Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).

NCT ID: NCT04712773 Recruiting - Cardiac Surgery Clinical Trials

Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

SYDNOS
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.

NCT ID: NCT04709627 Completed - Clinical trials for Hypothermia; Anesthesia

enFlow IV Fluid and Blood Warming System

Start date: July 6, 2021
Phase:
Study type: Observational

This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.

NCT ID: NCT04708288 Recruiting - Clinical trials for Obstructed Biliary and Pancreatic Duct

A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT

AM GI Registry
Start date: September 22, 2020
Phase:
Study type: Observational

Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication. For biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation. In 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent. Later, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period. Prior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the >20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients. Data from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.

NCT ID: NCT04707001 Recruiting - Clinical trials for Arthroplasty Complications

Urinary Retention After Arthroplasty

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

Arthroplasty increases the risk of postoperative urinary retention. Treatment of postoperative urinary retention is indwelling or intermittent catheterization. The need for catheterization is most commonly determined with an ultrasound scanner. Catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. There is no evidence of an optimal way to monitor the onset of spontaneous urination. The aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.