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NCT ID: NCT04436939 Completed - Dental Implants Clinical Trials

Soft Tissue Response to Peek and Ti Healing Abutments

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Introduction: Single-stage dental implant placement protocol involves the placement of healing abutments. In addition to osseointegration process, healing of peri-implant soft tissues is of a great importance too. Routinely, healing abutments made of titanium (Ti) are used. The aim is to find novel materials that would have the same mechanical properties, but less prone to plaque-adhesion and therefore showing lower local inflammatory soft tissue response. Polyetheretherketone (PEEK) is a thermoplastic polymer that has favorable mechanical characteristics, high biocompatibility and low submissiveness to microorganism adhesion. White color makes it aesthetically acceptable in the treatment of patients with thin gingival phenotype. The Aim: To compare the formation of dental plaque on PEEK and Ti healing abutments and examine the local response of peri-implant tissues. Materials and Methods: The study included 11 patients with at least two missing teeth in the posterior regions. In each patient, 2 implants were installed, with PEEK abutment (experimental group) placed on one implant, while on the other implant, Ti abutment (control group) was placed. Before prosthetic rehabilitation of patients, both abutments were replaced with new ones and a thin layer of peri-implant soft tissue was sent to histological analysis. Results: The average age of patients was 49 years. Out of 11 patients, 27% were female and 73% male. 36% of respondents were smokers. Histological immunohistochemical analysis of samples of peri-implant soft tissues showed massive inflammatory infiltration in subepithelial tissue in the experimental group (10/11), while the inflammatory infiltrate in the control group was classified as moderate (7/11) or weak (4/11). Conclusion: Both types of healing abutments have been shown to be successful in single-stage implantation protocol. However, contrary to expectations and preliminary findings from the literature, PEEK healing abutments showed a more pronounced inflammatory response of the surrounding soft tissues relative to Titanium abutments.

NCT ID: NCT04435431 Completed - Parkinson Disease Clinical Trials

A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia

Start date: October 29, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

NCT ID: NCT04430803 Completed - Aging Clinical Trials

Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging

H2AGE
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

This study evaluates the effects of six-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in men and women aged 70 years and over.

NCT ID: NCT04417413 Completed - Clinical trials for Pelvic Organ Prolapse

Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.

Start date: October 1, 2019
Phase:
Study type: Observational

The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.

NCT ID: NCT04364711 Completed - COVID-19 Clinical Trials

EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19

MERMAIDS 2
Start date: June 18, 2020
Phase:
Study type: Observational

Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). - incl. PBMC collection Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.

NCT ID: NCT04285515 Completed - Clinical trials for Major Depressive Disorder

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Start date: February 27, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

NCT ID: NCT04281472 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

ADHERE
Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

NCT ID: NCT04274582 Completed - Handball Players Clinical Trials

The Influences of Chokeberry Extract Supplementation on Handball Players

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Standardized questionnaires conducted under the supervision of a trained nutritionist were used to collect general data, nutritional habits and use of dietary supplements. The athletes who used any dietary supplements at least a month before the study, were excluded. All participants (or their parents if they were under the age of 18) signed an informed consent document. The study was approved by the Ethical committee of The Military Medical Academy, Belgrade. The study was conducted during regular competition season, and lasted for twelve weeks. All participants had the same training and nutritional regime, which excluded intake of berries. The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova Belgrade, Serbia. Process of extraction is performed under specific conditions which are subject of technical patent (producer EUHEM), for the purpose of production of extract with high concentration of polyphenols. The design of the product included few demands: sufficient daily dose of polyphenols to be dietary supplement, small volume which can be consumed as shot and acceptable taste for most consumers. Compliance was monitored by the trainers.

NCT ID: NCT04270747 Completed - Clinical trials for Neovascular (Wet) Age-related Macular Degeneration (AMD)

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.

NCT ID: NCT04263246 Completed - Clinical trials for Exercise Performance

Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status

PhytoDyNAmic
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

We evaluated here the effects of 6-week intervention with herbal supplement on exercise performance outcomes and serum biomarkers of antioxidant status. In addition, we also assessed the long-term effects (6-month) of the intervention in elderly adults.