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NCT ID: NCT05466292 Recruiting - Service Evaluation Clinical Trials

Evaluating a Clinical Ethics Committee (CEC) Implementation Process

Val_CEC
Start date: June 16, 2022
Phase:
Study type: Observational

This is a Mixed-method study with retrospective quantitative assessment and prospective qualitative evaluation focused on the development and implementation of a multidisciplinary Clinical Ethics Committee (CEC), 16 months from its implementation. A CEC is a multi-professionals service that aims to support healthcare professionals (HPs) and healthcare organizations in dealing with ethical issues of clinical practice, providing also ethics consultations (EC) for complex clinical cases, characterized by conflicting ethical perspectives. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. It was developed and implemented according to the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The purpose of this study is to evaluate the CEC's development and implementation process, after 16 months it entered into force. Study's hypothesis: the investigators expect to identify the relevant components that contribute to the CEC's successful implementation and integration into everyday practice. Findings would also identify required modifications to improve the service and develop practical strategies for enabling and sustaining the CEC delivery in clinical settings.

NCT ID: NCT05466006 Recruiting - Dental Implants Clinical Trials

Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.

NCT ID: NCT05465096 Recruiting - Hip Osteoarthritis Clinical Trials

Treatment of Osteoarthritis of the Hip Joint With Intra-articular Injection of Microfractured Autologous Adipose Tissue Containing Mesenchymal Stromal Cells.

Lipo-Hip
Start date: October 24, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the safety and efficacy up to 12 months of MF-AT in the echo-guided infiltrative treatment of hip OA through clinical, subjective and objective evaluations.

NCT ID: NCT05464498 Recruiting - Tendinopathy Clinical Trials

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

AKITENMED
Start date: June 13, 2022
Phase: N/A
Study type: Interventional

Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Insertional tendinitis involves the lower part of the tendon, where the tendon inserts at the level of the calcaneus, and can affect even patients who are not particularly athletically active. Noninsertional tendinitis occurs when the fibers in the middle portion of the tendon are affected, affects young and athletic people the most, and has a high incidence (30-50%) in middle-aged individuals. Considering that there are no strong evidence-based guidelines in the area of treatment of achilles tendinopathy, the aim of this research project is to understand through a multicenter, randomized clinical investigation the impact of treatment with a porcine collagen-based medical device administered in the peri-tendon area in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.

NCT ID: NCT05464290 Recruiting - Urethral Stricture Clinical Trials

The Nanofat Regenerative Surgery for Management of Genital Lichen Sclerosus in Male and Female Patients

LSNanofat
Start date: July 25, 2022
Phase: N/A
Study type: Interventional

Regenerative surgery is an emerging multidisciplinary field actually based on derived adipose tissue. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling. Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties.

NCT ID: NCT05464160 Recruiting - Brain Injuries Clinical Trials

Focal Muscular Vibration in Patients With Severe Acquired Brain Injury

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

Severe acquired brain injury (sABI) is a group of disorders that cause long-term disability. Rehabilitation is essential to counteract bed immobilization, muscle failure, pain, and sensory deficits that can affect the clinical and rehabilitation pathway of these patients. Focal muscle vibration (FMV) is a tool that uses low-amplitude, high-frequency vibrations that when applied to muscle-tendon units. This technique, administered at specific frequencies, amplitudes and durations, can generate action potentials of the same frequency as the stimulus applied to the muscle or tendon. This makes it possible to activate selected afferent fibers and stimulate targeted brain areas with persistent effects over time (long-term potentiation). Regarding the effect of counteracting vibration spasticity, FMV is able to inhibit the reflex arc and induce reciprocal inhibition of functional agonist muscle. In addition, the strong proprioceptive stimulus generated by vibration is able to reach the primary motor and somatosensory cortex, enhancing cortical mechanisms that regulate co-contraction between agonist and antagonist muscles, thereby reducing muscle tone and joint stiffness. In many studies, this technique has been shown to be effective in reducing pain and joint stiffness by improving muscle contraction and motor control.

NCT ID: NCT05463380 Recruiting - COVID-19 Clinical Trials

Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

EuCARE-HOSP
Start date: February 23, 2022
Phase:
Study type: Observational

The WP3 hospitalized cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data from hospitalized COVID-19 patients followed at 12 clinics from 11 countries from 4 continents. In a subset of patients, peripheral blood, viral isolates and/or viral sequences are collected for analysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2 diagnostics. Data and results from analysis of biological material will be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on clinical outcome of viral variants / viral sequences as well as the vaccines used and the vaccination schedules.

NCT ID: NCT05462873 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

Start date: April 4, 2023
Phase: Phase 1
Study type: Interventional

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

NCT ID: NCT05461170 Recruiting - Clinical trials for Hepatitis D, Chronic

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

Start date: September 17, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

NCT ID: NCT05460988 Recruiting - Periodontitis Clinical Trials

"Re-instrumentation vs Flap Surgery"

Start date: August 11, 2022
Phase: N/A
Study type: Interventional

There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets. The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated