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NCT ID: NCT05449639 Recruiting - Clinical trials for Urinary Incontinence

Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence

RELIEF-2
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

A second no-random open interventional pilot study sponsored by Relief srl

NCT ID: NCT05449587 Recruiting - Breast Augmentation Clinical Trials

Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix

MIRO
Start date: November 22, 2022
Phase:
Study type: Observational

Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.

NCT ID: NCT05448365 Recruiting - Uterine Fibroids Clinical Trials

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

NCT ID: NCT05447793 Recruiting - Wounds and Injuries Clinical Trials

Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft

FP
Start date: January 18, 2021
Phase:
Study type: Observational

Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms. The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages. In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control. The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex). The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez. To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature. The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.

NCT ID: NCT05447767 Recruiting - Clinical trials for Osteoarthritis, Knee

Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg

PATTERN
Start date: September 27, 2021
Phase: Phase 2
Study type: Interventional

Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation. Today, most of the available conservative treatments provide temporary relief of symptoms but have no effect on the cause and progression of the disease. Mesenchymal stem cells (MSC) have emerged as a durable and effective conservative treatment option for OA. They are tissue cell-rich concentrates that have demonstrated immunomodulatory activities in several in vitro and in vivo studies, particularly in orthopaedics. Thus, "minimal handling" methods for the intraoperative production of tissue cell-rich concentrates has become a widespread strategy in clinical practice. In particular, bone marrow aspirate concentrate (BMAC) and adipose tissue enriched SVF (at-SVF), i.e. the so-called 'orthobiologics', have proven to be cost-effective and promising sources with a high safety profile and positive short-term clinical results. Despite growing evidence on the use of orthobiologics, the different methods of preparation and administration and the lack of meaningful data collection do not allow for a clear understanding of the true efficacy of these treatments, resulting in a lack of patient-specific indications. Although the most common method of administering regenerative Although the most common method of administering regenerative medicinal products is by intra-articular injection, more recently it has been shown that in patients with OA the subchondral bone also undergoes significant pathological changes. Given this evidence, intra-osseous (bone-cartilage interface) injections of biological products may represent a promising approach.

NCT ID: NCT05445778 Recruiting - Ovarian Cancer Clinical Trials

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)

Start date: December 27, 2022
Phase: Phase 3
Study type: Interventional

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

NCT ID: NCT05444920 Recruiting - ATTR Amyloidosis Clinical Trials

The Italian Transthyretin Amyloidosis Web-Network

ITA-WebNet
Start date: July 13, 2022
Phase:
Study type: Observational [Patient Registry]

The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.

NCT ID: NCT05444465 Recruiting - Clinical trials for Rotator Cuff Injuries

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

IMPACT
Start date: August 30, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

NCT ID: NCT05443100 Recruiting - Obesity Clinical Trials

Impact of WBC on Patients With Metabolic or Neurological Diseases or Fibromyalgia (WBC-WBC-MeNeFi)

WBC-MeNeFi
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to investigate on different types of patients the effects of 10 sessions of whole-body cryostimulation (WBC): 1) in patients with obesity (BMI > 30), we want to investigate whether WBC increases thermogenesis, basal metabolic rate (BMR), respiratory quotient (which indirectly provides an estimate of energy substrate oxidation), reduces chronic inflammatory status, fatigue and pain, and improves functional abilities and general physical capacity; 2) in patients diagnosed with fibromyalgia, we want to investigate the reduction of pain, inflammatory status, increase in functional abilities and general physical abilities functional status and an improvement in mood; 3) in neurological patients diagnosed with Parkinson's disease, Multiple Sclerosis, and Disimmune Polyneuropathies, the effects of WBC on pain, fatigue, and sleep quality are to be investigated; 4) in normal/overweight (BMI<30 kg/m2) subjects, the effects of WBC on all parameters described previously for the other protocols are to be investigated. Specifically, for all enrolled subjects, we want to assess blood catecholamine levels, investigate the effects of sympathetic response on body composition, blood pressure, heart rate, lipid profile, and physical performance. Three hundred patients admitted for a rehabilitation program (diet + physiotherapy + exercise) will be non-randomly assigned to either a group following the program (R) or a group additionally receiving ten 2-3 minute WBC sessions at -110°C over two weeks (RWBC).

NCT ID: NCT05442567 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Start date: May 16, 2023
Phase: Phase 3
Study type: Interventional

The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.