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NCT ID: NCT05182177 Recruiting - Clinical trials for Reconstructive Surgical Procedures

The SurgiMend PRS Retrospective Study

Start date: January 31, 2022
Phase:
Study type: Observational

The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.

NCT ID: NCT05181644 Terminated - Scleroderma Clinical Trials

Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

SUITABLE
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

NCT ID: NCT05181618 Active, not recruiting - Severe Hemophilia A Clinical Trials

A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

Beyond ABR
Start date: June 20, 2022
Phase: Phase 4
Study type: Interventional

Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and <70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study.

NCT ID: NCT05181514 Completed - Clinical trials for Hypertriglyceridemia

Impact of Plasma Lipids on β Cell Function and Insulin Sensitivity

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

The investigators aim to evaluate whether and to what extent glucose tolerance, beta cell function, insulin clearance, and glucose metabolic fluxes change in response to an acute increase in plasma triglycerides during lipid infusion, independently of free fatty acid (FFA) levels, in nondiabetic subjects.

NCT ID: NCT05180864 Recruiting - Stomach Neoplasm Clinical Trials

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

OMEGA-2
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits. The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery. There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival. OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.

NCT ID: NCT05180474 Recruiting - Clinical trials for Endometrial Cancer, Endometrial Neoplasm

GEN1047 for Solid Tumors - First in Human (FIH) Trial

Start date: December 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The drug investigated in the study is an antibody, GEN1047. Since this is the first study of GEN1047 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1047 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1047. GEN1047 will be studied in a broad group of cancer participants, having different kinds of solid tumors. All participants will get GEN1047. The study consists of two parts: Part 1 tests increasing doses of GEN1047 ("escalation"), followed by Part 2 ("expansion") which tests the recommended GEN1047 dose from Part 1.

NCT ID: NCT05180357 Completed - Nasal Polyps Clinical Trials

RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

RANS
Start date: November 23, 2021
Phase:
Study type: Observational

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

NCT ID: NCT05179330 Completed - Brain Injuries Clinical Trials

Visual Feedback in Lower Limb Rehabilitation

Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Severe Acquired Brain Injury (sABI) is defined as "an encephalic impairment that occurs after birth and is not related to a congenital or degenerative disease. This impairment may be temporary, or permanent, and cause partial or functional disability or psychosocial distress." In Italy there are at least 10-15 new cases of sABI per year per 100,000 inhabitants; the estimated prevalence is about 150,000 cases per year. Often, people with sABI present focal neurological deficits, including alterations in strength, sensitivity, coordination and gait. Most of the rehabilitation protocols for people with sABI are derived from post-stroke studies, caused by lack of evidence on specific rehabilitation of people with sABI. Rehabilitation of people with sABI should begin as soon as possible, to prevent the onset of retractions and decubitus, and to regain joint mobility, strength, and coordination. OMEGO® (Tyromotion) is a newly developed device used in lower extremity rehabilitation, that provides visual and auditory feedback. Specifically, OMEGO® contains several games developed to enhance and promote learning behaviors, that simulate activities of daily living. The use of devices such as cycle ergometers is recommended in the rehabilitation of people with sABI; however, there are no studies demonstrating the effect of cycle ergometer training in association with visual feedback. The purpose of this study is to evaluate, both in people without apparent pathology (hereafter identified as "healthy") and in people with sABI, whether visual feedback during OMEGO® exercise modifies brain connectivity, emotional drive, and lower limb performance during a lower limb-specific motor rehabilitation task.

NCT ID: NCT05179174 Recruiting - Uveal Melanoma Clinical Trials

The Role of Genetic Mutations and of Circulating mRNAs in Uveal Melanoma

Start date: April 20, 2021
Phase:
Study type: Observational

The aim of the study is to identify genetic and epigenetic biomarkers in uveal melanoma, and to evaluate their diagnostic and prognostic role. In particular, the specific objectives are: 1. to identify the circulating somatic mutations associated with uveal melanoma; 2. to identify the de-regulated miRNAs associated with uveal melanoma; 3. to evaluate the diagnostic and prognostic role of the identified genetic and epigenetic markers; 4. to identify possible therapeutic targets.

NCT ID: NCT05179096 Completed - Depression Clinical Trials

Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study

MTC
Start date: August 20, 2021
Phase: N/A
Study type: Interventional

Background and study aims: Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament. Who can participate? Students attending the fourth or fifth year of primary school What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities. Questionnaires will be used to assess temperament, anxiety and depression before and after the intervention. What are the possible benefits and risks of participating? Benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.