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NCT ID: NCT06368258 Not yet recruiting - Clinical trials for Hypercholesterolemia

Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.

NCT ID: NCT06367933 Not yet recruiting - Surgery Clinical Trials

Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

MISNM
Start date: July 2024
Phase: N/A
Study type: Interventional

Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves.

NCT ID: NCT06365853 Not yet recruiting - Clinical trials for Recurrent Ovarian Cancer

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer [PSOC] or platinum-resistant ovarian cancer [PROC]) with high folate receptor alpha (FRĪ±) expression.

NCT ID: NCT06364267 Not yet recruiting - Breast Cancer Clinical Trials

Low Dose Tamoxifen vs Low Dose Exemestane in Post-menopausal Women at High Risk for Breast Cancer.

BabyTears
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.

NCT ID: NCT06364033 Not yet recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Biological and Clinical Efficacy of Shingrix in Patients With CLL

Start date: August 2024
Phase: N/A
Study type: Interventional

This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.

NCT ID: NCT06363643 Not yet recruiting - Clinical trials for Osteo Arthritis Knee and Hip

Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.

Start date: April 22, 2024
Phase: N/A
Study type: Interventional

Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity. Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations.

NCT ID: NCT06360887 Not yet recruiting - Shoulder Fractures Clinical Trials

Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.

NCT ID: NCT06360653 Not yet recruiting - Endometrial Cancer Clinical Trials

a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer

SISTER-RAY
Start date: June 2024
Phase: N/A
Study type: Interventional

The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer

NCT ID: NCT06358768 Not yet recruiting - Clinical trials for PPH - Postpartum Hemorrhage

Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations

PPH
Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management

NCT ID: NCT06358105 Not yet recruiting - Clinical trials for Coronary Artery Disease

Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

STARTERS
Start date: November 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes. The main questions it aims to answer are: - Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision? - Will major and minor procedural complications be reduced after simulator-based training? Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period. They will be supervised during their cath lab period as first operators by senior interventional cardiologists. During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.