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NCT ID: NCT05708612 Recruiting - Fecal Incontinence Clinical Trials

Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.

NCT ID: NCT05708235 Recruiting - Breast Cancer Clinical Trials

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

MiRaDoR
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease. The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase). After informed consent is obtained, a total of1,260 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature). At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy: Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10) If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.

NCT ID: NCT05708131 Recruiting - Clinical trials for Ventricular Tachycardia

Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

VTFM
Start date: July 13, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.

NCT ID: NCT05707780 Recruiting - Dental Materials Clinical Trials

Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

NCT ID: NCT05707312 Recruiting - Endometrial Cancer Clinical Trials

Staging Endometrial caNcer Based on molEcular ClAssification

Start date: January 1, 2023
Phase:
Study type: Observational

The SENECA study tries to evaluate the rate of lymph node involvement depending on the molecular subgroup in early-stage endometrial cancer (I/II) patients undergoing surgery as part of their treatment.

NCT ID: NCT05706857 Recruiting - Surgery Clinical Trials

Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery

CARDU-FAST
Start date: January 22, 2023
Phase: N/A
Study type: Interventional

Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.

NCT ID: NCT05706740 Recruiting - Terminal Cancer Clinical Trials

Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life

SERENITY
Start date: February 28, 2023
Phase:
Study type: Observational

Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial. The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.

NCT ID: NCT05706519 Recruiting - Clinical trials for Coronary Heart Disease

Metabolomics, Genomics and Nutrition for Cardiovascular Disease Precision Medicine

OMIC-CARD
Start date: December 19, 2022
Phase:
Study type: Observational [Patient Registry]

The objective of this project is to validate, through high-throughput advanced metabolomics techniques, the nutritional assessment tools to be used in the IMPaCT cohort. At the same time, the ability of metabolomics fingerprints of nutritional patterns to discriminate between patients with and without major cardiovascular disease will be identified. Finally, the modification of these predictions will be evaluated based on the genetic profiles. The main hypothesis holds that the integration of metabolomics, genomic and nutritional information will serve to personalize the approach to cardiovascular disease, both in prevention and treatment, and that these tools, in turn, will be valid enough to be applied systematically and efficiently in the IMPaCT cohort.

NCT ID: NCT05705973 Recruiting - Clinical trials for Cardiovascular Disease

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

NAGOMI COMPLEX
Start date: April 25, 2023
Phase:
Study type: Observational [Patient Registry]

The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.

NCT ID: NCT05705440 Recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this follow-up study is to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.