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NCT ID: NCT06065800 Recruiting - Sternum Closure Clinical Trials

STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery

STEADY
Start date: May 17, 2023
Phase:
Study type: Observational

The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery. The primary endpoint is the assessment of STEELEX® Sternum Set effectiveness for sternal healing at month 1 ± 1 week post-surgery. This study is designed as a prospective, non-interventional, single center, Post Market Clinical Follow-Up cohort study. The products under investigation will be used in routine clinical practice and according to the instructions of use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06064890 Recruiting - Clinical trials for Frontotemporal Dementia

A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)

ASPIRE-FTD
Start date: August 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function. The main questions that the study aims to answer are: 1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN? 2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels? 3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN? In this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years.

NCT ID: NCT06064760 Recruiting - Quality of Life Clinical Trials

Workshop on Strengths and Competences to Improve Psychological Wellbeing and Quality of Life of Grandparents

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Recent social and demographic changes in Western countries have led to a reorganization of the family relationships, such as grandparents-grandchildren bond. The Survey of Health, Ageing and Retirement in Europe (SHARE) shows, on the one hand, that 52% of grandparents are auxiliary caregivers of their grandchildren and, on the other hand, that more than 15% of grandparents regularly care for their grandchildren, being the Spanish percentage the second highest of Europe. Given these figures, it is clear that many grandparents today are playing an important role as socializing agents for their grandchildren. According to this, grandparents play their socializing rol by passing on their grandchildren skills, experiences, values, beliefs and affection. This bond not only influences positively on grandchildren, but also on grandparents. Caring for grandchildren allows grandparents to resolve the crises of generativity and integrity of self, included in Erikson's Theory of Psychosocial Development. Moreover, high leves of generativity are related with greater personal growth, one of the dimensions of psychological wellbeing. However, the literature on the socializing rol of grandparents is scarce and has focus on the negative effects of caring for grandchildren. In contrast, recent studies demonstrates that caring for grandchildren has positive effect on grandparents' health and life satisfaction. Being important to consider the negative consequences of this type of care, is also necessary to develop a new perspective, focus on protective factors of grandparents' psychological wellbeing and quality of life. According to McCubbin's Resilience Model of Family Stress, Adjustment and Adaptation, psychological resources and coping skills could be protective factors, minimizing the impact of caring for grandchildren. The present project considers two protective factors: personal strengths and emotional competences, variables that are worked on the workshops. By focusing on these aspects, not only an improvement in family relationships (grandparents-parents-grandchildren) is expected, but also an increase in the psychological well-being and quality of life of the participants. The development of intervention programs aimed at protective factors could be useful for grandparent caregivers, promoting their psychological well-being and quality of life.

NCT ID: NCT06063278 Recruiting - Bulimia Nervosa Clinical Trials

Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

SBSBN
Start date: May 6, 2022
Phase: N/A
Study type: Interventional

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

NCT ID: NCT06062420 Recruiting - Clinical trials for Neoplasms, Head and Neck

Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: November 14, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).

NCT ID: NCT06059638 Recruiting - Hypertension Clinical Trials

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

BACKBEAT
Start date: December 27, 2023
Phase: N/A
Study type: Interventional

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

NCT ID: NCT06059105 Recruiting - Clinical trials for Dental Implant Failed

Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated.

NCT ID: NCT06059001 Recruiting - Clinical trials for Metastatic Pancreatic Cancer

Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC

OMO-103-02
Start date: August 31, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label, multicentre, Phase 1b trial designed to determine the safety, tolerability, efficacy, PK, pharmacodynamics (PD) and proof-of-concept of OMO-103 in combination with the standard regimen gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer who are treatment-naïve in the advanced disease setting.