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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: NCT06064292 Completed - Aging Clinical Trials

Long Term Effects of Inspiratory Muscle Training in Cerebral Palsy

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Background: Respiratory disease is one of the main causes of morbidity and mortality in adults with cerebral palsy (CP). Adequate pulmonary function is essential to prevent these health problems, however respiratory muscle training has not yet been studied in CP patients. The main objective of the study was to investigate the maintenance over time of improvements in respiratory parameters achieved with inspiratory muscle training (IMT). Methods: This was a controlled, randomised, double-blind trial and with allocation concealment performed on 27 institutionalized CP patients randomly distributed in 2 groups, "high intensity training group" (HIT) and "low intensity training group" (LIT). Participants followed a specific IMT program for 8 weeks, HIT workload was 40% of maximum inspiratory pressure (MIP) and LIT workload was 20% MIP. Once finished 8-week training period, CP patients continued their daily activities. Respiratory muscle strength and pulmonary function were measured pre-IMT, post-IMT, 4, 12 and 24 weeks after finishing IMT.

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: NCT06063031 Completed - Clinical trials for Post-COVID Condition

Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition

ARACOV-02
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Once the acute phase of the disease has passed, about 40% of the people who discharged continue to have symptoms, and of these, between 50 and 70% present them up to three months later. These persistent symptoms include physical aspects such as fatigue and dyspnea, but also cardiac such as palpitations, cognitive such as mental confusion, and psycho-emotional such as depression, anxiety, and stress. SARS-CoV-2 infection is associated with a hyperinflammatory state, including excessive inflammatory cell infiltration, inflammasomes activation. In this context, omega-3 metabolites (Special Pro-resolving Mediators-SPMs) restore the balance in nutritional and molecular levels of eicosanoids. A more direct and targeted way to increase SPMs levels is Omega3 Essential Nutrition with natural SPMs taken by mouth. Today, there are dietary supplements containing SPMs (LIPINOVA®), made from fish oil through a fractionation process. LIPINOVA® is a nutritional supplement patented by Solutex GC S.L., obtained through several fractionation stages (extraction, purification, separation, concentration) from rich-in-omega-3 fish oil (without additives). Each capsule contains 498 mg of fish oil and 2 mg of tocopherols. This represents a variable quantity from 50 to 150 mg of EPA (20%), a variable quantity from 100 to 225 mg of DHA (30%), as well as the following quantities of EPA and DHA active metabolites, obtained from a pool of natural lipid mediators contained in omega-3 oil: 40-200 mcg of 17-HDHA, 25-200 mcg of 18-HEPE and 20-100 mcg of 14-HDHA. In addition to this, the appearance of this new health condition, post-COVID condition, has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient. Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients. Patients with this condition present an increase in fatigue, dyspnea and a decrease in their functional capacity and, therefore, a decrease in their quality of life, due to various pathogenic mechanisms that include chronic hyperinflammation. These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs (omega- 3).

NCT ID: NCT06062511 Completed - Nutrition, Healthy Clinical Trials

Poplar-type Propolis Dry Extract ESIT12 : Nutrikinetic and Bioavailability Studies

Start date: July 22, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate phenolic compounds from ESIT12, a poplar-type propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and metabolic profile over 48h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects.

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).