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NCT ID: NCT05642897 Recruiting - Clinical trials for Breast Cancer Female

Mind Programme for Women With Breast Cancer

MIND
Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.

NCT ID: NCT05642312 Recruiting - Clinical trials for Uveitic Macular Edema

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

Meerkat
Start date: January 9, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

NCT ID: NCT05640492 Recruiting - Depressive Symptoms Clinical Trials

Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)

Start date: January 5, 2023
Phase: N/A
Study type: Interventional

Depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. Depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. The Metacognitive Training for Depression in Later Life (MCT-Silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. It was developed by the partner institution's team, and has already demonstrated positive results. This project aims to extend the research study to Portugal, through cultural adaptation, pilot study, and a Randomized Controlled Trial (RCT). To this end, we defined the following aims: To plan and conduct a pilot study to assess the efficacy of the MCT-Silver in the Portuguese population; To conduct a multicenter randomized controlled trial (RCT).

NCT ID: NCT05639114 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

SIRIUS-SLE 1
Start date: March 2, 2023
Phase: Phase 3
Study type: Interventional

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

NCT ID: NCT05637619 Recruiting - Wear, Occlusal Clinical Trials

Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Start date: January 1, 2022
Phase:
Study type: Observational

Wear resistance is one of the most important physical properties of teeth, and wear resistance of zirconia against artificial acrylic, enamel and composite resin denture teeth has not been clearly established. Implant-supported dental restorations present a higher threshold for occlusion perception when compared to natural teeth, which can occlusal overload mechanisms or lead to wear of rehabilitation materials or the antagonist arch. In clinical conditions, however, many other factors influence the complex interaction between dental enamel and opposing substrates: patient-related factors such as dietary habits, dysfunctional occlusion, masticatory forces, and bruxism contribute to accelerated enamel loss of antagonist teeth.

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05635032 Recruiting - Sarcoidosis Clinical Trials

Fibrosing ILD Biomarkers That Rule Acceleration

FIBRALUNG
Start date: March 1, 2021
Phase:
Study type: Observational

FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies. Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.

NCT ID: NCT05632718 Recruiting - Clinical trials for Bariatric Surgery Patients

Is Resistance Exercise More Effective Than Endurance in Reducing Obesity Relapse in Post-bariatric Surgery Patients

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

The goal of this clinical trial is to compare the effects of resistance exercise and endurance in post-bariatric surgery patients with insuficcient weight loss. The main question it aims to answer is: - Is resistance exercise more effective than endurance exercise in preventing obesity relapse in post-bariatric surgery patients with insuficcient weight loss? - Is resistance exercise more effective than endurance exercise in increasing resting metabolic rate in post-bariatric surgery patients with insuficcient weight loss? Participants will be randomly assigned to one of the following groups: - Resistance group: performing resistance exercise-training for 16 weeks - Endurace group: performing endurance exercise-training for 16 weeks - Control group: no intervention / standard medical care

NCT ID: NCT05627362 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

ELMWOOD
Start date: January 27, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

NCT ID: NCT05626764 Recruiting - Solid Tumor Clinical Trials

QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management

Start date: January 27, 2020
Phase:
Study type: Observational

An increasing number of cancer patients are eligible to receive immunotherapy. Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results. However, real-life experience differs from clinical trial results, especially regarding the management of potential adverse events. HR-QoL (Health Related Quality of Life) is one of the components of QoL (Quality of Life) in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the 'real-world'. QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data (big data) to estimate patient QoL and find surrogate markers of QoL and its evolution. Within the QUALITOP consortium, 5 countries will collect prospective clinical and QoL data and also retrospective clinical data, and share it. This project will enable collecting, managing, sharing, modelling, processing, and exploiting big data on QoL. Furthermore, beyond the description of QoL, analytical tools (including causal inference methods and machine learning) are needed to understand the determinants of QoL and their complex relationships with irAEs (immune related Adverse Events) in a big-data context where standard statistical techniques would be limited. Artificial intelligence and causal models may be applied and developed to empower the patient, prevent adverse medical conditions, and promote QoL. The created knowledge will enable proposing guidelines for promoting better QoL. QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events (IR-AEs, such as toxicities) depending on the patient's profile in a real-world context. The richness of QUALITOP is in the diversity of the experts who will collaborate in it. Clinicians involved in the care (thus the health status of the patients) will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy. Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption. Epidemiologists, data scientists (including bioinformaticians and biostatisticians) and economists will extract information from the data and develop simulation models to produce knowledge. The project will take place in close relation with patient associations that will interact with experts to design the analyses, interpret their results, and proceed to their dissemination. The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life. - Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management (with data on clinical information, health-related QoL (HR-QoL), IR-AEs, drug consumption, lifestyle, and administrative data). - Accelerate knowledge directed to different stakeholders (patients, relatives, clinicians, pharmacists, health authorities, and the general public) for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools (artificial intelligence and causal models). - Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs (Sustainable Development Goals) for 4P medicine (Predictive, Preventive, Personalized, Participative) in immunotherapy for cancer patients.