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NCT ID: NCT05774106 Recruiting - Clinical trials for Mental Health Disorder

The Therapeutic Relationship Between the Case Manager and the Person With Severe Mental Health Disorder

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The first mental health case management programs appear progressively in Spain from the trend towards community mental health with the aim of caring for people with severe mental health disorders outside from hospitals, accompanying them in their recovery process. The mental health nurse case manager is an example of advanced practice in in terms of assistance to the most seriously ill in the community mental health network. The use of the therapeutic relationship as the central axis of care for the person is becomes an essential tool for patient recovery. This study aims, through participatory action, to inquire about the relationship therapy and its effect on the person's recovery. There will be a mixed methods research. First, a participatory intervention with nurses through the recording of four focus groups with the aim of understand, plan, change and maintain the practices surrounding the relationship therapy with their patients. Second, this intervention will be measured by administering scales to patients linked to the mental health case management program that provides service to different areas of the Barcelona Metropolitan Area. The variables to measure will be the quality of the therapeutic relationship, the recovery of the person and the overall functionality. These variables will be measured before and after finishing the participatory intervention. All data will be anonymized, transcribed and analyzed using the software correspondent.

NCT ID: NCT05772806 Recruiting - Stroke Clinical Trials

Diagnostic Approach of Early Atrial Fibrillation, Silent Stroke and Cognitive Disorder in Patients With High-risk

PREFA-TE
Start date: January 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine the impact of the combined use of cardiac rhythm recording devices, biomarkers, echocardiogram, and Magnetic Resonance Imaging (MRI) on the early detection of AF, silent stroke, and cognitive impairment in subjects older than 65 years at high risk. The main questions it aims to answer are: - The early detection of AF, allowing the establishment of preventive measures, will avoid its main complications, especially strokes and cognitive impairment or dementia, in patients at high risk? - Will cardiac rhythm monitoring devices be useful in the early detection of AF in patients at high risk? Participants will undertake an initial evaluation through an echocardiogram (to detect atrial dysfunction), cranial MRI (to detect silent strokes), plasma/serum collection to determine biomarkers, and a complete clinical assessment (including electrocardiogram, and scales for measurement of cognitive and functional status). The clinical evaluation will be repeated every 6 months and will allow the recording of the date of occurrence of the study events. In addition, annually, patients will be subjected to cardiac rhythm monitoring by electronic devices with the aim of improving AF detection.

NCT ID: NCT05772286 Recruiting - Healthy Clinical Trials

Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein SOSIP v8.2 763 Vaccine, Adjuvanted With MPLA Liposomes, in Healthy, HIV-Uninfected Adults

HIVAC-FOUND
Start date: July 24, 2023
Phase: Phase 1
Study type: Interventional

Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein SOSIP v8.2 763 Vaccine, Adjuvanted with MPLA Liposomes, in Healthy, HIV-Uninfected Adults

NCT ID: NCT05772182 Recruiting - Cardiac Arrhythmia Clinical Trials

Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias

SAVE-COR
Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

Noninvasive evaluation of the electrical status of the heart is based on the standard ECG but remains suboptimal due to difficulties with arrhythmia characterization and location. Electrocardiographic Imaging (ECGI) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. The applicant will develop a systematic evaluation of the ECGI as a tool to detect cardiac regions of interest in cardiac arrhythmias.

NCT ID: NCT05771480 Recruiting - Clinical trials for Biliary Tract Cancer

Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

TOURMALINE
Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.

NCT ID: NCT05770908 Recruiting - Clinical trials for Rotator Cuff Tendinitis

Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

Start date: April 7, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. The main question[s] it aims to answer are: - Does subjects improve more regarding shoulder disability and pain? - Are the subjects more satisfied with the treatment received? - Do the subjects adhere more to the exercise program? - Do the subjects perform better the trained exercises? - Do the subjects have greater expectations with the treatment received? Participants will perform a therapeutic exercise program within 6 months. Researchers will compare the addition of web-app animations to the classical paper-based information.

NCT ID: NCT05770700 Recruiting - Chronic Pain Clinical Trials

Effectiveness and Safety of Implantable Neurostimulation Systems for Chronic Pain: A Spanish Multicenter Study (STIM-RENASED)

STIM-RENASED
Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of implantable stimulation systems for chronic pain treatment in Spain.

NCT ID: NCT05770440 Recruiting - COVID-19 Clinical Trials

Impact of COVID-19 on Lung Function in COPD Patients.

EspirCOVID
Start date: March 1, 2023
Phase:
Study type: Observational

Background: In 2019, a novel coronavirus (SARS-COV2) was detected in Wuhan, China as a cause of acute respiratory distress syndrome (COVID-19). Other previous coronaviruses (SARS and MERS) have caused respiratory sequelae (pulmonary fibrosis) demonstrable by tomography and lung function tests. These alterations have begun to be detected in patients who have survived COVID-19. Hypotheses: SARS-COV2 infection accelerates the deterioration of lung function in patients with Chronic Obstructive Pulmonary Disease (COPD). Objectives: To analyze the evolution of lung function in COPD patients diagnosed with COVID-19, while comparing it with COPD patients without COVID-19 disease. Methodology: Cohort study. The COPD-COVID-19 cohort will consist of the COPD population with and without COVID-19. Previous pulmonary function data will be collected and 2 prospective visits (baseline and follow-up) with clinical assessments and functional tests will be performed. In the event that the participant suffers from COVID-19 during the follow-up, an additional visit will be performed 3 months after the diagnosis, and the final visit will take place 12 months after this additional visit. Determinations: Study factor: diagnosis of COVID-19. Response variable: change in the forced expiratory volume in the first second (FEV1) measured at the start of the study and after 1 year of this first assessment, considering also the basal FEV1 (before March 2020). Other variables: socio-demographic, clinical, functional and treatment. Expected results: Greater decrease in FEV1 in COPD patients with COVID-19, Applicability and Relevance: The proactive detection of functional sequelae will allow early treatment, including pulmonary rehabilitation, with the aim of improving the quality of life of these patients.

NCT ID: NCT05769868 Recruiting - Diabetes Mellitus Clinical Trials

Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments

CIBERbBECHO
Start date: April 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments.

NCT ID: NCT05769777 Recruiting - Dermatitis Atopic Clinical Trials

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

ATLANTIS
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: - A screening period of up to 2 to 4 weeks - An open label treatment period of up to 160 weeks (approximately 3 years) - A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.