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NCT ID: NCT06251037 Enrolling by invitation - Depressive Symptoms Clinical Trials

"Youth Aware of Mental Health" in Galicia

YAM
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to assess the effectiveness of the universal suicide prevention program "Youth Aware of Mental Health" in 3rd-year secondary education students in Galicia. The main questions it aims to answer are: - Is the YAM program effective in reducing severe suicidal ideation at 12 months from baseline within the experimental group and compared to the control group? - Is the YAM program effective in preventing the incidence of new suicidal attempts, 12 months from baseline in the experimental group compared to the control group? All participants in this study will be asked to: Complete a survey at baseline and after 12 months, consisting of measures for suicidal ideation and behavior, depressive symptoms, seeking help behaviors, bullying, problematic internet use, and emotional distress. Only those allocated to the experimental group will be asked to: Undergo the YAM program, an evidence-based intervention structured into five one-hour class group sessions (45-50 min.), focused on problem-solving by peers. The program consists of interactive presentations, dilemma discussions, role-playing, and reflection, all moderated by a trained YAM instructor. Twelve months after the intervention, all participants will undergo a re-evaluation using the same protocol. The researchers will compare differences in pre- and post-measures within the experimental and control groups, as well as between both groups, to assess the impact of the YAM intervention on outcomes such as suicidal ideation and attempts. At the end of the study, those who were allocated to the control group are going to be offered the YAM intervention program.

NCT ID: NCT06246019 Enrolling by invitation - Alzheimer Disease Clinical Trials

The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers

PLASMAR
Start date: February 7, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital. The main questions it aims to answer are: 1. Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit? 2. Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption? 3. Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption? 4. Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up? 5. Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit? Participants will be asked to: - Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study. - Complete specific scales in each visit. Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.

NCT ID: NCT06242613 Enrolling by invitation - Gastric Cancer Clinical Trials

National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer

ROBOTAG
Start date: May 13, 2023
Phase:
Study type: Observational [Patient Registry]

In recent years there has been a rapid incursion of robotic technology applied to almost all fields of surgery. In gastric cancer, whose mainstay of treatment is still surgical resection, gastrectomy with robotic lymphadenectomy is growing faster than the scientific evidence supporting its results. The "National Multicenter Cohort Study of ROBOT-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer" (ROBOTAG study) is proposed as a prospective multicenter Spanish nationwide study, comparing robotic gastrectomy versus conventional laparoscopic gastrectomy for the treatment of gastric cancer. This study aims to provide evidence on the feasibility, safety and complications, possible technical advantages, short and long term surgical and oncological results, as well as aspects related to quality of life, which can support the increase in cost and the important technological effort that underlies robotic surgery with respect to conventional laparoscopic access. The relevance of this project is doubled by directing the objectives, on the one hand, on a new and expensive technology that is reaching hospitals still surrounded by controversy about its real benefits; and on the other hand, by acting on a pathology for which most of the available studies come from Eastern countries, sometimes not very applicable to the Western context.

NCT ID: NCT06214624 Enrolling by invitation - Clinical trials for Coronary Heart Disease

Exercise and Brain in Coronary Heart Disease

Heart-Brain
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The Heart-Brain project is a randomized controlled trial designed to examine the effects of two different exercise programs of 12-week duration: 1) aerobic high intensity interval training (HIIT), and 2) aerobic HIIT plus resistance training, on brain health and other outcomes in coronary heart disease patients.

NCT ID: NCT06167252 Enrolling by invitation - Loneliness Clinical Trials

Map of Unwanted Loneliness

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

Creating a map of the magnitude of the problem and the response of primary care to unwanted loneliness among the elderly, stratifying different needs based on place of residence and proximity to available assistance programs to address this issue, which, due to its scale, calls for collaboration among various institutions, disciplines, and experiences.

NCT ID: NCT06164951 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PROPEL3
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

NCT ID: NCT06150859 Enrolling by invitation - Bereavement Clinical Trials

Ayahuasca Assisted Psychotherapy for Grief

PSICODUELAYA
Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

NCT ID: NCT06138808 Enrolling by invitation - Clinical trials for Epilepsy Intractable

5-SENSE Score Validation Study

Start date: January 9, 2024
Phase:
Study type: Observational

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

NCT ID: NCT06127888 Enrolling by invitation - Migraine Clinical Trials

Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia

RECEPTA
Start date: March 20, 2024
Phase:
Study type: Observational [Patient Registry]

Therapeutic exercise, including aerobic activity and strength training, has shown promise in treating primary headaches with a moderate effect size, despite limited evidence. Implementation requires specialized professionals, infrastructure, and defined care pathways. These strategies are cost-effective for similar chronic pain conditions. More research is needed to better understand the varying effects on headache frequency, duration, and intensity in larger patient samples.

NCT ID: NCT06124222 Enrolling by invitation - Quality of Life Clinical Trials

Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC

Start date: November 17, 2021
Phase: N/A
Study type: Interventional

The main goal of this clinical trial (pilot study) is to evaluate whether prosthetic rehabilitation modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in patients treated for head and neck cancer before and after the placement of fixed and/or removable prostheses. Hypothesis Prosthetic rehabilitation with fixed and/or removable prostheses modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in non-irradiated patients treated for head and neck cancer compared to irradiated patients. Study population The study population will consist of patients treated for head and neck cancer who are candidates for prosthetic rehabilitation. The type of prosthetic treatment recommended will be determined by a dental expert in the treatment of these patients. Interventions 1. - First session and recruitment: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life. 2. - Prosthodontic treatment. 3. - Second session (after insertion of the prosthesis) After an adaptation period of ± 15-30 days from the insertion of the prosthesis, the recordings carried out in the first session will be performed again: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life. 4. - Third session (follow-up 6 months) After a period of time of 3 months ± 7 days after the second session, the recordings carried out in the first and second sessions will be performed again: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life.