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NCT ID: NCT06447038 Enrolling by invitation - Clinical trials for Chronic Kidney Disease (CKD)

Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).

NDO
Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also "systemic damage" (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.

NCT ID: NCT06445673 Enrolling by invitation - Clinical trials for Pulmonary Arterial Hypertension

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

TripleTRE-NIS
Start date: June 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.

NCT ID: NCT06421402 Enrolling by invitation - COPD Clinical Trials

K-HEALTH in AIR - Barcelona Pilot - Cohort

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

The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe. With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period. The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.

NCT ID: NCT06411587 Enrolling by invitation - Stroke Clinical Trials

Analysis of the Correlation Between Ultrasound Imaging and Functional Parameters in the Medial Gastrocnemius Muscle in Post-stroke Patients With Spasticity in the Lower Limb

US-function
Start date: February 27, 2024
Phase:
Study type: Observational

The goal of this observational study is to understand the impact of spasticity on muscle changes and functional performance in stroke patients with lower limb spasticity in comparison to non-stroke individuals. The main questions it aims to answer are: - How does spasticity affect muscle changes and lower limb functional performance in stroke patients? - How do structural and textural parameters in ultrasound images differ between spastic stroke patients and non-stroke individuals? Participants will undergo ultrasound evaluation of their leg muscles to measure structural and textural parameters. They will also take part in functional assessments to assess their performance in activities related to lower limb mobility. Researchers will compare the structural and textural ultrasound parameters between stroke patients and non-stroke individuals to determine any notable differences. The study aims to identify the relationship between muscle changes, spasticity, and functional performance in stroke patients.

NCT ID: NCT06405451 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Respiratory Muscle Training Program in Patients With Multiple Sclerosis

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

This is a quasi-experimental pre-post trial aimed at investigating the effects of respiratory muscle training (RMT) as trunk stabilization exercise in patients diagnosed with multiple sclerosis (MS)

NCT ID: NCT06341634 Enrolling by invitation - Healthy Clinical Trials

Surveillance of Suicide Ideation in Adolescents (VISIA)

VISIA
Start date: February 6, 2024
Phase:
Study type: Observational

The goal of this observational study is to validate an AI algorithm's capability to differentiate the population with suicidal ideation from a control population using various multimodal variables, including voice analysis, facial emotions, natural language, and proteomics data. The primary research question it aims to answer is: Is it possible to identify suicidal ideation and suicide risk in adolescents early and non-intrusively using multimodal data analysis through digital instruments equipped with artificial intelligence? Participants in this study will be asked to: Complete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation. Provide voice recordings, facial emotion data, and linguistic content in natural and specific contexts. Participate in salivary proteomics data collection. This study compares three distinct groups: Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation. General Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation. Researchers will compare these groups to determine if the AI algorithm is effective in differentiating individuals with suicidal ideation (Group 1) from both a clinical control group (Group 2) and a general population control group (Group 3) using the collected multimodal data. The study aims to assess the algorithm's ability to identify early signs of suicide risk in these distinct participant populations.

NCT ID: NCT06338917 Enrolling by invitation - Mental Health Issue Clinical Trials

Mental Health and Vigorous-intensity Physical Activity

+MoveMENT
Start date: September 10, 2023
Phase: N/A
Study type: Interventional

People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities. The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood.

NCT ID: NCT06304883 Enrolling by invitation - Clinical trials for Early Alzheimer's Disease

Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

APOLLOE4-LTE
Start date: April 2, 2024
Phase: Phase 3
Study type: Interventional

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

NCT ID: NCT06290960 Enrolling by invitation - Rectal Cancer Clinical Trials

Patient Reported Outcomes Following Cancer of the Rectum

PROCaRe
Start date: September 1, 2021
Phase:
Study type: Observational

The surgical management of rectal cancer includes a Total Mesorectal Exicison (TME). TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer. The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by pereoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/withou derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another pimary neoplasm), 10) rectal resection following a 'watch & wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be 3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023). It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.

NCT ID: NCT06282432 Enrolling by invitation - Clinical trials for Leukocyte Adhesion Deficiency

Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I)

Start date: March 9, 2022
Phase:
Study type: Observational

This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene