Effectiveness of a Digital Health Application for Psoriasis
PsoriasisThis clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis. Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels...
Healthy VolunteersThe purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental...
PrematurityExtreme Prematurity3 moreExtreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants. The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay. Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions. These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years. Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.
Protocol to Support Breastfeeding for Postpartum Women and Mothers of Babies With Congenital Heart...
BreastfeedingCongenital Heart DiseaseTo evaluate the effect of applying a hybrid protocol (face-to-face and via call center) of breastfeeding assistance and guidance on the duration of breast milk supply to babies with congenital heart disease for 6 months.
Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries
Shoulder InjuriesTo evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
Solid Tumors With HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)3 moreThis first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive...
Digestive System NeoplasmsThe purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC)The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell TransplantationAllogeneic Stem Cell Transplantation1 moreThis is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation...
Ventricular TachycardiaVentricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death. The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can deliver a painful shock to restore normal heart rhythm but importantly does not treat the underlying cause. Current treatment for the prevention of recurrent VT include catheter ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates with CA are around 50%. The trial is to compare 2 different types of ablation catheter that are used to cauterise small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will provide comparable efficacy and safety for the treatment of VT as the current industry gold standard (TF).