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NCT ID: NCT06457633 Active, not recruiting - Fibromyalgia Clinical Trials

Effectiveness of Experiential Fibrowalk Therapy

EFW
Start date: May 9, 2024
Phase: N/A
Study type: Interventional

The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up, the efficacy in clinical symptoms and quality of life (3-month time horizon) of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia, in compare with original Fibrowalk and virtual Fibrowalk. Pre-post changes will be evaluated in various variables under investigation, will include kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity. The design of the present study with 3 treatment branches: Condition or disease Fibromyalgia Intervention/treatment Behavioral: TAU + Experiential Fibrowalk Behavioral: TAU + Fibrowalk Behavioral: TAU + virtual

NCT ID: NCT06457412 Recruiting - Obesity, Childhood Clinical Trials

Programme for Intervention in Paediatric Obesity

PinPo
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The PinPo program aims to carry out a comprehensive intervention for children aged 6 to 12 years with childhood obesity (with a BMI greater than the 99th percentile), fostering motivation and encouraging changes toward healthy lifestyle habits to achieve greater adherence and improved health. The program comprises 9 educational sessions designed by specialized professionals from various disciplines (pediatrics, psychology, nursing, nutrition), for a group of 10 children and another group of 10 family members and/or caregivers. These sessions are conducted in a hospital setting every 15 days, each lasting 90 minutes.

NCT ID: NCT06457399 Active, not recruiting - Airway Obstruction Clinical Trials

Heliox on the Work of Breathing in Adult Patients With Lower Airway Stenosis

Start date: April 27, 2022
Phase:
Study type: Observational

Heliox (a mixture of Helium and Oxygen) can reduce the work of breathing in patients with airway stenosis by modifying turbulent flow into laminar flow. The aim of this study was to analyze the effect of Heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured by electromyography and diaphragmatic ultrasound, thoracoabdominal synchrony assessed with plethysmographic bands, dyspnea, stridor, oxygen saturation, transcutaneous carbon dioxide value, blood pressure, heart rate and respiratory rate.

NCT ID: NCT06456502 Recruiting - Clinical trials for Post-acute COVID-19 Syndrome

Effectiveness of Non-invasive Neuromodulation in Patients With Long-COVID

Start date: June 2024
Phase: N/A
Study type: Interventional

Sleep quality and duration are critical to cognitive, emotional and physical well-being, and poor sleep quality has been associated with an increased risk of cognitive, psychological and cardiometabolic disorders. Several important physiological activities occur during sleep including a reduction in heart rate and blood pressure. In addition, sleep exerts important modulatory effects on hormone release. Previous studies have shown that lack of sleep can generate exaggerated cortisol responses or psychological and physiological stressors. Cortisol has widespread effects throughout the body and brain, affecting mood, arousal, energy, metabolic processes, and immune and inflammatory system functioning. Therefore, disruptions in cortisol secretion during the night can influence a wide variety of processes in our body that may contribute to the perception of poorer sleep quality. In addition, the salivary enzyme α-amylase is considered a biomarker of cognitive, psychosocial, emotional or physical stress. It is important to note that the autonomic nervous system (ANS) regulates several physiological processes, including heart rate, blood pressure, respiration, and digestion. The ANS consists primarily of the sympathetic system and the parasympathetic system. Increased parasympathetic activity is considered to promote health, whereas a dominant or overactive sympathetic branch is considered to be detrimental to health. A recent study found that both sleep quality and quantity of sleep were associated with resting ANS functioning. They found that poorer sleep quality was associated with greater sympathetic dominance. Research on the sympathetic and parasympathetic branches of the ANS has shown that autonomic imbalances are precursors to disease formation and other health-related risks. Coronavirus disease 2019 (COVID-19), has in many cases involved the presence of long-lasting symptoms several weeks or months after surviving acute infection with the virus, leading to a new disease called long COVID-19 or post-COVID-19 syndrome (PCS). A recent study showed that sleep quality influences the relationship between symptoms associated with sensitization and mood disorders with health-related quality of life in people suffering from long COVID. Non-invasive neuromodulation directed to ANS may be an option to treat the sleep disorders observed in patients with long COVID. OBJETIVES: Therefore, the primary objective of this study is to evaluate the efficacy of a treatment protocol on the ANS by means of non-invasive neuromodulation in aspects related to sleep in long COVID patients compared to placebo. As secondary objectives, we propose to evaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulation in aspects related to ANS functioning, psychological variables, fatigue, pain perception and quality of life in patients with long COVID.

NCT ID: NCT06456125 Active, not recruiting - Hemorrhage Clinical Trials

Safety and Efficacy Of Amber Peripheral Liquid Embolic System

OPAL
Start date: June 12, 2024
Phase: N/A
Study type: Interventional

A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs. The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06455436 Recruiting - Wound Heal Clinical Trials

Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments

Start date: May 8, 2024
Phase: N/A
Study type: Interventional

The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.

NCT ID: NCT06455150 Not yet recruiting - Clinical trials for Pelvic Floor Disorders

Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary

Start date: September 2024
Phase:
Study type: Observational

The objective of the study is to know the prevalence of pelvic floor dysfunctions in female badminton athletes compared to sedentary women, and the hypothesis is that the prevalence of pelvic floor dysfunctions is going to be higher in female badminton athletes.

NCT ID: NCT06454734 Recruiting - Clinical trials for Lymphedema, Lower Limb

Shock Wave Therapy for Lower Limb Lymphedema

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.

NCT ID: NCT06453174 Active, not recruiting - Psychosis Clinical Trials

CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project

CLUMP
Start date: January 1, 2024
Phase:
Study type: Observational

CLUMP is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (FEP). We aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with FEP. To achieve this aim, our objectives are to: (1) Introduce a pioneering early intervention model of Personalised Precision Psychiatry, including pharmacogenetics, for patients with FEP; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. We shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with FEP followed for one year. One cohort will be comprised of patients treated before the implementation of the early intervention model of Personalised Precision Psychiatry, and the other of new patients treated under this model. Also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.