Clinical Trials Logo

Filter by:
NCT ID: NCT05109845 Not yet recruiting - Suicidal Ideation Clinical Trials

Virtual Reality and Speech Analysis for the Assessment of Impulsivity and Decision-making

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

Introduction: Impulsivity is present in a range of mental disorders and has been associated with suicide. Traditional measures of impulsivity have certain limitations, such as the time required for administration or the lack of ecological validity. Virtual Reality (VR) may overcome these issues. This study aims to validate the VR assessment tool "Spheres & Shield Maze Task" and speech analysis by comparing them with traditional measures. The hypothesis is that these innovative tools will be reliable and acceptable by patients, potentially improving the simultaneous assessment of impulsivity, decision-making, and jumping to conclusions. Methods and analysis: The sample consisted of adults divided into three groups: psychiatric outpatients with a history of suicidal thoughts and/or behaviors, psychiatric outpatients without such a history, and healthy volunteers. The sample size required was estimated at 300 participants (100 per group). Participants will complete the Barratt Impulsiveness Scale 11; the Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency, Impulsive Behavior Scale; Iowa Gambling Task; Continuous Performance Test; Stop signal Task, and Go/no-go task, three questions of emotional affect, the Spheres & Shield Maze Task and two satisfaction surveys. During these tasks, participant speech will be recorded. External and internal consistency of the VR environment will be calculated. The association between VR-assessed impulsivity and history of suicidal thoughts and/or behavior, and the association between speech and impulsivity and decision-manking will also be explored. Ethics and dissemination: This study will result in a series of manuscripts that will be submitted to peer-reviewed journals for publication. It is hoped that this VR assessment tool combined with speech analysis can be used regularly in research and/or clinical settings in the near future.

NCT ID: NCT05104593 Not yet recruiting - Stroke Clinical Trials

An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With Dementia

CAREPATH
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as: 1. An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc). 2. Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions. 3. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery. 4. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.

NCT ID: NCT05097300 Not yet recruiting - Clinical trials for Chronic Tension-Type Headache

Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache.

NCT ID: NCT05075434 Not yet recruiting - Plantar Fascitis Clinical Trials

Effects of the Diacutaneous Fibrolysis Approach in Patients With Plantar Fasciitis.

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

Diacutaneous Fibrolysis (FD) is a physiotherapy technique based on Cyricax's transverse massage. Kurt Ekman, its creator, observed that Cyriax's deep transverse massage was intended to achieve a mechanical effect on the tissues, but this had a series of disadvantages such as the difficulty in penetrating between tissue septa due to the large surface area of the finger tips, as well as its soft consistency in the face of adhesions or fibrosis. Hypothesis: Adding FD to the gastrocnemius and plantar fascia to a primary care treatment protocol will produce a decrease in the stiffness (viscoelastic property) of the plantar fascia, an increase in length, width, height and a decrease in the plantar arch, as well as an increase in the length of the gastrocnemius greater than not adding it in subjects with plantar fasciitis. Data collection. Once the participant has passed the selection criteria and signed the informed consent form, the measurements of the anthropometric variables and classification of the foot with the Foot Posture Index will be carried out. Subsequently, the dependent variables will be collected, starting with active and passive gastrocnemius flexibility, followed by measurements with the anthropometric foot measurement platform (foot length, arch height in loading and unloading, arch height index, foot width in loading and unloading, windlass force at 20º, 40º and maximum, myotonometry measurements (tone, stiffness, elasticity, relaxation and creep) and pain. Once the initial variables have been recorded, the first patient intervention will be carried out according to the assigned group. A total of 8 sessions will be carried out over 4 weeks (2 sessions per week). The variables of this study will be collected at the beginning of the study and at the end of the 8 intervention sessions (1 month). Intervention "Protocol The usual protocol that the health service guidelines for this pathology will be carried out. The protocol consists of calf stretching exercises, plantar fascia, proprioception exercises, ultrasound, magnet therapy and gait re-education and proprioceptive exercises. The average intervention lasts between 30-45 minutes. "Protocol "+FD Participants in this group will additionally receive 15 minutes of the treatment technique. The FD intervention will be carried out with the same duration and protocol for all participants. The intervention protocol will be: Start with the point of maximum tension between the two muscle bellies of the calf and hamstring (Reverse hook). Then work on the peroneus longus lateralis and soleus. Then the external calf muscle belly and soleus and the internal calf muscle belly and soleus. Then work on the tendon of the flexor hallucis proprio of the big toe and the inner edge of the Achilles tendon and peroneus longus. Then treatment of the peroneus longus with the peroneus brevis. Scraping of the insertion of the Achilles tendon, hooking of the internal and external part of the plantar fascia. Finally, longitudinal friction of the plantar fascia. The participant will be in prone position with a support on the front of the leg with the foot off the stretcher. The physiotherapist will be in a standing position next to the participant. The procedure will be to palpate the different intermuscular septa and grooves and then perform the FD phases with the hook (supplementary transverse traction).

NCT ID: NCT05062967 Not yet recruiting - Liver Diseases Clinical Trials

Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.

NCT ID: NCT05058625 Not yet recruiting - Clinical trials for Sports Physical Therapy

Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players

LMTP_Volley
Start date: October 15, 2021
Phase: N/A
Study type: Interventional

To evaluate the effects of dry needling of latent myofascial trigger points on vertical jump height in female volleyball players

NCT ID: NCT05053984 Not yet recruiting - Multiple Sclerosis Clinical Trials

Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

NEUROECO
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

The Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterised by the appearance of lesions, characterised by heterogeneity in their anatomopathological, clinical and radiological presentation. Its aetiology is complex and multifactorial, with genetic and environmental interactions with a predominance in women (3:1) and is the second leading cause of disability in young adults (25-30 years). It has a socio-economic impact, affecting interpersonal relationships and causing a significant reduction in quality of life. MAIN OBJECTIVE To assess the effect on spasticity of the Percutaneous Ultrasound-guided Neuromodulation (PMN) technique in patients diagnosed with MS with upper limb spasticity. SECONDARY OBJECTIVES - To assess changes in the strength parameter of the wrist flexor musculature wrist before and after the application of a PMN programme. - To assess changes in the functionality scales (modified Asworth, established for spasticity - To assess changes in the range of motion (ROM) of the joints under study. - Assess changes in the quality of life scale (MSQOL54). - To assess the adverse effects of the technique. All patients will receive a Percutaneous Echoguided Neuromodulation (PNM) in the median nerve at the elbow, medial to the brachial artery, running between the humeral and ulnar heads of the pronator teres muscle. Once the nerve is located, a needle shall be inserted in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle cont raction for 1.5 minutes. After assessing the correct application of ethics in the study, it was decided to use the individual's own baseline data as a control group, as simulating the technique is complex.

NCT ID: NCT05047276 Not yet recruiting - Clinical trials for Uveal Melanoma, Metastatic

Phase I/II Study of AloCelyvir in Patients With Metastatic Uveal Melanoma

PULSE-UM
Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomized, single arm, single center, phase I/II study of AloCelyvir in subjects with mUM to the liver, the main site for M1 in this disease. This study is divided into 3 phases: Screening, Treatment, and Follow-up. After informed consent is obtained, subjects will enter in the Screening phase to assess eligibility criteria and perform a mandatory tumor biopsy. Upon meeting criteria, eligible subjects will be entered into the Treatment phase. Patients will receive AloCelyvir in weekly intravenous infusions at doses of 0.5x106 cells/kg for 8 weeks. After 4 first treatment doses a new tumor biopsy will be mandatory. Treatment will be maintained for 2 months (8 weeks) but can be stopped earlier if disease progression, unacceptable toxicity, or patient withdrawal. Subjects that are no longer receiving AloCelyvir will enter the Follow-up phase. Subjects that are no longer receiving AloCelyvir because of unacceptable toxicity or due to investigator judgment will undergo radiological evaluations of the tumor every 8 weeks during the first 12 months (48 weeks), and then every 12 weeks until the progression of disease (progression follow-up). Subjects that are no longer receiving Alocelyvir because of progression will enter the long term OS follow-up until their death or until the end of the study, whatever happens before. Subjects who have switched to an alternative treatment without disease progression will receive a formal follow-up with images tests until progression, and after progression long term follow up to record the date of death.

NCT ID: NCT05040867 Not yet recruiting - Breast Cancer Clinical Trials

Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.

NCT ID: NCT05019118 Not yet recruiting - Clinical trials for Subclinical Hypothyroidism

Dietary Intervention With Únicla Dairy Products (DANTIAN)

DANTIAN
Start date: September 6, 2021
Phase: N/A
Study type: Interventional

Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism