Fibromyalgia

This is a randomized controlled trial (RCT) to investigate potential effects (positive and negative) of a 3-day course with follow-up for 100 adults with CFS/ME. The 3-day course used in this trial is named the Lightning Process (LP). The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology. Positive and negative effects of the course on symptoms, disability and quality of life will be investigated, and a long-term follow-up of work participation conducted. Any adverse events experienced during or after the 3-day course will be handled according to protocol.

Multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on MR mixed reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.

The aim of the study is to check whether vagus nerve stimulation (VNS) combined with manual therapy (TM), given its neuroanatomical relationship with the structures involved in pain in the TMJ, is more effective in reducing pain, increasing joint range and increasing the quality ofthe patient lives than TM alone. The research team is made up of three physiotherapists. It has been decided to distribute the tasks as follows: * Physiotherapist 1 will be in charge of the treatment of all patients. * Physiotherapist 2 will be responsible for screening the sample and evaluating the study. * Physiotherapist 3 will be in charge of analyzing the results and statistics. This component of the team, being blinded and not knowing the group of origin of the patient, will be able to interpret the results without any type of convenience bias, showing absolutely transparency in the elaboration of the conclusions. Once the screening will be completed, the patients will be divided into two groups: an experimental group (TM + ENV) and a control group (TM + ENV placebo).The randomization will be carried out through the statistical program Epidat 4,237 9 obtaining two homogeneous groups. Each patient will be assigned a code with the aim that the physiotherapist who is in charge of the statistical analysis is not able to establish links between the data and the subjects to which it refers.

The study will be divided into three parts: Part A: Single Ascending Dose - healthy participants cohorts with up to 5 dose levels. Part B: Multiple Ascending Doses - healthy participants cohorts with up to 3 dose levels. Part C: Surgical patients cohorts with up to 3 dose levels. The primary Objective is to investigate the safety and tolerability of TT5 in single and multiple ascending intravenous doses in healthy participants and in surgical patients. The Secondary Objectives are To investigate the pharmacokinetics (PK) of TT5 after single and multiple ascending intravenous doses in healthy participants and after intravenous doses in surgical patients. * To investigate the acute and chronic psychological subjective response of the healthy participants and surgical patients to TT5 * To assess the pharmacodynamics (PD) of TT5 after intravenous doses in surgical patients. Exploratory Objectives areto explore potential fluid biomarkers for TT5

This project seeks to contribute to the evidence base regarding the utility of active distraction techniques, such as Grasp, in pediatric clinical settings. Findings may inform the development of non-pharmacological interventions aimed at improving the patient experience and reducing procedural distress among children. Grasp is a communication tool comprising both hardware and software components. The hardware consists of a handheld, soft silicone ball embedded with pressure sensors capable of detecting squeezes of varying intensity and duration. The software component is a dedicated application designed for use on an iPad, which forms an integral part of the system. Squeezing the ball generates visual and auditory feedback in real time via the application, presented through dynamic curves and sound cues, including musical elements. Data from the pressure sensors is transmitted live to the software via Bluetooth, enabling immediate sensory feedback. Grasp is CE-marked and registered as a medical device under ID NO918873724/0943-55311 by the Norwegian Directorate of Medical Products. The primary objective of this study is to evaluate the efficacy of Grasp as an active distraction tool in reducing perceived pain and distress in children undergoing minor but potentially distressing medical procedures. We aim to recruit children aged 8-15 years from Children and Youth Clinic (CYC) at Helse Bergen HF, Helsebanken General Practice, and TkVestland Dental Center. The procedures involved include peripheral venous cannulation (CYC), venipuncture for blood sampling (Helsebanken), and administration of local anesthesia via injection (dental clinic). Participants will be allocated using block randomization. The intervention group will engage with the Grasp system by repeatedly squeezing the ball before and during the procedure, triggering musical feedback. The control group will undergo standard care without the use of Grasp. We aim to recruit 50 participants at CYC, 50 participants at TK Vestland dental clinic and 20 participants at Helsebanken General Practices.In addition, we will explore the use of Grasp in six patients admitted to hospital with a newly diagnosed diabetes mellitus type 1 who will use Grasp during blood sugar measurement or subcutaneous insulin administration. (These six participants will not participate in the randomized controlled part of the study.) The primary outcome measure will be self-reported pain, assessed using a combined visual analogue scale (VAS) and numeric rating scale (NRS) (0-10). The secondary outcomes will include self-reported distress, measured using a combined VAS/NRS scale, as well as parents' or legal guardians' assessments of their child's pain and distress, also rated on a similar scale. Additionally, six participants recruited at CYC who have prior experience with peripheral venous cannulation and underwent the procedure using Grap, will be invited to take part in individual semi-structured interviews. These interviews will explore their subjective experiences with the intervention. The participant will fill out a paper form questionnaire prior to randomization regarding their prior experience, anticipated pain and how anxious they are about the upcoming procedure. Immediately after the needle prick procedure participants and parents will fill out the second form regarding their experience during this procedure. The participant at the dental office will be offered to use the Grasp further through the dental treatment and all participants and parents at the dental office will complete a final similar questionnaire after the completion of dental treatment. Multiple linear regression analyses will performed to examine the impact of the intervention adjusted for baseline scores. Statistical analyses will be done in R version 4.2.3. Systematic text condensation will be used to analyse the interviews.

This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.

Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.

An elevated Body Mass Index (BMI) in the child population represents a significant global public health concern. According to the World Health Organization (WHO), overweight occurs in children aged 6-19 when the BMI exceeds one or more standard deviations from the median established in WHO child growth patterns. Epidemiological data reflects that since the late 20th century, childhood obesity has increased from 4.9% (31.5 million) to 6% (40.6 million) worldwide. According to data from the Childhood Obesity Surveillance Initiative (COSI) within the European Union (EU), children in Spain aged 6-9 have a 42% overweight rate and a 19% obesity rate. In comparison, girls have a 41% overweight rate and a 17% obesity rate, positioning Spain as the fourth EU country with the highest prevalence of overweight and obesity in children. Within the national territory, 4 out of 10 schoolchildren have excess weight, with the highest prevalence in the southern regions. The autonomous community with the lowest incidence of childhood overweight is Navarra, with 15%, and the highest is the Region of Murcia, with 40%. Andalusians present a high prevalence rate of 33.4%. In general, the country's northern regions have lower figures, while the southern region has the highest rates of childhood overweight. It has also been observed that there is a higher likelihood of being overweight in rural areas than in urban areas. This could be due to regional differences in habits during the three critical periods for the development of childhood obesity: the preconception period involving maternal factors, the first 1000 days of life (9 months of pregnancy + 2 years of life), and the adiposity rebound between 5-7 years. Childhood overweight is also highly influenced by factors such as maternal overweight, early introduction of complementary feeding before 6 months of age, smoking during pregnancy, low parental educational levels, and the excessive use of screens such as mobile phones or tablets at an early age. The most relevant factors in overweight are diet, physical inactivity, physical activity, and lifestyle habits. However, when it comes to minors, all these factors are strongly influenced by the cultural, social, and institutional environment, as well as the family's socioeconomic level. In Spain, Andalusia is one of the autonomous communities with a lower income index (0.67) and a lower average expenditure on public health at 0.33%. However, the community puts in the most effort to implement policies against obesity, with a score of 5.19. Numerous campaigns have been launched to prevent childhood obesity, developed by the Spanish Agency for Consumer Affairs, Food Safety, and Nutrition (AECOSAN) as part of the nutrition, physical activity, and obesity prevention (NAOS) strategy. Additionally, the Andalusian Ministry of Health and Families has implemented plans such as "Growing in Health," "Evaluation of Food Offer in Andalusian Schools 2019-2020," and the "Health throughout Life" campaign. All these programs coincide on three fundamental aspects when addressing childhood obesity: interventions to modify dietary habits promoting balanced and healthy eating, increasing fruit and vegetable consumption while minimizing sugar intake; interventions to promote physical activity, encouraging at least one hour of exercise daily; and, lastly, family involvement interventions to achieve proper adherence to these changes. These interventions are necessary today because, over the past decades, there have been changes in eating patterns and diets, resulting in a decrease in the consumption of fruits, vegetables, legumes, and fresh products, as well as an increase in the consumption of processed foods with higher sugar, fat, salt content, and poorer nutritional quality. According to COSI initiative data, Spain is where children consume the least fruits and vegetables daily. There have also been changes in physical activity, with studies showing that 25% of Spanish children are sedentary. One of the direct consequences of childhood overweight is morphological heart alterations, reflected in left ventricular hypertrophy and cardiac diastolic alterations. Numerous scientific studies have established a close relationship between obesity in children and adolescents and an increase in epicardial fat, which can lead to cardiac and vascular abnormalities. In fact, having a high BMI at a young age has become a significant risk factor for the premature development of cardiovascular diseases that were previously considered exclusive to adults. These changes are visible through echocardiography, especially in epicardial fat. As a non-invasive diagnostic tool, Echocardiography has gained a fundamental role in early detection of these alterations in the pediatric population affected by an increase in epicardial fat. Its early implementation allows for precise cardiac and vascular function assessment, improving these young patients' quality of life and prognosis. These measurements and modifications have been analyzed recently, although more data on younger populations and post-pandemic needs to be collected. Furthermore, to address this growing challenge, it is crucial to raise awareness about the importance of maintaining a healthy weight early and promote research and the application of preventive and intervention strategies to reduce epicardial fat in the pediatric population. Due to all the aforementioned reasons, coupled with the limited number of current publications that deeply analyze the consequences of childhood obesity on the development of the musculoskeletal system and children's mobility, it is essential to conduct a study of the population and subsequently intervene to promote healthy growth and development in children. Therefore, the objective is to establish the impact of a nutritional intervention by a school nurse on a group of schoolchildren.

This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study the efficacy of 8 in-office acute treatment sessions (first 8 weeks) and 6 telephone delivered sessions (3 individual and 3 group) in the following months (from 9-36 weeks) of PATH- Pain vs. an equal number of sessions consisting of Attention Control Usual Care in improving cognitive, affective, and functional outcomes. Each therapy session will last approximately 50 minutes. Assessments will be conducted at study entry and weeks 5, 9 (end of acute treatment; includes assessment of cognitive functioning), 24, 36 (end of follow-up treatment; includes assessment of cognitive functioning) and 52 (includes assessments of cognitive functioning) after randomization. This is an efficacy trial, but by being delivered by certified mental health clinicians, it has a strong "real-world" focus.

With the approval of Ethics Committee of the McGill University Health Centre, a total of 69 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care one day before surgery All ICBs will be supervised by the coauthors and conducted preoperatively in an induction room. After skin disinfection and draping, the ICB will be performed with a previously described technique. In each group, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL plus PN 2 mg dexamethasone. The injectate will be slowly injected through the block needle. Patients will be randomized to receive the study drug, PN dexmedetomidine 0.67 mcg/kg or PN dexmedetomidine 1 mcg/kg, or PN dexmedetomidine 1.33 mcg/kg mixed with the above-mentioned LA solution. A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient, and investigator assessing the block will be blinded to group allocation. The primary outcome will be the duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers) for patients with successful ICBs. Patients will be provided with a data sheet and asked to record the time at which motor function returns. An investigator blinded to group allocation will collect this data sheet in person (inpatients) or by phone (outpatients) on postoperative day 1.