,athens, Greece

Stress and Musculoskeletal Health in Employees

The goal of this non-pharmacological randomized interventional study is to investigate work-related stress in relation to the musculoskeletal health of employees. The primary purpose of this study is to investigate if stress management interventions in employees can improve self-reported musculoskeletal health problems or Medically Unexplained Symptoms (MUS), in relation with biomarkers of stress. Secondary outcomes will include quality of life improvement and the number of absences from work, due to musculoskeletal conditions. The main question aims to answer if specific stress management techniques can improve the self-reported musculoskeletal health of employees. Researchers will compare the results between two groups (one participating in the the six (6) week program and the other not participating) to measure the effect size in the intervention group and between groups. Participants from both groups will be measured twice (on week 1 and week 8) with the same self-report questionnaires and stress biomarkers, if possible. Especially for the intervention group a six-week stress management program will be applied. This will include the participation in one and a half hour consultation meetings about stress, musculoskeletal health, psychosocial work-related factors, and how to improve well-being and work/life satisfaction.

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT

UAMs are a particularly vulnerable population, facing significant risks due to the compounded effects of trauma, displacement, and lack of family support. The study aims to fill a critical gap in the literature by providing an empirical evaluation of TF-CBT for this population, as no previous studies have utilized an RCT design to assess TF-CBT for UAMs in the Greek context. Study Objectives and Rationale The primary aim of this study is to empirically validate the effectiveness of TF-CBT for UAMs with PTSD symptoms. Secondary objectives include the adaptation of TF-CBT to the Greek cultural context, the development of guidelines for its implementation, and the provision of professional training for psychologists working with UAMs. The study will also assess the impact of TF-CBT on emotional well-being, PTSD symptoms, and overall mental health. Given the growing refugee population in Greece and the high levels of trauma experienced by UAMs, the need for culturally appropriate and evidence-based mental health interventions is urgent. Study Design and Methodology The study adopts a single-blinded, randomized controlled trial pre-post design, to compare the intervention group (TF-CBT) with the control group (TAU) and assess the efficacy of TF-CBT in accommodation centers and Supported Independent Living (SIL) programs in Greece for UAMs. Effectiveness will be evaluated through within-group comparisons of pre-treatment and post-treatment outcomes for the intervention group, as well as between-group comparisons of the TF-CBT group (n = 30) and the TAU group (n = 30). It is a multicenter study conducted across multiple refugee accommodation centers and Supported Independent Living (SIL) programs throughout Greece. Participants will be randomly assigned to either the intervention group (TF-CBT) or the control group (TAU). The trial will be conducted at three key time points: baseline (T0), immediately after the intervention (T1), and three months post-intervention (T2). Data will be collected through structured questionnaires, including the Child and Adolescent Trauma Screen (CATS) to evaluate trauma exposure and PTSD symptomatology, the Depression, Anxiety, and Stress Scale - 21 items (DASS-21) to measure levels of depressive, anxious, and stress-related symptoms, the Patient Health Questionnaire - 15 (PHQ-15) to assess somatic symptoms, the Strengths and Difficulties Questionnaire (SDQ) to evaluate emotional and behavioral difficulties and the World Health Organization - Five Well-Being Index (WHO-5) to assess overall emotional well-being and quality of life. All tools will be administered in languages familiar to the participants. Official or validated translations will be used when available. These include Greek, English, French, Arabic, Urdu, and Somali. Where validated translations are unavailable, community-based translation and back-translation procedures (Beaton et al., 2000) will be applied, with the assistance of trained volunteer interpreters to ensure cultural and linguistic appropriateness. While psychologists will oversee the assessment process to ensure it remains supportive and non-intrusive, they will not have access to the assessment data or results. Interpreters will be present when required to facilitate understanding, but they will not participate in the assessment itself. All responses will be anonymized and used solely for the purpose of evaluating the intervention's effectiveness. Psychologists, who are employed by the accommodation centers and Supported Independent Living (SIL) programs, will also be randomly assigned to the intervention or the control group. Therapists of the intervention group will receive specialized training in TF-CBT prior to the start of the study to ensure the highest quality of treatment and they will administer TF-CBT intervention under supervision. The TAU approach involves minimal intervention, consisting of routine clinical management and psychological support without a structured therapeutic framework. Moreover, the study will be conducted in collaboration with trained interpreters, to ensure that language barriers do not hinder the delivery and evaluation of the intervention. Demographic Data and Inclusion Criteria Participants in the study will be UAMs aged 15-18 years, currently residing in accommodation centers and Supported Independent Living (SIL) programs in Greece. To be eligible for inclusion, participants should have arrived in Greece as unaccompanied minors, be within the specified age range (15-18 years), have a formal diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria, or present with moderate to high levels of traumatic distress as indicated by the Child and Adolescent Trauma Screen (CATS), have maintained a stable living arrangement for at least 2-3 weeks prior to the intervention, and not be scheduled for relocation or transfer within the upcoming 2-3 months following the intervention's initiation. Exclusion criteria include: Diagnosed intellectual disability (IQ < 70) or other developmental disorders that may hinder participation, acute suicidality or recent severe self-injurious behavior, significant risk of violence toward others, comorbidity with bipolar disorder or psychotic disorders, and ongoing substance abuse or active addiction. Demographic information collected at baseline from both participants and the psychologists delivering the intervention will include age, gender, country of origin, and native language. Power Analysis The sample size for this study was determined based on an a priori power analysis conducted using G*Power software. A two-tailed t-test for independent samples, with equal group sizes, was selected as the statistical test. The significance level (α) was set at 0.05, and the desired statistical power was 0.80, consistent with standard practice. The analysis indicated that, for an effect size (d) of 0.75, a minimum of 29 participants per group would be required to achieve satisfactory power. Given this calculation, a sample size of 30 children per group was determined to provide adequate statistical power (1-β) to detect meaningful differences between groups at the specified effect size. Data Collection and Statistical Analysis Data collection will be conducted electronically using Google Forms, ensuring full confidentiality and participant anonymity. All responses will be anonymized and utilized to evaluate the effectiveness of the intervention across assessment time points. Statistical analysis will be conducted using SPSS latest edition. Descriptive statistics will summarize the key variables, and independent t-tests and chi-square tests will assess baseline equivalence between the groups. To evaluate the effectiveness of the intervention, a repeated measures ANOVA will examine the interaction between group (intervention vs. control) and time (pre-intervention, post-intervention, and follow-up). Effect size calculations (partial eta-squared and Cohen's d) will be used to quantify the magnitude of observed effects. Ethical Considerations The study will be conducted in full compliance with the Declaration of Helsinki and has received ethical approval from the Ethics Review Board of Panteion University in Athens, Greece. All participant data will be handled in accordance with the General Data Protection Regulation (GDPR). Prior to participation, all participants will provide informed consent, and psychologists will ensure that the process is voluntary and anonymous. To protect participants' confidentiality, a personal identification code will be used to link responses across time points without collecting personal identifiable information. Data will be securely stored and only accessible by the researchers involved in the study. Challenges and Limitations Conducting RCTs in refugee populations presents unique challenges, such as limited resources, high mobility of participants, and logistical constraints. The transient nature of UAMs necessitates short follow-up periods, which may limit the ability to assess long-term outcomes. Additionally, cultural and language barriers may affect the implementation and interpretation of both the intervention and assessment tools. However, this study will address these issues using culturally adapted tools, translator verification, and flexible intervention protocols. Expected Outcomes and Impact The study is expected to provide valuable insights into the effectiveness of TF-CBT for UAMs, contributing to the development of evidence-based guidelines and best practices for treating PTSD in this population. By improving mental health outcomes and offering training for psychologists, the study aims to enhance the quality of care for UAMs in Greece and other refugee-hosting countries. Furthermore, the findings will inform future research on trauma-focused interventions for refugee populations, with the potential for broader application across Europe and beyond.

GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms

Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Several factors seem to contribute to its development, such as psychological stress, intestinal dysbiosis, infections, post-traumatic syndrome and genetic predisposition. Regarding the nutritional management of IBS, there are several approaches to alleviate symptoms, such as the low-fructose diet low in fermentable oligosaccharides, disaccharides, monosaccharides and FODMAP polyols (LFD), recommendations from the British Institute of Health and Care Excellence (NICE) and the recently proposed combination of the Mediterranean diet and LFD (MED-LFD) proposed by our Research Group. However, genetic background expressed in single nucleotide polymorphisms (SNPs) appears to influence the response to even dietary interventions. The aim of this GWAS is to identify SNPs that are associated with the negative or positive response to the diet. At the baseline, blood samples will be collected for DNA extraction. Genotyping will be based on Next Generation Sequencing (NGS) technology to detect genetic factors associated with the effectiveness of the intervention. Symptom severity will be measured by the IBS-SSS scale. Mental health status will be assessed with the HADS (Hospital Anxiety and Depression Scale) questionnaire. Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial

Fibromyalgia is a multidimensional disease, as many factors contribute to its development (biological, genetic, psychosocial). As a result, it demands a multifaceted approach, from patient education to pharmacological treatment etc. Regarding the pharmacotherapy, that should be aimed at a mechanism-oriented fashion. [7] Consistent with this approach, centrally acting medications can be effective in fibromyalgia, particularly antidepressants and anticonvulsants, which increase the presence of pain-inhibitory neurotransmitters by facilitating descending pathways and decreasing dorsal horn sensitization, or decreasing systemic hyperexcitability. Clinical trials have failed to conclusively provide overall benefits of specific therapies to treat fibromyalgia. Therefore, current pharmacological treatments for patients suffering from this syndrome are mainly directed to palliate some symptoms, with relevant clinical benefits experienced only by a minority of individuals. In those treated with pharmacotherapy, a 50% reduction in pain intensity is generally achieved only by 10% to 25%. However, some treatments seem to significantly improve the quality of life of certain FM patients. Only a few drugs have been approved for use in the treatment of FM by the US Food and Drug Administration (FDA), whereas no drug has been approved for this indication by the European Medicines Agency. Thus patients with FM frequently need to be treated on an off-label basis. Currently, only 25% to 40% pain reduction is granted by drugs and meaningful relief occurs in only 40% to 60%, in part due to dose-limiting adverse effects and incomplete drug efficacy. These limitations in clinical practice have led some to hypothesize that a combination of different analgesic drugs acting through different mechanisms may provide superior outcomes compared to monotherapy. Moreover, drugs should be started at low doses and cautiously titrated because severalpatients, either do not tolerate or benefit from drug therapy. Because sleep disturbance, pain and psychological distress are the most amenable to drug therapy, drugs should be chosen to manage the individual's predominant symptoms. Currently, several drugs are frequently used alone or in combination to manage FM symptoms. However, the US FDA indicated for FM only three: two selective serotonin and norepinephrine reuptake inhibitors (SNRIs), duloxetine and milnacipran as well as an anticonvulsant, pregabalin. Although clinical evidence demonstrating the efficacy or effectiveness of opioids analgesics is scanty, these molecules are widely used for the treatment of FM. However, the long-term use of opioids in FM has been discouraged by several medical guidelines. As a result, there comes a need of a new treatment of fibromyalgia syndrome, which will be effective, safe, easily applied, with almost no side effects and low cost. Non-invasive neuromodulation techniques are gaining more and more the interest of the scientific society as regards a variety of medical conditions, such as chronic pain, epilepsy, rheumatoid arthritis. Transcutaneous Vagus Nerve Stimulation (tVNS) is one of these new techniques. The parasympathetic vagus nerve (10th cranial nerve) innervates multiple internal organs and integrates sensory, motor, and autonomic information by four vagal nuclei. The primary central relay of vagal afferents is the nucleus of the solitary tract in the brainstem, and several branches of this nucleus, project to different brain areas. The myelinated A- and B-fibers of the vagal nerve send somatosensory, motor, and autonomic signals, and the complex system of vagal projections is involved in inflammatory, immune, nociceptive, and emotional processes. A relevant role of the vagal nerve in pain processing is the transmission of peripheral inflammation signals to the central nervous system. Neuromodulatory activity has been identified in areas related to the sensory and emotional processing of pain, such as the insular cortex and the Anterior Cingulate Cortex (ACC), after vagal stimulation, which reveals that the central system of pain processing receives vagal afferences. In 1988 the first human implant of a vagal stimulating device was performed. In 1997, the US Food and Drug Administration (FDA) approved the use of Vagal Nerve Stimulation (VNS) as anadjunctive treatment for medically refractory epilepsy. Vagus nerve stimulation is a FDA-approved treatment for different pathologies. The regulation of the autonomic and immune systems and a specific effect on chemical mediators of inflammation are relevant physiological mechanisms of the VNS. At the present research study, we will use the 2016 revision to 2010/2011 ACR fibromyalgia diagnostic criteria. The treatment of fibromyalgia is based on a biopsychosocial approach and includes pharmacological and non-pharmacοlogical approaches, according to the EULAR recommendations. However, patients are still reporting high pain scores and increased interference with quality of life. Considering that the vagus nerve controls pain signals towards the central nervous system and growing evidence of autonomic dysfunction in fibromyalgia in terms of sympathetic hyperactivity, it can be argued that rebalancing the sympathetic- parasympathetic activity via vagal stimulation might reduce the intensity of pain and stabilize the autonomic symptoms of this disease. In addition, an immune system alteration seems to mediate the interaction between the autonomic nervous system and the chronic inflammatory state in fibromyalgia, apparently by the influence of inflammatory cytokines and chemokines. Stimulation of the auricular and cervical branches of the vagus nerve might reduce such inflammatory overactivity via efferent modulation of the activity of the inflammatory processes and hereby reduce pain symptoms. The potential of non-invasive stimulation of the auricular and cervical branches of the vagus nerve in repeated sessions to improve fibromyalgia symptoms has not been evaluated in randomized, sham-controlled clinical studies. Transcutaneous stimulation of the auricular and cervical branches of the vagus nerve (tVNS), are both non-invasive, low-intensity electric stimulation procedures. According to literature, the effectiveness of these non-invasive methods might not differ significantly from the invasive vagus nerve stimulation, while non-invasiveness provides an advantageous safety profile. Since fibromyalgia involves a dysregulation of the autonomic and immune systems, non-invasive tVNS is expected to improve the symptoms of fibromyalgia, including chronic, musculoskeletal, and generalized pain, through modulation of the vegetative and immune systems. The purpose of the proposed double blind placebo controlled randomized clinical trial is to investigate the effect of tVNS in Chronic Pain compared to medication and the future establishment of the given technique in the clinic. The research interest of the scientific community is growing more and more in recent years. However, research in thisfield is still in its infancy stages. At the same time the holistic treatment of chronic pain, including its neurobiological, psychosocial, cognitive and behavioral components, may become a valuable aid-giver in the best completion of the research project. Research question and Aim The hypothesis of our study is to evaluate, if the addition of transcutaneous stimulation of the auricular branch of the vagus nerves in patients suffering with fibromyalgia can lead to better pain control and quality of life. To investigate this, we will offer a 2 week treatment (14 sessions) in a double-sham controlled study. This study is designed to determine whether the standard pharmacological treatment paired with 14 sessions of tVNS can improve pain symptomatology in fibromyalgia and the whole range of FM symptoms, such as depression, anxiety, fatigue etc. by using appropriate scales as Numerical Rating Scale (NRS), Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Depression and Anxiety Stress Scale (DASS), Materials and Methods (binding+sham) Participants Our population will be comprised of fibromyalgia patients that are originally diagnosed or referred to Aretaieion Pain Clinic. For the diagnosis (or confirmation of diagnosis) we will be using the ACR (American College of Rheumatology) 2016 revised criteria. The present single center double blind sham-controlled randomized clinical trial will be conducted at the Pain Clinic of Aretaieion University Hospital, National and Kapodistrian University of Athens. Recruitment Methods Investigators may contact (or be contacted by) a potential subject by telephone or email or direct contact to discuss participation in this research protocol. The investigator will provide the subject with all the information contained in the written consent form and at the same time she will answer any questions regarding the research and give the subject sample, time to consider participation in the study, which may require a follow-up phone conversation or an in-person appointment at the Pain Clinic for a brief study enrollment screening visit.

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)