Localidad Puente Aranda, Colombia

  • Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"

    Methodological design: For the purposes of the present study, a double-blind, two-arm randomised clinical trial will be conducted. Participants in the intervention group will undergo and exercise protocol with the use of blood flow restriction (BFR). Participants in control group will follow the same exercise protocol but with sham BFR instead. Both groups will follow the same brace protocol. Intervention group: The intervention group will consist of people with a recent ACL tear who meet the eligibility criteria. Participants in this group will follow a splint use protocol. In particular, during the first 3 weeks (phase 1) a splint will be used with the knee immobilised at 90°, non-weight bearing walking with the use of walking aids according to age and mobility. During the 4th and 5th week (phase 2) the range of motion of the splint will be set to 60° to 90° and from 30° to 90° respectively. Walking will remain non-weight bearing. During the 6th week (phase 3) the degree of freedom of the splint will be placed at 0° allowing full flexion but preventing hyperextension of the joint. During this phase, partial bearing is allowed with the use of a walking aid. From the 7th week (phase 4) onwards the splint is removed and walking is done with no loading restrictions. Regarding the exercise program, participants in this group, during phase 1, will perform isometric quadriceps and hamstring contractions guided by a visual stimulus from an electronic hand dynamometer. The exercise parameters will be 75 repetitions divided into 4 sets (30,15,15,15) at 30% of the 1st maximum of the opposite leg. During phase 2, the exercise protocol is maintained as phase 1 with the only differences that the exercises will be performed at 60 degrees too. Additionally, the "sliding" exercise will be added where the heel is dragged on the bed causing knee flexion as well as the skateboard sliding exercise from a seated position in the allowed range of motion. Exercise parameters remain the same for all exercises as previous phase. In the 3rd phase, single leg squats up to 45° are added. Exercise parameters remain the same. In the 4th phase, the exercise protocol changes. Subjects start at a stationary bike for 5 minutes (without BFR) and the quadriceps and hamstrings isometrics are replaced with resistance exercises for extension and knee flexion. Sliding and single-leg squats are performed at an increased range of flexion (up to 90°) and climbing a 30cm step is added. All exercise parameters remain the same as in the previous phases. During the last phase (5th) gait retraining on a treadmill for 5 minutes and Y balance exercise is added. Both of these exercises will be performed without BFR. The break between sets will be 30 seconds and between exercises 1 minute. The exercise program of the intervention group will be performed under lower extremity blood flow restriction. Cuff pressure will be reduced during the breaks. The execution speed of the exercises will be 2 seconds of contraction followed by 2 seconds of return. Hold in all isometric exercises will be 3 seconds. Initial measurements will be taken upon enrollment of participants and will include MRI, Lachman test, arthrometer, strength, swelling, Lysholm scale, Tegner scale, pain (Vas), exercise pain (Vas). By the end of 2nd and 4th week, strength, swelling and pain (Vas) will be reassessed. The final measurements will be taken at the end of the intervention period and will include all the measurements taken initially. The participants will be given a home-base exercise program through an electronic platform which will provide the possibility of monitoring their compliance. At the same time, through the platform, the correct execution of the exercises will be ensured as all the exercises will be presented with videos and specific exercise parameters. Control Group: The control group will perform an identical program of splinting, exercises, home exercises and measurements as the intervention group. The blood flow restriction protocol will be performed in an identical manner to the intervention group, with only difference being that variables setting will be set at a control program (sham).

    Phase

    N/A

    Span

    35 weeks

    Sponsor

    European University Cyprus

    Nicosia

    Recruiting

  • Correlation of the Genetic Constitution of the Spent Blastocyst Media

    The study and selection of embryos before transfer is a key step for the success of infertility treatments in assisted reproduction. The current techniques applied are called preimplantation genetic testing of aneuploidies (PGT-A) and are highly sensitive and specific, although they require the retrieval of four to six cells (a biopsy) from an embryo at an early stage of development (blastocyst stage). Nowadays, the alternatives for embryo selection given to young and healthy women or to couples that do not want to undergo PGT-A are based on studying the morphology and development of the embryos. Unfortunately, these are not reliable methods to know if the embryos have the right number of chromosomes. A new method called non-invasive PGT-A (niPGT-A) analyses the genetic material released by the embryo to the culture medium (Spent Blastocyst Media, SBM) where the embryo grows in the IVF lab. This genetic material allows for identification of the chromosome number of the embryo. In a previous pilot study, the results of the analysis of the culture media were concordant with the results of the embryo biopsy in 85% of cases. The current study will analyze the genetic constitution of the SBM and correlate the results of the same analysis on the inner cell mass (ICM) and trophectoderm (TE) cells taken in different locations (multifocal biopsy) to improve our understanding of the mechanisms and origin of the embryo genetic content released to the culture medium during its preimplantational development. Once this prospective and observational study is approved by the competent Research Ethics Committee, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent only after finishing their assisted reproductive treatment. To comply with the design of this pilot study, a total number of 200 blastocysts donated to research after IVF/ICSI or PGT-A cycles has been estimated to generate enough results. After warming, blastocysts will be subjected to multifocal biopsies of TE, ICM isolation and collection of the SBM. This part of the study will be performed in the collaborating centers. Samples will be shipped to Igenomix Spain for the genetic research and further data analysis. The expected duration of the study is 18 months. Embryos will be included in the different participating centers for an estimated period of 9 months. Participants involvement in the study is just linked to the moment of the consent form signature for the embryo donation. This study will not imply any modification of a scheduled IVF/ICSI or PGT-A cycles nor extra visits to the recruiting centers.

    Phase

    N/A

    Span

    52 weeks

    Sponsor

    Igenomix

    Nicosia

    Recruiting

  • SCAD : a Registry of Spontaneous Coronary Artery Dissection

    Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: - First SCAD event visit (retrospectively on chart review) - First follow-up: at time of enrolment - Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.

    Phase

    N/A

    Span

    353 weeks

    Sponsor

    European Society of Cardiology

    Nicosia

    Recruiting

  • Brain Research and Integrative Neuroscience Network for COVID-19

    The two intervention protocols (digitalized CP and NIBS) required for this study have been developed and the required equipment (one existing and three new tDCS devices) has been acquired. Recruitment for the feasibility study is planned to begin in month 18, i.e., June 2024. Changes in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board. The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment. Specifically, the feasibility study will retain the two-group design (experimental and control). Forty participants with PCS will be recruited (instead of seventy, as originally planned). All participants will undergo the diagnostic protocols (the neuroimaging and neuropsychological assessments). Then, participants will be randomly assigned into two groups: the experimental, who will receive the active tDCS and CP intervention, and the control group, who will receive the sham tDCS and CP intervention. Following the intervention, all participants (experimental and control) will complete a series of dependent measures, including neuropsychological performance and quality of life measures. For neurophysiological measures, electroencephalography (EEG) has been replaced with functional near-infrared spectroscopy (fNIRS), which will be conducted both pre- and post-intervention. The current design will require a longer intervention period (as compared to the original design) and the complete delivery of the digitalized CP to maximize treatment effectiveness.

    Phase

    N/A

    Span

    59 weeks

    Sponsor

    University of Cyprus

    Nicosia

    Recruiting

  • Probiotics in Mild Alzheimer's Disease

    We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.

    Phase

    1

    Span

    154 weeks

    Sponsor

    University of Nicosia

    Nicosia

    Recruiting

  • Unraveling the Genetic Basis of Nicotine Addiction for Novel Therapeutic Strategies

    Cigarette smoking remains the largest preventable risk factor for chronic diseases and premature mortality worldwide. While several medications have been approved to aid smoking cessation, most individuals relapse following an initial period of abstinence, with only around 15% achieving long-term abstinence beyond 6-12 months. This highlights a critical need to identify novel drug targets and develop more effective pharmacotherapies to treat nicotine addiction and maintain long-term smoking abstinence. The proposed case-control study aims to leverage an interdisciplinary approach combining genetic epidemiology and molecular biology to: 1) Identify potential novel druggable targets for smoking cessation using a drug repurposing Mendelian randomization (MR) strategy, and 2) Assess whether epigenetic modifications (DNA methylation) of the identified drug target genes are associated with motivation to quit smoking, nicotine dependence severity, and vulnerability to smoking relapse following a cessation attempt. Specifically, NicoGen study utilizes large-scale genomic datasets of expression quantitative trait loci (eQTLs) and protein quantitative trait loci (pQTLs) to identify genetic variants that influence expression/levels of genes encoding druggable proteins (targets of approved drugs/clinical candidates). MR analyses will then determine if genetically-predicted expression of these genes is causally related to smoking cessation outcomes. Additionally, 200 current cigarette smokers (100 men, 100 women) will be recruited prior to smoking cessation for collection of biofluids for DNA extraction. The methylation levels of the top candidate drug target genes identified in will be assessed and compared between: 1) Cases who achieve ≥6 month abstinence vs. relapsed controls, 2) High vs. low motivation to quit groups, and 3) High vs. low nicotine dependence groups. This allows identification of epigenetic biomarkers predictive of cessation outcomes. Additionally, potential gender differences in the associations between gene methylation, motivation, dependence and relapse vulnerability will be explored to identify gender-specific drug targets.

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    University of Cyprus

    Nicosia

    Recruiting

  • The Role of Inflammation in Myocardial Infarction

    After an acute myocardial infarction (AMI) the inflammatory response seems to have a central role and is connected to major adverse outcomes such as ischemia-reperfusion injury, adverse cardiac remodeling, infarct size, and poor prognosis. The concept of monitoring inflammatory markers as predictors of post-myocardial prognosis is gaining more momentum. Finding the appropriate inflammatory biomarker that would serve as a prognostic marker after an AMI and could stratify the risk for adverse outcomes, could be extremely useful. INFINITY is a multi-center, prospective, observational cohort study, aiming to assess the complex role of inflammation in the post-AMI period. The study plans to include 120 consecutive patients above 18 years old admitted to the four centers participating in the study. A panel of inflammatory cytokines and adipokines will be recorded. A venous blood sample will be collected on patient admission (H0), 6-12 hours after admission (H6-12), 24-48 hours after admission (H24-48), and at the 30-day visit (D30). Blood will be collected for routine laboratory tests, as well as to measure the levels of the cytokines IL-6, IL-10, IL-18, IL-17, and the adipokines leptin, apelin, and chemerin. 60 carefully selected patients will consist of the control group. The control group will consist of individuals to whom the obstructive coronary artery disease would be ruled out either by invasive or non-invasive coronary angiography or by myocardium perfusion SPECT or stress echocardiography. The patient and control group will be matched at baseline by equating certain clinical characteristics of interest between the exposed and unexposed groups. The study will test the hypothesis that circulating plasma levels of the above inflammatory biomarkers reflect different clinical manifestations of coronary artery disease and correlate with coronary anatomy, the severity of coronary artery disease, and the prognosis in a 6-month follow-up period. Finally, will investigate whether the integration of the above inflammatory biomarkers into the already established prognostic risk stratification model, GRACE score, could further improve its predictive power.

    Phase

    N/A

    Span

    93 weeks

    Sponsor

    Nicosia General Hospital

    Nicosia

    Recruiting

  • Study of the Role of Genetic Modifiers in Hemoglobinopathies

    Hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia, are prevalent diseases with variable clinical manifestation and severity that are thought to be governed, in part, by genetic modifiers. Despite the identification and characterization of a few putative genetic modifiers by previous studies, these are as yet insufficient to guide treatment recommendations or risk-stratify patients reliably. Also, it is expected that many additional genetic variants exist that can modify disease and its severity. This large-scale genome-wide association study (GWAS) will utilize SNP chips to investigate the genetic profile of individuals with hemoglobinopathies, thereby addressing the challenges of previous studies related to small sample sizes and low statistical power, while promoting the participation of diverse populations worldwide. The study aims to i) discover new genetic modifiers of hemoglobinopathies, ii) validate previously reported genetic modifiers, iii) pool and analyze existing genomic data, iv) standardize phenotypic descriptions, v) develop a research resource of disease-specific data generated in INHERENT, including genomic, phenotypic, and functional data, and vi) develop risk scores that can be used for patient stratification. The main endpoints include: 1. Worldwide demography, including numbers of patients, main genotypes, and overall disease severity/burden in participating centres 2. Genetic modifiers affecting clinical or laboratory phenotypes of hemoglobinopathies, including 1. overall survival in SCD and/or thalassemia, 2. stroke and/or decreased neurocognitive function in SCD and/or thalassemia, 3. renal impairment in SCD and/or thalassemia, 4. leg ulcers in SCD, 5. priapism in SCD, 6. mild or severe acute pain and/or chronic pain syndromes in SCD, 7. pulmonary hypertension in SCD and/or thalassemia, 8. hyperhemolysis in SCD and/or thalassemia, 9. fetal hemoglobin levels, 10. degree of ineffective erythropoiesis, 11. hepatic fibrosis/cirrhosis and/or cardiac siderosis, 3. Genetic modifiers affecting response to treatment, including 1. response to hydroxyurea, 2. response to iron chelation treatment, 3. response to emerging therapeutic agents

    Phase

    N/A

    Span

    261 weeks

    Sponsor

    Cyprus Institute of Neurology and Genetics

    Nicosia

    Recruiting

  • Emotion Regulation For All (ER4ALL) Study

    Entering Higher Education (HE) marks a turning point for youth learning to function as independent adults, something that can be both exciting and challenging. Students are confronted with a considerable number of changes to manage (e.g. high academic expectations, making new relationships, making independent decisions), for which they may be psychosocially unfamiliar or uncomfortable. Several studies have indeed shown that rising levels of difficulty in socio-emotional adaptation for students in HE, is linked to decreased levels of engagement and completion rates. On the other hand, the acquisition of psycho-social skills, seems to have a positive effect on students' academic achievement, resilience, employability and thriving in life. A current challenge for HE Institutions is to ensure that during their studies, their future graduates, will have the opportunity to develop psycho-social skills, for effective management of challenges, which extend beyond academic contexts and outcomes throughout the life span in domains such as success in work, positive interpersonal relationships, and better mental health and overall well-being. Further examination of the potential impact of integrating empirically supported transversal components that derive from empirical research (e.g. emotion regulation skills), is needed. In addition to that, since the focus is on a university-wide student population, it would be useful to further investigate whether the standard mode of delivery (in which learning capacity, language ability, and executive functions are considered essential ingredients for program success), fits well to student population with diverse learning styles, academic performance or learning abilities, such as language skills (listening, reading, speaking and writing), executive skills (e.g. sustain attention) or cognitive processes such as memory and abstract thinking. A growing literature pinpoints to the potential of incorporating art-based methodologies, such as music which is characterized by personalized methods and has shown promising effects on its effectiveness for inclusive educational practices. Music is a promising means that can afford opportunities for learning not afforded by other modalities. Collectively, music holds the potential to address life-long needs for young adults, by infusing culturally appropriate practices that can be easily integrated into the young adults' everyday experiences at the level of their abilities. Music interventions have been linked to improvements in mental and physical capacities in various settings and populations. Research findings additionally support that music can be used as a tool for emotion regulation by reducing stress and stimulate cognitive processes such as attention, learning and memory. Taking into account the above, it is of great interest to develop and investigate how different modalities, such as music-based methodologies, can alter the effectiveness of existing empirically supported approaches, such as emotion regulation skills training. The primary objective of this study is to gain insight into the acceptability and feasibility of the "ER4ALL", a brief course for enhancing emotion regulation skills for students in higher education. The secondary objective of this study is to collect preliminary evidence for beneficial effects in increasing students' acquired knowledge on adaptive emotion regulation, thus improvement on general psychological functioning. The specific objectives of the study are to: 1. Determine feasibility and acceptability of the "ER4ALL" course. 1. To estimate feasible recruitment and refusal rates. 2. To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction (both qualitative and quantitative). 3. To determine the acceptability of course resources and factors influencing this (e.g. diverse learning styles or abilities). 2. Compare the effectiveness between two "ER4ALL" modalities: standard language-based mode Vs. music-based mode. 1. To explore preliminary differences on acceptability. 2. To explore preliminary differences on associated changes in acquired knowledge and psychological functioning.

    Phase

    N/A

    Span

    52 weeks

    Sponsor

    University of Cyprus

    Nicosia

    Recruiting

    Healthy Volunteers

  • Life Skills Boot Camp Study (LEVELUP2)

    The role of Higher Education in sustained economic growth, and social progress is critical. HE institutions (HEIs) as key 'future shaper' settings, host a significant proportion of talented youth, future workforce, and leader (Cawood, Dooris, & Powell, 2010; Suárez-Reyes, Muñoz Serrano, & Van den Broucke, 2019). Entering university marks a turning point for youth, since HEIs can empower young people to transform and expand skills to manage complex and global environmental and societal challenges. Soft skills, such as the ability to set goals and achieve them, to regulate emotions, to demonstrate agility and adaptability, and manage interpersonal relationships, are now an emerging trend for tackling global economic and societal challenges (World Economic Forum, 2016; Organisation for Economic Co-operation and Development, 2019). In addition, soft skills related to mental and physical health, wellbeing and adjustment, have received growing interest over recent years, and have become even more critical in the context of emerging needs to build resilience in the face of the Covid-19 pandemic and in preparation for future crises (Bauer, et al. 2021; Liang, et al. 2020; Nearchou, et al. 2020; Rousseau, & Miconi, 2020). Despite soft skills importance, evidence confirm a "skills gap", meaning that youth lack soft skills that are highly important in the workplace (Noah, & Aziz, 2020). Although students in HE commonly graduate with excellent technical academic skills to do well in their future profession, it is highly debated whether higher education graduates also have developed sufficient soft skills essential to do well at the workplace (Noah, & Aziz, 2020). Given these challenges to individuals' academic performance, work achievement, and mental health, it would be advisable to equip students with the resources required for life success. As these skills become increasingly of central interest to communities, it becomes a pertinent question on how to expand them within the academic context by learning relevant information and practicing skills in a way that is responsive to the needs of the wider student community. To deal with these situations, different types of skill training interventions/ competence-based education within HE, have been created to help students develop skills for self- development (e.g. Rubens et al., 2018) and alleviation of mental health symptoms/mental health promotion (for metanalyses see Conley, Durlak, & Kirsch, 2015; Conley et al., 2017; Yusufov et al., 2019). Current findings suggest that a) incorporating specific components (such as coping skills training or CBT and relaxation techniques for stress management, Yusufov et al., 2019) and b) specific training methodologies such as supervised skill training (Conley, Durlak, & Kirsch, 2015) or short-term/ brief trainings (Yusufov et al., 2019) may be beneficial for students and increase the feasibility of integrating these interventions in the HE context. In addition to determining the active ingredients of interventions, defining pragmatic challenges, such as the best methodologies to coordinate and integrate such interventions within the HE context are also of key importance (Conley et al., 2017). Continued research is needed to identify the specific systems and practices that will place students in an active role to define self-development goals and practice, in a systematic and guided form, some of these soft skills in real life settings. During the last decades, increasing attention toward multitiered frameworks of interventions has emerged, as an approach that takes into account the role of the context and the level of provided support to facilitate the personal competencies of all students (Jimerson, Burns, & VanDerHeyden, 2015; Arora et al. 2019). Τhe EU funded project LEVEL-UP (Ref: 2020-1-CY01-KA203-065985) is based on this kind of logic and aims to develop an innovative framework that lies in a 3- level support system that follows a linear, progressive fashion, starting from the broader application to the narrower one. According to the conceptualization of the project, in level 1, students will have the opportunity to gain up-to-date scientific knowledge on transversal skills through an introductory course. Through this course, students will be able to self-reflect on these skills and develop an Individual Skills Development Plan (ISDP). After completing the introductory course, each student will have the opportunity to broaden as well as to deepen specific transversal skills (based on their ISDP), through stepwise, guided and multi-contextual practical training. Specifically, students will be able to enroll in skills development programs (group-based) offered by experts within the HEI (level 2), practice, apply and refine them through feedback. Finally, in level 3, participants of level 2, who are identified through self- and instructor evaluation as presenting significant challenges in specific skills domains, would be able to develop and consolidate these skills under a more intensive and individualized supportive program. The present study is part of LEVEL UP project and its focus is to test the conjunction of the two levels of the proposed framework: at level 1 students get research-informed knowledge on soft skills and self-reflect on the level of mastery of these skills, and at level 2 they develop specific skills through the participation in an intensive and supervised skills training. The primary goal of this study is to determine the feasibility both of delivering level 2 as a standalone low-intensity skills training (with no pre-requisite) and as a part of the two-level system (level 1 as a pre-requisite for to participate in level 2). Specifically, we aim to examine the feasibility and acceptability of embedding a series of group-based soft skills trainings within university educational operations. These trainings cover three vital soft skills training topics: a) how to regulate emotions, b) how to interact with others in an effective manner and c) ways to build flexibility and their resiliency. Study aims/Objectives The objective of this study is to assess the acceptability and feasibility of the "Life Skills Boot Camp", a series of soft skills trainings for students in higher education. The acceptability and feasibility will be explored from the perspective of stakeholders, including students participating in trainings and trainers who provide them. The specific objectives of the study are to: 1. Determine feasibility and acceptability of the skills training by 1. estimating feasible recruitment and refusal rates. 2. measuring key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction. 3. determining the acceptability of course resources and factors influencing this. 4. measuring participants' willingness to participate in highly specialized soft skills training. 5. determining the acceptability of the boot camps as standalone training. 2. Identify under which conditions the "Life skills boot camp" are of added value to students' personal and professional development by a. recording the antecedents associated to students' perceived usefulness of boot camps trainings. In specific, perspectives of both students with previous relevant experience (having a boot camps training as a follow up to a previous introductory soft skills course) and students with no relevant experience will be evaluated in terms of training usefulness. 3. Evaluate the preliminary changes in soft skills and mental health of HE students after implementing the two-level soft skills intervention. 1. Examining changes in positive mental health, depression, anxiety and stress before the introductory course (level 1) and after the soft skills bootcamps (level 2) (only NL). 2. Analysing changes in social, emotion regulation, coping and resilience skills before and after the soft skills bootcamps (level 2) (only NL).

    Phase

    N/A

    Span

    37 weeks

    Sponsor

    University of Cyprus

    Nicosia

    Recruiting

    Healthy Volunteers

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