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  • Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma

    Phase

    N/A

    Span

    340 weeks

    Sponsor

    AbbVie

    Thessaloniki

    Recruiting

  • 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.

    Phase

    3

    Span

    295 weeks

    Sponsor

    AstraZeneca

    Thessaloniki

    Recruiting

  • Effectiveness of Dorsal Glide Mobilization on Ankle Mobility and Basketball Performance

    Background Ankle dorsiflexion is a crucial factor for functional lower limb performance, particularly in sports like basketball, where dynamic movements, direction changes, jumps, and landings are essential for athletic success. Eccentric exercise has been shown to improve dorsiflexion range of motion (ROM), enhancing muscle strength, flexibility, and athletic performance. Additionally, ankle joint mobilization, specifically posterior talocrural glide, has demonstrated promising results in improving mobility, restoring ROM, and reducing compensatory movement strategies. However, the combined effects of eccentric exercise and joint mobilization on increasing ankle dorsiflexion ROM and improving athletic performance in young basketball athletes have not yet been sufficiently investigated. Objective The purpose of this study is to investigate the effectiveness of combining eccentric exercise and posterior talocrural glide mobilization in improving ankle dorsiflexion ROM and enhancing athletic performance in young basketball athletes. Methods A randomized controlled trial will be conducted, including 40 young basketball athletes with confirmed restricted ankle dorsiflexion ROM. Participants will be randomly assigned to an intervention group and a control group. Both groups will follow a five-week training program consisting of eccentric exercises and stretching, performed three times per week, to improve athletic performance. The intervention group, in addition to the exercise program, will undergo ankle joint mobilization sessions for the same duration. Ankle dorsiflexion ROM, maximum isometric strength of the ankle muscles, fatigue resistance through specific endurance tests, and performance via functional tests will be assessed at baseline, at the end of the five-week program, and three months after the intervention. Statistical analysis will be conducted using a two-way repeated-measures ANOVA, with the significance level set at p < 0.05. Expected Outcomes Improvements in ankle dorsiflexion ROM, muscle strength, and athletic performance are expected, along with a reduction in fatigue and compensatory movement strategies. The intervention is also anticipated to enhance ankle stability and lower the risk of injuries.

    Phase

    N/A

    Span

    33 weeks

    Sponsor

    International Hellenic University

    Thessaloniki

    Recruiting

  • Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children

    A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops will be instilled using the Nanodropper® device, while standard drops will be instilled directly through the commercially available plastic multidose mydriatic dropper bottle. For all participants, the eyedrop will be firstly instilled in the right eye and this will be the eye that will be used for the analyses. Written informed consent will be obtained from the parents/guardians for the children's enrollment.

    Phase

    4

    Span

    65 weeks

    Sponsor

    Aristotle University Of Thessaloniki

    Thessaloniki

    Recruiting

  • A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants

    INTRODUCTION Many newborn infants have difficulty breathing after birth. Some of these babies have a tube inserted into their "windpipe" (trachea) - an endotracheal tube (ETT) - through which they are given breathing support (ventilation). When clinicians attempt to intubate (insert an ETT), they use an instrument called a laryngoscope to view the airway in order to identify the entrance to the trachea (larynx). Standard laryngoscopes have a "blade" (which, despite its name, is not sharp) with a light at the tip. Doctors insert the blade into the baby's mouth to view the larynx. Traditionally, clinicians used a standard laryngoscope to look directly into the baby's mouth to view the larynx (direct laryngoscopy, DL). When clinicians attempt to intubate newborns with DL, less than half of first attempts are successful. Also adverse effects - such as falls in the blood oxygen levels (fall in oxygen saturation (SpO2), or "desaturation"), slowing down of the heart rate (bradycardia), oral trauma - are relatively common. In recent years, video laryngoscopes (VL) have been developed. In addition to a light, VL have a video camera at the tip of the blade. This camera acquires a view of the larynx and displays it on a screen that the clinician views when attempting intubation (indirect laryngoscopy). In a randomised study performed at the National Maternity Hospital, Dublin, Ireland, more infants were successfully intubated at the first attempt when clinicians used VL compared to DL [79/107 (74%) versus 48/107 (45%), P<0.001]. While this study was large enough to show that VL resulted infants being successfully intubated at the first attempt in one hospital, it couldn't give information about how it might work in a range of hospitals, and it wasn't large enough to see what effect VL had on adverse events. There is a large difference in cost between a standard laryngoscope (approx. €300) and a video laryngoscope (approx. €21,000). This is a matter of concern for all hospitals, particularly in settings where resources are more limited. The investigators aim to assess whether VL compared to DL results in more infants being intubated at the first attempt without physiological instability. STUDY DESIGN A recent single centre study reported that that more newborn infants were successfully intubated at the first attempt when VL was used to indirectly view the airway compared to DL. This study was not large enough to determine the effect of VL on adverse effects that are seen commonly (e.g. desaturation) or more rarely (e.g. bradycardia, receipt of chest compressions or adrenaline, oral trauma) during intubation attempts. For the current study, the investigators chose a stepped-wedge cluster randomised controlled design, where the participating centre, rather than the individual infant, will be the unit of randomisation. This design has been found appropriate to test the effects of an intervention that encompasses a behavioural aspect and to implement interventions while studying them at the same time. In this study, all centres will begin in the "control group"; where clinicians will routinely attempt intubation with DL, as is their usual practice. At specified intervals, centres will be randomly assigned to cross over to the "intervention group", where clinicians will routinely attempt intubation with VL. All participating centers will have included patients in both arms by the end of the study. SAMPLE SIZE ESTIMATION To determine the intra-cluster correlation (that means the correlation between two observations from the same centre), the investigators used the dataset of the MONITOR trial that included infants from 7 delivery rooms worldwide. In this trial, the intra-cluster correlation for intubation in the delivery room was reported as 0.1. This complete stepped-wedge cluster-randomized design includes 21 time periods (including the baseline) and 20 centres that will be including patients, with each randomised to a unique sequence. Each time period lasts a fortnight. Each time period, 1 centre will switch their treatment from DL to VL. With all centres including 2 patients each time period, 42 patients will be included per centre which will provide a total sample size of 840 patients. Assuming a control proportion of 0.4, this sample will achieve 90% power (0.9091) to detect a treatment proportion of 0.55, assuming a conservative ICC of 0.05. The power is not very sensitive to ICC values up to 0.1 (power of >90% to detect difference 40% versus 56%). The test statistic used is the two-sided Wald Z-Test. TREATMENT OF SUBJECTS DIRECT LARYNGOSCOPY (DL, control period) At the start of the study, clinicians at participating centres will attempt intubation using a standard laryngoscope to perform DL as is their normal practice. VIDEO LARYNGOSCOPY (VL, intervention period) For each centre, a lot will be drawn which indicates the month in which endotracheal intubation will be routinely attempted with VL rather than DL. In the month before the switch, centres will be provided with a C-MAC VL by the manufacturers, Karl Storz-Endoskop (Tuttlingen, Germany). The system will be provided on loan for the duration of the study and will consist of an 8" high-definition monitor with connecting cable and reusable straight Miller type blades size 0 and size 1. The equipment will be demonstrated by representatives from Karl Storz, and clinicians who intubate babies at participating hospitals will be encouraged to practice with the equipment on mannequins. We will have an virtual meeting with each centre in the week before they are due to switch to review the protocol, data collection and to answer any queries that they may have. All other procedures in the delivery room and NICU will be performed according to international and local guidelines. All other aspects of the approach to intubation at the participating centre are at the discretion of the local clinicians and should remain the same for the duration of the study; e.g.: - The drugs used before intubation attempts (e.g. opiate, atropine, curare-like drug) - The route by which intubation is usually attempted (i.e. oral or nasal) - Whether they use a stylet is routinely used - Whether supplemental oxygen is given during attempts

    Phase

    N/A

    Span

    51 weeks

    Sponsor

    University College Dublin

    Thessaloniki

    Recruiting

  • A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants

    Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy. It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen. The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.

    Phase

    N/A

    Span

    51 weeks

    Sponsor

    University College Dublin

    Thessaloniki

    Recruiting

  • Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization

    The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safer hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound). Although perceived as usually asymptomatic, RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting. Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today the only randomized studies reagrding RAO treatment have used either low-molecular-weight-heparin (LMWH) or apixaban. This is a prospective, randomized study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure. RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients. Patients diagnosed with RAO will be randomized 1:1 into two groups: Treatment group, that will receive Rivaroxaban for 4 weeks. Control group, that will not receive any anticoagulation. All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.

    Phase

    4

    Span

    209 weeks

    Sponsor

    AHEPA University Hospital

    Thessaloniki

    Recruiting

  • PTeye in Parathyroid Adenoma

    Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. Two approaches are available to surgeons to perform near-infrared autofluorescence: (i) Camera-based systems (CBS) and (ii) Probe-based systems such as PTeye™ (Medtronic, Minneapolis, MN).The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

    Phase

    N/A

    Span

    9 weeks

    Sponsor

    Aristotle University Of Thessaloniki

    Thessaloniki

    Recruiting

  • Non-Surgical Laser Treatment for Peri-Implantitis: Er:YAG & Diode Laser RCT

    This study aims to compare the effectiveness of non-surgical peri-implantitis treatment using conventional ultrasonic debridement versus a laser-assisted approach. The primary objective is to assess clinical, microbiological, and metabolomic outcomes associated with each treatment modality. The study will be conducted at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki. Participants will be screened based on inclusion and exclusion criteria, and those diagnosed with peri-implantitis in at least one implant will be randomly assigned to either the control or experimental group. Study Procedures: Control Group: Treatment with ultrasonic scalers designed for implants and saline irrigation. Experimental Group: Treatment with Er:YAG (2940nm) and Diode (808nm) laser. Oral Hygiene Instructions: Provided at baseline and each follow-up visit. Microbiological Sampling: Collection of subgingival plaque using sterile paper cones before and after treatment (3 months), with analysis of P. gingivalis and F. alocis using qPCR. Metabolomic Analysis: Collection of peri-implant crevicular fluid before and after treatment for metabolomic profiling. Clinical Parameters: PPD, BOP, CAL, REC, and SUP will be recorded at baseline and after 3 months. Pain and Patient Satisfaction: VAS pain assessment at multiple time points and tracking of analgesic consumption. A patient satisfaction questionnaire will be completed at the end of the study. Study Outcomes: Primary Outcome: Reduction in peri-implant pocket depth and inflammation. Secondary Outcomes: Changes in microbiological and metabolomic markers, pain perception, and patient-reported satisfaction. This randomized controlled clinical trial aims to provide valuable insights into the efficacy of laser-assisted non-surgical therapy for peri-implantitis compared to conventional ultrasonic debridement. The findings could contribute to the optimization of non-surgical treatment protocols for peri-implant disease management.

    Phase

    N/A

    Span

    61 weeks

    Sponsor

    Aristotle University Of Thessaloniki

    Thessaloniki

    Recruiting

  • A Prospective, Single-center, Observational Study Aiming to Assess the Predictive Role of Flow Mediated Dilatation in Acute Coronary Syndromes, Combined With Echocardiographic and Biochemical Indices: The Novel Cor-IS Technology Will Also be Evaluated

    Phase

    N/A

    Span

    127 weeks

    Sponsor

    Aristotle University Of Thessaloniki

    Thessaloniki

    Recruiting

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