Clinical trials

Gastroscopy, performed as an invasive procedure for the diagnosis and treatment of upper gastrointestinal tract diseases, is often perceived by patients as an unpleasant and frightening experience, leading to anxiety (Hua et al., 2025). The onset of anxiety reduces procedure tolerance and negatively affects patient compliance (Yang et al., 2024). Factors such as pain, fear of complications, loss of control, and inadequate information are frequently cited as contributors to pre-gastroscopy anxiety (Helba, 2024). Anxiety triggers general stress responses-such as tachycardia, hypertension, and respiratory changes-associated with autonomic nervous system activation, and it impacts sedation requirements and cardiopulmonary risks (Liu, 2025). Breathing exercises, a non-pharmacological intervention, are widely recognized in the literature as effective in alleviating anxiety and fostering positive outcomes in patients (Aktaş, 2022; Bulut \& Karabulut, 2023). Breathing exercises stand out as a safe, low-cost method that modulates autonomic nervous system activity (Herawati et al., 2023). This study examines the effects of diaphragmatic breathing exercises performed prior to gastroscopy on anxiety, fear, and vital signs. The results of this study will establish a scientific foundation for healthcare professionals regarding the clinical application of breathing exercises and contribute to evidence-based practices aimed at reducing pre-gastroscopy anxiety and fear while enhancing personal coping.

The purpose of this study is to: * Determine the efficacy of nucresiran in patients with hATTR-PN by evaluating the effect on neurologic impairment, quality of life, nutritional status, disability, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.

This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. A total of 60 participants will be randomly assigned to one of three treatment groups according to the study protocol. Postoperative pain, facial swelling, and trismus will be evaluated on postoperative days 1, 2, 3, and 7. The findings of this study are expected to provide evidence regarding the effectiveness of PRF alone and PRF combined with corticosteroid treatment in reducing postoperative complications following impacted mandibular third molar surgery.

After a severe brain injury some patients survive but cannot communicate, and deciding early which of them are likely to recover consciousness remains one of the hardest problems in neurocritical care. Bedside examination alone misclassifies a substantial proportion of these patients. CyDoC-MAP is a single-centre, prospective, observational cohort study conducted at Nicosia General Hospital, the sole trauma referral centre for Cyprus. It enrols patients aged 16 years or older who are intubated within 24 hours of a moderate-to-severe traumatic brain injury or a haemorrhagic stroke (intracerebral or subarachnoid haemorrhage), and who are subsequently classified as being in a vegetative state / unresponsive wakefulness syndrome (VS/UWS) or a minimally conscious state (MCS) on the Coma Recovery Scale-Revised (CRS-R). Four assessment modalities are recorded: (1) the CRS-R, performed at least twice with an interval of at least 48 hours; (2) serum neuron-specific enolase (NSE) sampled within 24 hours of intubation; (3) the bispectral index (BIS), recorded at least twice with an interval of at least 48 hours, after five minutes of standardised noxious and auditory stimulation; and (4) in the traumatic subgroup only, 1.5 T magnetic resonance imaging performed 7-28 days after injury and graded 1-4 by lesion depth by two independent raters. Level of consciousness is reassessed with the CRS-R 6 to 12 months after the index event, and the total CRS-R score (0-23) at that reassessment is the primary outcome. The primary aim is to estimate the strength of the association between the bispectral index recorded on the ward and that later CRS-R score, and to quantify what the bispectral index adds beyond the baseline clinical assessment. The number of eligible patients at a single national centre does not support the development of a prognostic model; the study is designed to produce effect-size estimates with confidence intervals that will inform a subsequent multicentre study. The study is purely observational. No intervention is administered, no study procedure alters clinical management, and transfer to rehabilitation is never delayed for research purposes.

Ankle fractures are common injuries that can affect a patient's mobility, mood, sleep, and everyday life for months. The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is an English-language patient-reported outcome measure developed in Australia to capture this broader rehabilitation experience. No validated Turkish version of A-FORM currently exists. This prospective multi-centre observational study aims to translate the A-FORM into Turkish (A-FORM-TR), culturally adapt it for use in Turkish-speaking patients, and evaluate its psychometric properties. The investigators will recruit 150 adults with a unilateral ankle fracture, treated either surgically or conservatively, from three orthopedic centres in Turkiye and the Turkish Republic of Northern Cyprus. Participants complete the A-FORM-TR together with two established comparator questionnaires (AOFAS Ankle-Hindfoot Score and the Turkish Olerud-Molander Ankle Score). A subset of approximately 50 participants is re-administered the A-FORM-TR after 7 to 14 days to assess test-retest reliability, with a Global Rating of Change item identifying clinically stable patients. Analyses include classical test theory, confirmatory factor analysis, and Rasch measurement analysis.

This single-center, three-arm randomized controlled trial compares the effects of different myofascial release techniques, combined with a structured exercise program, on functional outcomes in individuals with chronic non-specific neck pain (CNNP). Eligible participants (aged 18 to 45 years, neck pain for at least 3 months, pain intensity VAS at least 3, and myofascial trigger points in the upper-quarter muscles) are allocated by simple randomization into three groups: * Conventional Therapy Group: hot pack, conventional TENS, and a structured exercise program. * Manual Myofascial Release Group: conventional therapy plus therapist-applied manual myofascial release. * Self-Myofascial Release Group: conventional therapy plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane. All interventions are delivered 3 days per week for 6 weeks. The primary outcome is pain intensity. Secondary outcomes include pressure pain threshold and tolerance, cervical range of motion, muscle stiffness, craniovertebral angle, cervical proprioception, muscle strength and endurance, disability, neck awareness, multidimensional biopsychosocial status, sleep quality, quality of life, and kinesiophobia. The aim is to determine whether manual or self-applied myofascial release, added to exercise, produces greater functional improvement in people with chronic non-specific neck pain.

SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

Intra-articular platelet-rich plasma (PRP) injection is a widely used treatment for knee osteoarthritis, but patients respond to it very differently and there is currently no simple, inexpensive way to predict who will benefit. The neutrophil-to-lymphocyte ratio (NLR) and related indices derived from a routine complete blood count reflect a person's baseline inflammatory state. This prospective single-arm observational cohort study investigates whether the baseline NLR, together with the platelet-to-lymphocyte ratio (PLR), the systemic immune-inflammation index (SII), and the monocyte-to-lymphocyte ratio (MLR), predicts the clinical response to intra-articular PRP in patients with Kellgren-Lawrence grade 2 to 3 knee osteoarthritis. The investigators will enroll 120 patients aged 40 to 60 years, each of whom receives a standardized course of three leukocyte-poor PRP injections one week apart. Patients are followed for 6 months, and the primary clinical outcome is the change in the WOMAC osteoarthritis index at 6 months. Outcome assessors are blinded to patients' blood-count values. If a baseline blood ratio predicts response, it could become a low-cost tool to guide patient selection for PRP.

Patients increasingly consult artificial intelligence (AI) chatbots such as ChatGPT for health information before clinical visits, yet the impact of an actual orthopedic consultation on patient trust in AI-derived information remains unknown. This prospective longitudinal observational study quantifies how a single orthopedic outpatient consultation modifies patient trust in AI chatbots, the concordance between AI-derived and physician-delivered information, and patient anxiety, using a paired pre-post survey design supplemented by a matched physician-side assessment. Adult patients (18 years and older) presenting to two orthopedic outpatient clinics in Cyprus complete a brief pre-consultation questionnaire (T0) capturing demographics, AI use patterns, prior AI consultation regarding the current complaint, baseline trust, expectations, and anxiety. Immediately after their consultation they complete a second questionnaire (T1) assessing concordance with physician advice, trust change, consultation facilitation, post-consultation anxiety, and future intention. The consulting physician completes a brief 30-second post-visit form capturing whether AI was discussed, the medical accuracy of AI-derived information conveyed by the patient, and the effect of the AI discussion on consultation duration. The primary outcomes are the paired within-patient change in AI trust between T0 and T1 and physician-patient concordance on AI versus physician advice. Target enrollment is 180 to obtain 150 paired completed assessments.

Brief Summary Myofascial pain syndrome (MPS) is a common musculoskeletal condition characterized by active trigger points (TrPs), which are hypersensitive, painful nodules within taut bands of skeletal muscle. The upper trapezius muscle is one of the most frequently affected sites. Trigger point injection (TPI) is a widely used minimally invasive treatment for patients who are refractory to conservative management. Corticosteroids provide rapid anti-inflammatory effects, whereas platelet-rich plasma (PRP) has regenerative properties through growth factors that may support tissue healing. Despite their widespread use, the optimal injectate for TPI remains unclear. Additionally, the potential benefit of combining PRP with corticosteroids has not been adequately studied in upper trapezius MPS. This study is a single-center, prospective, randomized, assessor-blinded controlled trial designed to compare the clinical effectiveness of three injection protocols: (1) PRP plus bupivacaine, (2) PRP plus betamethasone plus bupivacaine, and (3) betamethasone plus bupivacaine with saline (volume-matched control). A total of 150 patients with a single active trigger point in the upper trapezius will be included. The primary outcome is pain intensity measured by the visual analog scale (VAS) at 3 months. Secondary outcomes include pressure pain threshold (PPT), cervical range of motion (ROM), rescue analgesic use, recurrence rate, and adverse events at 1 week, 4 weeks, 3 months, and 6 months. All injections are performed by the same investigator using a palpation-guided technique, and outcome assessments are conducted by a blinded evaluator.

This study investigates how different types of fasting affect cell health, specifically focusing on how mitochondria (the energy-producing parts of cells) are cleared and renewed. While standard intermittent fasting allows water intake, Ramadan dry fasting involves total restriction of both food and fluids from dawn to sunset. Researchers want to see if the combined effects of fluid restriction and natural daily body rhythms during Ramadan trigger a stronger cellular cleanup process (called mitophagy) compared to standard 16:8 water-permitted fasting. The study will look at how these fasting habits change blood markers related to mitochondrial DNA and metabolic health across a 30-day period. This research will help determine if dry fasting offers distinct biological benefits for cellular renewal.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in older adults with hypertension. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) improve the abnormalities in circadian blood pressure variation experienced by older adults with hypertension, assessed using advanced actigraphy? Researchers will compare measurements between older adults with hypertension carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Have their blood pressure, oxygen saturation, ECG and heart rate variability measured using 24-hour advanced actigraphy in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in pregnant women. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index? Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Pittsburgh Sleep Quality Index questionnaire in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.

This randomised controlled study aims to evaluate the effects of mindfulness meditation on sleep quality, perceived stress and symptoms levels ion hemodialysis patients. Participants in the intervention group will receive a 4 week mindfulness meditation program in addition to routine care. Outcomes will be assessed before and after the intervention using validated measurement tools.

This is a prospective, single-center, randomized controlled educational trial comparing the effectiveness of PlayStation VR2-based immersive virtual reality (VR) anatomy teaching versus classical (lecture/atlas/3D-model) teaching for wrist anatomy among first-year medical students at Kyrenia University Dr. Suat Gunsel Hospital. Eighty healthy adult students will be randomized 1:1 into a VR Group (30-35-minute PSVR2 wrist anatomy module delivered on PlayStation 5) or a Classical Group (30-35-minute faculty-led standard anatomy education using lecture, atlas, and 3D anatomical models). The primary outcome is immediate post-test knowledge score (multiple-choice questions plus visual labeling; 0-30 scale). Secondary outcomes include a 2-4-week retention test, Likert-type learning satisfaction (15-75), cognitive load (0-10), and incidence and severity of VR-related side effects (dizziness, nausea, eye strain; 0-3 ordinal). Outcome assessors are blinded to allocation. The study aims to evaluate whether immersive VR is non-inferior or superior to classical teaching for initial acquisition and short-term retention of wrist anatomy knowledge, while characterizing tolerability of consumer-grade VR in an educational setting.

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Mild Cognitive Impairment (MCI) is defined as an impairment in a single cognitive function, usually memory, other than normal cognitive decline with age, that does not fulfil dementia criteria. Finger movements have been shown to stimulate the sensory-motor and cognitive parts of the cerebral cortex, as well as the supplementary motor area, Broca's area, premotor cortex, and prefrontal cortex, all of which contribute to movement skills. Asymmetrical hand and finger movements done concurrently were proven to improve cognitive processes and cerebral blood flow more than movements performed with one hand.

Cardiovascular disease (CVD) remains the leading cause of death worldwide. Prevention of CAD by targeting modifiable factors remains a key public health priority. L-Ascorbic Acid (Vitamin C - Vit. C) and Omega 3 fatty acids, Eicosapentaenoic / Docosahexaenoic Acid (EPO/DHA), powerful but also necessary antioxidants for the human body, after observational studies as well as randomized studies seem to have a beneficial effect in the direction of the prevention of CVD with pleiotropic mechanisms. Lignin, a polymer of plant origin that is considered a dietary fiber, has a developed porous structure and can retain exogenous and endogenous toxins, and pathogenic microorganisms. Lactulose considered a prebiotic provides a selective substrate for the metabolism of saccharolytic bacteria with bifidogenic activity and multiple benefits to the host's gut health. Coronary artery bypass grafting (CABG) is an established surgical intervention and treatment of symptoms of myocardial ischemia that improves patient survival Optimal Medical Therapy (OMT) after coronary arterial bypass grafting (CABG) as described in current clinical practice could be made even better by the addition of these beneficial food supplements. A randomized controlled trial is proposed in an intervention group of 54 post-CABG patients who will be given daily orally in addition to the usual medication, 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose and a control group of 54 patients (Control Group) in which only usual medication will be administered. The intervention will take place from the 15th postoperative day when CAGB patients are discharged and lasts for 2.5 months (10 weeks) postoperatively. The data will be collected on the 15th, 80-90th postop day in 6 months and 12 months postop and then the statistical analysis of the data will be performed. Considering the number of CABG surgeries performed electively in our clinic, this study is expected to be completed in approximately 2-3 years from the day of initiation. The expected knowledge through the expected results such as these will emerge from this study is the potentially beneficial effect of our food supplements administration (intervention), i.e. Vitamin C, EPO/DHA, Lignin \& Lactulose, on the postoperative course of our patients. Some degree of improvement in the well-being and clinical picture of our patients postoperatively is expected, which will be thoroughly investigated in each phase of the study.

The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients. However, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and/or decrease the interobserver variability during tumor delineation. This study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.

Advancements in systemic antineoplastic therapies have led to improved overall survival rates for many solid tumors. However, metastatic disease remains a significant challenge and remains the leading cause of mortality for these patients. Additionally, there is a high attrition rate after first-line standard treatment across various tumor types, with studies indicating that 20-70% of patients may be unable to undergo second-line therapy, depending on the tumor type. This highlights an urgent need to enhance outcomes from the first line of treatment. Although first-line therapy often represents the best available option, most patients experience relapse and disease progression despite an initial tumor response. This is attributed to both intrinsic and acquired resistance arising from the heterogeneity of primary tumors and metastases. To address this issue, metastasis-directed therapy (MDT) has been explored as a way to reduce tumor burden and mitigate the risk of resistance due to therapeutic selective pressure. MDT offers a promising opportunity to improve first-line treatment outcomes, but more precise patient selection criteria are needed to maximize therapeutic benefit and minimize the potential toxicity of ablative therapies. Indeed, despites its efficacy, fatal complication may occur so do grade 3 to 4 toxicities. Toxicity depends of the local ablative therapy (LAT) planned but as it will never be none, oncologists have to propose invasive treatment to patient that may benefit the most. Based on the published data, the investigators propose a pragmatic, selective approach centered on sensitivity to systemic therapy. The investigators aim to evaluate the benefit of local ablative therapy (LAT) in patients who demonstrate non-progressive disease after three months of first-line standard of care. Given the importance of this question across cancer subtypes, the investigators will employ a prospective database to enroll patients with various solid tumor type, excluding the ones for which the impact of LAT has already been explored or may be difficult to achieve. Outcomes of this strategy will be evaluated compared to outcomes from pivotal studies defining optimal standard first line therapy (OST) . Several analyses will be performed to better characterize the population for whom a multimodal approach may significantly improve their survival. The first one will aim to compare the median duration of response (mDOR) of the population treated with LAT compared to the mDOR reported by the pivotal study(ies) of each OST. This study will serve as a proof of concept, supporting chemosensitivity as a viable selection factor for multimodal treatment in a broad range of cancer types. Primary objective: Improvement of the duration of response (DOR) after completion of LAT compared to DOR reported in pivotal study that evaluated first line OST. Secondary objectives: * Evaluation of the safety of the addition of LAT. * Evaluation of overall progression free survival (PFS) and PFS at 1 year. * Evaluation of overall survival from OST start and from the time of LAT completion. * Documentation of acceptance and compliance to LAT decision by the institutional expert committee

With the increasing elderly population, nursing students' attitudes toward older adults and their levels of compassion competence have become increasingly important. While traditional educational methods may be insufficient in developing these skills, experiential learning approaches offer more effective outcomes. In particular, aging simulation applications enable students to understand the physical and emotional challenges experienced by older individuals, thereby enhancing their levels of empathy and compassion. The literature reports that simulation-based education has positive effects on attitudes and awareness. Therefore, the integration of aging simulation suits into nursing education is of great importance.