Clinical trials

To evaluate the efficacy of finerenone in reducing the incidence of any electrical instability or arrhythmias in the form of new-onset atrial fibrillation or atrial flutter (AFF), atrial tachycardia, extrasystoles (premature atrial and ventricular contractions, PACs and PVCs, respectively), ventricular arrhythmias, bradycardia, in patients with heart failure with preserved ejection fraction who are in sinus rhythm.

This randomized controlled trial aims to compare the efficacy and safety of systemic terbinafine combined with Q-switched Nd:YAG laser versus systemic terbinafine alone in the treatment of onychomycosis.

This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.

This randomized controlled trial aims to compare the efficacy and safety of nasal continuous positive airway pressure versus high-flow nasal cannula as initial non-invasive respiratory support in preterm infants with respiratory distress syndrome.

This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.

Chronic rhinosinusitis (CRS) is defined as persistent symptomatic inflammation of the nasal and sinus mucosa that lasts more than 3 months. Epidemiologic studies estimate that 10% to 15% of the US population has CRS with a prevalence of up to 12% in Western populations. CRS is defined as the symptomatic inflammation of the nose and para nasals in uses with the distinction based on the duration of the complaints. CRS is typically described more broadly as an inflammatory disorder and the importance of specific microbial agents in driving the process remains controversial. It is not clear what medical therapy should be followed as the proper treatment for CRS. The most common treatment of CRS includes medical therapy and in cases resistant to medication, endoscopic sinus surgery might be an option. (Kamaneh et al., 2020).

This prospective observational study aims to evaluate peripheral nerve ultrasound findings, particularly nerve cross-sectional area, in children with Guillain-Barré syndrome.

This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.

Submental fat accumulation, commonly known as a "double chin," is a frequent aesthetic complaint affecting the lower face and neck and is often associated with aging, weight gain, or a genetic predisposition (1). It develops from excess fat deposition in the superficial (pre-platysmal) and deep (post-platysmal) compartments of the neck (2), and can persist even in individuals of normal body weight owing to localized adipocyte hypertrophy that is resistant to diet and exercise (1). A large United States survey of adults aged 18-65 years found that 47% of respondents reported being bothered by the appearance of the area underneath their chin (3), and submental fullness has been consistently linked to lowered self-esteem and negative self-perception that motivate patients to seek treatment (1). Several objective grading systems have been developed to standardize submental fat assessment. The Clinician-Reported and Patient-Reported Submental Fat Rating Scales, validated during the pivotal ATX-101 clinical trials, and an ethnicity-specific reference-photograph set derived from this scale later achieved inter-rater kappa values between 0.70 and 0.91 (4). Newer severity tools, including the Clinician Submental Fat Scale (5) and the Clinician-Chin Assessment Tool (6), have also been used to stratify patients before enrollment in pharmacologic trials. Management options for submental fat span a wide spectrum. Injectable deoxycholic acid lipolysis has produced a significant reduction of submental fat in randomized placebo-controlled trials and meta-analyses, with a tolerable and mostly transient adverse-event profile, although a potential industry-sponsorship bias has been raised across the available trials (2). A newer injectable lipolytic agent achieved comparable improvement on clinician- and patient-reported scales, together with objective volume reduction on magnetic resonance imaging, in a large randomized Chinese cohort (7). Cryolipolysis has similarly demonstrated efficacy for submental fat reduction, with pooled data from multiple pre-post studies showing a mean fat-thickness reduction of about 2.8 mm and a favorable safety profile (8), a finding corroborated by three-dimensional imaging analyses showing measurable volumetric loss and high patient satisfaction (9). Other non-invasive energy-based approaches, including combined focused-electrical-stimulation and radiofrequency devices, have been shown histologically to induce adipocyte apoptosis in the submental region (10). For patients with marked skin laxity or advanced neck-laxity grades, surgical techniques such as submental liposuction with platysma plication or resection remain the treatment of choice, as demonstrated in a recent submentoplasty cohort (10). Given the absence of local Egyptian data comparing the full spectrum of double chin management options and the lack of information on the true burden of this condition among Egyptian patients, this cohort study is designed to systematically evaluate patients with submental fullness at Assiut University Hospital and to compare the effectiveness, safety, and patient satisfaction of the different available modalities, in order to generate evidence-based, locally relevant treatment guidance

Pre-eclampsia is a hypertensive disorder of pregnancy that can lead to significant health complications for both the mother and the fetus. Asymptomatic bacteriuria (ASB) occurs when significant amounts of bacteria are present in the urinary tract without causing symptoms such as burning, pain, or fever. Research suggests that persistent, asymptomatic bacterial growth can stimulate inflammatory responses and endothelial dysfunction, which may contribute to or worsen pre-eclampsia. However, local data regarding how frequently this condition occurs among pre-eclamptic women in Assiut remains limited. The primary purpose of this cross-sectional study is to determine the prevalence of asymptomatic bacteriuria among pregnant women diagnosed with pre-eclampsia admitted to or attending the Department of Obstetrics and Gynecology at Women's Health Hospital, Assiut University. The study also aims to identify the specific bacterial species responsible for these infections, assess their antibiotic susceptibility profiles, and evaluate potential sociodemographic and clinical risk factors. Enrolled participants will be asked to complete a structured interview questionnaire regarding their medical history, obstetric history, and sociodemographic details. Each participant will provide a single clean-catch midstream urine sample for quantitative urine culture and microbiological analysis. Positive culture results will be communicated to the treating clinical team to guide targeted antibiotic management.

This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease.

Functional endoscopic sinus surgery (FESS), or sinusoscopy, is a standard surgical procedure used to treat chronic rhinosinusitis and other conditions of the nasal sinuses. However, bleeding during surgery is a frequent challenge that can obstruct the surgeon's view, lengthen operative time, and increase the risk of complications. Vitamin C (ascorbic acid) supports collagen synthesis, capillary wall strength, and blood vessel integrity, which may help minimize mucosal bleeding during surgical procedures. The purpose of this randomized clinical trial is to evaluate whether administering preoperative Vitamin C reduces intraoperative bleeding, enhances surgical field visibility, and shortens operative duration in adult patients undergoing elective sinusoscopy. Participants will be randomly assigned to one of two groups: * Vitamin C Group: Receives a standardized 500 mg dose of Vitamin C before surgery. * Control Group: Receives standard perioperative care/placebo before surgery. Total blood loss will be recorded during surgery, surgical field clarity will be evaluated every 15 minutes using the Boezaart scale, and participants will be monitored for postoperative bleeding and potential side effects for up to 48 hours.

This study evaluates the anatomical and hearing outcomes of cartilage tympanoplasty in pediatric patients with chronic tympanic membrane perforations. A perforation (hole) in the eardrum in children can lead to recurrent ear discharge, chronic middle-ear infections, and conductive hearing loss. Cartilage tympanoplasty is a surgical technique that uses autologous cartilage (the patient's own cartilage tissue) to reconstruct and seal the eardrum. Cartilage is known for its rigidity and resistance to retraction, which may offer advantages in children who frequently experience middle-ear pressure and ventilation issues. Children aged 8 to 18 years presenting with large, subtotal, or persistent dry central perforations will undergo cartilage tympanoplasty at Assiut University Hospitals. All participants will undergo standardized pre-surgical and post-surgical evaluations, including otological microscopic examinations and pure-tone audiometry tests. The main objectives are to evaluate the graft success rate (complete anatomical closure and stability of the eardrum) and to measure functional hearing restoration, specifically changes in air-conduction thresholds and the air-bone gap (ABG).

Silicone oil is commonly used as a temporary intraocular tamponade to support the retina during vitreoretinal surgery for complex retinal detachment and other severe retinal conditions. Although removing silicone oil typically leads to visual improvement, the degree of visual recovery varies widely among patients. Optical coherence tomography (OCT) is a non-invasive imaging technique that provides detailed cross-sectional views of the macula, the central portion of the retina responsible for detailed vision. The primary aim of this observational study is to evaluate the relationship between specific macular OCT biomarkers (such as central macular thickness, ellipsoid zone integrity, and macular edema) measured before silicone oil removal and visual outcomes after surgery. Identifying these structural features may help ophthalmologists better predict visual recovery and counsel patients prior to surgery. Participants will undergo a standard comprehensive ophthalmic examination, best-corrected visual acuity (BCVA) testing, and a macular OCT scan prior to their scheduled silicone oil removal. Visual acuity will then be reassessed during a standard postoperative follow-up visit at least 1 month after surgery. Participation is observational and does not alter routine surgical or medical management.

Laparoscopic cholecystectomy (gallbladder removal) is one of the most common abdominal operations performed worldwide. Despite its minimally invasive approach, up to half of patients experience notable postoperative pain, which often requires opioid painkillers. Reducing perioperative opioid consumption through non-opioid medications helps minimize opioid-related side effects, improve comfort, and enhance postoperative recovery. The primary purpose of this clinical trial is to compare the pain-relieving and opioid-sparing effects of three intravenous medications (labetalol, magnesium sulfate, and lidocaine) administered during elective laparoscopic cholecystectomy under general anesthesia. Adult participants aged 18 to 60 years will be randomly assigned to one of three parallel groups: * Group Lb: Receives intravenous labetalol as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group M: Receives intravenous magnesium sulfate as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group L: Receives intravenous lidocaine as an initial loading infusion before induction followed by a continuous infusion during surgery. The main outcome measured is total perioperative opioid consumption during surgery and throughout the first 24 postoperative hours. Investigators will also assess hemodynamic parameters (heart rate and blood pressure), blood oxygen levels, postoperative pain intensity scores, surgeon satisfaction, and the occurrence of any adverse effects.

Upper abdominal pain is a common and often debilitating symptom in patients with pancreatic cancer and chronic pancreatitis, and is frequently under-treated by standard opioid therapy despite dose escalation and associated side effects \[1\]. In chronic pancreatitis, abdominal pain is present in the great majority of patients and is often the dominant factor driving impaired quality of life, with celiac plexus block considered an interventional option for temporary relief \[2\]. Pain arising from both malignant and benign upper abdominal pathology is transmitted through the celiac plexus, an autonomic plexus located in the retroperitoneum at the root of the celiac trunk, making it a rational target for pain-relieving intervention in either disease process \[3\]. Two image-guided approaches have been developed to interrupt this pathway: the percutaneous route, performed under fluoroscopic or CT guidance \[5\], and the endoscopic ultrasound-guided route, performed transgastrically at the time of upper endoscopy, which allows direct visualization of the celiac plexus and may reduce the risk of injury to adjacent structures compared with the percutaneous approach \[3,9\]. Neurolytic celiac plexus block has been shown to improve pain relief in patients with unresectable pancreatic cancer \[6\], while EUS-guided celiac plexus block has similarly demonstrated efficacy in relieving pain associated with chronic pancreatitis \[7\]. Direct comparisons between the two approaches, however, remain limited: existing trials and meta-analyses in both chronic pancreatitis \[2,8\] and pancreatic cancer \[4,9\] show inconsistent superiority of one technique over the other, and the choice between them in practice has historically relied more on institutional expertise than on robust head-to-head evidence

The present clinical study will be undertaken to evaluate and compare the clinical efficacy of two different volumes of distal ICBN block when combined with a baseline supraclavicular brachial plexus block during superficialization of upper arm arteriovenous fistula

This observational cross-sectional study aims to assess the relationship between inflammatory markers and pain intensity in adult patients with sickle cell disease. The study will evaluate inflammatory markers in patients with different clinical presentations, including steady state and vaso-occlusive crisis.

Diabetes mellitus (DM) is a globally prevalent metabolic disorder with an escalating burden on renal health. Diabetic kidney disease (DKD) represents the leading cause of end-stage renal disease (ESRD) worldwide, affecting approximately 20-40% of all diabetic patients . The pathophysiology of DKD involves progressive microvascular injury characterized by glomerular hyperfiltration, mesangial expansion, tubular damage, and ultimately interstitial fibrosis, culminating in irreversible loss of renal function . Despite advances in management, a substantial subset of diabetic patients develop significant renal structural damage while remaining normoalbuminuric, rendering conventional biomarkers such as urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) inadequate for early detection . Conventional renal screening relies heavily on serum creatinine and albuminuria thresholds; however, these markers reflect filtration loss that occurs only after considerable parenchymal injury has already taken place . Novel tubular biomarkers such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown promise in detecting early tubular damage, yet their routine clinical applicability remains limited by cost and lack of standardized thresholds . Renal biopsy, the gold standard for histological staging of DKD, is invasive, carries hemorrhagic risk, and is entirely impractical as a population-level screening tool . Renal Duplex Doppler ultrasonography has emerged as a valuable, safe, non-invasive modality for assessing intrarenal hemodynamics. The Renal Resistive Index (RRI), calculated as (Peak Systolic Velocity - End Diastolic Velocity) / Peak Systolic Velocity, and the Pulsatility Index (PI), defined as (Peak Systolic Velocity - End Diastolic Velocity) / Mean Velocity, reflect downstream microvascular impedance and arteriolosclerosis . Elevated RRI values have been independently associated with progressive renal functional decline, systemic arterial stiffness, and adverse cardiovascular outcomes across multiple patient populations . In the context of Type 2 Diabetes Mellitus (T2DM), elevated RRI has been consistently demonstrated to correlate with disease duration, poor glycemic control, microalbuminuria, and declining eGFR, with a diagnostic cut-off of approximately 0.65-0.70 proposed in several studies . Mahmoud et al. (2023) demonstrated that diabetic patients exhibited significantly higher mean RRI values compared to healthy controls, underscoring the utility of intrarenal Doppler indices in detecting early nephropathy before overt albuminuria manifests . In Type 1 Diabetes Mellitus (T1DM), particularly in pediatric and young adult cohorts, RRI has been shown to rise in parallel with glycemic variability and tubular injury markers, preceding the onset of microalbuminuria by years . The relationship between RRI and systemic microvascular complications such as retinopathy and neuropathy has also been explored, with evidence suggesting that elevated RRI may serve as a surrogate marker of global microvascular disease burden in diabetic patients . Furthermore, dynamic RRI assessment following physiological stimulation has demonstrated predictive value for long-term renal outcome in both T2DM and hypertensive patients . The prognostic significance of RRI extends beyond renal function, with studies reporting its independent association with major adverse cardiovascular events and all-cause mortality in chronic kidney disease populations . Despite this accumulating evidence, a critical gap remains: the vast majority of published studies have examined T1DM and T2DM populations independently, under heterogeneous Doppler acquisition protocols and with varying patient selection criteria. No adequately powered, three-arm comparative study has simultaneously evaluated RRI and PI across T1DM, T2DM, and matched healthy controls under a single, rigorously standardized protocol. Furthermore, data specific to the Egyptian population, which carries one of the highest global burdens of adult diabetes and diabetic nephropathy, are remarkably scarce. This study is therefore designed to address this methodological gap by conducting a structured comparative cross-sectional analysis of RRI and PI across all three groups, with comprehensive correlation to clinical, glycemic, and renal parameters, to establish locally validated diagnostic thresholds and advance the role of renal duplex sonography as a frontline early screening tool for diabetic renal microvascular disease.

ST-elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality globally, and timely reperfusion with primary percutaneous coronary intervention (PPCI) is the gold-standard treatment1. Current guidelines recommend a door-to-balloon (DTB) time of 90 minutes or less, as the benefits of PPCI increase in direct correlation with the brevity of reperfusion time. However, there is consistent epidemiological evidence that STEMI patients presenting during off-hours (nights, weekends, and holidays) experience delays in reperfusion and worse in-hospital outcomes compared to those presenting during regular business hours. Two competing hypotheses dominate the literature. The systems hypothesis suggests that delays in care delivery during nights and weekends-including longer catheterization laboratory activation time, reduced availability of experienced operators, and logistical constraints-are the primary drivers of worse outcomes. In support of this, some studies have found that the mortality difference between off-hours and on-hours presentations is attenuated after adjusting for DTB time (Chung et al., 2020), suggesting that system-level process measures may be actionable targets for quality improvement. Alternatively, the intrinsic severity hypothesis suggests that nocturnal STEMI presentations represent inherently more severe infarcts-characterized by higher thrombus burden, larger myocardial infarction size, and more frequent complications such as cardiogenic shock-independent of how rapidly reperfusion is achieved. Recent studies examining circadian variation in infarct size and myocardial injury biomarkers have found evidence of larger infarcts and worse systolic function in nocturnal-onset STEMI, with long-term mortality implications. Critically, the vast majority of evidence in this field derives from retrospective registry data, particularly from North American and Western European cohorts. Data from the Middle East and North Africa (MENA) region, where demographic and healthcare system profiles differ substantially from developed nations, are essentially absent from the literature. Furthermore, contemporary data on the prospective relationships between time-of-PPCI, operator experience, procedural quality parameters (such as myocardial blush grade and ST-segment resolution), and outcomes remain limited. A prospective study with granular intra-procedural data collection offers the opportunity to: (1) quantify the magnitude of the off-hours effect in a Middle Eastern context; (2) decompose the DTB time into its components to identify specific system bottlenecks; (3) assess whether operator seniority and team composition confound or mediate the off-hours effect6; and (4) evaluate whether procedural quality metrics (reperfusion grade, thrombus burden, microvascular perfusion) differ between daytime and nighttime PPCI and contribute to outcome disparities independent of system factors.

This cross-sectional study aims to assess cardiovascular structural and electrophysiological alterations in obese children attending Assiut University Children's Hospital.

Blood donation is essential for healthcare, but repeated whole-blood donation can deplete the body's iron stores. Standard pre-donation screening relies on hemoglobin levels to ensure donor safety; however, a drop in hemoglobin is a late sign of iron deficiency. Consequently, donors with subclinical or latent iron depletion often pass standard pre-donation screening unnoticed. The primary purpose of this study is to evaluate the clinical utility of Reticulocyte Hemoglobin Equivalent (RET-He) as an early laboratory marker for detecting iron deficiency among accepted blood donors. Because reticulocytes are newly formed red blood cells, RET-He reflects iron availability for hemoglobin production over the preceding few days, potentially detecting iron limitation much earlier than mature red blood cell indices or standard hemoglobin testing. In this prospective observational study, approximately 300 eligible voluntary blood donors aged 18 to 60 years will be enrolled at the Main Blood Bank of Assiut University Hospitals. At the time of routine donation, blood samples will be analyzed for complete blood count (CBC) with RET-He, serum ferritin, iron profile (serum iron, total iron-binding capacity, and transferrin saturation), and C-reactive protein (CRP) to control for inflammation. Participants will also be reassessed at their subsequent regular donation visit (after 90 days for males and 120 days for females) to evaluate changes in iron indices over time and explore whether adding RET-He improves donor eligibility assessment and long-term donor health.

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease, is an increasingly recognized comorbidity in people living with human immunodeficiency virus (HIV). Chronic low-grade inflammation, altered lipid metabolism, and certain antiretroviral therapy (ART) regimens may heighten the vulnerability of people living with HIV (PLWH) to liver fat accumulation, progressive liver fibrosis, and cardiometabolic complications. The primary purpose of this observational case-control study is to determine the prevalence, clinical characteristics, and laboratory findings of MASLD and hepatic fibrosis among PLWH compared with matched HIV-negative individuals. The study also aims to evaluate dietary quality, lifestyle habits, and cardiovascular risk profiles in both groups, and to determine whether adherence to a healthy lifestyle protects against significant liver disease. Adult participants (aged 18 years and older) attending the Department of Tropical Medicine and Gastroenterology at Assiut University Hospitals will be enrolled into two groups: people living with HIV and HIV-negative individuals matched by age, sex, and degree of liver steatosis. All participants will complete the following non-invasive evaluations: * Hepatic Assessment: Abdominal ultrasound and transient elastography (FibroScan) to detect fatty liver and quantify liver stiffness, alongside non-invasive scoring systems (FIB-4 score and NAFLD Fibrosis Score). * Laboratory Investigations: Fasting blood tests including liver function tests, lipid profiles, glycemic status (HbA1c), kidney function, complete blood count, and immune markers (CD4+ T-cell count and CD4/CD8 ratio). * Physical and Body Measurements: Measurement of body mass index (BMI), waist circumference, and mid-arm muscle circumference (MAMC). * Dietary and Lifestyle Questionnaires: Validated assessment tools including the Food Frequency Questionnaire (FFQ), Short Healthy Eating Index (sHEI), and Healthy Lifestyle Questionnaire to quantify nutritional quality, physical activity, and daily lifestyle habits. * Cardiometabolic Risk Calculation: Calculation of predicted cardiovascular risk using the American Heart Association PREVENT risk score. Findings from this study are intended to clarify the role of dietary quality and lifestyle factors in liver and metabolic health among people living with HIV, potentially informing proactive screening and management strategies.

This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in the diagnosis of respiratory distress syndrome among preterm neonates in comparison with chest X-ray.

This prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases.