Qena%20governorate, Egypt
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Phase
N/ASpan
5 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis
In patients with type 2 diabetes and advanced CKD, finerenone resulted in lower risks of CKD progression and cardiovascular events. Mineralocorticoid receptor over activation in the kidney leads to inflammation and fibrosis with subsequent progressive kidney disease. Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, had more potent anti-inflammatory and ant fibrotic effects than steroidal mineralocorticoid receptor antagonists. Finerenone has been shown to reduce the urinary albumin-to-creatinine ratio in patients with CKD treated with an RAS blocker, while having smaller effects on serum potassium levels than spironolactone. Glomerulonephritis (GN) is an inflammation affecting kidney glomeruli, and is considered an important cause of CKD. Reducing proteinuria is one of the main therapeutic targets in patients with GN.
Phase
2Span
29 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
Phase
N/ASpan
87 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Healthy Volunteers
Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars
The study will be a double-armed randomized controlled clinical trial, with parallel design. A total of 74 pediatric patients aged 4-8 years will be selected from the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Alexandria University, Egypt. Participants will be allocated into 2 groups according to the type of crown used. Group I (study group) will be treated with BioFlex crowns using Hall technique, while Group II (control group) will be treated with the SSCs using Hall technique. Clinical and radiographic success of both crowns will be assessed. The function of the temporomandibular joint (TMJ) will be evaluated using the Helkimo Clinical Dysfunction Index (Di) and the AAPD questionnaire. The Occlusovertical dimension measurements will also be evaluated using the Van der Zee and Van Amerongen method. Plaque and gingival health will be recorded using plaque and gingival indices, and the satisfaction level of the child will be assessed using the Facial Image Scale (FIS), while the satisfaction level of parents will be assessed using questionnaire.
Phase
N/ASpan
53 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients with Diabetic Macular Edema
Some evidence in the literature suggests that sodium glucose co-transporter 2 (SGLT2) inhibitors may be beneficial in reducing diabetic macular edema. The objective of this clinical trial is to investigate the efficacy and safety of dapagliflozin when combined with intravitreal aflibercept injections in the management of patients with type II diabetes mellitus and center-involved diabetic macular edema (ci-DME). This randomized, double-blind, parallel group, active control design, clinical trial, is investigating the effect of oral dapagliflozin 10 mg given once daily in addition to intravitreal aflibercept versus intravitreal aflibercept alone on reducing macular central subfield thickness (CST) and improving visual acuity in diabetic patients with ci-DME.
Phase
2Span
82 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)
Phase
N/ASpan
122 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Healthy Volunteers
Mobile Oral Health Intervention Effectiveness on Orthodontic Patients' Oral Hygiene and Oral Health Literacy
Phase
N/ASpan
34 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Healthy Volunteers
Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
This will be a prospective exploratory that will be conducted on patients with the inclusion and exclusion criteria detailed. At the baseline visit, the sociodemographic data (age, sex, smoking status) and clinical data (TN etiology (idiopathic or symptomatic), TN phenotype (purely paroxysmal or with concomitant continuous pain), clinical symptoms topography (V2, V3), brain MRI findings, previous medications and interventions, and comorbidities) will be collected. The patients will be randomly assigned to undergo bipolar PRF or monopolar PRF using a simple randomization technique. Pain scores will be assessed using the nominal rating scale (NRS) at baseline, within two weeks postoperatively, and at 1-month, 3-month, and 6-month intervals. Patient satisfaction will be assessed within two weeks following the intervention on a five-point Likert scale (5 represents very good and 1 means very bad). Treatment success will be defined as at least a 50% reduction in pain scores. The duration to pain control and the duration to pain recurrence/rebound will be assessed at follow-up visits. The patient's postoperative need for medications or further pain interventions will be detailed. Intraoperative and postinterventional complications will be monitored and documented. Study interventions For the PRF procedure, all patients will be prepared in the operating room and will undergo standard operative monitoring (i.e., blood pressure, electrocardiography, and pulse oximetry). They will be positioned in a supine position with slight neck extension. Sedation will be provided (100 Ig fentanyl and 2 mg midazolam intravenously). Skin preparation will be performed using chlorhexidine. I- Monopolar PRF In the monopolar PRF, an RF cannula (22-gauge, 100 mm, with a 10 mm active tip (SMK)) will be percutaneously advanced at the posterior border of the foramen ovale under fluoroscopic guidance. For confirming the detection of the mandibular nerve, sensory stimulation will be performed via the radiofrequency generator at a current of 0.5 to 1 V at a frequency of 50 Hz to elicit paresthesia response in the mandibular region. Motor stimulation will be performed via the generator at a current of 1 - 2 V applied at a frequency of 2 Hz to obtain a contraction response at the masseter muscle. After obtaining the appropriate responses, PRF will be applied at a fixed heat energy of 42 °C for a period of 240 seconds10. II- Bipolar PRF For bipolar PRF, two RF cannulas will be advanced in the foramen ovale under fluoroscopic guidance. The first (22-gauge, 100 mm, and 10-mm active tip (SMK)) will be placed at the anterior border of the foramen ovale, and then the second (same parameters) will be advanced at the posterior border. The correct position will be confirmed on the lateral position until the correct placement at V2. Sensory and motor testing will be performed as aforementioned in the monopolar PRF to confirm the appropriate capture of the trigeminal nerve. Following obtaining the appropriate responses, PRF will be performed in two cycles, three minutes each, at a temperature of 42ºC and a current of 85 V and a 20-millisecond pulse width13.
Phase
N/ASpan
87 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Trauma-Informed Motivational Interviewing in Rural Dwelling Samples
Introduction Leprosy remains a profoundly stigmatised condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. Traditional biomedical approaches, while essential for physical recovery, often neglect the psychological and social ramifications of the disease. Trauma-Informed Motivational Interviewing (TIMI) emerges as a promising paradigm to address these psychosocial challenges, enhancing resilience, improving self-perception, and fostering social re-engagement. Understanding the Psychological Impact of Leprosy Leprosy-related stigma is multifaceted, rooted in cultural beliefs, misinformation, and visible physical impairments. Affected individuals frequently endure social rejection, which fosters feelings of shame, body image dissatisfaction, and emotional distress. These experiences, akin to trauma, may disrupt self-efficacy and hinder engagement with both healthcare systems and social networks. Trauma-Informed Motivational Interviewing: Core Principles TIMI integrates two evidence-based approaches: Trauma-Informed Care (TIC) and Motivational Interviewing (MI). TIC emphasises understanding and acknowledging the impact of trauma on individuals' behaviours and emotional well-being. MI, a client-centred approach, fosters intrinsic motivation for change by exploring ambivalence and strengthening personal autonomy. The synergy of TIMI rests on five core principles: Safety: Ensuring physical and emotional safety in all interactions. Trustworthiness and Transparency: Building a collaborative, open relationship. Peer Support and Empowerment: Encouraging individuals to harness personal and community strengths. Collaboration and Mutuality: Shifting the power dynamic to promote shared decision-making. Cultural, Historical, and Gender Awareness: Respecting cultural narratives and addressing systemic inequalities. Addressing Key Psychosocial Challenges Combatting Discrimination and Stigma: TIMI helps reframe self-perceptions, encouraging individuals to challenge internalised stigma and societal bias. By fostering empathy and understanding, community members may also engage in reducing discriminatory attitudes. Improving Body Image and Self-Esteem: Acknowledging the emotional weight of physical changes, TIMI supports individuals in developing healthier self-concepts. Through guided dialogue, participants explore their strengths and redefine their value beyond appearance. Building Resilience: TIMI fosters a growth mindset, promoting coping strategies that empower individuals to navigate adversity. This is crucial in rural settings where access to mental health services may be limited. Enhancing Social Engagement: By empowering participants to explore their personal goals and values, TIMI helps identify pathways to meaningful social connections, promoting reintegration into community life. Implementation in Rural Contexts Adapting TIMI to rural environments necessitates a culturally sensitive approach. Training local healthcare providers, community leaders, and peer mentors in TIMI principles ensures sustainability. Additionally, integrating TIMI within existing community health frameworks, such as primary healthcare clinics or local support groups, facilitates accessibility.
Phase
N/ASpan
44 weeksSponsor
Alexandria UniversityAlexandria
Recruiting
Comparing Prophylactic Intravenous Pethidine and Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section
This study will be a single blinded, randomized, prospective controlled study. After obtaining written informed consents, 86 patients of American Society of Anesthesiologists physical status II, aged 20-40 years old, undergoing spinal anesthesia for elective cesarean section will be investigated at El-Shatby University Hospital. The patients will be randomized into two groups of n=43 each using a computer-generated sequence. Allocation concealment will be done using sealed envelope technique. Depending on the group allocation either to receive IV Pethidine 0.5mg/kg (Group A n=43 patients) as premedication mixed into 10 ml isotonic saline slowly IV or intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% (Group B n=43 patients). SA will be given at either L3-L4 or L4-L5 in the sitting position by the anesthetist using 22-25-gauge Quincke spinal needles. Patients will be covered with drapes but not actively warmed. 10mg ephedrine will be given if the patient becomes hypotensive (hypotension is defined as a decrease in MAP of >20% from the baseline). 0.5 mg atropine IV will be given if HR less than 50 beats/min. Rescue 4 mg ondansetron IV will be given for vomiting episodes. Room temperature will be maintained about 21 - 24ºC during the perioperative period in the OR and in the PACU, using temperature control system. The presence of shivering will be observed and graded after spinal injection by using Tsai and Chu Scale. The following parameters will be measured: 1. Vital signs (heart rate, and blood pressure) will be measured at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first two hours postoperatively 2. Body temperature (in degrees Celsius), will be measured, using axillary thermometer before drug administration then every 15 minutes till the end of surgery. After surgery, axillary temperature will be measured every 30 minutes for 2 hours. 3. Using Tsai and Chu Scale for shivering assessment, the incidence, duration, time interval from onset of spinal block to shivering occurrence, and intensity of shivering will be recorded every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively in the recovery room. 4. Complications of the drugs, such as nausea, vomiting and sedation will be recorded. The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering. The secondary aims will be to assess the effect of different routes of administration of the drug on hemodynamic stability, nausea, vomiting, and sedation.
Phase
3Span
16 weeksSponsor
Alexandria UniversityAlexandria
Recruiting