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NCT ID: NCT04864860 Recruiting - PreDiabetes Clinical Trials

Effect of Sea Weed (Ecklonia Cava Extract) on Blood Glucose and Insulin Level on Pre-diabetic Patients

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Introduction: The inhibition of α-amylase and α-glucosidase enzymes is suggested strategy for glycemic control particularly in people with prediabetes and diabetes. Polyphenola-rich brown seaweed extracts, have been proposed to have similar inhibition effect on α-amylases and α-glucosidases, thus improving diabetic related response. This proposal aims to investigate the effect of seaweed extract called E. cava on postprandial blood glucose (PPBG) and postprandial plasma insulin level (PPIL). Likewise, the study will examine any intolerance symptoms associated with the consumption of the studied seaweed extract. Objectives: Investigate the effectiveness of seaweed (E. cava) in reducing postprandial blood glucose and plasma insulin level in pre-diabetic patients, compared to placebo. Investigate the safeness and potential adverse effect of applying sea weed (E. cava) as a therapeutic diet composition on patient with pre-diabetes, compared to placebo. Methods: Double-blind, Randomized-controlled trial that will be conducted from 1st March 2021 to 20th July 2021 in Saudi Arabia. Participants will be eligible to participate in this study if they are diagnosed in their medical history as pre-diabetic patient through their medical records aged between 18 and 65 years with fasting plasma glucose (FPG) between 100 and 125 mg dL-1 as a set criterion by American Diabetic Association (ADA), and blood pressure within the normal range (systolic blood pressure ≤ 140 mmHg, diastolic blood pressure ≤ 90 mmHg set by World Health Organization (WHO) having no other health complications. Participants will be excluded if they are smoker, pregnant or lactation or having liver, thyroid, significant gastrointestinal disorders, taking any treatment with either insulin or anti-diabetic drugs or any other natural health products known to impact blood sugar. The number of individuals is required to detect differences of 38 units in BG and 2500-unit in plasma insulin (incremental under the curve (iAUC)) at 0.05 significance level with 80% power of the study. Study supplements (intervention and placebo) will be encapsulated in identical capsules and will be labelled with the letter A and B to conceal which supplement is given to participants each testing occasion. computer-generating randomization, data collection and analysis will be double-blinded. The intervention product used in this study is a dietary supplement capsules called "Seanol" that contain 13% pholoratannic polyphenol per capsule as stated by the manufacture company (seanol inside, 4215 95th St SW Lakewood, WA 98499 USA). Prior carbohydrates consumption, 2 capsule (1000 mg of E. cava), that contain 150 mg of pholorotanic polyphenol containing polyphenol will be administered at a single occasion for postprandial testing. This dose was selected to be similar to previous studies that shows no harm or sever adverse effect on participants (12, 14). placebo will be Similar in composition to the intervention. Plasma glucose concentration will be determined immediately by blood finger-prick sample following standard procedure using HemoCue Glucose 201 RT System (Radiometer Pacific Pty Ltd, Mount Waverley, VIC, Australia). Whereas, plasma insulin will be measured at the laboratory department at KKUH using enzyme-linked immunosorbent assay (ELISA) Statistics Mann-Whitney test will be used to determine differences for symptoms of intolerance between groups. Incremental area under the curve (iAUC), time to peak and peak blood concentration assessment will be used to assess postprandial responses of for plasma glucose and insulin level. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 20.

NCT ID: NCT04861272 Recruiting - Clinical trials for Cross Sectional Hospital Based Study

Risk Perception Associated With Covid-19 Among Anesthetists

Start date: April 15, 2021
Phase:
Study type: Observational

Since the outbreak of the COVID-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. So, they are subjected to a higher risk of infection compared to many other medical specialties. As a result, they are more subjected to psychological stresses. This study aimed to assess the level of stress associated with the COVID-19 pandemic among anesthesiologists.

NCT ID: NCT04857450 Recruiting - Anemia Clinical Trials

Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

The aim of this study was to try to reduce the required dose of etomidate used in anesthesia for upper endoscopy and colonoscopy in critically ill cardiac patients who complain of severe anemia in cardiac intensive care units by using a low dose of ketamine, which helps to reduce the side effects of etomidate, the most important of which is its suppressive effect on the adrenal gland and the secretion of cortisol in such critical cases, while maintaining hemodynamic stability, and the patient's satisfaction.

NCT ID: NCT04849468 Recruiting - Postoperative Pain Clinical Trials

Effect of Preemptive Intramuscular Diclofenac on Minimal Effective-Dose Bupivacaine Saddle Block for Minor Perianal Surgeries

Start date: June 1, 2019
Phase: Phase 2
Study type: Interventional

The research will be carried out in order to test the effect of Intramuscular (IM) Diclofenac, administered as preemptive analgesic with minimal effective dose spinal anesthesia in perianal surgeries, on prolonging the time to first request for analgesic and lowering analgesic consumption. Investigators hypothesized that using IM Diclofenac in this surgery will postpone the time to first analgesic request and will decrease the consumption of post-operative analgesics. Our method includes dividing the patients into control and study groups and recording the first analgesic request and post-operative analgesic consumption after surgery and comparing the results.

NCT ID: NCT04842474 Recruiting - Migraine Clinical Trials

Effectiveness of Gaze Stability Exercises on Balance and Activities of Daily Living Among Patients Suffering Vertigo With Vestibular Neuritis in Saudi Arabia

Start date: February 7, 2021
Phase: N/A
Study type: Interventional

Gaze stability exercise is a medical procedure for persons with unilateral vestibular disturbances such as vestibular neuritis or persons who have had tumors of their 8th nerve. They are a crucial part of the vestibular dysfunction rehabilitation protocols in health centers. These activities which involve turning one's eyes at different angles while having their eyes focused on an optotype are aimed at helping improve the vestibular ocular reflex (VOR), visual acuity during head movements and also reducing vertigo and dizziness. Study aim: This review will be establishing the effectiveness of applying gaze stability with balance exercises procedure among participants who are suffering vertigo due to vestibular neuritis. Methods: Twenty volunteers between the age of 25-59 years old, diagnosed, and confirmed to be suffering from vestibular neuritis and vertigo will be used in this study. Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes. The following outcome measures for each participant will be assessed pre-and post-treatment after completing four weeks of intervention. They include; Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale), Arabic version of Dizziness Handicap Inventory (A-DHI), Berg Balance Scale (BBS), and Katz Index of Independence in Activities of Daily Living (Katz ADL). The findings will then be subjected to statistical methods and data analysis using the SPSS toolkit. In this study we hypothesis that practicing gaze stability and balance exercises will have a positive influence on balance and activities of daily living among vestibular neuritis patients.

NCT ID: NCT04836598 Recruiting - Clinical trials for Cholecystitis, Chronic

Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.

Start date: November 30, 2016
Phase: N/A
Study type: Interventional

Background: Bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case. Objectives: The aim of this study was to investigate the safety and efficacy of an elective Bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with Bikini line laparoscopic cholecystectomy as minimal invasive scarless technique. We issued a modifications in order to minimize the number of ports (Brief ports) and modify port sites, using the Bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. Aiming at faster recovery, decrease pain and improve cosmoses. Bikini Line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. Obesity, intended as BMI 40, does not have any obstacle on the technical feasibility of BLLC.

NCT ID: NCT04775862 Recruiting - Colon Cancer Clinical Trials

A Prospective Study Utilizing Circulating Cell Free DNA (cfDNA) Use in the Detection of RAS Mutations in Patients With Advanced Colorectal Cancer.

Start date: February 21, 2021
Phase: Phase 2
Study type: Interventional

Colorectal cancer remains the commonest cancer among men, and third commonest among women in Saudi Arabia . Presentation with metastatic disease occurs in almost one third of patients , with 5-year survival decreasing significantly from 90% in stage 1 to 14% once the disease is metastatic . There is enthusiasm in the potential for liquid biopsies to provide easily accessible genetic biomarkers for mutational cancer characterization . Epidermal growth factor receptor (EGFR) monoclonal antibodies are widely used in the treatment of advanced colorectal cancer that do not harbor RAS mutations (RAS wild type). Hence genotyping of oncogenic RAS mutations is essential prior to the initiation of systemic therapy for such patients as the presence of these mutations predict resistance to EGFR targeted antibodies such as Cetuximab and Panitumumab . Detection of such mutations has been done on tissue biopsies with the disadvantage of this being an invasive procedure, and data suggesting that such testing may not be reflective of the true mutational burden of the disease since a single fragment of tissue may be inadequate to reflect the intratumoral heterogeneity. There is increasing evidence suggesting that liquid biopsies or blood based mutational profiling can provide a more comprehensive molecular profile of the disease, and carries the advantage of being minimally invasive. Serial liquid biopsies can act as a tool to identify spatial and temporal heterogeneity predicting response or resistance to targeted agents, and can shed light into the emergence (or disappearance) of specific mutations that may potentially be targeted with newer anti cancer agents . Circulating cell free DNA (cfDNA) consists of small nucleic acid fragments liberated from cells by rupture, necrosis or apoptosis, and is now increasingly being used to detect RAS (and other) mutations in patients with advanced colorectal cancers. KRAS has remained an "undruggable" target for decades until the most recent evidence that showed a new anticancer drug that targets KRAS G12C mutation. The investigators aim to perform cfDNA testing on patients with advanced colorectal cancers who have no RAS mutations (and hence start on EGFR inhibitors) as baseline, compare the results with mutational analysis on fresh tumor tissue, and perform cfDNA at first progression to determine what mutations have emerged, and specifically look for KRAS G12C mutation, which can be targeted with a new novel anti cancer drug . These patients will be collected over a 12 month period (with the aim of performing this on at least 100 patients), and followed from diagnosis (with baseline cfDNA) and until progression on EGFR inhibitors (where another cfDNA sample will be taken). A detailed proposal delineating this process will follow once accepted. This project is unique as it examines mechanisms of resistance to anti-EGFR inhibitors in our patients with advanced colorectal cancers, determines the prevalence of a specific mutation using liquid biopsies and examining cfDNA use, and may have therapeutic implications in facilitating obtaining KRAS G12C inhibitors for such patients.

NCT ID: NCT04767399 Recruiting - Post Operative Pain Clinical Trials

Comparison of Postoperative Pain After Instrumentation in Different Visits With Different Single File Systems.

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

Comparison of Postoperative Pain after Root Canal preparation, in Single and Multiple Visits, with Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Aim:1. Compare between the postoperative pain after root canal preparation, in single and multiple visits. 2. To assess the influence of reciprocating and rotary single-file systems instrumentation on post-operative pain.

NCT ID: NCT04746443 Recruiting - Covid19 Clinical Trials

Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey

Start date: December 8, 2020
Phase:
Study type: Observational

The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).

NCT ID: NCT04743765 Recruiting - Hip Fractures Clinical Trials

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

HIP ATTACK-2
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.