Ashland, Ohio

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

This study will be conducted in multiple sites in North America, Europe, Middle East and South America.

The Effect of Postural Correction On Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a disease that occurs when the normal physiological process termed gastroesophageal reflux (GER) begins to cause painful, harmful, or irritating signs and symptoms to certain individuals. This happens when the defence lines composed mainly of the lower esophageal sphincter (LES) and the angle of His are affected by a multitude of factors. These include abnormal resting pressure of the LES, increase intra-abdominal pressure compared to the resting pressure of the LES, certain medication side effects, and certain body positioning. The latter combined with posture has also been pointed out as a factor that might affect GERD by affecting the angle of His that acts similar to a valve between the esophagus and the curvature of the stomach. Several works of literature have found a link between GERD and postural abnormalities or deformities. Scoliosis, defined as a spinal deformity consisting of a lateral curvature with or without rotation of the vertebra, has been shown to be a risk factor of GERD. More specifically, a left-sided thoracolumbar or lumbar lateral curvature, especially when greater than 30 degrees, has been cited by several studies as a risk factor for consideration with regards to GERD. Accordingly, a certain relationship might be present between spinal deformities and/or abnormal spinal positioning, more specifically in the thoracic and thoracolumbar regions, and severity as well as prevalence of GERD. As such, the aim of this study is to investigate the effect of postural correctional interventions (PCI) on severity of GERD symptoms and quality of life in patients afflicted with the disease. The experimental group in this study will undergo real postural correctional exercises whereas the control group will undergo sham postural correctional interventions and then the two groups will be compared post-treatment based on GERD severity of symptoms as well as quality of life of the patients afflicted with GERD.

PLADO for Conservative Management of CKD

A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation

GlideScope-assisted flexible fiberoptic intubation has been successfully used in cases of anticipated and unexpected difficult airways. This technique depends on two operators where the second operator assists in holding the GlideScope while intubation is being attempted by the first operator. However, it is not yet established whether this two-operator technique has any effect on the success rate of first-attempt intubation by the GlideScope video laryngoscope. The primary objective of this study is to compare the first attempt success rate of endotracheal intubation using the GlideScope video laryngoscope when performed by two operators versus a single operator. Secondary objectives include assessing the time to intubate, the need for optimization maneuvers, the effect of the presence of predictors of difficult intubation, the occurrence of adverse events during intubation such as oxyhemoglobin desaturation to less than 90% measured by pulse oximetry, the incidence of airway trauma, and the incidence and severity of post-operative sore throat. In this prospective randomized controlled trial, 428 patients (214 in each group) adult patients will be enrolled in one of two groups over 9 months of work. They will be further stratified into blocks according to the presence of at least one predictor of difficult intubation. Patients allocated to the control group will be intubated using the GlideScope by a single operator (the resident on the study). Those allocated to the experimental group will be intubated using the GlideScope with the assistance of a second operator (the resident and the attending physician). In both groups, the time to intubate will be measured by the attendings on the study, along with other parameters collected by the resident on the study. If intubation fails, the airway will be subsequently managed using any technique deemed appropriate by the attending anesthesiologist. Data comparing the success rate of endotracheal intubation when a second operator assists in holding the GlideScope is missing. This two-operator technique is essential in the new multimodal airway management involving video-assisted flexible fiberoptic intubation. Our study will determine whether the assistance in using the GlideScope provides similar first attempt success rate of endotracheal intubation and thus guarantees securing a difficult airway.

This is a Prospective Observational Study Assessing the Variation of Impedance Across the Different Tissues to Locate and Block Nerves When Preforming an Axillary Peripheral Nerve Block. the Results Would Enhance Precision of Needle Placement and Increase the Success Rate of the Block.

COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children

Inadequately treated pain in children undergoing surgery is a major concern for health providers. Recent evidence indicates that pain sensitivity differs among races and ethnicities and genetic makeup. Catechol-O-methyltransferase (COMT) polymorphisms (rs6269, rs4633, rs4818 and rs4680) which are inherited together in different phenotypes influence clinical presentations and responses to pain. A118G single-nucleotide polymorphism (SNP) in the mu-opioid receptor1 (OPRM1) gene is associated with differences in pain perception and opioid requirements. The effect of genome variations in the COMT gene and in the OPRM1 on postoperative pain perception and morphine analgesia in children needs further exploration. The main objective of this study was to investigate whether the OPRM1 and COMT SNPs influence postoperative pain scores in children between the ages of 8 and 18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries. Secondary objective includes assessing whether OPRM1 and COMT SNPs influence postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the post anesthesia care unit (PACU), and signs of respiratory depression (RD) and postoperative nausea and vomiting (PONV). Methodology: A prospective cohort genotype-blinded observational study will be conducted. A convenience sample of 200 children between the ages of 8-18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries will be recruited from the American University of Beirut Medical Center (AUBMC). The primary outcome of the study is the post operative pain score in PACU. Secondary outcomes include the postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the PACU, and signs of RD and PONV. To test the hypothesis that COMT and OPRM1 SNPs are associated with postoperative analgesia outcomes in children, SPSS version 29 will be used. Allelic and genotype frequencies will be examined by the Hardy-Weinberg equilibrium (HWE) test. To analyze the association between the different genetic variations and the outcomes, bivariate analysis will be performed. Variables measured over time will be compared between the groups using an exploratory mixed model analysis. Time to first post-operative opioid requirement will be analyzed using the survival analysis Kaplan Meier curve. Such understanding will pave the way for individual tailoring and optimization of pain assessment and management in children undergoing orthopedic, abdominal, thoracic, and plastic surgical procedures.

Enhancing Difficult Laryngoscopy Prediction Through A Mixed Scoring System

The ability to predict a difficult airway is the cornerstone of avoiding its dreaded complication. To standardize the task of airway assessment, multiple scores have been developed and subsequently validated, such as the Wilson risk sum score, El-ghanzouri risk index, Arne risk index...Despite utilizing these tools, there are situations in which subjects classified as easy airways surprisingly present with challenging airways. This has raised the need for developing and validating newer airway assessment scores, that include quantitative ultrasound measurements. This study aims to develop a comprehensive airway assessment score including traditional bedside clinical tests and ultrasound measurements with high accuracy in predicting difficult airway, and to validate it through testing it on a large population sample. After obtaining the consent from patients to participate in the study, the day before the surgery in the PAU or patients' rooms, a member of the research team with experience in ultrasound, will collect the required data either in the preoperative unit or in the patient room the day before the surgery (for admitted patients). The traditional metrics collected are: Modified Mallampati score, inter-incisor distance, upper lip bite test, the maximum range of head and neck movement, neck circumference, thyromental distance, receding mandible, buck teeth, edentulousness, presence of beard, and sternomental distance and the ultrasound measurements collected are a distance from skin to epiglottis (DSE), hyomental distance (HMD), the ratio of hyomental distance in maximal head extension to hyomental distance in neutral position (HMDR), tongue thickness (TT), the ratio of pre-epiglottic distance to the epiglottic distance at the midpoint of the VC (Pre-E/E-VC), distance from skin to the hyoid bone (DSHB), and distance from skin to vocal cords (DSVC). After induction, the level of difficulty of laryngoscopy will be collected by a member of the research team. For clinical and sonographic criteria with statistical significance, the investigators will calculate their sensitivity, specificity, and positive and negative predictive values. To determine the quantitative variable cut-off, the investigators will establish the ROC (Receiver Operating Characteristics). After checking that the area under the curve (AUC) is significantly >0.7, the investigators will choose as the cut-off, the value of the variable that corresponds to the best "sensitivity-specificity" pair. Finally, to identify independent criteria associated with difficult laryngoscopy, the investigators will perform multivariable analysis by logistic regression. These independent predictive criteria are the score parameters defined by values corresponding to their respective odd ratios. Then the investigators establish the cutoff value of the score from its ROC curve. As the patients in this study are almost all Lebanese or Arab, potential bias and influencing factors must be considered when the models are used for patients in other countries. Also, this is a single institution study, a multicenter and multiracial study is needed to develop a score that can be widely used internationally.

The Effect of Taping on Plantar Pressure Distribution in Players With Chronic Ankle Instability

Basketball players frequently suffer from lateral ankle sprains and multiple repetitions can cause chronic ankle instability. The authors contend that professional basketball can no longer be regarded as a noncontact sport because of the rising rate of injuries to players in the league. An orthopedic strapping treatment for the foot called rigid taping involves applying tape along the plantar part of the foot and inferior to the malleoli. Another type of taping method gives the musculoskeletal system external support, kinesio-taping has long been employed in the rehabilitation and prevention of sports-related injuries in athletes and sports participants. The goal of an anti-pronation taping technique is to constrain an overpronated foot by offering temporary external support. Thus the aim of this study is to determine the immediate effects of rigid taping versus kinesio-taping on static and dynamic plantar pressure distribution in basketball players with chronic ankle instability. An explanation of the procedure and a written consent form will be provided, and the assessment will be taken at the beginning of the spring semester of 2024/2025 for inclusion and exclusion. Then the CAIT will be used followed by assigning the participants into a healthy group and an injured group for the observational part and collecting the data on the injured foot. Then further randomly divided the injured group into AP, LD, and a control group. Application of the interventions will be done to the affected foot and sham tape will be applied to the control group then the effects will be observed and the measurements will be noted and compared to the previous data. The CAIT will be used again to observe the differences that may result. The study will take place at Mousawat Institution.

The Effect of Blood Flow Restriction Training on Tennis Elbow

Lateral epicondylitis, commonly known as Tennis elbow, is a musculoskeletal condition characterized by pain at the lateral epicondyle due to repetitive forearm and hand movements. While it often improves over time, some cases may worsen. Diagnosis involves physical signs, including pain, decreased grip strength, tenderness, and pain during wrist flexion. Medical imaging such as MRI and clinical tests like Mills and Cozen's are used for confirmation. According to Lenoir, Mares, Carlier (2019), physical therapy is the primary treatment, with exercises like eccentric muscle strengthening, deep friction massage, stretching, ultrasound, and laser therapy proving beneficial. Blood flow restriction training (BFR) has gained interest for enhancing strength and muscle mass. BFR involves partially restricting blood flow using a strap or cuff, inducing muscle hypoxia. Despite the unclear mechanism, BFR has shown positive effects on muscle tissue, possibly related to hypoxia and muscular acidosis. The lack of studies on BFR's impact, especially on smaller muscle groups like fingers and wrists, creates a need for investigation. Given the commonality and impact of lateral epicondylitis symptoms, this study aims to compare the effectiveness between BFR training with standard PT exercises and standard PT alone in patients with lateral epicondylitis. Thus the purpose of this study is to prove that BFR training is more effective than standard physical training in improving the parameters surrounding tennis elbow. The participants will be randomized into 2 groups. The standard physical therapy (group1) training consists of :1-ultrasound therapy, 2-laser, 3-deep friction massage followed by ice on the proximal attachment of the extensor tendon, 4-heat, 5-stretching of the wrist flexors and extensors, 6-strengthing of the wrist extensors combined with BFR. (Group 2) will be treated with the same interventions excluding BFR training. Participants in both groups will be receiving treatment 2 times per week for 12 sessions.

Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction

Background: Intubation has always been linked to a transient increase in blood pressure and heart rate that could be deleterious in elderly and hemodynamically unstable patients. Fiberoptic intubation, which is currently used for suspected difficult intubation, could cause less marked rise in blood pressure and heart rate. Furthermore, "opioid free anesthesia" has gained popularity lately to avoid opioid adverse effects ranging from respiratory depression, postoperative ileus, sedation, nausea, vomiting and urinary retention. Specific aims: The primary objective of this study is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma. Methods: In this prospective randomized clinical trial, 90 (45 in each group) adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia, will be recruited over 1 year of work. Patients will be randomly allocated to 2 groups: The direct conventional laryngoscopy group performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade, and the fiberoptic guided intubation group. Significance: Studies comparing hemodynamic stability using fiberoptic intubation versus direct oral intubation in opioid free anesthesia are limited. The present study will assess whether fiberoptic intubation causes less hemodynamic instability than direct oral intubation in opioid free anesthesia induction, which will benefit patients with normal airways.