Moreno -pcia. De Bs. As.-, Argentina

  • Comparison of the Effects of Bio Ceramic and Epoxy Resin-based Sealers on Postoperative Pain After Root Canal Treatment

    Root canal sealers are essential for the success of endodontic treatment. Their physical properties, biocompatibility, and interactions with peri-apical tissues directly affect postoperative pain and healing. Endodontic sealers activate trigeminal nociceptors, leading to the release of CGRP (calcitonin gene-related peptide), which causes pain and a neurogenic inflammatory response. Resin-based sealers are widely used in endodontics due to their superior physicochemical properties. However, they have limitations, including the need for a completely dry canal due to their marked hydrophobicity and their initial cytotoxic activity, which cannot be entirely controlled. Bio-ceramic sealers represent a new generation of endodontic sealers that are favored by many dental professionals due to their small particle size (less than 2 micrometers), non-toxicity, high tissue compatibility, high hydrophilicity, and minimal dimensional changes. Retrospective studies have shown varying outcomes related to postoperative pain after root canal treatment using resin-based or bio-ceramic sealers. Aim: This study aims to compare the occurrence and intensity of postoperative pain and analgesic intake after root canal treatment using two different types of root canal sealers. Methods/Design: This study is a binary outcome randomized trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized trials of non-pharmacologic treatment. The study sample will consist of adult patients with a permanent single-rooted tooth diagnosed with asymptomatic apical periodontitis. Participants will be randomly allocated to be treated in the Endodontic clinic of PHCC Qatar with either resin-based sealers (control group) or bio-ceramic sealers (experimental group) to compare postoperative pain after root canal treatment. Patients will be observed for occurrence of pain or any other complications at 24 hours, 48 hours, and 7 days post-treatment. Postoperative pain will be assessed using a visual analog scale (VAS) at 24 hours, 48 hours, and one week post-treatment. Differences in the incidence of postoperative pain and the need for an analgesic will be analyzed using the chi-square test. Differences in pain intensity after treatment will be analyzed using the ordinal (linear) chi-square test.

    Phase

    N/A

    Span

    62 weeks

    Sponsor

    Primary Health Care Corporation, Qatar

    Doha

    Recruiting

    Healthy Volunteers

  • Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages

    Aneurysmal subarachnoid hemorrhage (aSAH) is a fatal neurosurgical emergency that may reach to a mortality of up to nearly 60% within one month of symptoms onset in untreated cases. Accounting for almost 5% of all stroke cases, aSAH predominantly affects the working age population with significant socioeconomic effect due to its impact on their quality of healthy life. Despite refined contemporary neurosurgical techniques and advancements in neurocritical care, secondary/delayed ischemia neurological deficits due to cerebral vasospasm, have been implicated as the main contributing factor, related to poor clinical outcome in nearly 30% of the patients. Although, over the years, many different treatment modalities have been used to counter the detrimental effects of vasospasm including calcium channel blockers and triple-H therapy (hypervolemic, hemodilution, hypertension) with no substantiative improvement in clinical outcome and a search for an effective management strategy continues. In aSAH, hyponatremia due to increased release of natriuretic factors and reduction in intravascular volume have been attributed to cause clinical vasospasm and delayed ischemic neurological deficits as a part of natural course of the disease. Reduced cerebral blood flow during aSAH has been explained based on two etiological factors. Firstly, immediately with the clinical onset of aSAH, there is a generalized decrease in brain oxidative metabolism that contributes to drop in global cerebral blood flow (CBF). This disruption in brain metabolic harmony is primarily caused by presence of toxic blood products in subarachnoid spaces although other contributing factors including acute hydrocephalus, brain edema and rise in intracranial pressure may also play their roles to already compromised CBF. Secondly, during the course of subsequent days to weeks when cerebral vasospasm sets in, it can further cause drop in CBF and cerebral metabolism. This drop in CBF is topographically heterogenous in brain parenchyma and this manifests as the delayed cerebral ischemia causing neurological deficits. Based on these pathophysiological mechanisms, the standard use of hypervolemic therapy was rationalized in neurosurgical practice in the past to mitigate the detrimental effects of hypoperfusion and it used to be achieved by routine use of crystalloids/isotonic solutions and complementary colloidal agents including dextran, hypertonic saline and human albumin in neurocritical care. In animal studies with rat models for acute focal ischemia, albumin treatment has effectively reduced size of penumbra. In contemporary clinical practice, the beneficial effects of human albumin has been investigated in cerebral strokes, acute brain injury, intracranial hemorrhages, including aSAH with promising results. In a pilot study conducted by Suarez et al (ALISAH) for a clinically safe dosage regimen for aSAH, it has also been observed that the use of albumin may be effective to prevent the deleterious effects of cerebral vasospasm by enhanced CBF leading to improvements in neurological outcome in aSAH patients. Ali A. et al recently published a systematic review that underscores obvious gaps in literature for the use of human albumin with no randomized control trial published to-date and highlighting the lack of any robust clinical evidence for the role of albumin to treat cerebral vasospasm in aSAH This single center RCT will aim to explore potential beneficial role of human albumin to improve clinical outcome in patients with aSAH.

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

    Healthy Volunteers

  • Enhancing Post-Stroke Dysphagia Rehabilitation

    This proposed study will be conducted using a prospective, three-group, randomized controlled trial. The participants for this study will be recruited from the post-acute and rehabilitation units who are diagnosed with post-stroke dysphagia at Hamad Medical Corporation hospitals in the State of Qatar.

    Phase

    N/A

    Span

    61 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

  • High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients

    High-flow nasal oxygen therapy (HFNO) has emerged over the last decade as a viable adjunct in the management of patients suffering from, or at risk of, hypoxemic respiratory failure. The mechanisms of its therapeutic benefit are not precisely understood but are thought to include a small but significant continuous positive airway pressure effect, and in the context of critically ill patients, the use of HFNO has been studied for the prevention of intubation, or as an alternative to Noninvasive Ventilation (NIV) for the prevention of intubation, in Type I respiratory failure patients, mostly with COPD or Heart Failure. Within the intensive care unit itself, HFNO has been studies in terms of preventing intubation, but it has been evaluated more in terms of preventing extubation failure. However, there have been no specific studies in Trauma Intensive Care Unit (TICU) patients. Patients suffering with polytrauma, who survive to TICU admission, are a unique population. There is a significant incidence of confusion and/or delirium post-extubation. In patients with respiratory failure post extubation, it is postulated (1) that the impaired mental state, however mild, may cause patients to a) be unable to tolerate NIV, b) swallow more air (on NIV) due to mild bulbar dysfunction, thus leading to an increased risk of regurgitation and possible aspiration pneumonitis. Furthermore, the use of NIV may c) impair effective oral nutrition in those patients without an NJ tube placed. Re-intubation (failed extubation) is defined variably as the need to intubate a patient within 72 hours of extubation in the critical care unit. Re-intubation is associated with increased intensive care and hospital length of stay, increased morbidity, and the physical risks to the patient inherent with the intubation process. It is unclear which, if any, interventions can help reduce the rate of extubation failure in Trauma Intensive Care patients. In this research study we are focusing on HFNO compared with NIV and conventional oxygen therapy in trauma patients to avoid reintubation. We propose that, when compared with either face-mask oxygen, NIV (CPAP), HFNO administered continuously for 24 hours post extubation of trauma patients on ICU, will result in better patient-related outcomes. Primary outcome measure: Our primary outcome measure is re-intubation rate within 72 hours of extubation Secondary outcome measures: Our secondary outcomes measures are CO2 accumulation rates, atelectasis rates, nutrition status within first 24 hours post extubation, and post-extubation rates of vomiting. Study design: Prospective, randomized clinical control study. There will be three arms to the study: a control arm, and two intervention arms. Randomization will do on a permuted block basis. The control arm will be patients receiving standard oxygen therapy, and the intervention arms will be either High Flow Nasal Oxygen Therapy, or Non-invasive Ventilation via mask. Study population: All patients intubated on the Trauma Intensive Care Unit at Hamad General Hospital will be considered eligible for the study. Written informed consent will be obtained from next of kin (NOK) if available or by the treating physician as a surrogate if the NOK are not available. Study Population Inclusion criteria: Adult intubated and ventilated patients who are victims of trauma and are being cared for on the Trauma Intensive Care Unit will be considered eligible for the study when they are considered fit for extubation. Exclusion criteria: - Patients who cannot be extubated (including patients requiring tracheostomy) - Patients with cribriform plate fractures - Patients with nasal occlusion for any reason - Patients with unstable mid-face fractures Sample size estimation: Based on an anticipated improvement rate of 25% reduction in extubation failure (from 8% to 6%), using High-flow nasal Oxygen Therapy and NIV (CPAP) with margin of error of 5%, and confidence level of 95%, a total of 100 intubated trauma patients needs to be included in the study (50 for each group). Moreover, 50 patients with facemask O2 will be included as a comparative or control group. The equation used for estimation of sample size: The standard normal deviate for α = Zα = 1.960 The standard normal deviate for β = Zβ = 1.645 Pooled proportion = P = (q1*P1) + (q0*P0) = 0.103 A = Zα√P(1-P) (1/q1 + 1/q0) = 2.198 B = Zβ√P1(1-P1) (1/q1) + P0(1-P0) (1/q0) = 2.878 C = (P1-P0)2 = 0.292 Total group size = N = (A+B)2/C = 88 Continuity correction (added to N for Group 0) = CC = 1/ (q1 * |P1-P0|) = 23 So, a total of 113 cases are required for this study (38 cases in each group), since the target reduction of extubation failure (effect size is small from 8% to 6% i.e., 25%) we prefer to include 50 cases in each group. Allocation ratio: 1:1:1 Study procedures: 1. The enrollment for the study will begin once patient is ready for extubation and at the same time will be randomized to the study arms. 2. All intubated patients with next of kin /deferred consent will be enrolled 3. The respiratory therapist will apply the intervention type based on physician order The study participants will be unblinded, as intervention is in the form of face mask O2, High flow nasal oxygen and NIV. These cannot be used in a blind approach. We have developed a flow-chart for the study participants, which include an escalation pathway. If HFNO fails, patients are escalated to NIV- CPAP. If Facemask O2 fails, patients are escalated to HFNO or NIV, depending on treating clinician preference. The maximum observation time allowed to test whether intervention is effective is one hour. Re-intubation requirement will be assessed by treating clinician depending on ABG/oxygenation/CO2 or WOB criteria, or 'clinician-judgement'. This may occur at any time. Screening and enrollment: The data will be prospectively collected for all intubated enrolled patients admitted to the Hamad General Hospital trauma ICU between 1 October 2020 and 31 December 2023. all ventilated patients will be recruited based on next of kin/deferred consent during the study period for the study in trauma ICU. The enrollment of the patients will be for 3 years from start of study period Follow up: Each patient will be followed up for 72 hours post extubation as a part of study Informed Consent: Unconscious patients with severe injury will not be able to provide informed consent. This trial will therefore use "Exception from Informed Consent Requirements for Emergency Research" (Policy # RES 11026) which involves the most vulnerable population of study subjects (i.e., a population with no capacity to control what happens to them and no capacity to consent, where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject's family member). Every possible effort will made to contact the subject's family member to obtain consent. However, it may be difficult to contact family members of migrant workers within the initial time frame in the emergency department. In such situation, initially the deferred consent document will be signed by two privileged physicians, one of whom will be the treating physician. After regaining complete consciousness patient will be asked for continuation in the study and if the subject agrees written informed consent will be obtained. As soon as is reasonably possible and appropriate the patient's NOK/person responsible will be informed of the patient's inclusion in the research and will be informed of the option to withdraw the patient from it without any reduction in quality of care. If the NOK/person responsibly chooses to withdraw their consent for continued participation, they will be asked for permission to use the data collected up to that time. Patients who recover sufficient cognition to understand the explanation of the study will be asked to consent to continue in the study or be offered the chance to withdraw. If the patient chooses to withdraw from the study, they will be asked for permission to use their data up to the time of withdrawal. All interaction between research staff and participants and their relatives will take into consideration the stress or emotional factors associated with critical illness and ensure that the dependency of potential participants and their relatives on medical personnel providing treatment does not compromise their actual or perceived freedom of decision making to participate. Risk This study does not add any novel risks to patients as all the interventions are currently used as part of standard bundles of care. Potential complications include local trauma, discomfort and pressure areas, epistaxis and gastric distension from the use of NIV. Dry airways are a potential complication of both face mask O2 and HFNCO2. These risks are the same as if the patients are receiving a standard clinical care of treatment or not participating in the research Data Collection & Integrity: The data will be prospectively collected for all intubated enrolled patients admitted to the Hamad General Hospital trauma ICU from 1 October 2020 to 31 December 2023. Patient data includes Age, Gender, Mechanism of injury, associated injury, Date & time of Trauma, arrival to Trauma room, admission, Vital signs in Trauma ICU, GCS, intubation date, and injuries, duration of hospital, ICU stay and mortality. Most importantly, the group allocation will be to Facemask O2, NIV-CPAP, or HFNO. We will compare the rates of re-intubation using a p-value of < 0.05 to confirm a statistical difference. Data will be anonymously collected, and the data sheet will be secured with the principal investigator. The name of the patients will not be disclosed and kept confidential. The study is complying with the "Records-based study" profile that was described by corresponding section of the collaborative Intuitional Training Initiative (CITI). Patients' name and HC numbers will be used temporarily and only upon data collection and cleaning, to prevent duplication and allows proper re-access to the corresponding data to refine them. Both the name and HC number will be deleted immediately after data entry and coding. Data will be presented as proportions, medians, or mean ± standard deviation (SD) as appropriate. Differences in categorical variables between respective groups will be analyzed using the chi square test. The continuous variables will be analyzed using Student's t-test. For skewed continuous data non-parametric Mann-Whitney test will be performed. Two-tailed P values of <0.05 will be considered significant. Data analysis will be carried out using the Statistical Package for Social Sciences version 18 (SPSS Inc. USA). Quality Assurance, Monitoring & Safety: The research team will be responsible for the data collection, entry, confidentiality and maintaining the quality of the data. It will also oversee the ethical conduct of the trial, safety, protection, privacy and confidentiality of the subjects and adherence to the study protocol. We will follow the instructions from institutional review committee to setup any independent monitoring committee, if needed.

    Phase

    N/A

    Span

    176 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

  • Cycloplegic Refraction in Pediatric Patients With Esotropia

    Many studies have been conducted over the last few decades to assess the need for cycloplegia in assessing refractive errors. Plenty of research on pediatric populations has demonstrated that a lack of cycloplegia may contribute to an overestimation of myopia prevalence or substantial mistakes in estimating the prevalence of emmetropia and hyperopia. (1,2) The amount of refractive error varies by individual, as well as the type of cycloplegic refractive error. (3) As a result, there is no reliable method for adjusting non-cycloplegic refractions to approximate cycloplegic refractions. Consideration should be given to the type of cycloplegic agent to be used, preferred dosing, optimal methods of instillation, indications for use, and potential side effects. Despite the fact that the benefits of a cycloplegic examination are undeniable, there is still some confusion and various practice methods when it comes to cycloplegic exams. (4) Although atropine is the most potent cycloplegic agent currently available in clinical practice, its long duration of action (up to 12 days) and well-known side effects have shifted clinical practice toward cyclopentolate use. Cyclopentolate has been shown to provide effective cycloplegia, even in patients with moderate to severe hyperopia, with a relatively short duration of action (up to 24 hours) and fewer side effects. Thus, since its introduction in 1951, cyclopentolate has largely replaced atropine as the standard of care for pediatric cycloplegic examination. (4,5,6) Nevertheless, numerous adverse effects of cyclopentolate for children have been observed, including dry mouth and skin, tachycardia, fever, hallucinations, delirium, restlessness, seizures, ataxia, acute midbrain hemorrhage, and even death. (7,8,9) Many studies compared cyclopentolate to tropicamide for cycloplegia. (10, 11, 12) Tropicamide, unlike cyclopentolate, is a cycloplegic with a rapid onset and a short duration of action lasting up to 6 hours. In addition, fewer side effects have been reported when compared to cyclopentolate. (3,11) According to the literature, cyclopentolate may cause +0.175 to +0.39 D more hyperopia than tropicamide, which is clinically insignificant. (10,11,13) Furthermore, it has been discovered that there is a strong correlation between the time spent waiting to complete the exam and patient satisfaction levels, so reducing the waiting time clearly increases satisfaction levels. (14, 15) Esotropia is a convergent misalignment of the visual axes. Esotropia can be categorized in a variety of ways, usually based on age of onset or underlying causes: Infantile esotropia or acquired esotropia or accommodative esotropia, either normal accommodative convergence/accommodation (AC/A) ratio or high AC/A ratio or partially accommodative esotropia or Nonaccommodative esotropia, and Sensory esotropia. (16) Prevalence estimates of strabismus range from 0.8% to 6.8% in different populations. In the United States, esotropia and exotropia have similar prevalence rates, whereas in Ireland esotropia has been reported five times more frequently than exotropia, and in Australia esotropia has been reported to be twice as frequent as exotropia. (17) The prevalence of esotropia in children increases with age (e.g., higher prevalence at 4 to 6 years compared with 6 to 11 months), moderate anisometropia, and moderate amounts of hyperopia. (18) The potential benefits of treatment for esotropia include promoting binocular vision and improving visual function in each eye. (19) If binocularity is achieved, the number of surgical procedures over a lifetime and overall cost to society may be reduced. (20) Fusion and stereopsis are necessary for some careers and may be useful in sports such as baseball and activities such as needlepoint and watching 3D movies. (21) The appearance of crossed eyes may reduce employment opportunities because of stigma and bias. (22) In addition, binocular alignment is important for the development of a positive self-image and enhances social interactions by normalizing appearance as well as eye contact. (23) In one study, children aged 5 years and older expressed a negative feeling about dolls that had been altered to be esotropic or exotropic. (24) In another study, elementary school teachers rated personal characteristics of children with esotropia and exotropia more negatively than orthotropic children. (25) In a sample of children enrolled in the Multi-ethnic Pediatric Eye Disease Study, strabismus was associated with a decreased general health-related quality of life in preschool children, based on the parents' proxy reporting. (26) Adequate cycloplegia is necessary for accurate retinoscopy in children because of their increased accommodative tone compared with adults. The aim of this randomized clinical trial (RCT) is to explore the cycloplegic effect of tropicamide versus cyclopentolate in refracting pediatric subjects with esotropia.

    Phase

    4

    Span

    66 weeks

    Sponsor

    Islamic Hospital, Jordan

    Doha

    Recruiting

    Healthy Volunteers

  • Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis

    Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. However, despite emerging evidence indicating similarities between primary and permanent tooth pulp response to dental caries, there is limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth diagnosed with irreversible pulpitis. Aim: This study primarily aims to assess the clinical and radiographic treatment outcomes of full pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. Methods/Design: Healthy cooperative children, between 4-9 years of age, who have painful primary molars with symptoms typical of irreversible pulpitis will be recruited for the study from paediatric dental clinics located in eight countries (Qatar, Saudi Arabia, Kuwait, U.A.E, Jordan, Egypt, U.S.A, and Thailand). The primary outcome that will be assessed are the clinical success rates after one-year and two-years of the pulpotomy intervention. The secondary outcomes that will be assessed include: (i) immediate post-operative pain relief after 24 h and 7-days of the pulpotomy intervention; and (ii) radiographic success rates after one-year and two-years of the pulpotomy intervention. The influence of baseline pre-operative variables (age; gender; tooth type; site of caries; pre-operative furcal radiolucency; pre-operative pain intensity) and intra-operative factors (time taken to achieve haemostasis) on treatment outcomes will also be evaluated. Discussion: This clinical trial seeks to provide evidence on whether pulpotomy can be used for the management of vital primary molars diagnosed with symptomatic irreversible pulpitis

    Phase

    N/A

    Span

    132 weeks

    Sponsor

    Qatar University

    Doha

    Recruiting

    Healthy Volunteers

  • Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial

    This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery. Assuming a incidence rate of post-operative nausea and vomiting of 40% in cardiac surgery (Sawatzky et al., 2014), and an anticipated incidence of clinically significant PONV using the simplified PONV impact scale of 20% (Myles et al., 2012), with a presumed 50% risk reduction with early feeding, a power of 80%, and alpha of 0.05, the minimum effective sample size would be 164 subjects (82 per arm). Assuming a drop out of 20%, the sample size was increased to 196 subjects (98 per arm). Adult patients' status post-operative cardiac surgery in CTICU of Heart Hospital, after extubation, meeting inclusion criteria will be included in the study. They will be divided into early and conventional diet groups. and randomized using web-based randomization to early diet (intervention arm) versus conventional diet (control arm) in 1:1 ratio. The patients of early group will be examined for water swallowing test (WST) at bedside after extubation. Before performing the WST, the patient must be evaluated for readiness including Awake, alert, cooperative, able to follow command, vital signs are stable, able to maintain at least 75-degree. in upright position, the patient can cough effectively, the patient can stick out tongue and move to the left and right, the patient can breathe comfortable. The patient's mouth will be cleaned, and the patient will be asked to drink each 5 ml of water (1 teaspoon) 3 times respectively. If the patient shows any abnormal signs, the test will be discontinued. If all steps are passed, then the patient will continue to drink the entire 90 ml of water from a cup or with a straw in sequential slowly and steadily swallowing without stopping (cup or straw can be held by clinician or patient). (Phothikun N, 2022). If the patient fails in water swallow test, early diet will not be resumed. The finding will be intimated to the physician in charge of the patient for further management. For the early group if they pass water swallow test oral diet will be resumed after 2 hours of extubation with water, followed by clear liquid diet after 4 hours and gradually laddered to solid diet as patient prefers/tolerates. For the conventional diet group, the existing standard feeding protocol will be followed, that is patient will be given only sips of water on the day of surgery and the diet will be resumed on the next day after surgery. The simplified post-operative nausea -vomiting impact score every 4th hourly for 24 hours, time of first bowel movement, the length of ICU stays in days and patient satisfaction level about timing of resuming oral diet using Visual analogue scale at the time of discharge from hospital (VAS) (Appendix 3) will be collected. Participants will be provided with VAS with a statement explaining what the scale was intended to measure that is the level of satisfaction on resuming diet early. Other signs of regaining gut functions like bowel sounds and flatus is not considered in this study because assessment of bowel sounds is not a reliable sign of gut function (Deane et.al,2021) and chances for ambiguity are high while the assessment of bowel sounds. Most of the patients after major surgery with general anaesthesia may not recognize the first flatus in immediate post-operative period. For the patient who is not tolerating the oral diet resumption with any signs of aspiration or clinically significant vomiting or paralytic ileus or patient dissatisfaction with oral diet resumption, early diet trial will be discontinued and reported accordingly. The study will be conducted at a single center and the patients will be followed for 5 days after surgery. The favorable circumstances enhance safety of early resumption of oral diet in adult cardiac surgery are as follows. The short acting Propofol is used as the major sedation after surgery to prevent prolonged sedative effect. Multimodal analgesia is used to reduce the use of narcotics. Patient controlled analgesia of low dose morphine or fentanyl is used along with intravenous paracetamol and non-pharmacological interventions like massage, changing positions and early mobilization out of bed. Sedation score is assessed every hour by the intensive care nurses using Ramsay Sedation scale. All patients are routinely placed on intravenous metoclopramide injections as prokinetic and antiemetic which may help to enhance peristalsis. Patients are also given oral mucosal massage with flavored glycerin swab sticks to enhance their appetite. All data will be analyzed using SPSS 24.0 statistical package. Descriptive statistics will be used to describe and compare socio-demographic data on participants between the intervention and control group. Continuous variables that follow a normal distribution will be expressed as means and standard deviations, whereas categorical variables will be presented as frequency counts and percentages. We will estimate simplified PONV (post-operative nausea vomiting) impact score for early and conventional diet groups. Quantitative data between the intervention and control groups will be analyzed using unpaired t or Mann Whitney U test as appropriate. Categorical data will be summarized using frequencies and proportions. Associations between two or more qualitative data variables will be assessed using Chi-square (χ2) test or Fisher Exact test as appropriate. Univariate and multiple regression analysis will be used to control and adjust for potential predictors and confounders such as type of age, gender, nationality and presence of comorbidities and motion sickness. Generalized estimating equation will be used to see the change over the post-operative nausea- vomiting impact score in both the groups over 24 hours. All tests will be two sided and p value considered <0.05 as significant. No adverse events are expected in either of the groups. Any accidental adverse event will be reported immediately to the physician and the details of the event, harm and treatments will be notified to MRC. And the instructions by MRC will be followed. A record of such events will be maintained for further reference. This is to state that this study will be conducted in full conformance with principles of the "Declaration of Helsinki", Good Clinical Practice (GCP) and within the laws and regulations of MoPH in Qatar. The participants will be able to withdraw from the study anytime without any liabilities during the research process.

    Phase

    N/A

    Span

    108 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

  • To Compare the Effect of Receiving the Technology-based Training Along With the Conventional Therapy to the Conventional Therapy Alone on Executive Functions Among People With Traumatic Brain Injury With Mild to Moderate Cognitive Deficit

    Cognitive deficit following traumatic brain injury is one of the important consequences affecting the individual's quality of life. Various cognitive intervention strategies are in practice and the use of technology-based cognitive interventions are into current practice. This study is a Pilot Randomized Control Trial which aims to compare the effect of receiving the technology-based training along with the conventional therapy to the conventional therapy alone on executive functions among people with traumatic brain injury with mild to moderate cognitive deficit. This study will be done in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. People with traumatic brain injury with mild to moderate cognitive deficit (MMSE>10 and <23), between the age group of 18 to 60 years, no previous history of head trauma and willing to comply with cognitive rehabilitation program will be recruited for this study. The investigators will be explaining the details of the study to the participants and the participants who are willing to take part in the study had to give their consent by signing the consent sheet. After which they will be randomized in either intervention or control group through envelop concealment method. After randomization, the participants will be assessed using the outcome measures such as MMSE, Cognitive FIM and Executive function performance test (EFPT), one day before the start of the intervention. Participants in the intervention group will be receiving extra 45 min of technology based cognitive circuit training using MYRO, BITS and Cognitive Rehametrics in addition to the conventional therapy and participants in the control group will be receiving the regular conventional therapy alone. As a part of conventional therapy, participants will be receiving an hour of occupational therapy which focuses on all aspects of the deficit. For cognitive deficit, the participants will be receiving traditional method of training that includes paper pencil task, tabletop activities, performance-based activities and computer-based activities. Participants in both the groups will be receiving the sessions 5 times a week for 6 weeks. At the end of 6 weeks, all the participants in both groups will be assessed using the outcome measures, and the data will be collated, coded and entered in an excel sheet. The coded data will be sent for the statistical analysis. Baseline characteristics will be presented as means±SD or median for continuous data, and as frequencies and associated percentages for categorical parameters. The statistical P value for change from baseline for quantitative outcomes will be calculated with a paired test or Wilcoxon signed rank test, and the P value for the difference between intervention and control groups will be calculated using unpaired t or Mann Whitney U tests appropriate. Associations between two or more qualitative variables will be assessed using Chi-square (χ2) or Fisher Exact tests as appropriate. Relationship between two quantitative variables (age, EFPT, FIM scores etc.) will be examined using Pearson's or Spearman's correlation coefficients. All primary efficacy analyses will be performed on the intent-to-treat (ITT) population.

    Phase

    N/A

    Span

    136 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

  • The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study

    Irregular menstrual cycles are defined as: - normal in the first year post menarche as part of the pubertal transition - > 1 to < 3 years post menarche: < 21 or > 45 days - > 3 years post menarche to perimenopause: < 21 or > 35 days or < 8 cycles per year - > 1 year post menarche > 90 days for any one cycle - Primary amenorrhea by age 15 or > 3 years post thelarche (breast development) When irregular menstrual cycles are present a diagnosis of PCOS should be considered. Biochemical hyperandrogenism: Calculated free testosterone, free androgen index or calculated bioavailable testosterone. Androstenedione and dehydroepiandrosterone sulfate (DHEAS) could be considered if total or free testosterone are not elevated. (ELIZA or radioimmunoassay). A comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia and hirsutism and, in adolescents, severe acne and hirsutism using the modified Ferriman Gallwey score (mFG). Transvaginal (transabdominal if virgins) Ultrasound and polycystic ovarian morphology: Ultrasound should not be used for the diagnosis of PCOS in those with a gynaecological age of < 8 years (< 8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. Transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥ 10ml. Endovaginal U/S should show a follicle number per ovary of ≥ 20 and/or an ovarian volume ≥ 10ml, ensuring no corpora lutea, cysts or dominant follicles are present.

    Phase

    N/A

    Span

    57 weeks

    Sponsor

    Woman's Health University Hospital, Egypt

    Doha

    Recruiting

  • Effect of Transformational Leadership Programme on Unit Charge Nurses Leadership Practices

    Leadership is defined as a process that persons usually perform to bring forth the best from themselves and their followers. After extensive review of literature it is identified that there is dearth of studies on the use of leadership programme among charge nurses. Most of the studies conducted on the leadership styles and their characteristics are correlational in nature where the causality is not measured. It is identified that there were few studies conducted on leadership styles in Qatar, but the investigators did not find studies conducted on effectiveness of targeted transformational leadership development interventions among charge nurses. The investigator is interested in developing a targeted leadership development programme based on transformational leadership theory and strong evidence to implement among charge nurses. Based on the current health scenario and considering the challenges posed by Covid-19, there is a need to develop transformational leadership skills of charge nurses with a view to develop future leaders. In this context the investigator is interested to conduct a study to answer the question, does targeted Transformational Leadership Programme change Transformational leadership practices among charge nurses? The aim of the study is to evaluate the effect of transformational leadership programme on unit charge nurses leadership practices. This study uses a prospective, parallel group, randomized control group design to compare those received transformational leadership programme to standard educational booklet among charge nurses.The samples will be divided into two groups and subjects will be randomly assigned to both groups.The research team will use blocked randomization method for randomly assigning the subjects to both arms.The study also explores the relationship between transformational leadership practices and work engagement among unit charge nurses. A total of 164 samples are needed for the study. The samples will be randomly assigned to the two arms. The leadership practice inventory will be used for assessment of leadership practices of charge nurses. This tool is considered as valid and reliable. Assessment using Leadership Practice Inventory will be done at the beginning of administering the intervention and after 3 months of training. Work engagement of staff nurses will be assessed using Utrecht Work Engagement Scale. An evidence based targeted transformational leadership programme is designed by the research team and validated. The programme includes a 2-day activity based educational training. Pre Reading material will be sent to study participants prior to the educational activity. The educational programme comprises of the following contents: Concept of leadership and work engagement, transactional and transformational leadership styles, advantages and disadvantages of transformational leaders. qualities of transformational leaders, 5- Practices of exemplary leadership practice, the 10 commitments of transformational leadership and developing transformational leadership skills for nurses. This educational programme will be administered to transformational leadership training group. Based on the feedback obtained from participants reflective assignments will be planned and evaluated. The participants are encouraged to put into practice the knowledge and skills gained during the educational programme. The subjects from control group will receive a educational booklet for self reading. The same leadership practice inventory will be used for assessment of leadership practices of subjects from the educational booklet group.

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Hamad Medical Corporation

    Doha

    Recruiting

    Healthy Volunteers

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