Sealed Envelopes Research Articles

Role of Ivermectin and Colchicine in Treatment of COVID-19: A Randomized Controlled Clinical Trial

Objective: To assess the effectiveness of ivermectin and colchicine as treatment options for COVID-19. Patients and methods: A three-arm randomized controlled clinical trial was conducted in triage clinic of family medicine department at Ain Shams University Hospitals on participants who had been diagnosed as COVID-19 patients with moderate severity. Patients aged <18 years or >65 years with any co-morbidities, pregnant or lactating female and with mild or severe COVID-19 confirmed cases were excluded. Randomization was done by using sealed envelopes for intervention or control. Patients are followed up to improvement of patient’s symptoms with no development of new symptoms over one month. Results: A total of 120 patients with COVID-19 were enrolled in the study, 40 patients in each arm. Their mean age was 40.16(SD 10.74) years. Out of them, 44 (36.6%) were male, 76(63.4%) were female. Mean duration of symptoms was 9.58 (SD 2.206), 9.9 (SD 2.07), and 9.53 (SD 2.37) in the ivermectin, colchicine and control groups, respectively. Most patients (67.5%, 70% and 72.5%) cured with residual symptoms with no difference in between the ivermectin, colchicine and control groups, respectively (P>0.05). Conclusion: Ivermectin and colchicine have no beneficial effect over the standard care in treatment of COVID-19.

Effectiveness of dynamic neuromuscular stabilization, neurodevelopmental techniques and proprioceptive neuromuscular facilitation on trunk and gait parameters in patients with subacute stroke: A three-arm parallel randomised clinical trial

Background Today, stroke is the principal cause of demise in both developed and developing countries. There are different techniques used to treat patients with sub-acute stroke. Trunk muscles play a key role, i.e. in keeping the spine and trunk in place. This stabilization requires moving the head and extremities freely and selectively. The aim of this study is to compare the effectiveness of dynamic neuromuscular stabilization (DNS), neurodevelopmental techniques (NDT) and proprioceptive neuromuscular facilitation (PNF) on trunk and gait parameters in the subacute phase of stroke. This study is intended to ascertain the efficacy of all three approaches individually and to compare the effectiveness of DNS, NDT and PNF on trunk and gait parameters. Furthermore, the findings of this study could be used to assist post-stroke survivors in their early recovery and improve their level of independence. Methods In this interventional study, participants will be divided into three groups, and in each group, 20 patients will be assigned randomly to each group using the sequentially numbered opaque sealed envelope method. Group A patients will be given DNS, Group B will be given NDT, and Group C will be given PNF. The patients will be given treatment for five days for four consecutive weeks. Outcome measures that will be used are trunk impairment scale (TIS), dynamic gait index (DGI) and gait parameters. Data will be collected before and after the 4-week treatment period. Conclusions After the study, a conclusion will be drawn regarding which treatment technique is most suitable among all the three strategies for treating stroke patients if the hypothesis of the study is found valid. Clinical Trials Registry – India (CTRI) reference no. CTRI/2022/06/043037; date of registration 22/05/2022.

Comparing the Effect of Bone-loading Exercises and Pulsed Electromagnetic Fields on Bone Turnover Markers in Women with Osteoporosis: A Randomized Clinical Trial Study Protocol.

Given the bone sensitivity to mechanical stimulus, bone-loading exercises and applying the Pulsed Electromagnetic Fields (PEMF(s)) are recommended for promoting bone strength. In this context, these two interventions 's effect on bone turnover markers (BTMs) in osteoporosis patients is yet to be clarified; consequently, an attempt is made in this study to compare the effect of these two interventions on bone turnover markers in women with Postmenopausal Osteoporosis (PMOP). This study is design as a randomized, single-center, three-arms, controlled trial. A total of 51 women with PMOP will be randomly assigned to three groups of 17, using opaque, sealed envelopes containing labels for A, B, and C groups. Group A) will receive bone-loading exercises, B) will follow the PEMF(s) and C) will be exposed to the combination of A and B. These three groups will require intervention for 24 sessions (2 sessions/week) next to their routine medical treatment (Alendronate+ Calcium+ Vitamin D). The primary outcome of this study is the serum biomarker of bone formation (bone-specific alkaline phosphatase, BSALP) and resorption (N-terminal telopeptide, NTX). The secondary outcomes consist of thoracic kyphosis angle, fear of falling, and quality of life. The outcomes are measured three times: at baseline, after 24 sessions of intervention, and at 12 weeks follow-up. A primary outcome will be measured and reported by a laboratory expert who is blinded to the participant grouping. The trial has the code of ethics for research (IR.TUMS.FNM.REC.1401.126) and the code of Iranian Registry of Clinical Trials (IRCT) (IRCT20221202056687N1). Study results are expected to be available by mid-2024. This trial will provide new practical knowledge on the bone-loading exercises and PEMFS(s)'s effect on PMOP women. This knowledge is of the essence for physiotherapists, clinicians, other healthcare professionals, and policymakers in the healthcare system.

Traditional Spinal Immobilization versus Spinal Motion Restriction in Cervical Spine Movement; a Randomized Crossover Trial.

Proper cervical spine immobilization is essential to prevent further injury following trauma. This study aimed to compare the cervical range of motion (ROM) and the immobilization time between traditional spinal immobilization (TSI) and spinal motion restriction (SMR). This study was a randomized 2x2 crossover design in healthy volunteers. Participants were randomly assigned by Sequential numbered, opaque, sealed envelopes (SNOSE) with permuted block-of-four randomization to TSI or SMR. We used an inertial measurement unit (IMU) sensor to measure the cervical ROM in three dimensions focusing on flexion-extension, rotation, and lateral bending. The immobilization time was recorded by the investigator. A total of 35 healthy volunteers were enrolled in the study. The SMR method had cervical spine movement lower than the TSI method about 3.18 degrees on ROM in flexion-extension (p < 0.001). The SMR method had cervical spine movement lower than the TSI method about 2.01 degrees on ROM in lateral bending (p = 0.022). The immobilization time for the SMR method was 11.88 seconds longer than for the TSI method (p < 0.001) but not clinically significant. SMR that used scoop stretcher resulted in significantly less cervical spine movement than immobilization with a TSI that used long spinal board. We recommend implementing the SMR protocol for transporting trauma patients, as minimizing cervical motion may enhance patient outcomes.

Ab. No. 137 Comparison of Effects of High Intensity Laser Therapy, Extracorporeal Shockwave Therapy and Ultrasound Therapy in Patients With Plantar Fasciitis: A Randomized Controlled Trial

Introduction: Ultrasound therapy (UST) is one of the common modality available for treatment of Plantar fasciitis (PF). Recent technological advancements have let to development of new modalities like High Intensity LASER therapy (HILT) &amp; Extracorporeal Shockwave therapy (ESWT) for treatment of PF. There is a lack of evidence as to suggest which modality is superior in the treatment of PF. Hence the purpose of the study was to observe the effect of HILT, ESWT &amp; UST on pain and function in patients with PF. Methods: Total of 120 participants fulfilling the inclusion/exclusion criteria were recruited after obtaining the informed consent &amp; were randomly assigned to 3 study-groups of 40 each and allocation was done using sealed envelope. Assigned treatment modality as per the prescribed dosage along with the exercise programme was given for period of 2 weeks. Outcome measures - Visual Analogue Scale (VAS), Pain perception threshold (PPT) &amp; Foot function index (FFI) were taken prior to &amp; after completion of treatment. Results: While comparing VAS, PPT &amp; FFI values of all 3 groups using one-way ANOVA, between group analysis showed statistically significant difference among the groups for VAS (F (2:105)4.444, p:0.0140) &amp; PPT (F (2:105)5.651, p:0.0047) &amp; not for FFI. Post -hoc analysis data revealed statistically significant difference for UST in PPT (p&lt;0.005) than HILT &amp; ESWT. &amp; for UST in VAS than HILT. Within the group analysis showed, statistically significant improvement in all 3 groups. Conclusion: All three modalities are effective in reducing pain &amp; improving function in patients with PF. UST seems to be better in reducing pain but in improving function none of the modality was found to be superior than other. Implication: UST can be preferred modality in alleviating the pain in patients with PF as its easily available and cost effective over the new expensive modalities.

Randomized trial of dentists' understanding: treatment benefit in absolute numbers vs relative risk reduction.

This study aimed to assess whether dentists correctly understand the benefit of a dental treatment when it is presented using absolute numbers or relative risk reduction (RRR). This parallel-group randomized controlled trial recruited dentists from 3 postgraduate courses in Rio de Janeiro, Brazil. Participants received, in sequentially numbered sealed opaque envelopes, the description of a hypothetical scenario of the benefit (avoidance of multiple tooth loss) of nonsurgical periodontal treatment without or with antibiotics. Treatment benefit was presented in 2 different formats: absolute numbers or RRR. Dentists were given 10 minutes to read the treatment scenario and answer 5 questions. The final sample for analysis included 101 dentists. When asked to estimate the number of patients out of 100 who would avoid multiple tooth loss without antibiotics, 17 dentists (33%) in the absolute numbers group and 12 (25%) in the RRR group provided the correct response (p = 0.39). Regarding treatment with antibiotics, 26 dentists (50%) in the absolute numbers group and 14 (29%) in the RRR group provided the correct response (p = 0.04). Only 16 dentists (31%) in the absolute numbers group and 12 (25%) in the RRR group gave correct answers for both questions (p = 0.51). Most dentists did not correctly understand the benefit of the treatment, irrespective of the format it was presented. Slightly more dentists correctly understood the benefit of the treatment when it was presented as absolute numbers than as RRR.

Efficacy of melatonin in decreasing the incidence of delirium in critically ill adults: a randomized controlled trial.

To determine whether enteral melatonin decreases the incidence of delirium in critically ill adults. In this randomized controlled trial, adults were admitted to the intensive care unit and received either usual standard care alone (Control Group) or in combination with 3mg of enteral melatonin once a day at 9 PM (Melatonin Group). Concealment of allocation was done by serially numbered opaque sealed envelopes. The intensivist assessing delirium and the investigator performing the data analysis were blinded to the group allocation. The primary outcome was the incidence of delirium within 24 hours of the intensive care unit stay. The secondary outcomes were the incidence of delirium on Days 3 and 7, intensive care unit mortality, length of intensive care unit stay, duration of mechanical ventilation and Glasgow outcome score (at discharge). We included 108 patients in the final analysis, with 54 patients in each group. At 24 hours of intensive care unit stay, there was no difference in the incidence of delirium between Melatonin and Control Groups (29.6 versus 46.2%; RR = 0.6; 95%CI 0.38 - 1.05; p = 0.11). No secondary outcome showed a statistically significant difference. Enteral melatonin 3mg is not more effective at decreasing the incidence of delirium than standard care is in critically ill adults.

The Effect of Intraoperative Music on Sedation, Anxiety, and Hemodynamic Responses among Patients Undergoing Lower Segment Cesarean Section under Spinal Anesthesia

Background and Aim: Anxiety levels are high in spinal anesthesia as patients are awake. Sedation has an advantage that patients feel comfortable but if sedative drugs are not used judiciously, they can suppress the cardiovascular and respiratory system, lower core body temperature, or severely lower blood pressure. Music reduces awareness under anesthesia and has antianxiety effects. The effect of music on sedation using bispectral index (BIS) along with anxiety and hemodynamic parameters at different time intervals has been studied. Material and Methods: A hospital-based prospective randomized interventional study was done on 60 patients aged between 18 and 35 years undergoing lower segment cesarean sections. Two groups (music headphones with music and nonmusic headphones without music), each containing 30 subjects, were formed using a simple random technique by the sealed envelope method. The levels of sedation using BIS were measured preoperatively, after giving spinal anesthesia, then every 10 min till the end of surgery. Moreover, hemodynamic parameters were also monitored and recorded preoperatively and every 10 min till the end of surgery. Anxiety was measured using a visual analog score for anxiety preoperatively and postoperatively. Results: The BIS index was significantly lower in the music group compared to the nonmusic group from 20 min after start of surgery to the end of surgery (86.17 ± 4.48 vs. 75.73 ± 3.97, P &lt; 0.001). Anxiety was also significantly lower in the music group than in the nonmusic group (4.03 ± 1.47 vs. 0.50 ± 1.57, P &lt; 0.005). Heart rate (HR) was lower in the music group after 20 min of music therapy compared to the nonmusic group (87.87 ± 11.21 vs. 79.67 ± 6.67, P = 0.004) but there was no statistically significant difference in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and saturation of oxygen between two groups. Conclusion: Our data showed that intraoperative music listening under regional anesthesia has effect on sedation, anxiety, and physiological variables. Therefore, music therapy can be used as nonpharmacological intervention for reducing anxiety and sedation during surgery.

Piroxicam gel versus injectable platelet rich fibrin in the treatment of stage III periodontitis

Background In view of the importance and prevalence of chronic periodontitis, there is still an urgent need to search for an effective therapy that is less expensive, easy to use, and readily available with no side effects. Injectable platelet rich fibrin (i-PRF) and piroxicam were considered as possible treatment options of periodontitis. Aim To evaluate the efficacy of piroxicam gel versus i-PRF in treatment of stage III periodontitis. Materials and method The current study was carried out as a randomized clinical trial. The participants diagnosed as having stage III, grade B periodontitis were selected from the patients attending Department of Periodontology and Oral Medicine, Faculty of Dentistry, Tanta University. The selected individuals randomly assigned into two groups (by means of a sealed envelope via masked supervisor): group I and group II. Forty sites (the deepest periodontal pockets) were selected. Twenty sites from GI was treated by piroxicam gel and 20 sites in GII were treated by i-PRF. The application was done 2 weeks after scaling and root planing and applied for five times one application every 2 weeks over 10 weeks. The comparison was assessed clinically and immunologically. Clinically, via recorded: probing pocket depth, clinical attachment loss, and bleeding on probing. Immunologically, via measuring: the levels of matrix metalloproteinases-8 in gingival cervical fluid samples. Clinical and immunological were recorded at baseline (before scaling and root planing), 4 weeks (2 weeks after first application), 8 weeks (at fourth application), and 12 weeks (2 weeks after the last application). Results Both groups showed significant improvement in all clinical and immunological parameters. Comparing GI and GII at each follow-up time point, there was significant amelioration in all assessed parameters in favor to GII. Conclusion The use of i-PRF is preferred over the use of piroxicam gel in the treatment of stage III chronic periodontitis, as it gives better clinical and immunological results.

Ab. No. 69 Comparative Study on Effect of Square Stepping Exercises With Conventional Balance Exercises on Balance in Community Dwelling Elderly Population: A Randomized Control Trial

Introduction: Determining &amp; comparing the effects of Square Stepping Exercises (SSE) versus Conventional balance exercises after 4 weeks training in the older adults. To tackle age-related decline in balance performance in elderly, physical interventions are essential. SSE is a novel intervention that can enhance balance and reduce the risk of falls. Methods: 40 healthy community dwelling older individuals of age 60 years &amp; more with ability to walk backwards for 3 meters were included in the study. Participants were randomly allocated into two groups of 20 each using sealed envelope method. Limits of Stability (LOS) and Mini-BES Test were assessed as outcome measures prior to and after the 4 weeks of training. Non-Parametric test were used to analyze the data of Mini BESTest as the data was not normally distributed. Whereas the rest of the data (LOS) were normally distributed, hence parametric tests were used to analyze. Results: Both the groups showed statistically significant results when compared to their pre-intervention scores (p&lt;0.0001) The between group comparison did not show any statistically significant difference on balance components (p&gt;0.05). Conclusions: Both Conventional balance training exercises and Square stepping exercises were found to be equally effective in improving balance in elderly. Implications: SSE does not have an advantage over the conventional balance exercises, however it can be used as an adjunct to the conventional balance training to introduce variety in training of community dwelling elderly with adequate safety measures in place.

Comparative Efficacy of Fentanyl Vs Dexmedetomidine Intrathecally as an Adjuvent to Isobaric Levo-Bupivacaine in Infra-Umbilical Surgery: A Prospective Randomized Study

Background: Fentanyl is a potent, highly lipophilic, synthetic opioid analgesic used as an adjuvant in spinal anaesthesia. Dexmedetomidine is also a potent, lipophilic, selective α2-adrenergic agonist. Compared to Dexmedetomidine, it has an earlier onset of block, better intraoperative analgesia with increased side effects(such as, nausea, vomiting or respiratory depression). Aim: To compare Fentanyl(25 ug) versus Dexmedetomidine(10 ug) as an adjuvant with 0.5% isobaric Levo-Bupivacaine in infra-umbilical surgeries. Material &amp; Methods: A prospective, randomized, controlled study. Department of Anaesthesia, K. D. Medical College, Hospital and Research Centre in Mathura. Patients between 20-60 years of either sex, ASA Grade I – II, scheduled for elective infra-umbilical procedures with no co-morbid conditions. Simple random method(sealed envelope). Results: The sensory block duration is 7.71±0.31 hrs in D group and 3.78±0.83 hrs in group F with p value &lt;0.05. The mean time taken for attaining motor blockade is 2.06 ± 1.17 mins in D group, 2.45 ± 1.39mins in F group. but statistically not significant between group D and in F group (p=0.2). The motor block duration is 7.33 ± 0.28hrs in group D and 3.39 ± 0.91 hrs in F group which suggestive of statistically highly significant (p=0.001). Conclusion: In infra-umbilical surgery, levo-Bupivacaine with adjuvant dexmedetomidine (10 ug) intrathecally has a longer duration of sensory and motor block with preserved hemodynamic stability and lesser adverse effects in comparison to adjuvant fentanyl(25 ug). However, onset of sensory block is earlier with fentanyl.

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

AimsThe PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. MethodsPARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. ConclusionThe PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

Comprehensive Cardiopulmonary Resuscitation Training for Foreign Medical Students

The purpose of this study was to assess acquired knowledge and practical skills in foreign medical students (FMS) after theoretical and practical training in cardiopulmonary resuscitation.Material and methods. We conducted a prospective randomized trial «Simulation-based CPR training among international medical students: perspectives for medical education» envolving students undergoing training in the 31.05.01 specialty — General Medicine in English. Sealed envelope randomization was used to assign the participants (N=71) to 3 groups. European Resuscitation Council (ECR) educational Guidelines for Resuscitation was studied by students of all 3 groups. Group 1 (N=21) students did not receive additional training materials and practices. Group 2 (N=25) students were additionally provided with a link to a video lesson on CPR on the ECR Youtube channel. Students from Group 3 (N=25) were additionally involved in developing 3 mind maps: on the anatomy and physiology of the heart and CPR algorithm. All participants underwent theoretical training at the 1st stage, and «Basic Cardiopulmonary Resuscitation and Automated External Defibrillation (AED)» simulation training at the second stage. At the end of the course, students’ practical skill in performing continuous chest compressions were examined.Results. The majority of examinees passed the ECR platform test on the first or second attempt. The participants of the simulation course demonstrated high learning efficiency: there were no statistically significant differences between the groups in the number and average frequency of compressions performed. Almost all participants correctly performed hand placement in the center of the chest for chest compression. Decompression phase efficiency reached 71–77% (P=0.811) in all groups. The majority of examinees performed chest compressions to the required depth and with the recommended frequency (P=0.62).Conclusion. The educational project initiated by foreign students yielded positive results: acquired knowledge of CPR algorithm, gained essential techniques of performing chest compressions and giving rescue breaths, retained skills in using automated external defibrillator, as well as teamwork skills.

Effect of nutritional intervention in child health care on improving growth and development and disease prevention of infants.

To explore the outcome of nutritional intervention in child health care on infant growth and disease prevention. It was a retrospective study. Ninty-two infants who received child health intervention in The Affiliated Hospital of Southwest Medical University from September 2020 to June 2022 were selected as the research objects. According to the random number table method, they were divided into control group (46 cases, routine health intervention) and observation group (46 cases, nutritional intervention based on the control group) using the sealed envelope system. The growth and development, nutritional diseases and guardian satisfaction of the two groups were compared. The scores of the observation group were higher than those of the control group in gross motor, fine motor, language and individual-social aspects. The total incidence of nutritional diseases in the observation group (2.17%) was lower than that in the control group (17.39%); In terms of total satisfaction rate, the observation group (100.00%) was higher than the control group (86.96%), with a statistical difference (P<0.05). Applying nutrition intervention to child health care plays an important role in maintaining the healthy growth and development of infants and reducing the incidence of nutritional diseases such as anemia and rickets. It needs to be promoted in clinical practice.

Is basal cisternostomy in traumatic brain injury a need of hour or white elephant - A randomized trial to answer.

Basal cisternostomy (BC) recently emerged as an adjuvant/alternative procedure to decompressive craniectomy (DC) in traumatic brain injuries (TBIs) with its potential to effectively reduce both intracranial pressure (ICP) and brain edema. However, its role in TBI is not yet established in the true sense and with clarity. The objective of the present study was to evaluate the effect of adjuvant BC on ICP, mortality, and clinicoradiological outcome. A single-center randomized control trial was conducted. Fifty patients were assigned to each DC-group and DC+BC-group. Randomization was done using the sealed envelope method. Both groups were followed in the postoperative period to compare the impact of surgery on ICP, radiological changes, and clinical outcome (mortality, days on ventilator/in intensive care unit (ICU), and Glasgow outcome scale-extended (GOS-E) at 12 weeks). Both groups were comparable in terms of preoperative clinicoradiological characteristics. On postoperative days 1, 2, and 3, mean ICP was significantly low in the DC+BC-group (P < 0.0001). The decline in ICP in the DC+BC-group was significant in both moderate and severe TBI patients. In comparison, DC+BC-group has a shorter duration of mechanical ventilation/ICU stay and significantly better GOS-E score at 12 weeks (P < 0.0001*). The mortality rate was less in the DC+BC-group (48%) as compared to the DC-group (64%). Among radiological features, mean midline shift and mean outward brain herniation were significantly less in the DC+BC group. Bone-flap replacement was possible in ten patients of DC+BC-group at the time of primary surgery. Results of our study indicated that BC is beneficial in reducing both ICP and brain edema, which translates into favorable clinicoradiological outcomes.

3D vs. 2D simulated fetoscopy for spina bifida repair: a quantitative motion analysis

3D imaging technology is becoming more prominent every day. However, more validation is needed to understand the actual benefit of 3D versus conventional 2D vision. This work quantitatively investigates whether experts benefit from 3D vision during minimally invasive fetoscopic spina bifida (fSB) repair. A superiority study was designed involving one expert team (>18 procedures prior) who performed six 2D and six 3D fSB repair simulations in a high-fidelity animal training model, using 3-port access. The 6D motion of the instruments was recorded. Among the motion metrics are total path length, smoothness, maximum speed, the modified Spectral Arc Length (SPARC), and Log Dimensionless Jerk (LDLJ). The primary clinical outcome is operation time (power 90%, 5% significance) using Sealed Envelope Ltd. 2012. Secondary clinical outcomes are water tightness of the repair, CO_2 insufflation volume, and OSATS score. Findings show that total path length and LDLJ are considerably different. Operation time during 3D vision was found to be significantly shorter compared to 2D vision (113pm 9 vs. 149pm 19 min; p = 0.026). These results suggest enhanced performance with 3D vision during interrupted suturing in fetoscopic SBA repair. To confirm these results, a larger-scale follow-up study involving multiple experts and novice surgeons is recommended.

Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial

In areas co-endemic for Plasmodium vivax and Plasmodium falciparum there is an increased risk of P vivax parasitaemia following P falciparum malaria. Radical cure is currently only recommended for patients presenting with P vivax malaria. Expanding the indication for radical cure to patients presenting with P falciparum malaria could reduce their risk of subsequent P vivax parasitaemia. We did a multicentre, open-label, superiority randomised controlled trial in five health clinics in Bangladesh, Indonesia, and Ethiopia. In Bangladesh and Indonesia, patients were excluded if they were younger than 1 year, whereas in Ethiopia patients were excluded if they were younger than 18 years. Patients with uncomplicated P falciparum monoinfection who had fever or a history of fever in the 48 h preceding clinic visit were eligible for enrolment and were required to have a glucose-6-dehydrogenase (G6PD) activity of 70% or greater. Patients received blood schizontocidal treatment (artemether-lumefantrine in Ethiopia and Bangladesh and dihydroartemisinin-piperaquine in Indonesia) and were randomly assigned (1:1) to receive either high-dose short-course oral primaquine (intervention arm; total dose 7 mg/kg over 7 days) or standard care (standard care arm; single dose oral primaquine of 0·25 mg/kg). Random assignment was done by an independent statistician in blocks of eight by use of sealed envelopes. All randomly assigned and eligible patients were included in the primary and safety analyses. The per-protocol analysis excluded those who did not complete treatment or had substantial protocol violations. The primary endpoint was the incidence risk of P vivax parasitaemia on day 63. This trial is registered at ClinicalTrials.gov, NCT03916003. Between Aug 18, 2019, and March 14, 2022, a total of 500 patients were enrolled and randomly assigned, and 495 eligible patients were included in the intention-to-treat analysis (246 intervention and 249 control). The incidence risk of P vivax parasitaemia at day 63 was 11·0% (95% CI 7·5-15·9) in the standard care arm compared with 2·5% (1·0-5·9) in the intervention arm (hazard ratio 0·20, 95% CI 0·08-0·51; p=0·0009). The effect size differed with blood schizontocidal treatment and site. Routine symptom reporting on day 2 and day 7 were similar between groups. In the first 42 days, there were a total of four primaquine-related adverse events reported in the standard care arm and 26 in the intervention arm; 132 (92%) of all 143 adverse events were mild. There were two serious adverse events in the intervention arm, which were considered unrelated to the study drug. None of the patients developed severe anaemia (defined as haemoglobin <5 g/dL). In patients with a G6PD activity of 70% or greater, high-dose short-course primaquine was safe and relatively well tolerated and reduced the risk of subsequent P vivax parasitaemia within 63 days by five fold. Universal radical cure therefore potentially offers substantial clinical, public health, and operational benefits, but these benefits will vary with endemic setting. Australian Academy of Science Regional Collaborations Program, Bill & Melinda Gates Foundation, and National Health and Medical Research Council.

Effects of stellate ganglion block on the perioperative hemodynamics for coronary artery bypass grafting surgery

ABSTRACT Background Stellate ganglion block (SGB) is a successful technique that can potentially maintain hemodynamics and terminate fatal arrhythmia. We aimed to study the efficacy of SGB on hemodynamic changes after on pump coronary artery bypass grafting (CABG) surgery. Methods Forty patients who underwent CABG surgery at the Cardiac Surgical Academy Ain Shams University Hospital were randomly allocated to receive SGB or placebo between June 2020 and February 2021. After fulfilling the inclusion criteria, patients were classified as American Society of Anesthesiologists III and IV. Patients were randomly assigned to one of two groups utilizing a computer-generated block number in a sealed envelope. Group S (20 patients) received SGB, and Group C (20 patients) included matched controls who received a placebo solution in the SGB. Primary outcome was perioperative changes in heart rate and systolic and diastolic blood pressures. Secondary outcomes included the incidence of atrial and ventricular fibrillation, and myocardial ischemia in addition to the times from ICU admission to extubation, ICU stay, and hospital stay. Results A statistically substantial increase in systolic and diastolic blood pressure as well as increased incidence of AF and VF was found in the control group compared to the SGB group with p values <0.001, <0.001, 0.037, and 0.028, respectively. Conclusion SGB can reduce the hemodynamic responses to surgery and anesthesia, intraoperative tachyarrhythmias, and ICU and hospital stays.

Effect of Abdominal Compression on Total Single-Balloon Enteroscopy Rate: A Randomized Controlled Trial

ObjectiveTo evaluate whether abdominal compression significantly increased the total enteroscopy rate in single-balloon enteroscopy (SBE). MethodsConsecutive patients who underwent SBE at 2 hospitals were prospectively included between June 1, 2020, and September 30, 2021. They were randomly divided into an abdominal compression group and a non–abdominal compression group with use of sealed envelopes generated by a computer. Total enteroscopy rates were compared between the groups. ResultsThe study included 200 patients. The total enteroscopy rates were 73% and 16% in the abdominal compression and non–abdominal compression groups, respectively (relative risk, 13.55; 95% CI, 6.79 to 27.00; P<.001). The total enteroscopy rate was higher in the 70 patients who were identified to have undergone no previous abdominal surgery or small intestinal stenosis than in the 32 patients who had undergone such procedures in the abdominal compression group (84% vs 47%; relative risk, 6.08; 95% CI, 2.36 to 15.67; P<.001). Relevant positive findings were not significantly different between the groups (58% vs 45%; P=.07). Binary logistic regression analysis found abdominal compression to be associated with a better total enteroscopy rate (odds ratio, 16.68; 95% CI, 7.92 to 35.15; P<.001), and the presence of previous abdominal surgery or small intestinal stenosis was associated with difficulty in completing the total enteroscopy procedure (odds ratio, 0.26; 95% CI, 0.12 to 0.58; P<.01). ConclusionAbdominal compression significantly increased the total enteroscopy rate in SBE. Complete total enteroscopy may be challenging in patients with a history of abdominal surgery or small intestinal stenosis.

The Impact of Psychological Nursing Intervention on Negative Emotions and Quality of Life in Elderly Patients with Chronic Hemodialysis for Uremia

Objective: This study aimed to investigate the impact of psychological nursing intervention on negative emotions and quality of life in elderly patients undergoing chronic hemodialysis for uremia. Methods: From January 2022 to June 2023, a total of 80 elderly patients receiving chronic hemodialysis for uremia were selected for the study. They were divided into two groups using a sealed envelope method, with 40 patients in each group. The control group received routine nursing interventions, while the observation group received psychological nursing intervention. Results: After 2 weeks of intervention, the observation group had significantly lower scores for negative emotions (P&lt;0.05), higher scores for quality of life (P&lt;0.05), and greater nursing satisfaction (P&lt;0.05) compared to the control group. Conclusion: Implementing psychological nursing intervention for elderly patients undergoing chronic hemodialysis for uremia can reduce negative emotions, improve quality of life, and increase nursing satisfaction. This intervention holds clinical significance.