TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.
PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan).
INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan.
MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization.
RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure.
BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation.
TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022.
TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 .
FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.
BACKGROUND: Absence of congenital cardiac catheterization registries in LMICs led to the development of the International Quality Improvement Collaborative Congenital Heart Disease Catheterization Registry (IQIC-CHDCR). As a foundation for this initiative, the IQIC is a collaboration of pediatric cardiac surgical programs from LMICs. Participation in IQIC has been associated with improved patient outcomes.
METHODS: A web-based registry was designed through a collaborative process. A pilot study was conducted from October through December 2017 at seven existing IQIC sites. Demographic, hemodynamic, and adverse event data were obtained and a novel tool to assess procedural efficacy was applied to five specific procedures. Procedural efficacy was categorized using ideal, adequate, and inadequate.
RESULTS: A total of 429 cases were entered. Twenty-five adverse events were reported. The five procedures for which procedural efficacy was measured represented 48% of cases (n = 208) and 71% had complete data for analysis (n = 146). Procedure efficacy was ideal most frequently in patent ductus arteriosus (95%) and atrial septal defect (90%) device closure, and inadequate most frequently in coarctation procedures (100%), and aortic and pulmonary valvuloplasties (50%).
CONCLUSIONS: The IQIC-CHDCR has designed a feasible collaborative to capture catheterization data in LMICs. The novel tool for procedural efficacy will provide valuable means to identify areas for quality improvement. This pilot study and lessons learned culminated in the full launch of the IQIC-CHDCR.
METHODS: An electronic search in PubMed and major endodontic journals was conducted using appropriate key words to identify investigations that examined the effectiveness of obturation material removal assessed by micro-computed tomography.
RESULTS: Among 345 studies, 22 satisfied the inclusion criteria. Seven studies compared hand instrumentation with Nickel-Titanium rotary or reciprocating systems. Three studies investigated rotary systems, and another three studies explored reciprocation. Eight studies compared rotary systems and reciprocation in removing filling materials from the root canal system. Other factors, such as the role of solvents and irrigant agitation, were discussed.
CONCLUSIONS: The application of different instrumentation protocols can effectively, but not completely, remove the filling materials from the root canal system. Only hand instrumentation was not associated with iatrogenic errors. Reciprocating and rotary systems exhibited similar abilities in removing root filling material. Retreatment files performed similarly to conventional ones. Solvents enhanced penetration of files but hindered cleaning of the root canal. The role of irrigant agitation was determined as controversial.
MATERIALS AND METHODS: We retrospectively reviewed our experience of pEVAR between April 2013 and July 2014. Primary success of the procedure was defined as closure of a common femoral artery (CFA) arteriotomy without the need for any secondary surgical or endovascular procedure within 30 days.
RESULTS: In total there were 10 pEVAR cases performed in the study period, one case in Queen Elizabeth Hospital during visiting vascular service. Patients have a mean age of 73.4 year old (66-77 year old) The mean abdominal aortic size was 7.2 cm (5.6-10.0cm). Mean femoral artery diameter was 9.0 mm on the right and 8.9 mm on the left. Mean duration of surgery was 119 minutes (98- 153 minutes). 50% of patients were discharged at post-operative day one, 30%- day two and 20%- day three. Primary success was achieved in 9 patients (90%) or in 19 CFA closures (95%). No major complication was reported.
DISCUSSION: We believe that with proper selection of patients undergoing EVAR, pEVAR offers a better option of vascular access with shorter operative time, less post- operative pain, shorter hospital stay and minimises the potential complications of a conventional femoral cutdown.
AIM OF THE STUDY: This study aimed to systematically review all available evidence which purports to support these claims.
MATERIAL AND METHODS: The systematic review accorded with the Cochrane Collaboration framework and PRISMA reporting. Databases including MEDLINE, Excerpta Medica Database (EMBASE), Cochrane library database, and Google Scholar were searched by keywords, Yahom and Ya-hom. Pharmacological and toxicity data from non-animal and animal studies were included.
RESULTS: Twenty-four articles: 2 on in vitro cell lines or bacteria, 3 in vitro cell-free, 5 in vitro animal, 13 in vivo and 1 human mainly reported (A) Cardiovascular effects (i) transient hypotension (0.2-0.8g/kg, intravenous injection (i.v.)), increased cerebral blood flow (2g/kg, single oral) and vascular dilatation/relaxation (ii) elevated blood pressure (BP) (0.2-0.8g/kg, i.v. or 2-4g/kg oral) and vasocontraction. Single Yahom doses (3g) given to healthy volunteers had no effect on cutaneous blood flow, ECG or systolic BP although marginally increased diastolic BP was claimed. (B) Yahom (2-4g/kg) completely inhibited gastric acid secretion evoked by gastric secretagogues. (C) Toxicity: Chronic oral doses of selected Yahoms to rodents (0.001-1g/kg) supports its status as generally regarded as safe.
CONCLUSIONS: Most studies supported declared objectives relating to perceived Yahom actions, but lacked background demonstrating clinical efficacy, and mechanistic data that would validate conclusions. Our study suggests that research into traditional medicinal herbs needs underpinning by appropriate clinical interventions and pharmacovigilance, thereby optimising efficacy and minimizing toxicity by combining traditional wisdom and modern testing.
METHODS: After Institutional Review Board approval (99-0793B), we retrospectively studied all patients diagnosed, treated and followed up with RVF at Chang Gung Memorial Hospital, Taiwan between January 1990 and December 2009. All female patients with International Classification of Diseases RVF were included. We reviewed demographic data, socioeconomic status, clinical presentation, comorbidities, method of treatment, duration of hospitalization and clinical outcome at 12 months postoperatively.
RESULTS: A total of 397 patients were included in the study. Fifty-six patients (14.1%) had conservative treatment and 341 patients (85.9%) underwent surgical intervention. A total of 125 patients underwent simple repair while 216 patients underwent reconstruction. Three hundred and forty-four patients (86.7%) had improved outcome at 12-month follow up. Age (P = 0.003), education level (P = 0.033), ability to pay insurance (P < 0.001), and choice of treatment (P < 0.0001) were identified as significant favorable factors. An etiological factor associated with favorable outcome was RVF from obstetric complication, while that resulting from malignancy had a less favorable outcome.
CONCLUSIONS: Age, education level and ability to pay insurance significantly affect 12-month outcome of RVF. Surgery is the preferred option, while medical treatment should be used only for small rectovaginal fistulas or for patients not suitable for surgery and anesthesia. More support and assistance should be offered to those patients with unfavorable factors, such as old age, low education level and inability to afford insurance. All RVF secondary to obstetrical injury had a 100% favorable outcome compared with those secondary to surgery or malignancy. Women with suspected RVF should receive prompt and extensive evaluation to ensure immediate effective management and prevention of further serious complications.
METHODS: A prospective, randomized, controlled trial was carried out at two tertiary hospitals. 32 patients diagnosed with chronic rhinosinusitis and had underwent endoscopic sinus surgery were enrolled. The study group received 2 mL of Tualang honey nasal dressing and the control group received nasal dressing with 2 mL of triamcinolone 20 mg/mL as positive control. A 2 cm nasal dressing was placed longitudinally into the middle meatuses of both nasal cavities. Postoperative healing assessments of edema, crusting, secretions, scarring and symptoms were performed at postoperative day 7, 14, 28 and at 3 months using Sinonasal Outcome Test 22 questionnaire and modified Lund-Kennedy scoring system.
RESULTS: There were no significant differences noted in the scores of Sinonasal Outcome Test 22 and modified Lund-Kennedy at Day 7, 14 and 28 (p>0.05) for both groups. At 3rd month, patients in the triamcinolone group had lesser symptoms and better endoscopic findings (p<0.05).
CONCLUSION: Tualang honey is not as effective as steroid in achieving good wound healing and surgical outcomes in post endoscopic sinus surgery patients. Thus, it is not suitable as a substitute for steroid to reduce symptoms and prevent recurrence of disease.