Objectives Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. 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.
Suicide terrorism is one of the most dreadful challenges for Pakistan as the country has been the primary and most frequent target of suicide terrorism in the world during recent years. Pakistan had two major sources of data on suicide bombings and related terrorism activities, the Pakistan Institute of Peace Studies and the Pakistan Body Count; however, these sources lacked comprehensive databases on these incidents and related news. The most reliable sources of information have been international data providers such as the Chicago Project on Security and Terrorism, the Global Terrorism Database Portal, and others. Recently, the Pakistan Body Count launched an improved version of its database with several new variables, updated information records, and error corrections. This study analyzes the datasets available from international organizations, the Pakistan Institute of Peace Studies, and the Pakistan Body Count and the variables recorded in them. It explains the benefits of the Pakistan Body Count data over other similar efforts, elaborates on the data collection methodology, provides a glimpse of possible analytics that can be performed using the updated dataset, and identifies areas of further improvement for this database.
Hurler syndrome is a rare autosomal recessive disorder of deficiency in the metabolism of glycosaminoglycans (GAGs), including heparan sulfate and dermatan sulfate, which consequently accumulate in the different organs of the body, resulting from deficiency of an enzyme named Alpha-Liduronidase. Here, we present an interesting case of a young female patient who presented with a combination of skeletal, oro-facial, ophthalmologic, neurological, and radiological findings of this disease. A diagnosis of Hurler syndrome (Mucopolysaccharidosis Type I) was made late in the disease due to lack of facilities, and the patient was ultimately managed supportively.
Cryptogenic strokes are strokes with no clear underlying cause. Patent foramen ovale (PFO) is believed to be one of the causes of cryptogenic strokes. To manage such cases, closing the PFO is usually considered an option. We report a case of a middle-aged male with lymphoma who presented with an altered mental status due to a stroke, which, on investigation, was found to be due to an underlying PFO. This report explores the factors that must be considered when making the decision to close the PFO and emphasizes the vital role of a multi-disciplinary team in determining the best course of action for patients with cryptogenic strokes.
Septic arthritis of the sternoclavicular joint (SCJ) is a rare condition with limited literature available. We present a case of a 31-year-old female patient with a history of opioid drug use who presented with septic arthritis of the left SCJ. The patient exhibited chest wall pain; imaging revealed septic arthritis with an associated retrosternal abscess. Treatment with antibiotics alone resulted in the resolution of the abscess, highlighting the potential for medical management without surgical intervention. This case report and literature review emphasizes the importance of considering septic arthritis in patients with vague chest pain, particularly those with a history of intravenous drug use, and raise awareness about the complications associated with opioid use.
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