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1.
Int Wound J ; 21(3): e14806, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38414325

RESUMO

This study was conducted to determine whether Naoxintong capsules may enhance wound healing and reduce postoperative complications in individuals having craniotomies. A total of 120 patients at Tongji Hospital, Shanghai, participated in this clinical perspective study conducted from April 2022 to June 2023. Participants were divided into treatment group (n = 60), receiving standard care plus Naoxintong capsules and control group (n = 60), receiving standard care only. Primary outcomes included the rate of wound healing, while secondary outcomes encompassed postoperative complications and patient-reported outcomes on pain and quality of life. The treatment group exhibited significantly enhanced wound healing rate than the control at Day 7 (40.33 vs. 25.67%, p < 0.05), Day 14 (75.17 vs. 50.83%, p < 0.05) and Day 28 (94.83 vs. 79.50%, p < 0.05). Postoperative complications were markedly reduced in the treatment group, with lower rates of infection (p < 0.05), wound dehiscence (p < 0.05) and cerebrospinal fluid leakage (p < 0.05). Furthermore, patient-reported outcomes significantly favoured the treatment group, with reduced pain scores and improved quality of life at 4 weeks post-surgery(p < 0.05). Naoxintong capsules thus significantly enhanced the wound healing and reduced postoperative complications, contributing to improved patient-reported outcomes in post-craniotomy patients. These findings advocated for the integration of Naoxintong in postoperative care, highlighting the potential of traditional Chinese medicine in modern surgical recovery protocols. Further studies with larger cohorts are recommended to validate these findings and explore the underlying mechanisms.


Assuntos
Medicamentos de Ervas Chinesas , Complicações Pós-Operatórias , Qualidade de Vida , Humanos , China , Complicações Pós-Operatórias/terapia , Craniotomia/métodos , Cicatrização , Dor
2.
Dose Response ; 21(3): 15593258231200527, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37701673

RESUMO

Apart from advances in pharmaceutical antidiabetic agents, efforts are being made toward hypoglycemic agents derived from natural sources. Cinnamon has been reported to have significant benefits for human health, particularly as an anti-inflammatory, antidiabetic, and anti-hypertriglyceridemic agent. The phytochemicals in cinnamon can be extracted from different parts of plant by distillation and solvent extraction. These chemicals help in decreasing insulin resistance and can act against hyperglycemia and dyslipidemia, inflammation and oxidative stress, obesity, overweight, and abnormal glycation of proteins. Cinnamon has shown to improve all of these conditions in in vitro, animal, and/or human studies. However, the mechanism of action of active ingredients found in cinnamon remains unclear. The current review presents the outstanding ability of cinnamon derivatives to control diabetes by various pathways modulating insulin release and insulin receptor signaling. It was also found that the type and dosage of cinnamon as well as subject characteristics including drug interactions are likely to affect the response to cinnamon. Future research directions based on this review include the synergistic usage of various cinnamon derivatives in managing and/or preventing diabetes and possible other relevant chronic diseases.

3.
Comput Methods Programs Biomed ; 240: 107682, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37429249

RESUMO

BACKGROUND: The flaws in dietary assessment methods can generate misleading information and thus may impact on the interventions planned based on that information. Context specific digitalization of dietary assessment tools is a potential way forward to reduce biases and resources involved in data handling. METHODS: Two versions of Twenty-Four Hour Recall (24HR) (traditional [24HR Ver-01] and digital [24HR Ver-02]) were tested for data agreement and feasibility by gathering cross sectional paired data on both the versions from 102 participants (18-25 years age). The web based 24HR was setup using the system of Intake24 (New Castle University) with incorporation of South Asian food data base for beverages. RESULTS: The data sets obtained from 24HR Ver-01 and 24HR Ver-02 on beverage consumption (food items as well as portion sizes) were compared for agreement. The highest percentage of agreement of food item reporting between 24HR Ver-01 and 24HR Ver-01 was during the lunch time. The average kappa value (κ =0.375833) for all the meals indicated a fair agreement betweenVer-01 and 24HR Ver-02 The correlation of portion sizes reported using 24HR Ver-01 and 24 HR Ver-02 was statisticallysignificant for morning snack, lunch and dinner (r = 0.465; r = 0.324; r = 0.407 respectively). According to Bland Altman plot, least agreement between the two versions was found in the portion sizes reported for morning snacks. Data collectors found 24 HR Ver-02 easier in terms of data processing but it was regarded time taking and less convenient by the participants. CONCLUSION: The Intake 24 (digital version of 24HR) can be a preferred tool of data collection as the data collected through it may reach fairly good levels of accuracy. Future directions for research like conducting a follow up study with cross over design, expanding the study using food items other than beverages, and testing the digital dietary assessment tool against an objective gold standard of dietary intake can be helpful in reaching more conclusive evidence.


Assuntos
Dieta , Avaliação Nutricional , Humanos , Autorrelato , Seguimentos , Estudos Transversais , Internet
4.
Phytother Res ; 37(2): 627-644, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36420866

RESUMO

Until now, no specific and effective treatment exists for coronavirus disease 2019 (COVID-19). Since honey and Nigella sativa (HNS) have established antiviral, antibacterial, antiinflammatory, antioxidant, and immunomodulatory properties, we tested their efficacy for this disease in a multicenter, placebo-controlled, and randomized clinical trial at four medical care facilities in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the trial. Patients were randomly assigned in a 1:1 ratio to receive either honey (1 g kg-1 day-1 ) and Nigella sativa seeds (80 mg kg-1 day-1 ) or a placebo for up to 13 days along with standard care. The outcomes included symptoms' alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. Three hundred and thirteen patients, 210 with moderate and 103 with severe disease, underwent randomization from April 30 to July 29, 2020. Among the moderate cases, 107 were assigned to HNS, whereas 103 were assigned to the placebo group. Among the severe cases, 50 were given HNS, and 53 were given the placebo. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (moderate cases: 4 vs. 7 days, Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, p < 0.0001 and for severe cases: 6 vs. 13 days, HR: 4.04; 95% CI: 2.46-6.64; p < 0.0001). HNS also cleared the virus earlier than placebo in both moderate cases (6 vs. 10 days, HR: 5.53; 95% CI: 3.76-8.14, p < 0.0001) and severe cases (8.5 vs. 12 days, HR: 4.32; 95% CI: 2.62-7.13, p < 0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% vs. 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, p < 0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, p < 0.0001). In severe cases, the mortality rate was less than 1/4th in the HNS group than in placebo (4% vs. 18.87%, OR: 0.18; 95% CI: 0.02-0.92, p = 0.029). No HNS-related adverse effects were observed. HNS, compared with placebo, significantly improved symptoms, expedited viral load clearance, and reduced mortality in COVID-19 patients. This trial was registered on April 15, 2020 with ClinicalTrials.gov Identifier: NCT04347382.


Assuntos
COVID-19 , Mel , Nigella sativa , Adulto , Humanos , SARS-CoV-2 , Paquistão/epidemiologia , Resultado do Tratamento
5.
Cureus ; 15(12): e49989, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38179365

RESUMO

INTRODUCTION AND OBJECTIVE: Safe care is a challenge around the globe, especially in developing countries. In resource-limited settings achieving patient safety is an additional complexity. Patient safety is now considered a significant public health concern worldwide. Despite a vital role in delivering quality care, little attention has been given to describe healthcare professionals' perceptions of the patient safety culture in Pakistan. This study aimed to assess the patient safety culture at a tertiary care public hospital in Lahore from the perspectives of doctors and nurses. METHODS: During this cross-sectional study, data were collected from 290 nurses and doctors using a validated safety assessment survey tool of the Hospital Survey of Patient Safety Culture (HSOPSC). The respondent's demographic characteristics and study variables influencing patient safety culture were presented, and a chi-square test was applied to identify the variables influencing patient safety. RESULTS: A total of 114 medical doctors (39.3%) and 176 registered nurses (60.7%) participated in assessing patient safety culture (PSC) across tertiary care public healthcare centers in Lahore. The dimensions of organizational learning and continuous improvement (90.6%) and teamwork within units (86.6%) were the highest. Other dimensions include feedback and communication about the error (71.8%), teamwork across units (74.9%), management support for patient safety (67.3%), supervisor/manager expectations, and actions promoting patient safety (64.6%), communication openness (64.5%), overall perceptions of patient safety (65.3%), frequency of events reported (58.7%), and handoffs and transitions (60.9%) showed moderate status. The dimensions of staffing (35.8%) and non-punitive response to errors (39.1%) had the lowest score. CONCLUSIONS: The present public hospital survey results revealed that medical staff working in a healthcare setting have a less positive perception of patient safety culture.

6.
Plants (Basel) ; 11(23)2022 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-36501389

RESUMO

The dangerous insect pest known as rice leaf folder Cnaphalocrocis exigua (Butler), which reduces rice output globally, twists and feeds on the young rice plant's leaves. Protein elicitors are hypothesized to be biological components that promote rice in becoming herbivore resistant. The evolving elicitor protein PeBL2, obtained from Brevibacillus laterosporus A60, was tested for biocontrol against C. exigua. Four distinct PeBL2 doses (74.23, 45.53, 22.26, and 11.13 µg mL-1) were assigned to evaluate the impact of PeBL2 on immature growth, survivability, and lifespan. Adult reproductive efficiency and the interaction between the pest and the disease were assessed against C. exigua. Further, the assessment of active compounds in PeBL2 with multi-acting entomopathogenic effects investigated the direct correlations of PeBL2 with temperature and climatic change in plants of rice (Oryza sativa L.). When compared to controls, PeBL2 treatments reduced the growing population of second- and third-generation C. exigua. Cnaphalocrocis exigua colonized control plants faster than PeBL2-treated O. sativa plants in a host selection test. PeBL2 doses delayed the development of the larval stage of C. exigua. PeBL2-treated seedlings generated less offspring than control seedlings, identical to fecundity. Trichomes and wax formation on PeBL2-treated leaves generated an adverse environment for C. exigua. PeBL2 altered the surface topography of the leaves, preventing colonization and reducing C. exigua reproduction. PeBL2-treated O. sativa seedlings exhibited somewhat increased amounts of jasmonic acid (JA), salicylic acid (SA), and ethylene (ET). Systemic defensive processes also included the activation of pathways (JA, SA, and ET). Following these results versus C. exigua, the use of PeBL2 in an agroecosystem with integrated pest management and biocontrol appears to be reasonable. These findings shed new light on a cutting-edge biocontrol technique based on B. laterosporus A60.

7.
J Pak Med Assoc ; 72(8): 1558-1563, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36280919

RESUMO

OBJECTIVE: To identify the association of maternal nutritional status with neonatal anthropometry. METHODS: The multi-centre, cross-sectional survey was conducted at two government and 5 private hospitals in Lahore, Pakistan, from July 2016 to August 2017, and comprised mothers and their neonates. A semi-structured self-administered questionnaire was used along with data from patient files. Maternal nutritional status was assessed through biochemical profile. Standard procedures and safety measures were employed during data collection of neonatal anthropometric measurements. Data was analysed using SPSS 22. RESULTS: Of the 800 subjects, 407(50.9%) were from government hospitals and 393(49.1%) from private hospitals. The mean maternal age was 27.72+14.42 years. Among the neonates, 365(45.6%) were girls and 435(54.4%) were boys. Significantly lower anthropometric measurements were noted in mothers with poor haemoglobin, haematocrit, red blood cell, fasting glucose levels as well as those with higher uric acid, and lower serum albumin, total protein, and in those with blood in urine (p<0.05). CONCLUSIONS: Maternal biochemical markers were found to be critical in evaluating mothers at risk of delivering neonates with low anthropometric measurements.


Assuntos
Estado Nutricional , Ácido Úrico , Recém-Nascido , Feminino , Masculino , Humanos , Adolescente , Adulto Jovem , Adulto , Estudos Transversais , Antropometria , Hemoglobinas/análise , Albumina Sérica , Glucose
8.
J Family Community Med ; 29(2): 117-124, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35754748

RESUMO

BACKGROUND: Tuberculosis (TB) is a persistent public health issue requiring consistent global effort for its eradication and control. Research on the subject plays a vital role in combatting the disease, giving future directions, and meeting the sustainable development goals (SDGs). This study aimed to evaluate the global TB research trends and performance from 2011 to 2020. MATERIALS AND METHODS: All the data for TB-related research publications from 2011 to 2020 were extracted from the Web of Science database and a comprehensive analysis was performed on the R-bibliometrix package. RESULTS: An increasing number of publications with an annual growth rate of 6.32% and a plateau in production from 2015 to 2018 was observed. Of 145 countries, the United States of America (USA), China, India, the United Kingdom, and South Africa led and made up half of the global contribution. Out of 91,862 authors, Zhang Y was the most productive with 205 articles and Barry CE had the highest H-index of 45. Only seven of the top 20 authors were from high-burden countries. The University of Cape Town was the leading institutional affiliation, followed by Stellenbosch University and the London School of Hygiene and Tropical Medicine. The most frequent international collaboration was between the USA and South Africa, occurring on 1203 instances. Only five of the top 30 high-burden countries were present in the top 30 collaborations. PLOS ONE, disseminating 2271 articles, was the most productive out of 3500 sources. CONCLUSION: The past decade has seen a steady increase in global TB research. Prominent authors, affiliations, and countries showed collaborative trends, but publications were found to be mostly from developed, low-burden countries except China, India, and South Africa. To meet the goals set by the SDGs and the WHO End TB Strategy, high-burden countries need to explore feasible opportunities and global support to enhance their expected TB-related research contributions.

9.
Microorganisms ; 10(6)2022 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-35744596

RESUMO

The emerging elicitor protein Hrip1 was evaluated for sublethal effects and biocontrol potential in the common bean Phaseolus vulgaris. In Megoura japonica Matsumura, purified elicitor protein Hrip1 was investigated for impacts on endurance, life expectancy, juvenile expansion, fully grown procreative performance, and pathogen-pest interface. The multi-acting entomopathogenic effects of the active compounds of Alternaria tenuissima active on Hrip1 in common bean (Phaseolus vulgaris L.) plants were also investigated. Megoura japonica population expansion was reduced by Hrip1 treatments (second and third generations). In a host selection test, control plants colonized quicker than Hrip1-treated P. vulgaris plants. Hrip1 influenced the longevity, development, and fertility of insects. Hrip1-elicitor protein concentrations aided M. japonica nymph development. Similarly, seedlings treated with Hrip1 generated fewer offspring than seedlings not treated with Hrip1. Hrip1 altered plant height and leaf surface structure, reducing M. japonica reproduction and colonization. Hrip1-treated P. vulgaris seedlings exhibited somewhat increased amounts of jasmonic acid, salicylic acid, and ethylene (ET). The integrated management of insect pests and biocontrol with Hrip1 in the agroecosystem appears to be suitable against M. japonica based on these findings.

10.
Trials ; 23(1): 58, 2022 Jan 19.
Artigo em Inglês | MEDLINE | ID: mdl-35045888

RESUMO

BACKGROUND: Coronavirus disease 2019 (COVID-19) caused by the novel coronavirus-infected millions globally. Despite a wide range of advised options for the treatment of COVID-19, a single strategy to tackle this pandemic remains elusive, thus far. That is why we are conducting a clinical trial to find out the efficacy of iodine complex to clear a viral load of severe respiratory syndrome coronavirus-2 (SARS-CoV-2) along with a reduction in time taken to alleviate symptoms. METHOD: The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a closed-label and adaptive with sample size reassessment, multi-centered design with a 1:1:1:1 allocation ratio and superiority framework. It will be conducted in Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic, and Doctors Lounge, Lahore, Pakistan. This study will have three arms of mild to moderately symptomatic COVID-19 patients (50 patients in each) which will receive ionic-iodine polymer complex with 200 mg of elemental iodine: interventional arm A will have encapsulated, arm B will receive suspension syrup form, arm C will get throat spray, while arm X will be standard care with placebo. Data will be collected on self-constructed, close-ended questionnaires after obtaining written consent. Data will be analyzed using SAS version 9.4. COVID-19 patients will be monitored by RT-PCR and HRCT (high-resolution computed tomography) chest. In addition to these, the duration of the symptomatic phase and mortality benefits will be analyzed in both groups. DISCUSSION: The study is designed to measure the superior efficacy of the iodine complex as an add-on in treating COVID-19-positive patients with mild to moderate symptoms. This combination is hypothesized to improve various parameters like rapid viral load reduction, clinical and radiological improvement, lower mortality, and reduction in hospitalization. The trial will aid in devising a better strategy to cope with COVID-19 in a relatively inexpensive and accessible way. The implications are global, and this could prove itself to be the most manageable intervention against COVID-19 especially for patients from limited-resource countries with deprived socioeconomic status. TRIAL REGISTRATION: ClinicalTrials.gov NCT04473261 . Registered on July 16, 2020.


Assuntos
COVID-19 , Iodo , Humanos , Pandemias , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
11.
Environ Sci Pollut Res Int ; 29(6): 8382-8392, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34490566

RESUMO

Considering that antimicrobial resistance (AMR) is a global challenge, there is a dire need to assess the knowledge, attitude, and practice (KAP) of clinicians in AMR endemic countries. The current multicenter, cross-sectional study aimed at highlighting gaps in antimicrobial (AM) stewardship and AMR among practicing doctors working in public tertiary care teaching hospitals of Lahore, Pakistan. A KAP survey, based on a self-administered questionnaire containing 45 questions, was distributed among 336 clinicians in 6 randomly selected hospitals. Overall, 92% of the clinicians considered AMR as a worldwide problem but only 66% disagreed that cold and flu symptoms require antibiotics. Moreover, around 68% of the doctors felt confident about their practice in AM but still, 96% felt the need to get more knowledge about AM drugs. The need for refresher courses on rational antibiotic use was expressed by 84% of the participants. The main contributing factors considered for AMR by the doctors included excessive AM usage in the medical profession (87.1%) and multiple antibiotics per prescription (76.4%). Pharmacologically, AM spectrum was accurately chosen by 1.4% for Ampicillin, 0.003% for Erythromycin and 0% for Levofloxacin. Clinically, more than 50% of the clinicians used miscellaneous AM for empirical therapy of respiratory tract infection and cholecystitis. The data was analyzed using Statistical Package for Social Sciences (SPSS) version 25. It is concluded that the knowledge of clinicians is relatively poor for AM spectrum and drugs of choice for certain infections. However, the clinicians are aware of their shortcomings and desire for improvement.


Assuntos
Gestão de Antimicrobianos , Estudos Transversais , Conhecimentos, Atitudes e Prática em Saúde , Hospitais , Humanos , Paquistão
12.
Microorganisms ; 9(11)2021 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-34835323

RESUMO

The green peach aphid (Myzus persicae Sulzer), a major and harmful chili aphid usually managed using chemical pesticides, is responsible for massive annual agricultural losses. The efficacy of two protein elicitors, PeaT1 and PeBC1, to stimulate a defensive response against M. persicae in chili was studied in this study. When compared to positive (water) and negative (buffer, 50 mM Tris-HCl, pH 8.0) controls, the rates of population growth (intrinsic rate of increase) of M. persicae (second and third generations) were lower with PeaT1- and PeBC1-treated chilli seedlings. M. persicae demonstrated a preference for colonizing control (12.18 ± 0.06) plants over PeaT1- (7.60 ± 0.11) and PeBC1 (6.82 ± 0.09) treated chilli seedlings in a host selection assay. Moreover, PeaT1- and PeBC1-treated chilli seedlings, the nymphal development period of the M. persicae was extended. Similarly, fecundity was lowered in the PeaT1- and PeBC1-treated chilli seedlings, with fewer offspring produced compared to the positive (water) and negative controls (50 mM Tris-HCl, pH 8.0). The trichomes and wax production on the PeaT1 and PeBC1-treated chilli leaves created a disadvantageous surface environment for M. persicae. Compared to control (30.17 ± 0.16 mm-2), PeaT1 (56.23 ± 0.42 mm-2) and PeBC1 (52.14 ± 0.34 mm-2) had more trichomes. The levels of jasmonic acid (JA), salicylic acid (SA), and ethylene (ET) were significantly higher in the PeaT1- and PeBC1-treated chili seedlings, indicating considerable accumulation. PeaT1 and PeBC1 significantly affected the height of the chili plant and the surface structure of the leaves, reducing M. persicae reproduction and preventing colonization, according to the data. The activation of pathways was also part of the defensive response (JA, SA, and ET). This present research findings established an evidence of biocontrol for the utilization of PeaT1 and PeBC1 in the defence of chili plants against M. persicae.

13.
Trials ; 22(1): 618, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526081

RESUMO

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.


Assuntos
COVID-19 , Mel , Nigella sativa , Adulto , Hospitais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
14.
Trials ; 22(1): 591, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488858

RESUMO

OBJECTIVES: The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. TRIAL DESIGN: This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. PARTICIPANTS: Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). INTERVENTION AND COMPARATOR: The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 µg/kg/48 h (Arm A) or subcutaneous IVM at 200 µg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). MAIN OUTCOMES: Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). RANDOMISATION: A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. BLINDING (MASKING): Patients, primary care physicians, outcome assessors and the data collection team will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 180 participants will be randomized into six arms with five investigational and one placebo group. TRIAL STATUS: Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. TRIAL REGISTRATION: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. 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.


Assuntos
COVID-19 , Ivermectina , Feminino , Humanos , Ivermectina/efeitos adversos , Estudos Multicêntricos como Assunto , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento , Zinco/efeitos adversos
15.
Artigo em Inglês | MEDLINE | ID: mdl-34337588

RESUMO

The COVID-19 pandemic is one of the unprecedented devastating catastrophes with severe public health threat globally. Low and middle income countries (LMICs) are trying hard to cope with the rapidly changing global scenario and trying to mitigate this double crisis of pandemic and economic recession. This pandemic, has led to major changes in global and regional health care delivery proceedings with surge in telemedicine to provide the required services and also giving priority to control the disease spread.

16.
Trials ; 22(1): 127, 2021 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-33568226

RESUMO

OBJECTIVES: The objective of the study is to measure the efficacy of ionic-iodine polymer complex [1] for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients. TRIAL DESIGN: The trial will be closed label, randomized and placebo-controlled with a 1:1:1:1 allocation ratio and superiority framework. PARTICIPANTS: All PCR confirmed COVID-19 adult patients including non-pregnant females, with mild to moderate disease, will be enrolled from Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic and Doctors Lounge in Lahore (Pakistan). Patients with any pre-existing chronic illness will be excluded from the study. INTERVENTION AND COMPARATOR: In this multi-armed study ionic-iodine polymer complex with 200 mg of elemental iodine will be given using three formulations to evaluate efficacy. Patients will be receiving either encapsulated iodine complex of 200 mg (arm A), iodine complex syrup form 40 ml (arm B), iodine complex throat spray of 2 puffs (arm C) or empty capsule (arm D) as placebo; all three times a day. All the 4 arms will be receiving standard care as per version 3.0 of the clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan. MAIN OUTCOMES: Primary outcomes will be viral clearance with radiological and clinical improvement. SARS-CoV-2 RT-PCR and HRCT chest scans will be done on the admission day and then after every fourth day for 12 days or till the symptoms are resolved. RT-PCR will only be shown as positive or negative while HRCT chest scoring will be done depending on the area and severity of lung involvement [2]. Time taken for the alleviation of symptoms will be calculated by the number of days the patient remained symptomatic. 30-day mortality will be considered as a secondary outcome. RANDOMISATION: Stratification for initial COVID-19 status (or days from initial symptoms as a proxy), age groups, gender, baseline severity of symptoms and co-morbidities will be used to ensure that the study arms remain balanced in size for the 1:1:1:1 allocation ratio. Randomization will be done using the lottery method. As patients are being admitted at different times, they will be recruited after obtaining their voluntary written informed consent following all standard protocols of the infection, control and disinfection. BLINDING (MASKING): This is a quadruple (participants, care providers, investigators and outcomes assessors) blinded study where only the study's Primary Investigator will have information about the arms and their interventions. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 200 patients will be randomized into four groups with three experimental and one placebo arm. TRIAL STATUS: Protocol Version Number is 2.3 and it is approved from IRB Shaikh Zayed Hospital with ID SZMC/IRB/Internal0056/2020 on July 14th, 2020. The recruitment is in progress. It was started on July 30, 2020, and the estimated end date for the trial is August 15, 2021. TRIAL REGISTRATION: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04473261 dated July 16, 2020. 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.


Assuntos
Tratamento Farmacológico da COVID-19 , Compostos de Iodo/administração & dosagem , Polímeros/administração & dosagem , SARS-CoV-2/genética , Índice de Gravidade de Doença , Adulto , COVID-19/epidemiologia , COVID-19/mortalidade , Cápsulas , Feminino , Humanos , Masculino , Sprays Orais , Paquistão/epidemiologia , Admissão do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Resultado do Tratamento
17.
Comput Methods Programs Biomed ; 192: 105459, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32234632

RESUMO

BACKGROUND AND OBJECTIVE: Mobile applications could be effectively used for dietary intake assessment, physical activity monitoring, behavior improvement, and nutrition education. The aim of this review is to determine the effectiveness of mobile applications in improving nutrition behaviors through a systematic review of literature. METHODS: The review protocol was registered with PROSPERO: registration number CRD42018118809, and followed PRISMA guidelines. We involved original articles including mobile electronic devices for improving dietary intake, physical activity, and weight management in adult populations in this review. Data were retrieved from January 2010 to December 2018 with PubMed, Web of Science, Excerpta Medica Database (Embase), and Cumulative Index to Nursing and Allied Health Literature (CINAHL) as data sources. Authors individually screened the titles and abstracts, then full articles in order to obtain papers that met inclusion criteria. RESULTS: The database search yielded 2962 records. After removing the duplicates and analyzing the full text papers a total of 8 original articles were reviewed. Two articles showed obvious bias and were not included in our results or discussion. The remaining six articles with low to moderate bias risk were included in this systematic review. Three selected studies were randomized control trials (RCTs) with over 180 participants each. The other three studies were a nested trial, a case-control trial, and a pilot RCT with 36, 162, and 24 participants respectively. All larger RCTs and the small case control trail showed significant improvements in some nutritional-health objectives measured. The other two trials showed insignificant improvements in outcomes measured between groups. CONCLUSION: This study highlights the potential significant health benefits acquirable through mobile health application-assisted nutrition interventions. Some of these studies required significant financial and time input from providers for the application's utilization. Further studies, perhaps with multiple intervention arms, are required to compare across programs the elements that are essential for health benefits observed.


Assuntos
Dieta , Comportamentos Relacionados com a Saúde , Aplicativos Móveis , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Distúrbios Nutricionais/prevenção & controle , Envio de Mensagens de Texto , Adulto Jovem
19.
Medicine (Baltimore) ; 98(40): e17461, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31577776

RESUMO

Antidiabetic medications are commonly used around the world, but their safety is still unclear. The aim of this study was to investigate whether long-term use of insulin and oral antidiabetic medications is associated with cancer risk.We conducted a well-designed case-control study using 12 years of data from Taiwan's National Health Insurance Research Database and investigated the association between antidiabetic medication use and cancer risk over 20 years. We identified 42,500 patients diagnosed with cancer and calculated each patient's exposure to antidiabetic drugs during the study period. We matched cancer and noncancer subjects matched 1:6 by age, gender, and index date, and used Cox proportional hazard regression and conditional logistic regression, adjusted for potential confounding factors, that is, medications and comorbid diseases that could influence cancer risk during study period.Pioglitazone (adjusted odds ratio [AOR], 1.20; 95% confidence interval [CI], 1.05-1.38); and insulin and its analogs for injection, intermediate or long acting combined with fast acting (AOR, 1.22; 95% CI, 1.05-1.43) were significantly associated with a higher cancer risk. However, metformin (AOR, 1.00; 95% CI, 0.93-1.07), glibenclamide (AOR, 0.98; 95% CI, 0.92-1.05), acarbose (AOR, 1.06; 95% CI, 0.96-1.16), and others do not show evidence of association with cancer risk. Moreover, the risk for specific cancers among antidiabetic users as compared with nonantidiabetic medication users was significantly increased for pancreas cancer (by 45%), liver cancer (by 32%), and lung cancer (by 18%).Antidiabetic drugs do not seem to be associated with an increased cancer risk incidence except for pioglitazone, insulin and its analogs for injection, intermediate or long acting combined with fast acting.


Assuntos
Hipoglicemiantes/administração & dosagem , Neoplasias/epidemiologia , Idoso , Estudos de Casos e Controles , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Modelos de Riscos Proporcionais , Fatores de Risco , Taiwan
20.
J Pak Med Assoc ; 69(3): 337-342, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30890824

RESUMO

OBJECTIVE: To assess reliability and validity of Revised Biggs Two-Factor Study Process Questionnaire to measure Learning approaches among medical students. METHODS: The cross-sectional study was conducted at Shaikh Zayed Medical College, Lahore, Pakistan, from November 15, 2014, to January 15, 2015. The 20-item Revised Biggs Two-Factor Study Process Questionnaire was used to assess medical students enrolled from the first to the final year of their studies. Data was analysed using SPSS 20. The reliability of the questionnaire was assessed by Cronbach's alpha, and confirmatory factor analysis was done to confirm the factor model. RESULTS: Of the 480 students approached, 284(59.2%) completed the questionnaire. Cronbach's alpha value was found acceptable at 0.79 and 0.72 for the deep approach and surface approach scales respectively. Comparative Fit Index value (0.858) confirmed a good fit for the model. CONCLUSIONS: Revised Biggs Two-Factor Study Process Questionnaire was found to be a reliable and valid instrument to measure learning approaches among medical students.


Assuntos
Aprendizagem , Estudantes de Medicina , Adolescente , Adulto , Estudos Transversais , Análise Fatorial , Humanos , Paquistão , Reprodutibilidade dos Testes , Inquéritos e Questionários , Adulto Jovem
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