MATERIALS AND METHODS: A prospective observational study was conducted between 1st October 2021 till September 2022 in the state of Johor, Malaysia. 300 patients with confirmed SARS-CoV-2 infection were randomly selected and followed up for six months. Data were analysed by using Chi-square test, Fisher's Exact test, Paired t test and Multiple logistic regression.
RESULTS: The prevalence of short-term neuropsychiatric symptoms was 78%, with anosmia being the most prevalent symptom. Long-term symptoms were found in 22.75% of patients, with headache being the most prevalent (p= 0.001). COVID-19 Stage 2 and 3 infections were associated with a higher risk of short-term neuropsychiatric symptoms, OR for Stage 2 infection was 5.18 (95% CI: 1.48-16.97; p=0.009) and for Stage 3 infection was 4.52 (95% CI: 1.76-11.59; p=0.002). Complete vaccination was a significant predictor of longterm symptoms with adjusted OR 3.65 (95% CI 1.22-10.91; p=0.021).
CONCLUSION: This study demonstrated that neuropsychiatric symptoms were common among COVID-19 patients in Johor, Malaysia and the risk of these symptoms was associated with the severity of the infection. Additionally, complete vaccination does not completely protect against long-term neuropsychiatric deficits. This is crucial for continuous monitoring and addressing neuropsychiatric symptoms in COVID-19 survivors.
METHODS: OPTIM1SE was a prospective, open-label, observational study. Patients with untreated KRAS wild-type mCRC and distant metastases were treated per locally approved labels and monitored for 3 years via electronic medical records. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS).
RESULTS: From November 19, 2013, to June 30, 2016, 520 patients were enrolled in 51 sites. Patients were mostly male (61.2%), with a mean age of 58.5 (±12.0) years; 420 patients received leucovorin, 5-FU, and irinotecan-based regimens and 94 received leucovorin, 5-FU, and oxaliplatin. The most common primary tumor site was the rectum (38.8%), with liver metastases (65.0%). ORR was 45.4% (95% CI, 41.1%-49.7%), including 26 patients (5.0%) with a complete response. Median PFS was 9.9 months (95% CI, 8.2-11.0); median OS (mOS) was 30.8 months (95% CI, 27.9-33.6). Higher mOS was associated with tumors of left compared with right-sided origin (hazard ratio, 0.69 [95% CI, 0.49-0.99]); higher ORR was also associated with liver metastases compared with all other metastases (55.4% vs. 40.2%). Adverse events were consistent with the known safety profile of cetuximab.
CONCLUSION: Cetuximab-based 5-FU regimens were effective first-line treatments for mCRC in routine practice, particularly in patients with left-sided disease and liver metastases only.
METHODS: Adults with active NIIPPU received adalimumab in this prospective, observational study (06/2017-04/2020). Patients were evaluated at baseline (V0) and four follow-up visits over 12 months (V1-V4).
PRIMARY ENDPOINT: proportion of patients achieving quiescence (anterior chamber (AC) cells grade and vitreous haze (VH) grade≤0.5+ in both eyes, no new active chorioretinal lesions) at any follow-up visit. Secondary endpoints: proportion of patients achieving quiescence at each visit; proportion of patients maintaining response; and proportion of patients with flares. Workability, visual function, healthcare resource utilisation, and safety were evaluated.
RESULTS: Full analysis set included 149 patients. Quiescence at any follow-up visit was achieved by 129/141 (91%) patients. Quiescence at individual visits was achieved by 99/145 (68%), 110/142 (77%), 102/131 (78%), and 99/128 (77%) patients at V1-V4, respectively. Number of patients in corticosteroid-free quiescence increased from 51/147 (35%; V1) to 67/128 (52%; V4; p<0.05). Proportion of patients with maintained response increased from 89/141 (63%; V2) to 92/121 (76%; V4; p<0.05) and proportion of patients with flare decreased from 25/145 (17%; V1) to 13/128 (10%; V4; p=0.092). Workability and visual function improved throughout the study. Proportion of patients with medical visits for uveitis decreased from 132/149 (89%; V0) to 27/127 (21%; V4). No new safety signals were observed.
CONCLUSION: These results demonstrated adalimumab effectiveness in improving quality of life while reducing economic burden of active NIIPPU.
METHODS: In this prospective cohort study, the QoL of 208 patients who underwent mastectomy and the BCS treatment were assessed, using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. The questionnaire was administered at the baseline, 6 and 12 months following diagnosis. One-way ANCOVA was used for statistical analysis.
RESULTS: A total of 208 female survivors of Stage 0-II breast cancer were included, among them 47.1% underwent BCS and 52.9% underwent mastectomy. Older (63.3%), Chinese women (63.6%), and patients with primary education (71.7%) were more likely to undergo mastectomy. At baseline, no significant differences were observed for QoL in both treatment groups. At 6 months, patients who underwent BCS had better social functioning scales( P = 0.006) and worse symptom scales for dyspnoea (P = 0.031), compared to mastectomy patients. One year after diagnosis, the role functioning score of the mastectomy group was significantly higher than the BCS group, specifically among patients who had undergone chemotherapy (P = 0.034).
CONCLUSION: Patients who underwent BCS had better social functioning and worse dyspnoea symptoms compared to patients undergoing mastectomy at six months. During one year, there were only significant improvements in the role functioning among the mastectomy groups compared to the BCS groups. After further stratification, only mastectomy patients who received chemotherapy exhibited improved role functioning compared to patients those who did not undergo chemotherapy. Providing social and physical support postoperatively and monitoring patients for cancer worry, or other symptoms in the long-term survivorship period would be important to ensure optimal QoL.
MATERIALS AND METHODS: A dose-ranging analysis using SKF7® was conducted through a randomized, double-blind, multicentre, placebo-controlled, phase 2 clinical trial involving individuals with obesity (N = 133) between January 2020 and April 2021. The potential percentage of change was assessed in relation to BW, BMI, WC and WHtR.
RESULTS: Average treatment effect estimates (treatment group vs. placebo) show a statistically significant reduction in the percentage of change for BW (mean = -2.915; CI: -4.546, -1.285), BMI (-2.921; CI: -4.551, -1.291), WC (mean = -2.187; CI: -3.784, -0.589) and WHtR (mean = -2.294, CI: -3.908, -0.681) in the group with a total of 750 mg of SKF7® (p
METHOD: In this prospective observational cohort study, 769 women prior to their labor induction had sleep and psychological well-being assessed using Pittsburgh Sleep Quality Index and Depression, Anxiety and Stress Scales. Women were asked about the adequacy of labor induction information provided and their involvement and time pressure felt in the decision-making for their labor induction. Maternal characteristics, induction and intrapartum care measures, and labor and neonatal outcomes were also assessed. Prior to discharge, women rated their satisfaction with their birth experience.
RESULTS: A total of 34 variables were considered for bivariate analysis, with 15 found to have P
MATERIALS AND METHODS: A randomised prospective crossover study was designed to compare the AR Gynae endotrainer versus Karl Storz SZABO-BERCI-SACKIER laparoscopic trainer as a tool for training gynaecology laparoscopic skills. Participants were assigned to perform two specially designed tasks used for laparoscopic training using both endotrainers. All subjects evaluated both simulators concerning their performance by the use of a questionnaire comparing: design, ports placement, visibility, ergonomics, triangulation of movement, fulcrum effect, depth perception, ambidexterity, resources for training, and resources for teaching. The overall score was defined as the median value obtained. The ability and time taken for participants to complete the tasks using both endotrainers were also compared. A total of 26 participants were enrolled in this study, including 13 Masters's students from the Department of Obstetrics & Gynaecology and 13 Masters's students from the Department of Surgery, Hospital Universiti Sains Malaysia (HUSM), Kelantan, Malaysia.
RESULTS: A better performance was observed with AR Gynae as compared to Karl Storz endotrainer in five out of ten items evaluated in the questionnaire. Additionally, the overall score of AR Gynae endotrainer (median of 3.98) was comparable to that of Karl Storz endotrainer (median of 3.91) with p=0.519. For the items design and resources for teaching, the evaluation for AR Gynae endotrainer was significantly higher with p-values of 0.003 and 0.032, respectively. All participants were able to complete both tasks using both endotrainers. The time taken to complete both tasks was comparable on both endotrainers. Also, the AR Gynae endotrainer was cheaper.
CONCLUSIONS: The AR Gynae endotrainer was found to be a convenient and cost-effective laparoscopic simulator for gynaecology laparoscopic training and was comparable to the established Karl Storz SZABO-BERCI-SACKIER laparoscopic trainer.
MATERIALS AND METHODS: Epidemiological data for selfreported bone fractures were obtained through direct interviews using a validated questionnaire from the Prospective Urban and Rural Epidemiology (PURE) study.
RESULTS: Of 15,378 respondents, 6.63% (n=1019) reported bone fractures, with a higher proportion of men (65.8%, n=671) than women (34.2%, n=348). Higher odds of selfreporting bone fractures were seen in males (aOR, 2.12; 95%CI: 1.69, 2.65), those with a history of injury (aOR 5.01; 95%CI: 3.10, 6.32) and those who were obese (aOR: 1.46; 95% CI: 1.13, 1.89), highly active (aOR 1.25; 95%CI: 1.02, 1.53), smokers (aOR 1.35; 95%CI: 1.11, 1.65) and alcohol consumers (aOR 1.67; 95%CI: 1.20,2.32).
CONCLUSION: Adopting a healthier lifestyle that includes a balanced diet and moderate physical activity is critical for weight loss, increased muscle and bone mass and better stability, which reduces the likelihood of fractures following a fall.
MATERIALS AND METHODS: We conducted a prospective, multicentre study in seven hospitals in West Malaysia. All the adults admitted in March 2017 fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI were included.
RESULTS: Of the 34,204 patients screened, 2,457 developed AKI (7.18%), 13.1% of which occurred in intensive care unit (ICU). There were 60.2% males with a mean age of 57.8 (±17.5) years. The most common comorbidities were hypertension (55.0%), diabetes (46.6%), ischaemic heart disease (15.1%) and chronic kidney disease (12.0%). The commonest causes of AKI were sepsis (41.7%), pre-renal (24.2%) and cardiorenal syndrome (10.8%). Nephrotoxin exposure was reported in 31%. At diagnosis, the proportion of AKI stages 1, 2 and 3 were 79.1%, 9.7%, 11.2%, respectively. Referral to nephrologists was reported in 16.5%. Dialysis was required in 176 (7.2%) patients and 55.6% were performed in the ICU. Acidosis (46.2%), uraemia (31.6%) and electrolyte disturbance (11.1%) were the commonest indications. Continuous renal replacement therapy (CRRT) was required in 14%. The average length of hospital stay was 9.5 days. In-hospital mortality was 16.4%. Among survivors, full and partial renal recovery was seen in 74.7% and 16.4% respectively while 8.9% failed to recover. After a mean follow-up of 13.7 months, 593 (30.2%) of survivors died and 38 (1.9%) initiated chronic dialysis. Mortality was highest among those with malignancies (Hazard Ratio, HR 2.14), chronic liver disease (HR 2.13), neurological disease (HR 1.56) and cardiovascular disease (HR 1.17).
CONCLUSION: AKI is common in hospitalised patients and is with associated high mortality during and after hospitalisation.
MATERIALS AND METHODS: In a prospective study with purposive sampling, amoxicillin/clavulanate tablet formulations for canine use were collected in four countries (wholesalers or veterinary practice) and shipped to a central bioanalytical laboratory. Twenty-four samples were collected from the UK (nine), Malaysia (nine), Serbia (four) and Thailand (two), yielding 18 different formulations (10 veterinary). Packaging inspection, tablet disintegration and content assay were conducted (validated high-performance liquid chromatography with ultra-violet detection); content was acceptable when within the 90% to 120% pre-specified range (US Pharmacopeia).
RESULTS: Secondary packaging was present for 13 of 24 samples and primary packaging integrity was verified for all but one sample. Amoxicillin trihydrate/potassium clavulanate label ratio was 4:1, except for three formulations (2:1). Tablet dose strength ranged from 250 to 625 mg. All formulations contained both analytes. For amoxicillin, two of 24 samples were out of specification with 72.8% (Malaysia) and 82.3% (Thailand) of labelled content. For clavulanate, four of 24 samples were out of specification with 46.9% (Serbia), 79.0% (UK), 84.3% (Serbia) and 86.5% (Thailand) of labelled content. One formulation (Thailand) failed for both analytes.
CLINICAL SIGNIFICANCE: Antimicrobial formulations of substandard quality have negative consequences for efficacy in patients and potentially promote antimicrobial resistance. There was evidence of substandard formulations in all countries, not only for amoxicillin but especially for clavulanate; this could compromise equitable access to acceptable quality essential veterinary medicines worldwide.
AIM: The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.
METHODS: We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).
RESULTS: Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p
METHODS: This prospective study was conducted in 9 randomly selected government maternity clinics in Kuala Lumpur, Malaysia. Healthy women aged 20-48 years old with single pregnancy were recruited using convenience sampling (n = 169). Sleep quality, light exposure at night, and psychological wellbeing were self-reported using the Pittsburgh Sleep Quality Index (PSQI), Harvard Light Exposure Assessment (H-LEA), and Depression, Anxiety, and Stress Scale (DASS-21) in the 2nd trimester and followed-up at the 3rd trimester.
RESULTS: During the 2nd and 3rd trimesters of pregnancy, mild to severe symptoms of stress (10.7 and 11.3%), anxiety (42 and 44.3%), and depression (9.6 and 16.6%) were observed among the participants. Adjusted multiple linear regression revealed that poor sleep quality and higher light exposure at night were attributed to greater stress and depression symptoms in the 3rd trimester. Higher lux level exposed from 10 pm to
MATERIALS AND METHODS: PubMed, Scopus, Web of Science, and Google Scholar were searched for relevant studies published up to April 15th, 2023. Studies that evaluated the association between PD and COVID-19 were included. Risk of bias was evaluated by two reviewers, and meta-analyses were performed using RevMan 5.3 software.
RESULTS: A total of 22 studies involving 92,535 patients from USA, Europe, Asia, the Middle East and South America were included; of these, 12 were pooled into the meta-analysis. Most of the studies (19 studies) reported a significant association between PD and COVID-19. The pooled data found a significant association between PD and COVID-19 outcomes: more severe symptoms (OR = 6.95, P = 0.0008), ICU admissions (OR = 3.15, P = 0.0001), and mortality (OR = 1.92, P = 0.21). Additionally, compared to mild PD, severe PD was significantly associated with higher risks of severe COVID-19 outcomes: severe symptoms (P = 0.02); ICU admission (P = 0.0001); and higher mortality rates (P = 0.0001). The results also revealed 58% higher risk for COVID-19 infection in patients with PD (P = 0.00001).
CONCLUSIONS: The present findings suggest a possible association between poor periodontal health and the risk of poor COVID-19 outcomes. However, owing to the observed methodological heterogeneity across the included studies, further prospective cohort studies with standardized methodologies are warranted to further unravel the potential association between periodontal disease and COVID-19 and its adverse outcomes.
METHODS: A parallel, open-label, 2-arm prospective, pilot randomised controlled trial was conducted at a long-term stroke service at a university based primary care clinic. All stroke caregivers aged ≥ 18 years, proficient in English or Malay and smartphone operation were invited. From 147 eligible caregivers, 76 participants were randomised to either SRA™ intervention or conventional care group (CCG) after receiving standard health counselling. The intervention group had additional SRA™ installed on their smartphones, which enabled self-monitoring of modifiable and non-modifiable stroke risk factors. The Stroke Riskometer app (SRATM) and Life's Simple 7 (LS7) questionnaires assessed stroke risk and lifestyle practices. Changes in clinical profile, lifestyle practices and calculated stroke risk were analysed at baseline and 3 months. The trial was registered in the Australia-New Zealand Clinical Trial Registry, ACTRN12618002050235.
RESULTS: The demographic and clinical characteristics of the intervention and control group study participants were comparable. Better improvement in LS7 scores were noted in the SRA™ arm compared to CCG at 3 months: Median difference (95% CI) = 0.88 (1.68-0.08), p = 0.03. However, both groups did not show significant changes in median stroke risk and relative risk scores at 5-, 10-years (Stroke risk 5-years: Median difference (95% CI) = 0.53 (0.15-1.21), p = 0.13, 10-years: Median difference (95% CI) = 0.81 (0.53-2.15), p = 0.23; Relative risk 5-years: Median difference (95% CI) = 0.84 (0.29-1.97), p = 0.14, Relative risk 10-years: Median difference (95% CI) = 0.58 (0.36-1.52), p = 0.23).
CONCLUSION: SRA™ is a useful tool for familial stroke caregivers to make lifestyle changes, although it did not reduce personal or relative stroke risk after 3 months usage.
TRIAL REGISTRATION: No: ACTRN12618002050235 (Registration Date: 21st December 2018).
MATERIALS AND METHODS: A two-arm prospective cohort study was conducted among adult patients with COVID-19 categories 2 and 3 treated with Paxlovid® and a matched control group. A standard risk-stratified scoring system was used to establish Paxlovid® eligibility. All patients who were prescribed Paxlovid® and took at least one dose of Paxlovid® were included in the study. The control patients were selected from a centralised COVID-19 patient registry and matched based on age, gender and COVID-19 stage severity.
RESULTS: A total of 552 subjects were included in the study and evenly allocated to the treatment and control groups. There was no statistically significant difference in 28-day hospitalisation after diagnosis [Paxlovid®: 26 (9.4%), Control: 34 (12.3%), OR: 0.74; 95%CI, 0.43-1.27; p=0.274] or all-cause death [Paxlovid®: 2 (0.7%), Control: 3 (1.1%), OR 1.51; 95%CI, 0.25-9.09; p=0.999]. There was no significant reduction in hospitalisation duration, intensive care unit admission events or supplementary oxygen requirement in the treatment arm. Ethnicity, COVID-19 severity at diagnosis, comorbidities and vaccination status were predictors of hospitalisation events.
CONCLUSION: In this two-arm study, Paxlovid® did not significantly lower the incidence of hospitalisation, all-cause death and the need for supplemental oxygen. Adverse effects were frequent but not severe. Paxlovid® efficacy varied across settings and populations, warranting further real-world investigations.