Tag: nevin manimala

Contemp Clin Trials Commun. 2021 Jun 29;23:100805. doi: 10.1016/j.conctc.2021.100805. eCollection 2021 Sep.

ABSTRACT

Herniated nucleus pulposus (NP), one of the most common diseases of the spine, is surgically treated by removing the sequestered NP. However, intervertebral disc (IVD) defects may remain after discectomy, leading to inadequate tissue healing and predisposing patients to IVD degeneration. An acellular, bioresorbable, ultra-purified alginate (UPAL) gel (dMD-001) implantation system can be used to fill any IVD defects in order to prevent IVD degeneration after discectomy. This first-in-human pilot study aims to determine the feasibility, safety, and perceived patient response to a combined treatment involving discectomy and UPAL gel implantation for herniated NP. We designed a one-arm, double-centre, open-label, pilot trial. The study started in November 2018 and will run until a sample of 40 suitable participants is established. Patients aged 20-49 years, diagnosed with isolated lumbar IVD herniation and scheduled for discectomy represent suitable candidates. All eligible participants who provide informed consent undergo standard discectomy followed by UPAL gel implantation. The primary outcomes of the trial will be the feasibility and safety of the procedure. Secondary outcomes will include self-assessed clinical scores and magnetic resonance imaging-based measures of morphological and compositional quality of the IVD tissue. Initial outcomes will be published at 24 weeks. Analysis of feasibility and safety will be performed using descriptive statistics. Both intention-to-treat and per-protocol analyses of treatment trends of effectiveness will be conducted.

PMID:34278043 | PMC:PMC8261539 | DOI:10.1016/j.conctc.2021.100805

Clin Transl Radiat Oncol. 2021 Jul 1;30:15-18. doi: 10.1016/j.ctro.2021.06.006. eCollection 2021 Sep.

ABSTRACT

PURPOSE: To examine the impact of epidermal growth factor receptor (EGFR) mutations on objective response to palliative lung radiotherapy in patients with metastatic non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS: A multicentre retrospective study was conducted of patients with metastatic NSCLC diagnosed between March 2010 and June 2012 who received palliative radiotherapy to the chest. Patients included for study had baseline imaging and follow-up imaging 1-3 months after radiotherapy. The primary endpoint was 1-3 month local objective imaging response by the Response Evaluation Criteria in Solid Tumours (RECIST). Patients were divided into EGFR mutation positive (EGFR+) and EGFR wild type (WT) cohorts for analysis.

RESULTS: There were 121 patients for study inclusion: 89 (74%) were EGFR WT and 32 (26%) were EGFR+. The response rate between EGFR WT and EGFR+ cohorts was not significantly different (49 vs. 63%, p = 0.21). On multivariate analysis, initiation of a tyrosine kinase inhibitor (TKI) after radiotherapy was associated with a higher rate of response (OR: 5.07, 95%CI: 1.08-23.69, p = 0.039) but EGFR mutation status was not. For the EGFR+ cohort, patients with disease progression after initial management on a TKI had a worse response rate compared to patients who were TKI-naïve before starting radiotherapy (30 vs. 77%, p = 0.018). Local control was not statistically different between the EGFR cohorts.

CONCLUSION: The EGFR mutation status alone was not an independent predictor of objective radiographic response to palliative thoracic radiotherapy. Acquired resistance to TKI therapy may be associated with disease cross-resistance to palliative radiotherapy.

PMID:34278010 | PMC:PMC8267427 | DOI:10.1016/j.ctro.2021.06.006

Heliyon. 2021 Jun 26;7(7):e07393. doi: 10.1016/j.heliyon.2021.e07393. eCollection 2021 Jul.

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, the health professionals who are at the frontline of this crisis have been facing extreme psychological disorders. This research aims to provide an overall scenario of the prevalence of depression, anxiety, stress, as well as insomnia and to inspect the changes in these prevalence over time by analyzing the existing evidence during this COVID-19 pandemic.

METHODS: A systematic search was performed on March 30, 2021, in PubMed, MEDLINE, Google Scholar databases, and Web of Science. To assess the heterogeneity, Q-test, I2 statistics, and Meta regression and to search for the publication bias, Eggers’s test and funnel plot were used. The random-effect model and subgroup analysis were performed due to the significant heterogeneity.

RESULTS: Among eighty-three eligible studies in the final synthesis, 69 studies (n = 144649) assessed the depression prevalence of 37.12% (95% CI: 31.80-42.43), 75 studies (n = 147435) reported the anxiety prevalence of 41.42% (95% CI: 36.17-46.54), 41 studies (n = 82783) assessed the stress prevalence of 44.86% (95% CI: 36.98-52.74), 21 studies (n = 33370) enunciated the insomnia prevalence of 43.76% (95% CI: 35.83-51.68). The severity of the mental health problems among health professionals increased over the time during January 2020 to September 2020.

LIMITATIONS: A significant level of heterogeneity was found among psychological measurement tools and across studies.

CONCLUSIONS: Therefore, it is an emergency to develop psychological interventions that can protect the mental health of vulnerable groups like health professionals.

PMID:34278018 | PMC:PMC8261554 | DOI:10.1016/j.heliyon.2021.e07393

Clin Transl Radiat Oncol. 2021 Jun 29;30:7-14. doi: 10.1016/j.ctro.2021.06.005. eCollection 2021 Sep.

ABSTRACT

BACKGROUND AND PURPOSE: Magnetic resonance-guided focal salvage high-dose-rate brachytherapy (FS-HDR-BT) for radiorecurrent prostate cancer (PCa) shows low toxicity rates. However, biochemical failure (BF) after treatment occurs frequently. We developed two prediction models for BF (Phoenix definition) with the aim of enhancing patient counselling before FS-HDR-BT and during follow-up.

MATERIALS AND METHODS: A prospective cohort of 150 radiorecurrent PCa patients treated with FS-HDR-BT between 2013 and 2020 was used for model development and internal validation. Multivariable Cox Proportional Hazards regression was applied. For model 1, only pre-salvage variables were included as candidate predictors. For model 2, additional (post-)salvage characteristics were tested. After calibration, nomograms and webtools were constructed. Finally, three risk groups were identified.

RESULTS: Sixty-one patients (41%) experienced BF. At baseline (model 1), age, gross tumour volume, pre-salvage PSA, and pre-salvage PSA doubling time (PSADT) were predictive of BF. During follow-up (model 2), age, pre-salvage PSA and PSADT, seminal vesicle involvement, post-salvage time to PSA nadir, and percentage PSA reduction were predictive of BF. The adjusted C-statistics were 0.73 (95% CI: 0.66-0.81) and 0.84 (95% CI: 0.78-0.90), respectively, with acceptable calibration. Estimated 2-year biochemical disease-free survival for the low-, intermediate-, and high-risk groups were 84%, 70%, and 31% (model 1), and 100%, 71%, and 5% (model 2).

CONCLUSION: Two models are provided for prediction of BF in patients with radiorecurrent PCa treated with FS-HDR-BT. Based on pre- and post-salvage characteristics, we are able to identify patients with a high risk of BF. These findings can aid patient counselling for FS-HDR-BT.

PMID:34278009 | PMC:PMC8261471 | DOI:10.1016/j.ctro.2021.06.005

Endocrinol Diabetes Metab. 2021 Jun 7;4(3):e00266. doi: 10.1002/edm2.266. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Thyroid cancer is the most common endocrine malignancy, and it has the fastest increase rate in incidence in both sexes, with a yearly increase of 3% over the last decade. Thyroid-stimulating hormone (TSH) is the main driver for the thyroid gland to produce thyroid hormone. The main purpose of this study was to assess the relationship between serum TSH level and the stage of malignancy in patients with differentiated thyroid cancer.

METHODS: This cross-sectional study was performed on 77 patients with thyroid cancer. The demographic characteristics, TSH level and stage of malignancy were recorded for all patients in the data collection form. The data analysis was conducted by descriptive statistics using SPSS 20.0 software.

RESULTS: The results show a significant relationship (p-value = .025) between the malignancy stage and serum TSH level. The mean TSH level in patients of stage 3 (5.70 ± 2.03) was significantly higher than patients in stage 2 (2.58 ± 0.52) and stage 1 (2.33 ± 0.28). No significant relationship was observed between the age of patients and serum TSH level. Although the mean serum TSH level in men (3.61 ± 0.98) was higher than in women (2.52 ± 0.25), the difference was not statistically significant.

CONCLUSIONS: According to the results of this study, serum TSH level can be considered as a predictor of the stage of differentiated thyroid cancer. Therefore, it can be used to predict the likelihood of cancer and improve the outcome and extent of thyroidectomy in patients with thyroid cancer.

PMID:34277989 | PMC:PMC8279600 | DOI:10.1002/edm2.266

J Clin Tuberc Other Mycobact Dis. 2021 Jun 22;24:100253. doi: 10.1016/j.jctube.2021.100253. eCollection 2021 Aug.

ABSTRACT

Tuberculosis (TB), which is caused by Mycobacterium tuberculosis (MTB), is a serious infectious disease with high infection and mortality rates and is a public health problem around the world. According to the World Health Organization (WHO) report, one-third of the world’s population is latently infected with MTB, and 5 to 10% of those with latent TB infection (LTBI) have the potential to develop active TB once in their lifetime. Therefore, TB management for promptly distinguishing LTBI from active TB and for proper treatment is important. LTBI is currently diagnosed using the tuberculin skin test (TST) and interferon gamma (IFN-γ) release assay (IGRA). However, this test is substantially limited by its inability to distinguish active TB from LTBI. It is necessary to discover indicators that can be used for effective TB management and to develop diagnostic methods. In the present study, we used IGRA and complete blood count (CBC) analysis for discrimination of active TB, LTBI, and healthy control groups. The results showed that the number of WBC was significantly increased in the group with active TB (p < 0.0100) and level of hemoglobin (Hb) was significantly decreased (p < 0.0010) in the CBC than those of the healthy control and LTBI groups. In the WBC differential count, the number of neutrophils and monocytes were increased (p < 0.0010) in active TB group, where as those of lymphocytes were significantly decreased (p < 0.0100) in active TB group compared healthy control group. Results verified that the levels of total WBC, Hb, neutrophils, lymphocytes and monocytes were statistically significant (p < 0.0500) and the AUC was approximately 0.8613. In addition, receiver operating characteristic (ROC) curve analysis was performed to confirm the clinical usefulness between active TB and healthy control groups. In conclusion, based on these data demonstrated that the usefulness of these potential indicators for differential diagnosis, according to the result can be provided for effective diagnosis and treatment by comparing the expression patterns of the markers in the whole blood of the active TB, LTBI, and healthy control groups. Furthermore, this study needs to investigate a larger number of clinical specimens later to develop biomarkers according to the state of infection with MTB such as LTBI and active TB, as well as after treatment.

PMID:34278005 | PMC:PMC8262775 | DOI:10.1016/j.jctube.2021.100253

Endocrinol Diabetes Metab. 2021 May 29;4(3):e00263. doi: 10.1002/edm2.263. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Type 1 diabetes mellitus (T1DM) is associated with earlier onset of cardiovascular disease. Recent evidence has found hyperglycaemia appears to play a greater role in this association among T1DM compared to T2DM. This study investigates the relationship between glucose and QTc (a key cardiovascular measure) using data from continuous electrocardiogram (ECG) and glucose monitors.

METHODS: Seventeen adults with T1DM were recruited at a clinical facility in Ireland. A continuous glucose monitoring system was fitted to each participant that measured glucose every 5 min for 7 days. The participants simultaneously wore a vest with sensors to measure 12-lead ECG data every 10 min for 7 days. Area under the glucose curve (AUC), proportion of time spent in hypoglycaemia and hyperglycaemia, and mean daily absolute deviation of glucose were calculated. Mixed effects ANOVA and functional regression models were fitted to the data to investigate the aggregate and time-dependent association between glucose and QTc.

RESULTS: All participants were male with an average age of 52.5 (SD 3.8) years. Those with neuropathy had a significantly higher mean QTc compared to their counterparts. Mean QTc was significantly longer during hyperglycaemia. There was a significant positive association between QTc and time spent in hyperglycaemia. A negative association was found between QTc and time spent in hypoglycaemia. A functional model suggested a positive relationship between glucose and QTc at several times during the 7-day follow-up.

CONCLUSION: This study used sensor technology to investigate, with high granularity, the temporal relationship between glucose and ECG data over one week. QTc was found to be longer on average during hyperglycaemia.

PMID:34277986 | PMC:PMC8279601 | DOI:10.1002/edm2.263

Endocrinol Diabetes Metab. 2021 May 7;4(3):e00258. doi: 10.1002/edm2.258. eCollection 2021 Jul.

ABSTRACT

AIMS: This study examined the effect of experimentally-induced hypoglycaemia on measures of myocardial blood flow and myocardial injury in adults with, and without, type 1 diabetes.

METHODS: In a prospective, randomised, open-label, blinded, endpoint cross-over study, 17 young adults with type 1 diabetes with no cardiovascular risk factors, and 10 healthy non-diabetic volunteers, underwent hyperinsulinaemic-euglycaemic (blood glucose 4.5-5.5 mmol/L) and hypoglycaemic (2.2-2.5 mmol/L) clamps. Myocardial blood flow was assessed using transthoracic echocardiography Doppler coronary flow reserve (CFR) and myocardial injury using plasma high-sensitivity cardiac troponin I (hs-cTnI) concentration.

RESULTS: During hypoglycaemia, coronary flow reserve trended non-significantly lower in those with type 1 diabetes than in the non-diabetic participants (3.54 ± 0.47 vs. 3.89 ± 0.89). A generalised linear mixed-model analysis examined diabetes status and euglycaemia or hypoglycaemia as factors affecting CFR. No statistically significant difference in CFR was observed for diabetes status (p = .23) or between euglycaemia and hypoglycaemia (p = .31). No changes in hs-cTnI occurred during hypoglycaemia or in the recovery period (p = .86).

CONCLUSIONS: A small change in CFR was not statistically significant in this study, implying hypoglycaemia may require more than coronary vasomotor dysfunction to cause harm. Further larger studies are required to investigate this putative problem.

PMID:34277982 | PMC:PMC8279606 | DOI:10.1002/edm2.258

Endocrinol Diabetes Metab. 2021 May 15;4(3):e00259. doi: 10.1002/edm2.259. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Cardiovascular (CV) effects of once-weekly subcutaneous (s.c.) semaglutide 0.5 and 1 mg and dulaglutide 1.5 mg are reported in their respective placebo-controlled cardiovascular outcome trials (CVOTs), SUSTAIN 6 and REWIND. There is no head-to-head CVOT comparing these treatments and heterogeneity between their CVOTs renders conventional indirect comparison inappropriate. Therefore, a matching-adjusted indirect comparison (MAIC) was performed to compare the effects of s.c. semaglutide and dulaglutide on major adverse cardiovascular events (MACE) in patients with and without established cardiovascular disease (CVD).

METHODS: Individual patient data from SUSTAIN 6 were matched with aggregate data from REWIND, using a propensity score method to balance baseline effect-modifying patient characteristics. Hazard ratios (HRs) for three-point (3P) MACE (CV death, non-fatal myocardial infarction, non-fatal stroke), anchored via placebo, were then indirectly compared between balanced populations. Sensitivity analyses were performed to test the robustness of the main analysis.

RESULTS: After matching, included effect modifiers were balanced. In the main analysis, s.c. semaglutide was associated with a statistically significant 35% reduction in 3P MACE versus placebo (HR, 0.65 [95% confidence interval [CI]; 0.48, 0.87]) and nonsignificantly greater reduction (26%) versus dulaglutide (HR, 0.74 [95% CI; 0.54, 1.01]). Results were supported by all sensitivity analyses.

CONCLUSIONS: This study demonstrated a statistically significant lower risk of 3P MACE for s.c. semaglutide versus placebo, in a population with lower prevalence of pre-existing CVD than that in the pre-specified primary analysis in SUSTAIN 6. Reduction in 3P MACE with s.c. semaglutide was greater than with dulaglutide, although not statistically significant.

PMID:34277983 | PMC:PMC8279621 | DOI:10.1002/edm2.259

Endocrinol Diabetes Metab. 2021 May 14;4(3):e00260. doi: 10.1002/edm2.260. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Anaemia is common but often overlooked in diabetes mellitus (DM) patients. There is also no official nationwide survey registry that estimated the prevalence of anaemia in DM patients in Ethiopia. Therefore, the main aim of this study is to determine the countrywide pooled prevalence and associated factors of anaemia in DM patients.

METHODS: This systematic review and meta-analysis were conducted as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. STATA 11 software was used for all statistical analysis. Random effects model was used to estimate the pooled prevalence of anaemia and associated factors at a 95% confidence interval (CI) with its respective odds ratio (OR). Subgroup analysis and egger test were used to determine heterogeneity and publication bias, respectively.

RESULTS: Nine articles were included in this systematic review and meta-analysis with a total of 2889 DM patients. The pooled prevalence of anaemia among DM patients in Ethiopia was 22.11% (95% CI: 15.83-28.39) I ² = 94.8%. The prevalence of anaemia in type I and type II DM patients was (16.78% [95% CI: 11.53-22.04]) and (31.12% [95% CI; 9.66-52.58]), respectively. The prevalence of anaemia was higher among male (36.72% [95% CI: 22.58-50.87] I ² = 97.6%) than female (27.51% [95% CI: 16.12-38.90] I ² = 96.3%). Moreover, the odds of anaemia were higher among patients with age ˃ 60 (OR = 2.98; 95% CI: 1.83, 4.87), low estimated glomerular filtration rate (eGFR) (OR = 8.59; 95% CI: 4.76, 15.57), and duration of illness ≥5 years (OR = 2.66; 95%: 1.38, 5.13).

CONCLUSIONS: The result of this review implies that anaemia is a moderate public health problem among DM patients in Ethiopia. Older age, poor glycemic control, low eGFR and longer duration of illness were found to be the contributing factors for the development of anaemia in DM patients. Therefore, by considering the negative impact of anaemia, it is important to include anaemia screening into routine assessment of DM-related complications targeting patients with older age, poor glycemic control, low eGFR, and longer duration of illness to reduce the magnitude of the problem.

PMID:34277984 | PMC:PMC8279623 | DOI:10.1002/edm2.260