scholarly journals The Value Assessment of Clinical Trials Based on Electrophysiologically Verified Lumboischialgia

2018 ◽  
Vol 49 (2) ◽  
Author(s):  
Draško Prtina ◽  
Dragan Ostojić ◽  
Alma Prtina
Keyword(s):  
Clinical Trials ◽  
Medical History ◽  
Statistical Significance ◽  
Clinical Signs ◽  
High Sensitivity ◽  
Value Assessment ◽  
Clinical Tests ◽  
Lumbosacral Region ◽  
Limit Value ◽  
Febrile Condition

Introduction: Lumboischialgia is defined as pain in the distribution of ischemic nerve caused by a pathological change in the nerve itself, whereas lumbago is a localized spondylogenic pain that is not followed by a neurological deficit, and is a consequence of muscular bone dysfunction of the lumbosacral region. Previous studies which investigated the value of clinical trials in the diagnosis of lumboischialgia did not find a high sensitivity and specificity in those tests.Objective: Our objective was to define clinical tests that indicate the existence of radiculopathy and to determine the value of the overall diagnostic finding in relation to the findings of the EMNG examination.Methods: The sample consisted of 100 patients of both genders, aged 18-65. The inclusive criteria were: strong lower back pain propagating in one of both legs and lasting for 1-3 months and the medical history suggesting a radicula lesion. Non-inclusion criteria were the following: symptoms of cauda equine, acute febrile condition, existence of tumors, vertebral fractures, lesions of central motoneuron, inability to perform the EMNG examination, acute psychotic conditions, operations of the spine and pregnancy. Immediately before each EMNG examination, medical history was taken with defined questions on the existence of pain stronger in the leg than in the spine, dermatome deficit, pain during labor and weakness in the leg.Results: Patients usually have a total of two (31%) and three (26%) positive clinical signs of lumboischialgia. By statistical analysis, three clinical trials proved to be discriminatory in terms of verification of radiculopathy: positive Lazarevic test, paresis of a particular muscle group, and absence or reduction of the patellar or Achilles reflex. After processing with logistic regression, the statistically predictive value is retained by a positive Lazarevic test. The analysis of the surface under ROC curve shows that the positivity of four or more clinical tests is statistically the best limit value, with a specificity of 67% and a sensitivity of 56%.Conclusion: The conducted study indicates the statistical significance of the frequency of positive clinical trials: Lazarevic test, objective muscular weakness and absent reflex, in persons with electrophysiologically verified lumboischialgia.

ASSECSSING MOCA TEST IN SUBACUTE STROKE PATIENTS AND COMPARE MOCA VERSUS MMSE

2016 ◽  
pp. 120-127
Author(s):  
Dinh Toan Nguyen
Keyword(s):  
Human Life ◽  
Statistical Significance ◽  
High Sensitivity ◽  
Stroke Patients ◽  
Cross Sectional ◽  
Female Age ◽  
Subacute Stroke ◽  
Duration Of Illness ◽  
Dsm Iv

Background: Dementia after stroke, particularly subacute period is often overlooked. Today the quality of human life is increasingly high, finding scales that have high value for detection of dementia in patients with stroke is increasingly interested. MoCA test is high sensitivity with mild dementia and identify more abnormalities of awareness caused by vascular, but MoCA have not been studied much in Vietnam. Objective: Assessing MoCA test in subacute stroke patients and compare MoCA versus MMSE in these patients. Subjects: 90 patients with subacute stroke period, these people are being treated at Department of cardiovascular internal medicine at Hue Central Hospital, from 7/2014 - 7/2015. Methods: cross-sectional description and analysis. Results: The mean age is 65.57 ± 13.38, accounting for 54.4% male and 45.6% female. Age, duration of illness has weak correlation with MoCA. The risk factors: hypertension, stroke ischemic transient, alcoholism, smoking, heart disease, diabetes, dyslipidemia related no statistical significance with MoCA. The proportion of dementia in subacute stroke according MoCA is 82.2%. The concordance between MoCA and MMSE was good (kappa = 0.684). Using DSM-IV criteria as the gold standard we found MoCA more valuable in the dementia diagnosis than MMSE (AUC 0.864 versus 0.774, p <0.05). Conclusion: The rate of dementia in stroke subacute period according MoCA is quite high. MoCA is valuable than MMSE in detecting dementia in patients with stroke subacute period, this scale is short, easy to implement so should put into using widely in clinical practice. Key words: MoCA test, subacute stroke, dementia

scholarly journals Exploring alterations in hematological and biochemical parameters, enzyme activities and serum cortisol in Besnoitia besnoiti naturally infected dairy cattle

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Luca Villa ◽  
Alessia Libera Gazzonis ◽  
Sergio Aurelio Zanzani ◽  
Silvia Mazzola ◽  
Alessia Giordano ◽  
...  
Keyword(s):  
Enzyme Activities ◽  
Biochemical Parameters ◽  
Statistical Significance ◽  
Clinical Signs ◽  
Serum Cortisol ◽  
Lower Percentage ◽  
Besnoitia Besnoiti ◽  
Laboratory Parameters ◽  
Bovine Besnoitiosis ◽  
Hematological And Biochemical Parameters

Abstract Background Besnoitia besnoiti is an Apicomplexan protozoa causative of bovine besnoitiosis, a chronic and debilitating disease of cattle, with a variety of pathological findings that could alter some laboratory parameters. A study was conducted in a bovine besnoitiosis endemically infected dairy herd located in Italy characterized by high intra-herd seroprevalence and cattle with clinical signs of the disease. In the study, alterations in laboratory parameters, i.e. hematological and biochemical parameters, enzyme activities and serum cortisol levels, in Besnoitia besnoiti naturally infected cows were investigated in depth. Methods Laboratory parameters in 107 cows, of which 61 were seronegative and 46 were seropositive to B. besnoiti, including 27 with clinical signs of bovine besnoitiosis, were compared. Generalized linear models were used to evaluate the effect of Besnoitia infection on the considered laboratory parameters. Results Hematological analyses revealed that B. besnoiti infection determined a significant alteration to the leukocyte differential, with a higher percentage of granulocytes and a lower percentage of lymphocytes in seropositive and clinically affected animals (Mann–Whitney U-test, P = 0.022); erythrocyte and platelet counts did not show any difference between the considered groups of cows. Biochemistry tests evidenced that the parasite infection influenced serum protein values in seropositive cows and glutamate dehydrogenase values in clinically affected animals. No or only slight differences were revealed for all of the other biochemical and enzyme activity parameters in B. besnoiti-infected animals. In addition, despite the lack of statistical significance, seropositive and clinically affected cows evidenced higher concentrations of serum cortisol values compared to seronegative animals. Conclusions Although physiological, pathological and farm-related factors could have influenced the results in investigated animals, further studies involving more animals from different farms would be advisable to infer the role of B. besnoiti on these alterations, since laboratory parameters could help veterinarians in the diagnosis of bovine besnoitiosis in cattle.

scholarly journals AB0815 FIRST DEGREE RELATIVES OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - CLINICAL, SEROLOGICAL AND IMMUNOLOGICAL CORRELATIONS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1432.2-1432
Author(s):  
B. Penev ◽  
G. Vasilev ◽  
D. Kyurkchiev ◽  
S. Monov
Keyword(s):  
Risk Factors ◽  
Systemic Lupus Erythematosus ◽  
Connective Tissue ◽  
Lupus Erythematosus ◽  
Current Knowledge ◽  
Statistical Significance ◽  
Clinical Signs ◽  
Connective Tissue Diseases ◽  
Pharmaceutical Products ◽  
Systemic Lupus

Background:Antinuclear antibodies (ANA) have been unequivocally recognized as essential for diagnosis and play both pathogenic and diagnostic roles in systemic lupus erythematosus (SLE). SLE and ANA have also been found to be more often among relatives of SLE patients. ANA and other immunological changes are known to appear prior to the clinical onset of the disease and thus can be used as predictors. Studies have reported that relatives of SLE patients who later transitioned to SLE displayed more lupus-associated autoantibody specificities and had early clinical signs. They also displayed elevated baseline plasma levels of inflammatory mediators, including B-lymphocyte stimulator (BLyS) and interferon-associated chemokines, with concurrent decreases in levels of regulatory mediators, e.g. tumor growth factor (TGF)-β. Commonly recognized risk factors for SLE are signs of past Epstein-Barr (EBV) infection, use of estrogen drugs and current smoking. It seems that ANA, immunologic changes and risk factors have not been investigated together in relatives of SLE patients.Objectives:The aim of the study was to determine the relative prevalence of clinical signs of SLE or connective tissue disease (CTD), smoking, use of estrogen drugs and levels of circulating ANA, BLyS, IFN-α, TGF-β, anti-EBV viral capsid antigen (VCA) IgM and IgG antibodies among sera of FDR, non-FDR healthy individuals and SLE patients.Methods:Forty three FDRs of SLE patients were studied along with 15 SLE patients and 15 clinically healthy subjects as control groups. The FDRs and the healthy answered a questionnaire about early clinical signs of CTD, smoking and estrogen use history. The questionnaire was developed based on the existing Screening Questionnaire for Connective Tissue Diseases and current knowledge of most early signs of CTD. Blood samples were obtained and tested for ANA, both by indirect immunofluorescence and immunoblot, anti-dsDNA by ELISA. ELISA was also performed to measure levels of BLys, IFN-α, TGF-β, anti-EBV IgM and IgG.Results:More than half of the FDRs displayed ANA in titer 1:160 or more, with predominately AC-4 type of fluorescence according to International Classification on ANA Patterns (ICAP) compared to only AC-1 and AC-0 among patients and controls respectively. A correlation between the ANA titer and the number of complaints was found. This was particularly valid or reported skin complaints and oral ulcers which appeared more frequently when ANA was 1:320 or above (p=0,018 and 0,038 respectively). Furthermore, oral ulcerations showed positive correlation with the presence of anti-Ro60. No associations were found in the healthy group between reported complaints and ANA titers. Smoking and estrogen use did not differ across the three groups. Patients showed significant differences in levels of BLys (p=0,027), TGF-β (p=0,019) and anti-EBV IgG (p=0.041) compared to both FDRs and controls. Without reaching statistical significance, levels of TGF-β tend to split the FDR group into “healthy-like” and “SLE-like”.Conclusion:Our results show that FDR ANA levels are between those of SLE patients and healthy subject groups. This is consistent with previous studies. The data also suggest that ANA positivity correlates with reported complaints, some of which could be interpreted as very early clinical signs of SLE. Of note, anti-Ro60 is known to be among the earliest ANA that appear in “future” SLE patients and in this study they are related to oral complaints that could be caused by early sicca phenomena. Immunologically, our data support previous findings [1] that the FDRs are a heterogenic group with different “lupus-developing” potential.References:[1]Munroe МE. et al, Soluble Mediators and Clinical Features Discern Risk of Transitioning to Classified Disease in Relatives of Systemic Lupus Erythematosus Patients, Arthritis Rheumatol. 2017 March; 69(3): 630–642.Disclosure of Interests:Bogdan Penev: None declared, Georgi Vasilev: None declared, Dobroslav Kyurkchiev: None declared, Simeon Monov Speakers bureau: I have been paid for giving lectures on statistical data on efficacy of many pharmaceutical products on various companies

MO368THE INCIDENCE AND RISK FACTORS FOR ACUTE KIDNEY INJURY IN PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS: A REAL-LIFE STUDY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Deniz Can Güven ◽  
Deniz Aral Ozbek ◽  
Taha Koray Sahin ◽  
Melek Seren Aksun ◽  
Gozde Kavgaci ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Immune Checkpoint Inhibitors ◽  
Multivariate Analyses ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Real Life ◽  
Kidney Injury

Abstract Background and Aims The immune checkpoint inhibitors (ICIs) became a vital part of cancer treatment. The ICIs seem to be safer than chemotherapy for kidneys in clinical trials. However, recent observational studies from high-resource settings pointed out the possible underreporting of renal adverse events like acute kidney injury (AKI) in the clinical trials due to focusing only to the renal immune-related adverse events. Additionally, clinical trials generally enroll a fitter population with lesser comorbidities and include mostly treatment-naive patients making studies in real-life cohorts imperative for evaluating the AKI rates during ICI treatment. From these points, we aimed to evaluate the AKI rates and predisposing factors in ICI-treated patients. Method This retrospective study has evaluated the data of adult metastatic cancer patients treated with ICIs in Hacettepe University Cancer Center from 01.2014 to 12.2019. All patients other than the ones treated within the context of clinical trials or followed in other institutions after the first dose of ICIs were included. Baseline demographics, cancer types, patient weight and heights, ICI type and the number of cycles, serum creatinine and the estimated GFR values under treatment, regular medications, and comorbidities were recorded. AKI was defined by Kidney Disease Improving Global Outcomes criteria. The predisposing factors to AKI development were evaluated with the univariate and multivariate analyses. Results A total of 147 patients were included in the analyses. Median age was 61 [interquartile range (IQR) 51-67], and 69.4% of the patients were male. Patients were given a median of 8 (IQR 5-17) ICI cycles. Patients with melanoma (24.5%), non-small cell lung cancer (15%), and renal cell carcinoma (25.9%) comprised almost 2/3 of the cohort and 72.8% of the patients were treated with nivolumab. Hypertension was the most common comorbidity (38.1%), followed by chronic kidney disease (21.2%) and type 2 diabetes (19.7%). Median Charlson Comorbidity Index (CCI) was 8 (7-9). Median follow-up was 10.3 (IQR 6.3-19.4) months, and patients had median 9 (IQR 5-18) serum creatinine measurements. During the follow-up, 28 patients (19%) had at least one AKI episode with multiple AKI episodes in 3 patients (10.7%). The median time to AKI development was 2.53 (IQR 1.39-6.19) months. Almost all AKI events were mild (grade 1 or 2 in 27/28) and reversible (25/28). In univariate analyses, coronary artery disease (CAD) (p=&lt;0.001), chronic kidney disease (CKD) (p=0.002), previous nephrectomy (p=0.015), iodinated contrast exposure in the week before immunotherapy (p=0.035), the use of renin-angiotensin-aldosterone system inhibitors (p=0.046) or proton pump inhibitors (PPI) (p=0.041) was associated with an increased AKI risk. The association between diabetes (p=0.067), higher CCI (9 vs. ≥9, p=0.107), baseline lactate dehydrogenase levels (p=0.177), and performance status (ECOG 0 vs. ≥1, p=0.235) and AKI risk did not reach statistical significance. In multivariate analyses, patients with CKD (OR: 3.719, 95% CI: 1.375- 10.057, p=0.010) or CAD (OR: 4.774, 95% CI: 1.803- 12.641, p=0.002) had increased AKI risk. Additionally, regular PPI use (OR: 2.734, 95% CI: .991- 7.542, p=0.052) had borderline statistical significance for AKI development. The development of AKI was not associated with decreased survival (HR: 0.726, 95% CI: 0.409-1.291, p=0.276). Conclusion In this study, we observed AKI development under ICIs in almost one in five cancer patients. The increased AKI rates in patients with CAD, CKD, or regular PPI use pointed out the need for better onco-nephrology collaboration in all ICI-treated patients, with a particular emphasis in these high-risk patients.

Markers of the early stage of rheumatoid arthritis

2016 ◽  
Vol 51 (4) ◽  
pp. 305-314
Author(s):  
Beata Polińska ◽  
Joanna Matowicka-Karna ◽  
Halina Kemona
Keyword(s):  
Rheumatoid Arthritis ◽  
Human Population ◽  
Early Stage ◽  
Clinical Signs ◽  
High Sensitivity ◽  
Unknown Etiology ◽  
Serological Tests ◽  
Citrullinated Peptide ◽  
Peptide Antibodies

Rheumatoid arthritis (RA) is a chronic, autoimmune connective tissue disease of unknown etiology. RA affects about 1% of the human population, women suffer three times more often than men, with the peak incidence between the age of 40 to 50. The up-to-date criteria from 2010 for the diagnosis of RA include: occurrence and duration of clinical signs, indicators of inflammation and serological tests. Neopterin, a protein released by macrophages, is a sensitive indicator of inflammation and the severity of RA. Regarding the serological tests, anti-cyclic citrullinated peptide antibodies represent a well-known marker with the specificity for RA of about 98%. The antibodies may be present in the serum of patients even a few years before the first clinical signs of the disease, heralding erosive changes in the joints and more severe course of RA. The literature also contains reports about autoantibodies anti-CarP and anti-Sa/ anti-MCV, which may occur in people with pain and swelling of joints and precede full-blown development of RA as well as reflect disease activity. Serological diagnosis of RA may be supported by some genetic tests based on PCR for detecting mutations e.g. C1858T in the PNPN22 gene. In turn, the quantitative analysis of different classes of miRNAs seems justified in order to better classify patients showing symptoms of RA. Further studies are needed that take into account the role of different markers in the development of RA, and confirm the high sensitivity and specificity of these markers in the diagnosis of the disease.

Basal high-sensitivity-C-reactive protein levels in patients with spontaneous venous thromboembolism

2005 ◽  
Vol 93 (03) ◽  
pp. 488-493 ◽  
Author(s):  
Rainer Vormittag ◽  
Thomas Vukovich ◽  
Verena Schönauer ◽  
Stephan Lehr ◽  
Erich Minar ◽  
...  
Keyword(s):  
Risk Factor ◽  
Venous Thromboembolism ◽  
Statistical Significance ◽  
Factor V Leiden ◽  
High Sensitivity ◽  
Prothrombin G20210a ◽  
Factor V ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Hs Crp

SummaryThe role of C-reactive protein (CRP) in venous thromboembolism (VTE) is still under discussion because of controversial results in the literature. Conflicting data may have partly been due to bias by exogenous factors altering CRP levels. We investigated CRP concentrations in patients with spontaneous VTE applying a study design that allowed the measurement of basal high sensitivity (hs)-CRP levels. Patients with a history of deep vein thrombosis (DVT, n=117) and pulmonary embolism (PE, n=97) were compared to healthy individuals (n=104). Hs-CRP levels (mg/dl) were significantly higher in patients (n=214, median/interquartile range: 0.171/0.082–0.366) than in controls (0.099/0.053–0.245, p=0.001). The unadjusted odds ratio (OR) for VTE per 1 mg/dl increase of CRP was 2.8 [95% confidence interval (CI): 1.1–6.8, p=0.03]. This association remained significant after adjustment for factor V Leiden, prothrombin G20210A and factor VIII activity above 230% (OR = 2.9, 95% CI [1.1–7.5]), but became remarkably attenuated and lost its statistical significance after adjustment for BMI alone (OR = 1.7 [0.7–4.0]). CRP was also not independently associated with VTE in subgroups of patients (those with DVT without symptomatic PE, those with PE and patients without established risk factor) in multiple regression analysis. In summary, we observed significantly higher basal hs-CRP levels in patients with spontaneous VTE compared to healthy controls. This association was independent of hereditary and laboratory risk factors for VTE, but lost its significance after adjustment for BMI. Increased basal CRP levels do not appear to represent an independent risk factor for VTE.

scholarly journals Linear trend in patients with ovarian cancer in period 2001-2008 at Oncology Institute of Vojvodina

2010 ◽  
Vol 63 (9-10) ◽  
pp. 607-610 ◽  
Author(s):  
Goran Malenkovic ◽  
Tihomir Dugandzija ◽  
Aljosa Mandic ◽  
Marija Velaga ◽  
Olivera Tesic ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Ovarian Carcinoma ◽  
Linear Trend ◽  
Statistical Significance ◽  
Positive Family History ◽  
High Sensitivity ◽  
Diagnostic Procedures ◽  
Malignant Neoplasms ◽  
Female Population ◽  
Advanced Stages

Introduction. Ovarian cancer is one of the leading health problems, as it is the underlying cause of disease and deaths of a large number of women around the world. Postmenopausal female population, in whom ovarian carcinoma is most often diagnosed in advanced stages of the disease, is primarily affected. Material and methods. We used data from Hospital Registry for Malignant Neoplasms at Oncology Institute of Vojvodina, for the period from 2001 to 2008, according to which 422 cases of ovarian carcinoma were reported. The obtained data were classified into three groups according to FIGO classification of ovarian malignant neoplasms. The statistical assessment of data employed the method of linear trend and tests of statistical significance (t-test). Results. The results of our study showed that most cases of diagnosed disease were advanced forms of ovarian cancer, FIGO stages II and IV. The linear trend of the reported cases in stage I for the period 2001/2008 showed a descending trend. According to the processed data, in the same period of time, stage II showed an ascending trend, while stages III and IV described together showed a moderate ascending linear trend. Conclusion. A vast majority of cases of ovarian cancer are detected in advanced stages of the disease, which is at the same time the group with the worst prognosis. Special attention should be paid to the group of patients with positive family history, as well as the presence of BRCA1 and BRCA 2 genetic mutations. Currently existing diagnostic procedures have not given good results individually in terms of high sensitivity for diagnosis of early stages.

Clinical trials in wound care II: achieving statistical significance

2002 ◽  
Vol 11 (4) ◽  
pp. 156-160 ◽  
Author(s):  
P. Venkatraman ◽  
S. Anand ◽  
C. Dean ◽  
R. Nettleton
Keyword(s):  
Clinical Trials ◽  
Wound Care ◽  
Statistical Significance

scholarly journals Systematic Review and Meta-Analysis of Linezolid and Daptomycin for Treatment of Vancomycin-Resistant Enterococcal Bloodstream Infections

2013 ◽  
Vol 57 (10) ◽  
pp. 5013-5018 ◽  
Author(s):  
Donald W. Whang ◽  
Loren G. Miller ◽  
Neil M. Partain ◽  
James A. McKinnell
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Bloodstream Infections ◽  
Small Sample ◽  
Antibiotic Selection ◽  
Vancomycin Resistant

ABSTRACTBloodstream infections due to vancomycin-resistant enterococci (VRE-BSI) result in substantial patient mortality and cost. Daptomycin and linezolid are commonly prescribed for VRE-BSI, but there are no clinical trials to determine optimal antibiotic selection. We conducted a systematic review for investigations that compared daptomycin and linezolid for VRE-BSI. We searched Medline from 1966 through 2012 for comparisons of linezolid and daptomycin for VRE-BSI. We included searches of EMBASE, clinicaltrials.gov, and national meetings. Data were extracted using a standardized instrument. Pooled odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using a fixed-effects model. Our search yielded 4,243 publications, of which 482 contained data on VRE treatment. Most studies (452/482) did not present data on BSI or did not provide information on linezolid or daptomycin. Among the remaining 30 studies, 9 offered comparative data between the two agents. None were randomized clinical trials. There was no difference in microbiologic (n= 5 studies, 517 patients; OR, 1.0; 95% CI, 0.4 to 1.7;P= 0.95) and clinical (n= 3 studies, 357 patients; OR, 1.2; 95% CI, 0.7 to 2.0;P= 0.7) cures between the two antibiotics. There was a trend toward increased survival with linezolid compared to daptomycin treatment (n= 9 studies, 1,074 patients; OR, 1.3; 95% CI, 1.1 to 1.8;I2= 0 [whereI2is a measure of inconsistency]), but this did not reach statistical significance (P= 0.054). There are limited data to inform clinicians on optimal antibiotic selection for VRE-BSI. Available studies are limited by small sample size, lack of patient-level data, and inconsistent outcome definitions. Additional research, including randomized clinical trials, is needed before conclusions can be drawn about treatment options for VRE therapy.

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