Clinical Trial Test Using Chinese Trial Number

2020 ◽  
Keyword(s):  
Clinical Trial ◽  
Trial Number ◽  
Trial Test

scholarly journals Testing the Sensitivity and Specificity of ICU Patients and Diagnose Statistics Hypothetical Errors

2019 ◽  
Vol 8 (10) ◽  
pp. 1042-1045
Keyword(s):  
Experimental Data ◽  
Clinical Trial ◽  
Sensitivity And Specificity ◽  
False Negative ◽  
Theoretical Concept ◽  
Statistical Hypothesis ◽  
True Positive ◽  
True Negative ◽  
Icu Patients ◽  
Trial Test

Statistical performance especially for certain information based on data analyse and incorporate clinical trial incomplete observation. The handling statistical hypothesis measure to regulate, type one error and type two errors is related to the assessment of sensitivity and specificity in clinical trial test and experimental data. A theoretical concept is considered two types of errors has been made and measure to find out of False positive, False Negative, True Positive and True Negative. The study presumed to analyse the ICU patient’s condition based on who have admitted in elective or emergency. We are conclude that there is association between types of admission and patient’s status

scholarly journals Changes in global and thalamic brain connectivity in LSD-induced altered states of consciousness are attributable to the 5-HT2A receptor

eLife ◽  
2018 ◽  
Vol 7 ◽  
Author(s):  
Katrin H Preller ◽  
Joshua B Burt ◽  
Jie Lisa Ji ◽  
Charles H Schleifer ◽  
Brendan D Adkinson ◽  
...  
Keyword(s):  
Gene Expression ◽  
Clinical Trial ◽  
Brain Connectivity ◽  
Critical Role ◽  
Resting State Functional Connectivity ◽  
Healthy Human ◽  
Double Blind ◽  
Trial Number ◽  
Rational Development ◽  
Human Participants

Background:Lysergic acid diethylamide (LSD) has agonist activity at various serotonin (5-HT) and dopamine receptors. Despite the therapeutic and scientific interest in LSD, specific receptor contributions to its neurobiological effects remain unknown.Methods:We therefore conducted a double-blind, randomized, counterbalanced, cross-over studyduring which 24 healthy human participants received either (i) placebo+placebo, (ii) placebo+LSD (100 µg po), or (iii) Ketanserin, a selective 5-HT2A receptor antagonist,+LSD. We quantified resting-state functional connectivity via a data-driven global brain connectivity method and compared it to cortical gene expression maps.Results:LSD reduced associative, but concurrently increased sensory-somatomotor brain-wide and thalamic connectivity. Ketanserin fully blocked the subjective and neural LSD effects. Whole-brain spatial patterns of LSD effects matched 5-HT2A receptor cortical gene expression in humans.Conclusions:Together, these results strongly implicate the 5-HT2A receptor in LSD’s neuropharmacology. This study therefore pinpoints the critical role of 5-HT2A in LSD’s mechanism, which informs its neurobiology and guides rational development of psychedelic-based therapeutics.Funding:Funded by the Swiss National Science Foundation, the Swiss Neuromatrix Foundation, the Usona Institute, the NIH, the NIAA, the NARSAD Independent Investigator Grant, the Yale CTSA grant, and the Slovenian Research Agency.Clinical trial number:NCT02451072.

scholarly journals High-intensity training enhances executive function in children in a randomized, placebo-controlled trial

eLife ◽  
2017 ◽  
Vol 6 ◽  
Author(s):  
David Moreau ◽  
Ian J Kirk ◽  
Karen E Waldie
Keyword(s):  
Clinical Trial ◽  
Working Memory ◽  
Cognitive Control ◽  
High Intensity ◽  
Controlled Trial ◽  
Moderate Intensity ◽  
Promising Alternative ◽  
Trial Number ◽  
High Intensity Training ◽  
Intensity Training

Background:Exercise-induced cognitive improvements have traditionally been observed following aerobic exercise interventions; that is, sustained sessions of moderate intensity. Here, we tested the effect of a 6 week high-intensity training (HIT) regimen on measures of cognitive control and working memory in a multicenter, randomized (1:1 allocation), placebo-controlled trial.Methods:318 children aged 7-13 years were randomly assigned to a HIT or an active control group matched for enjoyment and motivation. In the primary analysis, we compared improvements on six cognitive tasks representing two cognitive constructs (N = 305). Secondary outcomes included genetic data and physiological measurements.Results:The 6-week HIT regimen resulted in improvements on measures of cognitive control [BFM = 3.38, g = 0.31 (0.09, 0.54)] and working memory [BFM = 5233.68, g = 0.54 (0.31, 0.77)], moderated by BDNF genotype, with met66 carriers showing larger gains post-exercise than val66 homozygotes.Conclusions:This study suggests a promising alternative to enhance cognition, via short and potent exercise regimens.Funding:Funded by Centre for Brain Research.Clinical trial number:NCT03255499.

scholarly journals Effects of water, sanitation, handwashing, and nutritional interventions on telomere length among children in a cluster-randomized controlled trial in rural Bangladesh

eLife ◽  
2017 ◽  
Vol 6 ◽  
Author(s):  
Audrie Lin ◽  
Benjamin F Arnold ◽  
Andrew N Mertens ◽  
Jue Lin ◽  
Jade Benjamin-Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Telomere Length ◽  
Controlled Trial ◽  
Intervention Group ◽  
Unexpected Finding ◽  
Telomere Attrition ◽  
Trial Number ◽  
Rural Bangladesh ◽  
Geographical Clusters

Background:Shorter childhood telomere length (TL) and more rapid TL attrition are widely regarded as manifestations of stress. However, the potential effects of health interventions on child TL are unknown. We hypothesized that a water, sanitation, handwashing (WSH), and nutritional intervention would slow TL attrition during the first two years of life.Methods:In a trial in rural Bangladesh, we randomized geographical clusters of pregnant women into individual water treatment, sanitation, handwashing, nutrition, combined WSH, combined nutrition plus WSH (N + WSH), or control arms. We conducted a substudy enrolling children from the control arm and the N + WSH intervention arm. Participants and outcome assessors were not masked; analyses were masked. Relative TL was measured at 1 and 2 years after intervention, and the change in relative TL was reported. Analysis was intention-to-treat.Results:Between May 2012 and July 2013, in the overall trial, we randomized 720 geographical clusters of 5551 pregnant women to a control or an intervention arm. In this substudy, after 1 year of intervention, we assessed a total of 662 children (341 intervention and 321 control) and 713 children after 2 years of intervention (383 intervention and 330 control). Children in the intervention arm had significantly shorter relative TL compared with controls after 1 year of intervention (difference −163 base pairs (bp), p=0.001). Between years 1 and 2, TL increased in the intervention arm (+76 bp) and decreased in the controls (−23 bp) (p=0.050). After 2 years, there was no difference between the arms (p=0.305).Conclusions:Our unexpected finding of increased telomere attrition during the first year of life in the intervention group suggests that rapid telomere attrition during this critical period could reflect the improved growth in the intervention group, rather than accumulated stress.Funding:Funded by The Bill and Melinda Gates Foundation.Clinical trial number:NCT01590095.

scholarly journals A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis

eLife ◽  
2016 ◽  
Vol 5 ◽  
Author(s):  
Ming Chao ◽  
Hao Wu ◽  
Kai Jin ◽  
Bin Li ◽  
Jianjun Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lactic Acidosis ◽  
Survival Data ◽  
Clinical Investigation ◽  
Geometric Mean ◽  
Randomized Study ◽  
Objective Response ◽  
Controlled Study ◽  
Trial Number ◽  
Randomized Controlled

Background:Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) study.Methods:The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor.Results:In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit.Conclusions:Bicarbonate markedly enhances the anticancer activity of TACE.Funding:Funded by National Natural Science Foundation of China.Clinical trial number:ChiCTR-IOR-14005319.

scholarly journals A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients’ economic outcomes in Eswatini

eLife ◽  
2020 ◽  
Vol 9 ◽  
Author(s):  
Janina Isabel Steinert ◽  
Shaukat Khan ◽  
Khudzie Mlambo ◽  
Fiona J Walsh ◽  
Emma Mafara ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Time Use ◽  
Living Standards ◽  
Hiv Positive ◽  
Stepped Wedge ◽  
Household Expenditures ◽  
Trial Number ◽  
Art Initiation ◽  
Source Type ◽  
Clinical Trials Registry

Background:Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.Methods:We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.Results:A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.Conclusions:Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.Funding:Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.Clinical trial number:NCT02909218 and NCT03789448.

scholarly journals Identification of human glucocorticoid response markers using integrated multi-omic analysis from a randomized crossover trial

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Dimitrios Chantzichristos ◽  
Per-Arne Svensson ◽  
Terence Garner ◽  
Camilla AM Glad ◽  
Brian R Walker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Council ◽  
Mononuclear Cells ◽  
University Hospital ◽  
Medical Society ◽  
Serious Adverse Events ◽  
Peripheral Blood Mononuclear ◽  
Disease Etiology ◽  
Trial Number ◽  
Clinical Trials Registry

Background:Glucocorticoids are among the most commonly prescribed drugs, but there is no biomarker that can quantify their action. The aim of the study was to identify and validate circulating biomarkers of glucocorticoid action.Methods:In a randomized, crossover, single-blind, discovery study, 10 subjects with primary adrenal insufficiency (and no other endocrinopathies) were admitted at the in-patient clinic and studied during physiological glucocorticoid exposure and withdrawal. A randomization plan before the first intervention was used. Besides mild physical and/or mental fatigue and salt craving, no serious adverse events were observed. The transcriptome in peripheral blood mononuclear cells and adipose tissue, plasma miRNAomic, and serum metabolomics were compared between the interventions using integrated multi-omic analysis.Results:We identified a transcriptomic profile derived from two tissues and a multi-omic cluster, both predictive of glucocorticoid exposure. A microRNA (miR-122-5p) that was correlated with genes and metabolites regulated by glucocorticoid exposure was identified (p=0.009) and replicated in independent studies with varying glucocorticoid exposure (0.01 ≤ p≤0.05).Conclusions:We have generated results that construct the basis for successful discovery of biomarker(s) to measure effects of glucocorticoids, allowing strategies to individualize and optimize glucocorticoid therapy, and shedding light on disease etiology related to unphysiological glucocorticoid exposure, such as in cardiovascular disease and obesity.Funding:The Swedish Research Council (Grant 2015-02561 and 2019-01112); The Swedish federal government under the LUA/ALF agreement (Grant ALFGBG-719531); The Swedish Endocrinology Association; The Gothenburg Medical Society; Wellcome Trust; The Medical Research Council, UK; The Chief Scientist Office, UK; The Eva Madura’s Foundation; The Research Foundation of Copenhagen University Hospital; and The Danish Rheumatism Association.Clinical trial number:NCT02152553.

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