Result Publication of Chinese Trials in World Health Organization Primary Registries

Result publication is the key step to improve the transparency of clinical trials.To investigate the result publication rate of Chinese trials registered in World Health Organization (WHO) primary registries.We searched 11 WHO primary registries for Chinese trials records. The progress of each trial was analyzed. We searched for the full texts of result publications cited in the registration records. For completed trials without citations, we searched PubMed, Embase, Chinese Biomedical Literature Database (Chinese), China Knowledge Resource Integrated Database, and Chinese Science and Technology Periodicals Database for result publications. The search was conducted on July 14, 2009. We also called the investigators of completed trials to ask about results publication.We identified 1294 Chinese trials records (428 in ChiCTR,743 in clinicaltrials.gov,55 in ISRCTN, 21 in ACTRN). A total of 443 trials had been completed. The publication rate of the Chinese trials in WHO primary registries is 35.2%(156/443).The publication rate of Chinese trials in clinicaltrials.gov, ChiCTR, ISRCTN, and ACRTN was 36.5% (53/145), 36.3% (89/245), 26.0%(9/44), and 55.6%(5/9), respectively. The publication rate of trials sponsored by industry(23.8%) was lower than that of sponsored by central and local government(31.7%), hospital(35.1%), and universities (40.7%). The publication rate for randomized trials was higher than that of cohort study and case-control study (33.2% versus 16.7%, 22.2%). The publication rate for interventional studies and observational studies was similar(33.4% versus 33.3%).The publication rate of the registered Chinese trials was low, with no significant difference between ChiCTR and clinicaltrials.gov. An effective mechanism is needed to promote publication of results for registered trials in China

Antihypertensive treatment among inpatients with hypertension at Anhui Provincial Hospital in China: a cross-sectional study

The aim of this study was to assess the prescribing pattern of antihypertensive treatment among inpatients with uncomplicated and complicated hypertension at Anhui Provincial Hospital (First Class Public Hospital) in the central region of China in accordance with the recommendations of current international guidelines. A retrospective cross-sectional study was performed from 1 January to 31 December, 2009. A total of 2010 hypertensive inpatients were included. Among 683 inpatients receiving monotherapy, calcium channel blockers (CCBs) were the most frequently drugs used in uncomplicated hypertensive patients (57.41 %) and those with stroke (61.73 %). Beta-blockers (BBs) (27.90 %) and angiotensin-converting enzyme inhibitors (ACEIs, 26.17 %) were the preferred agents in hypertensive patients with coronary heart disease (CHD). Among 1327 inpatients with combination therapy, two-drug regimen was the most popular, except for the hypertensive patients with stroke. The pattern of antihypertensive utilization appears to be partly in accordance with the recommendations of international guidelines. There was a tendency to use CCBs in hypertensive patients with stroke, whereas BBs and ACEI were the most prescribed in those with CHD.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Statistical optimisation of process variables and large-scale production of Metarhizium rileyi (Ascomycetes: Hypocreales) microsclerotia in submerged fermentation

Microsclerotia (MS) formation was successfully induced in Metarhizium rileyi (Ascomycetes: Hypocreales) in liquid culture. To optimise the process variables of liquid fermentation, we first used a two-level fraction design to confirm the variables, including inoculum density, initial pH, shaker speed, and temperature, affecting M. rileyi MS production. Three variables were found to be important. Subsequently, a 23 full factorial central composite design (CCD) and response surface methodology were applied to ascertain the optimal level of each variable. A second-order polynomial was determined and shaker speed and inoculum density were found to be the primary variables affecting MS yields. Finally, we realised and optimised M. rileyi MS submerged fermentation based on previous findings. A maximum MS yields (3.84 × 104 MS/mL) were recorded in submerged fermentation at an initial pH of 5.5, growth temperature of 26°C, inoculum density of 10%, higher aeration rate (150 rpm in the initial 3 days and 200 rpm in the subsequent 3 days), and higher agitation rate of 800 L/h sterile air

Characterization and Determination of the Alkaloid Metabolites of Evodiae fructus in Rat Urine by Liquid Chromatography-Tandem Mass Spectrometry Detection

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Interaction Modeling and Stability Analysis of Gridforming Energy Storage System Based on SISO Transfer Functions

With the rapid expansion of photovoltaic (PV), gridforming energy storage systems (GFM-ESS) have been widely employed for inertia response and voltage support to enhance the dynamic characteristics. Converters with different synchronization methods represent significant differences in dynamic behavior. The interactions between grid-forming (GFM) and grid-following (GFL) devices with multi-time scale control may lead to small-signal instability in hybrid systems. This paper investigates a grid-connected system comprising a grid-forming energy storage system and a grid-following PV system (GFL-PV). Based on single-input-single-output (SISO) transfer functions, a dynamic interaction model for the PV-ESS system is established. Combining the open-loop transfer functions of full-loop and subloop, the proposed model reveals how GFM-ESS modifies the dynamic characteristics of GFL-PV under weak grid conditions. Subsequently, the impact of different control loops and parameters on the small-signal stability of the system is analyzed. The stability margins of both devices are also compared through the SISO model. Electromagnetic transient simulation results in MATLAB/Simulink and experiments validate the effectiveness of the proposed models and analyses

A Highly Efficient Channel Sounding Method Based on Cellular Communications for High-Speed Railway Scenarios

An efficient channel sounding method using cellular communication systems is proposed for high-speed railway (HSR) propagation environments. This channel measurement technique can be used conveniently to characterize different HSR scenarios, which can significantly improve the measurement efficiency. Based on downlink signals of wideband code division multiple access (WCDMA) and the long term evolution (LTE), principles and methodologies of HSR channel sounding are presented. Using the WCDMA signal, a measurement campaign is conducted in real-world HSR scenarios and statistical characterizations are provided using a radio network analyzer. Due to the limits of the radio network analyzer, afterwards, a software defined radio (SDR)-based channel data recorder is developed allowing users to collect the signals from different wireless cellular systems. Especially, the estimation accuracies are validated in lab by the faded signals emitted from a vector signal generator. The results show that the channel data recorder provides a particularly good match to the configured fading channels. Therefore, this measurement method can be employed to investigate the HSR channel, and to establish the channel models under the various HSR scenario