title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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16S rRNA gene sequencing processing. | We quality controlled dereplicated 16S sequences without primers and denoised them into amplicon sequence variants (ASVs) using the R package DADA2 (v1.20.0) using the pooled settings for denoising and chimera removal ( | PMC10294643 | ||
Estimation of microbial beta diversity. | We calculated weighted UniFrac distances to obtain the pairwise beta diversity, which we further evaluated by the adonis2 function using the R package vegan to test the significance with 999 permutations ( | PMC10294643 | ||
Estimation of microbial alpha diversity. | REGRESSION | We used the R package DivNet to estimate Shannon diversity using ecological network regression models. We employed the function “betta” ( | PMC10294643 | |
Source tracking of microbiota. | To estimate the sources of the infant microbiota at different body sites, we performed bacterial source tracking using FEAST ( | PMC10294643 | ||
Differential abundance analysis. | We used ANCOM to search for differentiated bacterial taxa by randomization group ( | PMC10294643 | ||
Data availability. | Sequencing reads were deposited in the Sequence Read Archive (SRA) under Inclusion and exclusion criteria for the clinical trial. Download | PMC10294643 | ||
ACKNOWLEDGMENTS | INFECTIOUS DISEASES, LUNG, ALLERGY, BLOOD, HEART | We acknowledge Quest Diagnostics for their support of this study (maternal screening labs). Study data were collected and managed using REDCap electronic data capture tools hosted at the Inova Health System.Funding was provided by National Institute of Allergy and Infectious Diseases of the National Institutes of Healt... | PMC10294643 | |
REFERENCES | PMC10294643 | |||
Background | INFLUENZA | The morbidity of influenza in children increased rapidly in decade. Reduning injection (RDN), a small but fine Chinese herbal formula, has antipyretic, antiviral, anti-inflammatory effects. We intend to evaluate the efficacy and safety of RDN for the influenza in children versus Oseltamivir, explore the possible antivi... | PMC10357598 | |
Method | fever | DISEASE, SECONDARY, INFLUENZA | We design a randomized, double-blind, double-dummy, parallel control of positive drug, multi-centre clinical study. According to the formula of mean superiority test, a total of 240 patients with influenza in children will be randomized 1:1 into the experimental group and control group. The experimental group will take... | PMC10357598 |
Discussion | INFLUENZA | The study is launched to evaluate the efficacy and safety of RDN for the treatment of influenza in children and to provide an alternative option for influenza in children. | PMC10357598 | |
Trial registration | This study is registered in ClinicalTrials.gov as NCT04183725, registered on 3 December, 2019. | PMC10357598 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12906-023-04037-1. | PMC10357598 | ||
Keywords | PMC10357598 | |||
Introduction | fever, Fever | INFLUENZA A, VIRUS, INFLUENZA, INFLUENZA | Influenza, a negative-strand RNA virus of the Orthomyxoviridae family, is classified into influenza A, B and C viruses (IAV, IBV and ICV). Specially, with its “reassortment” of segmented genomes [Fever, occurring in 95% of influenza children, is the most salient sign, 59% of children 3 years has fever 39.0℃ [Reduning (... | PMC10357598 |
Method | PMC10357598 | |||
Study design | INFLUENZA | This is a randomized, double-blinded, double-dummy, parallel control of positive drug, multi-centre clinical study. The trial will be conducted in ten centers at China and collaborate with hospitals including Children’s Hospital Of Soochow University, Anhui Provincial Children’s Hospital, Qilu Children’s Hospital of Sh... | PMC10357598 | |
Sample size estimation and randomization | INFLUENZA | Taking time of temperature recovery as clinical main efficacy indicator, we calculate two groups’ sample size using mean superiority test formula. According to data of efficacy evaluation about adult influenza treating with RDN and Oseltamivir in the early stage, the per protocol set (PPS) of time of temperature recove... | PMC10357598 | |
Blinding | taste, smell and packaging of the simulant, CRF | ADVERSE EVENTS, CRF, EMERGENCY, BLIND | This is a double-blind (patients and clinicians are blinded) and double-dummy study. A two-stage blind design is adopted. The first stage was the group corresponding to number of each case (such as group A, group B) and the second stage was the intervention corresponding to each group (experimental group or control gro... | PMC10357598 |
Eligibility criteria | The diagnostic criteria will be formulated from epidemiological history, clinical manifestations and laboratory diagnosis according to | PMC10357598 | ||
Inclusion criteria | ;Patients | VIRUS, INFLUENZA |
Patients get influenza within 48 h with positive results of rapid defection for virus antigen.Apart from general influenza symptoms, patients’ temperature before study is over 38℃;Patients’ age is between 2 and 14 years and informed consents (from guardian or patient themselves) is got. | PMC10357598 |
Exclusion criteria | allergic, infections, immunodeficiency, virus infection | INFLUENZA, VIRUS INFECTION, MYCOPLASMA INFECTION, INFECTIONS, IMMUNODEFICIENCY, SEVERE MALNUTRITION |
Patients is not common influenza (severe or critical) or concomitant other respiratory or pulmonary infections;Patients is not virus infection (mycoplasma infection or bacterial infection);Patients’ laboratory examination results such as serum creatinine (SCR), alanine aminotransferase (ALT) or aspartate aminotransfer... | PMC10357598 |
Exit criteria | CRF | ADVERSE REACTIONS, CRF, BLIND, COMPLICATIONS | Patients will leave the trial when one of the following criteria is met:
The symptoms of patients get worse after 3 days of medication;Some comorbidities, complications or special physiological changes occur during the test;Patients with poor compliance don’t reach 80% of the prescribed amount should be used in the tri... | PMC10357598 |
Suspension criteria | mistakes |
Serious problems about safety occur in the trial;The curative efficacy of drugs is too poor or even ineffective and has no clinical value in the trial;Severe mistakes of clinical trial protocol are founded that is difficult to evaluate the efficacy of the drug; or obvious deviation occur in the progress of implementat... | PMC10357598 | |
Elimination criteria |
Patients do not meet the inclusion criteria are founded after enrollment;Drugs out of prescribed plan are used in the trial;Cases no medication after enrollment;Cases no evaluation or record about medication. | PMC10357598 | ||
Informed consent | The participants are between 2 ~ 14 years old. After a full explanation by the clinicians, written informed consent from participants (or their parent or legal guardian in the case of children under 16) will be obtained before intervention [ | PMC10357598 | ||
Interventions | All researchers are clinical doctors and they will receive standardized training before starting trial. The experimental drug is RDN and the control drug is Oseltamivir. RDN simulant and Oseltamivir simulant have no active ingredients, the former is intravenous drip with normal saline (NS) or grape sugar (GS) avoiding ... | PMC10357598 | ||
Discontinuation | RECURRENCE | Clinical symptoms and signs have no improvement or aggravation compared with those before enrollment after taking the medicine for 3 days or more. That needs to switch to another treatment and stop the medication. After completing the post-treatment evaluation and related laboratory tests, this case is declared over an... | PMC10357598 | |
Concomitant | CRF | ADVERSE EVENTS, SECONDARY, CRF | Drugs out of curative plan such as heat-clearing and detoxicating traditional Chinese medicine and oral or intravenous hormone that maybe affect the effect of Oseltamivir shall not be used. When taking antipyretic and analgesic drugs necessarily, the usage and dosage of antipyretic and analgesic drugs are recorded as o... | PMC10357598 |
Follow-up | All included patients will be re-evaluated after five days of treatment to assess the efficacy and safety. Patients whose symptoms worsened will receive a supply of relevant medicine and a written withdrawal schedule. | PMC10357598 | ||
Outcomes | By searching for relevant literature [ | PMC10357598 | ||
Primary outcome measure | Time of temperature recovery.
Definition: time when axillary temperature drops below 37.3℃ without repetition after the first use of the drug.Regulation of axillary temperature recording (Mercury thermometer and body temperature measuring instrument): after the first usage in 24 h, the temperature will be measured in t... | PMC10357598 | ||
Secondary Outcome measure | fever | DISEASE, INFLUENZA, REMISSION, COMPLICATIONS, INFLUENZA |
In clinical manifestation, we will record such as time point of fever subside, time point of disease alleviate, degree of disease remission and disappearance rate of individual symptoms;In laboratory examination, we will record the rate of negative conversion of Influenza viral;In treatment, we will record the usage a... | PMC10357598 |
Criteria of comprehensive efficacy | VIRUS, INFLUENZA | Criteria of cure: the curative effect of clinical symptoms reaches the level of cure after finishing medication and the rapid detection for virus antigen of influenza turns negative. All two criteria must be met.Criteria of invalid treatment: the curative effect of clinical symptoms is invalid, aggravated or complicate... | PMC10357598 | |
Safety assessments | anaphylaxis | ANAPHYLAXIS | All participants will undergo the following laboratory examination. Safety assessments include vital signs, blood routine, urine routine, liver function, kidney function and twelve-lead electrocardiogram (ECG). We will judge anaphylaxis according to Assessment of study endpoints is shown in Table
Measurement items and... | PMC10357598 |
Data management | CRF | CRF | CRF will be written by researcher and that will be delivered to the specific data administrators to establish a database after passing the examination of the clinical supervisor. The data on CRF is inputted into the database by two independent data administrator respectively which is reviewed manually, checked by compu... | PMC10357598 |
Data statistic and analysis | PMC10357598 | |||
Data selection | DISEASE | Four datasets will be conducted intention to treat (ITT), full analysis sets (FAS), per protocol set (PPS), and safety analysis set (SS). ITT is conducted for efficacy and AEs. FAS refers to the ideal set of participants who are as close as possible to the principle of intention to treat and is obtained after removing ... | PMC10357598 | |
Statistical method | Data analysis will be performed by professional statisticians using SAS 9.1.3. For measurement data, Group t test or Wilcoxon rank sum test will be used for comparison between groups; for counting data, χ | PMC10357598 | ||
Analysis contents |
List the frequency of cases enrolled, violated and dropped out;List the details of cases of violation, dropout, low compliance, time-window violation, out of protocol drug usage.List the datasets for analysis.Comparability analysis: compare demographic data and other baseline indicators to measure the balance of each ... | PMC10357598 | ||
Quality control | PMC10357598 | |||
Measures of quality control | Sponsor and researchers will adopt standard operating procedures (SOP) to ensure implementation of quality control and quality assurance systems for clinical trials. We will verify all observations and findings to make sure each conclusion in clinical trial deriving from original data. Meanwhile we will conduct quality... | PMC10357598 | ||
Training of investigators | Supervisor with each sub-center will conduct clinical trial training for researchers before starting trials. They will know experimental drug’s nature, function, efficacy and safety (including related information before marketing), and any new information about the drug that finding during the trial. | PMC10357598 | ||
Enhancement of compliance of patients | CRF | CRF |
Researchers will conduct informed consent carefully to ensure subjects understand experimental requirements fully and comply to trial. They should know that the sponsor will provide free trial medication, laboratory examination fees and so on.Using dose counting method monitors subjects compliance. Compliance = actual... | PMC10357598 |
Monitoring of clinical trials | CRF | CRF | The sponsor appoints supervisor. Supervisor will visit trial hospitals on-site regularly to guarantee clinical protocol’s implementation strictly, and check original data to ensure it is identical with CRF. | PMC10357598 |
Audit of clinical trials | CRF | CRF | The drug supervision and administration department and sponsor will entrust inspectors to conduct inspection systematically to ensure the execution of the trial consistent with protocol, and the data reported by the sub-center is identical with CRF or other original records. The audit will be carried out by personnel w... | PMC10357598 |
Discussion | INFLUENZA | Influenza is getting more and more serious these years and early antiviral treatment can maximize clinical benefits [There are two limitations in the study. One is that children cannot express their discomfort symptoms well; another is the results of clinical symptom record table might have subjective factors. | PMC10357598 | |
Acknowledgements | The assistance and efforts of every researchers in this trial deserve gratitude. | PMC10357598 | ||
Authors’ contributions | WL | WL and XY conceived the project. WL contributed knowledge of core outcome set development and wrote the protocol. XY provided supervision for all aspects of the project. YS wrote the manuscript. WL and XY reviewed the manuscript. All authors have read and approved the final manuscript. | PMC10357598 | |
Funding | Z0687 | This trial is supported financially by National Natural Science Foundation of General Program (81973982), National Key R&D Program of China (2018YFC1707400) and Fundamental Research Funds for the Central public welfare research institutes (Z0687). | PMC10357598 | |
Data Availability | The data will be available when collected. | PMC10357598 | ||
Declarations | PMC10357598 | |||
Competing interests | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10357598 | ||
Ethics approval and consent to participate | The trial obtained ethical clearance from Ethics Committee of The First Affiliated Hospital of Henan University of Chinese medicine. The participants are between 2 ~ 14 years old, we will comply to the | PMC10357598 | ||
Consent for publication | Not applicable. | PMC10357598 | ||
Trial status | The study is currently at the systematic literature review stage. | PMC10357598 | ||
Abbreviations | Reduning injectionInfluenza-like illnessadverse reactionadverse eventnormal salinegrape sugarelectrocardiogramthe Medical Dictionary for Regulatory Activitiesblood pressureheart ratepulsecase report formper protocol setintention to treatfull analysis setssafety analysis setCochran Mantel Haenszelstandard operating proc... | PMC10357598 | ||
References | PMC10357598 | |||
Results | PMC10014105 | |||
Apremilast reduces binge-like drinking behavior and the motivation for ethanol in a genetic risk model of drinking to intoxication. | AUDs | To test whether PDE4 inhibition reduces binge-like alcohol drinking, we administered apremilast to selectively bred “High Drinking in the Dark” (replicate HDID-1 and HDID-2) mice of both sexes prior to measuring limited access drinking using the widely adopted “Drinking in the Dark” (DID) assay (Next, we found that 2 c... | PMC10014105 | |
The NAc is a critical site of action for reduction of drinking by apremilast. | Recent evidence suggests that increased expression of PDE4 subtypes, namely PDE4b, is linked to human AUD (Next, we sought to determine how acute treatment with apremilast altered functional activity in NAc D1 MSNs and D2 MSNs, which together comprise greater than 90% of the neurons in the NAc and are the 2 major outpu... | PMC10014105 | ||
Apremilast reduces dependence-induced escalations in alcohol intake in C57BL/6J mice. | alcohol dependence | To test whether apremilast reduces harmful drinking associated with alcohol dependence, 2 models of dependence-induced escalations in ethanol drinking were used in C57BL/6J mice, an established high-drinking strain from which both methods were developed (Because dependence in individuals with AUD is characterized by ch... | PMC10014105 | |
Individuals with AUD consume fewer drinks per day when treated with apremilast. | nausea and vomiting, DSM-5 | DISORDERS | A phase IIa double-blind, placebo-controlled POC study was conducted with the aim of clinically validating the effect of apremilast on decreasing alcohol intake in preclinical models of AUD. It was hypothesized that individuals with AUD who were treated with apremilast would consume significantly fewer standard drinks ... | PMC10014105 |
Discussion | ADVERSE EFFECTS | We leveraged gene expression profiles of drinking to intoxication to identify compounds that might be repurposed to reduce excessive alcohol drinking characteristic of AUD. The FDA-approved PDE4 inhibitor apremilast was identified as the most promising target for repurposing, given a lower likelihood of severe PDE4 adv... | PMC10014105 | |
Methods | Further information can be found in | PMC10014105 | ||
Data availability. | The drinking, behavioral, gene expression, and electrophysiological data supporting the findings of this study have been deposited and are available in the Figshare digital repository (10.6084/m9.figshare.14687358). | PMC10014105 | ||
Statistics. | Significance was set at an | PMC10014105 | ||
Study approvals. | For animal studies, all procedures were approved by the local Institutional Animal Care and Use Committee and were conducted in accordance with the NIH | PMC10014105 | ||
Author contributions | RA | Preclinical: ARO, KBG, RA Mangieri, RA Morrisett, AJR, and MFL conceived and performed the preclinical experiments, performed analyses, and wrote the manuscript. EJF, AT, KGT, and HCA performed the preclinical experiments. PM analyzed preclinical data. JCC, MR, and HCB conceived the preclinical experiments and edited t... | PMC10014105 | |
Supplementary Material | PMC10014105 | |||
01/19/2023 | In-Press Preview | PMC10014105 | ||
03/15/2023 | Electronic publication | PMC10014105 | ||
Apremilast reduces binge-like drinking behavior and ethanol motivation in mice selectively bred for drinking to intoxication. | ( | PMC10014105 | ||
Apremilast reduces binge-like drinking behavior through increasing excitability of D1, but not D2, MSNs. | ( | PMC10014105 | ||
Apremilast reduces dependence-induced escalations in ethanol drinking in C57BL/6J mice. | ( | PMC10014105 | ||
Apremilast reduces alcohol intake in non–treatment-seeking individuals with an AUD. | ( | PMC10014105 | ||
1. Introduction | obesity, Obesity, hypertension | OBESITY, OBESITY, OBESE, HYPERTENSION, DISEASES | (1) Background: The ‘Living Better’ web-based programme has shown short- and long-term benefits for body composition and psychological variables in obese patients with hypertension by promoting a healthier lifestyle. To further explore the potential of this programme, in this work we aimed to explore the possible effec... | PMC10097159 |
2. Materials and Methods | PMC10097159 | |||
2.1. Study Design | The present study was a prospective, single-centre, randomised clinical trial that followed the ethical guidelines established in the Declaration of Helsinki and was approved by the Hospital of Sagunto Human Ethics Committee. The trial was registered at ClinicalTrials.gov (NCT04739033) and conducted according to the de... | PMC10097159 | ||
Eligibility Criteria | hypertension, overweight | HYPERTENSION | Eligible participants were all adults/older adults aged between 18 and 75 years with hypertension and who were overweight (BMI > 24.9 kg/m | PMC10097159 |
2.2. Procedure | obesity, Hypertension | OBESITY, HYPERTENSION, HYPERTENSION | This work took place at the Hospital Universitario de Sagunto (Valencia, Spain) between February and June 2021. All participants from the hospital’s Hypertension and Vascular Risk Unit with the obesity–hypertension phenotype who had not previously participated in the Living Better studies [ | PMC10097159 |
2.3. Intervention | obesity | OBESITY, HYPERTENSION | Living Better is a computerised intervention that is self-administered through the internet. The treatment protocol consists of 9 modules and incorporates psychological strategies that encourage a healthy lifestyle by progressively establishing healthy eating habits and increasing the level of PA, as recommended by int... | PMC10097159 |
2.4. Outcome Measures | The patient’s age, sex, and the number of visits to the specialist were all registered before the randomisation process was implemented. Furthermore, the variables listed below were recorded via the same platform as the intervention programme. | PMC10097159 | ||
2.5. Primary Outcome | Because of the indications of the health authorities and hospital regulations related to the COVID-19 pandemic, the participants were instructed to register their BMI in a pharmacy near their homes. They were also instructed to go to the pharmacy while fasting to avoid the possibility that any food or drink ingested co... | PMC10097159 | ||
2.6. Secondary Outcomes | Physical activity levels were evaluated using the abbreviated version of the International Physical Activity Questionnaire (IPAQ short form), which has been validated for use in the Spanish population [Motivation towards physical activity (PA) was evaluated using the validated Spanish version of the Behavioural Regulat... | PMC10097159 | ||
2.7. Statistical Analysis | A sample size of 50 patients per group was required to achieve a statistically significant 0.85-point BMI reduction between the estimated mean and the sampling mean, in line with previous study data [ | PMC10097159 | ||
3. Results | We screened 557 participants in this randomised controlled trial. A total of 425 individuals were not allocated for randomisation because they did not respond to the invitation by postal mail (The results of the two-way ANOVA analyses showed significant time-by-group interaction effects for the intrinsic motivation to ... | PMC10097159 | ||
4. Discussion | obesity | OBESITY, HYPERTENSION | This study analysed the influence of the audiovisual presence of patients’ own specialist doctor in an online intervention programme designed to promote a healthy lifestyle, adherence to the Mediterranean diet, motivation to change eating habits, eating behaviour, and motivation towards PA in patients with an obesity–h... | PMC10097159 |
5. Conclusions | Our findings suggest that the presence of patients’ own doctor in the audiovisual content of an online intervention programme aimed at promoting a healthy lifestyle did not show significant additional benefits in terms of BMI, levels of physical activity, adherence to the Mediterranean diet, eating behaviour, or motiva... | PMC10097159 | ||
Author Contributions | M.R.-C., R.M.B., E.R. and J.F.L. conceived this research methodology and wrote/prepared the original draft. P.M.-B. and R.H. were responsible for the methodology. M.R.-C. and J.F.L. conducted a formal analysis. R.M.B., E.R. and J.F.L. managed the investigation. P.M.-B., M.R.-C. and R.H. reviewed and edited the manuscri... | PMC10097159 | ||
Institutional Review Board Statement | This study, where human participants were involved, was approved by the Human Research Ethics Committee at the Hospital Universitario de Sagunto and followed the ethical guidelines established in the Declaration of Helsinki. It was also reviewed and approved on 6 June 2019 by the University CEU-Cardenal Herrera Ethics ... | PMC10097159 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10097159 | ||
Data Availability Statement | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10097159 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10097159 | ||
References | PROGRESSION | Progression of the participants through the trial.Pre- and post-differences between the experimental and the control groups in terms of intrinsic motivation (Baseline characteristics of the study participants.Data presented as mean (SD).Results of the 2 × 2 ANOVA tests.Data presented as mean (SD). | PMC10097159 | |
Objective | This study compared in vitro the anastomosis cleaning efficacy of different irrigant activation techniques at different levels; control group non-activation (NA), passive ultrasonic irrigation (PUI) using Irrisafe, and EDDY sonic activation. | PMC10007824 | ||
Methods | Sixty anastomosis-containing mesial roots of mandibular molars were mounted in resin, sectioned at 2, 4, and 6 mm from the apex. Then reassembled and instrumented in a copper cube. For the irrigation technique roots were randomly divided into 3 groups ( | PMC10007824 | ||
Results | All three irrigation techniques significantly improved anastomosis cleanliness ( | PMC10007824 | ||
Conclusions | Irrigant activation improves anastomosis cleanliness. EDDY was the most efficient in cleaning anastomoses located in the critical apical part of the root canal. | PMC10007824 | ||
Clinical relevance | APICAL PERIODONTITIS | Cleaning and disinfection of the root canal system followed by apical and coronal sealing is the key for healing or prevention of apical periodontitis. Remnants of debris and microorganisms retained within the anastomoses (isthmuses), or other root canal irregularities may lead to persistent apical periodontitis. Prope... | PMC10007824 |
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