scholarly journals Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiqian Yang ◽  
Hesong Xiao ◽  
Yi Zeng ◽  
Liangliang Huang ◽  
Ke Ji ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Intestinal Flora ◽  
World Health ◽  
Control Group ◽  
Metagenomic Sequencing ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Faecalibacterium Prausnitzii ◽  
Health Organization

Study Objectives. To study the relationship between perimenopausal insomnia (PI) and intestinal flora and the potential mechanism of Tianwang Buxin granules (TWBXG) in exerting its clinical efficacy. Methods. The subjects included 13 PI patients from the Hubei Provincial Hospital of TCM, Hubei University of TCM, and Wuhan Traditional Chinese Medicine Hospital, and the corresponding noninsomniac spouses of the patients were selected as controls. TWBXG was continuously administered for 4 weeks. The feces of PI patients and their noninsomniac spouses before and after treatment with TWBXG were collected. The intestinal flora composition of each group was detected by metagenomic sequencing, and the efficacy of TWBXG was evaluated by the PSQI scale. Results. Compared with the control group, the model group showed an increase in the abundance of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum, while those of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii were decreased. Compared with pretreatment, the PSQI score was significantly reduced ( P < 0.05 ), the abundance of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii increased, and that of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum decreased after treatment. However, there was still a certain gap in the abundance of related flora in the treatment group compared with the control. Conclusion. PI is associated with disturbances in the intestinal flora and is mainly related to the disorders of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, Blautia obeum, Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii. TWBXG can effectively treat PI, and its effect may be achieved by regulating the disordered intestinal flora. Clinical Trials. The study was registered in the Chinese clinical trial registry and approved by the World Health Organization clinical trial registration platform (Effects of the modified Tianwang Buxin granule and modified Tianwang Buxin decoction pieces on insomnia: a randomized, controlled trial, ChiCTR-IPR-17011549).

scholarly journals Progress in trial registration in Latin America and the Caribbean, 2007–2013

2017 ◽  
Vol 41 ◽  
pp. 1 ◽  
Author(s):  
Pablo Rodríguez-Feria ◽  
Luis Gabriel Cuervo
Keyword(s):  
Clinical Trial ◽  
Latin America ◽  
Trial Registration ◽  
World Health ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Publication Rates ◽  
Clinical Trial Registries ◽  
The Caribbean ◽  
Health Organization

This descriptive study identifies trends in clinical trial registration in the World Health Organization International Clinical Trial Registry Platform (ICTRP) for Latin America and the Caribbean (LAC), from 2007–2013, and provides adjusted estimates for registration rates by population and publications (2007–2011). Trends and data are presented by subregion and language in interactive graphs, including annual registration rates by population (2007–2011) and publications (LILACS and MEDLINE) listed in SCIENTI Network (Science and Technology Indicators). Of the 11 945 clinical trials involving LAC countries, 8 282 were in South America, with Brazil leading at 4 070 (49%); 2 421 in North and Central America, with Mexico leading at 1 886 (78%); and 1 242 in the Caribbean, with Puerto Rico leading at 857 (69%). After adjusting by population and publication rates Chile, Panama, Argentina, and Peru led registration rates per 1 million inhabitants. Variations in the number of trials per year are quite substantial. Clinical trial registration increased in a steady yet inconsistent way. The implementation of the Policy on Research for Health has been followed by an increase in countries that require registration and have established clinical trial registries. However, there is room for improvement in adherence throughout LAC. Trial registration is offered gratis by Brazilian, Cuban, Peruvian, and United States registries, among others.

scholarly journals A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

2021 ◽  
Author(s):  
Xingqu Chen ◽  
Linji Li ◽  
Li Yang ◽  
Aijiao Li ◽  
Miao Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Postoperative Cognitive Dysfunction ◽  
Control Group ◽  
Neurocognitive Disorder ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD).Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P＜0.001, at 7th day) (1% vs 21.1%, P＜0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P＜0.001). The postoperative hospitalisation time （9.99 vs 12.41, P＜0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463. http://www.chictr.org.cn/showproj.aspx?proj=33065

scholarly journals The effect of Moringa oleifera capsule in increasing breastmilk volume in early postpartum patients: A double-blind, randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0248950
Author(s):  
Siraphat Fungtammasan ◽  
Vorapong Phupong
Keyword(s):  
Clinical Trial ◽  
Moringa Oleifera ◽  
Controlled Trial ◽  
World Health ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Early Postpartum ◽  
Moringa Oleifera Leaves ◽  
Health Organization ◽  
Postpartum Mothers

Moringa oleifera is an herbal galactagogue that has been used to increase the volume of breastmilk. Few studies have evaluated the effect of Moringa oleifera in breastfeeding. There are conflicting data whether it can increase the volume of breastmilk or not. Thus, the objective of this study is to evaluate the efficacy of Moringa oleifera leaves in increasing the volume of breastmilk in early postpartum mothers. A randomized, double-blind, placebo-controlled trial will be conducted. The outcomes of this study will provide the data of Moringa oleifera as an herbal medication to increase the volume of breastmilk. This information will be used to increase the rate of exclusive breastfeeding for the first 6 months as recommended by the World Health Organization. Clinical trial registration This clinical trial was registered at ClinicalTrials.gov (Clinical trials registration: NCT04487613).

scholarly journals A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

2021 ◽  
Author(s):  
Xingqu Chen ◽  
Linji Li ◽  
Li Yang ◽  
Aijiao Li ◽  
Miao Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Postoperative Cognitive Dysfunction ◽  
Control Group ◽  
Neurocognitive Disorder ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD). Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P＜0.001, at 7th day) (1% vs 21.1%, P＜0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P＜0.001). The postoperative hospitalisation time （9.99 vs 12.41, P＜0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463.http://www.chictr.org.cn/showproj.aspx?proj=33065

scholarly journals Efficacy of an Internet-Based Intervention for Subclinical Depression (MoodBox) in China: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 11 ◽  
Author(s):  
Xu Chen ◽  
Xiaolong Zhang ◽  
Xuequan Zhu ◽  
Gang Wang
Keyword(s):  
Clinical Trial ◽  
Intervention Program ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Alternative Treatment Option ◽  
Subclinical Depression

Background: Subclinical depression is a prevalent mental health problem and increases the incidence of the onset of major mood disorders, such as major depressive disorder (MDD). Psychological interventions have been proved to be effective for reducing depressive symptoms for people with subclinical depression and can prevent the onset of MDD. However, people have limited access to face-to-face psychotherapy. Internet-based psychological intervention is an alternative treatment option. The aim of the study is to evaluate the efficacy of MoodBox, an online psychological intervention program, for subclinical depression.Methods: This study is a multicenter, randomized, controlled, non-blinded superiority study with three parallel groups. A total of 435 first-year university students with subclinical depression will be recruited. Eligible participants will be randomly assigned to the MoodBox group, the online psychoeducation group, and the naturalistic observation group at a ratio of 1:1:1. The intervention period is 8 weeks, and participants will be continuously followed up for 1 year. The primary outcome of the study is the efficacy of the intervention, defined as measured by the Patient Health Questionnaire (PHQ-9).Discussion: This is the first study to innovatively develop and test an intervention to improve psychological well-being and decrease the incidence of MDD in a subclinical depression population in China. Once proven effective and acceptable, MoodBox could be potentially integrated into the routine clinical service to facilitate the management for people with subclinical depression.Clinical Trial Registration: The trial is registered with the Chinese Clinical Trial Registry on 21 July 2020 (No. ChiCTR2000034826).

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals TELENURSING FOR THE CONTROL OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING: A RANDOMIZED CLINICAL TRIAL

2019 ◽  
Vol 28 ◽  
Author(s):  
Andressa Carneiro França ◽  
Andrea Bezerra Rodrigues ◽  
Maria Isis Freire de Aguiar ◽  
Renan Alves Silva ◽  
Fernanda Macedo Cartaxo Freitas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Nursing Intervention ◽  
Nausea And Vomiting ◽  
Rank Test ◽  
Control Group ◽  
Telephone Intervention ◽  
Clinical Trial Registry ◽  
Experimental Group ◽  
Antineoplastic Chemotherapy

ABSTRACT Objective: to verify the effectiveness of telenursing in the control of nausea and vomiting induced by antineoplastic chemotherapy. Method: a randomized controlled trial of 61 cancer patients undergoing outpatient chemotherapy treatment, randomized into experimental group and control group. Nausea and vomiting were evaluated by the instrument Multinational Association on Supportive Care in Cancer. The telephone intervention was performed four times after chemotherapy. To verify the effects of this on the variables, the Mann-Whitney test and Student's t-test were used. Wilcoxon signed-rank test was applied to confirm the hypothesis of differences in the pre- and post-test intragroup scores. Results: the groups were homogeneous regarding sociodemographic and clinical characteristics. The experimental group showed a statistically significant reduction in the occurrence of nausea (p=0.0089), in the degree of nausea, in two moments, between 24 hours and three days, and three days and five days (p=0.007 and p=0.009, respectively), in the occurrence of vomiting (p=0.008) and in the number of vomiting episodes (p=0.020). Conclusion: telephone intervention is a potential nursing intervention to reduce nausea and vomiting associated with antineoplastic chemotherapy. Brazilian Clinical Trial Registry: RBR-6s8qm5.

scholarly journals Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sarai Mirjam Keestra ◽  
Florence Rodgers ◽  
Daphne Lenz ◽  
Rhiannon Osborne ◽  
Till Bruckner ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Median Number ◽  
World Health ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Link Type ◽  
The Us ◽  
Health Organization ◽  
The Uk

AbstractClinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017–2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trials-tracker.com) for clinical trials registered on ClinicalTrials.gov. This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov. The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov: (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions’ reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.

scholarly journals A Single-Center Retrospective Study of the Impact of Thyroid Cancer on the Malignant Risk of Contralateral TI-RADS 3 and 4 Nodules

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Confounding Factors ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
The Difference ◽  
The Impact ◽  
Experimental Group

Background. The incidence of thyroid nodules increases in the general population. Similarly, we have also seen a dramatic increase in the number of thyroid surgeries. However, the mortality rate of thyroid cancer remained stable or even decreased. The purpose of our study was to investigate whether thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. Methods. We conducted a retrospective cohort study in our institution for all thyroid procedures due to nodules from December 2018 to December 2019. All eligible patients were divided into the experimental group (bilateral nodules) and the control group (unilateral nodules) to assess whether the proportion of malignant nodules was different between the two groups. Multivariate logistic regression analysis was used to control potential confounding factors to investigate whether their differences were statistically significant. Results. A total of 330 patients underwent thyroid surgery, of whom 137 were eligible, including 84 in the experimental group and 53 in the control group. The proportion of malignant nodules was significantly different between the experimental group and the control group (29.8% versus 58.5%, unadjusted OR 0.30, 95% CI: 0.17–0.82, p = 0.001 ). However, after controlling for potential confounding factors, including age ( p = 0.004 ), gender ( p = 0.775 ), and TI-RADS classification ( p ≤ 0.001 ), we found that the difference was not significant (adjusted OR 1.08, 95% CI: 0.39–3.01, p = 0.886 ). Conclusion. There is no evidence that thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. This study has been registered with the Chinese Clinical Trial Registry (clinical trial registration number: ChiCTR2000038611, registration time: September 26, 2020).

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