bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and Safety of Modified Bushen Yiqi Formulas(MBYF) as Add-On To Formoterol and Budesonide in The Management of COPD: Study Protocol for A Multi-Center, Double-Blinded, Placebo-Controlled, Parallel-Group, Randomized Clinical Trial
Authors: Kong Qing , Cao Yuxue , Gao Zhen , Sun Jing , Zhang Hongying , Du Yijie , Lv Yubao , Zhou Sihan , Tang Zihui , Liu Baojun , Dong Jingcheng 
Published: June 2021

Abstract
Introduction Inhaled glucocorticoid Corticosteroids(ICS), long-acting β2-adrenoceptor agonists(LABA)and other drugs have limited therapeutic effects on COPD with significant individual differences. Traditional Chinese Medicine (TCM) modified Bushen Yiqi formulas༈MBYF༉demonstrates advantages in COPD management in China. This study aims to confirm the related genes affecting the therapeutic effect in the treatment of COPD and evaluate the efficacy and safety of MBYF as an add-on to budesonide/ formoterol on COPD patients. Methods and analysis In this multicenter, randomized, double-blinded, placebo-controlled, parallel-group study, eligible patients with COPD will randomly receive 360-day placebo or MBYF as an add-on to budesonide/ formoterol in 1:1 ratio, and followed-up bimonthly. The primary outcomes are frequency, times and severity of acute exacerbation of COPD (AECOPD), COPD assessment test (CAT) score, pulmonary function tests(PFTs). The secondary outcomes include the modified medical research council (mMRC) dyspnea scale、six minutes walking test (6MWT)、BODE index、quantitative scores of TCM syndrome、inflammation indexes and hypothalamic pituitary adrenaline (HPA) axis function. We also test the genotype to find the relationship between drugs and efficacy. All the data will be recorded in case report forms(CRFs) and analyzed by SPSS V.20.0. Trial registration number ChiCTR1900026124, Prospective registration. Protocol version 2019-09-15
Randomized Phase II Study of Gemcitabine and S-1 Combination Therapy Versus Gemcitabine and Nanoparticle Albumin-Bound Paclitaxel Combination Therapy in Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015)
Authors: Yamada Daisaku , Kobayashi Shogo , Takahashi Hidenori , Akita Hirofumi , Yamada Terumasa , Asaoka Tadafumi , Shimizu Junzo , Takeda Yutaka , Yokoyama Shigekazu , Tsujie Masanori , Tomokuni Akira , Tanemura Masahiro , Morimoto Osakuni , Murakami Masahiro , Kim Yongkook , Nakahira Shin , Hama Naoki , Sugimoto Keishi , Hashimoto Kazuhiko , Doki Yuichiro , Eguchi Hidetoshi 
Published: June 2021

Abstract
Background: Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in patients with localized PDAC. To date, there is one prospective study providing evidence for the superiority of a neoadjuvant strategy over upfront surgery for localized PDAC. However, which NAC regimen is optimal remains unclear.Methods: A randomized, exploratory trial was performed to examine the clinical benefits of two chemotherapy regimens, gemcitabine plus S-1 (GS) and gemcitabine plus nab-paclitaxel (GA), as NAC for patients with planned PDAC resection. Patients were enrolled after the diagnosis of resectable or borderline resectable PDAC. They were randomly assigned to either NAC regimen. Adjuvant chemotherapy after curative resection was highly recommended for 6 months in both arms. The primary endpoint was tumor progression-free survival time, and secondary endpoints included the rate of curative resection, the completion rate of protocol therapy, the recurrence type, the overall survival time and safety. The target sample size was set as at least 100.Discussion: This study is the first randomized phase II study comparing GS combination therapy with GA combination therapy as NAC for localized pancreatic cancer.Trial registration: This trial began in April 2016 and was registered with the UMIN Clinical Trials Registry (UMIN000021484).
The effect of warm contrast medium and other factors in pain assessment of infertile patients during HSG procedure
Authors: Ersak Burak , Tasci Yasemin , Findik Rahime Bedir , Tugrul Duygu , Tokmak Aytekin , Kokanali Mahmut Kuntay 
Published: June 2021

Abstract
Purpose

To compare pain scores of infertile patients during and after hysterosalpingography (HSG) procedure using visual analoge scale (VAS) between cold and warm contrast medium and to investigate whether using warm contrast can alter spontaneous pregnancy rate.
Methods

Prospective randomized study between March-September 2017. Primary infertile patients undergoing HSG procedure. Patients’ age, body mass index(BMI), history of previous surgery, duration of infertility and pain levels during the most painful menstrual period were recorded. The pain severity was questioned during and at the 30th minute after the procedure using VAS. While patients who underwent HSG using a contrast medium at body temperature 37°C were defined as warm group(n:55), patients who underwent HSG using a contrast medium at room temperature 23°C were defined as cold group(n:55).
Results

There were no significant differences between the groups in terms of age, BMI, duration of infertility, previous surgery and VAS during menstruation. The mean duration of HSG of warm group patients was significantly lower(p = 0.001). Warm group patients’ mean VAS score during and 30 minutes after HSG were significantly lower than in the control group ( 5.3 ± 4.2 vs 7.5 ± 2.0), (1.1 ± 0.9 vs 2.4 ± 1.4), respectively. While severe pain percentage during HSG in warm group was %25.5, it was %66.7 in the control group. In logistic regression analysis, warm and cold groups were only found as significant related factors for severe pain felt during procedure(p < 0.001, OR = 0.19, 95% CI = 0.08–0.46).
Conclusion

The use of contrast media at body temperature during HSG procedure reduces the pain associated with the procedure.
Transcranial DC Stimulation in Patients with Migraine: a study protocol for a randomized clinical trial
Authors: Pimenta Luana Dias Santiago , de Araújo Elidianne Layanne Medeiros , Silva Joyce Poláine dos Santos , França Jamyson Júnior , Brito Pedro Nascimento Araújo , Lopez Luiz Carlos Serramo , Andrade Suellen 
Published: June 2021

Abstract
BackgroundChronic migraine is a disease with a difficult diagnosis and an as yet undefined pathophysiology. Its symptoms affect the quality of life and the daily activities of the individual, leading to momentary disability. This study is a controlled clinical trial of a randomized parallel group that will select patients aged between 18–65 years who are diagnosed with chronic migraine.Methods / DesignThis study will be held at the Aging Studies Laboratory and Neuroscience of the Federal University of Paraíba, where twelve sessions of transcranial direct current stimulation (tDCS) and associated with mindfulness practices will be applied over four weeks (one per week). Muse, a portable electroencephalogram (EEG), will be used to measure brain wave biomarkers before and after the intervention. We will use, at the beginning and end of treatment and one month after the completion of any intervention, the score on the Migraine Disability Assessment (MIDAS) questionnaire as the primary outcome and the scores on the HIT-6 (Headache Impact Test) questionnaire and on the Five Facet Mindfulness Questionnaire (FFMQ-BR) as the secondary outcomes.DiscussionBased on the use of tDCS in patients with chronic pain, and in benefits of Mindfulness practice in these patients, the objective is to evaluate if the mindfulness-associated tD provides satisfactory results in the painful prophylaxis of patients with chronic migraine.Trial registrationClinicaltrials.gov, NCT04219345. Registered 16 September 2019. Retrospectively registered.
Xiao Zheng San Jie Granules in the Treatment of Qi Deficiency and Blood Stasis Syndrome in Patients With Diabetic Kidney Disease Stage IV: Protocol for a Randomised, Double-blind, Placebo-controlled, Multi-centre Trial
Authors: Ai Sinan , Han Yizhen , Gao Yabin , Wang Yaoxian , Zhou Jingwei , Liu Weijing , Han Xueting , Chen Zhenjie , Liu Qingqing , Chen Weihong , Han Mei , Wang Zhen 
Published: June 2021

Abstract
Introduction Diabetic kidney disease (DKD) is a major microvascular complication of diabetes mellitus (DM) and the primary cause of end-stage renal disease. Routine medication might result in adverse effects which limit their usage. Laboratory studies have shown that Xiao Zheng San Jie (XZSJ) granules is effective in reducing the levels of urinary protein and blood creatinine in rats with DKD. Hence, we aim to conduct a clinical trial to determine the efficacy and safety of XZSJ granules among patients with DKD Stage IV, who present with the syndromes of qi deficiency and blood stasis. The purpose of this paper is to report the methodology of this trial.Methods and analysisThis is a randomised, double-blind, placebo-controlled, multi-centre clinical trial. A total of 72 patients with DKD Stage IV who have the syndromes of qi deficiency and blood stasis will be randomly assigned to either intervention or placebo group. In addition to routine medication, the intervention group will be given XZSJ formula (in granules) and the control group will be given placebo for 12-weeks. Data collected at baseline as well as weeks 4, 8 and 12 will be recorded in case report forms and subsequently entered into EpiData 3.1 electronic database. Adverse events will also be documented. Primary outcomes – estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and serum creatinine – will be assessed after 12 weeks. Ethics and disseminationThis trial has been approved by the Research Ethics Committee of Dongzhimen Hospital (DZMEC-KY-2018-60). Informed consent will be obtained from all participants. Results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.DiscussionThis trial might provide information on an effective method for the treatment of DKD, especially for patients who present with the syndromes of qi deficiency and blood stasis. We hope that this trial will serve as a reference for the conception of high-quality Traditional Chinese Medicine trials in the future, which incorporate syndrome diagnosis into the study design.Trial registration Chinese Clinical Trial Registry, ChiCTR1900021391. Registered 18 February 2018, http://www.chictr.org.cn/showproj.aspx?proj=36106.
A Mixed-Methods Study of Multi-Level Factors Influencing Mammography Overuse: Implications for De-implementation.
Authors: Austin Jessica D. , Tehranifar Parisa , Rodriguez Carmen B. , Brotzman Laura , Agovino Mariangela , Ziazadeh Danya , Moise Nathalie , Shelton Rachel C. 
Published: June 2021

Abstract
Background

There is growing concern that routine mammography screening is overused among older women. Successful and equitable de-implementation of mammography will require a multi-level understanding of the factors contributing to mammography overuse.
Methods

This explanatory, sequential, mixed-methods study collected survey data (n = 52, 73.1% Hispanic, 73.1% Spanish-speaking) from women ≥ 70 years of age at the time of screening mammography, followed by semi-structured interviews with a subset of older women completing the survey (n = 19, 63.2% Hispanic, 63.2% Spanish-speaking) and providers (n = 5, 4 primary care, 1 obstetrics and gynecology) to better understand multi-level factors influencing mammography overuse and inform potential de-implementation strategies. We conducted descriptive analysis of survey data and content analysis of qualitative interview data. Survey and interview data were examined separately, compared, integrated, and organized according to Norton and Chambers Continuum of Factors Influencing De-Implementation Process.
Results

Survey findings show that 87.2% of older women believe it is important to plan for an annual mammogram, 80.8% received a provider recommendation, and 78.9% received a reminder in the last 12 months to schedule a mammogram. Per interviews with older women, the majority were unaware of or did not experience overuse and intended to continue mammography screening. Findings from interviews with older women and providers suggest that there are multiple opportunities for older women to obtain a mammogram. Per provider interviews, almost all reported that overuse was not viewed as a priority by the system or other providers. Providers also discussed that variation in mammography screening practices across providers, fear of malpractice, and monetary incentives may be reasons for overuse. Providers identified potential strategies including patient and provider education around harms of screening, leveraging the electronic health record to identify women who may no longer benefit from screening, customizing system-generated reminder letters, and organizing workgroups to develop a standard process of care around mammography screening.
Conclusions

Multi-level factors contributing to mammography overuse are dynamic and reinforced. To ensure equitable de-implementation, there is a need for more refined theories, models, and frameworks for de-implementation with a strong patient-level component that considers the interplay between multilevel factors and the larger care delivery process.
Mobile App And Digital System For Patients After Myocardial Infarction (AfterAMI); Study Protocol For A Randomized Controlled Trial
Authors: Krzowski Bartosz , Peller Michał , Boszko Maria , Hoffman Paulina , Żurawska Natalia , Jaruga Karolina , Skoczylas Kamila , Osak Gabriela , Kołtowski Łukasz , Grabowski Marcin , Opolski Grzegorz , Balsam Paweł 
Published: June 2021

Abstract
Background: Treatment of acute myocardial infarction has been studied and improved over the past years. However, the initial months after myocardial infarction are crucial from the perspective of the patient's prognosis. It is extremely important to take care of all cardiovascular risk factors.Mobile application ‘afterAMI’ supported by a web system is a novel telemedical tool developed to support patients and physicians during cardiac rehabilitation. The application has an educational model with a focus on cardiovascular risk factors and lifestyle after myocardial infarction. Moreover, it offers a module that controls vital signs like blood pressure, heart rate, weight, and many others. Additionally, the application will send reminders for better drug adherence.Methods: A group of 100 patients with myocardial infarction on admission at the 1st Chair and Department and of Cardiology, Medical University of Warsaw, will be recruited into the study. The project aims to assess the impact of the application-supported model of care in comparison with standard rehabilitation. At the end of the study, cardiovascular risk factors will be analysed, along with issues like rehospitalizations, patients' knowledge of risk factors, returning to work, and quality of life. In this prospective, open-label, randomized, single-center study, all 100 patients will be observed for 6 months after discharge from the hospital. Endpoints will be assessed during control visits 1- and 6-months after inclusion into the study.Discussion: This project is an example of a telemedical solution application embracing everyday clinical practices, conforming with multiple international cardiac societies’ guidelines. Cardiac rehabilitation process enhancements are required to improve patients’ prognosis. The evidence regarding the use of the mobile application in the described group of patients is limited and usually covers a small number of participants. The described study aims to discuss whether telemedicine use in this context is beneficial for the patients.Trial registration: ClinicalTrials.gov, NCT04793425, registered 11 March 2022.
Efficacy And Safety Of 5% Lidocaine Patches For Postoperative Pain Management In Patients Undergoing Unilateral Inguinal Hernia Repair: Study Protocol For A Prospective, Double-Blind, Randomized, Controlled Clinical Trial
Authors: Ahn Hong-min , Oh Heung-Kwon , Kim Duck-Woo , Kang Sung-Bum , Koo Bon-Wook , Lee Pyung-Bok 
Published: June 2021

Abstract
Background: Acute postoperative pain is a common complication of inguinal hernia repair. Pain management using local application of anesthetic agents over the skin surrounding the surgical incision may reduce the requirement for other pain medications. Targeted topical analgesics such as 5% lidocaine patches have been known to improve acute and chronic pain. However, the clinical effect of lidocaine patches on postoperative pain after inguinal hernia repair has not been studied, especially in patients undergoing surgery at day surgery units.Methods/design: This is a single-center, prospective, double-blind, randomized, controlled clinical trial. Participants with unilateral inguinal hernia will be randomized to the lidocaine patch group or the placebo patch group. Based on the randomized allocation sequence, either lidocaine patches or placebo patches will be attached near each participant’s surgical wound after open hernia repair under general anesthesia. Participants will be asked to follow-up at our outpatient clinic on the first postoperative day and at one week after surgery. The primary outcome is pain intensity, which will be measured using the Visual Analogue Scale (VAS) at the time of discharge from the day surgery unit. The secondary outcomes are VAS score at 24 hours and one week after surgery. We will collect and analyze the participants’ clinical data (amount of intraoperative opioid use, time to recovery, and pain intensity at 30 min after surgery) and demographic characteristics (age, sex, body weight, and height).Discussion: This trial may not only provide evidence on the efficacy of a 5% lidocaine patch for acute postoperative pain management after unilateral inguinal hernia repair, but also demonstrate the efficacy and safety of the patch for post-discharge pain management.Trial registration: ClinicalTrials.gov: NCT04754451 (registered on February 10, 2021). https://clinicaltrials.gov/ct2/show/NCT04754451
Adults' Addictive Behavior Can be Prevented if Parents are Aware.
Authors: v sabapathi , J Selvin paul peter 
Published: June 2021

Abstract
Addiction is characterized as the inability to avoid using a physical drug or engaging in virtual mode behavior. Due to the influence of the situation and surrounding factors, every person performs or engages in some action. This type of behaviour could become addictive if it becomes habit forming. If an action is carried out by unconscious actions, it has the potential to become addictive. A method of calculating operation in relation to an object. If an action is carried out by unconscious actions, it has the potential to become addictive. A method of evaluating behaviour related to an addictive concern that can help determine the presence of addiction. Since the decision to confess to the addiction is unclear. In this regard, tobacco use analysis is an important part of preventing addiction and raising awareness. Tobacco consumption assessment studies in India are urgently needed, and parental care, especially in adults, must be improved to protect them from tobacco and other drug inducing substances. The motivating factor for first-time tobacco use, as well as the effects of smoking, were discovered in this research. The first tobacco, whether smoking or smokeless tobacco, is stimulated by smoking motive influences both directly and indirectly (orally consume).
Outcomes of Induction Versus Spontaneous Onset of Labour at 40 and 41 Gw: Findings From A Prospective Database, Sri Lanka
Authors: Senanayake Hemantha , Mariani Ilaria , Valente Emanuelle Pessa , Piccoli Monica , Armocida Benedetta , Businelli Caterina , Rishard Mohamed , Covi Benedetta , Lazzerini Marzia 
Published: June 2021

Abstract
Objectives

The World Health Organization recommends induction of labour (IOL) for low risk pregnancy from 41 + 0 gestational weeks (GW). Nevertheless, in Sri Lanka IOL at 40 GW is common practice. This study compares maternal/newborn outcomes after IOL versus spontaneous onset of labour (SOL) at 40 GW (IOL40) and 41 GW (IOL41).
Methods

Data were extracted from the routine prospective individual patient database of the Soysa Teaching Hospital for Women, Colombo. IOL and SOL groups were compared using logistic regression.
Results

Of 13670 deliveries, 2359 (17.4%) were singleton and low risk at 40 or 41 GW. Of these, 456 (19.3%) women underwent IOL40, 318 (13.5%) IOL41, and 1585 (67.2%) SOL. Both IOL40 and IOL41 were associated with an increased risk of any maternal/newborn negative outcomes (OR = 2.21, 95%CI = 1.75–2.77, p < 0.001 and OR = 1.91, 95%CI = 1.47–2.48, p < 0.001 respectively), maternal complications (OR = 2.18, 95%CI = 1.71–2.77, p < 0.001 and OR = 2.34, 95%CI = 1.78–3.07, p < 0.001 respectively) and CS (OR = 2.75, 95%CI = 2.07–3.65, p < 0.001 and OR = 3.01, 95%CI = 2.21–4.12, p < 0.001 respectively). Results did not change in secondary and sensitivity analyses.
Conclusions

Both IOL groups were associated with higher risk of negative outcomes compared to SOL. Findings, potentially explained by selection bias, local IOL protocols and CS practices, are valuable for Sri Lanka, particularly given contradictory findings from other settings.
Bendamustine Plus Rituximab Versus R-Minichop as First-Line Treatment in Unfit Patients with Diffuse Large B-Cell Lymphoma
Authors: Zhang Dongdong , Liu Tao , Kaweme Natasha , Dong Youhong , Zhang Liling 
Published: June 2021

Abstract
Objective: To evaluate the efficacy and safety of bendamustine plus rituximab (BR) and low-does CHOP chemotherapy regimen-rituximab combination (R-miniCHOP) in elderly patients with diffuse large-B cell lymphoma, unfit for full dose immunochemotherapy.Method: Patients over 70 years with diffuse larger B-cell lymphoma or follicular lymphoma grade 3B, defined as unfit according to Comprehensive Geriatric Assessment (CGA), were included in our study. BR or R-miniCHOP was individualized according to the patients’ performance status and the presence of comorbidities. All the patients were received 4-6 cycles of immunochemotherapy at three-week intervals. Objective remission rate and adverse reaction were evaluated between the two groups.Result: This study included thirty-two patients enrolled between January 2020 and November 2020. The median age was 74 years (range 70-82). Twelve patients received BR, whereas twenty patients were treated with R-miniCHOP. The objective remission rate in the BR group was a slightly higher than the R-miniCHOP group (83.3% vs 75%), but with no statistical significance (P = 0.581). Furthermore, the objective remission rate was influenced by a serum beta 2 microglobulin concentration of 3 mg/L or less. The BR group showed a lower incidence of leukopenia than the R-miniCHOP group (P = 0.029), but had a higher incidence of fever (P = 0.036). Conclusion: BR showed equivalent efficacy but more improved safety in unfit patients with diffuse large-B cell lymphoma compared to R-miniCHOP. BR should be considered as an alternative treatment in this subgroup of patients.