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Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patientswith pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

Frontiers of Medicine 2022, Volume 16, Issue 5,   Pages 736-744 doi: 10.1007/s11684-021-0870-5

Abstract: A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM andlay a foundation for further clinical research.A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients

Keywords: pneumoconiosis     randomized controlled trials     traditional Chinese medicine    

A meta-analysis of randomized trials of maintenance bacillus Calmette-Guerin instillation efficacy against

PAN Jiangang, ZHOU Xing, CHEN Zhiguang, HAN Ruifa

Frontiers of Medicine 2008, Volume 2, Issue 3,   Pages 259-263 doi: 10.1007/s11684-008-0049-3

Abstract: All available published data of randomized clinical trials comparing transurethral resection plus intravesicalstatistically significant difference in the s for tumor recurrence between the two treatment groups was found (randomizedThe randomized model combined effect of Pasteur F and other strains were 0.50 (95% CI 0.26 to 0.95,

Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR

Wenjie Zhu, Binghe Xu

Frontiers of Medicine 2021, Volume 15, Issue 2,   Pages 208-220 doi: 10.1007/s11684-020-0795-4

Abstract: We conducted a meta-analysis and systemic review on randomized controlled trials evaluating various targetedPUBMED and EMBASE databases were searched for eligible trials.ratios (HRs) for progression-free survival (PFS), odds ratios (ORs) for objective response rate (ORR), clinical

Keywords: endocrine-resistant     HR+/HER2- advanced breast cancer     randomized clinical trials    

Low-carbohydrate diets lead to greater weight loss and better glucose homeostasis than exercise: a randomizedclinical trial

Frontiers of Medicine 2021, Volume 15, Issue 3,   Pages 460-471 doi: 10.1007/s11684-021-0861-6

Abstract: Lifestyle interventions, including dietary adjustments and exercise, are important for obesity management. This study enrolled adults with overweight or obesity to explore whether either low-carbohydrate diet (LCD) or exercise is more effective in metabolism improvement. Forty-five eligible subjects were randomly divided into an LCD group (n=22) and an exercise group (EX, n=23). The subjects either adopted LCD (carbohydrate intake<50 g/day) or performed moderate-to-vigorous exercise (≥30 min/day) for 3 weeks. After the interventions, LCD led to a larger weight loss than EX (−3.56±0.37 kg vs. −1.24±0.39 kg, P<0.001), as well as a larger reduction in fat mass (−2.10±0.18 kg vs. −1.25±0.24 kg, P=0.007) and waist circumference (−5.25±0.52 cm vs. −3.45±0.38 cm, P=0.008). Both interventions reduced visceral and subcutaneous fat and improved liver steatosis and insulin resistance. Triglycerides decreased in both two groups, whereas low-density lipoprotein cholesterol increased in the LCD group but decreased in the EX group. Various glycemic parameters, including serum glycated albumin, mean sensor glucose, coefficient of variability (CV), and largest amplitude of glycemic excursions, substantially declined in the LCD group. Only CV slightly decreased after exercise. This pilot study suggested that the effects of LCD and exercise are similar in alleviating liver steatosis and insulin resistance. Compared with exercise, LCD might be more efficient for weight loss and glucose homeostasis in people with obesity.

Keywords: low-carbohydrate diet     obesity     nonalcoholic fatty liver disease     continuous glucose monitoring     mean sensor glucose    

Clinical trials of the new 3-dimensional reticular intrauterine device for reproductive women

Qiu Yi,Wang Leiguang and Yu Ling

Strategic Study of CAE 2014, Volume 16, Issue 5,   Pages 39-46

Abstract:

This study aimed at exploring a new 3-dimensional reticular intrauterine device (3-DR-IUD) composed of nitinol and silicone rubber and observing the contraceptive efficacy and side effects of the device in reproductive women. The frame of the 3-DR-IUD was constructed with silicone rubber and nitinol wire. The 3-DR-IUD was placed into uterus in an outpatient procedure. One hundred and fifty- two women were divided equally into the 3-DR-IUD group (n=76) and the 2- dimensional intrauterine device (2- D- IUD) group (n=76,control group). Patient follow-ups were performed in 1~12 months post-operation. The side effects of intrauterine device (IUD),such as abnormal leucorrhea,menstrual flow changes in uterine bleeding profusely and pain,etc,were investigated. The pregnancy rate,expulsion rate,removal rate of IUD for medical reasons and the continuation rate were evaluated. The ultrasound and pelvic X-ray were carried out to examine IUDs. The results showed that two groups with 76 cases of each successfully placed IUD and there were no severe pain during the operation. The incidence of lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DR-IUD group (7.9 %,6/76) were significantly lower than that of the 2-DIUD group (40.8 %,31/76) during the first 12 months for use of IUD (P<0.000 1). The pregnancy rate,expulsion rate and take-off rate due to symptom were 0 %,0 % and 1.3 % in 3-DRIUD group,respectively,and 1 of 76 woman take-off 3-DR-IUD was due to allergy for silicon rubber. The continuation rate was 98.7 % (75/76) in the 3-DR-IUD group,comparing with the 2-D-IUD group (86.8 % ,66/76),the difference was significantly (P=0.009). Therefore,the 3-DR-IUD demonstrates long-term patient tolerability,satisfaction and efficacy as a contraceptive.The 3-DR-IUD appears to be a new,safe and effective devise of contraception.

Keywords: 3-DR-IUD     clinical trials     side effects     contraceptive efficacy    

Rare tumors: a blue ocean of investigation

Frontiers of Medicine 2023, Volume 17, Issue 2,   Pages 220-230 doi: 10.1007/s11684-023-0984-z

Abstract: exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinicalinsufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinicaltrials., we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical

Keywords: rare tumors     diagnosis flowchart     treatment strategy     clinical trials recommendation    

versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomizedclinical trial

Frontiers of Medicine 2022, Volume 16, Issue 2,   Pages 276-284 doi: 10.1007/s11684-021-0855-4

Abstract: We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX+ dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference –5.1%, 95% confidence interval (CI) –19.4% to 9.2%, P=0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P=0.577). For the single-course MTX+ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%–36.6%, P<0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P=0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.

Keywords: gestational trophoblastic neoplasia (GTN)     methotrexate (MTX)     dactinomycin (ACTD)    

Overcoming the challenges of conducting translational research in cell therapy

Sowmya Viswanathan, Armand Keating

Frontiers of Medicine 2011, Volume 5, Issue 4,   Pages 333-335 doi: 10.1007/s11684-011-0166-2

Abstract: Cell therapy holds promise in addressing a number of unmet medical needs but despite its considerable impetus, faces numerous challenges including support for translational research in this area. Here, we examine the challenges confronting cell therapy research including the limited funding available for translational research partly due to the uncompetitive nature of required validation studies in cell therapy that of necessity are not hypothesis-driven. Other issues include lack of standardization of definitions of cell products, uncertainty regarding optimum preclinical animal models, duplication of efforts to secure regulatory approval and a lack of uniformity of nomenclature for some cell products. Nonetheless, several initiatives to address all of these issues are underway.

Keywords: stem cells     clinical trials     funding     animal models     standardization     common definitions    

Next Steps for Efficacy Evaluation in Clinical Trials of COVID-19 Vaccines

Hu-Dachuan Jiang, Li Zhang, Jing-Xin Li, Feng-Cai Zhu

Engineering 2021, Volume 7, Issue 7,   Pages 903-907 doi: 10.1016/j.eng.2021.04.013

older patients with chronic obstructive pulmonary disease: a subgroup analysis from a four-center, randomized

Minghang Wang,Jiansheng Li,Suyun Li,Yang Xie

Frontiers of Medicine 2014, Volume 8, Issue 3,   Pages 368-375 doi: 10.1007/s11684-014-0360-0

Abstract: older patients with chronic obstructive pulmonary disease (COPD) through a four-center, open-label, randomized

Keywords: chronic obstructive pulmonary disease     older adult     clinical trial     Bu-Fei Jian-Pi granules     Bu-Fei Yi-Shen    

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

Li Ni, Zheng Wen, Xiaowen Hu, Wei Tang, Haisheng Wang, Ling Zhou, Lujin Wu, Hong Wang, Chang Xu, Xizhen Xu, Zhichao Xiao, Zongzhe Li, Chenze Li, Yujian Liu, Jialin Duan, Chen Chen, Dan Li, Runhua Zhang, Jinliang Li, Yongxiang Yi, Wei Huang, Yanyan Chen, Jianping Zhao, Jianping Zuo, Jianping Weng, Hualiang Jiang, Dao Wen Wang

Frontiers of Medicine 2021, Volume 15, Issue 5,   Pages 704-717 doi: 10.1007/s11684-021-0853-6

Abstract: We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian

Keywords: COVID-19     SARS-CoV-2     Shuanghuanglian oral liquid     clinical trial    

Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation

Zhaoxiang Bian, Baoyan Liu, David Moher, Taixiang Wu, Youping Li, Hongcai Shang, Chungwah Cheng

Frontiers of Medicine 2011, Volume 5, Issue 2,   Pages 171-177 doi: 10.1007/s11684-011-0132-z

Abstract: The reporting standards for randomized controlled trials were first published in 1996 by a group of scientistsunder the name “CONSORT,” which means consolidated standards of reporting trials.

Keywords: CONSORT for TCM     reporting standards     future development    

Three-dimensional conformal and intensity modulated radiation therapy for hepatocellular carcinoma:basic study and clinicaltrials

Jiang Guoliang

Strategic Study of CAE 2009, Volume 11, Issue 10,   Pages 129-136

Abstract:

This report consists of two parts: basic study and clinical trial forAnd 3 clinical trials have been carried out, which yielded encouraging outcome with 3-year rvivals oftechnique of HCC irradiation,which is fit to Chinese HCC,has been successfully applied in a series of clinicaltrials.It demonstrates that radiation therapy is one of the treatment choices for medically inoperable

Keywords: 3-dimensional conformal radiation therapy     intensity modulated radiation therapy     epatocellular carcinoma     liver irradiation tolerance    

Current State of Monoclonal Antibody Therapy for Allergic Diseases Review

Yan Chen, Wei Wang, Huihui Yuan, Yan Li, Zhe Lv, Ye Cui, Jie Liu, Sun Ying

Engineering 2021, Volume 7, Issue 11,   Pages 1552-1556 doi: 10.1016/j.eng.2020.06.029

Abstract: the cytokines and immunoglobulin involved in the development of allergic diseases, and to discuss the clinical

Keywords: Allergic disease     Monoclonal antibody     Anti-IgE     Cytokines     Clinical trials    

Quality Control and Nonclinical Research on CAR-T Cell Products: General Principles and Key Issues Review

Yonghong Li, Yan Huo, Lei Yu, Junzhi Wang

Engineering 2019, Volume 5, Issue 1,   Pages 122-131 doi: 10.1016/j.eng.2018.12.003

Abstract: At present, exciting results are being achieved in clinical applications of CAR-T cells for patients

Keywords: Chimeric antigen receptor T cells     Quality control     Nonclinical research     Safety     Efficacy     Clinicaltrials     Cancer immunotherapy    

Title Author Date Type Operation

Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patientswith pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

Journal Article

A meta-analysis of randomized trials of maintenance bacillus Calmette-Guerin instillation efficacy against

PAN Jiangang, ZHOU Xing, CHEN Zhiguang, HAN Ruifa

Journal Article

Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR

Wenjie Zhu, Binghe Xu

Journal Article

Low-carbohydrate diets lead to greater weight loss and better glucose homeostasis than exercise: a randomizedclinical trial

Journal Article

Clinical trials of the new 3-dimensional reticular intrauterine device for reproductive women

Qiu Yi,Wang Leiguang and Yu Ling

Journal Article

Rare tumors: a blue ocean of investigation

Journal Article

versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomizedclinical trial

Journal Article

Overcoming the challenges of conducting translational research in cell therapy

Sowmya Viswanathan, Armand Keating

Journal Article

Next Steps for Efficacy Evaluation in Clinical Trials of COVID-19 Vaccines

Hu-Dachuan Jiang, Li Zhang, Jing-Xin Li, Feng-Cai Zhu

Journal Article

older patients with chronic obstructive pulmonary disease: a subgroup analysis from a four-center, randomized

Minghang Wang,Jiansheng Li,Suyun Li,Yang Xie

Journal Article

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

Li Ni, Zheng Wen, Xiaowen Hu, Wei Tang, Haisheng Wang, Ling Zhou, Lujin Wu, Hong Wang, Chang Xu, Xizhen Xu, Zhichao Xiao, Zongzhe Li, Chenze Li, Yujian Liu, Jialin Duan, Chen Chen, Dan Li, Runhua Zhang, Jinliang Li, Yongxiang Yi, Wei Huang, Yanyan Chen, Jianping Zhao, Jianping Zuo, Jianping Weng, Hualiang Jiang, Dao Wen Wang

Journal Article

Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation

Zhaoxiang Bian, Baoyan Liu, David Moher, Taixiang Wu, Youping Li, Hongcai Shang, Chungwah Cheng

Journal Article

Three-dimensional conformal and intensity modulated radiation therapy for hepatocellular carcinoma:basic study and clinicaltrials

Jiang Guoliang

Journal Article

Current State of Monoclonal Antibody Therapy for Allergic Diseases

Yan Chen, Wei Wang, Huihui Yuan, Yan Li, Zhe Lv, Ye Cui, Jie Liu, Sun Ying

Journal Article

Quality Control and Nonclinical Research on CAR-T Cell Products: General Principles and Key Issues

Yonghong Li, Yan Huo, Lei Yu, Junzhi Wang

Journal Article