multicenter clinical trial
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2021 ◽  
Vol 70 (5) ◽  
Author(s):  
Luca FIORILLO ◽  
Salvatore BOCCHIERI ◽  
Chiara STUMPO ◽  
Roberta MASTROIENI ◽  
Giulia AMOROSO ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ying Cao ◽  
Peijuan-Wang ◽  
Yan Lu ◽  
Yue Chen ◽  
Si Chen ◽  
...  

Abstract Introduction Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. Methods and design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization. Ethics and dissemination This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals. Trial registration ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx.


Author(s):  
Kazuo Noda ◽  
Yasuhiro Katayama ◽  
Eiichi Sawaragi ◽  
Michiharu Sakamoto ◽  
Hiroki Yamanaka ◽  
...  

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Ge Fang ◽  
Yaxin Wang ◽  
Zhenqian Yan ◽  
Xiaowen Zhou ◽  
Xingyu Fan ◽  
...  

Background. Damp phlegm and blood stasis pattern (DPBSP) is the main pattern in coronary heart disease (CHD) patients. To quantify and standardize the diagnosis of DPBSP, questionnaires are usually administered. The CHD Damp Phlegm and Blood Stasis Pattern Questionnaire (CHD-DPBSPQ) is the standard metric for measuring CHD-DPBSP signs and symptoms in practice and clinical research. The CHD-DPBSPQ has moderate diagnostic efficiency, as evidenced by its receiver operating characteristic curves. Furthermore, and high reliability and validity have been shown in some studies but not in a multicenter clinical trial. Our purpose was to evaluate the test-retest reliability of a proprietary CHD-DPBSPQ. Methods. The CHD-DPBSPQ uses a standard procedure for measuring symptoms. The (interrater) reliability and validity of this questionnaire have been previously studied. Here, we evaluated the test interval and weighted kappa value of items of test-retest (intrarater) reliability of the CHD-DPBSPQ. The test-retest reliability was evaluated by the intraclass correlation coefficient (ICC) for the total CHD-DPBSPQ score and the phlegm domain and blood stasis domain scores. Weighted kappa statistics were calculated for the individual CHD-DPBSPQ items. Results. Using the CHD-DPBSPQ, 79 patients with late-stage CHD who were participating in a multicenter clinical trial were assessed twice. The ICCs for the CHD-DPBSPQ score were as follows: 0.827 for the total CHD-DPBSPQ, 0.778 for the phlegm domain score, and 0.828 for the blood stasis domain score. The reliability was slightly better in patients whose test interval was ≤14 days. The weighted kappa values of individual items showed moderate consistency. Conclusions. The CHD-DPBSPQ was found to have excellent test-retest reliability in this sample of patients.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4761-4761
Author(s):  
Yi Li ◽  
Jingsong He ◽  
Xiaoyan Han ◽  
Gaofeng Zheng ◽  
Enfan Zhang ◽  
...  

Abstract Background Research has demonstrated that histone deacetylase (HDAC) is overexpressed in plasma cells. Panobinostat was the first HDAC inhibitor (HDACi) approved by FDA for the treatment of patients with relapse and refractory multiple myeloma (RRMM) in 2015. Chidamide is an oral subtype-selective HDACi, which was independently developed in China and approved as peripheral T-cell lymphoma. Preclinical findings have demonstrated the anti-myeloma activities of chidamide in vitro and in vivo. Currently, patients are recommended to take bortezomib and/or lenalidomide in first line treatment and might become less sensitive or resistant when disease progressed. Choices are limited for these patients as not all the new agents (i.e., second generation of PIs/ IMiDs, monoclonal antibody, et al.) were covered by insurance in China, which calls for more efficient and economical options. Here we report the initial efficacy and safety of this prospective, phase IIa, multicenter clinical trial with the chidamide based oral quadruplet regimen in patients with RRMM (ChiCTR2000035100). Methods The TC2D regimen (thalidomide 100mg on days 1-28, chidamide 5mg on days 1-24, cyclophosphamide 50mg on days 1-24 and dexamethasone 20mg on days 1,8,15 and 22) was administered to patients with RRMM of a 28-day cycle. In this trial, evaluation of overall response rate (ORR) was based on patients whose response ≥MR and clinical beneficial rate (CBR) was calculated in patients completed at least 3 cycles of TC2D regimen and reached ≥SD in this trial. Results A total of 32 patients were enrolled as of June 30, 2021, with a median age of 63.5 years (range 49-74). iFISH detected high-risk cytogenetics (defined by the presence of del (17p) or p53 mutation, t (4:14), t (14:16), t (14:20), amp (1q)) in 23 patients, and 82% (19/23) of which had unfavorable cytogenetics. All patients were exposed to at least one kind of PIs and/or IMiDs and 75% were double refractory to bortezomib and lenalidomide. 18 patients received 1-3 prior lines and 43% (14/32) were heavily pre-treated (>3 lines). The median number of cycles completed was 3 (range 1-15) and 59% (19/32) patients completed ≥ 3cycles at the cut-off date (Table 1). With the median follow-up of 6 months (range 0.7-19.5), the median progression free survival (PFS) was 3.3 months and the 6-mon PFS rate was 27.5% (Fig1a). Median overall survival (OS) has not reached yet, 6-mon survival rate was 82%, and the estimated 12-month survival rate was 65% (Fig 1b). Study end points were death (8 cases, 25%) and disease progression (24 cases, 75%). Patients who received ≥3 cycles of treatment had a superior median PFS (3.8 vs 1.4 months, P=0.01) than < 3 cycles. Of the 28 patients whose follow-up time more than 3 months, ORR was 25% and CBR was 46.4%, respectively. Better CBR (56.3% vs. 33.3%) and ORR (31.3% vs. 16.7%) were observed in patients who received less than 3 prior lines of therapy, although with no significant statistical difference. Stratified analysis of PFS showed no significant differences in sex, age, clinical classification, cytogenetic risk, prognosis score (DS and ISS staging system), and the status of ASCT. Stratified analysis of OS showed similar results to those associated with PFS. Grade 3/4 adverse events were mainly hematological toxicity (neutropenia 28%, anemia 34%, thrombocytopenia 15.6%), which could be tolerated. Fatigue was reported in 68.8% (22/32) of the patients. The incidence of all-cause infection was 37.5% (12/32). There were no treatment related deaths observed. Conclusions To our knowledge, this is the first report of chidamide-based oral quadruplet regimen for patients with RRMM. The preliminary results suggested excellent efficacy and relatively high safety, and different groups of patients could benefit from treatment with this regimen. A longer treatment period may strengthen this effect. The most common adverse events were hematological toxicity which could be controlled. As we known, choices of treatment are also influenced by physical and emotional impact of hospitalization or frequent hospital visits, which reflects the patient's ability to continue their treatment and quality of life. Hospitalization and intravenous fluids are not involved in this oral quadruplet treatment, which bring far more convenience and could be a cost-effective alternative for patients with RRMM. Updated results will be presented at the following trial. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
Author(s):  
Zhijian Gu ◽  
Jun Cong ◽  
Biao Gong ◽  
Rong Cen ◽  
Yongqi Chen ◽  
...  

Abstract Background: Multifocal atrophic gastritis and intestinal metaplasia are considered to be important links of the gastric precancerous cascade. But, there is a lack of definite therapeutic drugs for them. Many studies have shown traditional Chinese medicine is effective and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a Chinese patent medicine, Elian granules, to investigate the efficacy and safety of this drug in treating chronic atrophic gastritis patients with or without intestinal metaplasia.Methods: This is a phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 240 participants will be assigned to treatment group or placebo control group with a 1:1 ratio. Then, the experimental drug or placebo will be taken with boiling water,2 small bags (24.2g) each time, twice times a day, half an hour after each meal for 24 weeks. The primary outcome is to observe gastric mucosal histological changes after 6 months in patients with atrophic gastritis with or without intestinal metaplasia based on OLGA/OLGIM. The secondary outcome included dyspepsia symptom score and quality of life scale.Discussion: This study is designed to evaluate the efficacy and safety of Elian granule in a randomized, double-blind, placebo-controlled, multicenter manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for chronic atrophic gastritis(CAG) treatment.Trial registration: The registration number, ChiMCTR2000003929, was assigned by the Registry Platform For Evidence Based Traditional Chinese Medicine on 13 September 2020.


2021 ◽  
Vol 70 (5) ◽  
Author(s):  
Luca FIORILLO ◽  
Salvatore BOCCHIERI ◽  
Chiara STUMPO ◽  
Roberta MASTROIENI ◽  
Giulia AMOROSO ◽  
...  

2021 ◽  
Author(s):  
Chen Xu ◽  
Miaomiao Sun ◽  
Mei Jin ◽  
Zengshan Li ◽  
Rong Qin ◽  
...  

Abstract Background Former single center studies indicated that HER2 assessment with two primary tumor blocks (dual block HER2 assessment) could be an efficient and practical approach to overcome the adverse impact of heterogeneity and acquire a HER2 positive rate in gastric cancer (GC). This multicenter prospective clinical trial (NCT 02843412) was launched to verify its value and generality. Methods A total of 3806 participants with primary GCs have been enrolled from 8 hospitals in China. Two primary tumor blocks were selected and recorded as block 1 and block 2 after histological evaluation. An HER2 (4B5) rabbit monoclonal antibody was used for the immunohistochemistry (IHC) analysis. In total patients, HER2 IHC positive (3+) rate with dual block assessment (9.4%) was higher than that with single block assessment (block 1: 7.8%, block 2: 7.8%) (P < 0.001). Compared with single-block assessment, dual-block assessment increased the positive rate by approximate 20%. Similarly, HER2 equivocal (2+) rate was increased in dual block assessment (25.8%), which was higher than that in single block assessment (block 1: 20.3%, block 2: 20.9%) (P < 0.001). Conversely, dual block assessment demonstrated a lower HER2 negative (0/1+) rate (64.8%) than single block assessment (block1: 71.9%, block 2: 71.3%) (P < 0.001). These findings were also confirmed in individual hospitals. Conclusions Dual block HER2 assessment effectively increased HER2 IHC positive rate in resected specimens of GC. We recommended dual block HER2 assessment be promoted in routine clinical practice in GC.


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