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Multicenter Clinical Trial - DOAJ

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Last Updated: 25 July 2022

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Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial

Introduction: This investigator-initiated clinical trial aims to determine the effectiveness and safety of administering selective internal radiation therapy with resin yttrium-90 microspheres and standard chemotherapy in unresectable intrahepatic cholangiocarcinoma. Methods: In patients with unresectable ICC, a phase 2 single-arm multicenter research was conducted. On days one and eight of a 21-day cycle, siRT was administered at a dose of 120 Gy targeted at tumor, followed by the introduction of gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days one and eight. The median PFS was 9 months in 16 patients undergoing chemotherapy, with a median OS of 21. 6 months. No new safety alert was found, with only 10% of patients suffering from grade 3 or higher treatment-related adverse events. The average time from SIRT to chemotherapy was 29 days. Conclusions: The treatment of SIRT and standard gemcitabine and cisplatin chemotherapy is safe and effective for unresectable ICC.

Source link: https://doi.org/10.1159/000525489


The Effect of Mindfulness Yoga in Children With School Refusal: A Study Protocol for an Exploratory, Cluster-Randomized, Open, Standard Care-Controlled, Multicenter Clinical Trial

Anxiety and depression are two of the most typical emotional difficulties for children who do not attend school. MethodsThis paper describes a methodology for a cluster-randomized controlled trial of a mindfulness yoga therapy for children with school refusal. Using the Spence Children's Anxiety Scale-Children's Anxiety Scale-Children's Anxiety Scale-Children's Anxiety Scale and Protocol, we found that anxiety among children with school refusal remained the most common result, as well as researching whether mindfulness yoga can reduce student anxiety in children with school refusal. We believe that we can help to reduce the number of children who have refused to attend school, as well as the reduction of the number of children who have refused to attend classes in this manner.

Source link: https://doi.org/10.3389/fpubh.2022.881303


The effect of Bushen Culuan Decoction on anovulatory infertile women among 6 different diseases: a study protocol for a randomized, double-blinded, positively controlled, adaptive multicenter clinical trial

On day 5 of every menstrual period, the treatment group will undergo a 14-day surgical administration with Bushen Culuan Decoction 13 g three times a day, as well as a 5-day treatment with clomiphene citrate placebo tablets 50 mg once a day. The control group will begin a 14-day course with Bushen Culuan Decoction placebo 13 g three times a day, as well as a 5-day clomiphene citrate tablets 50 mg every day during the menstrual period. Discussion by the Medical Ethics Committee of the Chinese Academy of Medical Sciences The aim of this RCT is to determine if Bushen Culuan Decoction has a higher pregnancy rate than clomiphene citrate in women with anovulatory infertility, as well as the identification of the anovulatory diseases for which Bushen Culuan Decoction has higher success.

Source link: https://doi.org/10.1186/s13063-022-06289-7


A randomized, parallel control and multicenter clinical trial of evidence-based traditional Chinese medicine massage treatment VS External Diclofenac Diethylamine Emulgel for the treatment of knee osteoarthritis

Both massage and topically administered NSAIDs are safe and effective treatment for knee osteoarthritis in knee osteoarthritis, according to the author, but different massage sects in China caused evaluation difficulties for treating KOA. knee osteoarthritis treatment in China can be standardized by the massage methods and procedures, so we brought together multi-disciplinary experts in China to obtain an evidence-based traditional Chinese medicine massage therapy of knee osteoarthritis. Compared to External Diclofenac Diethylamine Emulgel, the intention of this review will be to give clinicians a complementary and alternative therapy for patients, as well as assessing the effectiveness and safety of evidence-based traditional Chinese medicine massage therapy of KOA. As the experimental group, 100 participants will receive External Diclofenac Diethylamine Emulgel 3x per day for ten weeks, and 100 participants will receive Evidence-based traditional Chinese medicine massage 2 sessions per week for ten weeks as the control group.

Source link: https://doi.org/10.1186/s13063-022-06388-5


Efficacy and safety of Elian Granules in treating chronic atrophic gastritis: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial

Although many studies have shown that traditional Chinese medicine is safe with no adverse side effects, no further studies have been conducted in a scientifically rigorous manner. Our aim is to conduct a high-quality trial of a Chinese patent medicine, Elian Granules, to investigate its efficacy and safety in treating patients with persistent atrophic gastritis with or without intestinal metaplasia. After 6 months, OLGA/OLGIM staging methods determined that the primary result is the reporting of histological changes in the gastric mucosa of patients with atrophic gastritis with or without intestinal metaplasia. The secondary findings include the examination of dyspepsia and quality of life based on the dyspepsia symptom score and the quality-of-life scale. This trial may not only provide evidence for a phase III clinical trial, but it also provides an alternative treatment for chronic atrophic gastritis. ChiMCTR2000003929 is the website of a trial registration scheme for Evidence-Based Traditional Chinese Medicine.

Source link: https://doi.org/10.1186/s13063-022-06395-6


Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial

Background: The use of pharmacological drugs for congestive heart failure with ventricular arrhythmia is limited. The aim of this research was to investigate the effects of Chinese traditional medicine Shensong Yangxin capsules on heart rhythm and function in CHF patients with frequent ventricular premature complexes. This double-blind, placebo-controlled, multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX and placebo groups for 12 weeks of therapy. SSYX caused a significant decrease in the total number of VPCs than the placebo did. Conclusions: SSYX was shown to have the benefits of VPCs suppression and cardiac function improvement in this 12-week pilot study, with high satisfaction in the midst of standard therapy for CHF.

Source link: https://doi.org/10.4103/0366-6999.209906


Dual block HER2 assessment increased HER2 immunohistochemistry positive rate in resected specimens of gastric cancer: a prospective multicenter clinical trial from China

Abstract Background: The results of two preliminary tumor blocks found that HER2 analysis with two primary tumor blocks could be an effective and cost-effective way to combat heterogeneity's negative effect and result in a HER2 positive rate in gastric cancer in comparison to previous single center studies. Methods An estimated of 3806 patients with primary GCs from 8 hospitals in China have been admitted to 3806 patients. Following histological examination, two primary tumor blocks were identified and recorded as block 1 and block 2; block 1 and block 2 were discovered and reported as block 1 and block 2 respectively. Results In total patients, the HER2 IHC positive rate with dual block testing was higher than that with single block assessment. Conversely, dual block assessments revealed a lower HER2 negative rate than single block assessment. Conclusions: In resected specimens of GC, a dual block HER2 assessment significantly raised the HER2 IHC positive rate. In GC routine clinical practice, we recommended that dual block HER2 testing be included.

Source link: https://doi.org/10.1186/s13000-022-01230-7


Adding Concurrent Chemotherapy to Intensity-Modulated Radiotherapy Does Not Improve Treatment Outcomes for Stage II Nasopharyngeal Carcinoma: A Phase 2 Multicenter Clinical Trial

paraphrasedoutput:Methods and Materials: Participants in this randomized phase 2 investigation [registered with ClinicalTrials. gov] were randomly assigned to either IMRT alone or IMRT combined with concurrent cisplatin in this randomized phase 2 study. 93. 4% vs. 95. 9% vs. 94. 3%, 93. 6% vs. 94. 6% vs. 94. 7%, 94. 6% vs. 95. 9% respectively, 93. 9% vs. 94. 5% vs. 94. 0%, 93. 3%, RFFS, DFS, 90. In the CCRT group, the incidence of grade 2 to 4 leukopenia was higher. Conclusion: Patients with stage II NPC did not get better longevity or disease control, but it did have a detrimental effect on bone marrow function, which was not evident between the two groups.

Source link: https://doi.org/10.3389/fonc.2020.01314


Evaluation of a blockchainā€based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs

Abstract Blockchain is a new data architecture characterized by a logical sequence of blocks in a decentralized fashion. Abstract Blockchain is a novel data architecture that can be used to build a new data architecture. In a decentralized and multicenter trial, we sought to determine the true value of a blockchain-based democratic consent platform in an international context. By entering the unique drug code on the form, each subject was expected to report the self-u2010 measured body temperatures and take a virtual investigational drug. Overall, the respondents used 90. 8% u00b1 19. 2% of the total drug, with a median response time of 2. 8 h. In conclusion, we tested a blockchain-based dynamic consent platform in real clinical trial settings.

Source link: https://doi.org/10.1111/cts.13246

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions