Behandlung des Impingement-Syndroms der Schulter: diagnostische Arthroskopie oder arthroskopische subacromiale Dekompression oder Bewegungstherapie?

2018 ◽  
Vol 28 (05) ◽  
pp. 256-256
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Subacromial Decompression ◽  
Shoulder Impingement ◽  
Diagnostic Arthroscopy

Referat zur Arbeit von Paavola M, Malmivaara A, Taimela S, Kanto K, Inkinen J, Kalske J,Sinisaari I, Savolainen V,Ranstam J, Järvinen TLN for the Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators “Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial”. BMJ 2018; 362: k2860

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

scholarly journals Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033815
Author(s):  
Tian-tian Ma ◽  
Zhikai Yang ◽  
Sainan Zhu ◽  
Jing-hong Zhao ◽  
Yi Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Psychological Status ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Restless Legs ◽  
Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

Trifluoperazine (“Stelazine”) a Controlled Clinical Trial in Chronic Schizophrenia

1961 ◽  
Vol 107 (447) ◽  
pp. 250-257 ◽  
Author(s):  
W. J. Stanley ◽  
D. Walton
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
Pernicious Anaemia ◽  
Chronic Schizophrenia ◽  
Mental Illnesses ◽  
Controlled Clinical Trial ◽  
Vitamin B ◽  
Uncontrolled Trial ◽  
New Compounds

So many new compounds are now being introduced for the treatment of psychiatric disorders that it is difficult for the clinician to assess the accuracy of the claims made for them. If a form of therapy is one hundred per cent. effective in a disease which was previously one hundred per cent. fatal, for example vitamin B12 in pernicious anaemia, the question of a controlled trial does not arise. But even the manufacturers do not claim such a degree of effectiveness for drugs advocated for the treatment of mental illnesses, and in addition the natural course of such illnesses is very variable, so that it is essential that clinical trials of these drugs should be controlled. Foulds (1958) has reviewed British and American clinical trials of drugs in psychiatry during the years 1951 to 1956, and has shown that the less controlled a trial, the more likely it is to result in a favourable report on the drug being tested, presumably because of bias on the part of the clinician. Forrester (1958), however, on the basis of a completely uncontrolled trial of Stelazine on only twenty-five patients, concluded that “the amount of improvement in a few cases was not sufficient to encourage the further use of the drug”.

scholarly journals Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Xie Xiaoyan ◽  
Danghan Xu ◽  
Lixing Zhuang ◽  
Hui Liu ◽  
Sui Tan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bronchial Asthma ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Blood Analysis ◽  
Quality Data ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Asthma Control Test

Abstract Background Bronchial asthma (BA) is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat BA, although the evidence and mechanism are inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of the SHP in the treatment of BA in the chronic persistent or clinical remission stage and to provide high-quality data for further research.Methods: We propose a multicenter, double-blinded, parallel, randomized, placebo-controlled clinical trial involving 4 study hospitals in China. A total of 72 eligible participants will be randomized into an SHP group and a placebo group. They will receive SHP for 3 treatment sessions(TSs). The primary outcome will be changes in forced expiratory volume in one second after 3 TSs. Secondary outcomes will include: (1) the Asthma Quality of Life Questionnaire, Asthma Control Test, and Asthma Long-term Follow-up Scale; (2) levels of Metallothionein-2 and Transgelin-2 in blood and urine; and (3) levels of IL-5, IL-13, IL-23, IL-25, and thymic stromal lymphopoietin in blood. Analysis of the data will be performed at baseline, at the end of the 2nd and 3rd TSs and at 24-week follow-up. The safety of the SHP will be evaluated at each TS.Discussion: The aim of this trial is to determine whether SHP is more effective than placebo in the treatment of patients with BA, and whether SHP works by reducing airway inflammation and reversing bronchoconstriction.Trial registration: Chinese Clinical Trial Registry(http://www.chictr.org.cn), ChiCTR1900024616. Registered on 19 July 2019.

scholarly journals Gonadotropin-releasing hormone agonist versus expectant management for treating multiple leiomyomas after myomectomy: the study protocol for a multicentre, prospective, randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e044347
Author(s):  
Jia Wei ◽  
Xiangyi Ma ◽  
Wenwen Wang ◽  
Minli Zhang ◽  
Zhiying Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Expectant Management ◽  
Gonadotropin Releasing Hormone ◽  
Controlled Clinical Trial ◽  
Releasing Hormone ◽  
Gonadotropin Releasing Hormone Agonist ◽  
Pathological Result ◽  
Randomised Controlled

IntroductionLeiomyoma recurrence is a major concern for long-term myomectomy management, especially for multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is one of the most effective medications to reduce the volume of fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no randomised clinical trial determining the efficacy of GnRHa treatment for preventing multiple leiomyomas recurrence after myomectomy.Methods and analysisWe are conducting a phase IV randomised controlled trial in women aged 18–45 undergoing myomectomy for multiple leiomyomas. After surgery, women whose pathological result confirms multiple leiomyomas are randomised in a 1:1 ratio into an observation or GnRHa group. The primary outcome is the recurrence of either clinical symptoms or fibroids on imaging. Patients will be assessed for adverse events during the follow-up.Ethics and disseminationThe study was approved by the Medical Ethics Committee of the Tongji Hospital Affiliated with the Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180311) according to the submitted study protocol (V.1.0, 10 November 2017) and informed consent (V.1.0, 10 November 2017). The results will be presented at domestic and international conferences and published in peer-reviewed journals.Trial registration numberChiCTR-IPR-17012992.

scholarly journals Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Yongliang Feng ◽  
Jing Chen ◽  
Tian Yao ◽  
Yue Chang ◽  
Xiaoqing Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Neutralizing Antibodies ◽  
Health Care Systems ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Shanxi Province ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population. Methods In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis. Results A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0–14, 0–21, and 0–28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4–108.4) in the 0–14 group, which was significantly lower compared with 134.4 (95% CI: 123.1–145.7) in the 0–21 group (P < 0.001 vs 0–14 group) and 145.5 (95% CI: 131.3–159.6) in the 0–28 group (P < 0.001 vs 0–14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild. Conclusions Both a two-dose of inactivated SARS-CoV-2 vaccine at 0–21 days and 0–28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0–14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%. Trial registration Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn. Graphical Abstract

scholarly journals A systematic literature review- Calcineurin inhibitors treatment in systemic sclerosis

2021 ◽  
Author(s):  
Nina Hofmann ◽  
◽  
Robert Ambühl ◽  
Suzana Jordan ◽  
Oliver Distler
Keyword(s):  
Clinical Trial ◽  
Systemic Sclerosis ◽  
Treatment Effectiveness ◽  
Case Reports ◽  
Controlled Trial ◽  
Calcineurin Inhibitors ◽  
Controlled Clinical Trial ◽  
Eligibility Criteria ◽  
Disease Manifestation ◽  
Review Question

Review question / Objective: To systematically review treatment effectiveness and adverse events of calcineurin inhibitors (CNIs) such as cyclosporine A (CsA) and tacrolimus in patients with systemic sclerosis (SSc). Condition being studied: Systemic sclerosis. Eligibility criteria: • Publications with SSc patients treated with CNIs and available information on the outcome of CNI therapy on SSc disease manifestation will be analysed.• Article types: case reports, clinical study, clinical trial, controlled clinical trial, historical article, randomized controlled trial.

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