clinical trial registry
Recently Published Documents


TOTAL DOCUMENTS

825
(FIVE YEARS 707)

H-INDEX

15
(FIVE YEARS 7)

Author(s):  
Nevine El Nahas ◽  
Fatma Fathalla Kenawy ◽  
Eman Hamid Abd Eldayem ◽  
Tamer M. Roushdy ◽  
Shahinaz M. Helmy ◽  
...  

Abstract Background Spasticity is a common complication of many neurological diseases and despite contributing much disability; the available therapeutic options are limited. Peripheral magnetic stimulation is one promising option. In this study, we investigated whether peripheral intermittent theta burst stimulation (piTBS) will reduce spasticity when applied directly on spastic muscles. Methods In this sham-controlled study, eight successive sessions of piTBS were applied directly to spastic muscles with supra threshold intensity. Assessment was done by modified Ashworth scale (mAS) and estimated Botulinum toxin dose (eBTD) at baseline and after the 8th session in both active and sham groups. Results A total of 120 spastic muscles of 36 patients were included in the analysis. Significant reduction of mAS and eBTD was found in the active compared to sham group (p < 0.001). The difference in mAS was also significant when tested in upper limb and lower limb subgroups. The degree of reduction in mAS was positively correlated with the baseline scores in the active group. Conclusion piTBS could be a promising method to reduce spasticity and eBTD. It consumes less time than standard high frequency protocols without compromising treatment efficacy. Trial registration: Clinical trial registry number: PACTR202009622405087. Retrospectively Registered 14th September, 2020.


2022 ◽  
Vol 2022 ◽  
pp. 1-10
Author(s):  
Jieying He ◽  
Chong Li ◽  
Jiali Lin ◽  
Beibei Shu ◽  
Bin Ye ◽  
...  

Proprioceptive deficit is one of the common sensory impairments following stroke and has a negative impact on motor performance. However, evidence-based training procedures and cost-efficient training setups for patients with poststroke are still limited. We compared the effects of proprioceptive training versus nonspecific sensory stimulation on upper limb proprioception and motor function rehabilitation. In this multicenter, single-blind, randomized controlled trial, 40 participants with poststroke hemiparesis were enrolled from 3 hospitals in China. Participants were assigned randomly to receive proprioceptive training involving passive and active movements with visual feedback (proprioceptive training group [PG]; n = 20 ) or nonspecific sensory stimulation (control group [CG]; n = 20 ) 20 times in four weeks. Each session lasted 30 minutes. A clinical assessor blinded to group assignment evaluated patients before and after the intervention. The primary outcome was the change in the motor subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-M). Secondary outcomes were changes in box and block test (BBT), thumb localization test (TLT), the sensory subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-S), and Barthel Index (BI). The results showed that the mean change scores of FMA-UE were significantly greater in the PG than in the CG ( p = 0.010 for FMA-UE-M, p = 0.033 for FMA-UE-S). The PG group was improved significantly in TLT ( p = 0.010 ) and BBT ( p = 0.027 ), while there was no significant improvement in TLT ( p = 0.083 ) and BBT ( p = 0.107 ) for the CG group. The results showed that proprioceptive training was effective in improving proprioception and motor function of the upper extremity in patients with poststroke. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2000037808).


Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Xiaochen Yang ◽  
Lanping Liu ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
...  

Abstract Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019


Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Wen Liu ◽  
Bin Yang ◽  
Jun-Wei Ji ◽  
Hua Yang ◽  
Hong-Hao Song ◽  
...  

Abstract Background It is well known that obstructive jaundice could affect the pharmacodynamics of some anesthetics, and the sensitivity of some anesthetics would increase among icteric patients. Remimazolam is a new ultra-short-acting intravenous benzodiazepine sedative/anesthetic, which is a high-selective and affinity ligand for the benzodiazepine site on the GABAA receptor. However, no study has reported the pharmacodynamics of remimazolam in patients with obstructive jaundice. We hypothesize that obstructive jaundice affects the pharmacodynamics of remimazolam, and the sensitivity of remimazolam increases among icteric patients. Methods/design The study will be performed as a prospective, controlled, multicenter trial. The study design is a comparison of remimazolam requirements to reach a bispectral index of 50 in patients with obstructive jaundice versus non-jaundiced patients with chronic cholecystitisor intrahepatic bile duct stones. Remimazolam was infused at 6 mg/kg/h until this endpoint was reached. Discussion Remimazolam could be suitable for anesthesia of patients with obstructive jaundice, because remimazolam is not biotransformed in the liver. Hyperbilirubinemia has been well-described to have toxic effects on the brain, which causes the increasing of sensitivity to some anesthetics, such as desflurane, isoflurane, and etomidate. Furthermore, remimazolam and etomidate have the same mechanism of action when exerting an anesthetic effect. We aim to demonstrate that obstructive jaundice affects the pharmacodynamics of remimazolam, and the dose of remimazolam when administered to patients with obstructive jaundice should be modified. Trial registration Chinese Clinical Trial Registry ChiCTR2100043585. Registered on 23 February 2021


2022 ◽  
Vol 8 ◽  
Author(s):  
Dafeng Liu ◽  
Yongli Zheng ◽  
Jun Kang ◽  
Dongmei Wang ◽  
Lang Bai ◽  
...  

Background: Some patients with comorbidities and rapid disease progression have a poor prognosis.Aim: We aimed to investigate the characteristics of comorbidities and their relationship with disease progression and outcomes of COVID-19 patients.Methods: A total of 718 COVID-19 patients were divided into five clinical type groups and eight age-interval groups. The characteristics of comorbidities were compared between the different clinical type groups and between the different age-interval groups, and their relationships with disease progression and outcomes of COVID-19 patients were assessed.Results: Approximately 91.23% (655/718) of COVID-19 patients were younger than 60 years old. Approximately 64.76% (465/718) had one or more comorbidities, and common comorbidities included non-alcoholic fatty liver disease (NAFLD), hyperlipidaemia, hypertension, diabetes mellitus (DM), chronic hepatitis B (CHB), hyperuricaemia, and gout. COVID-19 patients with comorbidities were older, especially those with chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Hypertension, DM, COPD, chronic kidney disease (CKD) and CVD were mainly found in severe COVID-19 patients. According to spearman correlation analysis the number of comorbidities was correlated positively with disease severity, the number of comorbidities and NAFLD were correlated positively with virus negative conversion time, hypertension, CKD and CVD were primarily associated with those who died, and the above-mentioned correlation existed independently of age. Risk factors included age, the number of comorbidities and hyperlipidaemia for disease severity, the number of comorbidities, hyperlipidaemia, NAFLD and COPD for the virus negative conversion time, and the number of comorbidities and CKD for prognosis. Number of comorbidities and age played a predictive role in disease progression and outcomes.Conclusion: Not only high number and specific comorbidities but also age are closely related to progression and poor prognosis in patients with COVID-19. These findings provide a reference for clinicians to focus on not only the number and specific comorbidities but also age in COVID-19 patients to predict disease progression and prognosis.Clinical Trial Registry: Chinese Clinical Trial Register ChiCTR2000034563.


2022 ◽  
Author(s):  
Ya-nan Zong ◽  
Chuan-ya Xu ◽  
Yue-qing Gong ◽  
Xiao-qing Zhang ◽  
Hong Zeng ◽  
...  

Abstract Background To compare the effectiveness of intraoperative cell salvage (IOCS) combined with a modified leucocyte depletion filter (MLDF) with IOCS combined with a regular leucocyte depletion filter (RLDF) in eliminating tumour cells from blood salvage during metastatic spine tumour surgery (MSTS). Methods Patients with a known primary epithelial tumour who underwent MSTS were recruited for this study. Blood samples were collected in 5 stages: from the patients’ vein before anaesthesia induction (S1), from the operative field during tumour manipulation (S2), and from the operative blood after IOCS processing (S3) and after IOCS+RLDF (S4) and IOCS+MLDF (S5) processing. The polyploids of tumour cells in the blood samples were collected and counted with immunomagnetic separation enrichment and fluorescence in situ hybridization. Results We recruited 20 patients. Tumour cells were detected in 14 patients (70%) in S1, 16 patients (80%) in S2, 13 patients (65%) in S3, and 12 patients (60%) in S4. MLDF was added in 8 patients. Tumour cells were detected in only 1 of 8 patients in S5 (12.5%). There were significantly fewer tumour cells in the samples collected after MLDF processing (S5) than in the samples collected after RLDF (S4) and around the tumour (S2) (P = 0.016 and P = 0.039, respectively). Although no significant difference was observed between S4 and S1, a downward trend was observed after IOCS+RLDF processing. Conclusions Tumour cells could be removed by IOCS combined with RLDF from blood salvaged during MSTS, but residual tumour cells remained. The findings support the notion that MLDF eliminates tumour cells more effectively than RLDF. Hence, this technique can be applied to MSTS. Trial Registration ChiCTR1800016162 Chinese Clinical Trial Registry http://www.chictr.org.cn/showproj.aspx?proj=27263


2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Yan Li ◽  
Rongguo Fu ◽  
Jie Gao ◽  
Li Wang ◽  
Zhaoyang Duan ◽  
...  

AbstractFull-dose prednisone (FP) regimen in the treatment of high-risk immunoglobulin A nephropathy (IgAN) patients, is still controversial. The pulsed intravenous methylprednisolone combined with alternative low-dose prednisone (MCALP) might have a more favorable safety profile, which has not been fully investigated. Eighty-seven biopsy-proven IgAN adult patients and proteinuria between 1 and 3.5 g/24 h after ACEI/ARB for at least 90 days were randomly assigned to 6-month therapy: (1) MCALP group: 0.5 g of methylprednisolone intravenously for three consecutive days at the beginning of the course and 3rd month respectively, oral prednisone at a dose of 15 mg every other day for 6 months. (2) FP group: 0.8–1.0 mg/kg/days of prednisone (maximum 70 mg/day) for 2 months, then tapered by 5 mg every 10 days for the next 4 months. All patients were followed up for another 12 months. The primary outcome was complete remission (CR) of proteinuria at 12 months. The percentage of CR at 12th and 18th month were similar in the MCALP and FP groups (51% vs 58%, P = 0.490, at 12th month; 60% vs 56%, P = 0.714, at 18th month). The cumulative dosages of glucocorticoid were less in the MCALP group than FP group (4.31 ± 0.26 g vs 7.34 ± 1.21 g, P < 0.001). The analysis of the correlation between kidney biopsy Oxford MEST-C scores with clinical outcomes indicated the percentages of total remission was similar between two groups with or without M1, E1, S1, T1/T2, and C1/C2. More patients in the FP group presented infections (8% in MCALP vs 21% in FP), weight gain (4% in MCALP vs 19% in FP) and Cushing syndrome (3% in MCALP vs 18% in FP). These data indicated that MCALP maybe one of the choices for IgAN patients with a high risk for progression into ESKD.Trial registration: The study approved by the Chinese Clinical Trial Registry (registration date 13/01/2018, approval number ChiCTR1800014442, https://www.chictr.org.cn/).


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Yong Yang ◽  
Wenkang Yan ◽  
Minyi Ruan ◽  
Lan Zhang ◽  
Jinzhen Su ◽  
...  

Abstract Background Lung recruitment is a maneuver used to decrease the length of intubation in preterm neonates. This study aimed to compare the therapeutic efficacy of lung recruitment plus intubation-surfactant-extubation (INSURE) procedure and INSURE alone for the preterm neonates with respiratory distress syndrome. Methods From 2017 to 2019, 184 preterm neonates (gestational age 24–32 weeks) with respiratory distress syndrome were enrolled and randomized into the lung recruitment group receiving lung recruitment (25 cm H2O, 15 s) plus INSURE and the control group receiving INSURE only. The primary outcome was the need for mechanical ventilation (MV) within 72 h after extubation. The secondary outcomes included duration of MV, noninvasive ventilation, total oxygen therapy, hospitalization time, and complications. Results Compared to the control group, the lung recruitment group had a significantly lower proportion of preterm neonates requiring MV within 72 h after extubation (23% vs. 38%, P = 0.025) and pulmonary surfactant administration, as well as a shorter MV duration. There was no significant difference in the incidences of complications (all P > 0.05) and in-hospital mortality (2% vs. 4%, P = 0.4) between the lung recruitment group and control group. Multivariate logistic regression analysis demonstrated that the control group had a 2.17-time higher risk of requiring MV than the lung recruitment group (AOR: 2.17, 95% CI: 1.13–4.18; P = 0.021). Compared with infants with a normotensive mother, infants with a hypertensive mother have a 2.41-time higher risk of requiring MV (AOR: 2.41, 95% CI: 1.15–5.05; P = 0.020). Conclusion Lung recruitment plus INSURE can reduce the need for MV within 72 h after extubation and did not increase the incidence of complications and mortality. Trial registration Chinese Clinical Trial Registry ChiCTR1800020125, retrospectively registered on December 15, 2018.


BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053488
Author(s):  
Yang Guo ◽  
Xia Dou ◽  
Xing-ling Jian ◽  
Kao-yuan Zhang ◽  
Ying-jie Zheng ◽  
...  

IntroductionAtopic dermatitis (AD) is a chronic inflammatory skin disease and skin microbiota dysbiosis shows an important role in the pathogenesis of AD. Effects of treatment on skin microbiota for patients with AD have been evaluated in recent years; however, the results remained controversial across studies. This systematic review will summarise studies evaluating the effect of treatments on skin microbiota among patients with AD.Methods and analysisWe will search PubMed, EMBASE, Web of Science, ClinicalTrials.gov and Chinese Clinical Trial Registry in November 2021; other data sources will also be considered, including searching specific authors and screening references cited in the enrolled articles. Interventional studies, which enrolled patients with AD receiving treatments and reported treatment-related skin microbiota changes, will be included. Our primary outcomes include skin microbiota diversity and treatment-related differential microbes; the secondary outcomes include microbiota functions and microbial interactions. Risk of bias assessment will be performed using Cochrane risk-of-bias tool for randomised trials, risk of bias in non-randomised studies of interventions and methodological index for non-randomised studies. Two researchers will independently perform study selection, data extraction and risk of bias assessment, with disagreements resolved by group discussions. Subgroup analyses will be performed according to different types of treatment for AD.Ethics and disseminationEthics approval is not required for this systematic review. Findings will be disseminated via peer-reviewed publication or conference proceedings.PROSPERO registration numberCRD42021246566.


2021 ◽  
Vol 12 (4) ◽  
pp. 961-966
Author(s):  
Pranesh Prakash Gaikwad ◽  
Mamta Nakade ◽  
Santosh Kamble ◽  
Abhijit Shekhar ◽  
Prashant Khade ◽  
...  

Background & Objectives: Pain in Sciatica can be incredibly painful and intolerable which seeks immediate medical attention. Various treatment modalities are widely used but have side effects too. One of them is Ghati Yantra Raktamokshana (Bloodletting with modified cupping). This systematic review provides an assessment on evidence of pain management of Gridhrasi (Sciatica) by Ghati Yantra Raktamokshana (Bloodletting with Modified Cupping). Methods: The databases of PubMed, Scopus, Cochrane Library, AYUSH portal, Shodhganga, Clinical trial registry of India, Google scholar were searched systematically (since inception to February 2021) for relevant articles about the effect of Ghati Yantra Raktamokshana in pain management of Gridhrasi. All randomized controlled trials as well as non-randomized controlled trials, before and after studies and single group clinical studies assessing the efficacy of Ghati Yantra Raktamokshana in pain management of Gridhrasi was included. Results: The original search yielded 774 articles of which only 6 articles (1-pilot study, 1-case study and 4-single arm studies) met the inclusion criteria and they showed the effectiveness of Ghati Yantra Raktamokshana in Pain management of Gridhrasi. Interpretation & Conclusions: Though review shows that the Ghati Yantra Raktamokshana is effective in Pain management of Gridhrasi but due to the methodological and clinical heterogeneity and risk of bias of the included trials requires more strong evidences in terms of RCT’s with larger sample size and for longer duration to definitely conclude its effectiveness.


Sign in / Sign up

Export Citation Format

Share Document