scholarly journals Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhi-peng Xiao ◽  
ke Jin ◽  
Jie-qing Wan ◽  
Yong Lin ◽  
Yao-hua Pan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Blood Flow ◽  
Cerebral Blood Flow ◽  
Ischemic Stroke ◽  
Multimodal Imaging ◽  
Imaging Techniques ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cerebrovascular Reserve ◽  
Randomized Controlled

Abstract Background Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke. Methods/design This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months. Discussion Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016. All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.

scholarly journals Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical trial

2019 ◽  
Author(s):  
xiao zhipeng ◽  
ji ke ◽  
lin yong ◽  
wan jieqing ◽  
pan yaohua ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Arterial Occlusion ◽  
Transluminal Angioplasty ◽  
Cerebrovascular Reactivity ◽  
Stroke Recurrence ◽  
Controlled Clinical Trial ◽  
Cerebrovascular Reserve ◽  
Randomized Controlled ◽  
Cerebral Arterial Occlusion

Abstract Background Cerebrovascular reactivity (CVR), index of cerebral hemodynamics, might guide the treatment of ischemic stroke. However, the previous studies that the therapeutic strategy of stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters, such as cerebral blood flow, and CVR factors are not under consideration. Measurement of CVR by multimodal image might improve the prognosis for ischemic stroke. Methods/design The study is a prospective, randomized, paralleled controlled clinical trial to examine the multimodal image evaluation for CVR. A total of 66 eligible patients will be recruited from Renji hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR>10% group and CVR<10% group. And the patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary end point is all adverse events and ipsilateral stroke recurrence at 6, 12, 24 months after the management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, 24 months. Discussion Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, randomized, paralleled controlled registry study, together with other ongoing studies, will present more evidence for optimal individualized accurate treatment of ischemic stroke.

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Yinan QIN ◽  
Qianqian Lei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals A comparison of therapies using Eyetronix Flicker Glass and standard adhesive patches in children with anisometropic amblyopia: A randomized controlled trial

2020 ◽  
Author(s):  
Seung Hyun Min ◽  
Shijia Chen ◽  
Jinling Xu ◽  
Bingzhen Chen ◽  
Hui Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Contrast Sensitivity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Treatment Groups ◽  
Anisometropic Amblyopia ◽  
Randomized Controlled

AbstractPurposeRecently, Eyetronix Flicker Glass (EFG) was introduced as a novel treatment for amblyopia. We conducted a randomized clinical trial to compare the efficacy of the therapies using the Eyetronix Flicker Glass and standard adhesive patches.MethodsWe tested 31 children (aged 4-13 years) with anisometropic amblyopia. They were assigned into one of the two treatment groups and were treated for 12 weeks. The first group was treated with the Eyetronix Flicker Glass for one hour per day (Flicker Group), and the latter with standard patches (Patching Group) for two hours per day. We considered best-corrected visual acuity (BVCA) of the amblyopic eye after 12 weeks of treatment as the primary outcome. Secondary outcomes were BVCA of the amblyopic at other timepoints of measurement (before the treatment, 3 and 6 weeks) as well as contrast sensitivity of the amblyopic eye, stereopsis and fusion range at all timepoints.ResultsVisual acuity in the amblyopic eye was significantly improved in both treatment groups at week 12 relative to baseline. The magnitude of improvement was similar. Contrast sensitivity of the amblyopic eye at 3, 6 and 12 cpd was large but not so at 18 cpd for both groups. Stereopsis did not improvement in both groups. However, fusion range significantly improved in the Flicker Group at week 12 relative to baseline.ConclusionAfter 12 weeks, EFG therapy improves amblyopic eye’s visual acuity, its contrast sensitivity and fusion range of the patients. EFG therapy improves both monocular and binocular functions.Clinical trial registry numberChiCTR2000034436 from the Chinese Clinical Trial Registry

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulder: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Yinan QIN ◽  
Qianqian Lei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Primary success of electrical cardioversion for new-onset atrial fibrillation and its association with clinical course in non-cardiac critically ill patients: sub-analysis of a multicenter observational study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Nozomu Shima ◽  
Kyohei Miyamoto ◽  
Seiya Kato ◽  
Takuo Yoshida ◽  
Shigehiko Uchino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Sinus Rhythm ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Icu Discharge ◽  
Primary Success ◽  
Success Group ◽  
Onset Atrial Fibrillation ◽  
New Onset

Abstract Background Electrical cardioversion (ECV) is widely used to restore sinus rhythm in critically ill adult patients with atrial fibrillation, although its prognostic value is uncertain. This study aims to elucidate the clinical meaning of successful ECV. Methods This is a sub-analysis of the AFTER-ICU study, a multicenter prospective study with a cohort of 423 adult non-cardiac patients with new-onset atrial fibrillation (AF). Patients that underwent ECV within 7 days after initial onset of AF were included in the sub-analysis. We compared intensive care unit (ICU) and overall hospital mortality, survival time within 30 days, cardiac rhythm at ICU discharge, and the length of ICU and overall hospital stay between patients whose sinus rhythm was restored immediately after the first ECV session (primary success group) and those in whom it was not restored (unsuccessful group). To find the factors related to the primary success of ECV, we also compared patient characteristics, the delivered energy, and pretreatment. Results Sixty-five patients received ECV and were included in this study. Although 35 patients (54%) had primary success, recurrence of AF occurred in 24 of these patients (69%). At ICU discharge, three patients still had AF in the unsuccessful group, but no patients in the primary success group still had AF. ICU mortality was 34% in the primary success group and 17% in the unsuccessful group (P = 0.10). Survival time within 30 days did not differ between the groups. Delivered energy and pretreatment were not associated with primary success of ECV. Conclusions The primary success rate of ECV for new-onset AF in adult non-cardiac ICU population was low, and even if it succeeded, the subsequent recurrence rate was high. Primary success of ECV did not affect the rate of mortality. Pretreatment and delivered energy were not associated with the primary success of ECV. Trial registration UMIN clinical trial registry, the Japanese clinical trial registry (registration number: UMIN000026401, March 31, 2017).

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