scholarly journals Protocol for a randomized controlled trial testing inhaled nitric oxide therapy in spontaneously breathing patients with COVID-19

2020 ◽  
Author(s):  
Chong Lei ◽  
Binxiao Su ◽  
Hailong Dong ◽  
Bijan Safaee Fakhr ◽  
Luigi Giuseppe Grassi ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Randomized Controlled Trial ◽  
Hospital Care ◽  
Massachusetts General Hospital ◽  
Controlled Trial ◽  
Control Group ◽  
Research Committee ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Inhaled No

AbstractIntroductionthe current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health. The number of infected patients is continuously increasing and the need for Intensive Care Unit admission ranges from 5 to 26%. The mortality is reported to be around 3.4% with higher values for the elderly and in patients with comorbidities. Moreover, this condition is challenging the healthcare system where the outbreak reached its highest value. To date there is still no available treatment for SARS-CoV-2. Clinical and preclinical evidence suggests that nitric oxide (NO) has a beneficial effect on the coronavirus-mediated acute respiratory syndrome, and this can be related to its viricidal effect. The time from the symptoms’ onset to the development of severe respiratory distress is relatively long. We hypothesize that high concentrations of inhaled NO administered during early phases of COVID-19 infection can prevent the progression of the disease.Methods and analysisThis is a multicenter randomized controlled trial. Spontaneous breathing patients admitted to the hospital for symptomatic COVID-19 infection will be eligible to enter the study. Patients in the treatment group will receive inhaled NO at high doses (140-180 parts per million) for 30 minutes, 2 sessions every day for 14 days in addition to the hospital care. Patient in the control group will receive only hospital care. The primary outcome is the percentage of patients requiring endotracheal intubation due to the progression of the disease in the first 28 days from enrollment in the study. Secondary outcomes include mortality at 28 days, proportion of negative test for SARS-CoV-2 at 7 days and time to clinical recovery.Ethics and disseminationThe trial protocol has been approved at the Investigation Review Boards of Xijing Hospital (Xi’an, China) and The Partners Human Research Committee of Massachusetts General Hospital (Boston, USA) is pending. Recruitment is expected to start in March 2020. Results of this study will be published in scientific journals, presented at scientific meetings, and on related website or media in fighting this widespread contagious disease.Trial registrationClinicaltrials.gov. NCT submitted

Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Author(s):  
Kai-ni Shen ◽  
Wei-jun Fu ◽  
Yu Wu ◽  
Yu-jun Dong ◽  
Zhong-xia Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Light Chain ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Stage Ii ◽  
Control Group ◽  
Al Amyloidosis ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.

scholarly journals Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial

Nitric Oxide ◽  
2019 ◽  
Vol 84 ◽  
pp. 60-68 ◽  
Author(s):  
Jeffrey A. Kline ◽  
Michael A. Puskarich ◽  
Alan E. Jones ◽  
Ronald A. Mastouri ◽  
Cassandra L. Hall ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Pulmonary Embolism ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Inhaled Nitric Oxide ◽  
Intermediate Risk ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

scholarly journals The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 18 (12) ◽  
pp. 6615
Author(s):  
Rosa Cabanas-Valdés ◽  
Lídia Boix-Sala ◽  
Montserrat Grau-Pellicer ◽  
Juan Antonio Guzmán-Bernal ◽  
Fernanda Maria Caballero-Gómez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Core Stability ◽  
Control Group ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Subacute Stroke ◽  
Local Strength ◽  
Multicenter Randomized Controlled Trial ◽  
Dynamic Sitting

Background: Trunk impairment produces disorders of motor control, balance and gait. Core stability exercises (CSE) are a good strategy to improve local strength of trunk, balance and gait. Methods and analysis: This is a single-blind multicenter randomized controlled trial. Two parallel groups are compared, and both perform the same type of therapy. A control group (CG) (n = 110) performs conventional physiotherapy (CP) (1 h per session) focused on improving balance. An experimental group (EG) (n = 110) performs CSE (30 min) in addition to CP (30 min) (1 h/session in total). EG is divided in two subgroups, in which only half of patients (n = 55) perform CSE plus transcutaneous electrical nerve stimulation (TENS). Primary outcome measures are dynamic sitting, assessed by a Spanish version of Trunk Impairment Scale and stepping, assessed by Brunel Balance Assessment. Secondary outcomes are postural control, assessed by Postural Assessment Scale for Stroke patients; standing balance and risk of fall assessed by Berg Balance Scale; gait speed by BTS G-Walk (accelerometer); rate of falls, lower-limb spasticity by Modified Ashworth Scale; activities of daily living by Barthel Index; and quality of life by EQ-5D-5L. These are evaluated at baseline (T0), at three weeks (T1), at five weeks (end of the intervention) (T2), at 17 weeks (T3) and at 29 weeks (T4). Study duration per patient is 29 weeks (a five-week intervention, followed by a 24-week post-intervention).

scholarly journals A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Julie Redfern ◽  
Genevieve Coorey ◽  
John Mulley ◽  
Anish Scaria ◽  
Lis Neubeck ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Risk Factor ◽  
Digital Health ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

scholarly journals Observation on Pain Release by Long-Round Needle Therapy in Knee Osteoarthritis Related with Meridian-Sinews Theory

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Yuan-shi Liu ◽  
Li-gong Xue ◽  
Xiao-jian Ma ◽  
Chun-shan Liu
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Therapy Group ◽  
Controlled Trial ◽  
Control Group ◽  
Curative Effect ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Therapy Sessions

To evaluate the effectiveness of long-round needle therapy for pain relief in patients with knee osteoarthritis, 192 patients were included in a multicenter, randomized, controlled trial. 97 patients were randomized to the long-round needle therapy group (EG), and 95 patients were randomized to the control group (CG). In EG, the long-round needle therapy was performed once every 7 days for 3 therapy sessions. Ibuprofen sustained-release capsules were administered orally in CG, 1 pill each time, twice daily for 3 weeks. Curative effect was measured after the therapy and was evaluated at a 3-month follow-up interview. In EG, the treatment resulted in a basic cure for 79 patients, was effective for 15 patients, and was ineffective for 1 patient. In CG, the treatment resulted in a basic cure for 30 patients, was effective for 38 patients, and was ineffective for 21 patients. In the follow-up examination in EG, 75 patients were basically cured, and the treatment was effective for 11 patients and ineffective for 9. In CG, 22 were basically cured, 31 found the treatment effective, and 36 found the treatment ineffective. The curative effects in EG after both the treatment and the 3-mouth followup were significantly more superior than that in CG (P<0.01) which should be adopted more widely.

scholarly journals Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects

2021 ◽  
Vol 11 (1) ◽  
pp. 104
Author(s):  
Franco Molteni ◽  
Eleonora Guanziroli ◽  
Michela Goffredo ◽  
Rocco Calabrò ◽  
Sanaz Pournajaf ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lower Limb ◽  
Controlled Trial ◽  
Gait Training ◽  
Control Group ◽  
Clinical Effects ◽  
Walking Test ◽  
Randomized Controlled ◽  
Subacute Stroke ◽  
Multicenter Randomized Controlled Trial

Background: Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training. Methods: A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS). Results: The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2. Conclusions: The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

scholarly journals Leg-Length-Evening Device Improves Balance in Patients Wearing a Controlled Ankle Motion Boot: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0013
Author(s):  
Daniel D. Bohl ◽  
Nasima Mehraban ◽  
Alexander J. Idarraga ◽  
Kevin J. Wu ◽  
Milap Patel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Leg Length ◽  
Ankle Motion ◽  
Randomized Controlled ◽  
Plantar Aspect ◽  
Total Pain ◽  
Multicenter Randomized Controlled Trial

Category: Other Introduction/Purpose: Patients are often made weight-bearing as tolerated (WBAT) in a controlled ankle motion (CAM) boot for the management of various foot and ankle conditions. The CAM boot causes a leg-length discrepancy (LLD) between the booted (longer) and contralateral (shorter) lower extremities. This discrepancy can potentially cause balance problems, undue strain on joints, and discomfort in patients. We hypothesized that a leg-length evening orthotic placed on the plantar aspect of the contralateral shoe improves balance among patients who are WBAT in a CAM boot. Methods: Patients made WBAT in a CAM boot were randomized to either the leg-length-evening orthotic intervention group or to a control group in which patients wore a normal shoe of their choice. Patients were followed for two weeks and asked a series of questions pertaining to balance and pain experienced at their knees, hips, and back. Balance was the primary outcome and was scored from 0 (no difficulty with balance) to 10 (great difficulty with balance). Results: Out of 107 subjects enrolled and randomized, 95 (88.8%) completed the study, satisfying the a priori sample size requirement of 94 patients. There were no differences in baseline characteristics between groups (p>0.05 for each). Intervention patients reported less difficulty with balance than control patients (intention-to-treat analysis: 2.0+-1.5 versus 3.2+-1.8, p=0.001; as-treated analysis: 2.1+-1.7 versus 3.0+-1.7, p=0.009). Intervention and control patients did not differ with respect to pain experienced at their knees, hips, or back, or in a composite total pain score (p>0.05 for each). Conclusion: This multicenter randomized controlled trial found that adding a limb-length-evening orthotic to the plantar aspect of the contralateral shoe in a patient that is WBAT in a CAM boot improves balance. The trial was powered to identify a difference in the primary outcome measure of balance and may have been insufficiently powered to identify differences in knee, hip, back, or total pain.

scholarly journals Comparing the Efficacies of Telemedicine and Standard Prenatal Care on Blood Glucose Control in Women With Gestational Diabetes Mellitus: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Ying Tian ◽  
Suhan Zhang ◽  
Feiling Huang ◽  
Liangkun Ma
Keyword(s):  
Randomized Controlled Trial ◽  
Health Education ◽  
Prenatal Care ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Qualification Rate

BACKGROUND Gestational diabetes mellitus (GDM) can usually be well controlled by health education and lifestyle management, resulting in better pregnancy outcomes. However, standard clinical prenatal care, which consists of clinic visits every 2 weeks, may not provide sufficient management for women with GDM. Telemedicine demonstrates a potential to fill this gap. OBJECTIVE The objective of this study was to investigate whether health education and lifestyle management delivered through a WeChat group chat was more effective in controlling blood glucose (BG) than standard clinical prenatal care among women with GDM. METHODS In this multicenter randomized controlled trial, women with GDM diagnosed by an oral glucose tolerance test between 23 and 30 (+6) gestational weeks were randomized to a WeChat group chat–based BG management group or a routine clinical prenatal care group. The primary outcome was the change in the glycemic qualification rate during the follow-up period in both groups. The secondary outcomes were pregnancy outcomes. RESULTS A total of 309 women with GDM participated in the trial, with 162 women randomized to the control group and 147 to the intervention group. No significant differences in baseline characteristics were found between the control and intervention groups. Participants were further divided into 4 groups according to gestational weeks at enrollment for further analysis. The glycemic qualification rate of the intervention group was higher than that of the control group at nearly all time points in Groups 1 to 3, among which 3 time points reached statistical significance: Group 1 at T3 (54.8% vs 83.3%) and Group 2 at T3 (62.5% vs 80.0%) and T7 (75.0% vs 100%). The glycemic qualification rate gradually increased as gestational weeks progressed in both groups, regardless of the intervention method. None of the pregnancy outcomes measured, including delivery mode, premature rupture of the membranes, preterm birth, infant's birth weight, and postpartum hemorrhage, were significantly different between the control and intervention groups. CONCLUSIONS This multicenter randomized controlled trial that assessed women with noninsulin-dependent GDM demonstrated that additional instant messaging platforms, such as WeChat, used for health education and lifestyle intervention in China tend to be more effective for BG control than standard clinical prenatal care alone. CLINICALTRIAL ClinicalTrials.gov NCT03748576; https://clinicaltrials.gov/ct2/show/NCT03748576

scholarly journals Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: a study protocol for a multicenter randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jing-wen Sun ◽  
Ming-liang Sun ◽  
Da Li ◽  
Jun Zhao ◽  
Su-hua Shi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Group A ◽  
Irritable Bowel ◽  
Group B ◽  
Experimental Group

Abstract Background Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease is found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients compared with those of conventional treatments. We also aim to identify the optimal acupoint combination recommended for IBS and to clarify the clinical advantage of the “multiacupoint co-effect and synergistic effect.” Methods and analysis A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly stratified into acupuncture group A, acupuncture group B, or the control group in a 1:1:1 ratio with a central web-based randomization system. The prespecified acupoints used in the control group will include bilateral Tianshu (ST25), Shangjuxu (ST37), Neiguan (PC6), and Zusanli (ST36). The prespecified acupoints used in experimental group A will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6). The prespecified acupoints used in experimental group B will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Zusanli (ST36). Each patient will receive 12 acupuncture treatments over 4 weeks and will be followed up for 4 weeks. The primary outcome is the IBS-Symptom Severity Scale (IBS-SSS) score. The secondary outcomes include the Bristol Stool Form Scale (BSFS), Work and Social Adjustment Score (WSAS), IBS-Quality of Life (IBS-QOL), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) scores. Both the primary outcome and the secondary outcome measures will be collected at baseline, at 2 and 4 weeks during the intervention, and at 6 weeks and 8 weeks after the intervention. Ethics and dissemination The entire project has been approved by the ethics committee of the Beijing University of Chinese Medicine (2020BZYLL0903). Discussion This is a multicenter randomized controlled trial for IBS in China. The findings may shed light on the efficacy of acupuncture as an alternative to conventional IBS treatment. The results of the trial will be disseminated in peer-reviewed publications. Trial registration Chinese Clinical Trials Register ChiCTR2000041215. First registered on 12 December 2020. http://www.chictr.org.cn/.

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