scholarly journals Treatment of chronic subdural hematoma with atorvastatin combined with low-dose dexamethasone: phase II randomized proof-of-concept clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Dong Wang ◽  
Chuang Gao ◽  
Xin Xu ◽  
Tao Chen ◽  
Ye Tian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
T Cells ◽  
Subdural Hematoma ◽  
Controlled Trial ◽  
Chronic Subdural Hematoma ◽  
Complete Recovery ◽  
Neurological Function ◽  
Clinical Trial Registration ◽  
Neurological Improvement

OBJECTIVEThe authors sought to test the hypothesis that adding dexamethasone (DXM) to atorvastatin (ATO) potentiates the effects of ATO on chronic subdural hematoma (CSDH).METHODSSixty patients with CSDH underwent 5 weeks of treatment with an additional 7-week follow-up. Patients were randomized to receive a 5-week regimen of ATO 20 mg daily or ATO 20 mg daily plus a DXM regimen (ATO+DXM). The 5-week DXM regimen was 2.25 mg daily for 2 consecutive weeks, followed by 0.75 mg twice daily for 2 weeks and 0.75 mg once daily for 1 week. The primary endpoint was hematoma reduction assessed by neuroimaging at baseline and at 5 weeks of follow-up. Secondary outcomes included neurological improvement assessed by using the Markwalder’s Grading Scale and Glasgow Coma Scale (MGS-GCS).RESULTSThe mean patient age was 66.6 years, and 25% of patients were women. The patients who were treated with ATO+DXM had more obvious hematoma reduction at the 5th week (between-groups difference 18.37 ml; 95% CI 8.17–28.57; p = 0.0005). This reduction started from the 2nd week (14.51 ml; 95% CI 4.31–24.71; p = 0.0056) of treatment and persisted until the 12th week (17.50 ml; 95% CI 7.30–27.70; p = 0.0009). Complete recovery of neurological function (MGS-GCS grade 0) at 5 weeks was achieved in 83.33% and 32.14% of patients in the ATO+DXM and ATO groups, respectively. At the 5th week, patients receiving ATO+DXM had significantly lower levels of T cells and higher levels of regulatory T cells and endothelial progenitor cells in their peripheral blood.CONCLUSIONSATO+DXM was more effective than ATO alone in reducing hematoma and improving neurological function in patients with CSDH. These results require further confirmation in a randomized placebo-controlled trial.Clinical trial registration no.: ChiCTR-IPR-14005573 (http://www.chictr.org.cn/index.aspx)

scholarly journals Atorvastatin combined with or without dexamethasone for the treatment of chronic subdural hematoma in super-aged patients

2020 ◽  
Author(s):  
Wei Quan ◽  
Jiangyuan Yuan ◽  
Xuanhui Liu ◽  
Pan Li ◽  
Jinhao Huang ◽  
...  
Keyword(s):  
Subdural Hematoma ◽  
Chronic Subdural Hematoma ◽  
Complete Recovery ◽  
Aged Patients ◽  
Surgical Interventions ◽  
Aged People ◽  
Beneficial Effects ◽  
Neurological Improvement ◽  
Minimally Invasive Surgical ◽  
Magnetic Resonance Imaging Mri

Aim：Chronic subdural hematoma (CSDH) is common in aged people, and minimally invasive surgical interventions such as burr-hole-drainage and twist-drill craniostomy are the first-line therapeutic options for this condition. However, the mortality rate among super-aged patients (over 90 years of age) with CSDH is as high as 38.4% after these surgical procedures. Atorvastatin alone or in combination with dexamethasone has been proven to be effective in eliminating CSDH. In the current study, the researchers evaluated the therapeutic efficacy of atorvastatin with or without dexamethasone on the CSDH patients over 90 years. Methods：The study attempted to treat 12 super-aged patients with primary or post-operative relapsed CSDH by using atorvastatin alone or in combination with dexamethasone. The changes in hematoma volume measured with computed tomography (CT) or magnetic resonance imaging (MRI) and the patients’ neurological improvement were monitored by activities of daily living (ADL) and modified Rankin scale (MRS) scores. Results：Treatment with atorvastatin or atorvastatin combined with low-dose dexamethasone had beneficial effects on hematoma elimination and/or symptom remission within 6 to 24 weeks in 12 super-aged patients. All of them showed complete recovery after 1~4 years of follow-up. Conclusion：The findings in this study indicate that atorvastatin with or without dexamethasone is safe and effective for the treatment for CSDH in super-aged patients.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Intelligence at Six Years in Relation to Neonatal Bilirubin Level: Follow-up of The National Institute of Child Health and Human Development Clinical Trial of Phototherapy

PEDIATRICS ◽  
1991 ◽  
Vol 87 (6) ◽  
pp. 797-805
Author(s):  
Peter C. Scheidt ◽  
Barry I. Graubard ◽  
Howard J. Hoffman ◽  
Dolores A. Bryla ◽  
Karin B. Nelson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Child Health ◽  
Human Development ◽  
Bilirubin Level ◽  
Controlled Trial ◽  
Full Scale ◽  
The Central Nervous System ◽  
Bilirubin Toxicity

Results of the National Institute of Child Health and Human Development Randomized Controlled Trial of Phototherapy were examined for the relationship of neonatal bilirubin level to neurological and developmental outcome at 6-year follow-up. This analysis focused on 224 control children with birth weight of less than 2000 g. Bilirubin levels were maintained below previously specified levels by the use of exchange transfusion only (24%). Rates of cerebral palsy were not significantly higher for children with elevated maximum bilirubin level than for those whose level remained low. No association was evident between maximum bilirubin level and IQ (Full Scale, Verbal, or Performance) by simple correlation analysis (r = -.087, P = .2 for Full Scale) or by multiple linear regression adjusting for factors that covary with IQ (β = -.15, P = .58). IQ was not associated with mean bilirubin level, time and duration of exposure to bilirubin, or measures of bilirubin-albumin binding. Thus, over the range of bilirubin levels permitted in this clinical trial, there was no evidence of bilirubin toxicity to the central nervous system. Measures used to control the level of bilirubin in low birth weight neonates appear to prevent effectively the risk of bilirubin-induced neurotoxicity.

scholarly journals Clinical Outcomes of Computational Virtual Mapping-Guided Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Clinical Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Yong-Soo Baek ◽  
Oh-Seok Kwon ◽  
Byounghyun Lim ◽  
Song-Yi Yang ◽  
Je-Wook Park ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Catheter Ablation ◽  
Computational Modeling ◽  
Controlled Trial ◽  
Dominant Frequency ◽  
Complication Rates ◽  
Clinical Recurrence ◽  
Significant Difference

Background: Clinical recurrence after atrial fibrillation catheter ablation (AFCA) still remains high in patients with persistent AF (PeAF). We investigated whether an extra-pulmonary vein (PV) ablation targeting the dominant frequency (DF) extracted from electroanatomical map–integrated AF computational modeling improves the AFCA rhythm outcome in patients with PeAF.Methods: In this open-label, randomized, multi-center, controlled trial, 170 patients with PeAF were randomized at a 1:1 ratio to the computational modeling-guided virtual DF (V-DF) ablation and empirical PV isolation (E-PVI) groups. We generated a virtual dominant frequency (DF) map based on the atrial substrate map obtained during the clinical AF ablation procedure using computational modeling. This simulation was possible within the time of the PVI procedure. V-DF group underwent extra-PV V-DF ablation in addition to PVI, but DF information was not notified to the operators from the core lab in the E-PVI group.Results: After a mean follow-up period of 16.3 ± 5.3 months, the clinical recurrence rate was significantly lower in the V-DF than with E-PVI group (P = 0.018, log-rank). Recurrences appearing as atrial tachycardias (P = 0.145) and the cardioversion rates (P = 0.362) did not significantly differ between the groups. At the final follow-up, sinus rhythm was maintained without any AADs in 74.7% in the V-DF group and 48.2% in the E-PVI group (P < 0.001). No significant difference was found in the major complication rates (P = 0.489) or total procedure time (P = 0.513) between the groups. The V-DF ablation was independently associated with a reduced AF recurrence after AFCA [hazard ratio: 0.51 (95% confidence interval: 0.30–0.88); P = 0.016].Conclusions: The computational modeling-guided V-DF ablation improved the rhythm outcome of AFCA in patients with PeAF.Clinical Trial Registration: Clinical Research Information Service, CRIS identifier: KCT0003613.

scholarly journals Twist drill aspiration of chronic subdural hematoma at the Ignace Deen hospital of Conakry

2021 ◽  
Vol 9 (5) ◽  
Author(s):  
Alpha Boubacar Bah ◽  
Seylan Diawara ◽  
Ibrahima Sory Souare ◽  
Abdoulaye Barry ◽  
Ansoumane Donzo ◽  
...  
Keyword(s):  
Subdural Hematoma ◽  
Chronic Subdural Hematoma ◽  
Outcome Data ◽  
Twist Drill ◽  
Suitable Alternative ◽  
Female Ratio ◽  
Tertiary Centre ◽  
Male Female Ratio ◽  
Reasonable Approach

Bedside percutaneous twist drill aspiration (TDA) is described as a surgical method of management of Chronic subdural hematoma (CSDH) and appear to be a reasonable approach in low medical resources environment. We report the results of TDA of CSDH in a single tertiary centre in Conakry Republic of Guinea in West Africa, for the period March 2015 to October 2017. The charts and medical record of 38 cases of CSDH treated with TDA were collected retrospectively, with a mean follow-up of 84.2 days. The outcome data assessed were neurologic status evaluated by the follow-up Markwalder grading scale (MGS: 0=normal to 4=coma), recurrence, infection and mortality. The Male-Female ratio was 1.3:1. Mean age at diagnosis was 78.2+/-12 years. Traumatic brain injury (TBI) was identified as causal in 28.2% of cases studied. All patients were operated on under local anesthesia and had a postoperative drain left in place for 3 days. The mean postoperative MGS was 1.06, up from a mean preoperative MGS of 3.7. Two cases of recurrence occurred subsequent to TDA causing death and three other patients died from unknown causes during the follow-up period. No cases of post-operative infection were diagnosed during the follow-up. Our study shows that Bedside TDA appears to be a suitable alternative to burr hole craniotomies in urgent cases of CSDH in the low socio-economic setting, where a surgical theatre is not always available.

scholarly journals Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Controlled Trial ◽  
Control Group ◽  
Health Maintenance ◽  
Ocular Symptoms ◽  
Thought Disorders ◽  
Multicenter Randomized Controlled Trial ◽  
Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

Chronic Subdural Hematomas: To Drain or Not to Drain?

Neurosurgery ◽  
1985 ◽  
Vol 16 (2) ◽  
pp. 185-188 ◽  
Author(s):  
Thomas Marc Markwalder ◽  
Rolf W. Seiler
Keyword(s):  
Clinical Improvement ◽  
Closed System ◽  
Subdural Hematoma ◽  
Drainage System ◽  
Chronic Subdural Hematoma ◽  
Burr Hole ◽  
Postoperative Phase ◽  
Consecutive Series ◽  
Neurological Improvement ◽  
Burr Hole Evacuation

Abstract A consecutive series of 21 adult patients with chronic subdural hematoma was studied in respect to postoperative resolution of subdural collections and clinical improvement after burr hole evacuation without subdural drainage. This series was compared to a previously studied series of patients with chronic subdural hematoma in whom postoperative closed system drainage had been installed. Using the identical protocol for treatment and postoperative follow-up, we obtained identical results with respect to time-related neurological improvement and persistence of subdural collections in the undrained and drained series, except that the steadily progressive clinical improvement during the early postoperative phase (24 hours) in all cases of the drained series was not universal in the undrained cases. Our study suggests that, to avoid the possibility of early postoperative clinical deterioration, burr hole craniostomy and closed system drainage is advisable. We think that subdural drainage is not necessary when the installation of the drainage system seems to be technically difficult, as it may be in cases with considerable perioperative cortical expansion.

scholarly journals Sensorimotor vs. Motor Upper Limb Therapy for Patients With Motor and Somatosensory Deficits: A Randomized Controlled Trial in the Early Rehabilitation Phase After Stroke

2020 ◽  
Vol 11 ◽  
Author(s):  
Nele De Bruyn ◽  
Leen Saenen ◽  
Liselot Thijs ◽  
Annick Van Gils ◽  
Eva Ceulemans ◽  
...  
Keyword(s):  
Upper Limb ◽  
Controlled Trial ◽  
Motor Impairment ◽  
Early Rehabilitation ◽  
Stroke Patients ◽  
Post Intervention ◽  
Clinical Trial Registration ◽  
Additional Therapy ◽  
Somatosensory Function

Background: Somatosensory function plays an important role in motor learning. More than half of the stroke patients have somatosensory impairments in the upper limb, which could hamper recovery.Question: Is sensorimotor upper limb (UL) therapy of more benefit for motor and somatosensory outcome than motor therapy?Design: Randomized assessor- blinded multicenter controlled trial with block randomization stratified for neglect, severity of motor impairment, and type of stroke.Participants: 40 first-ever stroke patients with UL sensorimotor impairments admitted to the rehabilitation center.Intervention: Both groups received 16 h of additional therapy over 4 weeks consisting of sensorimotor (N = 22) or motor (N = 18) UL therapy.Outcome measures: Action Research Arm test (ARAT) as primary outcome, and other motor and somatosensory measures were assessed at baseline, post-intervention and after 4 weeks follow-up.Results: No significant between-group differences were found for change scores in ARAT or any somatosensory measure between the three time points. For UL impairment (Fugl-Meyer assessment), a significant greater improvement was found for the motor group compared to the sensorimotor group from baseline to post-intervention [mean (SD) improvement 14.65 (2.19) vs. 5.99 (2.06); p = 0.01] and from baseline to follow-up [17.38 (2.37) vs. 6.75 (2.29); p = 0.003].Conclusion: UL motor therapy may improve motor impairment more than UL sensorimotor therapy in patients with sensorimotor impairments in the early rehabilitation phase post stroke. For these patients, integrated sensorimotor therapy may not improve somatosensory function and may be less effective for motor recovery.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03236376.

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