scholarly journals The cerebral mechanism underlying the acupoints with specific effect for gallbladder stone disease: protocol for a randomized controlled task-fMRI trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ning Sun ◽  
Yuan-Fang Zhou ◽  
Jie Zhou ◽  
Wen-Wei Zuo ◽  
Xiang-Yin Ye ◽  
...  
Keyword(s):  
Rating Scale ◽  
Gallbladder Disease ◽  
Specific Effect ◽  
Stone Disease ◽  
Central Mechanism ◽  
Gallbladder Stone ◽  
Clinical Trial Registry ◽  
Before And After ◽  
Fatty Food ◽  
Superior Effect

Abstract Background As it has been recorded in ancient Chinese classics, Yanglingquan (GB34) and Dannangxue (EX-LE6) are two important acupoints that can regulate the function of the gallbladder. Acupuncture at these two acupoints is considered particularly effective for gallbladder disease treatment, especially for alleviating gallbladder stone disease (GSD) symptoms that can be aggravated after intaking high-fat food. However, the superior effect between the two acupoints still needs to be further explored, as well as the underlying central mechanism has never been investigated to date. Methods and design Ninety participants diagnosed with GSD will be randomly divided into group A (acupuncture at GB34), group B (acupuncture at EX-LE6), and group C (acupuncture at non-acupoint) in a ratio of 1:1:1. All of them will receive a 30-min acupuncture treatment with fatty-food cues being presented before and after acupuncture. During the task, participants will be scanned by MRI and required to rate their desire for high-/low-fat food with an 11-point Likert scale. Additionally, the participants’ pain/discomfort sensation will be evaluated using the Numeric Rating Scale (NRS) at four timepoints, including before the 1st task fMRI scan, before and after acupuncture, and after the 2nd task fMRI scan. For both behavior and fMRI data, the ANOVA analysis will be conducted among three groups to testify the immediate effect of GB34 and EX-LE6. The post hoc t-test will be employed to further explore the superiority between acupuncture with GB34 and EX-LE6. Furthermore, correlation analyses will be conducted to investigate a possible correlation between neural changes and clinical data. Discussion In comparison to the non-acupoint, the results will firstly explore the superior effect between acupuncture with GB34 and EX-LE6 on GSD patients by observing their behavioral and neural response change to fatty-food cue, and then to investigate the underlying central mechanism. Trial registration Chinese Clinical Trial Registry ChiCTR2000034368. Registered on 3 July 2020.

Impact of Michigan’s new opioid prescribing laws on spine surgery patients: analysis of the Michigan Spine Surgery Improvement Collaborative

2020 ◽  
pp. 1-6
Author(s):  
Paul Park ◽  
Victor Chang ◽  
Hsueh-Han Yeh ◽  
Jason M. Schwalb ◽  
David R. Nerenz ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Spinal Surgery ◽  
Readmission Rate ◽  
Rating Scale ◽  
Short Term ◽  
Readmission Rates ◽  
Opioid Prescribing ◽  
Number Of Patients ◽  
Before And After ◽  
The Impact

OBJECTIVEIn 2017, Michigan passed new legislation designed to reduce opioid abuse. This study evaluated the impact of these new restrictive laws on preoperative narcotic use, short-term outcomes, and readmission rates after spinal surgery.METHODSPatient data from 1 year before and 1 year after initiation of the new opioid laws (beginning July 1, 2018) were queried from the Michigan Spine Surgery Improvement Collaborative database. Before and after implementation of the major elements of the new laws, 12,325 and 11,988 patients, respectively, were treated.RESULTSPatients before and after passage of the opioid laws had generally similar demographic and surgical characteristics. Notably, after passage of the opioid laws, the number of patients taking daily narcotics preoperatively decreased from 3783 (48.7%) to 2698 (39.7%; p < 0.0001). Three months postoperatively, there were no differences in minimum clinically important difference (56.0% vs 58.0%, p = 0.1068), numeric rating scale (NRS) score of back pain (3.5 vs 3.4, p = 0.1156), NRS score of leg pain (2.7 vs 2.7, p = 0.3595), satisfaction (84.4% vs 84.7%, p = 0.6852), or 90-day readmission rate (5.8% vs 6.2%, p = 0.3202) between groups. Although there was no difference in readmission rates, pain as a reason for readmission was marginally more common (0.86% vs 1.22%, p = 0.0323).CONCLUSIONSThere was a meaningful decrease in preoperative narcotic use, but notably there was no apparent negative impact on postoperative recovery, patient satisfaction, or short-term outcomes after spinal surgery despite more restrictive opioid prescribing. Although the readmission rate did not significantly increase, pain as a reason for readmission was marginally more frequently observed.

scholarly journals Therapeutic Use of Cerebellar Intermittent Theta Burst Stimulation (iTBS) in a Sardinian Family Affected by Spinocerebellar Ataxia 38 (SCA 38)

2021 ◽  
Author(s):  
Angela Sanna ◽  
Paolo Follesa ◽  
Paolo Tacconi ◽  
Mariangela Serra ◽  
Maria Giuseppina Pisu ◽  
...  
Keyword(s):  
Spinocerebellar Ataxia ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Therapeutic Use ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Motor Cortex Excitability ◽  
Before And After ◽  
Theta Burst ◽  
Serum Bdnf

AbstractSpinocerebellar ataxia 38 (SCA 38) is an autosomal dominant disorder caused by conventional mutations in the ELOVL5 gene which encodes an enzyme involved in the synthesis of very long fatty acids, with a specific expression in cerebellar Purkinje cells. Three Italian families carrying the mutation, one of which is of Sardinian descent, have been identified and characterized. One session of cerebellar intermittent theta burst stimulation (iTBS) was applied to 6 affected members of the Sardinian family to probe motor cortex excitability measured by motor-evoked potentials (MEPs). Afterwards, patients were exposed to ten sessions of cerebellar real and sham iTBS in a cross-over study and clinical symptoms were evaluated before and after treatment by Modified International Cooperative Ataxia Rating Scale (MICARS). Moreover, serum BDNF levels were evaluated before and after real and sham cerebellar iTBS and the role of BDNF Val66Met polymorphism in influencing iTBS effect was explored. Present data show that one session of cerebellar iTBS was able to increase MEPs in all tested patients, suggesting an enhancement of the cerebello-thalamo-cortical pathway in SCA 38. MICARS scores were reduced after ten sessions of real cerebellar iTBS showing an improvement in clinical symptoms. Finally, although serum BDNF levels were not affected by cerebellar iTBS when considering all samples, segregating for genotype a difference was found between Val66Val and Val66Met carriers. These preliminary data suggest a potential therapeutic use of cerebellar iTBS in improving motor symptoms of SCA38.

scholarly journals Implementation and effectiveness of an intensive education program on phosphate control among hemodialysis patients: a non-randomized, single-arm, single-center trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jinmei Yin ◽  
Jun Yin ◽  
Rongli Lian ◽  
Peiqiu Li ◽  
Jing Zheng
Keyword(s):  
Education Program ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Maintenance Hemodialysis ◽  
Single Center ◽  
Clinical Trial Registry ◽  
Before And After ◽  
Intensive Education ◽  
Phosphate Control

Abstract Background Hyperphosphatemia is a common complication in patients on maintenance hemodialysis. Patients’ adherence to phosphorus control can be improved by consistent education. However, few studies have focused on the model construction and effects of health education on phosphate control for hemodialysis patients. Objective To develop an intensive education program focusing on phosphate control among hemodialysis patients and to analyze the effectiveness of this program. Design A non-randomized, single-arm, single-center trial lasting for 6 months. Setting This program was conducted in a hemodialysis center in a teaching hospital in Zhuhai, China. Participants Patients on maintenance hemodialysis with hyperphosphatemia. Methods An intensive hyperphosphatemia control education program lasting for 6 months was conducted among 366 hemodialysis patients applying the First Principles of Instruction model, which focused on mastering four stages: (a) activation of prior experience, (b) demonstration of skills, (c) application of skills and (d) integration of these skills into real-world activities. The controlled percentage of serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders before and after the education program were assessed. Results The proportion of controlled serum phosphorus was significantly increased from 43.5 to 54.9% (P<0.001). The scores on the knowledge of phosphate control were improved significantly from 59.0 ± 18.9 to 80.6 ± 12.4 (P < 0.001). The proportion of high adherence to phosphate binders was increased dramatically from 21.9 to 44.5% (P < 0.001). Conclusion The intensive education program can effectively improve serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders among hemodialysis patients. Trial registration Chinese Clinical Trial Registry, ChiCTR2100042017. Retrospectively registered January 12th, 2021.

scholarly journals Otoskills training during covid-19 pandemic: a before-after study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maxime Fieux ◽  
Antoine Gavoille ◽  
Fabien Subtil ◽  
Sophie Bartier ◽  
Stéphane Tringali
Keyword(s):  
Surgical Training ◽  
Rating Scale ◽  
Surgical Simulation ◽  
Global Rating Scale ◽  
Middle Ear Surgery ◽  
Global Rating ◽  
Training Requirements ◽  
Significant Difference ◽  
Before And After ◽  
Total Performance

Abstract Background The ongoing COVID-19 pandemic has disrupted the surgical training of residents. There is a real concern that trainees will not be able to meet their training requirements. Low-fidelity surgical simulation appears to be an alternative for surgical training. The educational benefits of repeating ossiculoplasty simulations under a microscope have never been evaluated. With this study we aimed to evaluate the differences in performance scores and on a global rating scale before and after training on an ossiculoplasty simulator. Methods In this quasi-experimental, prospective, single-centre, before-after study with blinded rater evaluation, residents performed five microscopic ossiculoplasty tasks with a difficulty gradient (sliding beads onto rods, the insertion of a partial prosthesis, the insertion of a total prosthesis, and the insertion of a stapedotomy piston under microscopic or endoscopic surgery) before and after training on the same simulator. Performance scores were defined for each task, and total performance scores (score/min) were calculated. All data were collected prospectively. Results Six out of seven intermediate residents and 8/9 novices strongly agreed that the simulator was an effective training device and should be included in the ENT residency program. The mean effect of training was a significant increase in the total performance score (+ 0.52 points/min, [95 % CI, 0.40–0.64], p < 0.001), without a significant difference between novice and intermediate residents. Conclusions This preliminary study shows that techniques for middle-ear surgery can be acquired using a simulator, avoiding any risk for patients, even under lockdown measures.

scholarly journals Evaluation of fecal microbiota transplantation in Parkinson's disease patients with constipation

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Xiao-yi Kuai ◽  
Xiao-han Yao ◽  
Li-juan Xu ◽  
Yu-qing Zhou ◽  
Li-ping Zhang ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Neurodegenerative Disorder ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Motor Symptoms ◽  
Gastrointestinal Dysfunction ◽  
Before And After ◽  
Non Motor Symptoms

AbstractParkinson’s disease (PD) is a neurodegenerative disorder and 70–80% of PD patients suffer from gastrointestinal dysfunction such as constipation. We aimed to assess the efficacy and safety of fecal microbiota transplantation (FMT) for treating PD related to gastrointestinal dysfunction. We conducted a prospective, single- study. Eleven patients with PD received FMT. Fecal samples were collected before and after FMT and subjected to 16S ribosomal DNA (rDNA) gene sequencing. Hoehn-Yahr (H-Y) grade, Unified Parkinson's Disease Rating Scale (UPDRS) score, and the Non-Motion Symptom Questionnaire (NMSS) were used to assess improvements in motor and non-motor symptoms. PAC-QOL score and Wexner constipation score were used to assess the patient's constipation symptoms. All patients were tested by the small intestine breath hydrogen test, performed before and after FMT. Community richness (chao) and microbial structure in before-FMT PD patients were significantly different from the after-FMT. We observed an increased abundance of Blautia and Prevotella in PD patients after FMT, while the abundance of Bacteroidetes decreased dramatically. After FMT, the H-Y grade, UPDRS, and NMSS of PD patients decreased significantly. Through the lactulose H2 breath test, the intestinal bacterial overgrowth (SIBO) in PD patients returned to normal. The PAC-QOL score and Wexner constipation score in after-FMT patients decreased significantly. Our study profiles specific characteristics and microbial dysbiosis in the gut of PD patients. FMT might be a therapeutic potential for reconstructing the gut microbiota of PD patients and improving their motor and non-motor symptoms.

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

scholarly journals Electroconvulsive Therapy and Age: Effectiveness, Safety and Tolerability in the Treatment of Major Depression among Patients under and over 65 Years of Age

2021 ◽  
Vol 14 (6) ◽  
pp. 582
Author(s):  
Monika Dominiak ◽  
Anna Z. Antosik-Wójcińska ◽  
Marcin Wojnar ◽  
Paweł Mierzejewski
Keyword(s):  
Major Depression ◽  
Autobiographical Memory ◽  
Electroconvulsive Therapy ◽  
Cognitive Functions ◽  
Rating Scale ◽  
Short Form ◽  
Serious Adverse Events ◽  
Before And After ◽  
Trail Making ◽  
Resistant Depression

Electroconvulsive therapy (ECT) remains the most effective therapy in treatment-resistant depression. However, the safety of ECT has been consistently questioned, particularly among elderly patients. We assessed the efficacy and safety of ECT in patients before and after 65 years old. The study was conducted between 2015 and 2018 and included 91 patients (61 under and 29 over 65 years old) with major depression undergoing ECT. The Hamilton Depression Rating Scale was used to evaluate efficacy. Cognitive functions were assessed using: MMSE, RAVLT, Trail Making Test, Stroop Test and Autobiographical Memory Interview-Short Form. ECT was more effective in older patients as compared to younger (p < 0.001). No serious adverse events were observed in either group. Increased blood pressure and arrhythmias were more common in the older compared to the younger group (p = 0.044 and p = 0.047, respectively), while disturbances of consciousness did not differ between groups (p = 0.820). Most of the cognitive functions remained unchanged compared to baseline, whereas the outcomes of MMSE, RAVLT and Stroop tests showed greater improvements in the older compared to the younger group (all p < 0.05). The decline in the retrieval consistency of autobiographical memory was more pronounced in the younger group (p = 0.024). ECT is a highly effective, safe and well-tolerated method of treating depression regardless of age.

scholarly journals Diet modification impact on ADHD outcome

2021 ◽  
Vol 45 (1) ◽  
Author(s):  
Olweya Mohammed Abd El Baaki ◽  
Enas Raafat Abd El Hamid ◽  
Safaa Taha Zaki ◽  
Amani Salah El Din Alwakkad ◽  
Rania Nabil Sabry ◽  
...  
Keyword(s):  
Protein Intake ◽  
Rating Scale ◽  
Behavioral Therapy ◽  
Short Form ◽  
Adhd Symptoms ◽  
Parent Rating ◽  
Dietary Analysis ◽  
Dietary Recall ◽  
Diet Modification ◽  
Before And After

Abstract Background Attention-deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders, affects 5% of children worldwide and characterized by impaired inattention, hyperactivity and impulsivity. One of the risk factors that precipitate ADHD is food. Food affects behavior of children by different ways such as food allergy, food intolerance and gut–microbiota–brain axis. The study aimed to assess effect of diet modification on ADHD outcome and the role of food as a precipitating factor for ADHD symptomatology. The study included 47 children newly diagnosed with ADHD, not receiving medical or behavioral therapy, their ages ranged from 6 to 9 years and their intelligence quotient not below 70 with no associated comorbidities. All participants were subjected to Full history taking, clinical examination, anthropometric measurements, 24 h dietary recall. Dietary analysis and Conner’s parent rating scale-revised short form (CPR-RS) were done before and after diet modification program for 5 weeks. Results There was improvement in ADHD symptoms as measured by CPR-RS after 5-weeks of diet modification program. Carbohydrate and protein intake decreased significantly after diet modification program. Energy intake did not show statistical difference while fat intake increased significantly after the diet program. Vitamin A, C, riboflavin, thiamin and iron intakes decreased significantly after diet program but were within the recommended dietary allowance. Conclusion Following the Diet modification program, ADHD symptoms were improved as documented by decrease in CPR scores. Diminished carbohydrate and protein intake in diet were positively associated with improvement of ADHD symptoms. Diet modification program succeeded in reducing obesity and then ADHD symptoms.

scholarly journals Decreasing leakage during continuous femoral nerve catheter fixation using 2-octyl cyanoacrylate glue (Dermabond®): a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Theerawat Chalacheewa ◽  
Vanlapa Arnuntasupakul ◽  
Lisa Sangkum ◽  
Rungrawan Buachai ◽  
Jiravud Chanvitayapongs
Keyword(s):  
Peripheral Nerve ◽  
Rating Scale ◽  
Controlled Trial ◽  
Insertion Site ◽  
Femoral Nerve ◽  
Catheter Removal ◽  
Cyanoacrylate Glue ◽  
Clinical Trial Registry ◽  
Catheter Dislodgement ◽  
Peripheral Nerve Catheter

Abstract Background Continuous peripheral nerve catheters (CPNCs) have been used for postoperative pain relief. A common problem encountered with CPNCs is pericatheter leakage, which can lead to dressing adhesive failure. Frequent dressing changes increase the risk of catheter dislodgement and infections. Adhesive glue is effective in securing the peripheral nerve catheter and decreasing leakage around the catheter insertion site. This study aimed to evaluate the incidence of pericatheter leakage with fixation using 2-octyl cyanoacrylate glue (Dermabond®) as compared to sterile strips. Methods Thirty patients undergoing unilateral total knee arthroplasty (TKA) with continuous femoral nerve catheter for postoperative analgesia were randomized into the catheter fixation with 2-octyl cyanoacrylate glue (Dermabond®) group or the sterile strip group. The primary outcome was the incidence of pericatheter leakage. Secondary outcomes included the frequent of catheter displacement, the difficulty of catheter removal, pain score and patient satisfaction. Results The incidence of pericatheter leakage at 24 and 48 h was 0% versus 93 and 0% versus 100% in the Dermabond® and sterile strip groups, respectively (P < 0.001). The incidence of displacement at 24 and 48 h was 6.7% versus 93.3 and 6.7% versus 100% in the Dermabond® and sterile strip, respectively (P < 0.001). There was no difference in numeric rating scale, difficulty of catheter removal, or satisfaction scores between groups. Conclusions Catheter fixation with 2-octyl cyanoacrylate glue (Dermabond®) decreased the incidence of pericatheter leakage, as well as catheter displacement, over 48 h as compared to sterile strip fixation. Trial registration This trial was registered on Thai clinical trial registry: TCTR20200228002, registered 24 February 2020- Retrospectively registered.

scholarly journals Analgesic Effects of Preincision Ketamine on Postspinal Caesarean Delivery in Uganda’s Tertiary Hospital: A Randomized Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-6
Author(s):  
Richard Mwase ◽  
Tonny Stone Luggya ◽  
John Mark Kasumba ◽  
Humphrey Wanzira ◽  
Andrew Kintu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rating Scale ◽  
Breakthrough Pain ◽  
Numerical Rating Scale ◽  
Postoperative Pain Management ◽  
Mulago Hospital ◽  
Clinical Trial Registry ◽  
Analgesic Effects ◽  
Pain Scores ◽  
Intravenous Ketamine

Background. Good postoperative analgesic management improves maternal satisfaction and care of the neonate. Postoperative pain management is a challenge in Mulago Hospital, yet ketamine is accessible and has proven benefit. We determined ketamine’s postoperative analgesic effects.Materials and Methods. We did an RCT among consenting parturients that were randomized to receive either intravenous ketamine (0.25 mg/kg) or placebo after spinal anesthetic. Pain was assessed every 30 mins up to 24 hours postoperatively using the numerical rating scale. The first complaint of pain requiring treatment was noted as “time to first breakthrough pain.”Results. We screened 100 patients and recruited 88 that were randomized into two arms of 44 patients that received either ketamine or placebo. Ketamine group had 30-minute longer time to first breakthrough pain and lower 24-hour pain scores. Postoperative diclofenac consumption was lesser in the ketamine group compared to placebo and Kaplan-Meier graphs showed a higher probability of experiencing breakthrough pain earlier in the placebo group.Conclusion. Preincision intravenous ketamine (0.25 mg/kg) offered 30-minute prolongation to postoperative analgesia requirement with reduced 24-hour pain scores. We recommend larger studies to explore this benefit. This trial is registered with Pan African Clinical Trial Registry numberPACTR201404000807178.

Sign in / Sign up

Export Citation Format

Share Document