scholarly journals Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Chun Yang ◽  
Xianjian Huang ◽  
Junfeng Feng ◽  
Li Xie ◽  
Jiyuan Hui ◽  
...  
Keyword(s):  
Epidural Hematoma ◽  
Controlled Trial ◽  
Brain Herniation ◽  
Post Injury ◽  
Link Type ◽  
Randomized Evaluation ◽  
Surgical Options ◽  
Acute Epidural Hematoma ◽  
Treatment Procedures

Abstract Background The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, controversy exists on the optimal surgical options for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted with the decision to evacuate the hematoma with decompressive craniectomy (DC) or craniotomy. Methods/design Patients of both sexes, age between 18 and 65 years, who presented to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, were assessed against the inclusion and exclusion criteria to be enrolled in the study. Clinical and radiological information, including diagnosis of AEDH, treatment procedures, and follow-up data at 1, 3, and 6 months after injury, was collected from 120 eligible patients in 51 centers. The patients were randomized into groups of DC versus craniotomy in a 1:1 ratio. The primary outcome was the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes included incidence of postoperative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicators within 6 months post-injury. Discussion This study is expected to support neurosurgeons in their decision to evacuate the epidural hematoma with or without a DC, especially in patients with brain herniation, and provide additional evidence to improve the knowledge in clinical practice. Trial registration ClinicalTrials.govNCT 04261673. Registered on 04 February 2020

scholarly journals Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Chun Yang ◽  
Xianjian Huang ◽  
Junfeng Feng ◽  
Li Xie ◽  
Jiyuan Hui ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Decompressive Craniectomy ◽  
Epidural Hematoma ◽  
Controlled Trial ◽  
Economic Benefits ◽  
Brain Herniation ◽  
Post Injury ◽  
Randomized Controlled ◽  
Cerebral Herniation ◽  
Acute Epidural Hematoma

Abstract Background: Expeditiously surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, controversy exists on the optimal surgical treatment for AEDH, especially for patients with brain herniation. Neurosurgeons are confronted by the decision to evacuate the hematoma with decompressive craniectomy or craniotomy. Here, we present the protocol for a randomized controlled trial targeted at comparing the outcome and economic benefits of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury (TBI) patients with cerebral herniation undergoing evacuation of AEDH.Methods/design: Patients of both genders, aged from 18 to 65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH with herniation, comply with other inclusion and exclusion criteria are enrolled. Clinical information, including diagnosis of AEDH, clinical radiological information and treatment procedures, follow-up data of 1, 3 and 6 months post injury are collected on 120 eligible patients, randomized into groups of decompressive craniectomy versus craniotomy in a 1:1 ratio among 51 centers. The primary outcome is the Glasgow Outcome Score-Extended (GOSE) at 6 months post-injury. Secondary outcomes include incidence of post-operative cerebral infarction, incidence of additional craniocerebral surgery, and other evaluation indicator within 6 months post-injury.Discussion: This study is expected to help neurosurgeons make a better decision to evacuate the epidural hematoma with or without a DC, especially for patients with brain herniation, and improve current situation of lack of general evidence.Trial registration: Clinicaltrials.gov: NCT 04261673 (Registration date: 04 February 2020)

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).

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals A criteria-based rehabilitation program for chronic mid-portion Achilles tendinopathy: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Colin Griffin ◽  
Katherine Daniels ◽  
Caroline Hill ◽  
Andrew Franklyn-Miller ◽  
Jean-Benoît Morin
Keyword(s):  
Lower Limb ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Achilles Tendinopathy ◽  
Treadmill Running ◽  
Plantar Flexor ◽  
Post Intervention ◽  
Link Type

Abstract Background Achilles tendinopathy (AT) is a common overuse injury in running-related sports where patients experience pain and impaired function which can persist. A graded rehabilitation program has been successful in reducing pain and improving function to enable a return to sport. The aim of this study is to compare the effectiveness of a criteria-based rehabilitation program including strength and reactive strength targets, with a previously successful rehabilitation program on changes in pain and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire. Secondary aims will be to assess changes in calf strength, reactive strength, and lower limb running and forward hop biomechanics over the course of a 12-week rehabilitation program, and long-term follow-up investigations. Methods Sixty eligible participants with chronic mid-portion AT who train in running-based sports will be included in this study. They will be randomly assigned to a group that will follow an evidence-based rehabilitation program of daily exercises with progression guided by symptoms or a group performing 3 high-intensity rehabilitation sessions per week with individualised load targets progressing to reactive strength exercises. Testing will take place at baseline, week 6 and 12. Plantar flexor peak torque will be measured using isokinetic dynamometry, reactive strength will be measured using a drop jump and lower limb biomechanical variables will be measured during a single leg forward hurdle hop test and treadmill running using 3D motion analysis. Follow-up interviews will take place at 6, 12 and 24 months after beginning the program which will assess patient participation in sport and possible re-injury. Discussion This is the first study to propose an individualised criteria-based graded rehabilitation program in patients in with chronic mid-portion Achilles tendinopathy where progression is guided by strength and reactive strength outcome measures. This study will provide a comprehensive assessment of plantar flexor strength, reactive strength and lower limb biomechanical variables in running and forward hopping with the VISA-A questionnaire as the primary outcome measure and long term post-intervention follow-up assessments performed. Trial registration ClinicalTrials.gov (ID: NCT04384874). Registered retrospectively on April 23rd 2020.

scholarly journals The iHealth-T2D study: Statistical analysis plan for a cluster randomised controlled trial with intensive family-based lifestyle modification programme to reduce type 2 diabetes risk amongst South Asians

2020 ◽  
Author(s):  
Mirthe Muilwijk ◽  
Marie Loh ◽  
Sara Mahmood ◽  
Saranya Palaniswamy ◽  
Samreen Siddiqui ◽  
...  
Keyword(s):  
Lifestyle Modification ◽  
South Asians ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Statistical Analysis Plan ◽  
Link Type ◽  
Family Based ◽  
Randomised Controlled

AbstractBackgroundSouth Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high-costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.MethodsThe iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. A total of 3,682 South Asian men and women with age between 40-70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥95cm in Sri Lanka, or ≥100cm in India, Pakistan and UK) and/or prediabetes (HbA1c ≥6.0%)] were included in the trial. Here we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after three years of follow-up after enrolment to the study, and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after one and three years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.DiscussionThe iHealth-T2D trial will provide evidence whether an intensive family-based lifestyle modification programme in South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/; ClinicalTrials.govNCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.

scholarly journals Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e022242 ◽  
Author(s):  
Kerstin Kempf ◽  
Martin Röhling ◽  
Stephan Martin ◽  
Michael Schneider
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Reduction ◽  
Controlled Trial ◽  
Eating Behaviour ◽  
Healthcare Setting ◽  
Intention To Treat ◽  
Link Type ◽  
Randomised Controlled

ObjectivesWe examined the effect of a telemedical coaching (TMC) programme accompanied with or without telemonitoring on weight loss in an occupational healthcare setting with a three-armed randomised controlled trial (NCT01837134’Pre-results').MethodsOverweight employees (n=104, body mass index [BMI] ≥25 kg/m2) were invited by their medical corporate department and randomised into either a TMC group (n=34) or in one of the two control groups (C1, n=34; C2, n=36). TMC and C1 were equipped with telemonitoring devices (scales and pedometers) at baseline, and C2 after 6 months. Telemonitoring devices automatically transferred data into a personalised online portal. TMC was coached with weekly care calls in months 3–6 and monthly calls from months 7 to 12. C2 had a short coaching phase in months 6–9. C1 received no further support. After the 12-month intervention phase, participants could take advantage of further company health promotion offers. Follow-up data were determined after 12 months of intervention and per-protocol (PP) and intention-to-treat (ITT) analyses were performed. Weight change was followed up after 36 months. Estimated treatment difference (ETD) was calculated for weight reduction.ResultsETD from TMC to C1 (−3.6 kg 95% CI −7.40 to −0.1, p=0.047) and to C2 (−4.2 kg [−7.90 to −0.5], p=0.026) was significantly different at the 12 months follow-up in the PP-analysis, but lost significance in the ITT analysis. All groups reduced weight after 12 months (−3.3 to −8.4 kg [5.5–10.3 kg], all p<0.01) and sustained it during the 36 months follow-up (−4.8 to −7.8 kg [5.6–12.8 kg], all p<0.01). ETD analyses revealed no difference between all groups neither in the PP nor in the ITT analysis at the 3 years follow-up. All groups reduced BMI, systolic and diastolic blood pressure and improved eating behaviour in the PP or ITT analyses.ConclusionsTMC and/or telemonitoring support long-term weight reduction in overweight employees. The combination of both interventions points towards an additional effect.Trial registration numberNCT01837134.

Traumatic Acute Epidural Hematoma: Unrecognized High Lethality in Comatose Patients

Neurosurgery ◽  
1984 ◽  
Vol 15 (5) ◽  
pp. 617-620 ◽  
Author(s):  
John M. Seelig ◽  
Lawrence F. Marshall ◽  
Steven M. Toutant ◽  
Belinda M. Toole ◽  
Melville R. Klauber ◽  
...  
Keyword(s):  
Ct Scan ◽  
Epidural Hematoma ◽  
Vegetative State ◽  
Closed Head Injury ◽  
Data Bank ◽  
Motor Score ◽  
Computed Tomographic ◽  
Satisfactory Outcome ◽  
Acute Epidural Hematoma

Abstract A series of 51 comatose patients suffering traumatic epidural hematoma after closed head injury is reviewed. This prospective series was accumulated from the National Pilot Traumatic Coma Data Bank during a 2-year period and represents 9% of all patients entered into the Data Bank. The overall mortality was 41%, with 4% remaining in the vegetative state. Fifty per cent of these patients, all of whom were in coma, also had an associated intracerebral contusion. There was no difference in outcome with regard to sex, mode of injury, or the presence or absence of contusion or shift on the computed tomographic (CT) scan. The motor score immediately before operation was the most powerful preoperative predictor of outcome. Sixty-seven per cent or two-thirds of the patients with a motor score of 4, 5, or 6 on the Glasgow coma scale had a satisfactory outcome at last follow-up examination. In contrast, in patients with a motor score of 3 or less, two-thirds either died or remained in a vegetative state. The acute traumatic epidural hematoma is often lethal in the comatose patient. We recommend early evacuation of epidural hematomas, i.e., when they are first noted on the CT scan, rather than waiting for clinical motor deterioration.

scholarly journals Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sai Ho Sin ◽  
Jing Wu ◽  
Yuchen Kang ◽  
Kar Hung Kevin Yip ◽  
Ngo Suet Kong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Control Group ◽  
Waitlist Control ◽  
Link Type ◽  
Waitlist Control Group ◽  
Banxia Xiexin Decoction

Abstract Background Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome. Methods/design A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests. Discussion This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome. Trial registration ClinicalTrials.govNCT04398888. Registered on May 21, 2020

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