observational trial
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2022 ◽  
Vol 12 (6) ◽  
pp. 37-41
Author(s):  
Kamthe Kunal ◽  
Kohli Pooja ◽  
Wankhede Tushar

Despite the advances in technology and robotics, the basics of surgical management are not changed drastically. The science of life, Ayurveda has extensive knowledge of surgeries, including complicated procedures mentioned in the classical texts. However, with time, the ability of anaesthetics and analgesic agents has been lost. This resulted in the lagging of Ayurvedic Surgical wisdom and the rise of modern analgesics and anaesthetics in the market. These current products have potential side effects, and hence a safer and better alternative to these products can boost Ayurveda Surgery worldwide. Trailokya Vijaya Vati (TVV) is one such Ayurvedic formulation that is explained for its potent analgesic activity. The present study was conducted to evaluate the safety and efficacy of TVV in post-operative pain management in patients undergoing anorectal procedures. The observational trial suggested a reduction in time to sleep (p < 0.05), less incidence of insomnia and undisturbed sleep in the treatment group than the control. The formulation was also well tolerated with no or minimal requirement of rescue analgesics. The efficacy observed in the study suggests the formulation can be explored further on a larger population with a diverse activity profile.


2021 ◽  
Vol 3 (Supplement_4) ◽  
pp. iv3-iv3
Author(s):  
Omar Butt ◽  
Alice Zhou ◽  
Ken Lee ◽  
Gregory Wu ◽  
Sheng-Kwei Song ◽  
...  

Abstract BACKGROUND Immune effector cell associated neurotoxicity syndrome (ICANS) remains a devastating, frequent complication of chimeric antigen receptor (CAR) T cell therapy for advanced-stage hematologic malignancies. Symptoms range from encephalopathy and headaches to aphasia, strokes, and diffuse cerebral edema. Persistent mild cognitive symptoms have also been reported. Unfortunately, the underlying pathophysiology driving ICANS is poorly understood. Current proposed models center on systemic inflammatory changes leading to endothelial dysfunction, blood-brain barrier (BBB) breakdown, and systemic cytokine and/or monocytes infiltration into the central nervous system (CNS). However, these models do not integrate predisposing risk factors for the development of ICANS. We previously demonstrated that pre-infusion plasma neurofilament light chain (NfL), a marker of neurodegeneration, may predict development of ICANS. Early elevations in NfL suggest development of ICANS is also related to pre-existing neuroaxonal injury. The longitudinal relationship between latent neuroaxonal injury, blood brain barrier (BBB) integrity, neuroinflammation, and cognition remains unknown. METHODS This prospective, observational trial examines the relationship between multi-modal (blood, cerebrospinal fluid (CSF), neuroimaging) biomarkers and cognition in a cohort of twenty patients undergoing standard-of-care CAR T cellular therapy. Biomarkers for neural injury include blood and CSF NfL and volumetric measures derived from structural magnetic resonance imaging (MRI). Biomarkers for neuroinflammation include blood and CSF glial fibrillary acidic protein (GFAP) and qualification of white matter hyper-intensity burden on MRI. BBB integrity will be quantified using the serum/CSF albumin ratio. Finally, neuropsychological performance testing will assay cognitive performance across multiple cortical domains including attention, memory, and executive function. Participants will undergo a baseline (pre-infusion) examination, followed by evaluation (blood draw, voluntary lumbar puncture, MRI scan, and cognitive testing) on post-infusion day 3 (D3), D30, D90, and D180. The primary outcome is percent change in a given biomarker level. RESULTS/CONCLUSIONS This ongoing trial has 2 of 20 planned participants enrolled.


2021 ◽  
Vol 50 (1) ◽  
Author(s):  
Juan Sebastián Parada Zuluaga ◽  
Diego Alejandro Bastidas Palacios ◽  
Yerlin Andrés Colina Vargas ◽  
Nury Isabel Socha García ◽  
Juan Guillermo Barrientos Gómez ◽  
...  

Introduction: The duration of labor and the immediate puerperium are affected by obstetric and maternal-fetal factors. Interventions to provide obstetric analgesia may prolong the hospital stay. Objective: To characterize the procedure for obstetric analgesia and describe the time elapsed between analgesia and delivery and postpartum surveillance in healthy mothers. Methods: Observational, descriptive trial. The time elapsed between analgesia and delivery, and postpartum surveillance were measured in healthy pregnant women with vaginal delivery and a prescription of a neuraxial analgesia technique. Results: 226 patients were included. The mean time elapsed between analgesia an delivery was 4 hours (IQR 3-7). 50.7 % (n = 114) received early analgesia (neuraxial technique with ≤ 4 centimeters of cervical dilatation), of which 48.2 % (n = 109) experienced a duration of analgesia until delivery longer than expected. The mean cervical dilatation at the time of the neuraxial approach was 4 centimeters (IQR 4-6) and the epidural technique was the most frequently used – 92.9 % (n = 210). The mean postpartum surveillance was 20 hours (IQR 15-27). Conclusions: Half of the patients included received early analgesia and around fifty percent of them took longer than expected in completing delivery. The postpartum surveillance time was consistent with the provisions of the Ministry of Health and with the current trend of a short postpartum surveillance aimed at early hospital discharge and the benefits thereof.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mariell Hoffmann ◽  
Sandra Stengel ◽  
Johanna Forstner ◽  
Annika Baldauf ◽  
Gunter Laux ◽  
...  

Abstract Background A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by admission to hospital with the aim of preventing an overburdening of clinics. However, little is known of the effect of risk factors on the course of the infection of outpatient patients. To support general practices in managing high risk patients, we designed a COVID-19 surveillance and care tool (CovidCare). It includes an initial assessment of yet known risk factors and symptoms and a continuous telephone monitoring of signs and symptoms. This study aims to investigate the effects of different risk factors on the course of the COVID-19 disease, utilisation of different health care services and to gain insights into the utilisation of CovidCare in general practices. Methods We will conduct a multi-centered prospective, longitudinal non-controlled observational trial of COVID-19 patients in general practices. Overall, 700 GPs who participate in general-practice centered care by the AOK Baden-Württemberg (large German sickness fund) are eligible and will be invited for study participation, including adult, outpatient COVID-19 patients (or urgent suspicion and ≥ 50 years) with at least one additional known risk factor, who participate in general-practice centered care. The primary outcome is hospitalisation due to COVID-19. Secondary outcomes are diagnosis of pneumonia, utilisation of palliative care, mortality rate, anxiety and identification of predictive risk factors. Quantitative data analysis will focus on valid descriptive figures and mixed regression models. The accompanying process evaluation is based on interviews and questionnaires from general practice staff and patients. The analysis of the process evaluation is descriptive and explorative. Discussion The use of the COVID-19 surveillance and care tool is expected to encourage the provision of structured quality of care during the ongoing pandemic. This trial will provide an understanding of the COVID-19-disease and the effect of several risk factors on the course of the disease and health care utilisation. The results can be used for a better management of the COVID-19 pandemic and its consequences. Trial registration German Clinical Trials Register DRKS00022054.


2021 ◽  
pp. 1-14
Author(s):  
Gabriele Rotter ◽  
Sylvia Binting ◽  
Tatjana Tissen-Diabaté ◽  
Miriam Ortiz ◽  
Benno Brinkhaus

<b><i>Background and Aim:</i></b> Patients with chronic musculoskeletal pain diseases (CMPDs) often use osteopathic medicine (OM), although the changes in patients with pain diseases are still insufficiently investigated. This study aimed to observe changes along and after OM in addition to routine care on pain, functioning, and quality of life in patients with four CMPDs. <b><i>Methods:</i></b> In this observational trial with follow-up, patients suffering from chronic neck pain (CNP, <i>n</i> = 10), chronic low back pain (CLBP, <i>n</i> = 10), chronic shoulder pain (CSP, <i>n</i> = 10), or chronic knee pain (CKP, <i>n</i> = 10) received up to six OM sessions in addition to routine care. <b><i>Results:</i></b> A total of 40 patients (73% female, mean age 47.7 ± 8.3 years, mean pain intensity 59.4 ± 12.5 mm, measured by a visual analog scale [VAS] 0–100 mm) were included. After 26 weeks, there was an improvement in the VAS pain score in the whole population (mean difference to baseline –33.1 mm [95% CI –40.5 to –25.7]), as well in the patients with the four diseases: CNP (–33.7 mm [–54.7 to –12.6]), CLBP (–28.2 mm [–47.9 to –8.4]), CSP (–32.4 [–46.8 to –18.0]), and CKP (–38.1 mm [–49.1 to –27.0]). Regarding disease-specific outcomes, we found improvements in CNP, as measured by the neck disability index (scale 0–50; mean difference –3.6 [–9.0 to 1.9]), CLBP, as measured by the low back pain rating scale (scale 0–60; –3.4 [–12.5 to 5.7]), CSP, as measured by the disabilities of the arm, shoulder and hand score (scale 0–100; –13.4 [–23.1 to –3.7]), and CKP, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (scale 0–96; –13.0 [–23.5 to –2.5]). These improvements persisted through week 52. No adverse events were observed. <b><i>Conclusion:</i></b> The study observed beneficial changes along and after the OM treatment in addition to routine care in patients with four different CMPDs. High-quality, multicenter randomized controlled trials are strongly needed to compare the effectiveness of OM and standard care interventions in treating CMPDs in the future. We have provided sufficient data for sample size calculations for these trials.


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