Comparative Clinical Trial Research Articles

Prospective comparative clinical trials of novel non-invasive intracranial pressure pulse wave monitoring technologies: preliminary clinical data.

Intracranial pressure (ICP) monitoring is crucial in the management of traumatic brain injury (TBI) and other neurological conditions. Elevated ICP or too low intracranial compliance (ICC) can compromise brain perfusion. Simultaneous monitoring of ICP and ICC is needed to optimize patient-specific brain perfusion in pathological conditions. Surrogate ICC changes can be extracted by analysis of ICP pulse wave morphology. Non-invasive, fully passive sensor and ICC changes monitoring are needed. This study introduces Archimedes, a novel, fully passive, non-invasive ICP wave monitor that utilizes mechanical pulsatile movement of the eyeball to assess ICP pulse waveforms. Preliminary findings indicate a high correlation r = [0.919; 0.96] between non-invasive and invasive ICP pulse wave morphologies, demonstrating the device's potential for accurate ICP pulse waveform monitoring. Additionally, the monitor can discern ICC changes, providing valuable insights for TBI and normal tension glaucoma patients according to the shape of non-invasive measured ICP pulse wave. The k-nearest neighbours algorithm used in preliminary glaucoma studies yielded promising diagnostic performance, with an accuracy of 0.89, sensitivity of 0.82, specificity of 1.0 and area under curve 0.91. Ethical approvals for ongoing studies have been secured. Initial results indicate that Archimedes real-time ICC non-invasive monitor is safe, cost-effective alternative to conventional monitoring techniques.

Pitfalls of Choosing a Study End Point Including Cardiovascular Death in Comparative Clinical Trials

Pitfalls of Choosing a Study End Point Including Cardiovascular Death in Comparative Clinical Trials

Contactless radar-based heart rate estimation in palliative care – a feasibility study and possible use in symptom management

BackgroundHeart rate (HR) monitoring is a medical standard to provide information about a patient’s health status. In palliative care, relationship and social engagement are crucial therapeutic concepts. For fear of disrupting communication, social contact, and care, continuous HR monitoring is underutilised despite its potential to inform on symptom burden and therapeutic effects. This study investigates radar-based HR monitoring as an innovative and burden-free approach for palliative care patients, compares its accuracy with conventional ECG methods, and shows potential for therapeutic guidance.MethodsA single-centre, comparative clinical trial was conducted with palliative care patients at the ward of the Department of Palliative Medicine of the University Hospital of Erlangen. The HR measurements obtained with radar were compared with Holter ECG (study arm I, overnight) and Task Force® Monitor (TFM)-based ECG validation recordings (study arm II, one hour). In addition, long-term radar measurements without validation were analysed in comparison with clinical health records (study arm III).ResultsBoth validation methods showed correlation by scatter plot, modified Bland-Altman plot, and equivalence testing. N = 34 patients participated in study arm I. HR of 4,079 five-minute intervals was analysed. Radar measurements and ECG showed high agreement: difference of HRs was within \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document}5 bpm in 3780 of 4079 (92.67%) and within ±13.4 bpm (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document}1.96 times the SD of the mean) in 3979 (97.55%) intervals, respectively. In study arm II, n = 19 patients participated. 57,048 heart beats were analysed. The HR difference was within \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document}5 bpm for 53,583 out of 57,048 beats (93.93%) and within \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document}8.2 bpm ( ± 1.96 times the SD of the mean) in 55,439 beats (97.25%), respectively. Arm III showed HR changes extracted from radar data in correlation with symptoms and treatment.ConclusionRadar-based HR monitoring shows a high agreement in comparison with ECG-based HR monitoring and thus offers an option for continuous and above all burden-free HR assessment, with the potential for use in symptom management in palliative care, among others. Further research and technological advancements are still necessary to fully realize this innovative approach in enhancing palliative care practices.

Comparing the efficacy of repositioning manoeuvres over medications in the treatment of posterior and lateral canal benign paroxysmal positional vertigo: a prospective, randomized and comparative study

Background: Benign paroxysmal positional vertigo (BPPV) is a benign peripheral disorder of vestibular system and is the most common cause of peripheral vertigo. The aim of our study was to compare and assess the efficacy of Epley’s and Barbeque roll over manoeuvres with labyrinthine sedatives in the management of Benign Paroxysmal Positional Vertigo (BPPV) over a period of one month and to know the prevalence of BPPV in different age and gender groups among the two semicircular canals(posterior and lateral). Methods-This prospective randomized comparative clinical trial included 60 patients with clinically diagnosed BPPV in a tertiary care centre and were investigated for a period on one year. The clinical diagnosis of specific canal type of BPPV was assessed based on the diagnostic tests, Dix Hallpike test and McClure test. In manoeuvre group, posterior canal BPPV, Epley’s manoeuvre was performed and for lateral canal BPPV, Barbeque roll over manoeuvre was performed as treatment. In pharmacological group, labyrinthine sedatives i.e. either cinnarizine 25mg twice a day or betahistine 16 mg twice a day were administered for one month as treatment. Results: Results were assessed at the end of 48 hours (immediate time period) and at four weeks’ time period after the treatment, under three different outcome categories namely disappeared, improving and unchanged. Treatment of Benign Paroxysmal Positional Vertigo with repositioning manoeuvre had higher success percentage of 83.3% than the medical treatment. Conclusion: The treatment of BPPV with repostioning manoeuvres had a better outcome than the medical treatment.

Involving Youth with Intellectual and/or Developmental Disabilities as Collaborators in a Comparative Effectiveness Trial: A Community-Engaged Research Approach

BackgroundPractices to include youth with intellectual and/or developmental disabilities (IDD) are necessary to design and implement research that specifically meets the behavioral health needs of this population. This article describes a protocol for engaging youth with IDD as collaborators in a comparative effectiveness clinical trial using a community-engaged research (CEnR) approach. MethodsOur engagement protocol, guided by the Community Engaged Research (CEnR) Framework, emphasized harm avoidance, accessibility, demonstrated value, capacity bridging and co-learning, shared power and equity in decision-making, accountability and respect, and transparent communication. We involved seven youth with IDD in a Youth Advisory Committee (YAC) and four youth with IDD in a Summer Scholars program, ensuring consistent and structured engagement throughout the study. ResultsYouth with IDD maintained high levels of engagement in both the YAC and Summer Scholars Program with 100 % retention across two years. Youth used multiple modalities to provide feedback on aspects of the research project, resulting in study modifications, the co-development of products, and tangible improvements in the accessibility and relevance of the study for youth with IDD. ConclusionResearchers and clinicians seeking to engage the historically underserved population of disabled youth in clinical trial research can leverage our findings to enhance the accessibility and inclusivity of their studies.

A US payer budget impact analysis of Flurpiridaz-PET-MPI compared to SPECT-MPI in the diagnosis of coronary artery disease

Aims This economic model was developed to assess the budget impact of a novel radiotracer, Flurpiridaz (F18-PET-MPI), compared to SPECT-MPI from a US payer perspective. Materials and Methods The model was developed comparing F18-PET-MPI and SPECT-MPI, with F18-PET-MPI modality share increasing from 0.5% to 2.5% of the total MPI modality share, over a 5-year time horizon. The model estimates the impact of diagnostic performance on downstream healthcare resource utilization (HCRU) including invasive coronary angiography (ICA), revascularization, pharmacological treatment, and cardiac outcomes (CO) such as cardiac mortality (CM) and myocardial infarction (MI). Four suspected CAD populations, including general and difficult-to-image subgroups, were analyzed. Clinical inputs used to support the parameterization of the model were sourced from a systematic literature search and included claims-based real-world evidence, observational, and multicenter registry studies to inform the rates of HCRU and CO, and head-to-head comparative clinical trial data advised diagnostic performance inputs. Reimbursement codes informed MPI modality costs. Results are reported as per-member per-month (PMPM) based on a hypothetical health plan. Results In all suspected CAD populations analyzed, there was a nominal cost increase in the world with F18-PET-MPI. The 5-year average PMPM incremental budget impact ranged from $0.02 to $0.05 across all suspected CAD subgroups. Cost-savings were associated with decreased downstream CO such as CM, MI, and ICA. Limitations and Conclusion The available literature to source all parameters in the model was limited; therefore, assumptions and additional calculations were made based on published evidence to inform the model. A one-way sensitivity analysis was performed to confirm and address uncertainty in key parameters. This comprehensive analysis illustrates that the superior diagnostic performance of F18-PET-MPI may result in reduced adverse CO events and associated costs, increased appropriate identification and treatment of CAD, and a minimal increase in overall costs among general and difficult-to-image patient subgroups.

Ustekinumab Biosimilars

Ustekinumab is a fully human IgG1k monoclonal antibody that binds with high affinity and specificity to the p40 subunit of interleukins (IL-) 12 and 23, inhibiting their activity by preventing binding to their receptors. The European extension of the patent (Supplementary Protection Certificate) of ustekinumab expired on 20 July 2024. Biosimilar alternatives to ustekinumab are now an additional option for treating patients. The efficacy data for this drug in moderate-to-severe psoriasis obtained both from clinical trials and indirect comparisons through meta-analyses, are superior to those of etanercept and adalimumab, and its safety profile is more favorable than that of tumor necrosis factor (TNF) inhibitors. Several ustekinumab biosimilars have already been approved by regulatory agencies: between October 2023 and October 2024, Wezlana® (Amgen ABP 654), Uzpruvo® (Alvotech AVT04) and Pyzchiva® (Samsung/Bioepis SB17) have been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). SteQeyma® (Celltrion Healthcare CT-P43) was approved by the EMA in August 2024. Otulfi® (Fresenius Kabi/Formycon) was approved by the FDA in October 2024. Several other potential biosimilar candidates are under development, including BAT2206 (Bio-Thera), DMB-3115 (Dong-A ST), QX001S (Qyuns Therapeutic), BFI-751 (BioFactura), NeuLara (Neuclone), ONS3040 (Oncobiologics), and BOW090 (Epirus Biopharmaceuticals). In most cases, these monoclonal antibodies are expressed in cell lines (e.g., Chinese Hamster Ovary, CHO) different from those used for the originator (Sp2/0 spleen cell murine myeloma); of note, the cell line of origin is not a requirement for biosimilarity in the totality-of-evidence comparison exercise and may facilitate the production and reduce the immunogenicity of biosimilars originated in CHO cultures. This narrative review summarizes the available data on characteristics of the full comparability exercises and comparative clinical trials of these drugs.

Measurement of acute postoperative pain intensity in orthopedic trials: a qualitative concept elicitation study.

Pain intensity is an important outcome in clinical trials of surgery because pain relief is important to patients. Currently, recommended scales are the numeric rating scale 0-10 and visual analogue scale. However, these scales allow for considerable influence of individual imagination, previous experience, and coping skills, limiting proficiency in comparative clinical trials. We aimed to explore postoperative expressions of "how much it hurts"-the first step to improve pain intensity measurement. This was a qualitative study using inductive content analysis: words and visual cues describing pain intensity were collected from (i) existing pain intensity measures by search of COSMIN, PubMed, and Google, (ii) patient interviews recorded and transcribed word-for-word, (iii) clinician interviews transcribed likewise, and (iv) 100 patient telephone interviews with notes taken. After familiarization, the collected expressions were labelled inductively in categories and assembled in tables (case and theme-based matrices). Descriptors fell into 12 categories: intensity (slight/strong), evaluative (negligible/unbearable), cognitive impact (distracting/can be ignored), activity impact (limits some/all activity), sleep impact (can/cannot sleep), examples (like stubbing a toe), physical signs (crying/writhing), associated symptoms (nauseating/tiring), treatment (ice helps/need morphine), affective (annoying/dreadful), discriminative (aching/piercing), and general recovery (hindering recovery/functional interference). Many visual cues were also identified. Literature and recorded interviews gave rise to the categories, and telephone interviews found saturation, providing no further categories. Pain intensity is expressed by terms that fall into 12 categories and by a variety of graphic elements. This advances development of a patient-reported outcome measure of pain intensity for orthopedic trials.

Laser hemorrhoidoplasty versus hemorrhoidectomy in the treatment of surgically indicated hemorrhoids in inflammatory bowel patients: a randomized comparative clinical study.

This study aims to assess and compare the outcomes of traditional surgery and laser surgery for anal hemorrhoids in patients with inflammatory bowel disease. This is a single-center prospective randomized comparative clinical trial performed at Zagazig University Hospitals from September 2023 to September 2024. The study comprised 48 patients who were admitted during this period and had inflammatory bowel disease along with hemorrhoids. The patients were randomly allocated into two groups: Group I consisted of 24 patients who underwent laser hemorrhoidoplasty, selected based on odd numbers, while Group II consisted of 24 patients who underwent traditional surgery, selected based on even numbers. Group I, which underwent laser treatment for hemorrhoids in inflammatory bowel patients, demonstrated significantly better outcomes than traditional surgery (p < 0.001) regarding operation time, pain score and duration, postoperative anal discharge, return to work time, and patient satisfaction. Moreover, laser treatment was found to be more effective than traditional surgery for treating hemorrhoids in inflammatory bowel patients in terms of postoperative bleeding and anal stenosis. Additionally, there was a higher frequency of residual hemorrhoids in laser group. Laser treatment is mostly superior to traditional surgery for hemorrhoids in inflammatory bowel patients. Clinical Trial.gov (NCT06216223), registered on December 27, 2023, last updated in May 12, 2024. PROTOCOL REGISTRATION ID: #101080-5-9-2023.

Accuracy of dental implant placement with CAD-CAM 3D printed and conventional thermoplastic surgical pilot guides: A clinical comparative trial

Statement of problemDental implant placement is routinely guided by using 2-dimensional radiographs and thermoplastic surgical guides (CTGs), which may lack accuracy. Three-dimensionally (3D) printed surgical guides (3DGs) have been recommended to improve accuracy. However, they require additional training on specific technology. The current knowledge on indications for CTGs and 3DGs is limited. PurposeThe purposes of this clinical comparative trial were to compare the accuracy of implant placement using a CTG or 3DG pilot surgical guide (3DGp) and to evaluate clinical outcomes related to the surgical procedure. Material and methodsPatients planned for a single implant were recruited and assigned to either the CTG or 3DGp group. The ideal implant position was determined through virtual treatment planning using intraoral digital scans and cone beam computed tomography (CBCT). Deviations were determined by superimposing the postsurgical digital scans and the virtually planned implant position. The Mann Whitney U Test was performed for each measure (α=.05). A linear regression model was performed to estimate and control for the effect of covariables. ResultsTwenty participants were recruited (10 CTG and 10 3DGp). Mean initial ISQ values were 69 ±13 and 76 ±8 for the CTG and 3DGp group, respectively. There was no significant difference in primary (P=.15) or secondary (P=.383) stability between the CTG and 3DGp groups. Data revealed minimal deviations for both groups (P>.05). Bone type (P=.026) and secondary stability (P=.031) had a significant effect on angular deviation. ConclusionsCTG accuracy was similar to that of 3DGp. Reduced angular deviation was noted in the presence of softer bone type and higher secondary stability.

Study protocol for a French multicenter randomized controlled trial evaluating the medicoeconomic impact of Surgical vs Endovascular Arteriovenous Access Creation for Hemodialysis in End-stage Renal Disease (ENDO-FAV)

BackgroundVascular access is indispensable for performing hemodialysis in patients with end-stage renal disease. The Kidney Disease Outcome Quality Initiative and the French Health Authority advocate for native arteriovenous fistulas (AVFs) as a primary option owing to their association with lower morbidity, mortality, and enhanced quality of life. However, a significant proportion of AVFs fail to mature, and many require multiple re-interventions, increasing overall costs. To address these issues, endovascular techniques for AVF creation have been developed. These methods use energy-based technologies, avoiding vessel dissection and preserving perivascular tissues. Initial results are promising, but these devices are expensive, and the technical act of creating an endovenous fistula is not recorded in the coding of the common classification of medical procedures and, as such, cannot be reimbursed by health insurance in France. Although international studies suggest their effectiveness, no French studies have yet replicated or confirmed these findings in the local context, which would help to support a reimbursement request from health insurance. MethodsThis protocol represents the first French medicoeconomic study to compare the two available endovascular AVF creation devices (Ellipsys and WaveLinQ) with traditional open surgery. This multicenter, comparative clinical trial will randomize patients into two parallel groups: (1) endovascular AVF creation using either the WaveLinQ or Ellipsys device, and (2) surgical proximal AVF creation (brachiocephalic/brachiobasilic). Randomization will be balanced and stratified by center and dialysis timing. Follow-up assessments will occur at 1 week and 1, 3, 6, 12, and 18 months. The primary objective is to evaluate the cost effectiveness of endovascular AVF creation compared with open surgery from the perspective of the French health care system. The primary end point is the cost-utility ratio (cost per quality-adjusted life year gained) of endovascular AVF vs open surgery. Utility is assessed using the EQ-5D-5 L questionnaire, with costs derived from micro-costing and the National Health Data System. Secondary outcomes include health economics with total costs at 18 and 36 months, success rate of vascular access creation, AVF maturation and functionality, recirculation rates, early and late access failures, cannulation success, primary and secondary patency, reintervention rates, and adverse events. Based on a cost-utility threshold of €30,000 per quality-adjusted life year, cost difference estimates, and standard deviations from previous studies, anticipated sample size is 126 patients per group (endovascular and surgical), totaling 252 patients with approximately 142 patients for the Ellipsys device and 110 patients for WaveLinQ, based on the capacity of 7 centers using Ellipsys and 4 centers using WaveLinQ. ConclusionsThis multicenter randomized controlled trial will provide contemporary data on the clinical outcomes and prognoses for endovascular AVF techniques, potentially establishing endovascular methods as a viable and cost-effective alternative to traditional surgical AVF creation.

Efficacy of Brahmi vati and Aswagandharista (Ayurvedamedication) in major depressive disorder: A randomized controlled trial

BackgroundRole of Ayurveda medications in the management of Major depressive disorder (MDD) is explored. ObjectiveTo evaluate the effect of Brahmi vati and Aswagandarista in the management of MDD. MethodsStudy was a Randomized, Controlled, parallel group comparative clinical trial. Fifty patients meeting the MDD (DSM V) diagnostic criteria from teaching hospital were recruited in the study. They were divided in two 2 groups. Control group were administered with Escitalopram 10 mg twice a day. Ayurveda group were intervened with tablet Brahmi vati 500 mg thrice a day and Liquid Aswagandarista 10 ml thrice a day. Interventions were for 60 days. Assessments were done on every 15th day. Assessments criteria included Hamilton Depression Rating scale (HDRS), Hamilton Anxiety Rating scale (HARS), UKU Side effect scale (UKU), Brief Psychotic Rating Scale (BPRS), WHO quality of life -BREF (WHOQOL-BREF), Pittsburgh Sleep Quality Index (PSQI) and Clinical Global Impression scales (CGI) were assessed at all the time points. Blood parameters like Haemoglobin, Serum creatinine and Liver function tests were evaluated at pre and post study. ResultsBetween group comparison showed significant improvements in WHOQOL-Bref (p < 0.001), UKU (p = 0.04) favouring Ayurveda group and PSQI (p = 0.02) improvements in control group. Improvements in other parameters were comparable. Within group assessment showed significant (p < 0.001) improvement in HDRS, HARS, BPRS, CGI-S, CGI-GI in both the groups. Liver function tests and serum creatines were within normative limits. ConclusionAyurveda medications produced significant improvements comparable to escitalopram with additional advantages in quality of life and side effects profile.

CAF to the Rescue! Potential and Challenges of Combination Antifungal Therapy for Reducing Morbidity and Mortality in Hospitalized Patients With Serious Fungal Infections.

The global burden of invasive fungal disease is substantial and escalating. Combination antifungal therapy (CAF) may improve patient outcomes by reducing development of resistance, improving drug penetration and rate of fungal clearance, and allowing for lower and less toxic antifungal drug doses; yet, increased cost, antagonism, drug-drug interactions, and toxicity are concerns. Clinical practice guidelines recommend antifungal monotherapy, rather than CAF, for most invasive fungal diseases due to a lack of comparative randomized clinical trials. An examination of the existing body of CAF research should frame new hypotheses and determine priorities for future CAF clinical trials. We performed a systematic review of CAF clinical studies for invasive candidiasis, cryptococcosis, invasive aspergillosis, and mucormycosis. Additionally, we summarized findings from animal models of CAF and assessed laboratory methods available to evaluate CAF efficacy. Future CAF trials should be prioritized according to animal models showing improved survival and observational clinical data supporting efficacy and safety.

Holmium versus thulium fibre laser for ureteroscopy and lithotripsy: When, why and how?

Background: The holmium: yttrium-aluminum-garnet (Ho:YAG) laser, which has been the gold standard for lithotripsy, has evolved to high frequency systems with pulse modulation. However, there is now an alternative laser for lithotripsy - the thulium fiber laser (TFL). Purpose: While bench testing has shown superior fragmentation performance of the TFL compared to Ho:YAG, initial clinical results for ureteroscopy have not been as dramatic. We therefore analyze laboratory and clinical studies comparing these two laser platforms. Our goal is to offer insights into when and why to choose one laser over the other for ureteroscopy, along with strategies for optimal use. Methods: In this narrative review we describe the characteristics of each laser and provide an overview of the in vitro studies comparing Ho:YAG and TFL for fragmentation, retropulsion and heat generation. We also review evidence from prospective comparative effectiveness clinical trials for ureteroscopy and lithotripsy. We provide our schema for when we use each laser for ureteroscopy, the rationale and our approach with laser settings. Conclusions: Ho:YAG and TFL have distinct wavelengths, pulse duration, peak power, and water absorption parameters that make them suitable for different scenarios. The decision between which laser to choose rests upon individual preferences and confidence levels of use, with the ultimate priority for safe patient use.

Comparing the subvastus and medial parapatellar approaches in total knee replacement

Background: This study aimed to compare the outcomes of the subvastus and medial parapatellar approaches in total knee replacement (TKR), focusing on postoperative pain, knee function recovery, quadriceps strength, hospital stay, complications, and patient satisfaction. Methods: This prospective comparative clinical trial was conducted over 18 months at a tertiary care hospital. A total of 120 patients, aged 50-75 years with knee osteoarthritis, were divided into two groups, group A (subvastus approach) and group B (medial parapatellar approach). Pain, range of motion (ROM), quadriceps strength, length of hospital stay, complications, and patient satisfaction were evaluated postoperatively at 1, 3, 6, and 12 months. Data were analyzed using SPSS, with significance set at p&lt;0.05. Results: Group A showed significantly lower pain at 1 and 3 months, with VAS scores of 4.1 and 2.8, respectively (p&lt;0.05). ROM was significantly greater in Group A at 1 and 3 months (105.2° and 120.8°, p&lt;0.05). Quadriceps strength improved faster in group A at 3 months (MMT score: 4.0, p=0.04). Group A also had a shorter hospital stay (4.5 vs 5.8 days, p=0.01). Complications and long-term satisfaction were similar across both groups. Conclusion: The subvastus approach offers advantages in early recovery, including reduced pain, quicker ROM recovery, and shorter hospital stays. However, long-term outcomes are comparable between both approaches.

Novel Technique for Degenerative Lumbar Spine Fusion: Unilateral Pedicle Screw Fixation Combined with Contralateral Interbody Cage Fusion for Posterior Lumbar Interbody Fusion

Abstract Objective The common traditional surgical techniques for posterior lumbar interbody fusion (PLIF) and fixation are bilateral pedicle screw fixation with or without interbody cage fusion and unilateral pedicle screw fixation with ipsilateral cage fusion. However, the novel unilateral pedicle screw fixation combined with the contralateral interbody cage fusion technique may provide the benefits and avoid the hazards of those traditional techniques. This prospective randomized comparative clinical trial aims to compare pedicle screw fixation with contralateral interbody cage fusion and unilateral pedicle screw fixation with ipsilateral cage fusion in single-level PLIF and fixation. Methods This comparative prospective study was conducted on 60 patients subjected to a single-level PLIF and unilateral pedicle screw fixation during the period from January 2022 to July 2022 to compare two different surgical modalities: group A (unilateral pedicle screw fixation with contralateral interbody cage fusion) and group B (unilateral pedicle screw fixation with ipsilateral cage fusion). Results Operative time, blood loss, operative complications, and visual analog scale improvements showed insignificant differences between the two groups, while group A showed significant improvements in the Oswestry Disability Index and wider coronal disc heights contralateral to the screw, which is the side of the cages, during postoperative follow-up. Conclusion Unilateral pedicle screw fixation with contralateral cage fusion during the PLIF and pedicle screw fixation procedure is preferred to maintain bilateral coronal disc heights and thus better clinical and mechanical results without affection of the preceding disc.

Comparative clinical trial of Langenlianqiao oral liquid and Lianhuaqingwen capsule in the treatment of mild cases of coronavirus disease 2019 (COVID-19)

ObjectiveTo evaluate the clinical efficacy of Langenlianqiao (LGLQ) oral liquid treatment and provide a reference basis for the clincal treatment of coronavirus disease 2019 (COVID-19).DesignAn experimental clinical study was conducted on three groups with confirmed diagnoses of COVID-19.SiteThis study was conducted at Changde Hospital.ParticipantsA total of 253 patients were enrolled in this study.MethodsThe patients were divided into the LGLQ treatment group (100 cases), the Lianhuaqingwen (LHQW) treatment group (100 cases) and the placebo control group (53 cases), according to the treatment each group received. The occurrence of major clinical symptoms, the duration of symptom disappearance, the number of days in hospitalisation and the duration of infection were compared among the three groups.ResultsCompared with the placebo control group (10.0 [1.2] d, 9.4 [1.3] d), the duration of infection and hospitalisation effectively decreased in the LGLQ group (6.8 [0.6] d, 7.4 [0.8] d) and the LHQW group (6.8 [1.0] d, 7.3 [1.0] d). Furthermore, the incidence of fatigue in the LGLQ group (4.0%) was lower compared to the LHQW group (14.0%) and the placebo control group (15.1%), but this difference was not statistically significant (P = 0.580 for LGLQ vs. LHQW, P = 0.246 for LGLQ vs. placebo). In the treatment of cough, the LGLQ group showed a significantly different effect compared to both the LHQW group (P = 0.014) and the placebo group (P = 0.016). Additionally, for dry cough specifically, LHQW was effective in reducing its incidence compared to the placebo control group (P < 0.05), while LGLQ showed no statistically significant difference from either LHQW (P = 0.39) or the placebo group (P = 0.14). However, neither the LGLQ group nor the LHQW group showed a reduction in the duration of symptom disappearance in patients with pre-existing symptoms (P > 0.05).ConclusionsCompared with the placebo control group, the LGLQ group showed an improvement in the clinical symptoms of COVID-19 and a decrease in the duration of hospitalisation and infection, which confirmed that the LGLQ treatment had the same antiviral effect as the LHQW treatment. This may provide in-depth insights for antiviral therapy research.

A comparative randomised clinical trial of Amrutadi kwath and Vasadi kath in the management of Vatarakta (Gout)

Vatarakta specially occurs in Madhyavastha which is Parihanikala in which Dhatukshaya takes place. Khavaigunya (Rikta srotas) occurs in Asthi which is responsible for the production of Vatarakta. Vatarakta is a disease related with khavaigunya found in raktavaha strotas which include vitiated vata and rakta, so termed as vatarakta. Due to properties of sukshmatva and saratva of vayu, dravatva and saratva of rakta they spread all over the body. Symptoms of Vatarakta are shool, toda, daha, vaivarnya described by various acharya. Symptoms of Gouty arthritis are similar as of vatarakta Joint pain, Swelling, stiffness, disability and crepitations over small joint. Gouty arthritis is the most common form of arthritis, which occurs in middle age. Amrutadi Kwath and Vasadi Kwath have most of contents are snigdha, guru and mrudu. By virtue of these properties, this alleviates vata and pitta. Hence these are used in diseases which arise due to vitiation of vata and pitta. in vatarakta by its vatapittashamaka prabhav and snigddha, mrudu gunas by vatanulomana kriya. Amrutadi kwath is very effective in relieving the symptoms of vatarakta. Materials and Method: Total 80 patients of the age group 25-60 years presenting with signs and symptoms of vatarakta were selected randomly from OPD of the department of kayachiktsa. The 40 patients of trial group were treated with Amrutadi kwath and 40 patients of control group were subjected to vasadi kwath. Conclusion: Amrutadi Kwath showing significant results than Vasadi Kwath in symptoms of Vatarakta (Gout).

When You Get to the Fork in the Road, Take It: The Challenges in Managing Patients With Advanced Prostate Cancer.

As is the case with most solid tumors, the heterogeneity of the disease biology of prostate cancer presents clinicians managing this disease with daily challenges. However, in contrast to other common cancers such as breast, lung, and colorectal cancers, there are unique challenges in prostate cancer management, including the variety of clinicians who manage aspects of the disease (urologists, medical oncologist, radiation oncologists) and the striking absence of prospective comparative data to inform the optimal sequence of systemic therapy in patients with metastatic castration-resistant disease. The purpose of this review is to attempt to assist practicing oncologists with sorting through the myriad of prostate cancer disease subsets and the challenges in making therapeutic decisions in multiple data-free zones given the absence of level 1 comparative clinical trials in the metastatic hormone-sensitive and castration-resistant states.

Impact of Two Implant-Abutment Connection Types on Crestal Bone Stability: A 3-Year Comparative Split-Mouth Clinical Trial.

This prospective, preliminary controlled clinical trial investigates the comparative effectiveness of platform-switching (PS) versus traditional butt-joint or platform-matching (PM) implant-abutment connections on peri-implant crestal bone stability. Utilizing a split mouth design, 10 systemically healthy patients (n= 20 implants) had adjacent non-restorable maxillary anterior teeth replaced with two different implants (butt-joint connections and platform-switching interfaces). Patients underwent alveolar ridge preservation, followed by implant placement: platform-matching implants were inserted at crestal bone level, and platform-switching implants were placed 1mm subcrestally. Customized Zirconia crowns were then fabricated for both systems. Outcome measures included bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), which were evaluated through standardized periapical radiographs over 3-year timeframe. Results showed significantly higher initial MBL in the PM group (0.86 ± 0.13 mm) compared to the PS group (0.34±0.29 mm) [p value: p<0.01]. Moreover, at the three-year follow-up, the crestal bone levels remained above the implant shoulder until the third year of the study for the PS subcrestal group (PS: -0.15±0.39 mm) and slightly below the implant platform in the PM crestal group (PM: 0.55±0.19). After 3 years, the PS group also exhibited lower mean BOP percentages (12%) than the butt-joint group (17%). This study suggests that subcrestal placement with PS and internal connections can provide better long-term peri- implant bone preservation, thereby potentially improving implant success and aesthetic outcomes in the anterior maxillary region.