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Data from: Agreements between industry and academia on publication rights: a retrospective study of protocols and publications of randomized clinical trials
Background: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions: Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
Data from: Low prevalence of methicillin-resistant Staphylococcus aureus among men who have sex with men attending an STI clinic in Amsterdam, a cross-sectional study
Objective: Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) is common among men who have sex with men (MSM) in the USA. It is unknown whether this is also the case in Amsterdam, the Netherlands. Design: Cross-sectional study. Setting: Sexually transmitted infection outpatient low- threshold clinic, Amsterdam, the Netherlands. Participants: Between October 2008 and April 2010, a total of 211 men were included, in two groups: (1) 74 MSM with clinical signs of a skin or soft tissue infection (symptomatic group) and (2) 137 MSM without clinical signs of such infections (asymptomatic group). Primary outcome measures: S aureus and MRSA infection and/or colonisation. Swabs were collected from the anterior nasal cavity, throat, perineum, penile glans and, if present, from infected skin lesions. Culture for S aureus was carried out on blood agar plates and for MRSA on selective chromagar plates after enrichment in broth. If MRSA was found, the spa- gene was sequenced. Secondary outcome measures: Associated demographic characteristics, medical history, risk factors for colonisation with S aureus and high-risk sexual behaviour were collected through a self- completed questionnaire. Results: The prevalence of S aureus colonisation in the nares was 37%, the pharynx 11%, the perianal region 12%, the glans penis 10% and in skin lesions 40%. In multivariable analysis adjusting for age, anogenital S aureus colonisation was significantly associated with the symptomatic group (p=0.01) and marginally with HIV ( p=0.06). MRSA was diagnosed in two cases: prevalence 0.9% (95% CI 0.1% to 3.4%)). Neither had CA-MRSA strains. Conclusions: CA-MRSA among MSM in Amsterdam is rare. Genital colonisation of S aureus is not associated with high-risk sexual behaviour.
Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study
<p><b>Background:</b> High patient participation in clinical research reduces selection bias, and ensures the generalisability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.</p> <p><b>Methods:</b> We submitted by mail two vignettes that described clinical research studies – a drug trial, and a diagnostic study – to patients recently discharged from hospital, and assessed</p> <p><b>Background:</b> High patient participation in clinical research reduces selection bias, and ensures the generalisability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.</p> <p><b>Methods:</b> We submitted by mail two vignettes that described clinical research studies – a drug trial, and a diagnostic study – to patients recently discharged from hospital, and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on demand.</p> <p><b>Results:</b> Of 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% <i>vs</i>. 76.2%; <i>P</i> <0.001). In the drug trial, participation was significantly higher when the new drug was presented as presumably better than the old (<i>vs</i>. equipoise) and when the study was funded by public sources (<i>vs</i>. industry), but was not affected by the allocation method. None of the factors tested in the diagnostic study was associated with participation.</p> <p><b>Conclusions:</b> Patients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed, and when the trial was funded by industry. These results suggest that some features of study design can influence participation.their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on demand.</p>
Data from: Clinical Outcomes Associated with the use of the NexSite™ Hemodialysis Catheter with New Exit Barrier Technology: Results from a Prospective, Observational Multi-center Registry Study
Purpose: Decreasing the risk of catheter related bloodstream infections (CRBSIs) remains a key focus for improving outcomes and reducing cost of care for hemodialysis (HD) patients. Recent studies demonstrate CRBSI rates can be improved by managing bacterial colonization at the catheter exit site. Herein we present the results of a study documenting the clinical performance of the NexSite® HD catheter, a new tunneled central venous catheter which incorporates Exit Site Management (ESM) technology. Methods: We conducted an observational study using a prospective, multi-center registry of HD patients implanted with the NexSite® HD catheter. The primary endpoint for the study was CRBSI rate for a period up to 180-days following catheter placement. Secondary endpoints included device placement success rate, exit site healing, development of an exit site or tunnel infection, and early or late non-infectious catheter-related complications. All reasons for early non-elective catheter removal were recorded. Results: A total of 115 HD patients at 6 sites were included in the final analysis. Cumulative catheter use was 10,924 days with a mean duration of 95 days. Seven patients experienced CRBSIs during the study period resulting in a CRBSI rate of 0.64 per 1,000 catheter-days. Seventy-four patients (64.3%) had either elective catheter removal (n=56) or utilized the catheter for the entire 180-day observation period (n=18). Thirty-five patients (30%) underwent non-elective device removal either due to CRBSI (n=5), low flow (n=16), exit site issues (n=7), or for other causes (n=7). Six patients died during the observation period with 1 death due to CRBSI-associated complications and the remaining 5 deaths attributed to non-device related causes. Conclusion: Our findings demonstrate that the NexSite HD catheter equipped with ESM technology can achieve a CRBSI rate in compliance with the NKF KDOQI (National Kidney Foundation Kidney Disease Outcome Quality Initiatives) Clinical Performance Guidelines stated goal of less than 1.0/1,000 catheter-days when used in hemodialysis patients using current standard of care nursing protocols.
Data from: Clinical characteristics and lipid lowering treatment of patients initiated on Proprotein convertase subtilisin/kexin type 9 inhibitors – a nationwide cohort study
Objectives: Given the novelty of proprotein convertase subtilisin–kexin type 9 inhibitors (PCSK9i), little is known regarding overall implementation or clinical characteristics among patients who initiate treatment. We aimed to assess the total number of patients initiated on PCSK9i along with a description of the clinical characteristics and lipid lowering treatment (LLT) of such patients. Setting: A register based descriptive cohort study of patients receiving a PCSK9i in the time period from 01-01-2016 to 31-03-2017 using a cross-linkage between three nationwide Danish registers. Information regarding PCSK9i prescriptions, patient demographics, concurrent pharmacotherapy, comorbidities, and previous coronary procedures was identified. Results: Overall, 137 patients initiated treatment with PCSK9i in the study period from 11 in the first quarter of 2016 to 40 in the first quarter of 2017. The majority had a history of ischemic heart disease (67.9%) with ischemic stroke and diabetes mellitus being present in 7.3% and 16.8% of patients, respectively. All patients initiated on PCSK9i had been previous prescribed statin treatment with Atorvastatin and Simvastatin being most frequently prescribed in 53% and 36% of patients, respectively. The majority of patients had received both statins and Ezetimibe (94.9%) and approximately half of these patients had also received bile acid sequestrant (45.3%). Clinical characteristics mainly differed in patients receiving triple LLT compared to patients not receiving triple LLT in the regards of heart failure. Conclusion: Patients treated with PCSK9i were rare, characterized by having ischemic heart disease and had received various and intensive conventional LLT prior to PCSK9i initiation in agreement with current international guidelines.
Data from: First Latin American clinical practice guidelines for the treatment of systemic lupus erythematosus: Latin American Group for the Study of Lupus (GLADEL, Grupo Latino Americano de Estudio del Lupus)–Pan-American League of Associations of Rheumatology (PANLAR)
Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. Patients with SLE in Latin America face special problems that should be considered when therapeutic guidelines are developed. The objective of the study is to develop clinical practice guidelines for Latin American patients with lupus. Two independent teams (rheumatologists with experience in lupus management and methodologists) had an initial meeting in Panama City, Panama, in April 2016. They selected a list of questions for the clinical problems most commonly seen in Latin American patients with SLE. These were addressed with the best available evidence and summarised in a standardised format following the Grading of Recommendations Assessment, Development and Evaluation approach. All preliminary findings were discussed in a second face-to-face meeting in Washington, DC, in November 2016. As a result, nine organ/system sections are presented with the main findings; an 'overarching' treatment approach was added. Special emphasis was made on regional implementation issues. Best pharmacologic options were examined for musculoskeletal, mucocutaneous, kidney, cardiac, pulmonary, neuropsychiatric, haematological manifestations and the antiphospholipid syndrome. The roles of main therapeutic options (ie, glucocorticoids, antimalarials, immunosuppressant agents, therapeutic plasma exchange, belimumab, rituximab, abatacept, low-dose aspirin and anticoagulants) were summarised in each section. In all cases, benefits and harms, certainty of the evidence, values and preferences, feasibility, acceptability and equity issues were considered to produce a recommendation with special focus on ethnic and socioeconomic aspects. Guidelines for Latin American patients with lupus have been developed and could be used in similar settings.
Clinical Usefulness of Capnographic Monitoring for Feeding Tube Insertion in Critically Ill Patients: Retrospective Cohort Study
<p><strong>Background</strong>: It is not rare for a small-bore feeding tube to be inserted incorrectly into the respiratory system in critically ill patients. Thus, monitoring is necessary to prevent respiratory malplacement of the tube. We investigated the utility of capnographic monitoring for the prevention of respiratory complications due to feeding tube mispositioning in critically ill patients.</p> <p><strong>Methods:</strong> This study is a pre- and post-intervention study, including a total of 445 feeding tube placements events that were retrospectively studied in the medical and surgical intensive care units of the Samsung Medical Center. We compared the outcomes between the time periods before and after the capnographic monitoring and respiratory complications.</p> <p><strong>Results:</strong> Feeding tubes were inserted in 275 cases without capnographic monitoring. Capnographic monitoring was performed in 170 cases. Sixteen patients (4%) had respiratory complications in total tube placements. Tracheal insertion was in 11 (2%) patients and pneumothorax in 5 (1%) patients. Fourteen cases of respiratory complications were detected in control group (14/275, 5%, ten tracheal insertions and four pneumothoraxes). Two cases of respiratory complications were detected in the capnographic monitoring group (2/170, 1%, one tracheal insertions and one pneumothorax). Respiratory complications were less detected in capnographic monitoring group than control group.</p> <p><strong>Conclusions:</strong> Capnographic monitoring is simple, easy to learn, and may be useful to prevent respiratory complication during feeding tube insertion in critically ill patients.</p>
Clinical and laboratory variables of severe malaria extracted from included studies
<p>Data extracted from included studies per prognostic indicator needed to construct two-by-two tables made up of outcome (survival/death) and presence/absence of an indicator.</p>
Comparison of Clinical Efficacy and Safety of Amnio-Graft Versus Skin Graft in Injury Patients: Retrospective Cohort Study
<p>Al Mujtahid Hospital, Damascus, Syria</p><p><strong>Title of the Study</strong>: Comparison of Clinical Efficacy and Safety of Amnio-Graft versus Skin Graft in Plastic Surgery</p><p><strong>Principal Investigator</strong>: Dr. Wael Barazi, President of the Plastic Surgery Department</p><p><strong>Study Duration</strong>: From February 19, 2023, to October 23, 2023</p><p>I. <strong>Background and Rationale</strong>:</p><p>Plastic surgery, a rapidly evolving field, continuously explores novel techniques to enhance patient outcomes. This retrospective cohort study aims to compare the clinical efficacy and safety of amnio-graft and skin graft procedures performed in the Plastic Surgery Department of Al Mujtahid Hospital in Damascus, Syria.</p><p>II.<strong> Objectives</strong>:</p><p>To assess the clinical efficacy of amnio-graft and skin graft procedures.</p><p>To evaluate the safety profile of amnio-graft and skin graft procedures.</p><p>To compare the outcomes of patients undergoing plastic surgery with amnio-graft versus skin graft.</p><p>III. <strong>Study Design</strong>:</p><p>This study will adopt a retrospective cohort design, analyzing data collected from patient records in the Plastic Surgery Department during the specified study duration.</p><p>IV. Participants:</p><p>The study will include all patients who underwent either amnio-graft or skin graft procedures within the defined study period.</p><p>V. <strong>Data Collection</strong>:</p><p>Primary Data:</p><p>Patient demographics</p><p>Preoperative clinical characteristics</p><p>Surgical details</p><p>Postoperative outcomes</p><p>Adverse events</p><p>Secondary Data:</p><p>Histopathological findings</p><p>Follow-up information</p><p>Hospitalization duration</p><p>Any additional relevant clinical information</p><p>VI. <strong>Data Analysis</strong>:</p><p>Statistical analysis will be conducted to compare clinical outcomes and safety profiles between the amnio-graft and skin graft groups. Descriptive statistics, such as mean, median, and standard deviation, will be used, and inferential statistics, including chi-square tests and t-tests, will be applied where appropriate.</p><p>VII. <strong>Ethical Considerations:</strong></p><p>Patient Confidentiality:</p><p>All patient information will be kept confidential, with data anonymized during analysis.</p><p><strong>Informed Consent:</strong></p><p>As this is a retrospective study, no new interventions will be performed. Informed consent will not be obtained.</p><p><strong>Patient Welfare:</strong></p><p>Patient welfare and safety are paramount. The study design aims to minimize risks associated with data collection.</p><p><strong>VIII. Potential Risks and Benefits:</strong></p><p><strong>Risks</strong>:</p><p>There are no additional risks associated with this retrospective study as it involves the analysis of existing medical records.</p><p><strong>Benefits</strong>:</p><p>The study results may contribute to improved decision-making in plastic surgery procedures, enhancing patient outcomes.</p><p><strong>IX. Approval</strong>:</p><p>This research protocol has been reviewed and approved by the Institutional Review Board (IRB) of Al Mujtahid Hospital.</p><p>IRB Approval Date: [27/11/2023]</p><p>IRB Approval Code: [<strong>63211</strong>]</p><p><i>Note: Any amendments to this protocol will require additional review and approval by the Institutional Review Board.</i></p><p> </p>
Dataset for research: "MTA and Koedam Score Contributes to Cognitive Impairment in Probable Alzheimer, Vascular and Mixed Dementia: A Memory Clinic Study in Indonesia"
<p>This is a dataset for research : "MTA and Koedam Score Contributes to Cognitive Impairment in Probable Alzheimer, Vascular and Mixed Dementia: A Memory Clinic Study in Indonesia"</p> <h1><strong><span>Abstract</span></strong></h1> <p><strong><span>Background</span></strong><span>. Medial Temporal Atrophy (MTA) and Parietal Atrophy (Koedam score) have been used in clinical practice to help the diagnosis of Alzheimer’s disease. However, the role of this brain imaging marker in early detection of other type of dementia remains elusive. The study aims to investigate the association between MTA and Koedam scores with the cognitive function in dementia patients (Alzheimer, vascular and mixed dementia).</span></p> <p><strong><span>Method</span></strong><span> <span>This was a</span> cross-sectional study using<span> data from a</span> Memory Clinic in Dr. Sardjito General Hospital Yogyakarta, Indonesia. The data was collected from January 2020 until December 2022. We collected the data regarding demographic and clinical characteristics, including head MRI data and Montreal Cognitive Assessment (MoCA) score. The cut-off points of MTA score and Koedam score were determined by using Receiver Operating Curve (ROC) and Youden Index. Multivariate analysis was performed to investigate variables which were associated with the cognitive function. </span></p> <p><strong><span>Result </span></strong><span>From 61 dementia patients, 22.95% was probable Alzheimer’s disease, 59.01% was vascular dementia, and 18.03% was mixed dementia. Correlation test showed that MTA and Koedam score were negatively associated with Montreal Cognitive Assessment-Indonesian Version (MoCA-INA) score. A bivariate analysis supports the findings that patients with combination of MTA score ≥3 and Koedam score ≥2 was more likely to have poor cognitive function (OR= 11.33; p<0.05). Multivariate analysis showed higher MTA (≥3) and Koedam (≥2) scores were associated with poor cognitive function in dementia patients (OR= 13.54, 95% CI= 1.77-103.43, <em>p</em>=0.01 and OR= 5.52, 95% CI= 1.08-28.19, <em>p</em>=0.04)</span></p> <p><strong><span>Conclusion </span></strong><span>Higher MTA and Koedam score contribute to worse cognitive function in any type of dementia patients. </span></p> <p><strong><span>Keywords.</span></strong><span> Imaging Marker, Medial Temporal Atrophy (MTA), Koedam Score, Cognitive Function, Dementia</span></p>
Climate footprint of industry-sponsored clinical research: An analysis of a phase-1 randomized clinical study and discussion of opportunities to reduce its impact
<p>Objective: To calculate the global warming potential, in carbon dioxide (CO<sub>2</sub>) equivalent emissions, from a phase-1 clinical study Design: Retrospective analysis. Data source: Internal data held by Janssen Pharmaceuticals Studies included: Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019-2021 Main outcome: measure CO<sub>2</sub> equivalents for trial activities calculated according to IPCC 2021 impact assessment methodology Results: The CO2-eq emissions generated by the trial was 17.65 tonnes. This is equivalent to the emissions generated by driving the average petrol-fueled family car 71,004km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study patients generated the most emissions (5,419kg, 31% of overall emissions), followed by trial site utilities (2,725kg, 16% of overall emissions), and Janssen site staff travel (2,560kg, 15% of overall emissions). In total, the movement of people (patient travel, Janssen site staff travel, and trial site staff travel) accounted for 8,914kg or 51% of overall trial emissions. Conclusions: Opportunities exist to reduce many of the largest contributors to the clinical trial's CO<sub>2</sub>-eq emissions. The largest contributor was patient travel (31%) and combined with sponsor (15%) and site staff (5%) travel, the movement of people was responsible for 51% of CO<sub>2</sub>-eq emissions. Decentralized trial models which seek to bring clinical trial operations closer to the patient offer opportunities to reduce patient travel. The electrification of sponsor vehicle fleets and society's transition towards electric vehicles may result in further reductions.</p>
Multi-center study on overall clinical complexity of patients with prolonged disorders of consciousness of different etiologies
<p><strong>Aim</strong>: to assess overall clinical complexity of patients with acquired disorders of consciousness (DoC) in vegetative state/unresponsive wakefulness syndrome (VS/UWS) vs. minimally conscious state- MCS) and in different etiologies..<strong>Design:</strong> Multi-center cross-sectional observational study.<strong>Setting</strong>: 23 intensive neurorehabilitation units.<strong>Subjects</strong>: 264 patients with DoC in the post-acute phase: VS/UWS = 141, and MCS = 123 due to vascular (n = 125), traumatic (n = 83) or anoxic (n = 56) brain injury.<strong>Main Measures</strong>: Coma Recovery Scale-Revised, and Disability Rating Scale (DRS); presence of medical devices (e.g., for eating or breathing); occurrence and severity of medical complications.<strong>Results</strong>: patients in DoC, and particularly those in VS/UWS, showed severe overall clinical complexity. Anoxic patients had higher overall clinical complexity, lower level of responsiveness/consciousness, higher functional disability, and higher needs of medical devices. Vascular patients had worse premorbid clinical comorbidities. The two etiologies showed a comparable rate of MC, higher than that observed in traumatic etiology.<strong>Conclusion</strong>: overall clinical complexity is significantly higher in VS/UWS than in MCS, and in non-traumatic vs. traumatic etiology. These findings could explain the worse clinical evolution reported in anoxic and vascular etiologies and in VS/UWS patients and contribute to plan patient-tailored care and rehabilitation programmes.</p>
Contrast MR Based Radiomics and Machine Learning Analysis to assess clinical outcomes following liver resec-tion in Colorectal Liver Metastases: a preliminary study
<p>We uploaded the images of the manuscript "Contrast MR Based Radiomics and Machine Learning Analysis to assess clinical outcomes following liver resection in Colorectal Liver Metastases: a preliminary study" accepted on Cancers.</p> <p>Vincenza Granata1*, Roberta Fusco2, Federica De Muzio3, Carmen Cutolo4, Sergio Venanzio Setola1, Federica dell’ Aversana5, Alessandro Ottaiano6, Antonio Avallone6, Guglielmo Nasti6, Francesca Grassi5, Vincenzo Pilone4, Vittorio Miele7-8, Luca Brunese3, Francesco Izzo9, Antonella Petrillo1</p> <p>1Division of Radiology, “Istituto Nazionale Tumori IRCCS Fondazione Pascale – IRCCS di Napoli”, Naples, Italy</p> <p>2Medical Oncology Division, Igea SpA, Napoli, Italy</p> <p>3Department of Medicine and Health Sciences “V. Tiberio”, University of Molise, 86100 Campobasso, Italy</p> <p>4Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy</p> <p>5Division of Radiology, “Università degli Studi della Campania Luigi Vanvitelli”, Naples, Italy</p> <p>.6Division of Abdominal Oncology, “Istituto Nazionale Tumori IRCCS Fondazione Pascale – IRCCS di Napoli”, Naples, Italy</p> <p>7Division of Radiology, “Azienda Ospedaliera Universitaria Careggi”, Florence, Italy</p> <p>8Italian Society of Medical and Interventional Radiology (SIRM), SIRM Foundation, via della Signora 2, 20122 Milan, Italy</p> <p>9Division of Epatobiliary Surgical Oncology,“Istituto Nazionale Tumori IRCCS Fondazione Pascale – IRCCS di Napoli”, Naples, Italy</p> <p> </p>
Multi-center observational study on occurrence and related clinical factors of neurogenic heterotopic ossification in patients with disorders of consciousness
<p><strong>Aims</strong>: to assess occurrence and clinical correlates of neurogenic heterotopic ossifications (NHO) in patients with prolonged disorder of consciousness (DoC).<strong>Design</strong>: multi-center cross-sectional observational study.<strong>Setting</strong>: 23 intensive neurorehabilitation units.<strong>Subjects</strong>: 287 patients with prolonged disorder of consciousness (DoC; 150 in vegetative state, VS, and 128 in minimally conscious state, MCS) of different etiology (vascular = 125, traumatic = 83, anoxic = 56, others = 14).<strong>Main Measures</strong>: clinical evidence of NHO confirmed by standard radiological and/or sonographic evaluation; Coma Recovery Scale-Revised; Disability Rating Scale (DRS); Early Rehabilitation Barthel Index; presence of ventilator support, spasticity, bone fractures and paroxysmal sympathetic hyperactivity.<strong>Results</strong>: 31 patients (11.2%) presented NHO. Univariate analyses showed that NHO was associated with VS diagnosis, traumatic etiology, high DRS category and total score, and high occurrence of limb spasticity and bone fractures. A cluster-corrected binary logistic regression model (excluding spasticity available in a subset of patients) showed that only lower DRS total score and presence of bone fractures were independently associated with NHO.<strong>Conclusions</strong>: NHO are relatively frequent in patients with DoC, and are independently associated with functional disability, bone fractures and spasticity. These findings contribute to identifying patients with DoC prone to develop NHO and requiring special interventions to improve functional recovery.</p>
Radiomics metrics combined with clinical data in the surgical management of early-stage (cT1-T2 N0) of tongue squamous cell carcinomas: a preliminary study
<p>We uploaded the clinical and the hematological parameters of enrolled patients in the study "Radiomics metrics combined with clinical data in the surgical management of early-stage (cT1-T2 N0) of tongue squamous cell carcinomas: a preliminary study" accepted on Biology journal.</p> <p>Clinical and hematological parameters include: age; gender; DOI, NLR; PLR; LMR; SIRI; SII; T stage; grading; metastatic lymph nodes; perineural infiltration; vascular infiltration.</p> <p> </p>
Supplemental material for: Clinical and neuroimaging outcomes of direct endovascular thrombectomy vs. bridging therapy in large vessel occlusion patients: a secondary analysis of SELECT cohort study
<p><b>Objective:</b> To evaluate the comparative safety and efficacy of direct endovascular thrombectomy(dEVT) compared to bridging therapy(BT:IV-tPA+EVT) and assess if BT potential benefit relates to stroke severity, size and initial presentation to EVT vs. non-EVT center.</p> <p><b>Methods:</b> In a prospective multicenter cohort-study of imaging selection for endovascular thrombectomy[SELECT], anterior-circulation large vessel occlusion (LVO) patients presenting to EVT-capable centers within 4.5hours from last-known-well were stratified into BT vs. dEVT.<b><i> </i></b>The primary outcome was 90-day functional independence[modified Rankin Scale(mRS)=0-2]. Secondary outcomes included a shift across 90-day mRS grades, mortality, symptomatic intracranial hemorrhage. We also performed subgroup-analyses according to initial presentation to EVT-capable center (direct versus transfer), stroke severity and baseline infarct core volume.</p> <p><b>Results:</b> We identified 226 LVOs (54%:men, mean age:65.6±14.6years, median NIHSS-score: 17, 28% received dEVT). Median time from arrival to groin-puncture did not differ in BT-patients when presenting directly[dEVT:1.43 (IQR=1.13-1.90) hours vs. BT:1.58(IQR=1.27-2.02)hours,p=0.40] or transferred to EVT-capable centers[dEVT:1.17 (IQR: 0.90-1.48) hours vs. BT:1.27 (IQR: 0.97-1.87) hours,p=0.24]. BT was associated with higher odds of 90-day functional independence (57% vs. 44%,aOR=2.02,95%CI:1.01-4.03,p=0.046) and functional improvement (adjusted cOR=2.06,95%CI:1.18-3.60,p=0.011), and lower likelihood of 90-day mortality (11% vs. 23%,aOR: 0.20,95%CI:0.07-0.58,p=0.003). No differences in any other outcomes were detected. In subgroup-analyses, BT patients with baseline NIHSS-scores<15 had higher functional independence likelihood compared to dEVT (aOR=4.87,95%CI:1.56-15.18,p=0.006); this association was not evident for patients with NIHSS-scores≥15 (aOR=1.05,95%CI:0.40-2.74,p=0.92). Similarly, functional outcomes improvements with BT were detected in patients with core volume strata (Ischemic core <50cc: aOR: 2.10, 95% CI:1.02-4.33, p=0.044 vs ischemic core ≥50cc: aOR: 0.41,95% CI:0.01-16.02,p=0.64) and transfer status (transferred: aOR: 2.21,95% CI:0.93-9.65,p=0.29 vs direct to EVT center: aOR:1.84,95%CI:0.80-4.23,p=0.15). </p> <p><b>Conclusions:</b> Bridging therapy appears to be associated with better clinical outcomes, especially with milder NIHSS-scores, smaller presentation core volumes and those who were "dripped and shipped".</p> <p><b>Classification of Evidence: </b>This study provides Class III evidence that for patients with ischemic stroke from anterior-circulation LVO within 4.5 hours from last-known-well, bridging therapy compared to direct endovascular thrombectomy leads to better 90-day functional outcomes.</p>
AfriDx D6.7 [Dataset v2]: AfriDx Clinical study of NAT in COVID-19
<p>This dataset underlies <a href="https://afridx.ceb.cam.ac.uk/files/afridx_deliverables_6.7_final.pdf">AfriDx D6.7</a> report on Clinical study of NAT in COVID-19.</p> <p><strong>Summary of Project</strong></p> <p>The AfriDx Project comprises nucleic acid testing (NAT) for COVID-19 using the PATHPOD system and compared with the RT-qPCR as the gold standard. KNUST, KCCR and NMIMR received PATHPOD and cartridges from the DTU (see D2.2). The cartridges for the testing were shipped in two (2) batches. Training on PATHPOD usage was done and used for testing covid-19 samples. Data obtained was compared with the gold standard RT-PCR.</p> <p>The overall the testing against RT-LAMP was circa 60% sensitive, but the specificity dropped from 80.0% in the first batch to 24% in the second batch. Analysis of the factors causing the drop in specificity is on-going.</p> <p>In the first batch a total of 1,947 tests were conducted, with 531 positive and 1416 negative results, producing 302 samples returning a false positive (FP) 133 samples giving a false negative (FN). The data showed that the FNs could be related to the copy number of virus in the sample, with a strong correlation with RT-PCR C<sub>T</sub> value and true positive/false negative LAMP outcome. The second batch of nucleic acid testing recorded a total of 1,612 test for N-gene in Ghana with 1208 positive and 404 negative tests. This showed an exceptionally high occurrence of false positive test results: 1134 (76.2%) samples returned a false positive (FP) compared with the RT-PCR and 49 (3.9%) samples gave a false negative (FN). Nevertheless, the correlation with C<sub>T</sub> remained, suggesting that the PATHPOD was functioning correctly and that the results were revealing some contamination or deterioration of reagents or sample.</p> <p>Some initial analysis of the raw data from PATHPOD revealed some characteristics of sample and/or reagent contamination as well as the outcome of a poorly sealed cartridge, that would result in an erroneous signal. Further analysis is needed to fully understand any design modifications that might be beneficial. The impact of shipping and storage on the cartridges also has potential impact and it is particularly noteworthy that the second batch of testing, using cartridges from the same manufacturing run as the first batch, performed less well.</p> <p><strong>Methodology</strong></p> <p>The PATHPOD equipment was placed on a clean and flat surface and switch on with the knob located at the back of equipment to turn on the equipment. The oropharyngeal sample in 300ul of PBS was heated at 95 <sup>0</sup>C for 5min to inactivate virus. The master mix room table was disinfected with suitable disinfectant against DNA/RNA contamination. Wearing appropriate gloves, the Pathpod cartridge was removed from the refrigerator and allow 15-30 min at room temperature for the cartridge to acclimatize, and place in the chip holder. The attached temporary sealer film covering the wells was removed and discarded.</p> <p>After short vortex of sample, 6 µl of sample and/or controls were added directly into the center of the well. the yellow paper from the PCR film was removed and placed over the film chip. The film was sealed properly to the chip using a soft roller ready for processing in the PATHPOD system.</p> <p>Using the Pathpod keyboard, sample ID was entered and COV assay was selected. The start bottom was pressed to heat the machine, thereafter the cartridge was inserted and start bottom was pressed again to run the program. When the assay was completed, result was read from both the screen and the LEDs next to the keyboard. Ensuring that the position on the machine matches the position on the chip. The following interpretation was inferred as results:</p> <p>GREEN LIGHT: NEGATIVE BLINKING RED LIGHT: POSITIVE YELLOW LIGHT: RE-TEST THE SAMPLE</p> <p><strong>Datasets</strong></p> <p>First Batch Data:</p> <table> <tbody> <tr> <td><strong>Dataset</strong></td> <td><strong>Description</strong></td> </tr> <tr> <td>PATHPOD ID 25.zip</td> <td>Raw data from all runs on PATHPOD Device ID 25 in Batch 1</td> </tr> <tr> <td>PATHPOD ID 26.zip</td> <td>Raw data from all runs on PATHPOD Device ID 26 in Batch 1</td> </tr> <tr> <td>PATHPOD ID 30.zip</td> <td>Raw data from all runs on PATHPOD Device ID 30 in Batch 1</td> </tr> <tr> <td>AfridX evaluation data_KNUST.V2.xlsx</td> <td>Comparison data for RT-PCR and PATHPOD performed at KNUST</td> </tr> <tr> <td>ALL tests_for DTU. V2.xlsx</td> <td>Comparison data for RT-PCR and PATHPOD performed at NMIMR</td> </tr> </tbody> </table> <p>Second Batch Data:</p> <table> <tbody> <tr> <td><strong>Dataset</strong></td> <td><strong>Description</strong></td> </tr> <tr> <td>PATHPOD ID 25 - BATCH 2.zip</td> <td>Raw data from all runs on PATHPOD Device ID 25 in Batch 2</td> </tr> <tr> <td>PATHPOD ID 26 - BATCH 2.zip</td> <td>Raw data from all runs on PATHPOD Device ID 26 in Batch 2</td> </tr> <tr> <td>AFRIDx DATA SECOND BATCH.xlsx</td> <td>Comparison data for RT-PCR and PATHPOD Second Batch</td> </tr> </tbody> </table> <p><br> </p> <p><br> </p> <p><br> </p> <p><br> </p> <p><br> </p> <p><br> </p>
Data from: Clinical outcomes and safety of polymyxin B versus tigecycline combination therapy for pneumonia of carbapenem-resistant Klebsiella pneumoniae: A retrospective cohort study
<p><strong>Purpose:</strong> Infection by carbapenem-resistant <em>Klebsiella pneumoniae</em> (CRKP) has high mortality. There is no clear optimal therapeutic choice for pneumonia caused by CRKP. The aim of this study was to compare the clinical outcomes and safety of the standard doses of polymyxin B-based regimens vs tigecycline-based regimens and to identify risk factors for mortality.</p> <p><strong>Methods:</strong><strong> </strong>This retrospective cohort study included patients with pneumonia caused by CRKP for three years. The primary outcomes were 7-day bacterial eradication rate and 14- and 28-day all-cause mortality. The secondary outcome was incidence of acute kidney injury.</p> <p><strong>Results:</strong><strong> </strong>Seventy-three patients were included in this study, 29 in the<strong> </strong>polymyxin B-based combination therapy group and 44 in tigecycline-based combination therapy group. There were no significant differences between the two groups in terms of the 7-day bacterial eradication rate (31.0% vs 20.5%, <em>P</em>=0.409), the 14-day all-cause mortality (37.9% vs 22.7%, <em>P</em>=0.160), and the incidence of acute kidney injury (14.3% vs 6.8%, <em>P</em>=0.526). The 28-day all-cause mortality in the polymyxin B-based therapy group was higher than in the tigecycline-based group (75.9% vs 45.5%, <em>P</em>=0.010). Binary logistic regression analysis revealed that male and previous use of carbapenems were independent factors associated with 28-day all-cause mortality for patients treated with polymyxin B (<em>P</em><0.05).</p> <p><strong>Conclusions:</strong><strong> </strong>Polymyxin B-based combination therapy at the standard dose should be used with caution for patients with CRKP-induced pneumonia, especially for men who used carbapenems prior to CRKP detection.</p>
Endorsement of reporting guidelines and clinical trial registration across urological medical journals: a cross-sectional study
Open the record for dataset details and reuse information.
Effects of the Hypnotic Alkylphenol Derivative Propofol on Breast Cancer Progression. A Focus on Preclinical and Clinical Studies.
<p>Propofol is a hypnotic alkylphenol derivative with many biological activities. It is predominantly used in anesthesia and is the most used parenteral anesthetic agent in the United States. Accumulating preclinical studies have shown that this compound may inhibit cancer recurrence and metastasis. Nevertheless, other investigations provided evidence that this compound may promote breast cancer cell progression by modulating different molecular pathways. Clinical data on this topic are scarce and derive from retrospective analyses. For this reason, we reviewed and evaluated the available data to reveal insight into this controversial issue. More preclinical and clinical investigations are necessary to determine the potential role of propofol in the proliferation of breast cancer cells.</p>
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Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.