Kornimate/medical-research-clean huggingface dataset:
niv in covid-19 respiratory failure

Conditions: COVID-19 Pneumonia

Summary: a retrospective, single centre observational study to validate use of the hacor score (duan et al, 2017) in determining efficacy of non-invasive ventilation in covid-19 respiratory failure.

the investigators will retrospectively analyse medical records of patients with confirmed covid-19 respiratory failure who received continuous positive airway pressure (cpap) via facemask, as per clinician decision, in the high dependency unit (hdu) or intensive care unit (icu) of university hospital crosshouse between 1st march 2020 and 30th april 2021. by collecting baseline demographics and physiological data (including apache ii and clinical frailty score) and calculating the hacor score at initiation of cpap, then at 1hr, 6hrs, 12hrs, 24hrs and 48hrs after initiating cpap the investigators aim to validate use of the hacor score in determining efficacy of niv in covid-19 respiratory failure. the investigators will also collect other variables (crp and lymphocytes, lactate, mean arterial pressure, temperature) to determine if these factors have utility in predicting efficacy of niv in covid-19 respiratory failure.

Eligibility criteria:
inclusion criteria: 1. confirmed covid-19 respiratory failure 2. niv treatment instituted as per clinician decision 3. admitted to hdu or icu between 1/3/20 and 30/4/21 exclusion criteria: 1. patients with immediate indication for invasive ventilation 2. patients whose primary diagnosis was not covid-19 respiratory failure, but received niv in that time period

Keywords: covid-19 hacor non-invasive ventilation cpap
evaluation of the efficacy of cure-ex treatment in onychomycosis

Conditions: Onychomycosis

Summary: open label study to evaluate the efficacy of cure-ex device in the treatment of onychomycosis.

each affected nail will be treated twice daily for 24-30 weeks. efficacy will be evaluated by measuring the growth of healthy nail.

Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with clinical and mycological onychomycosis (by culture and smear). 2. subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study. 3. subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study. exclusion criteria: 1. lunula infected with onychomycosis. 2. pregnant or breast feeding female.
collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in south africa

Conditions: HIV/AIDS; Depression; Chronic Diseases of Lifestyle

Summary: with increasing access to antiretroviral therapy (art) in south africa, hiv has transitioned from a terminal illness to a long-term condition. it is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the hiv itself, as well as adverse effects of medication. this requires an expansion of the purview of hiv care beyond direct hiv clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. cobalt is a pragmatic cluster randomized controlled trial (rct) in public sector primary care clinics in the north west province of sa. it will assess mental health and hiv outcomes for depressed adults receiving art by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.


Eligibility criteria:
inclusion criteria: clinics: 1) 40 nurse-led primary care clinics providing art in the dr kenneth kaunda and bojonala districts of the north west province, south africa patients: 1. age ≥ 18 years and 2. receiving art at the time of enrollment and 3. depressive symptoms, as indicated by a total score of 9 or more on the phq-9 and 4. planning to reside in the area for the next year and 5. capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and 6. written consent to participate in the study exclusion criteria: clinics: 1) clinics which participate in the formative research and piloting of the intervention patients: 1) inability to meet the above inclusion criteria
an open-label safety and tolerability study of nusinersen (isis 396443) in participants with spinal muscular atrophy (sma) who previously participated in isis 396443-cs2 (nct01703988) or isis 396443-cs10 (nct01780246)

Conditions: Spinal Muscular Atrophy

Summary: the primary objective of this study is to examine the safety and tolerability of nusinersen (isis 396443) administered intrathecally to participants with spinal muscular atrophy (sma) who previously participated in isis 396443-cs2 (nct01703988) or isis 396443-cs10 (nct01780246). the secondary objective is to examine the plasma and cerebrospinal fluid (csf) pharmacokinetic(s) (pk) of nusinersen administered intrathecally to participants with sma who previously participated in isis 396443-cs2 or isis 396443-cs10.

this study was conducted and the protocol was registered by ionis pharmaceuticals, inc. in august 2016, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * clinical signs attributable to spinal muscular atrophy * satisfactory completion of dosing and all study visits in isis 396443-cs2 (nct01703988) or isis 396443 cs10 (nct01780246) with an acceptable safety profile, per investigator judgement. * able to complete all study procedures, measurements and visits and parent/participant has adequately supportive psychosocial circumstances, in the opinion of the investigator * estimated life expectancy \> 2 years from screening * meets age-appropriate institutional criteria for use of anesthesia/sedation, if use is planned for study procedure key exclusion criteria: * have any new or worsening of existing condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the participant participating in or completing the study. * dosing in isis 396443-cs2 (nct01703988) or isis 396443-cs10 (nct01780246) within 180 days (6 months) of screening, or longer ago than 396 days (13 months) from screening * hospitalization for surgery (i.e. scoliosis surgery) or pulmonary event within 2 months of screening or planned during the duration of the study * presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy * clinically significant abnormalities in hematology or clinical chemistry parameters * treatment with another investigational drug, biological agent, or device within 1-month of screening or 5 half-lives of study agent, whichever is longer. any history of gene therapy or cell transplantation. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: spinal muscular atrophy sma smn smnrx isis-smnrx isis 396443 ionis-smnrx ionis-smn rx spinraza
a study to compare pharmacokinetics and pharmacodynamics of ipx066 to standard carbidopa-levodopa

Conditions: Parkinson's Disease

Summary: this study evaluated the pharmacokinetics, motor effects, and assessed the safety of ipx066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced parkinson's disease.

this was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in ld-experienced subjects with parkinson's disease (pd). subjects received 7 days of one treatment (ipx066 or ir cd-ld) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (ir cd-ld or ipx066). during the approximate 7-day washout period, subjects took their prestudy cd-ld regimen. pharmacokinetic and efficacy/pharmacodynamic measurements were done on days 1 and 8. safety measures (electrocardiograms \[ecgs\], clinical laboratory tests, vital signs, adverse events \[aes\], and concomitant medications) were evaluated over the course of the study.

Eligibility criteria:
inclusion criteria: 1. male or female diagnosed with idiopathic pd, without any known cause for parkinsonism. 2. if female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as nova ring, oral, injected, transdermal patch, implanted, or barrier). the subject must agree to take every precaution to ensure that pregnancy will not occur during the study. 3. at least 30 years old at the time of diagnosis of pd. 4. mini mental state examination (mmse) ≥ 26 at screening visit. 5. a responder to ld and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release cd ld for at least 1 month. 6. must have predictable fluctuations between "on" and "off" states. 7. hoehn and yahr stage i-iv when "on". 8. able to provide informed consent and willing to sign health insurance portability and accountability act (hipaa) authorization. 9. able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. exclusion criteria: 1. pregnant or breastfeeding. 2. diagnosed with atypical parkinsonism. 3. history, physical findings or laboratory results suggesting a diagnosis other than pd. 4. allergic or nonresponsive to previous cd-ld therapy. 5. any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the investigator's opinion, may jeopardize the subject's safety. 6. exposure to any investigational agent within 30 days prior to visit 1. 7. donated blood or plasma within 28 days. 8. had prior functional neurosurgical treatment for pd (ablation or deep brain stimulation).

Keywords: parkinson's
study of neonatal igg fc receptor expression in natural killer t cells expressing an invariant t receptor : implication in the pathophysiology of systemic lupus

Conditions: Systemic Lupus Erythematosus; Physiopathology

Summary: this study evaluates the variation of expression of the neonatal fc receptor (fcrn) in natural killer t cells expressing an invariant t receptor (inkt) and monocytes along with the surface expression of fc gamma type ii receptor (rii) and riii in active or newly diagnosed lupus patients compared to inactive lupus patients.

the role of fcrn in autoimmune diseases remains to be clarified, but it has been implicated in numerous pathophysiological mechanisms, notably in the management of immune complexes or the recycling of autoantibodies. in humans, this role in the metabolism of autoantibodies has recently led to the development of therapeutic antibodies for autoimmune diseases such as autoimmune thrombocytopenia and myasthenia. the lupus erythematosus is an auto-immune disease mediated by igg and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components, one of them being inkt cells. studies in patients or in lupus mouse models have shown a decrease in inkt cells correlated with disease activity as well as tissue infiltration in relation to clinical manifestations. their actual role in this pathology remains to be clarified between regulatory or pro-inflammatory effect. the possible role of inkt as a regulatory cell in lupus pathology and the possible involvement of fcrn in their development reinforces the interest of their simultaneous study in humans. the aim of this study will be to evaluate the impact of the expression of fcrn and other fc gamma receptors cooperating with fcrn (fc gamma rii and riii) in inkt cells in lupus patients in relation to disease activity and therapy. this study will be conducted in parallel on monocytes, cells involved in the metabolism of immune complexes and likely to be activated by inkt cells. these results will be compared to healthy controls and integrated into mechanistic studies in a mouse model.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of definite systemic lupus which may be associated with secondary antiphospholipid syndrome and/or secondary gougerot-sjögren's * lupus patient, newly diagnosed or known, untreated or in relapse * lupus patient considered stable by the treating practitioner * requiring blood sampling for follow-up exclusion criteria: * main autoimmune disease other than lupus * patient under legal protection, guardianship or curators * opposition to data processing

Keywords: lupus
effects of different stimuli in patients with disorders of consciousness

Conditions: Disorder of Consciousness

Summary: in recent years, promoting wakening attempts in patients with disorders of consciousness are increasing, but there are a lack of objective indicators to evaluate the efficacy and further researches on the brain mechanism during the wakening processing. so, the study first assessed the cerebral response during emotional acoustic stimuli with quantitative eeg and erp(event-related potential), and next, the investigators explored the relationship between brain activation and patients' recovery.

auditory stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (doc)，especially the emotional sound; however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. in this study, investigators assessed the response of different brain regions to three acoustic stimuli using quantitative electroencephalography (qeeg) and erp(event-related potential),and further investigated the predictive value of qeeg in the prognosis of doc.

Eligibility criteria:
brain-damaged patients : inclusion criteria: 1. disorders of consciousness (traumatic brain injury, stroke or anoxic encephalopathy) 2. coma diagnosis (plum and posner, 1966), vegetative state (task force, 1994) or minimally conscious state (giacino, ashwal et al. 2002) 3. lack of autonomic crisis since one week minimum 4. medical condition considered stable 5. patients who do not present hearing loss. peaks i and ii of brainstem auditory evoked potentials (baep) will be normal. exclusion criteria: 1. hearing problem 2. uncontrolled epilepsy 3. autonomic crises 4. medical unstable state 5. pregnant or likely to be (interrogation data) or breastfeeding woman healthy participants : inclusion criteria: 1. subjects with normal hearing 2. absence of neurological disorder 3. subjects able to understand the experimental instructions exclusion criteria: 1. hearing problems and / or hearing loss higher than 30 decibels hearing level (db hl) at a frequency band from 250 to 8000 hz 2. neurological disorders 3. pregnant or likely to be (interrogation data) or breastfeeding woman

Keywords: eeg;doc;auditory
the efficacy of watch and wait strategy or surgery after neoadjuvant immunotherapy for locally advanced colorectal cancer with dmmr/msi-h guided by mrd dynamic monitoring: a single-center, open-label, prospective, phase ii clinical trial.

Conditions: Clinical Complete Response Rate With Negative MRD

Summary: this study is a single arm, single center, phase ii, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (mrd) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dmmr/msi-h).


Eligibility criteria:
inclusion criteria: * ( 1 ) disease characteristics 1. histologic confirmation for colorectal adenocarcinoma; 2．immunohistochemical identified as dmmr and/or pcr and/or ngs detection for msi-h; 3．according to uicc/ajcc tnm staging system (in 2017 version 8) assessment for locally advanced colorectal cancer (ii - iii, namely ct3-4 and/or n + ）； 4.\* clinical staging methods: colon ct staging, approved by pelvic magnetic resonance imaging (mri) and the rectum rectum cavity ultrasound combined with staging, 5．no signs of intestinal obstruction;or intestinal obstruction after proximal colon obstruction has been relieved after colostomy surgery; 6．no distant metastasis was confirmed by comprehensive examination (distant organs or (and) the distant lymph node metastasis); ( 2 ) previous treatment 1．no colorectal cancer surgery before; 2. no previous chemotherapy or radiotherapy ; 3. had not received biological treatment ; 4. previous endocrine therapy : no restriction. exclusion criteria: * 1.immunohistochemistry of tumor biopsy specimens suggested pmmr or microsatellite instability detection suggested mss ; 2. chronic hepatitis b or c ( high-copy viral dna ) with a history of hiv infection or active phase ; 3.autoimmune diseases ; 4.other active clinical severe infections ( \> nci-ctc3.0 version ) ; 5. patients with clinical stage i ; 6.preoperative evidence of distant metastasis ; 7. cachexia, organ dysfunction ; 8. have a history of pelvic or abdominal radiotherapy ; 9. patients whose seizures require treatment ( e.g. steroids or antiepileptic treatment ) ; 10.5 years have a history of other malignant tumors, except for cured cervical carcinoma in situ or skin basal cell carcinoma ; 11. chronic inflammatory bowel disease, intestinal obstruction ; 12. drug abuse and medical, psychological or social conditions may interfere with patient participation in the study or have an impact on the evaluation of the results of the study ; 13.known or suspected allergies to the study drug or any drug related to this test ; any unstable condition or condition that may endanger patient safety and compliance ;
the clinical informationist: does the model work

Conditions: Critical Illness

Summary: this study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care units at vanderbilt university medical center

background to evaluate the role of the clinical informatics consult service(cics), an informationist service at the eskind biomedical library (ebl) at vanderbilt university medical center (vumc, in clinical decision-making, the ebl has been awarded a 3-year grant from the national library of medicine (5 r01 lm07849-02). the cics is a well-established program that facilitates evidence-based practice by delivering targeted information in answer to complex, patient-specific questions. the cics places librarians with specialized training in medical subject areas and in information retrieval ("clinical informationists") on clinical teams in intensive care settings. acting as expert consultants, they analyze the biomedical literature to identify, filter, and present the best examples of each clinical viewpoint expressed about key problems. evaluation project working in cooperation with the center for evaluation and program improvement (cepi) at peabody college of vanderbilt, the investigators will evaluate formally the role of cics in clinical decision-making and evidence-seeking behavior. while past studies have evaluated clinical medical librarians' roles, few if any studies have examined the effectiveness and utility of the new clinical informationist approach in sites where informationists are well-established. the project will also create reusable evaluation tools transferable across environments. through a combination of observation and interviews, investigators will examine librarian involvement in three existing vanderbilt cics intensive care units. the project will collect detailed information about the ways in which clinicians incorporate cics-provided information into their workflows. next, investigators will conduct a randomized trial to evaluate the effect of cics on decision-making. investigators will compare clinicians' intended course of care vs. actual care when cics results are provided and when clinicians seek information themselves. finally, "virtual cases" developed from actual patient cics-related scenarios in each clinical unit will be incorporated into training tools that can be used to export elements of the cics model to other locations. demonstration of the utility of the clinical informationist approach can foster widespread adoption nationally, and increase the degree to which clinical practice becomes evidence-based.

Eligibility criteria:
inclusion criteria: evidence-based questions requested by clinician on current service as an attending, resident, fellow, or nurse practitioner on one of the units included in the study exclusion criteria: all others

Keywords: ebm evidence based medicine informationist clinical medical librarian
rebecca-3 study, research on breast cancer induced chronic conditions supported by causal analysis of multi-source data

Conditions: Cancer Related Fatigue

Summary: the overall aim of the rebecca project is to exploit the potential of "real-world data" to support clinical research and improve existing clinical workflow. the primary aim of the rebecca-3 study is to use multi-source "real-world data" to monitor the quality of life (qol) of prostate cancer patients who are affected by cancer-related fatigue during and after treatment. this is to investigate whether the rebecca monitoring is accepted by male patients and can be used within various forms of cancer. study design: 40 prostate cancer patients that undergo radiology and/or chemotherapy treatment will be included at the time of diagnosis. after end of primary treatment, the patients will receive a smartwatch, and have to download a rebecca patient app on their mobile and a pc plug-in on their pc so that we can monitor their qol for 4 months. in addition to collecting digital qol parameters through the rebecca-system, patient-reported qol measures will also be collected through standardized proms and self-evaluation forms. further, biological samples (blood, urine, and faeces) are collected at three time points of the study (i.e., at the time of: diagnosis, completed treatment, and 4 months post treatment), to investigate immunologic biomarkers, dna methylation patterns and microbiota for assessment of new biological and prognostic information related to the development of cancer-related fatigue in prostate cancer patients.


Eligibility criteria:
inclusion criteria: * prostate cancer patients with histologically detectable m0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start * male prostate cancer patients under 80 years of age. * patients who have an increased life expectancy beyond the first 3 months after starting treatment. * patients who have the ability to understand the protocol and can participate in the follow-up plan. * patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule. * patients who have a smart phone. exclusion criteria: * patients who do not consent to the study protocol. * patients with a previous cancer diagnosis (except skin cancer treated only by surgery). * patients who have previously been treated with any form of chemotherapy/radiotherapy. * foreign-language patients without sufficient norwegian understanding * patients who do not have a smartphone