Kornimate/medical-research-clean huggingface dataset:
comparison of sensitivity between presepsine and lactate for the diagnosis of severe sepsis.

Conditions: Severe Sepsis and Septic Shock

Summary: severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. the potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. conventional biomarkers are an important support for the emergency physician. however, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggests that they can be more efficient in this area. in this single-center, prospective, non-interventional study, we propose to compare the sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic shock we emit to main hypothesis that the sensitivity of presepsine is higher than that of lactate for the diagnosis of severe sepsis.

severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. the potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. the conventional biomarkers are an important support for the emergency physician. however, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggest that they can be more efficient in this indication. presepsine is a soluble fragment of cd14, its concentration is a reflection of cellular activity (macrophages and monocytes) in response of a sepsis's aggression. today, it's possible to asses the presepsine value at bedside, with new device (pathfast), in just 17 minutes, reinforcing the interest for this biomarker. we will conduct a single-center, prospective, non-interventional study, between december 2014 and july 2015 in the university emergency department of nice. the primary outcome is to compare the sensitivity of presepsine to lactate for the diagnosis of severe sepsis and septic shock. the dosage of presepsine will be made in 194 patients over 18 years old , with at least two s.i.r.s criteria, a suspected infection, and the presence of one organ failure. the secondary outcomes are to asses the link between the presepsine value and the germ responsible of sepsis, the correlation between presepsine value at the admission and the mortality at j-28. and we will try to determine if there is a correlation between the initial presepsine value, and the p.i.r.o score.

Eligibility criteria:
inclusion criteria: * age\> 18 years * presence of at least two sirs criteria (t °\> 38.3 ° or \ 90 / min, tachypnea\> 20 / min, recent alteration of consciousness) * suspected infection * indication of an arterial lactate assay on medical advice * affiliation to social security * informed consent exclusion criteria: * renal dialysis * scalable neoplasia chemotherapy * patient palliative care * private patient freedom or under legal protection
ociperlimab with tislelizumab and chemotherapy in participants with untreated metastatic non-small cell lung cancer

Conditions: Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC); Nonsmall Cell Lung Cancer, Stage IV

Summary: this is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic nsclc


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically documented locally advanced or recurrent nsclc that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous nsclc. 2. no prior systemic therapy for locally advanced or metastatic squamous or non-squamous nsclc, including but not limited to chemotherapy or targeted therapy. participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization. 3. archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of pd-l1 levels and retrospective analyses of other biomarkers. only participantswho have evaluable pd-l1 results are eligible. 4. at least one measurable lesion by the investigator per recist v1.1. . 5. eastern cooperative oncology group (ecog) performance status ≤ 1. key exclusion criteria: 1. known mutations in: * egfr gene note: for non-squamous nsclc, articipants with unknown egfr mutation status will be required to have a tissue-based egfr test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna)-based egfr test locally. participants found to have egfr-sensitizing mutations will be excluded. * alk fusion oncogene. * braf v600e * ros1 2. prior treatment with egfr inhibitors, alk inhibitors, or targeted therapy for other driver mutations. 3. any prior therapy targeting t-cell costimulation or checkpoint pathways in metastatic nsclc. 4. any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization. 5. infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: metastatic lung cancer non-squamous ociperlimab tislelizumab anti-pd-1 bgb-a317 bgb-a1217 anti-tigit
monofocal iol visual outcomes when targeting mini monovision

Conditions: Cataract; Presbyopia

Summary: this study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (iol) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 d) in patients with or without astigmatism undergoing routine cataract surgery.


Eligibility criteria:
inclusion criteria: * subject is undergoing bilateral cataract extraction with intraocular lens implantation. * willing and able to provide written informed consent for participation in the study * willing and able to comply with scheduled visits and other study procedures. * scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries. * subjects who require an iol power in the range of +5.0 d to +34.0 d only. * potential postoperative visual acuity of 0.2 logmar (20/32 snellen) or better in both eyes. exclusion criteria: * severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. * uncontrolled diabetes. * use of any systemic or topical drug known to interfere with visual performance. * contact lens use during the active treatment portion of the trial. * any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. * clinically significant corneal dystrophy. * irregular astigmatism. * history of chronic intraocular inflammation. * history of retinal detachment. * pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. * previous intraocular surgery. * previous refractive surgery. * previous keratoplasty * severe dry eye * pupil abnormalities * subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yag capsulotomy, i.e. lasik) * anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). * any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. * participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
study of gs-0272 in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the goals of this clinical study are to learn more about the study drug, gs-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (ra). the primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of gs-0272 and to characterize the pharmacokinetics of gs-0272 following multiple doses of gs-0272, in participants with ra.


Eligibility criteria:
key inclusion criteria: * age limit for the republic of korea for male or nonpregnant female is between 19 and 75 years of age. part a (rheumatoid arthritis (ra) cohorts)-specific inclusion criteria: * diagnosis of ra at least 3 months prior to screening fulfilling the 2010 american college of rheumatology (acr)/european league against rheumatism (eular) classification criteria. * ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csdmards) for at least 12 weeks prior to the first dose of study drug, with a stable dose for at least 4 weeks prior to the first dose of study drug, as follows: * individuals must not be on a biologic disease-modifying antirheumatic drugs (bdmard)/targeted synthetic disease-modifying antirheumatic drug (tsdmard) at day 1 or during the study and must discontinue b/tsdmard use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug. part b (active ra cohort)-specific inclusion criteria: * participant is seropositive as demonstrated by a positive anti-cyclic citrullinated peptide (anti-ccp) antibody and/or positive rheumatoid factor at screening. * participant has an elevated high-sensitivity c-reactive protein (hscrp) greater than upper limit of normal (uln). * participant has 6 or more swollen and 6 or more tender joints as assessed on the sjc66/tjc68. distal interphalangeal joints will not be counted towards the 6 joint eligibility. * participant has had inadequate response or intolerance to at least 1 but not more than 3 bdmard/tsdmard therapeutics with no more than 2 moas. a lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of ra. key exclusion criteria: * meet any of the protocol-specified infection criteria (hepatitis c, hepatitis b, hiv, tuberculosis, others). * inadequate response or intolerance to more than 3 bdmards/tsdmards with more than 2 moas. note: other protocol defined inclusion/exclusion criteria may apply.
multi-omics analysis of oral-gut microbial profiles

Conditions: Periodontitis

Summary: periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. the long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. the present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage iii-iv periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. age, gender and bmi-matched healthy individuals will be recruited as controls.


Eligibility criteria:
inclusion criteria: * periodontitis stage iii or iv * bmi between 20 and 29 kg/m2 * free diet * presence of at least 20 teeth exclusion criteria: * systemic diseases (including diabetes, thyroid, liver, or kidney diseases) * dietary allergies * use of antibiotics or probiotics during the previous 90 days * pregnancy or breast feeding
screening method in sacral neuromodulation

Conditions: Overactive Bladder; Urinary Retention

Summary: the purpose of this study was to evaluate whether there is a difference in long-term outcome between patients screened with the percutaneous nerve evaluation (pne) and first stage tined lead procedure (tlp).

purpose: to evaluate if there is a difference in long-term outcome of sacral neuromodulation (snm) between patients screened with the percutaneous nerve evaluation (pne) and first stage tined lead procedure (tlp). furthermore, we wanted to evaluate the outcome in patients who only responded to screening with tlp after failure of initial pne. materials and methods: we evaluated all patients screened for eligibility to receive snm treatment since the introduction of the tined lead technique in our centre in 2002. in may 2009, all implanted patients were asked to keep a voiding diary to record the effect of snm on urinary symptoms. success was defined as more than 50% improvement in at least one of the relevant voiding diary parameters compared to baseline. chi square analysis was used to evaluate differences in long-term outcome for the separate screening methods. results: in total, 92 patients were screened for snm. of the 76 patients who were screened with pne, 35 (46%) met the criteria for permanent implantation, whereas 11 of the 16 patients (69%) who underwent direct screening with tlp had permanent stimulators placed. of the 41 patients who failed pne and subsequently underwent screening with tlp, 18 (44%) were implanted with an ins after showing a successful response. the mean follow-up was 53 months (range 35-77 months) at the time of voiding diary analysis. statistical analysis showed no difference between type of screening and long-term success (p=0.94). conclusion: although first stage tlp is a more reliable screening tool than pne, the long-term success rate does not seem to be dependent on the screening method. furthermore, patients who initially failed pne but responded to prolonged screening with tlp, appear to be at least as successful in the long-term as patients who directly responded to pne or tlp.

Eligibility criteria:
inclusion criteria: * patients who have been treated for overactive bladder syndrome or chronic non-obstructive urinary retention with sacral neuromodulation by using the tined lead exclusion criteria: * patients with bilateral implantation of a tined lead * patients who have been treated with sacral neuromodulation for pelvic pain

Keywords: sacral neuromodulation screening percutaneous nerve evaluation tined lead
timing of weight bearing after hallux valgus surgery

Conditions: Hallux Valgus and Bunion

Summary: investigate the optimal timing for weight bearing after hallux valgus surgery. hypothesis: early weight bearing does not affect outcome after the endoscopic distal soft tissue procedure for hallux valgus correction.

introduction: * rehabilitation plans after hallux valgus/bunion surgery is varied * from a patient's perspective, full weight bearing is paramount for quality of life and return to work/study * no high-level study showing the optimal time to resume full weight bearing available hypothesis: early weight bearing (at 2 weeks post-op) does not affect outcome after the endoscopic distal soft tissue procedure for hallux valgus correction trial design: * parallel group * random allocation * operating surgeon blind to randomisation study setting: * general regional hospital * single centre

Eligibility criteria:
inclusion criteria: * all patients undergoing the edstp recruited exclusion criteria: * cases requiring additional procedures (eg 2nd toe correction) * mental incapacitation * physical disability hindering rehabilitation (eg cva, neurological disorder)

Keywords: hallux valgus bunion post-operative rehabilitation weight bearing status
curosurf/budesonide for infants with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome

Summary: infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to brochopulmonary. cursurf is used worldwide in infants with respiratory distress syndrome, budesonide is a glucocorticoid with a high local anti-inflammatory effect.our hypothesis is cursurf combined with budesonide could reduced the need of cursurf and incidence of brochopulmonary dysplasia.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of respiratory distress syndrome exclusion criteria: * pneumothorax * surgical disease * major congenical defects

Keywords: infant respiratory distress syndrome
effects of cognitive behavior therapy on quality of life in paroxysmal atrial fibrillation patients

Conditions: CBT

Summary: health-related quality of life (hrqol) was commonly impaired in atrial fibrillation patients. depression, anxiety, and illness perception are psychological correlates of hrqol. our previous study had shown good effects of cbt on the quality of life in af patients. this study aimed to establish the long-term efficacy of cbt on both psychological distress and hrqol. method: the study was a prospective, open study, pseudo-randomization with a pretest-posttest design and a 6-month follow-up. a total of 102 patients with paroxysmal af were enrolled, and 90 patients were assigned (1:1) to 10 weeks of cbt focused on anxiety symptoms or to treat as usual in the end. item short form health survey (sf-12), gad-7, phq-9, university of toronto atrial fibrillation (afss), and brief illness perception questionnaire (bipq) were measured as outcomes.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for participation were: (a) age 18-75 years; (b) af diagnosis, based on a 12-lead ecg and cardiologist-led examination following the 2016 esc guidelines for the management of atrial fibrillation5 and (c) paroxysmal af diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week 18. (d) ability to read and write in chinese. exclusion criteria: * (a) severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%); (b)af soon after thoracic surgery; (c) malignant disease with a 1-year survival rate or a terminal illness diagnosis; (d) a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder);(e) regular psychological therapy with a mental health condition; (f) participation in another study; (g) cognitive impairment interfering with their ability to participate in the study.
immuno & safety study of gsk biologicals' thio or preservative free hepatitis b vaccine in subjects aged 11-15 yrs

Conditions: Hepatitis B

Summary: to evaluate the persistence of antibodies against hepatitis b at 30, 42, 54 and 66 months after the first dose of the hepatitis b primary vaccination course. subjects were aged 11 to 15 years at the time of the primary vaccination course. at the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

all subjects who participated in the primary study, in which they received either 2 or 3 doses of gsk biologicals hepatitis b vaccine, and who consented to participate in the long-term follow-up at month 42 were contacted by the investigators. no additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Eligibility criteria:
inclusion criteria: * subjects have participated in primary study hbv-280 * written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Keywords: persistence hepatitis b vaccine
the effect of yoga on respiratory functions, symptom control and life quality of asthma patients

Conditions: Asthma; Yoga

Summary: this study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.

while there are studies conducted with yoga on different patient groups in turkey, no studies have been found on asthma patients specifically. for this reason, it was thought that studies are needed which will prove the effect of yoga practices in preventing and controlling symptoms of asthma patients and which will contribute to nursing literature.

Eligibility criteria:
inclusion criteria: * must be between 18 and 55 years old * must be diagnosed with asthma at least for six months, * must be living in the city centre, * must be literate and volunteered to participated in the study, were included in the study exclusion criteria: * be participated in a regular exercise program in the last 6 months, * be have another respiratory system disease * be in the exacerbation period, * have a physical disease or cognitive deficiency and a psychiatric disease diagnosis that could prevent understanding the training given,

Keywords: asthma nursing patient yoga
intelligent assistive technologies for dementia

Conditions: Healthy Adult

Summary: with the haal(healthy ageing eco system for people with dementia) project, the netherlands, taiwan, italy, austria, and denmark combine their strength, co-create, evaluate and share their experiences in supporting dementia care by state-of-the-art aal bundles.co-design sessions will take place before developing the dashboard, consisting of (in)formal carers, and older people/clients they care for. the haal project will conduct field trials with the first version of the dashboard (alpha testing) and after alpha testing, a beta version of the dashboard will be developed according users' feedback. then more end-users will be incorporated in beta testing.the aims of the dashboard are to provide support to reduce the workload of the caregivers and allow psychological relief, which eventually support clients' wellbeing.


Eligibility criteria:
inclusion criteria: caregiver * principal caregivers of pwd(people with dementia) or organizer or manager of care organization care recipient * aged ≥ 65 * global deterioration scale(gds):2-4 level * healthy adult (no skeletal muscle, neurological,eye and hearing disease)

Keywords: dementia care hand rehabilitation haal dashboard