Kornimate/medical-research-clean huggingface dataset:
anesthesia geriatric evaluation and quality of life after cardiac surgery

Conditions: Quality of Life

Summary: a prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in cardiac surgery patients.

introduction: the current population is ageing in a rapid pace. currently elderly represent 17.8% of the dutch population. most recent estimates show this will increase to 25.6% 20 years' time. this rise in elderly will also reflect on the population of patients being referred for cardiac surgery. especially elderly patients are at risk for postoperative complications, mortality or functional decline. in frail elderly this effect might be more pronounced. frailty is an umbrella term that encompasses patient related factors such as weight loss, muscle wasting, inactivity, comorbidities and polypharmacy. current scoring systems that are used to predict postoperative mortality and complications following cardiac surgery perform poorly in the elderly population and do not take into account frailty. moreover they are designed to predict mortality and complications and are not validated to predict patient reported outcome measures such as quality of life or functional status. the aim of the age study is assess the value of frailty factors in predicting an improvement in quality of life one year after cardiac surgery. methods: the age study is a prospective observational cohort study. all patients aged 70 years or older, scheduled for cardiac surgery, mentally competent and have signed informed consent are eligible for the study. during routine preoperative screening patients will be screened for frailty using different questionnaires and physical tests. the battery of tests exist of short form 36 (sf36), multi nutritional assessment (mna), mini mental state examination (mmse) and nagi's scale for disability, three physical tests: five meter walking speed, timed get up and go test and hand grip strength. a non-invasive measurement of advanced glycation endproducts (ages) and a medication review. a blood sample will be taken to determine vitamin status, iron deficiency, pre-operative inflammatory parameters, cmv status, pneumococcal carriage and cardiac biomarkers. after surgery electronic patients charts will be studied to score postoperative complications or mortality. three months and one year after cardiac surgery patients will receive sf-36 and world health organization disability assessment schedule (whodas) 2.0 questionnaires to determine quality of life and functional status.

Eligibility criteria:
inclusion criteria: * aged 70 years or older * mentally competent * planned cardiac surgery (coronary, valvular, rhythm, aortic or combination of those) * signed informed consent

Keywords: frail elderly cardiac surgical procedure risk assessment quality of life
comparison of epzicom and truvada for the initial once daily hiv treatment

Conditions: HIV Infections

Summary: a non-inferiority randomized control trial in treatment naïve hiv patients to compare virologic effect of two backbone regimens with epzicom (lamivudine and abacavir) and truvada (emtricitabine and tenofovir). both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

in treatment naïve hiv-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with truvada. this non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks. the primary endpoint is the antiretroviral effect over 48 weeks. the secondary endpoints are; 1. the immunologic effects from baseline at the 48th and 144th week 2. reasons of treatment failure by 144th week 3. adverse events and their rate of incidence by 144th week 4. serum concentration of tenofovir in selected patients 5. serum concentration of atazanavir in selected patients 6. renal complication in tenofovir arm

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hiv infection, * antiretroviral initiation is recommended by current clinical guidelines, * treatment naïve, * age over 20 years old japanese, * able to obtain written informed consent exclusion criteria: * current malabsorption condition, * prior use of lamivudine for hepatitis b treatment, * positive serology of hepatitis b surface antigen, * patients who have following abnormal laboratory results within 6 weeks prior enrollment; 1. alanine aminotransferase is more than 2.5 times higher of upper normal limit 2. estimated glomerular filtration rate is less than 60ml/min by cockcroft-gault equation 3. serum phosphate level is less than 2.0mg/dl * patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition * patients in pregnancy or breat feeding * patients who are taking medications contraindicated combine use of study medicine * patients whose primary care physicians consider inadequate to be enroll the study

Keywords: hiv initial therapy once daily randomized trial non inferiority treatment naive
internet-delivered cbt for insomnia: role of sleep-related cognitions

Conditions: Insomnia

Summary: the object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. in this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. participants in the waiting-list condition receive treatment after the post-test. the interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. participants will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. in this study we are interested in sleep-related worry and daily complaints measured with a diary. we expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.


Eligibility criteria:
inclusion criteria: * insomnia disorder according to dsm-5 * sleep onset latency/wake after sleep onset \> 30 minutes , three times or more a week * insomnia three months or longer * access to internet exclusion criteria: * earlier cognitive behavioral treatment for insomnia * start other psychological treatment in the last 6 months * doing shift work * pregnancy or breast feeding * schizophrenia or psychosis * suicidal plans * sleep apnea * drugs or alcohol abuse
brief mindfulness intervention for patients at a free acute care clinic

Conditions: Pain

Summary: this is a single-site, two-arm, parallel-group randomized clinical trial (rct). the clinical effects of a 4-minute audio-recorded mindfulness intervention for 100 english-speaking patients and 100 spanish-speaking patients at a free acute care clinic will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria:
inclusion criteria: * age ≥18 * seeking treatment at the shepherd's hope downtown clinic exclusion criteria: * cognitive impairment preventing completion of study procedures. * other unstable illness judged by medical staff to interfere with study involvement.
assessment of novel sound changing principles in hearing instruments to determine their application - 2019_20

Conditions: Hearing Loss

Summary: a methodical evaluation of novel sound changing principles in ce-labelled sonova brand hearing instruments (e.g. phonak hearing instruments) is intended to be conducted on hearing impaired participants. these sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. the aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (phase of development). both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. this will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarter based in stäfa


Eligibility criteria:
inclusion criteria: * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * known central hearing disorders * colour blinded
risk factors for severe disease in hospitalized patients with covid-19 and the effect of azvudine treatment: a retrospective cohort study

Conditions: COVID-19

Summary: the purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with covid-19, including basic diseases, laboratory parameters, and clinical manifestations; in addition,to explore whether azvudine can reduce the mortality of hospitalized patients with covid-19.

4201 covid-19 patients discharged from our hospital were enrolled. binary logistic regression analysis and roc curve were used to investigate the role of comorbidities, laboratory parameters and clinical manifestation on progression of covid-19 patients. we used propensity-score models conditional on baseline characteristics and univariate cox regression model to examine whether azvudine can reduce the mortality of covid-19 patients.

Eligibility criteria:
inclusion criteria: the covid-19 positive patients exclusion criteria: 1. patients treated with both azvudine and monotamivir; 2. patients receiving other antiviral drugs such as nematavir/ritonavir; 3. age \&lt; 18 years old

Keywords: covid-19 azvudine severity
prospective study of an investigational toric soft contact lens

Conditions: Myopia; Astigmatism; Refractive Error

Summary: the purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available focus® dailies® toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

eligible participants were randomized 2:1 to wear either dailies® aquacomfort plus® toric or focus® dailies® toric.

Eligibility criteria:
inclusion criteria: * sign informed consent document. if under legal age of consent, legally authorized representative must sign informed consent document and participant must sign assent document. * normal eyes not using any ocular medications that would contraindicate lens wear. * willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial. * spectacle cylinder prescription between 0.50 and 2.00 diopters. * best spectacle corrected visual acuity 20/25 (snellen) or better in each eye at distance. * other protocol-defined inclusion criteria may apply. exclusion criteria: * anterior segment infection, inflammation, or abnormality. * any active anterior segment or systemic disease that would contraindicate contact lens wear. * use of systemic medications that would contraindicate lens wear. * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study. * history of herpetic keratitis. * history of refractive surgery or irregular cornea. * history of pathologically dry eye. * corneal vascularization greater than 1 mm of penetration. * eye injury within twelve weeks immediately prior to enrollment in this trial. * participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial. * other protocol-defined exclusion criteria may apply.

Keywords: toric contact lenses daily disposable contact lenses astigmatism soft contact lenses contact lens comfort
the use of quantitative pregnancy test in amniotic fluid as a diagnostic tool for rupture of fetal membranes

Conditions: Premature Rupture of Membrane

Summary: two groups will be recruited. the first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. the second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. quantitative and qualitative pregnancy tests will be measured in this fluid.

beta subunit of human chorionic gonadotropin assay will be measured in the vaginal washing in two groups. the first group are pregnant women in the second or third trimester. these women have definite rupture of membranes diagnosed by visual leaking of the amniotic fluid from the cervix during speculum examination. the second group are pregnant women with intact membranes. assessment of both the qualitative and quantitative beta subunit of human chorionic gonadotropin will be done

Eligibility criteria:
inclusion criteria: * pregnant women between 14 and 40 weeks gestation with history of gush of vaginal fluid * pregnant women between without history of gush of vaginal fluid exclusion criteria: * presence of vaginal bleeding * presence of any obstetric emergency as cord prolapse
simplified diagnostic algorithm for evaluation of neonates with prenatally detected hydronephrosis

Conditions: Congenital Hydronephrosis

Summary: patients with congenital hydronephrosis will be identified by inpatient consultations performed by dr. assadi for congenital hydronephrosis and by outpatient problem lists with congenital hydronephrosis of dr. assadi's existing patients. given standard evaluation will be evaluated to determine if based on initial ultrasound classification an algorithm can be developed to target evaluation studies for the initial evaluation. with a goal of targeting the few children that have need of additional intervention and minimizing the studies performed on children who will spontaneously resolve.

patients with congenital hydronephrosis will be identified by inpatient consultations performed by dr. assadi for congenital hydronephrosis and by outpatient problem lists with congenital hydronephrosis of dr. assadi's existing patients. once identified, the patient's grade of hydronephrosis will be recorded from initial ultrasound based on society of fetal urology (sfu) classification. if no initial sfu classification was assigned to the hydronephrosis a pediatric radiologist will review the initial ultrasound images and classify the grade of hydronephrosis based upon sfu criteria. the patients ensuing evaluation of their hydronephrosis that took place will then be recorded and de-identified. data to be collected will include: ultrasound evaluations of the abdomen, retroperitoneum, or renal system, voiding cysto-urethrogram (vcugs), nuclear studies: diuretic enhanced technetium-99m dietylene triamine penta-acetic acid renogram (dtpa) or technetium-99m mercapto-acetyl-triglycine renogram (mag3), referral to pediatric urology for pyeloplasty, serum electrolytes, blood urea nitrogen (bun) and creatinine, urinalysis, urinary tract infections, and placement on long-term antibiotic prophylaxis. the follow up evaluation that took place for each patient will then be compared to our proposed algorithm for congenital hydronephrosis evaluation and treatment. this algorithm will be designed based on clinical experience of expert opinion and literature review of each step in the evaluation and treatment. primary outcomes will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty. secondary outcomes will be incidence of urinary tract infections and placement on long term antibiotic prophylaxis for urinary tract infection prophylaxis.

Eligibility criteria:
inclusion criteria: * inclusion criteria for the study were confirmation of the diagnosis of prenatal hydronephrosis by postnatal renal ultrasound exclusion criteria: * prior history of uti * diagnosis of cystic renal dysplasia with poorly functioning kidney * previous operation on the urinary tract system * and other deformities of the external genital organs or anomalies in cardiopulmonary and central nervous system

Keywords: newborn infant congenital hydronephrosis postnatal imaging evaluation diagnostic algorithm
postmarket registry for evaluation of the superion® spacer

Conditions: Lumbar Spinal Stenosis

Summary: to gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the superion® indirect decompression system (ids).

to gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the superion® ids in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from l1 to l5.

Eligibility criteria:
inclusion criteria: * male and female patients ≥45 years of age * symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from l1 to l5 * meeting the labeled indications for use of the superion® indirect decompression system (ids) exclusion criteria: * not contraindicated as described in the labeled indications for use

Keywords: lss
tarceva and radiotherapy in locally advanced lung cancer non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the trial is a phase ii study of daily tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage iib-iiib). the objective of the phase ii trial is to examine tarceva concomitant with curatively intended irradiation 66 gy (2 gy x 33 f, 5 f per week).


Eligibility criteria:
inclusion criteria: * age ≥18 years * patients with histologically or cytologically documented diagnosis locally advanced nsclc stage iib to iiib without pleural effusion * performance status ≤2 on the ecog scale * serum bilirubin must be ≤1.5 upper limit of normal (uln) * alat ≤2 x uln * able to comply with study and follow-up procedures * patients with reproductive potential must use effective contraception * written (signed) informed consent to participate in the study exclusion criteria: * any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease) * any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) * inability to take oral medication, or requirement of intravenous alimentation * nursing mothers

Keywords: lung cancer non-small cell lung cancer tarceva radiotherapy local-regionally advanced non-small cell lung cancer
clinical research study to learn about the effect and safety of different doses of fe 999302 when given as a single dose for final development of the eggs after ovarian stimulation

Conditions: Infertility

Summary: the primary purpose of this trial is to compare three different doses of fe 999302 with 250 µg ovitrelle and 10,000 iu novarel on oocyte maturity when administered as a single dose for final development of the oocytes in women undergoing controlled ovarian stimulation.


Eligibility criteria:
inclusion criteria: * pre-menopausal women between the ages of 18 and 42 years. the subjects must be at least 18 years (including the 18th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent. * infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage i/ii or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (ivf) and/or intracytoplasmic sperm injection (icsi) using fresh or frozen ejaculated sperm from male partner or sperm donor. * infertility for at least 1 year before screening for subjects \<35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility). * no more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking exclusion criteria 3, 4, and 5 into account). * regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory. exclusion criteria: * known polycystic ovary syndrome (pcos) associated with anovulation or known endometriosis stage iii-iv (american society for reproductive medicine, 2012). * considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 iu/day highly purified human menopausal gonadotropin (hp-hmg), as judged by the investigator. * poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 iu/day or higher. poor response is defined as \<4 oocytes retrieved, or cycle cancellation prior to oocyte retrieval due to inadequate follicular development. * excessive ovarian response in a previous controlled ovarian stimulation cycle for ivf/icsi using a daily fsh/hmg dose of ≤225 iu, defined as ≥25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (ohss). * severe ohss in a previous controlled ovarian stimulation cycle.