Kornimate/medical-research-clean huggingface dataset:
open-label prospective study comparing long-term outcome with or without hfnc in patients with stable hypercapnic copd

Conditions: COPD

Summary: the aims of the study are to compare long-term one-year outcome with or without airvotm in stabile hypercapnic copd patients, who are non-compliant to niv after an acute exacerbation of copd.

when compared to niv, much less experience is available from clinical studies on hfnc therapy. until now, few studies have investigated the effect of hfnc therapy on hypercapnic copd patients and the number of patients recruited in these studies is limited. airvotm therapy could be good choice of treatment for those copd patients that are not compliant to niv but need treatment for hypercapnia in order to reduce copd exacerbations and enhance qol.the aims of the study are to compare long-term one-year outcome with or without airvotm in stabile hypercapnic copd patients, who are non-compliant to niv after an acute exacerbation of copd.

Eligibility criteria:
inclusion criteria:copd patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of copd are hypercapnic (capillary pco2 \>6.5 kpa) and not willing to use niv or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try niv (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of copd are defined according to the gina guidelines (gold 2019). exclusion criteria: 1) osa (diagnosed osa or high suspicion osa because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) bmi\>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.
the role of endothelium dysfunction in progression of ckd (chronic kidney disease) after aki (acute kidney injury)

Conditions: Acute Renal Failure; Chronic Kidney Failure; Endothelial Dysfunction; Hemolytic-uremic Syndrome (HUS)

Summary: to understand how aki (acute kidney injury) leads to chronic kidney disease so therapies can be found to alter the progression of events thereby significantly impacting the long-term outcomes of children who develop aki.

this research study is designed to study what happens to the kidneys after they have an injury. there is some evidence that even if there appears to be great improvement of kidney function, an injury can put patients at risk for long-term problems with their kidney function and increase their risk to have high blood pressure. we want to collect information from participants to help explain why this injury can cause future problems, including chronic kidney disease (ckd) which may help us prevent these health problems.

Eligibility criteria:
inclusion criteria: * children between age 2-20 * decrease in renal function by 25% or greater * renal function has returned to normal exclusion criteria: * history of chronic disease * cancer * congenital heart disease * organ transplantation * liver disease * pulmonary disease * diabetes other primary metabolic condition * severe neurologic impairments * hypertension * auto-immune * infectious disease or renal disease * smokers * renal disease w/primary cause i.e. - hus or glomerulonephritis * severe allergies including allergy to seafood and/or iodine

Keywords: endothelium chronic kidney disease acute kidney injury hemolytic-uremic syndrome (hus)
hpv self-sampling in somali women

Conditions: Cervical Cancer; Papillomavirus Infection; Uterine Diseases; Uterine Cervical Disease

Summary: this study plans to assess the effect of implementing hpv self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old somali women who are due for cervical cancer screening.


Eligibility criteria:
inclusion criteria: * identify as a somali woman * between ages of 30-65 * eligible for cervical cancer screening exclusion criteria: * ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix

Keywords: dna virus infections virus diseases infections tumor virus infections papilloma uterine diseases uterine cervical diseases somali women primary care cancer screening
first-in-man trial of nnc114-0005 in healthy subjects and subjects with rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-il-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels in healthy subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (ra) and at 3 s.c. dose levels in healthy subjects.


Eligibility criteria:
inclusion criteria: * for all subjects the following applies: * male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. male subjects must also agree to refrain from sperm donation from screening (trial start) until 120 days beyond trial drug administration * for healthy subjects (hs) the following additional criteria applies: * male subjects, aged between 18 and 60 years (both inclusive) and in good health, as determined by past medical history, physical examination, vital signs, (electrocardiogram) ecg, and laboratory tests at screening (trial start) * for subjects with rheumatoid arthritis (ra) the following additional criteria applies: * diagnosed with ra at least 3 months prior to trial drug administration * active ra, characterised by a disease activity score 28 (das28)-c-reactive protein (crp) greater than 3.2 * effective methods of contraception * male and female subjects aged greater and equal to 18 and greater and equal to 75 years * females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year). if female of child-bearing potential must be willing to use highly effective method of birth control during the trial until their final visit * methotrexate treatment (mtx) treatment for at least 12 weeks at a stable dose (dose at least 7.5 mg/week and maximum 25 mg/week inclusive) for at least 4 weeks prior to trial product administration * concomitant medication according to specific list exclusion criteria: * for all subjects the following applies: * body mass index (bmi) between 20.0-38.0 kg/m2 (both inclusive) * females with a positive pregnancy test * history of regular alcohol consumption exceeding 14 drinks per week for females or 21 drinks per week for men * donation or loss of at least 400 ml of blood within 8 weeks prior to trial product administration * for healthy subjects (hs) the following additional criteria applies: * body weight greater than 110.0 kg * for subjects with rheumatoid arthritis (ra) the following additional criteria applies: * chronic inflammatory autoimmune disease other than ra (except secondary sjögren's syndrome or stable hypothyroidism) * history of or current inflammatory joint disease other than ra such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or lyme disease
study on skin toxicities induced by cancer treatments

Conditions: Solid Tumor, Adult; Breast Cancer; Lung Cancer

Summary: the skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.


Eligibility criteria:
inclusion criteria: 1. patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not; 2. patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic; 3. treatment planned for a minimum period of 3 months (from the date of inclusion); 4. having a social security protection; 5. signed informed consent form of the study. exclusion criteria: 1. patient treated for lymphoma, leukemia or inflammatory breast cancer ; 2. patient with a solid tumour which location is other than breast or lung; 3. patient with a tumor wound ; 4. patient with a general condition \> 2 at baseline (ecog classification) ; 5. patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ; 6. patient unable to receive information about the study and to give consent ; 7. persons deprived of liberty or guardianship ; 8. impossible submission to study procedures for geographical or psychological reasons.
community-onset bacteremia due to esbl producing e.coli or k.pneumoniae in china: prevalence, risk factors and prognosis

Conditions: Community Acquired Infection

Summary: escherichia coli is the leading cause of community-onset gram-negative bloodstream infections. there has been a dramatic increase in the prevalence of extended-spectrum b-lactamases producing e. coli and k.pneumoniae in the community, which was considered to be exclusively a nosocomial pathogen in recent years. as a result, the treatment options for community-onset infections due to esbl-producing e. coli or k.pneumoniae are limited and the initial empirical therapy is often ineffective and associated with increased mortality. although there were some reports of the risk factors of community-onset esbl producing e. coli in spain, korea, and canada, few empirical data were available about china. therefore, the investigators aim was to investigate the epidemiology, risk factors, and the hospital outcomes for patients with community-onset bacteremia caused by esbl producing e. coli or k.pneumoniae in china.

eligibility criteria: 1. inclusion criteria:blood cultures demonstrated e.coli or k.pneumoniae among nonhospitalized patients or within 48 h after hospitalization. 2. exclusion criteria:patients with hospitalization in the past 1 month. outcome measures: 1. risk factors for community-onset bacteremia due to esbl producing e. coli or k.pneumoniae 2. microbial and clinical efficacy of commonly used antibiotics for community-onset bacteremia due to esbl producing e. coli or k.pneumoniae

Eligibility criteria:
inclusion criteria: * older than 18 years old * community-onset bacteremia exclusion criteria: * recent hospitalization within one month in any hospital
circumferential section pane less than 1 mm in esophagectomy for esophageal cancer.

Conditions: Esophageal Cancer

Summary: a suspicious circumferential resection margin (crm), defined as tumor cells within 1 mm of the crm, is still controversial. the aim of this study was to compare the clinical significance of a suspicious crm to histologically positive (r1) and negative margin (r0) resections in patients with pt3 esophageal and ge-junction tumors.

from our prospectively build database 923 consecutive pt3 patients operated between january 1990 and june 2013 were selected. crm status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery. kaplan-meier survival curves were generated, and factors affecting survival were assessed by cox regression multivariate analysis.

Eligibility criteria:
inclusion criteria: * pathologic t3 tumours of esophagus or gej exclusion criteria: * pt other than pt3 * r2 resections

Keywords: esophagectomy
volume challenge added to dse in the diagnosis of severe lflgas

Conditions: Aortic Valve Stenosis

Summary: the aim of this study is to test the diagnostic added value of volume challenge (vc) to low-dose dobutamine stress echocardiography (lddse) in patients with a low-flow, low-gradient aortic stenosis (lflgas). this study will assess if lddse plus vc allows to increase the proportion of patients in whom a true severe as can be differentiated from a pseudo severe as.

the design of the study is a monocentric prospective non-randomized pilot clinical trial. a standard lddse will be performed. the stroke volume (sv) will be recorded. the addition of vc with the passive leg raise method at peak dobutamine dose will be performed. a transesophageal echocardiography (tee) with low dose dobutamine and a bolus of normal saline will be performed as a validation method to measure ava with the planimetry method. the sv will be recorded. proportion of patient receiving the diagnosis of true severe as defined as a combination of ava \<1.0 cm2 and ∆sv ≥ 20% will be compared between standard lddse and lddse with addition of vc. calculating sensitivity, specificity, performing roc curve analysis and calculating the youden-index, the accuracy of the test method (lddse plus passive leg raising) for the detection of truly severe as in comparison with the reference method (tee) will be determined.

Eligibility criteria:
inclusion criteria: * age \> 18 years * written informed consent * patients with lflgas (mean gradient: \< 40 mmhg, ava ≤ 1.0 cm2 (by continuity equation using lvot diameter) svi ≤ 35 ml/m2), by rest tte exclusion criteria: * hypersensitivity to dobutamine or midazolam * lack of safe contraception defined as: female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * enrolment of the investigator, his/her family members, employees and other dependent persons * previous enrolment into the current study, additional specific exclusion criteria regarding stress echocardiography: * systolic left ventricular ejection fraction (lvef) \< 20% * more than mild aortic regurgitation * mitral valve disease, defined by mitral valve area \< 2.0 cm2 or more than mild mitral regurgitation * unstable angina * acute pulmonary oedema * signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation * signs of relevant right ventricular heart failure defined as central venous pressure (cvp) \> 15 mmhg estimated with dilatation and collapsibility of vena cava inferior (vci) * severe pulmonary, renal or hepatic disease additional specific exclusion criteria regarding transesophageal echocardiography: * oesophageal varices * history of bariatric surgery

Keywords: low - flow low - gradient low - dose dobutamine volume challenge echocardiography
shorter treatment of replacement therapy for frozen embryo transfer (fet)

Conditions: Infertility

Summary: this is a single-centre pilot study, randomized, controlled open-label trial with the aim to assess the clinical pregnancy rate and the early pregnancy loss rate between two different schemas for frozen embryo transfer cycles stimulated with hrt. furthermore, the investigators would like to evaluate the predictivity of pregnancy and early miscarriage by looking at the endocrinological profile (estradiol and progesterone levels) within the endometrial preparation and the day of embryo transfer (et).

women planned for a fet-hrt will be asked to do a blood test day 1 of their cycle in order to evaluate the endocrine profile; those with basal hormonal values will receive 6 mg oral estradiol daily beginning from day 1 of their cycle. on day 7 of the treatment a blood test for the serum hormone evaluation and an ultrasound will be planned in order to evaluate the endometrium thickness; those who will meet the criteria (endometrium thickness ≥7mm) will be randomized. in the 7 days estradiol (e2) arm (a) the study coordinator will plan the fet after 6 days of progesterone supplementation (13 days of e2 intake). in the 14 days e2 arm (b) the team will plan on day 14 of treatment with e2 the serum hormone evaluation and an ultrasound in order to evaluate the endometrium thickness, consequently the fet will be planned after 6 days of progesterone supplementation (after 14 days of e2 intake). furthermore, all the patients included in the study will undergo a blood test on the day of the transfer for the evaluation of the hormones level. for the assessment of the pregnancy a first blood test will take place 12 days after the et and a blood test with an ultrasound will take place at 7 weeks for the evaluation of the clinical pregnancy.

Eligibility criteria:
* women aged ≥18 and \< 40 years * unexplained infertility * normal uterine cavity * ivf/icsi * ivf cycle with gnrh agonist or antagonist * single day 5 blastocyst transfer * top quality embryo (at least bl 3ba) at the moment of et * signed informed consent * participants can be included only once in the trial * informed consent documents signed prior to screening evalua-tions.
home-based program "t&e" for fall prevention and qol in elderly: a randomised control pilot-study

Conditions: Accidental Falls

Summary: the aim of the pilot-study is to evaluate the feasability of a future rct, regarding recruitement of eligible participants, adhesion rate, datarecording and cost. in this feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one of two interventions. the control group gets a well-known home-based exercise program (otago) aiming to prevent falls where the exercises are prescribed by a physical therapists. the exercises will be presented on a booklet and on printed cards. the intervention group consists of an exercise program, the "t\&e" program, where the elderly persons can choose the exercises depending on their abilities. the exercises in the "t\&e" program will be presented in a printed manual and shown on videos on an electronic tablet. both intervention groups receive 6 hours of instruction and control/supervision sessions by physical therapists. in addition, the participants will exercise alone. the interventions will be performed over 24 weeks. in this pilot study, the hypothesis is that the adhesion rate is at least 65%. other feasibility criteria will be costs, data recording issues and the qualitative evaluation of the booklet and the tablet. falls will be assessed with a falls calendar. the amount of physical activity of the participants is assessed with an accelerometers (actigraph) and quality of life will be assessed with opqol-35 at baseline, week 16 and week 24.


Eligibility criteria:
inclusion criteria: * living at home * ability to perform standing position independently with/without walking aids (rollator crutch) * reported fall(s) during the last 12 months and/or fear of falling (short fes-i ≥8) * understand french / german exclusion criteria: * actually in treatment with a physical therapist * participate at an other home-based programm exercises * mms score ≥ 25.

Keywords: elderly, home-based exercises programm
online wic nutrition education to promote farmers' market fruit and vegetable purchases and consumption

Conditions: Cardiovascular Diseases; Cancer; Type 2 Diabetes; Obesity

Summary: this study is evaluating the wic fresh start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the special supplemental nutrition program for women, infants and children (wic).

this study is evaluating the wic fresh start program, a theory-driven, web-based nutrition education lesson to promote fruit and vegetable (fv) consumption among women enrolled in the special supplemental nutrition program for women, infants and children (wic). designed to leverage vouchers provided to wic participants for fv purchases through the farmers' market nutrition program (fmnp) and monthly cash value vouchers (cvvs) redeemable at farmers' markets, the lesson is conceptually grounded in formative research on knowledge, attitudes and skills influencing farmers' market fv purchases and consumption and theoretical understanding of approaches for modifying them. lesson content delivery is primarily through short video segments and audio output to increase accessibility for low-literate learners. informed by a community-based participatory research approach, wic participants are engaged as full partners in the development of the lesson and the delivery of content (videos feature wic participants). the setting is a large wic agency serving three new jersey counties. separate samples of women were recruited to participate in 1) focus groups for guiding lesson content development (n = 56 participants) and pretesting the resulting content (n = 52 participants), 2) cognitive testing to assess the clarity and interpretability of items and response formats in measures of knowledge, attitudes and skills developed for the study (n = 15), 3) one-on-one sessions to assess reactions to initial versions of video segments developed for the lesson (n = 20), and 4) the outcome evaluation (n = 744). stratified based on fmnp voucher receipt, participants are randomized to receive the lesson or existing online health education. outcome measures (administered orally to reduce literacy demands of the response task) are completed at pretest (immediately before the lesson), posttest (two weeks after the lesson), and 3 and 6 months after posttesting. short- and long-term lesson effects on fv intake, fmnp voucher redemption and the redemption of cvvs at farmers' markets will be evaluated. evidence for mediation by knowledge, attitudes, and skills of lesson effects on fv intake and voucher redemption, dose-response relationships, and user satisfaction with the lesson also will be examined.

Eligibility criteria:
inclusion criteria: * pregnant or postpartum wic participant * female caregiver of infant/child wic participant exclusion criteria: * restrictions on food intake * classified by wic as high risk/requiring an individualized nutrition care plan

Keywords: fruit, vegetables, income, wic program, farmers' market