Kornimate/medical-research-clean huggingface dataset:
study of breast tissue in women not previously diagnosed with breast cancer who are undergoing fine needle aspiration

Conditions: Breast Cancer; Healthy, no Evidence of Disease

Summary: rationale: studying samples of blood and breast tissue from healthy women in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to breast cancer risk. purpose: this research study is looking at breast tissue in women not previously diagnosed with breast cancer who are undergoing fine-needle aspiration.

objectives: primary * to determine if breast tissue dna methylation profile and hormone concentration change across follicular and luteal phase, or across menopause, in random fine needle aspiration samples of women with no prior diagnosis or treatment for breast cancer. * to determine if dna methylation profile and breast hormone levels correlate with mammographic density, cytomorphology, or gail risk estimates. * to develop a high throughput commercial assay for dna methylation profiling for assessing breast cancer risk. * to develop a highly sensitive, specific, and novel nanoassay for estradiol and progesterone. outline: this is a multicenter study. premenopausal women are stratified by menstrual cycle phase (mid-follicular \[day 5-10\] vs mid-luteal \[day 20-25\]), based on an adjusted 28-day cycle. patients undergo breast density measurement by digital mammography. blood samples are obtained and analyzed for estradiol, progesterone, and follicle-stimulating hormone measurements, to define menstrual/menopausal status, and for dna extraction. patients also undergo random fine needle aspiration. biopsy material from aspiration is analyzed for cytomorphology, steroid radioimmunoassay (ria), steroid nanoassay, and dna methylation studies (via polymerase chain reaction). the aspiration samples are also analyzed for estradiol and progesterone levels using high-pressure liquid chromatography and ria.

Eligibility criteria:
disease characteristics: * women meeting one of the following requirements: * regularly cycling premenopausal women under 45 years of age * perimenopausal women 45-55 years of age who have had ≥ two periods in the past 6 months * postmenopausal women under 60 years of age (no menstrual period for 12 months and follicle-stimulating hormone (fsh) levels \> 25 iu/dl) * no history of breast cancer diagnosis or prior treatment for breast cancer * negative breast evaluation within the past 3 months patient characteristics: * see disease characteristics prior concurrent therapy: * no concurrent oral contraceptives * at least 2 weeks since prior aspirin, non-steroidal anti-inflammatory drugs, and vitamin e

Keywords: breast cancer healthy, no evidence of disease
classification of covid-19 infection in posteroanterior chest x-rays

Conditions: COVID-19

Summary: the objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of covid-19 pcx images.

the december 2019 outbreak of covid-19 has now evolved into a public health emergency of global concern. given the rapid spread of infection, the rapid depletion of hospital resources due to high influxes of patients, and the current absence of specific therapeutic drugs and vaccines for treatment of covid-19 infection, it is essential to detect onset of the disease at its early stages. radiological examinations, the most common of which are posteroanterior chest x-ray (pcx) images, play an important role in the diagnosis of covid-19. the objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of covid-19 pcx images. the primary experimental dataset consisted of 115 covid-19 positive and 115 covid-19 negative pcx images, the latter comprising roughly equally many pneumonia, emphysema, fibrosis, and healthy images (230 total images). two common convolutional neural network architectures were used, vgg16 and densenet121, the former initially configured with off-the-shelf (ots) parameters and the latter with either ots or exclusively x-ray trained (xrt) parameters. the ots parameters were derived from training on the imagenet dataset, while the xrt parameters were obtained from training on the nih chest x-ray dataset, chestx-ray14. a final, densely connected layer was added to each model, the parameters of which were trained and validated on 87% of images from the experimental dataset, for the task of binary classification of images as covid-19 positive or covid-19 negative. each model was tested on a hold-out set consisting of the other 13% of images. performance metrics were calculated as the average over five random 80%-20% splits of the images into training and validation sets, respectively.

Eligibility criteria:
inclusion criteria: * single pcx images collected from patients over 18 years of age exclusion criteria: * ct scans composed of multiple concerted x-rays * single pcx images collected from patients under 18 years of age

Keywords: machine learning x-ray classification covid-19 posteroanterior convolutional neural network architectures
a study to compare the efficacy and safety of luspatercept (ace-536) versus epoetin alfa for the treatment of anemia due to ipss-r very low, low, or intermediate risk myelodysplastic syndromes (mds) participants who require red blood cell transfusions and are esa naïve

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to determine the effectiveness of luspatercept (ace-536) compared to epoetin alfa on red blood cell (rbc) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dl in participants with anemia due to revised international prognostic scoring system (ipss-r) very low, low, or intermediate risk myelodysplastic syndromes (mds) who require rbc transfusions and have never been exposed to erythropoiesis stimulating agent (esa).


Eligibility criteria:
inclusion criteria: * documented diagnosis of myelodysplastic syndromes (mds) according to who 2016 classification that meets revised international prognostic scoring system (ipss-r) classification of very low, low, or intermediate risk disease, and have \< 5% blasts in bone marrow * endogenous serum erythropoietin (sepo) level of \< 500 u/l * requires red blood cell (rbc) transfusions, as documented by the criteria: average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (prbcs) confirmed for a minimum of 8 weeks immediately preceding randomization * eastern cooperative oncology group (ecog) score of 0, 1, or 2 exclusion criteria: * clinically significant anemia due to iron, vitamin b12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia * known history of diagnosis of acute myeloid leukemia (aml) * uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (sbp) of ≥ 150 mmhg and/or diastolic blood pressure (dbp) ≥ 100 mmhg despite adequate treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: luspatercept ace-536 anemia myelodysplastic syndromes blood transfusion rbc transfusion erythropoiesis-stimulating agents erythropoietin myelodysplasia epoetin alpha
increased knowledge improve oral hygiene in patients with gingivitis

Conditions: Gingivitis

Summary: proper plaque control is essential for to maintain oral and general health therefore, improving patient motivation is crucial for to prevent oral diseases including periodontal diseases. the aim of this clinical trial is to evaluate the effect of periodontal health education session (phes) including the pathogenesis and consequences of periodontal diseases on oral hygiene motivation in patients with gingivitis.

a randomized controlled clinical trial design with 50 subjects (26 females and 24 males) was carried out in a group of gingivitis patients who underwent periodontal treatment. subjects were randomly allocated into phes group (test, n = 25) and standard oral hygiene education group (ohe) (control, n=25). test group received information about the pathogenesis of periodontal diseases, its consequences, its interaction with systemic diseases and the importance of daily proper cleaning by experienced periodontologist via brochure. control group received only standard oral hygiene instructions. the rustogi modified navy plaque index (rmnpi) and papillary bleeding index (pbi) were utilized to evaluate the oral hygiene at baseline and repeated at 1, 3 and 6 months follow-up. the clinical outcome variables of rmnpi (primary outcome) and pbi (secondary outcome) scores were analysed with mann whitney u test. friedman-wilcoxon sign ranked test was used for within group comparison. all data were analysed using the statistical software (spss, version 19.0, chicago, il, usa). a p-value of \<0.05 was accepted as statistical significance.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with gingivitis (no clinical attachment loss) and no previous periodontal treatment, * non-smokers, * aged\>22 years old and who have a university degree, * had a visible plaque level \> 50%. exclusion criteria: * patients having systemic conditions that could affect the healing process and prevent the application of oral hygiene instructions, * patients rehabilitated with teeth/implant supported prostheses, * patients diagnosed with periodontitis, * patients having defective restorations/active teeth related infection or ongoing orthodontic treatment * patients who had to be out of the city in a long time during the study period.

Keywords: motivational interview periodontal disease oral hygiene
effect of music in reducing pain and anxiety during hysterosalpingography in women with primary infertility

Conditions: Pain

Summary: this study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

this study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

Eligibility criteria:
inclusion criteria: * women aged 18-45 years. diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for hsg as part of infertility evaluation. exclusion criteria: * using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, current pregnancy or suspicion of pregnancy.active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
comparative effect of air heat versus infra red heat on pain and wound healling after vaginal delivery episiotomy

Conditions: Episiotomy Wound

Summary: to become "mother" is a beautiful gift given by god to woman. giving birth is a powerful and life changing even with a lasting impact on women and their families. pregnancy and labor are exceptional occasions in women's lives. post-delivery is very decisive period for compassionate woman who had under gone episiotomy which is a throbbing and disquiet procedure during this time. episiotomy wound healing takes weeks to years depending on health conditions and treatment of the perineum itself. episiotomy care is very essential, if neglected it can lead to severe complications like infection, wound gapping.


Eligibility criteria:
inclusion criteria: * primiparous women * postnatal mothers delivered within 12-24hours. * have a normal vaginal delivery with episiotomy * fand second degree episiotomy. exclusion criteria: * instrumental delivery ( forceps/ventous) * lower segment cesarian section * history of medical problem as hypertension and diabetes or anemia * perineal tear * infected wound * twin pregnancy

Keywords: air heat infrared heat episiotomy kegel exercises pain relief
gut microbiota and antibiotics - prevention of side effects by new prebiotics

Conditions: Changes in the Gut Microbiota During an Antibiotic Treatment

Summary: antibiotics disturb the balance of gut microbiota causing dysbiosis. the purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.

thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. the children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment. the children will give a faecal sample in the beginning and at the end of the study. the samples will be used for the analysis of microbiota and differences in the microbiota between the groups.

Eligibility criteria:
inclusion criteria: * an infection requiring antibiotic treatment assessed by a doctor exclusion criteria: * coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study

Keywords: antibiotics, prebiotics, dysbiosis
a trial to reduce delirium in aged post acute patients

Conditions: Delirium; Aging

Summary: the purpose of this study is to develop a comprehensive delirium abatement program of care of delirious patients in the post acute care setting and to evaluate its impact on persistence and severity of delirium and on functional recovery.

common, morbid, and costly, delirium affects one third of hospitalized elders, and plays a central role in the cascade of adverse events that leads to functional decline and loss of independence. moreover, as acute care stays continue to shorten and evidence mounts that delirium may persist for many weeks, concern about delirium can no longer be confined to the hospital. it is believed that a delirium abatement program may significantly reduce the persistence of delirium in post-acute settings, and thereby improve functional recovery both during the post-acute stay and after discharge. the delirium abatement program (dap) will be designed to assist facility staff to 1) detect delirium among new admissions, 2) evaluate common underlying causes of delirium, 3) prevent complications commonly associated with delirium, and 4) restore delirious patients' cognitive, behavioral, social and self care functioning to baseline status. this three year trial will enroll 500 delirious patients admitted to eight boston area post-acute skilled nursing facilities. the dap intervention will be carried out in four facilities. four other facilities, matched to the intervention by demographic, facility, and clinical characteristics, will serve as controls. patients will be recruited within 72 hours (maximum 120 hrs) of admission, assessed weekly while in the facility, and at one, three, and six months following admission.

Eligibility criteria:
inclusion criteria: * admission to study site following acute care medical/surgical hospitalization * aged 65 or older * english-speaking * communicative prior to acute illness * not admitted for terminal care (life expectancy greater than 6 months) * residence within 25 miles of research site exclusion criteria: * significant hearing impairment which precludes interviews * end stage dementia (complete adl dependence) * previous study enrollment

Keywords: cognition disorder organic brain syndrome patient care management long term care extended care facility
effect of ikervis® eye drops once daily on the quality of vision in dry eye disease patients with severe keratitis

Conditions: Keratitis

Summary: the proposed 3-month study is a prospective, open-label, multicentre, phase iv, proof of concept study. the study is designed to assess the effect on the quality of vision of ikervis® (1mg/ml ciclosporin) eye drops administered once daily in dry eye disease (ded) patients with severe keratitis, as well as its safety and efficacy.

in this phase iv clinical trial the month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of ikervis® in ded patients with severe keratitis. to assess the effect on the quality of vision of ikervis® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (ded) patients with severe keratitis over 3 months of treatment. to assess the safety of ded patients with severe keratitis treated with ikervis® (1mg/ml ciclosporin) for 3 months.

Eligibility criteria:
inclusion criteria: * patient eligibility is determined according to the following criteria: 1. in the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2. the patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures 3. male or female patient is aged 18 years or above. 4. ded patients with persistent severe keratitis at the screening and baseline visits defined as the following: • cfs score of 3, 4 or 5 on the modified oxford scale 5. patient must be willing and able to undergo and return for scheduled study-related examinations. 6. the same eye (eligible eye) should fulfill all the above criteria. exclusion criteria: * patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the screening visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.
dose-escalation study to evaluate the safety and tolerability of gs030 in subjects with retinitis pigmentosa

Conditions: Non-syndromic Retinitis Pigmentosa

Summary: the objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called gs030-dp (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called gs030-md (stimulating glasses) in subjects with documented diagnosis of non-syndromic retinitis pigmentosa


Eligibility criteria:
main selection criteria: * age ≥18 years to ≤75 years at the time of icf signature. * diagnosis of non-syndromic rp defined as: * clinical diagnosis of non-syndromic rp based on history, mid-peripheral visual dysfunction, and fundoscopic appearance. * diagnosis of non-syndromic rp is confirmed on full-field erg * visual acuity: * visual acuity in the dose-escalation cohorts of no better lp. * visual acuity in the extension cohort of no better than cf pending review of dose-escalation cohort data by the dsmb. * relatively preserved ganglion cell layer volume and retinal nerve fiber layer thickness, as measured with spectral domain optical coherence tomography (sd-oct). * interpupillary distance of ≥51 mm and ≤72 mm. * refractive error of the study eye between -6 diopters and +6 diopters. main non-selection criteria * prior receipt of any gene therapy. * subjects who have undergone significant ocular surgery (per investigator determination) within 3 months prior to visit 1. * presence of narrow iridocorneal angles contraindicating pupillary dilation. * presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including sd-oct, during the study period. * presence of any systemic or ocular diseases, or pathologies, other than non-syndromic rp, or their associated therapies, that can cause or have the potential to cause vision loss. * prior vitrectomy or vitreomacular surgery. * presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by sd-oct examinations and assessed by the investigator to significantly affect central vision. * current evidence of retinal detachment assessed by the investigator to significantly affect central vision. * active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis. * presence of an active implantable medical device. * subjects who have undergone thermal laser procedure to the retina within 3 months of trial entry, or any prior thermal laser procedure to the macular region.

Keywords: eye diseases hereditary eye diseases retinal degeneration inherited retinal diseases rod & cone dystrophies retinitis pigmentosa gene therapy optogenetic intravitreal injections aav vectors medical device visual interface
detection of oncogenic tumor mutations in the urine and blood of lung and colorectal cancer patients

Conditions: Lung Cancer; Colorectal Cancer

Summary: the purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. gene mutations are when dna in a gene is damaged in a way that changes the genetic message carried by that gene. gene mutations can sometimes cause lung cancers. these gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. all lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.


Eligibility criteria:
inclusion criteria: lung cancer: for patients participating in part a (initial testing) and part b (serial testing): * patients must have a diagnosis of stage iv lung adenocarcinoma undergoing systemic therapy. * patients must have had or intend to have egfr mutation testing (specifically including exon 19 deletions and l858r) performed on their tumor with results available from a clia certified laboratory. * ≥ 18 years of age specific to patients participating in part b (serial testing): * patients must be planning to receive cancer care at memorial-sloan kettering. * patients must have a confirmed egfr mutant lung cancer (exon 19 deletions and l858r) with molecular testing results available from a clia certified laboratory. * must be within 3 months of their diagnosis of metastatic lung cancer. * treatment plan should include an egfr tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol. colorectal cancer: for patients participating in part a (initial testing) and part b (serial testing): * patients must have a diagnosis of stage iv colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-egfr based therapy. * patients must have had or intend to have ras/raf mutation testing on their tumor with results available from a clia certified laboratory. for the patients who recently progressed on anti-egfr must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment). * \>18 years of age specific to patients participating in part b (serial testing): * patients must be planning to receive cancer care at memorial-sloan kettering. * patients must have a confirmed ras/raf mutant colorectal cancer with molecular testing results available from a clia certified laboratory. * must be within 3 months of their diagnosis of metastatic colorectal cancer. exclusion criteria: lung cancer and colorectal cancer * comorbidities that would prohibit or make serial urine collection difficult or impossible

Keywords: detection of oncogenic tumor mutations blood urine 14-114