Kornimate/medical-research-clean huggingface dataset:
dario blood glucose monitoring system - android devices user performance study report

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the accuracy of the dario blood glucose monitoring system as compared to a reference method (yellow springs instrument 2300 stat plus) and to evaluate the usability of the device when used by laypersons.

the objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the dario blood glucose monitoring system paired with a reference device from one of three android smart mobile device families as compared to the results from the yellow springs instrument 2300 stat plus. the usability of the dario blood glucose monitoring system when paired with a reference device from one of three android smart mobile device families and used by laypersons is also evaluated.

Eligibility criteria:
inclusion criteria: * subject has type 1 or type ii diabetes * subject speaks and reads english proficiently * subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study) exclusion criteria: * subject has medical training or works in the field of blood glucose monitoring systems. * subject is critically ill. * subject has an impairment that prevents him/her from following the study procedures. * subject has any condition that the principal investigator believes may interfere in the subject's participation in the study. * hematocrit levels outside the range of 20%-60%.
mycophenolate mofetil (mmf) in patients with iga nephropathy

Conditions: IgA Nephropathy

Summary: iga nephropathy (igan) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with igan, including children, will eventually progress to chronic renal insufficiency (cri) and end stage renal disease (esrd). the study is to evaluate the safety and benefits of mmf in patients with igan who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (acei) and fish oil supplements (fos).

a multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (mmf) will lead to significant and sustained improvement in proteinuria in patients with iga nephropathy who have been pre-treated (and continue to be treated) with acei and fos compared to a placebo control group of patients receiving comparable doses of acei and fos without mmf. data for this outcome will be examined every six months and at the end of 2 years of study. comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (upr/cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (gfr).

Eligibility criteria:
inclusion criteria: * patients ages 7-70 years old * renal biopsy, diagnostic for iga nephropathy * must be able to take oral medication exclusion criteria: * clinical and histologic evidence of systemic lupus erythematosus * well-documented history of henoch-schonlein purpura. * clinical evidence of cirrhosis or chronic liver disease * abnormal laboratory values at the time of study entry * estimated gfr outside of protocol defined limits * history of significant gastrointestinal disorder * active systemic infection or history of serious infection within one month of entry or known infection with hiv, hepatitis b, or hepatitis c. * other major organ system disease or malignancy * current or prior treatment with mmf or azathioprine

Keywords: proteinuria immunoglobulin a
effect of estrogen on mental and social functioning in girls with turner's syndrome

Conditions: Turner's Syndrome

Summary: rationale: turner's syndrome is a disease in which females are missing all or part of one x chromosome and do not produce estrogen. giving estrogen is standard treatment for girls who have turner's syndrome. estrogen may be effective treatment for mental and social functioning problems experienced by girls with turner's syndrome. purpose: clinical trial to study the effectiveness of long term estrogen therapy on mental and social functioning in girls who have turner's syndrome.

protocol outline: participants are evaluated for cognitive and social function at entry and 4 years following entry. assessments include the wechsler intelligence scale for children-revised, a child behavior checklist, the children's self-concept scale, and visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks. patients (and parents) undergo x-chromosome analysis; brain magnetic imaging is optional. controls are matched using school selection and telephone interviews. a study duration of 12 years is estimated.

Eligibility criteria:
protocol entry criteria: * girls aged 8 and 12 years with turner's syndrome-compatible karyotype * age-matched girls without turner's syndrome entered as controls * concurrent registration on thomas jefferson university growth study required of subjects with turner's syndrome

Keywords: turner's syndrome genetic diseases and dysmorphic syndromes rare disease
prospective, randomized multi-center study of using the hyper-cl™ lens in subjects suffering from bacterial keratitis

Conditions: Bacterial Keratitis

Summary: this study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with hyper-cl™ lens + antibiotics compared with treatment with antibiotics only, in subjects with bacterial keratitis. the design of the hyper-cl™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.

the hyper-cl™ therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Eligibility criteria:
inclusion criteria: 1. subject is 18-86 years old 2. subject with bacterial keratitis in one eye only 3. subject with bacterial keratitis of at least grade 2 score in average length of infiltration and in average length of epithelial defect (1mm or above) 4. best-corrected visual acuity of 6/60 or better in the uninvolved eye 5. no prior antibiotic treatment for current bacterial keratitis 6. subject understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed exclusion criteria: 1. perforation or imminent perforation of cornea 2. subject with glaucoma shunts (e.g. ahmed valve) and or bleb 3. sign of inflammation in both eyes 4. severe itching suggesting viral infection or allergy reaction 5. subepithelial infiltrate suggesting viral infection 6. dendrite like ulcer or suspecting of herpes keratitis 7. previous penetrating keratoplasty 8. no light perception in the affected eye 9. pregnancy 10. other active ocular infection 11. any infiltration suggesting other than bacterial infection e.g. parasite, fungal 12. any corneal transplant 13. post refractive surgery 14. corneal inlays 15. any other condition which in the opinion of the investigator would place the patient at undue risk for participation. 16. participation in another clinical study within the past 30 days
effects of low impact elliptical training on knee osteoarthritis outcomes.

Conditions: Osteoarthritis, Knee

Summary: this research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.

this study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles. there are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint. this activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. this activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. the fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in oa.

Eligibility criteria:
inclusion criteria: * 40- to 65-year-old. * diagnosed cases of grade 1 and 2 knee oa. * healthy and overweight patients will be included. (18.5- 29.5) exclusion criteria: * acute musculoskeletal injury. * low back pain and sciatica. * hip and ankle pathology. * acute infection, fever. * the patient taking supplements and medications. * any knee deformity.

Keywords: knee osteoarthritis
effects of training on central auditory function in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to characterize the central auditory processing (cap) deficits that result from multiple sclerosis (ms).

five general types of evaluations will be employed over multiple study sessions at the national center for rehabilitative auditory research (ncrar). first, a neurologist will review the subject's medical history and perform a neurologic exam to confirm ms diagnosis. second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. additionally, subjects will complete a case history and series of hearing handicap inventories. third, a battery of behavioral procedures will be used to characterize central auditory processing. fourth, auditory evoked potential studies will be performed. emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. fifth, subjects will receive magnetic resonance imaging (mri) evaluation to determine sites and amount of neural degeneration.

Eligibility criteria:
inclusion criteria: * age 21-65 years; * a clinical or laboratory supported diagnosis of "definite" ms; * a diagnosis of relapsing-remitting, primary progressive, or secondary progressive ms; * a kurtzke expanded disability status score (edss) of 0 to 7.0, inclusive; * no history of a clinical relapse or change in edss for three months preceding entry into the study; and * a brain mri scan that shows at least three white-matter lesions on t2-weighted images consistent with ms exclusion criteria: * current major disease or disorder other than ms (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes); * other neurological conditions that could interfere with the ability to respond to tests and questionnaires; * non-native speaker of english (since test materials are presented in english); * pregnant (due to potential negative effects on the fetus during fmri); * more than a mild degree (less than a 40 db hl four-frequency pure-tone average \[pta\]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact cap test results); * metal implants (due to fmri constraints); and * left-handedness

Keywords: ms cap
effect of the consumption of ferric hydroxide adipate on urinary phosphorus excretion.

Conditions: Healthy; Chronic Kidney Diseases

Summary: ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary organic acid that was developed at mrc human nutrition research. we aim to determine if the ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate concentration, compared with the administration of placebo plus the same food on a different occasion. we hypothesise that ferric hydroxide adipate binds some phosphate ions in the gastrointestinal tract, which prevents part of the phosphate load in a meal from being absorbed. on another visit, calcium will be given with the same food, as a positive control, since this element is well known to restrict dietary phosphate absorption through the formation of insoluble calcium phosphates in the gut lumen. we will compare urinary phosphate concentrations after co-ingestion of the calcium salt and food versus urinary phosphate following ferric hydroxide adipate and the same food. additionally, the calcium data will be compared with placebo data, since a significant reduction in urinary phosphate concentrations after calcium treatment will confirm the suitability of the study design. finally, iron absorption from the ferric hydroxide adipate treatment will be determined by labelling this preparation with 58fe and measuring day 14 erythrocyte 57fe:58fe. the study design is: three-way cross-over volunteer absorption study. volunteers will not be told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental calcium). researchers co-ordinating the study on a day to day basis will be aware of treatment allocation, but analysts will not be told which samples correspond to which treatments.


Eligibility criteria:
inclusion criteria: - males and females, aged \>18 years, who are generally healthy. exclusion criteria: * pregnancy and lactation * iron deficiency and iron deficiency anaemia * weight change of +/-2kg in the past month * dysphagia * surgery in the past three months * cancer in the last ten years * diabetes * known medical and genetic conditions interfering with calcium and phosphate metabolism: e.g. hyper/hypo-parathyroidism, fanconi syndrome, hyper/hypothyroidism (except individuals who are taking stable doses of thyroid hormones) * chronic infection or chronic inflammation * cardiovascular disease * chronic respiratory disease * abnormal renal function (based on glomerular filtration rate) * known renal disease * abnormal liver function/known liver disease * hereditary haemochromatosis or haemoglobinopathies * gastrointestinal disease * bone disease * hypertension * current use of proton pump inhibitors * use of other medication that affects mineral homeostasis (on a case by case basis, in consultation with hnr clinician) * extreme muscle hypertrophy (e.g. body building)

Keywords: urinary phosphate iron hydroxide hypophosphatemia phosphate binder ferric hydroxide adipate
the diagnosis value of serum marker in stroke associated with nonvalvular atrial fibrillation.

Conditions: Ischemic Stroke

Summary: the purpose of this study is to evaluate the diagnostic value of serum nt - probnp in stroke associated with nonvalvular atrial fibrilltion.

all included in the cases in 7 days of blood samples, the detection of serum nt - probnp.through the single factor analysis to determine the serum nt - probnp central source sex stroke prediction values.

Eligibility criteria:
inclusion criteria: * 18 ≤ age ≤ 85; * meet the clinical diagnostic criteria for acute ischemic stroke; * onset within 7 days; exclusion criteria: * severe systemic disease (chronic inflammation, infection, blood system diseases, cancer, kidney failure, liver failure,heart failure); * nearly a month history of myocardial infarction; * pregnant; * serious neurological disease that the diagnosis is unclear;

Keywords: atrial fibrillation nt-probnp cardioembolic stroke
clinical evaluation of cem-guided biopsy

Conditions: Contrast Enhanced Mammography-guided Biopsy

Summary: cem-guided biopsy is an optional accessory of senographe pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from contrast enhanced mammography (cem) images. this information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (fna). this device cannot be used for reasons other than its intended use. this evaluation is being done to learn more about the cem-guided biopsy. clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.

pristina serena cem is an option to the standard pristina serena breast biopsy unit. it is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from contrast enhanced mammography (cem) images. it is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or fine needle aspiration (fna) for cytopathology analysis. the main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use cem-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. all feedbacks are collected by observations, interviews and surveys. the evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal cem or mri examination, and considered eligible for this procedure as per standard of care. eligible subjects undergo the clinically indicated breast biopsy procedure using the pristina serena cem-guided biopsy. region of interest location is determined by using stereotactic pairs of cem images after injection of iodinated contrast media. all necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.

Eligibility criteria:
inclusion criteria: * adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal cem or mri examination, and considered eligible for this procedure as per standard of care. * are able and willing to comply with study procedures * are able and willing to provide written informed consent to participate exclusion criteria: * findings not accessible for stereotactic guidance biopsy * are currently lactating * have breast implants

Keywords: contrast enhanced mammography breast cancer interventional breast procedures
prognostic significance of the lung immune prognostic index (lipi) in postoperative clear cell renal cell carcinoma: a multicenter retrospective cohort study

Conditions: ccRCC

Summary: this retrospective study included 704 patients with ccrcc who underwent radical or partial nephrectomy. patients were stratified into the lipi good group and the intermediate/poor (int./poor) group based on dnlr (≥ 3) and ldh (≥ 245 u/l) levels. propensity score matching (psm) was used to adjust for baseline differences and minimize selection bias. kaplan-meier survival curves and cox regression models were employed to evaluate the impact of lipi and other clinical factors on recurrence-free survival (rfs) and overall survival (os).


Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed with ccrcc; 2. underwent radical or partial nephrectomy. exclusion criteria: 1. presence of concurrent malignancies; 2. missing data or failure to follow-up
optilume post approval clinical evaluation of andrology parameters

Conditions: Urethral Stricture

Summary: single-arm, prospective study assessing semen quality after treatment with the optilume urethral dcb in men between 22 and 65 years of age.

male subject diagnosed with a stricture in the anterior urethra that can be treated with the optilume urethral dcb. thirty-four (34) subjects will be enrolled at up to ten (10) sites in the united states. clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating lower urinary tract symptoms (luts), sexual function, and voiding function. semen quality parameters will be assessed at baseline, 3 months, and 6 months post-treatment. subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.

Eligibility criteria:
inclusion criteria: 1. male subjects between 22 and 65 years of age 2. subject diagnosed with a stricture in the anterior urethra that is able to be treated with the optilume urethral dcb in accordance with the approved instructions for use 3. subject is willing to provide written informed consent and comply with study required follow-up assessments 4. subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples): 1. total sperm ≥39 million 2. sperm concentration ≥15 million/ml 3. total motility ≥40% 4. progressive motility ≥32% 5. morphology ≥4% exclusion criteria: 1. subjects with a known hypersensitivity to paclitaxel or structurally related compounds 2. subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function 3. subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout 4. subject is unwilling to abstain or utilize a condom for 30 days after the procedure 5. subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential 6. history of cancer in any body system that is not considered in complete remission
a comparison between surgical techniques for securing conjunctival autografting in primary pterygium surgery

Conditions: Pterygium

Summary: pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, the standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. the investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

design: prospective randomized comparative interventional clinical study setting: assiut university hospital \& el-mabarah hospital for health insurance methods: the study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

Eligibility criteria:
inclusion criteria: 1. patients complaining of primary progressive nasal pterygium. 2. patients with pterygium threatening the visual axis. exclusion criteria: 1. double head pterygium. 2. pseudopterygium 3. recurrent pterygium 4. patients with history of any bleeding abnormalities 5. patients with ocular surface diseases eg- blepharitis, sjogren syndrome and dry eye.