Kornimate/medical-research-clean huggingface dataset:
test of digital breast tomosynthesis vs. common mammography to detect breast cancer for women undergoing breast biopsy

Conditions: Breast Cancer

Summary: comparison of the ability of dbt and ffdm to detect breast cancer.

enrolled women will undergo bilateral dbt. prior breast imaging data (screening and diagnostic mammography) must have been conducted on ge equipment and the images must be available (or imaging must be repeated). dbt images will be read on-site by one or more qualified radiologists. all subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. images will be processed and evaluated by independent readers.

Eligibility criteria:
inclusion criteria: * women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy * able and willing to comply with study procedures, and have signed and dated the informed consent form * surgically sterile or postmenopausal exclusion criteria: * pregnant or trying to become pregnant * has signs or symptoms of breast cancer * has been previously included in this study * has breast implants * has a history of breast cancer and is in active treatment * has breasts too large to be adequately positioned for the dbt examination

Keywords: mammography mammogram breast abnormal and normal breast tissue
rtms on mismatch negativity of schizophrenia

Conditions: Schizophrenia; Mismatch Negativity

Summary: auditory mismatch negativity deficit is a robust neurophysiological biomarker of schizophrenia. repetitive transcranial magnetic stimulation (rtms) is a neuromodulation method and can be used to modulate excitability of specific brain cortical region. we hypothesize that mmn deficit of schizophrenia is related to inferior frontal gyrus (ifg) hypofunction, and this deficit can be improved by using rtms to enhance ifg function. it is a randomized, double-blinded, sham-controlled clinical trial. forty-eight schizophrenia patients with mmn deficits (mean amplitude at fcz \> -0.7 ㎶) will be recruited and then randomized at a 1:1 ratio to rtms group and sham-stimulation group. subjects in rtms group will receive high frequency rtms over ifg, while in the other group subjects will receive sham stimulation at ifg. frameless stereotaxy navigation will be used to guide the rtms coil to ifg. the primary outcome is the change of mmn mean amplitude at fcz after stimulation. we hypothesize that the change of mmn mean amplitude is significantly larger in rtms group than in sham-stimulation group. their cognitive function and clinical condition will be evaluated carefully before and after experiments.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition, text revision * mean amplitude of mmn at fcz greater than -0.7 ㎶ * moderate or milder disease severity (scoring 4 or below according to clinical global rating scale) exclusion criteria: * unwillingness or inability to cooperate with the experiments * with mental retardation, epilepsy, or other major brain pathology (e.g. cerebrovascular accidents or major head injury) * with alcohol or other illicit substance abuse * with major debilitating systemic diseases or difficulties in ambulation * with hearing impairments as screened by audiometry over 500 hz, 1000 hz and 6000 hz * with pacemaker, intra-ocular metal foreign body, intracerebral vessel clip, artificial cardiac valve, electronic implant in the body, claustrophobia, or previous surgery involving the brain * being pregnant or to be pregnant during the clinical trial. a pre-tms evaluation scale will be applied to ensure the safety

Keywords: repetitive transcranial stimulation inferior frontal gyrus
vascular pathophysiology in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is a medical problem whose importance is increasing in recognition and awareness. the national commission on sleep disorders estimates that 15 million americans have osa, many of whom remain undiagnosed (24). osa is associated with the development of hypertension and other cardiovascular diseases (1,2). patients with osa, like those with congestive heart failure, hypertension, hypercholesterolemia and diabetes, exhibit impaired edv (25-32). osa is also associated with impairments in endothelium-dependent cerebral blood flow responses, which may be a risk factor for stroke (33). impaired edv is a result of reduced production or inadequate action of nitric oxide. since edv worsens with disease progression and improves with disease treatment, it serves as a prognostic marker of vascular function (34-37). in osa, hypoxia and neurohumoral disturbances increase generation of reactive oxygen species (ros) that neutralize nitric oxide and impair endothelium-dependent responses (9,10,38). one source of ros in endothelial cells is the enzyme xanthine oxidase (38). xo is an enzyme present in the vascular endothelium that significantly contributes to generation of ros in congestive heart failure, hypercholesterolemia and diabetes (13-17). inhibition of xo improves endothelium-dependent resistance vessel responses in these populations (13-17), but it is unknown if xo significantly contributes to oxidative stress and endothelial dysfunction in osa. the central hypothesis of this application is that inhibition of xo with allopurinol will reduce oxidative stress and generation of ros, thereby improving nitric oxide bioavailability and edv in osa. our hypothesis has been formulated on the basis that patients with osa experience repeated hypoxemia that increases activity of xo and other enzymes, thus increasing the generation of ros that negatively impact edv. hypoxia is detrimental to vascular homeostasis since it increases generation of ros through direct mechanisms and via activation of xo.


Eligibility criteria:
inclusion criteria: * patients with sleep disordered breathing: * significant obstructive sleep apnea as verified by complete overnight polysomnography with apnea-hypopnea index (ahi) \> 10 events per hour. * fasting total cholesterol \< 240 mg/dl * fasting blood glucose \< 120 mg/dl * control subjects: * free of sleep disordered breathing verified by complete overnight polysomnography or oxygen desaturation screening (ahi \< 5 events per hour) * fasting total cholesterol \< 240 mg/dl * fasting blood glucose \< 120 mg/dl exclusion criteria: * presence of any cardiovascular diseases or medical conditions that will affect vascular responses (other than sleep apnea) * subject taking any vasoactive medications, willing to stop taking vitamins or supplements for study participation * current smokers * history of adverse reaction to allopurinol, acetylcholine, nitroprusside, verapamil or lidocaine
home use of dual-light photodynamic therapy for chronic periodontitis

Conditions: Periodontal Diseases; Periodontitis; Plaque, Dental; Plaque Induced Gingivitis

Summary: this early-stage research is designed to determine the efficacy of the lumoral method in chronic periodontitis patients. improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. in addition, the device might have a photobiomodulation effect on periodontal tissues.

periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. the disease is strongly associated with deranged biodiversity patterns in dental plaque. the lumoral is a ce-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. the device mechanism of action is antibacterial photodynamic therapy. the device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. the plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. the antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. ninety (90) stage i-iii periodontitis patients are randomized to lumoral treatment group or control group. both groups shall receive mechanical plaque control by scaling and root planning (srp) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. all the patients shall be assessed for the clinical periodontitis status. these assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

Eligibility criteria:
inclusion criteria: * periodontal disease stage i-iii, according to criteria the american academy of periodontology (aap) with at least 2 mm interdental cal in the site of greatest loss. * age of 18- 85 years * presence of ≥20 teeth, including implants * agreement to participate in the study and to sign a written consent form * able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol exclusion criteria: * presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol * removable major prosthesis or major orthodontic appliance * pregnancy or lactation * use of antibiotics within 2 weeks prior the study * a need for immediate antimicrobial treatment for periodontitis

Keywords: lumoral lumorinse plaque periodontitis plaque control apdt ammp-8
micro rnas as a marker of aortic aneurysm in hereditary aortopathy syndromes

Conditions: Marfan Syndrome; Loeys-Dietz Syndrome; Thoracic Aortic Aneurysm and Dissection Syndromes; Ehlers-Danlos Type IV Syndrome; Turner Syndrome

Summary: the primary objective of this study is to determine whether specific patterns of circulating micro-ribonucleic acids (mirnas) are associated with aortic aneurysm and dissection in patients with hereditary aortopathy syndromes. the most common of these syndromes is marfan syndrome (mfs), but several other recognized aortopathy syndromes are well characterized. the investigators propose the use of a simple blood test, from which mirna profiles can be measured in individuals with aortopathy syndromes to be compared with mirnas observed in a control population that has no known predisposition for aortic disease. the investigators hypothesize that microrna profiles in individuals with marfan syndrome, and related disorders, will be distinct from those seen in a control group. the investigators predict that up- or down-regulation of certain mirnas will correlate with the presence and severity of aortic aneurysm, responses to medical therapy, and ultimately could be used to determine when an individual may be at risk of dissection.


Eligibility criteria:
inclusion criteria: to be in the study, the participant must meet the following criteria 1. diagnosis of hereditary aortopathy based upon: * confirmation of a disease causing mutation in a known aortopathy disorder or * confirmation of disease based on published clinical criteria 2. participants is male or female and greater than 30 days old 3. participants are able to undergo standard of care cardiac monitoring including an echocardiogram 4. willing and able to provide written informed consent by parent(s) or guardian(s) after the nature of the study has been explained and prior to any research related procedures 5. signed hippa compliant research authorization exclusion criteria: participant will be excluded from the study for any of the following criteria 1. diagnosis of a hereditary aortopathy can not be confirmed 2. existence of an additional comorbid condition- including a co-existing genetic syndrome, heart failure, renal disease, rheumatologic disease, history of malignancy, thyroid disease, recent stroke, other life-limiting illness not related to cardiovascular disease. 3. extreme prematurity, \<28 weeks gestational age

Keywords: aortopathy syndrome aortic aneurysm aortic dissection connective tissue disorder
the usability, acceptability, and perceived value of the cornerstones4care powered by glooko app

Conditions: Diabetes Mellitus, Type 2

Summary: this is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. participants will have either two or three visits at hitlab during the 28-day study period.

the purpose of this study is to evaluate the utility and user experience of a mobile application, called cornerstones4care powered by glooko app (c4c), for persons diagnosed with diabetes type 2.subjects will be asked to use the cornerstones4care powered by glooko app for an approximately 20 minute monitored demonstration session, followed by a 28-day period of daily engagement with the application.the cornerstones4care powered by glooko app lets users input nutrition, medication, exercise and other daily information to assist in the management of diabetes type 2. it also has the ability to sync with connected devices, such as blood glucose monitors. additionally, the application offers a library of educational content for users.

Eligibility criteria:
inclusion criteria: 1. be diagnosed with type 2 diabetes 2. live in the new york metropolitan area 3. be at least 18 years of age 4. able to read, write, and speak in english 5. have an iphone or android phone 6. use a blood glucose meter 7. regularly take insulin by injection 8. be willing to follow study requirements for a 28-day period exclusion criteria: 1. not be diagnosed with type 2 diabetes 2. not living in the new york metropolitan area 3. be less than 18 years of age 4. be unable to read, write, and speak in english 5. not have an iphone or android phone 6. not use a blood glucose meter 7. not regularly take insulin by injection 8. be unwilling to follow study requirements for a 28-day period

Keywords: diabetes type 2 diabetes type ii diabetes insulin mobile applications diabetes mellitus diabetes mellitus, type 2 smartphone application health application
a new treatment of retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: this study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

the retinitis pigmentosa(rp) is an hereditary disease which causes visual deficiency leading to blindness. the methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. but all these methods own limitations can not be conquered in a short period. it was proved that vascular endothelial growth factor (vegf) and pigment epithelium derived factor (pedf) decreased in the aqueous humor of patients of rp. but the traditional exogenous nerve growth factors (ngfs) were immunogenic proteins and may cause inflammation. autoserum contain a large amount of active factors and will not cause exclusive reaction. in this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of retinitis pigmentosa exclusion criteria: * suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease * combined with serious systemic disease * can not cooperate with the interventions and examinations.
an efficacy and safety study of srm003 in the treatment of subjects undergoing placement of an arteriovenous graft to facilitate hemodialysis access

Conditions: Arteriovenous Graft

Summary: a study to evaluate the efficacy of srm003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. it is hypothesized that when placed outside the blood vessel, the seeded srm003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.


Eligibility criteria:
inclusion criteria: 1. subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. 2. subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 3. subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent prosthetic expanded polytetrafluoroethylene avg placed in the upper extremity. 4. subject must have a life expectancy of at least 78 weeks after randomization. 5. subject must be able to understand and be willing to complete all study requirements. exclusion criteria: 1. subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 78 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 78 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization. 2. subject has had more than 3 access placement surgeries (defined as a new access, not a revision) in the target limb. 3. subject has medical conditions and diseases that may cause non-compliance with the protocol 4. subject has a known allergy to bovine/porcine products or collagen/gelatin products. 5. subject has a history of intravenous drug use within 6 months prior to screening 6. subject is morbidly obese, defined as having a body mass index \>40. 7. pregnant or nursing woman, or plans to become pregnant during the study.

Keywords: vascular injury arteriovenous graft surgery hemodialysis access
evaluation of a cam system for colorectal polyp size measurement

Conditions: Colorectal Polyp; Colorectal Adenoma

Summary: accurate polyp size measurements are essential for risk stratification, selection of polypectomy techniques, and surveillance interval assignments. evidence indicated that the clinical implementation of artificial intelligence is an optimal tool to improve the measurement of polyps during colonoscopy. this study aimed to evaluate the performance of a computer-aided measuring (cam) system (endodass) and compare its accuracy with routine sizing methods during real-time colonoscopy.

this study will be conducted in 2 phases: the first phase will evaluate the value of the application of the computer-aided measuring (cam) system for polyp size measurement accuracy in a small sample of clinical videos, recording the corresponding clinical videos for cam measurements after measuring polyp size using real-time visual assessment and non-scaled device (open biopsy forceps or snare) assessment, and comparing the different methods of polyp size measurement through a video-based analysis \[autonomous artificial intelligence (ai) measurement, ai-assisted human measurement, non-scaled device assessment, and visual assessment\] with different groups of endoscopists ( experts, gastroenterologists, surgeons, fellows) evaluating the corresponding clinical videos during real-time measurements, to obtain pilot data on the relative accuracy of polyp size measurement when using the cam system, to test the feasibility of size measurement of freshly resected polyp specimens and to determine the sample size and reference for evaluating the cam system in the subsequent phases of a randomized controlled trial of the study. the second phase will assess the value of using the ai-assisted human measurement versus the non-scaled device assessment for polyp size measurement accuracy in a clinical randomized controlled trial using a prospective, multicenter, patient-single-blind, randomized controlled trial design in which subjects are randomly assigned to the cam group and the non-scaled device measurement group in a 1:1 ratio. each patient will have a maximum of 3 polyps included in the study.

Eligibility criteria:
inclusion criteria: 1. adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status. 2. colonoscopy screening, surveillance, or diagnostic participants. 3. informed consent obtained. exclusion criteria: 1. anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy. 2. inflammatory bowel disease. 3. aronchick score \>3 at entry. 4. incomplete case report form (crf) data. 5. emergency colonoscopy. 6. pregnancy or lactation. 7. gastrointestinal obstruction. 8. refusal to participate.

Keywords: artificial intelligence polyp size deep learning colonoscopy depth map
intra-abdominal umbilical vein aneurysm

Conditions: Obstetric Complication

Summary: the purpose of this study is to investigate the ultrasound characteristics and outcome of pregnancies with fetal intra-abdominal umbilical vein aneurysm.

intra-abdominal umbilical vein aneurysm is a rare pathology of the fetal venous system. its incidence is low, evaluated between 0.4 and 1.1 / 1000. intra-abdominal umbilical vein aneurysm is identified as an oval or rounded, anechoic mass located between the abdominal wall and the lower edge of the liver. it is defined by two criteria: either a diameter greater than 9 mm or a diameter of the subhepatic segment of the umbilical vein greater than 50% of the diameter of its intrahepatic segment. the complications that can occur during pregnancy are mainly represented by the mfiu, the occurrence of thrombosis and intrauterine growth retardation (iugr). their overall frequency is evaluated at 10%. a complete fetal morphological assessment is necessary to eliminate the presence of other lesions. however, ultrasound monitoring is recommended during the third trimester in search of an increase in dilation and especially the appearance of a thrombus. a particular clinical form, related to abnormal umbilical vein involvement in the infra-hepatic portal system, must be individualized because of a high risk of thrombosis. it justifies the realization of an abdominal ultrasound in the first days of life

Eligibility criteria:
inclusion criteria: * all patients who have avo partially intra-abdominal isolated or associated with other abnormalities. * patients over the age of 18 who agree to participate in the study after oral information given by the sonographer. * any patient seen in 1st intention or 2nd intention. * gestational age between 20 and 35 weeks exclusion criteria: * patient refusing to participate in the study.