Kornimate/medical-research-clean huggingface dataset:
abnormal uterine bleeding and progestin-only contraceptives

Conditions: Contraception

Summary: the use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns. progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . the progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production. the most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by food and drug administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean. the etonogestrel implant (implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method. a common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.


Eligibility criteria:
inclusion criteria: 1. women aged between 18-40 years. 2. women with more than 12 month postpartum. 3. women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood). 4. women wanted to use dmpa, etonogestrel subdermal implant or pops only for pregnancy prevention for at least 1 year. exclusion criteria: 1. women on any anticoagulant therapy. 2. women who had a history of uterine, cervical or ovarian pathology. 3. women who had uterine bleeding disturbance (including amenorrhea) before recruitment. 4. women received dmpa injection within the previous 9 months except they had three spontaneous regular menstrual cycles. 5. severely anemic women (hemoglobin \< 8gm/dl). 6. women with any contraindications for pocs following the who eligibility (altshuler al et al., 2015). 7. women refused to participate in the study.
undetectable ige as a sentinel biomarker for humoral immunodeficiency

Conditions: Immune Deficiency

Summary: this study is trying to find out if an undetectable serum immunoglobulin e (ige) is a biomarker, or early sign of, the development of immune deficiency.

ige is the antibody thought to be responsible for developing allergies. undetectable serum ige (an ige below the lower limit of detection) is found in about 3% of the general population. in the past, it has been thought that having an undetectable ige does not have any health impact, other than meaning that you are at low risk for having allergies. however, recent studies of patients with undetectable ige have shown higher rates of infections, autoimmune disease and cancer. patients with an immune deficiency called common variable immunodeficiency (cvid) also have higher rates of infections, autoimmune disease and cancer. recently, we have shown that most patients with cvid have a low/undetectable serum ige. this study is trying to find out if an undetectable serum ige is a biomarker, or early sign of, the development of cvid or other antibody deficiencies

Eligibility criteria:
inclusion criteria: * age 18-80 * willingness and ability to comply with scheduled visits and study procedures * undetectable serum ige (defined as \>2 iu/ml or the lower threshold of detection) * normal or high serum immunoglobulins (within or above laboratory reference range for igg, iga, and igm) * patients previously seen at the university of virginia asthma, allergy, and immunology clinics where undetectable serum ige was noted * control subjects must have participated in study irb#14457 (only applicable for healthy controls in epsilon germline transcript portion of the study) exclusion criteria: * the following vulnerable populations will be excluded: pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantaged, non-english speaking subjects * known personal history of immunodeficiency * known personal history of recurrent infections * low serum immunoglobulins (below the laboratory reference range for igg, iga, or igm) * recent or current treatment with systemic immunosuppression within the past 30 days

Keywords: immunodeficiency ige
pepsin in patients with functional dyspepsia

Conditions: Functional Gastrointestinal Disorders; Abdominal Pain; Dyspepsia; Nausea; Vomiting; Flatulence

Summary: this non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. the change of the gastrointestinal symptom score (gis©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. safety measures included recording of aes and physical examination as well as measurement of vital signs. the aim was to observe 100 patients during the course of this non-interventional study.


Eligibility criteria:
inclusion criteria: * patients with dyspepsia * women and men aged between 18 and 75 exclusion criteria: - unwilling to consent

Keywords: dyspepsia observational trial enzyme therapy pepsin
safety and efficacy of the ultimaster stent

Conditions: Coronary Artery Disease; Drug-eluting Stents

Summary: durable polymer was considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. ultimaster stent (ultimaster, terumo corporation, tokyo, japan) are thin strut, silorimus-eluting, biodegradable copolymer to completely degrade over 3-4 months.

drug-eluting stents (des) significantly improved outcome compared wiht bare-metal stents because of slow-elution of the antiproliferative drug mixed with a polymer coated on the stent surface. however, the polymers used in the first-generation des were considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. one strategy to mitigate this problem is a biodegradable polymer, which dissolves over time and leaves only the metalic struts behind. ultimaster stent are silorimus-eluting, biodegradable poly dl-lactide-co-caprolactone copolymer (pdlla+pcl) to completely degrade over 3-4 months and is also made of 80μm thin strut. the aim of the current study is to investigate the efficacy and safety outcomes in patients treated with ultimaster stents in real-world.

Eligibility criteria:
inclusion criteria: 1. age 19 or older 2. clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndromes (unstable angina, non-st-elevation myocardial infarction, st-elevation myocardial infarction) 3. no restrictions on the number of blood vessels, number of lesions, and length of lesions 4. those who voluntarily gave written consent to participate in this clinical study exclusion criteria: 1. life expectancy within 1 year 2. subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor 3. if other researchers judge that it is inappropriate to participate in this study
the relevance of performing lumbar puncture in infants aged 3 to 12 months with first episode of febrile convulsion

Conditions: Febrile Convulsions

Summary: the actual recommendations for infants aged 3 to 12 months presented with first episode of febrile convulsions highly recommend performing lumbar puncture in order to rule out bacterial meningitis. on the other hand, recent studies in the era of anti pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. the purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of bacterial meningitis among infants admitted with the first episode of febrile convulsions.

demographic data, including ethnic origin, age an gender will be recorded. the type of convulsions (simple or complex), duration, and time since the fever was noticed will be also recorded. another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (csf) results and the final diagnosis including the cause of fever.

Eligibility criteria:
inclusion criteria: * infants aged 3 to 12 months who presents with first episode of febrile convulsions during the period 1/1/2000 until 31/12/2010 exclusion criteria: * infants with previous neurological diseases, or * recent neurological disease that are not included in the characteristics of febrile convulsion

Keywords: infants
qoca®-image medical platform - smart vcf risk management system

Conditions: Compression Fracture

Summary: this project aims to develop and validate an automatic detection and classification system for vertebral compression fractures on computer tomography (ct) images using an artificial intelligence (ai) system (named smart bone) by quanta.

a computer search of ct scans (2010.01.01-2018.09.30) was performed in wan fang hospital. those ct images that were retrospectively reviewed by experienced radiologists. the ct scans of 1000-1500 subjects aged 50 and above with and without thoracic or lumbar compression fractures were included in this project for machine learning and deep learning. the control group included those without compression fractures while the patient group were those with compression fractures. subjects that did not meet the inclusion criteria were excluded. the cortical layer of the t12-l5 spine images were manually labelled with the labeling software by the the technologists and confirmed the correctness of the image by an experienced radiologist. all the de-linked and completed images were provided to quanta computer inc. for subsequent classification and analysis of ai machines for deep learning to facilitate the development of a system for automatic detection of pressure fractures by ct. this newly developed automatic system will be of valuable clinical impact in assisting radiologists to detect and classify vertebral compression fractures precisely and accurately.

Eligibility criteria:
inclusion criteria: * cases with ct examinations acquired between 2010.01-2018.09 * cases with ct examinations performed with one of the following protocol: whole body, abdomen, and spine * cases must be \>/= 50 years of age * cases with reports from ct examinations ditched as positive or negative compression fractures within a search range from t12 to l5 vertebrae. * ct images with raw data that are allowed to be reconstructed in axial view with a slice thickness of 1.3 mm * ct images with raw data that are allowed to be reconstructed in sagittal view with a slice thickness of 2.5 mm exclusion criteria: * ct images with imaging artifacts, foreign bodies, or implants * cases with comorbid conditions, such as infection, cancer metastasis, chronic osteomyelitis, or other nonosteoporotic compression fracture
a comparison of thoracic electrical bioimpedance and flotrac/vigileo

Conditions: Stroke Volume Variation; SVV-FloTrac; Thoracic Electrical Bioimpedance; Fluid Responsiveness

Summary: stroke volume variation (svv) is an indicator used to assess the patient's volume status. the flotrac system (edwards lifesciences, irvine, ca) continuously monitors cardiac output (co) and svv (svv-flotrac) by analyzing the systemic arterial pressure wave. numerous studies have demonstrated that svv-flotrac serves as a reliable indicator of fluid responsiveness. however, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.in contrast, transthoracic electrical bioimpedance (bioz.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. in this study, the primary aim was to assess the agreement between simultaneously measured svv-flotrac and svv-bioz.


Eligibility criteria:
inclusion criteria: * age 18≤ age ≤65. * patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia * 18 kg/m2≤bmi≤30 kg/m2 * asa classification i-iii * patients signed informed consent form exclusion criteria: * arrhythmias * the patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy） * severe heart failure (mets\<4) * the patient is diagnosed with severe hepatic dysfunction (childepugh class c) * the patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery) * there is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed * history of allergy to anesthetic drugs * weight\<40kg * allergies to 6% hydroxyethyl starch, fresenius kabi, deutschland
t4n5 liposome lotion compared with placebo lotion for preventing actinic keratoses in patients with xeroderma pigmentosum

Conditions: Precancerous Condition

Summary: rationale: patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. these skin lesions, such as actinic keratoses, can develop into skin cancer. t4n5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum. purpose: randomized double-blinded phase iii trial to compare treatment using t4n5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

objectives: i. compare the safety and efficacy of t4n5 liposome lotion vs. a placebo lotion in reducing the incidence of actinic keratoses and protecting against other ultraviolet skin damage in patients with xeroderma pigmentosum. outline: randomized, double-blind study. groups of 6 patients are randomly assigned in a 2:1 ratio to arms i and ii, respectively. arm i: chemoprevention. lotion composed of t4 endonuclease v protein encapsulated in liposomes and suspended in phosphate-buffered saline in a hydrogel base, t4n5 liposome lotion, t4n5. arm ii: control. liposomes suspended in phosphate-buffered saline in a hydrogel base, placebo, plcb. projected accrual: 6-30 patients will be entered in this multicenter study.

Eligibility criteria:
disease characteristics: diagnosis of xeroderma pigmentosum confirmed by unscheduled dna synthesis assay at least one histologically confirmed actinic keratosis all actinic keratoses removed prior to treatment no associated syndromes, e.g., cockayne's syndrome or trichothiodystrophy patient characteristics: age: 1.66 to 60 other: good general health and mental capacity no illegal drug use no pregnant or nursing women negative pregnancy test required of fertile women effective contraception required of fertile women prior concurrent therapy: see disease characteristics

Keywords: actinic keratosis
nutritional perihabilitation in older veterans undergoing surgery

Conditions: Malnutrition; Nutritional Risk; Abdominal Surgery

Summary: this research study will be conducted in two parts. the first part will consist of selecting appropriate screening and assessment tools for veterans undergoing elective surgery and identifying the number of veterans who are malnourished and at risk of malnutrition. the second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.

in year 1 of the two-part research study, an observational, prospective study of 75 veterans preparing for elective surgery will be conducted. the purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. in years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. the purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. the study will take place two weeks prior to an elective abdominal or gi surgery and will continue 4 weeks post surgery.

Eligibility criteria:
inclusion criteria: * elective abdominal surgery * upper gi * colorectal * hepatobiliary * pancreatic * intra-abdominal * abdominal aortic aneurysm * referred to the va perioperative optimization of senior health clinic * able to record dietary intake or has a proxy who can record dietary intake exclusion criteria: * cognitive impairment * unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks * living in skilled nursing facility * no access to telephone

Keywords: protein supplementation older adults nutrition perihabilitation perioperative optimization veterans
validation of visual analog scales to measure satisfaction and well-being at work (sowell-vas)

Conditions: Validation; Visual Analogue Scale; Occupational Stress

Summary: we spend a third of our life at work. psychosocial risks (psr) are a major issue in occupational health 1. approaching the different dimensions of psr calls on a dozen essential components: workload, autonomy, social support, burnout, anxiety, efforts made, rewards, work addiction, investment, etc. a specific questionnaire which usually contains 20 to 30 questions, so that having an overall view of psr using the current reference questionnaires (karasek, siegrist, etc.) represents a total of more than 300 questions. the response time is thus incompatible with current medical practice (passage in the waiting room before the occupational health medical examination) and leads to a majority of non-responses during anonymous questionnaires on the internet. on the other hand, these validated questionnaires were carried out by different people and are very heterogeneous between them, including in their formulation, so that the respondents have the impression of disorganization and anarchy. there is therefore a need for short, quick and uniform questionnaires. evas offer the incredible advantage of meeting these criteria: speed, uniformity, precision. from a data analysis point of view, evas also have the advantage of offering a continuous quantitative response, allowing the use of all statistical approaches. if some questionnaires have already been validated in the form of eva, such as the eva stress versus the " perceived stress scale " questionnaire (pss), the eva workload and eva autonomy at work versus the karasek questionnaire, the other reference questionnaires are not yet validated in eva (burnout, anxiety, efforts / rewards, work addiction, etc.).


Eligibility criteria:
inclusion criteria: * all voluntary adults with a professional activity. exclusion criteria: * minor * person not volunteer to participate. * protected adults (curatorship, guardianship, safeguard of justice)
evaluating the effect of chronic antihypertensive therapy on vasopressor dosing in septic shock

Conditions: Septic Shock

Summary: retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

this will be a retrospective four-cohort study. the four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ace-inhibitor), 2) on chronic β-blocker, 3) on ace-inhibitor, and 4) on both chronic β-blocker and ace-inhibitor

Eligibility criteria:
inclusion criteria: * adult patients 18 years of age or older * diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin) * admitted to an intensive care unit (icu) at rush university medical center (rumc) * time frame: 01/01/2012 to 07/1/2016 exclusion criteria: * pregnant patients * transfer from outside hospital on vasopressors * admitted in cardiopulmonary arrest * prior arrest within 24 hours of admission to rumc

Keywords: chronic antihypertensives septic shock vasopressor vasopressor dosing
in vivo smart biopsy device protocol in radiology

Conditions: Breast Cancer; Image Guided Biopsy

Summary: this study is designed to demonstrate the feasibility of use of the smart biopsy device in real clinical settings.

this is a single arm, multicenter study. it will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast. the study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.

Eligibility criteria:
inclusion criteria: * women over 18 years of age * undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast * signed informed consent form exclusion criteria: * concurrent infectious disease * pregnancy or breastfeeding * participating in any other investigational study for either drug or device which can influence collection of valid data under this study * implanted devices / implants in the operated breast