Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of argatroban to treat heparin-induced thrombocytopenia

Conditions: Heparin-Induced Thrombocytopenia

Summary: the purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (hit)/ hit and thrombosis syndrome (hitts). this multi-center trial covers mainly the patients with cardiovascular diseases. subjects are included in the trial when they are clinically diagnosed of hit/hitts. initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the us. the reason of the lower initial dose is that the approved dose of argatroban in japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. a sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aptt, and blood drug concentration.


Eligibility criteria:
inclusion criteria: 1. males of non-pregnant females \>=20 and \<=80 years of age 2. those with the diagnosis of hit or hitts made by the following diagnostic criteria, or those who have positive results of hit antibody * diagnostic criteria of hit * a fall in platelet count to less than 100,000/μl or a 50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than hit * diagnostic criteria of hitts * those who met the diagnosis criteria of hit * presence of an arterial or venous thrombosis documented by appropriate imaging technique (ultrasound, angiography etc.) or supported by clinical evidence such as a myocardial infarction, stroke, pulmonary embolism, or other clinical indications of vascular occlusion(absence of pulse, cold, cyanotic extremities, etc.) * patients with history of hit/hitts with positive test results (hit antibody or platelet function test) could be enrolled without present thrombocytopenia 3. patients willing and able to give informed consent exclusion criteria: 1. any condition which in the investigator's opinion, contraindicated the use of argatroban or endangered the patient if he or she participated in this trial 2. clinically significant or uncontrolled endocrine, renal, pulmonary, gastrointestinal, or psychiatric disorder of sufficient severity that the investigator deemed antithrombotic therapy with argatroban to be contraindicated 3. unexplained aptt\>200% of control at baseline 4. documented coagulation disorder or unexplained bleeding diathesis unrelated to hit 5. lumbar puncture within the past 7 days 6. known clinical site of bleeding. patients with a known site of clinical bleeding could be enrolled if the investigator deemed the risk of continued thrombosis outweighed the potential bleeding risk 7. serious liver disfunction 8. females of known or suspected pregnancy 9. breast feeding females 10. participation in other clinical drug trials within the past 30 days 11. history of hypersensitivity to argatroban 12. concomitant use of cimetidine 13. previous participation in this trial

Keywords: heparin-induced thrombocytopenia argatroban cardiac surgery acute coronary syndrome thrombosis amputation anticoagulation
defile-qol5 - evaluation of the long-term surgical management of the thoraco-brachial displacement syndrome

Conditions: Thoracic Outlet Syndrome

Summary: the study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the university hospital of angers for the management of a thoraco-brachial outlet syndrome. it includes all vascular and neurological manifestations related to intermittent or permanent compression of the vasculo-nervous bundle of the upper limb. before and after the operation, these patients had agreed to complete the quality of life questionnaires, the disabilities of the arm, shoulder and hand questionary (dash) and the short-form 12 (sf-12). the objective of the present study is to evaluate the long-term quality of life, using the questionnaires mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet syndrome and who participated in the defile-qol study in 2016.

all patients included in the defile-qol study (in 2016) receive an information letter. without opposition from them after 4 weeks, they are contacted by telephone. the telephone interview begins with an explanation of the study and a time to answer any questions from the patient. if they agree to participate, they answer the dash and the sf-12 questionnaires, for an estimated duration of 15 minutes. following the telephone interview, the patient's participation in the study was terminated. the date of the information and the patient's non-objection are documented in the patient's source file.

Eligibility criteria:
inclusion criteria: * adult * having participated in the initial study : "defile-qol" exclusion criteria: * opposing participation in the research * unable to answer questionnaires
the prevalence of osteoporotic vertebral compression fractures (ovcf) in korean post menopausal women

Conditions: Osteoporosis, Postmenopausal

Summary: this is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. post menopausal patients who visit os(orthopedic surgery) including ghs(general hospitals) and clinics will be enrolled.

this is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. post menopausal patients who visit os(orthopedic surgery) including ghs(general hospitals) and clinics will be enrolled. they will take the evaluation of spine x-ray and answer to a few questions. their medical record will be reviewed and relevant clinical findings will be collected.

Eligibility criteria:
inclusion criteria: * subjects who were diagnosed post menopausal state * subjects over 50 years old * the definition of post menopause women : women whose last menstruation was over 12months ago * subjects who visit orthopedic surgery * subjects who have informed consents exclusion criteria: * subjects who are not confirmed as post menopause state * subjects who do not understand the contents of questionnaire * subjects over 80 years old * subjects experienced any high energy fracture (including trash and fall) within 3 months. * subjects experienced a fracture except vertebral fracture within 6 months * unable to evaluate l-spine bmd over 2 levels because of spinal fracture or instrumentation for l-spine 1-4. * unable to evaluate bmd at both femur because of hip fracture or instrumentation.
the value of endocervical and endometrial lidocaine flushing before office hystroscopy

Conditions: Pain During Hystroscopy

Summary: women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

patients were asked to urinate to evacuate the bladder. posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline. after 5 mins the procedure was started a rigid 3.5 mm hystroscope with an optic of 30 degrees was used. normal saline solution was used as distension media, with 120 mmhg intrauterine pressure, vaginoscopic approach, nocervical tenaculum or dilators used. post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

Eligibility criteria:
inclusion criteria: * all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: aub, infertility exclusion criteria: * women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy
pilates exercises on postpartum fatigue, maternal functioning and quality of life

Conditions: Maternal Fatigue

Summary: the aim of the study is to determine the effect of pilates exercises on postpartum fatigue, maternal functioning and quality of life.

the effect of pilates exercises in reducing postpartum fatigue is not well known however in recent study pilates exercises alone was quantified which was based on home exercises and had a positive effect, it was conducted in primiparas women, there was also possibility of recall bias due to self report nature of data

Eligibility criteria:
inclusion criteria: * multiparous females * age 18 to 45 years * females with vaginal delivery * two weeks after spontaneous vaginal delivery * fatigue score of \>11 on fatigue assessment scale exclusion criteria: * postpartum depression score greater or equal to 10 , based on the edinburgh postnatal depression scale (epds) * postpartum anemia * generalized anxiety disorders * chronic illnesses (diabetes /hypothyroidism)

Keywords: pilates maternal fatigue maternal functioning
study to evaluate the pharmacokinetics (pk) of e7090 (herein referred to as tasurgratinib) and its metabolite in participants with mild and moderate hepatic impairment compared to healthy participants

Conditions: Hepatic Impairment

Summary: the primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on pk of tasurgratinib after a single dose administration.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) between 18 to 40 kilogram per square meter (kg/m\^2). 2. for cohorts a and b: stable hepatic impairment conforming to child-pugh classification a and b. 3. for cohort c: healthy participants matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20 percent \[%\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ecg), and clinical laboratory determinations. exclusion criteria: key exclusion for all participants: 1. following ocular disorders 1. current evidence of grade 2 or higher corneal disorder 2. current evidence of active macular disorder (example, age-related macular degeneration, central serous chorioretinal disease) 2. known to be human immunodeficiency virus (hiv) positive at screening. 3. a prolonged qt/qtc interval (\[qt interval using fridericia's formula\] qtcf greater than (\>) 480 millisecond \[ms\]) demonstrated on ecg. additional exclusion criteria for hepatically impaired participants (cohorts a and b) in addition to the exclusion criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. these include: 1. any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing. 2. presence of severe ascites, edema, or uncontrolled hepatic encephalopathy 3. the participant's standard therapy/concomitant medication for diseases related to hepatic disease has not remained stable/unchanged for at least two weeks before dosing of study drug. additional exclusion criteria for healthy participants (cohort c) in addition to the exclusion criteria for all participants, other standard exclusion criteria for healthy participants in phase 1 studies will be used. these include: 1. syphilis as demonstrated by positive serology at screening. 2. any abnormal finding based on physical examination, assessment of vital signs, ecg, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.

Keywords: hepatic impairment e7090 tasurgratinib
sodium zirconium cyclosilicate lowers hyperkalemia after parathyroidectomy

Conditions: Sodium Zirconium Cyclosilicate; Hyperkalemia; Hyperparathyroidism, Secondary

Summary: sodium zirconium cyclosilicate (szc) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. however, the effects of szc during the perioperative period remained unknown. this experiment aimed to determine whether using szc would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (ptx).

secondary hyperparathyroidism (shpt) is a common and severe manifestation of chronic kidney disease (ckd), especially in end-stage renal disease (esrd) patients. shpt is characterized by elevated parathyroid hormone (pth) synthesis and secretion accompanied by parathyroid cell hyperplasia.elevated pth level is considered as a risk factor for fracture, hyperphosphatemia, anemia, and cardiovascular calcification that worsens the health-related quality of life and increases mortality. parathyroidectomy (ptx) has been considered the first-line treatment for severe shpt. generally, approximately 29% of patients with end-stage renal disease undergo parathyroidectomy to control secondary hyperparathyroidism. successful ptx may rapidly reduce serum pth levels and alleviate clinical symptoms. postoperative hyperkalemia is one common complication after ptx. with an incidence of 25-80%, in previous research, hyperkalemia has been reported during and immediately after ptx, leading to devastating consequences. szc increases fecal potassium excretion and lowers serum potassium levels by binding potassium ions, demonstrated to reduce serum potassium to normal levels within 48 hours in hyperkalemia patients. nevertheless, the effects of szc during the perioperative period remained unknown. sixty-two patients with secondary hyperparathyroidism (shpt) were randomly recruited into the experimental and control groups. patients in the experimental group were required to take szc 10g before ptx. laboratory chemistries, including serum potassium levels, serum calcium levels and serum pth were obtained before and after surgery. we aimed to determine whether using szc would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (ptx).

Eligibility criteria:
inclusion criteria: * secondary hyperparathyroidism (shpt) is a common and severe manifestation of chronic kidney disease (ckd), especially in end-stage renal disease (esrd) patients. esrd mhd with shpt patients were recruited into this study exclusion criteria: * patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.
a mobile app to improve participation in following-up cohorts

Conditions: Participants of Longitudinal Cohort Studies; Controls

Summary: the main objective is to test the superiority of a newly developed mobile application - recap_mylife - for data collection in cohort studies in order to increase participation in follow-up evaluations. we hypothesize that data collection through a mobile app will contribute to improvements in participation. an accurate assessment of the potential benefits and drawbacks of using this mobile technology tool for data collection in cohort studies will be conducted. for such, the study will be conducted in three cohorts developed in different temporal, cultural, and geographic contexts, increasing the generalization of the results found. this evaluation is intended to contribute to the development of more appropriate tools for data collection and consequently to increase participation in epidemiological studies.

this is a multicenter, two-arm, parallel unmasked pragmatic randomized controlled trial with baseline and post-intervention (4 weeks from baseline) assessments. a convenience sample of participants of three population-based cohorts of individuals born very preterm and/or very low birth weight will be randomized and allocated 1:1 to either a mobile app intervention group or into the control arm (usual data collection methods). secondary aims of this study are: 1. to evaluate the usability and acceptability of the mobile app among cohort participants. 2. to investigate the potential hawthorne effect on the results on physical activity behavior and mood status. 3. to measure the agreement between passively tracked physical activity by the mobile app and physical activity measured weekly with a self-reported questionnaire. 4. to measure the agreement between mood status collected by the mobile app through ecological momentary assessment and mood status measured weekly with a self-reported questionnaire. 5. to survey participant's preferences about the different data collection methods. intention-to-treat approach will be applied in the data analysis.

Eligibility criteria:
inclusion criteria: * individuals aged 16 years or over * individuals with no evidence of visual impairment, physical condition that may affect the ability to walk, or major cognitive or motor disabilities until the enrollment of the study * individuals owning a smartphone with an android software version 7 or newer. exclusion criteria: -

Keywords: cohort studies mobile applications data collection
laparoscopic adjustable gastric banding in adolescents

Conditions: Morbid Obesity

Summary: this study is to determine if the lap-band system is safe and effective for use in morbidly obese adolescents.

this study is to determine if the lap-band system is safe and effective for use in morbidly obese adolescents

Eligibility criteria:
inclusion criteria: * ages 14-19 * bmi \> 35 * history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months. * confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol. exclusion criteria: * history of congenital or acquired anomalies of the gi tract. * history of esophageal motility disorders * uncontrolled psychiatric problems * previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis. * uncontrolled eating disorders

Keywords: lap-band morbid obesity adolescents
the clinical performance of the oxysoft daily disposable silicone hydrogel soft contact lens

Conditions: Myopia

Summary: the objective of this study is to demonstrate that the oxysoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.

this is a double blind randomized control study to evaluate a daily disposable contact lens. it is planned to have 30 evaluable subjects at least divided evenly among 3 independent pis. each pi will enroll 12 subjects at least. the ration of evaluable test subjects to control subjects will be 2 to 1. the study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. it is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including adverse reactions, slit-lamp findings and symptoms, problems, and complaints, vision acuity, keratometry change and reason for discontinuation.

Eligibility criteria:
inclusion criteria: * subject should have normal eye and use no ocular medications * va correctable to 0.1 logmar or better, with spherical lenses ranging in power from -1.00 to -10.00 d myopia, astigmatism =\< 2.00 d * willing to comply with all study procedures and be available for the duration of the study. * provide signed and dated informed consent form. exclusion criteria: * subjects have history of allergies that would contraindicate "normal" contact lens wear. * subjects have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type ii diabetes, slip lamp findings greater than grade i (such as cornea or interstitial edema). * subjects have medications that would contraindicate contact lens wear. * the presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. * a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. * a history of papillary conjunctivitis that has interfered with contact lens wear. * any active participation in another clinical trial within 30 days prior to this study. * have had any cornea surgery. * currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month. * monocular or monovision fits * alcoholic or drug abused.

Keywords: contact lens material silicon hydrogel
effectiveness of a website and telemonitoring in patients with heart failure.

Conditions: Heart Failure

Summary: the number of people with heart failure is increasing in the western world. mainly due to better treatment of myocardial infarctions and ageing of the population. the amount of health care workers is unfortunately not increasing. we want to investigate how two electronic devices (a website and an interactive web-based platform) influence the self-care, quality of life, hospitalizations and mortality by delivering care from a distance. we also want to investigate if a higher quality of care is delivered despite of less frequent visits to a nurse and/or doctor. the study takes place in the netherlands and is a randomized trial. patients with heart failure, registered by an outpatient heart failure clinic or general practitioner can take part. they will be randomized to 3 groups: group 1 receives standard care, group 2 receives standard care with the website, group 3 receives an adjusted care pathway, with both the website and the interactive web-based platform connected to a telemonitoring system. in this group all routine consultations with heart failure nurses and general practitioner will be substituted by this device.


Eligibility criteria:
inclusion criteria: * heart failure established according to the guidelines of the european society of cardiology, and confirmed with echocardiography at least three months earlier. the three month period is used to allow for enough time for essential education and initiation of treatment. * sufficient cognitive and physical function to understand the aim of the study and perform or undergo the required measurements and sign informed consent. * aged 18 years or over. exclusion criteria: * non-availability of internet and e-mail. * inability to work with internet and e-mail. * inability of the patient and his/her family or care takers to read and understand dutch.

Keywords: telemedicine heart failure self care quality of life mortality hospitalization
the effects of neprilysin on glucagon-like peptide-1

Conditions: Diabetes; Heart Failure

Summary: in the current study we wish to investigate the effects on glucagon-like peptide-1 (glp-1) of a neprilysin inhibitor

glucagon-like peptide-1(glp-1) is secreted during a meal and increases glucose induced insulin secretion. the enzyme dipeptidyl peptidase 4(dpp-4) cleaves intact glp-1 within minutes and dpp-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. a few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of glp-1 but if this is the case in humans is unknown. we therefore administered a nep inhibitor, 194mg sacubitril, a dpp-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of glp-1

Eligibility criteria:
inclusion criteria: * men * body mass index between 20-25 exclusion criteria: * acute diseases within the two weeks * chronic diseases * smoker * alcoholism, drug addiction or recent weight loss * blood donation within the last 3 months

Keywords: glp-1 neprilysin dpp-4