Kornimate/medical-research-clean huggingface dataset:
to demonstrate the relative bioavailability of sandoz inc. and tyco healthcare (tofranil) 50 mg imipramine hydrochloride tablets in healthy adults volunteers under fasting conditions

Conditions: Depression

Summary: to demonstrate the relative bioavailability of sandoz inc. and tyco healthcare (tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antidepressant
gestational diabetes mellitus, obesity and periodontal disease

Conditions: Diabetes Mellitus, Gestational; Periodontal Diseases; Obesity

Summary: this study evaluated the periodontal condition of gestational diabetes mellitus (gdm) patients and a healthy non-pregnant control group. for the gdm group all medical data were recorded, including obesity/insulin resistance indicators.

gestational diabetes mellitus is associated to a worse periodontal condition. many patients with these two diseases are also obese. after delivery, some patients maintain the pre-pregnancy obesity status and this condition is also associated to periodontal disease. the mechanisms involved in the relationship of all these medical and periodontal conditions are not clear.

Eligibility criteria:
inclusion criteria: * inclusion criteria for gdm group was pregnant women with diagnosis of gdm based on glucose determination described in a previous study (19) and under medical treatment of an endocrinologist and the presence of at least one tooth per sextant. * inclusion criteria for control group were absence of periodontal disease, mean age similar to test group and presence of at least one tooth per sextant. exclusion criteria: * the exclusion criteria for gdm group were pregnant women without diagnosis of diabetes, age below 18 years or higher than 42 years, and the presence of other systemic diseases. * in control group, women were excluded if they were pregnant, had diabetes or other systemic disease and age below 18 years or higher than 42 years.

Keywords: gestational diabetes mellitus obesity periodontal disease
external body pressure in heart failure with preserved ejection fraction

Conditions: Heart Failure, Diastolic

Summary: the primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. aim 1 will study healthy volunteers and heart failure patients non invasively while aim 2 will study heart failure patients invasively (intracardiac pressures).


Eligibility criteria:
* heart failure study population * inclusion criteria (aim 1 and 2): * age greater than or equal to 30 yrs * established diagnosis of hfpef with left ventricular ejection fraction greater than or equal to 50% * nyha ii-iii symptoms * stable hf drug regimen for the preceding 1 month * wedge pressure greater than or equal to 15 mmhg at rest or greater than or equal to 25 mmhg with peak exercise * (for aim 2 only) scheduled for an elective right heart catheterization at duke university hospital. * exclusion criteria (aim 1 and 2): * hf hospitalization for type i myocardial infarction within 3 months * infiltrative (ie amyloid) or hypertrophic cardiomyopathy * uncontrolled atrial or ventricular arrhythmia * chronic oxygen use * history of vasovagal syncope * considered inappropriate to participate by pi or sub-i * healthy volunteers (controls) * inclusion criteria (aim 1): * age greater than or equal to 30 yrs * able to speak english * ambulatory \[assistive devices ok\] * able to provide informed consent * exclusion criteria (aim 1): * acute myocardial infarction (3-5 days) * unstable angina * uncontrolled arrhythmia causing symptoms or haemodynamic compromise * syncope * active endocarditis * acute myocarditis or pericarditis * symptomatic severe aortic aneurysm * uncontrolled asthma * arterial desaturation at rest on room air \<85% * untreated left main stem coronary stenosis * asymptomatic severe aortic stenosis * severe untreated arterial hypertension at rest (\>200 mm hg systolic, \>120 mm hg diastolic) * tachyarrhythmias or bradyarrhythmias * hypertrophic cardiomyopathy * significant pulmonary hypertension * thrombosis of the lower extremity until treated for a minimum of 2 weeks * within 2 weeks of acute symptomatic pulmonary embolus * abdominal aortic aneurysm \>8.0 cm * electrolyte abnormalities * pregnancy * inmate of correctional facility (i.e. prisoner) * diagnosed history of dementia * inability to ambulate independently * considered inappropriate to participate by principal investigator
open-label, extension study to 810p202

Conditions: Impulsive Aggression Comorbid With ADHD in Children

Summary: open-label, extension study for subjects that completed 810p202 to examine long term safety and tolerability of repeated dosing of spn-810m as an adjunctive therapy in children with impulsive aggression comorbid with attention-deficit/hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: 1. successful completion of the 810p202 study. 2. continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ecgs). 3. weight of at least 20kg. 4. able and willing to swallow tablets whole and not chewed, cut or crushed. 5. written informed consent/assent obtained from the subject's parent or legally-authorized representative (lar), and written informed assent obtained from the subject if required. exclusion criteria: 1. body mass index (bmi) in 97th percentile or above. 2. clinically significant change in health status that, in the opinion of the investigator, would prevent the subject from participating in this study or successfully completing this study. 3. pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential). 4. any reason which, in the opinion of the investigator, would prevent the subject from participating in the study or complying with the study procedures.
long-term safety follow-up of participants exposed to the candidate ebola vaccines ad26.zebov and/or mva-bn-filo

Conditions: Hemorrhagic Fever, Ebola

Summary: the purpose of the study is to assess the long-term safety profile of ad26.zebov and mva-bn-filo in participants previously exposed to these vaccines in phase 1, 2, or 3 clinical studies.

this is a multi-country, prospective, long-term clinical safety study for collection of serious adverse events and pregnancy outcomes following administration of ad26.zebov and/or mva-bn-filo vaccines among participants who were enrolled in phase 1, 2 or 3 clinical studies. the safety data will be collected in 3 cohorts; cohort 1- adult and pediatric participants that received ad26.zebov and/or mva-bn-filo in phase 1, 2 or 3 clinical studies (adults, adolescents and children), cohort 2- female participants who became pregnant with estimated conception within 28 days after vaccination with mva-bn-filo or within 3 months after vaccination with ad26.zebov will be followed to the end of their pregnancy for pregnancy outcomes (cohort 2). after the end of pregnancy, female participants will continue to be followed in cohort 1. cohort 3 - children born to female participants exposed to ad26.zebov and/or mva-bn-filo who became pregnant with estimated conception within 28 days after vaccination with mva-bn-filo or within 3 months after vaccination with ad26.zebov. safety data will be collected on all consenting participants.

Eligibility criteria:
inclusion criteria: * male or female who participated in a phase 1, 2 or 3 clinical study with human adenovirus serotype 26 (ad26) expressing the ebola virus mayinga variant glycoprotein (ad26.zebov) and/or modified vaccinia virus ankara - bavarian nordic filo-vector (mva-bn-filo) and has been exposed to ad26.zebov and/or mva-bn-filo (cohort 1) * female who participated in a phase 1, 2 or 3 clinical study with ad26.zebov and/or mva-bn-filo and became pregnant with estimated conception within 28 days after vaccination with mva-bn-filo or within 3 months after vaccination with ad26.zebov (cohort 2) * child born to female participants exposed to ad26.zebov and/or mva-bn-filo in a phase 1, 2, or 3 clinical study who became pregnant with estimated conception within 28 days after vaccination with mva-bn-filo or within 3 months after vaccination with ad26.zebov (cohort 3) * must sign an informed consent form for the current study (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study (or let their child participate); assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) exclusion criteria: * no exclusions beyond those that are not meeting the inclusion criteria

Keywords: healthy ebola viruses ebola virus disease (evd) filoviruses safety human adenovirus serotype 26 (ad26) expressing the ebola virus mayinga variant glycoprotein (ad26.zebov) modified vaccinia virus ankara - bavarian nordic filo-vector (mva-bn filo) hemorrhagic fever
thermachoice iii under local sedation in the office setting

Conditions: Heavy Uterine Bleeding

Summary: investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

a safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. this study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. this study will include twenty patients.

Eligibility criteria:
inclusion criteria: * heavy uterine bleeding exclusion criteria: * uterine or cervical cancer * unable to tolerate office hysteroscopy * uterine fibroid tumors that distort endometrial cavity * uterine cavity greater than 12 cm * patients with hyperplasia or premalignant changes of the endometrium * active genital or urinary tract infections * intrauterine device * pregnant or want to become pregnant
compont - varicose veins of the lower extremities

Conditions: Varicose Veins of Lower Limb

Summary: the purpose of this clinical trial is to evaluate the effectiveness and safety of medical adhesive produced by beijing compont medical devices co., ltd. in the treatment of varicose veins in the lower extremities. the main questions it aims to answer is: what medical problems do participants have when using tissue glue? researchers will compare medical adhesive to closurefast endovenous radiofrequency ablation (rfa) catheter (produced by medtronic inc. to see if medical adhesive works to treat varicose veins in the lower extremities. participants will: treated with closed varicose veins of the lower extremity by medical adhesive or closurefast. return to the hospital at 1, 12, and 24 weeks postoperatively for doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.


Eligibility criteria:
inclusion criteria: * clinically diagnosed as great saphenous vein varices. (this operation only dealt with one side varicose veins of the lower extremities.) * ceap is graded c2-c6. * doppler ultrasound confirmed the patency of deep veins of lower limbs. * sign informed consent, voluntarily participate in the trial and follow up as required exclusion criteria: * a history of lower extremity deep vein thrombosis or pulmonary embolism * recurrent varicose veins * the diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm * the great saphenous vein is severely distorted or tuberculated at the root * sepsis or septicemia * allergic to n-butyl cyanoacrylate * the distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm * severe cardiopulmonary disease, shock, coma or multiple organ failure * lactating or pregnant women * participated in other clinical trials within 1 month before surgery * the researchers considered it unsuitable for inclusion

Keywords: varicose veins of lower limb nbca
external micropulse diode laser transscleral trabeculoplasty (emdlt) for severe open angle glaucoma

Conditions: Primary Open Angle Glaucoma

Summary: to prove that external contact micropulse diode laser trabeculoplasty (emdlt) can significantly lower intraocular pressure in cases of advanced open angle glaucoma.

micropulse diode laser trabeculoplasty applied through a gonioscopy len has been shown to be effective in lower the pressure for patients with primary open angle glaucoma (poag). we believe that applied externally, the contact diode micropulse laser will be effective in lowering intraocular pressure for patients with advance open angle glaucoma with minimal side effects

Eligibility criteria:
inclusion criteria: * • diagnosis of primary open angle glaucoma * advanced glaucoma with intraocular pressure higher than 21mmhg on one or more topical medications (for at least 2 months) * visual acuity worse than 6/6 * age more than 21 years * poor candidate for additional filtration surgery exclusion criteria: * • age less than 21 years * any eye surgery within 2 months of enrolment * any patient with rubeosis * unable to give informed consent

Keywords: primary open angle glaucoma
dermatomyositis and polymyositis registry

Conditions: Dermatomyositis; Polymyositis

Summary: by creating a registry, physicians will have the opportunity to understand the clinical outcomes of myositis patients treated with acthar. despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. there may be several types of immune and inflammatory myositis (iim) that do not fit well into the typical sub classifications of myositis.

retrospective and prospective data will be collected from physicians who have prescribed acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. through biopsy analysis, subcategories of iim will be determined and could illustrate which of these iims may be more responsive to acthar therapy.

Eligibility criteria:
inclusion criteria: 1. age 18-85 2. male or female 3. clinical or pathologic diagnosis of polymyositis or dermatomyositis 4. capable of providing informed consent and complying with treatment regimen exclusion criteria: 1. history of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex 2. recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin 3. any other co-morbid condition which would make completion of the trial unlikely 4. if female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control

Keywords: myositis acthar treatment
effect of glp-1 receptor (glp-1r) agonists on cardiac function and on epicardial adipose tissue (eat) volume and on myocardial tg content in obese diabetics

Conditions: Obesity; Diabetes

Summary: glucagon-like peptide-1 (glp-1) receptor agonist are new treatment of type 2 diabetes, they lower blood glucose level (by enhancement of glucose-dependent insulin secretion and suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing of gastric emptying. beneficial effects of glp-1 and glp-1 receptor (glp-1r) agonists on cardiovascular function have been suggested. they improve biomarkers of cv risk, decrease systolic blood pressure, improve endothelial function and have beneficial effects on myocardium. nevertheless, few studies have analysed the effect of glp1 treatment on myocardial function in type 2 obese diabetic. myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes mellitus. it was recently shown that 16 weeks of caloric restriction in obese patients with diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac output, normalized stroke volume, lv mass and normalized end diastolic volume), and diastolic function. however, no study has evaluated the impact of glucagon-like peptide-1 (glp-1) receptor agonist in obese diabetics on myocardial tg content. recent studies have suggested that increased epicardial adipose tissue (eat) could be an important risk factor for cardiac diseases. we and others have already evidenced a correlation between the volume of epicardial adipose tissue and the presence or the severity of coronaropathy. the impact of weight loss on the volume of eat or the characteristics of eat is mostly unknown.


Eligibility criteria:
inclusion criteria: * - patients with type 2 diabetes according to who criteria * age\> 18 years * bmi ≥ 30 kg/m2 * hba1c\> 7% and \<10% * processing by ado (metformin and glimepiride) * effective contraception (for women) * signed informed consent by the patient before inclusion in the protocol exclusion criteria: * ongoing pregnancy or become pregnant within six months of the study protocol * breastfeeding * recent weight loss (\> 5% of total weight) * treatments changing the distribution of adipose tissue as corticosteroids or glitazones * acute coronary syndrome or unstable angina during the last three months * contraindications to cardiac mri (mechanical heart valve, pacemaker, metallic intraocular foreign body, claustrophobia) * contraindication to cold test: raynaud's syndrome * contraindication to exenatide: * neoplasia active or untreated or in remission for less than 5 years (except for basal cell carcinoma or in situ cervical or prostate) * contraindication to ado (depending on specific product) in combination with exenatide. * history of kidney transplant or dialysis or plasmatique creatinine\> 1.5 mg / dl for men and\> 1.2 mg / dl for women * digestive diseases, including gastroparesis * plasma triglycerides\> 1000 mg / dl * history of pancreatitis confirmed biologically * contraindication or hypersensitivity to exenatide or one of its social coverage composantsabsence
metal on metal versus metal on highly crossed linked polyethylene sytem

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Congenital Dysplasia of the Hip; Ankylosing Spondylitis; Post-traumatic; Arthrosis; Injury of Hip and Thigh

Summary: this trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.


Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects 65 years of age or older * subjects undergoing cementless hip arthroplasty. if a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(at the discretion of the surgeon). the cup in this situation may have a metal or poly articulation. the patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized) * subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint. * subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions. exclusion criteria: * subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis. * subjects with gross obesity, \>45% over ideal body weight for age and height. refer to appendix a, obesity table. * subjects with active infections. * subjects with malignancy in the area of the involved hip joint. * subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period. * subjects with a diagnosis of fibromyalgia * female subjects who are pregnant or may be pregnant. * subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule. * subjects who have a known sensitivity to device materials.
exploring the impact of monocytes in myeloproliferative neoplasia (emynem)

Conditions: Myeloproliferative Neoplasm

Summary: impact of monocytes on myeloproliferative neoplasm hematopoietic stem cell growth and differentiation in vitro


Eligibility criteria:
inclusion criteria: * diagnosis of mpn in the participating center * over 18 yo exclusion criteria: * not able to consent
prediction of outcome in severe preeclampsia

Conditions: Leiden Factor V Deficiency,Preeclampsia; Doppler Examination; Palental Pathology

Summary: this summary studied the predictive values of factor v leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

leiden mutation is activated protein c resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor v deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

Eligibility criteria:
inclusion criteria: severe preeclampsia in 3rd trimester - exclusion criteria:twin pregnancy. fetal congenital anomalies. diabetic patient, impaired renal function. any medical disorders even that htn. any placental pathology,autoimmune diseases. women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy. -
efficacy and safety of hydrolyzed ginseng extract on impaired fasting glucose

Conditions: Hyperglycemia

Summary: this study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(hge) on glycemic status in subjects with impaired fasting glucose(ifg).

this study was a 8 weeks, randomized, double-blind, placebo-controlled trial. twenty subjects were randomly divided into hge or a placebo group. fasting and postprandial glucose profiles during oral glucose tolerance test (ogtt) were assessed before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 20-70 years with fasting glucose 100\~126 mg/dl exclusion criteria: * abnormal lipid profile values * acute/chronic inflammation * treated with corticosteroid within past 4 weeks * cardiovascular disease * allergic or hypersensitive to any of the ingredients in the test products * history of disease that could interfere with the test products or impede their absorption * participation in any other clinical trials within past 2 months * renal disease * abnormal hepatic function * under hypolipidemic drugs therapy within past 3 months * under antipsychotic drugs therapy within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * history of alcohol or substance abuse * pregnancy or breast feeding

Keywords: hge, impaired fasting glucose, clinical trial