Kornimate/medical-research-clean huggingface dataset:
sonohysterography , 3d ultrasonography and hysteroscopy in assessment of uterine factor in cases of female infertility

Conditions: Infertility

Summary: prospective comparative study including 100 infertile patients with suspected uterine lesion. 2d ultrasound, sonohysterography , 3d ultrasound and hysteroscopy will be done to evaluate uterine cavity.

all patients will be examined by 2d transvaginal ultrasound using a 6.5 mhz probe (sonoace 5000, medison co. ltd, korea). examination is performed after emptying of the bladder in dorsal lithotomy position. three dimensional ultrasound will be performed using medison, voulson 530 d-mt ultrasound machine (medison co. ltd, korea). the uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed. sonohysterography will be done after introduction of the catheter into the cervix, a twenty milliliter syringe which is prefilled with the distending media (saline) is then fitted to the catheter. the speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix. the uterus is then visualized in the longitudinal plane to demonstrate the endometrial cavity and the catheter. once this is possible, sterile saline is slowly injected through the catheter into the uterine cavity; up to ten milliliter of saline is usually enough for the procedure. hysteroscopy will be done under general anesthesia. the hysteroscopy is rigid continuous flow diagnostic hysteroscopy . it has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.

Eligibility criteria:
inclusion criteria: * suspected uterine factor of infertility exclusion criteria: * tubal, ovarian or male factor of infertility

Keywords: 2d ultrasound 3d ultrasound sonohysterography hysteroscopy uterine factor of infertility
high-intensity exercise and endothelial function in type 1 diabetes(hiit-t1d)

Conditions: Type 1 Diabetes Mellitus; Endothelial Dysfunction

Summary: to study the effect of 8 week high-intensity interval training (hiit) compared with moderate intensity (mct) interval training and sedentary patients(con) with type 1 diabetes. adult t1dm patients without known complications are randomised in blocks into these 3 groups according to their baseline flow mediated dilation (fmd). after 8 week exercise training, the main outcome, fmd, is re-evaluated. additional variables such as vo2 peak for cardiovascular fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity are also evaluated.

in a randomized controlled open trial, 36 adult type 1 diabetes mellitus (t1dm) patients without known complications were randomized into 3 groups: hiit n=12; mct n=12 and a sedentary control group (con) n=12. total sample size was calculated to a power of 80% alha 0.05 and a difference in mean fmd of 2%. before randomisation, flow mediated dilation (fmd) and maximal exercise capacity (vo2 peak)is determined. block randomisation based on fmd rank values are done to equalize baseline fmd. exercise sessions are performed in cycle ergometers during 40 minutes, 3 times a week, along 8 weeks. hiit protocol, intensity vary from 50 to 85% of the maximum heart rate (hrmax), while in mct, hr remained stable at 50% hrmax. endothelial function was measured by flow mediated dilation (fmd) for endothelium-dependent vasodilation (edvd) and smooth-muscle function was measured by nitroglycerine mediated dilation (endothelium independent vascular dilation) - (eivd). peak oxygen consumption (vo2peak) and oxidative stress markers were determined before and after the training period. ed was defined as an increase of less than 8% in vascular diameter after cuff release.

Eligibility criteria:
inclusion criteria: t1dm * physically inactive or not involved in exercise training programs in the previous 6 months * interested in starting an exercise training program. exclusion criteria: * smokers, * pregnancy * co-morbidities not related to diabetes * drugs other than insulin * loss of renal function (serum creatinine above 1.5 mg/dl), * moderate to severe retinopathy or blindness, * suspected or confirmed coronary artery disease, * severe peripheral neuropathy * foot ulcers or history of previous foot ulcer * suspected or confirmed clinical autonomic neuropathy.

Keywords: exercise high-intensity interval training type 1 diabetes endothelial dysfunction
characterization of the inhibitory effects of fevipiprant (qaw039) on activation of eosinophils and ilc2 cells by prostaglandin d2 metabolites

Conditions: Atopic Asthma

Summary: the aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of prostaglandin d2 metabolites to the dp2 receptor in comparison to prostaglandin d2. the inhibitory activity of a potent dp2 receptor antagonist, fevipripant, shall be determined.

the inhibitory activity of a potent dp2 receptor antagonist shall be determined. for these experiments eosinophil granulocytes and ilc2 cells will be isolated from the collected blood samples and used in specific assays in respect to their functional reactivity against the dp2 receptor antagonist fevipiprant after respective stimulation using prostaglandin d2 metabolites or prostaglandin d2. major rationale is to show and determine the ec70 of the effectivity of fevipiprant against prostaglandin d2 metabolite triggered activation of eosinophil granulocytes and ilc2 innate lymphoid cells.

Eligibility criteria:
inclusion criteria: * women will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal iuds or double-barrier methods, i.e. any double combination of iud, condom with spermicidal gel, diaphragm, sponge, and cervical cap). * body weight ≥ 50 kg and bmi within the range 19-32 kg/m² * history of allergic asthma since at least 12 months * a concentration of at least 0,15 x 106/ml eosinophils in peripheral blood exclusion criteria: * history of an acute infection two weeks prior to the screening visit. * intake of oral steroids within 4 weeks prior to screening * past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis). * participation in another clinical trial 30 days prior to enrollment. * donation of more than 100 ml of blood in the preceding 2 months before the screening visit.
comparative study on the effects of sublingual misoprostol in addition to standard amtsl in low risk parturients in lasuth, ikeja.

Conditions: Primary Postpartum Haemorrhage

Summary: postpartum haemorrhage is the leading cause of maternal haemorrhage globally. with active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. hence the need for an effective oxytocic in third stage of labour.

this is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. eligible subjects will be ransomised into 2 groups of 330 participants. all patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. however, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). measured mean blood loss will be comparee in the 2 groups using statistical analysis.

Eligibility criteria:
inclusion criteria: * singleton in longitudinal lie and cephalic presentation exclusion criteria: * refusal of consents, multiple gestation

Keywords: uterine atony
phase ii study of rindopepimut (cdx-110) in patients with glioblastoma multiforme

Conditions: Malignant Glioma

Summary: this study is designed to evaluate the clinical activity of cdx-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). study treatment will be given until disease progression and patients will be followed for long-term survival information. efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.


Eligibility criteria:
inclusion criteria: * newly diagnosed de novo gbm with documented egfrviii expression in tumor tissue. * gross total resection followed by conventional chemoradiation therapy without progression of disease. exclusion criteria: * presence of diffuse leptomeningeal disease or gliomatosis cerebri. * systemic corticosteroid therapy \> 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment. * patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of gliadel® wafers. * known allergy or hypersensitivity to klh, gm-csf or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

Keywords: egfrviii vaccinetemozolomidecancer vaccineimmunotherapy
the relationship between scapular endurance, core endurance, and functional performance in adolescent tennis players

Conditions: Athletic Injuries; Sports Physical Therapy

Summary: this study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. the hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players.

tennis is a sport characterized by coordinated, repetitive, and powerful movements along the kinetic chain. being both overhead and rotational, achieving a good shot in tennis involves transferring high forces and energy from the lower extremities to the upper extremities through the trunk. in this context, core muscles play a crucial role in athletic performance by stabilizing the shoulder girdle, pelvis, and spine, acting as a pivot point for extremity movements. therefore, good core strength is essential during a stroke. additionally, as the acceleration of the ball is influenced by both maximum external and internal rotation of the shoulder, tennis players require good shoulder mobility and stability. in this regard, the scapula in the shoulder girdle provides a stable foundation for the glenohumeral mobility necessary for the shot. both the core and scapular regions serve as pivot points for upper extremity functional activities. therefore, this study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. the hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players.

Eligibility criteria:
inclusion criteria: * adolescent tennis players exclusion criteria: * athletes with a history of musculoskeletal injury or surgery in the last year that would prevent the tests from being performed * athletes who feel pain in the trunk and lower extremities during the tests

Keywords: core endurance scapular endurance adolescent tennis player upper extremity functional performance
autoimmunity in sisters of lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: this study enrolled over 400 unaffected sisters of young women diagnosed with sle. these unaffected sisters are being followed with an annual health questionnaire (csq) and blood sample.

systemic lupus erythematosus (sle) is a chronic autoimmune disease that causes inflammation and is accompanied by the development of autoantibodies. the inflammation caused by sle may affect the skin, joints, lungs, blood, kidneys and nervous system. the cause of sle is unknown, but research has indicated that it is caused by a combination of genetic and environmental factors. autoimmune diseases often run in families. close relatives of people with these diseases are at greater risk of developing the same or another autoimmune disease. the study is designed to determine several things: if sisters of people with sle make the same antibodies that are present in people with sle, whether or not environmental factors affect the chances of developing these antibodies and if so what these environmental factors may be, if the presence of these antibodies in healthy people leads to increased risk for the development of sle. this study enrolled over 400 unaffected sisters of young women diagnosed with sle. these unaffected sisters are being followed with an annual health questionnaire (csq) and blood sample. participation is voluntary and participants can stop participating at any time.

Eligibility criteria:
sister diagnosed with sle: inclusion criteria: 1. proband must be a female and have documented sle that meets acr criteria. sle must be diagnosed by and including age 40. 2. proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. both full and half siblings qualify. exclusion criteria: if inclusion criteria above are met for the proband, there are no exclusions. sister who does not have sle: inclusion criteria: 1. female with a full or half sister who has been documented sle that meets acr criteria. 2. sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of sle. 3. sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up. 4. sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet. exclusion criteria: if sister meets inclusion criteria, there will be no exclusions.

Keywords: sle sister autoimmune disease
prevalence of osteosarcopenic obesity in older adults

Conditions: Obesity; Sarcopenia; Osteopenia; Osteoporosis

Summary: osteosarcopenic obesity (oso) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. it is the latest point of impairment in the bone,muscle and adipose tissue in older adults. oso, as the name suggests, is the combination of three syndrome frequently encountered in the elderly: osteopenia/osteoporosis, sarcopenia and obesity. the aims of study are to determine the prevalence of oso syndrome in community-dwelling adults of turkey and determine the possible factors regarding risk of falling in this population


Eligibility criteria:
inclusion criteria: * age of 65 or over * being had been examined for all the primary outcome measures (i.e. the results of primary outcomes must be in the patient's file) exclusion criteria: * severe cognitive dysfunction * not being able to walk independently for 4 m
open-label drug interaction study between eslicarbazepine acetate and lamotrigine.

Conditions: Epilepsy

Summary: single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers

single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: group a: pre-treatment with esl, treatment with esl and ascending doses of lamotrigine (lmt) in last phases; group b: pre-treatment with lmt, treatment with lmt and ascending doses of esl in last phases

Eligibility criteria:
inclusion criteria: * availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (icf) duly read, signed and dated by the volunteer * male aged of at least 18 years but not older than 45 rears with a body mass índex (bmi) greater than or equal to 19 and below 30 kg/m * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3) * healthy according to the medical history, laboratory results and physical examination * light-, non- or ex-smokers. a light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day i of thi s study the informed consent form must be signed by all volunteers, prior to their participation in the study. exclusion criteria: * significant history of hypersensitivity to lamotrigine, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects * history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy * presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease * presence of significant heart disease or disorder according to ecg * presence or history of significant central nervous system disorder like convulsion or depression * presence or history of significant ocular disease * maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
thromboelastometry prediction utility for risk of abortion

Conditions: Pregnancy Trimester, First; Abortion, Threatened

Summary: this study will use thromboelastometry in ed patients with vaginal bleeding, as well as healthy pregnant controls, to determine if abnormal results are associated with the presence of vaginal bleeding as well as later complications during pregnancy.

first, a case control study with samples collected from patients in the ed and ob clinic at mount sinai hospital will be performed. blood samples are being collected at time of study entry. patient health history will be collected and blood samples will be tested using thromboelastometry in prospective fashion. samples will be compared between groups. a prospective cohort will then be established using the subjects from the case control study. the purpose of this prospective cohort will be to collect outcomes of pregnancies to determine association with the initial thromboelastometry results.

Eligibility criteria:
inclusion criteria: * subjects will include pregnant women seen in the ed and ob clinic. the ed patients will include those seen for vaginal bleeding during pregnancy at less than 20 weeks gestation. ob clinic patients will include those seen for first prenatal visit at which blood draw is performed, as long as this is also within 20 weeks estimated gestational age. exclusion criteria: * patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia, or other coagulopathy will be excluded. * patients with ectopic pregnancies will also be excluded.

Keywords: thromboelastometry vaginal bleeding early pregnancy
oat products in the treatment of coeliac disease in children

Conditions: Clinical and Nutritional Safety.

Summary: in many northern european countries oat-based products have been used in the dieto-therapy of coeliac disease for many years. the purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of italian celiac patients in pediatric age.

several clinical trials have demonstrated that most celiac patients, both of pediatric and of adult age, can take medium-high quantity of oat (50-100 g/day), without any negative clinical effects. in a small number of cases intestinal dyspeptic disorders, especially meteorism, can be observed, particularly during the first weeks of oat intake. they are generally without clinical significance because they are a consequence of the increased fibre intake. there are only few cases of "true" oats intolerance. the addition of oat improves the nutritional quality of the gluten-free diet, particularly due to the increased intake of fibre and some oligoelements (iron, zinc, tiamin, pholates) and expands the spectrum of food choices. in many northern european countries oat-based products have been used in the dieto-therapy of coeliac disease for many years. for the oat-based product to be considered suitable in the dieto-therapy of coeliac disease, the absence of gluten contamination and possibly the origin from a variety of oat which is without traces of gluten cross-reactive peptides must be guaranteed. the purpose of this study is to evaluate clinical tolerance and liking of gluten-free products containing oatmeal from a specific oat variety (not contaminated with gluten) in a sample of italian celiac patients in pediatric age.

Eligibility criteria:
inclusion criteria: the study will include patients aged between 4 and 14, under treatment with a gluten-free diet for coeliac disease (bioptic diagnosis) for at least two years. exclusion criteria: diagnosis not confirmed by intestinal biopsy, cases with little adherence to the treatment (anti-ttg positive at basal evaluation), cases of potential coeliac disease (completely normal mucous membrane), cases with an associated sieric iga deficit, cases with associated diseases (es. diabetes type 1).

Keywords: coeliac disease oat
special survey on parkinson's disease (pd) patients without concomitant use of l-dopa

Conditions: Parkinson Disease

Summary: the survey is conducted to collect safety and effectiveness information in parkinson's disease patients treated with pramipexole without concomitant l-dopa supplementation in the daily clinical settings in japan.


Eligibility criteria:
inclusion criteria: patients with parkinson's disease who do not receive l-dopa supplementation exclusion criteria: patients should have been treated according to the japanese insert slip