Kornimate/medical-research-clean huggingface dataset:
compare efficacy of oxytocin administrations on postpartum uterine contractility

Conditions: Post Partum Haemorrhage

Summary: this is a phase i open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. two administrations of oxytocin will be tested, after which uterine contractility will be assessed.


Eligibility criteria:
inclusion criteria: * healthy, term pregnant female with a gestational age of 37-42 weeks (singleton) * undergoing a planned primary and uncomplicated caesarean section (cs) for their first born under regional anaesthesia * aged between 18 and 40 years (both inclusive) * ability to communicate well with the investigator and to comply with the requirements of the entire study * willing to give informed consent in writing. exclusion criteria: * being obese with bmi ≥35 before pregnancy * history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder * history of cervical cancer * history of severe infection of the uterus * previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility * any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the investigator * conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study medication * contraindications for oxytocin use * hypersensitivity to the active substances or to any of the excipients of the investigational product (test product or comparator drug) * present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics, vasopressin-like drugs * administration of any other investigational drug within 3 months before first dosing * tobacco use (smoking or snuffing), currently or within the last 6 months before screening
testing for arterial disease in diabetes (tread) study

Conditions: Diabetic Foot; Peripheral Arterial Disease; Diabetic Foot Ulcer; Peripheral Vascular Diseases; Peripheral Artery Disease; Critical Limb Ischemia; Critical Lower Limb Ischemia

Summary: this study will focus on determining; * how accurate the test is in detecting poor circulation * how it's accuracy compares to other commonly used tests, and * whether test results are linked to the chance of ulcer healing or amputation. across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. their results will be compared to a full version of the ultrasound test to identify the most accurate.

in the uk, over 7,000 amputations are performed each year because of diabetes. most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. the most important cause of this is poor circulation to the feet. currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. because of this, poor circulation can be missed and its treatment delayed. a focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. it is safe, painless and i have previously proven that it can be learned and performed quickly. it may help avoid amputations by detecting poor circulation so that it can be treated quickly.

Eligibility criteria:
inclusion criteria: * all diabetic patients presenting to the diabetic foot clinics will be eligible for the study. exclusion criteria: * patients unable to provide informed consent will also be excluded.

Keywords: peripheral vascular diseases diabetic foot critical limb ischemia diagnosis peripheral arterial disease diabetic foot ulcer duplex ultrasound ultrasound
the retinal function in relation to glucose changes

Conditions: Diabetes

Summary: this project has the following specific purposes: * to develop a clinically usable test to determine the blood glucose level or hba1c-level, to which the retina is adapted. this will be performed by means of erg implicit time measurements in relation to the blood glucose level during an oral glucose tolerance test (ogtt) and inter- or extrapolation to the level of blood glucose (or hba1c) where implicit time is normal. * to examine darkadaptation in diabetics in relation to changes in the glucose level. * to examine vessel diameter changes in diabetic individuals when changing the glucose level transiently

study 1: 24 type 2 diabetics with minimal diabetic retinopathy but varying hba1c level. study 2: 24 type 2 diabetics with minimal diabetic retinopathy. study 3: 24 type 2 diabetics with minimal diabetic retinopathy. plan of trial: study 1: test individuals will be examined at baseline: prior history of illness, eye examination, blood test, fundusphoto and fullfield-erg. afterwards test individuals will take an oral glucose tolerance test (ogtt) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. immediately after the sugar intake test individuals will be examined by repeated fullfield-erg's and blood glucose measurements (every 30 min) until the blood glucose level has been normalized. study 2: test individuals will be examined at baseline: prior history of illness, eye examination, blood test, fundusphoto and dark adaptation. afterwards test individuals will take an oral glucose tolerance test (ogtt) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. 80 minutes after the sugar intake test individuals will be examined by repeated dark adaptation and blood glucose measurements. study 3: test individuals will be examined at baseline: prior history of illness, eye examination, blood test, fundusphoto. afterwards test individuals will take an oral glucose tolerance test (ogtt) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. at baseline (fasting) and 80 minutes after the sugar intake test individuals will be examined by redfree photos of optic disc and blood glucose measurements.

Eligibility criteria:
inclusion criteria: * type 2 diabetic individuals. age \> 17 \< 80 * dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. age \>17 \< 60 years * with minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs exclusion criteria: * test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
post-reimbursement study to follow spinal neurostimulator devices for pain therapy (french scs registry)

Conditions: Chronic Pain Syndrome

Summary: observational study to evaluate the long term efficacy of spinal cord stimulation (scs) over 2 years following scs implant. this study is requested by french health authorities for reimbursement renewal, to maintain reimbursement for scs in approved indication in france.


Eligibility criteria:
inclusion criteria: * patient indicated for spinal cord stimulation (pain therapy) * patient implanted for less than 3 months or hospitalized for the implant of a medtronic neurostimulator including: * primary implant with spinal cord stimulation indication and positive test of stimulation or * device replacement of a medtronic neurostimulator used for pain therapy * evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant. * treatments must also be available * patient read and signed the data release form exclusion criteria: * patient declined participation * patient is not available for follow up * stimulation of other body part than spinal

Keywords: chronic neuropathic pain syndrome spinal cord stimulation painstim devices efficacy safety
a trial to evaluate the efficacy and safety of efla400 korea red ginseng extract on sexual function in men with erectile dysfunction

Conditions: Healthy Subjects(Only Men)

Summary: korea red ginseng has been used in maintaining vitality throughout the globally and metabolism and actions on neurologic, cardiovascular, and endocrinologic system are studied. krg has been used in various ailment, and to prove its efficacy for erectile dysfunction an international study on contries other than korean was performed. in the present study, subjects with borderline organic and psychogenic erectile dysfunction will be included. krg will be give daily, and placebo will be give as control. outcomes including libido, erection, sexual activity, and sexual satisfaction will be measured.

among the three main lines of therapy for erectile dysfunction (ed), that is, oral therapy, self-injection therapy and penile prosthesis implantation, the first line therapy is always the first option. despite the successful advent of sildenafil, the first effective oral agent for ed, further development of new drugs and phytochemical studies of widely known herbal plants are desirable. furthermore, there seems to be a large population that prefers to use phytotherapies rather than pharmaceutical drugs for their health. korean red ginseng, a phytotherapy plants, used frequently for ed. ginseng is one of the most popular herbs in both eastern and western countries. it is known as a traditional asian medicine for stimulation of sexual function and studies have shown the effects of ginseng on relaxation of penile corpus cavernous smooth muscle in many studies. in the present study, the investigators will be determined the real role of korean red ginseng in the treatment of ed.

Eligibility criteria:
inclusion criteria: * aged 17-70 years * iief(international index of erectile function)-5 scores ≤ 21 subjects. exclusion criteria: * they had other neurologic or psychiatric disorder * significant hepatic or renal function impairment (hepatic enzymes \>1.5 times the upper limit of normal and/or serum creatinine \>1.8 mg per 100 ml) * hypertension (\>170/110 mm hg), hypotension (\<90/50 mm hg) or significant cardiovascular disease (unstable angina, coronary artery disease, myocardial infarction or myocardial revascularization). * peyronie's disease

Keywords: erectile dysfunction korean red ginseng iief(international index of erectile function) mshq(male sexual health questionnaire,)
new body mass index (bmi) cut-offs for the diagnosis of obesity and comorbidities

Conditions: Obesity; Overweight; Diabetes Mellitus, Type 2

Summary: obesity is a serious medical problem because it increases the risk of cardiovascular disease (cvd), type 2 diabetes mellitus, and certain forms of cancer. the definition of obesity is based on an excess of body fat, not of bmi. however, bmi is the reference used to establish a graded classification of weight relative to height. although bmi is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. the present study contemplates the determination of the per cent body fat with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities.

the prevalence of overweight and obesity has increased alarmingly in the last decades. obesity is a serious medical problem because it increases the risk of hypertension, type 2 diabetes mellitus, coronary heart disease, sleep-breathing disorders, and certain forms of cancer. obesity is defined medically as a state of increased adipose tissue of sufficient magnitude to produce adverse health consequences. the definition of obesity is based on an excess of body fat, not of bmi. however, bmi is the reference used to establish a graded classification of weight relative to height. although bmi is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. the present study contemplates the determination of the per cent body fat (by air displacement plethysmography) in more than 5,000 subjects representing the whole bmi range, with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities. the specific objectives are: a) to know the body fat percentage means for normal weight, overweight and obesity for both sexes. b) to know the body fat percentage means for normal weight, overweight and obesity for the different age ranges. c) to analyse the relationship between body fat percentage and bmi values in order to detect misclassified individuals. d) to establish new cut-offs for body fat percentage and the normality ranges according to its relationship with cardiovascular risk factors that could be useful in the diagnosis and therapy of obesity.

Eligibility criteria:
inclusion criteria: * bmi \>18.5 * no major organ disease unrelated to excess body weight exclusion criteria: * pregnancy/lactation * history of eating disorder or major psychiatric illness

Keywords: body mass index body fat obesity overweight diabetes mellitus, type 2 air displacement plethysmography
rankl inhibition and mammographic breast density

Conditions: Dense Breasts

Summary: data supporting a role for rankl signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of rankl inhibition in primary breast cancer prevention are not yet available. the hypothesis is that rankl inhibition with denosumab will decrease mammographic density in high-risk premenopausal women with dense breasts. to address this, the investigators have developed this clinical trial to quantify the impact of rankl inhibition on mammographic density in high-risk premenopausal women with dense breasts and to determine the effect of rankl inhibition on markers of proliferation and biomarkers of breast cancer risk. successful demonstration that rankl inhibition reduces mammographic density could open up additional approaches to primary breast cancer prevention in high-risk premenopausal women, who do not have dominant genetic predisposition.


Eligibility criteria:
inclusion criteria: * female. * premenopausal (when menopausal status is uncertain, the investigators will measure follicle-stimulating hormone and estradiol to ascertain that a partcipant is premenopausal) * at least 40 years of age. * dense breasts on routine mammogram (bi-rads category c and d) * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * history of breast or any other invasive cancer except for dcis (ductal carcinoma in situ) who received only lumpectomy, lcis (lobular carcinoma in situ), atypical hyperplasia, non-melanoma skin cancer, carcinoma in situ of the cervix. * current use of tamoxifen, aromatase inhibitors, or bisphosphonates, or rankl inhibitors * concurrent participation in another cancer chemoprevention trial (unless no longer receiving the intervention). * pregnant, lactating, or planning to get pregnant while the trial is ongoing. * recent history of invasive dental procedure (e.g. tooth extraction, dental implant, oral surgery). * unhealed and/or planned dental/oral surgery. * history of osteonecrosis/osteomyelitis of the jaw. * history of osteoporosis or severe osteopenia.

Keywords: mammographic density breast cancer rankl denosumab prevention premenopausal
standard oxygen versus high flow nasal cannula oxygen therapy in patients with acute hypoxemic respiratory failure

Conditions: Acute Respiratory Failure; Hypoxemic Respiratory Failure

Summary: first-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. in a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. to improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure


Eligibility criteria:
inclusion criteria: all consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria: * respiratory rate \>25 breaths/min whatever the oxygen support * pulmonary infiltrate, * pao2/fio2 ≤200 mmhg * informed consent from the patient or relatives. exclusion criteria: * paco2 \> 45 mm hg * need for emergent intubation: pulse oximetry \< 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or glasgow coma scale below 8 points * hemodynamic instability defined by signs of hypoperfusion or use of vasopressors \> 0.3 µg/kg/min * glasgow coma scale equal to or below 12 points * exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of gold classification), or another chronic lung disease with long term oxygen or ventilatory support * cardiogenic pulmonary edema as main reason for acute respiratory failure * coronavirus sars-2 infection as reason for acute respiratory failure (the soho-covid study has been completed) * post-extubation respiratory failure within 7 days after extubation, * post-operative patients within 7 days after abdominal or cardiothoracic surgery, * do not intubate order; * already included in the study, refusal to participate or participation in another interventional study with the same primary outcome. * patients without any healthcare insurance scheme or not benefiting from it through a third party, * persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Keywords: acute hypoxemic respiratory failure de novo respiratory failure high-flow nasal oxygen standard oxygen
intraoperative sedatives and postoperative pain

Conditions: Arthritis, Degenerative

Summary: in this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients undergoing total knee arthroplasty * age: 20 - 80 yrs exclusion criteria: * asa classification ≥ 3 * patient who do not want sedation during the surgery * patient who wants general anesthesia * cardiovascular disease * liver dysfunction * renal dysfunction

Keywords: dexmedetomidine propofol pain, postoperative
a study of arry-334543 and docetaxel in patients with advanced cancer

Conditions: Advanced Cancer

Summary: this is a phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug arry-334543 and docetaxel (with prophylactic growth factor support). patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. approximately 30 patients from the us will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel. * tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * must be able to take and retain oral medications. * other criteria exist. key exclusion criteria: * active concomitant malignancies. * uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start). * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c. * requiring intravenous (iv) alimentation. * pregnancy or lactation. * chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug. * anti-erbb1 and/or erbb2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug. * history of hypersensitivity to or intolerance of docetaxel. * other criteria exist.
are serum levels of vascular endothelial growth factor a marker for the early diagnosis of ectopic pregnancy?

Conditions: Ectopic Pregnancy

Summary: objective: this study evaluated serum vascular endothelial growth factor (vegf) concentrations in women with ectopic pregnancy (ep), abnormal intrauterine pregnancy (aiup) and normal intrauterine pregnancy (niup). methods: this was a prospective, case-control study comparing serum vegf concentrations among 72 women with ectopic pregnancy (n=35), abnormal iup (n=15) and normal iup (n=22) matched for gestational age. for the determination of serum vegf concentration a solid phase sandwich elisa was used. patients were stratified according to serum vegf above or below 200pg/ml. results: the serum level of vegf was significantly higher in women with ectopic pregnancy (median 211.1 pg/ml; range 5 - 1017.0 pg/ml) than in women with normal iup (median 5 pg/ml; range 5- 310.6 pg/ml) p \< 0.0001. serum vegf concentrations did not show any statistically significant difference between women with aiup (median 231.9 pg/ml range 5 - 813.7 pg /ml ) and ep (median 211.1 pg/ml range 5 - 1017.0 pg/ml). when cut-off concentrations of 200 pg/ml for vegf were used, a niup could be distinguished from an unviable (ep and aiup) with a sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative predictive value of 46.5%.. conclusions: serum vegf could not distinguish between an ep and an aiup. however, serum vegf concentrations above 200 pg/ml could discriminate a niup from an unviable pregnancy (ep or aiup) with a ppv of 92.9%.


Eligibility criteria:
inclusion criteria:the inclusion criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hcg. - exclusion criteria:the exclusion criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal). -