Kornimate/medical-research-clean huggingface dataset:
phase 3 study to evaluate the efficacy and safety of pergoveris® in assisted reproductive technology (espart)

Conditions: Infertility

Summary: this is a phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of pergoveris® (recombinant human follicle stimulating hormone \[r-hfsh\]/recombinant human luteinising hormone \[r-hlh\]) and gonal-f® for multifollicular development as part of an assisted reproductive technology (art) treatment cycle in poor ovarian responders, as aligned with the 2011 consensus meeting of the european society of human reproduction and embryology (eshre) criteria.


Eligibility criteria:
inclusion criteria: * poor ovarian responders according to specific criteria that are aligned with poor ovarian response (por) criteria defined by the 2011 consensus meeting of the european society of human reproduction and embryology (eshre) as mentioned in the protocol * female subjects, less than (\<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and art treatment, including intracytoplasmic sperm injection (icsi) * absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy * absence of any medical condition in which pregnancy is contraindicated * body mass index 18 to 30 kilogram per square meter (kg/m\^2), inclusive * motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). intracytoplasmic sperm injection will be allowed during this trial * minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening * signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment exclusion criteria: * two episodes of por after maximal stimulation * history or presence of tumors of the hypothalamus or pituitary gland * history or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization * presence of endometriosis grade iii - iv, confirmed or suspected * presence of uni- or bilateral hydrosalpinx * abnormal gynecological bleeding of undetermined origin * contraindication to being pregnant and/or carrying a pregnancy to term * history or presence of ovarian, uterine or mammary cancer * use of testicular or epididymal sperm * other protocol defined exclusion criteria could apply

Keywords: espart reproductive techniques, assisted infertility pergoveris® gonal-f®
screening for coronary artery disease after mediastinal irradiation

Conditions: Radiation Therapy; Coronary Artery Disease; Hodgkin Lymphoma

Summary: survivors of hodgkin lymphoma (hl) are known to have an increased risk of developing late treatment sequelae such as cardiovascular events due to coronary artery disease. at present no active screening is performed in these patients since it is not known whether screening and subsequent treatment by means of revascularization is effective in reducing the risk of cardiovascular events in symptomatic individuals. in the trial the efficacy and therapeutic consequences of screening for coronary artery diasease by multi-slice ct (msct) among asymptomatic hl survivors will be evaluated.

objectives: 1. to determine whether msct as a screening method of hl survivors treated with mediastinal irradiation accurately identifies asymptomatic significant coronary artery disease. 2. to establish the prevelance of coronary abnormalities in hl survivors treated with mediastinal irradiation 3. to determine the frequency and type of intervention 4. to evaluate the acceptance of screening and asses quality of life among hl survivors. study polulation: 50 long term survivors of hl, previously treatef with mediastinal irradiation without present evidence of cardiovascular disease intervention: ct-coronary angiography and calcium score, to be performed as a screening method (to indicate further diagnostic treatent procedures)

Eligibility criteria:
inclusion criteria: * history of hodgkin lymphoma(all stages) with at least 10 disease free survival * current age between 35-60 * mediastinal irradiation as part of hl treatment, radiotherapy data available * written informed consent exclusion criteria: * current treatment for cardiovascualr disease, excelt hypertension hypercholesterolemia or cardiac murmurs * known or sypmtomatic heart failure * impaired kidney function (cockcroft \< 55 ml/min) * known contrast allergy * invasive angiography in past 2 years * presence of life threatening disorder

Keywords: radiation therapy coronary artery disease hodgkin lymphoma
care courses for mild head injury patients

Conditions: Mild Head Injury

Summary: background / rationale at. the mild head injury. in france, the incidence of head injuries is estimated at 100,000 per year in france. 80% of mild head trauma. this is a pattern of frequent use of the health system. the reason for consultation, benign appearance, present a significant risk of complication. in 15 to 25% of the evolution of head injury is unfavorable. disorders of attention, memory disorders, psychiatric events and mood changes may occur. these symptoms are grouped into a syndrome, post-concussion syndrome. the post-concussion syndrome: it affects approximately 20,000 people per year in france. this is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to dsm-iv (diagnostic and statistical manual). symptoms may persist for more than 3 months after head injury. this syndrome is responsible for suffering, personal and professional sound and quality of life of patients. it is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. it gives rise to many financial implications with compensation requirements and expertise consultations. intention of work in a recent study by a team of neuropsychologists kremlin bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.

methodology : design: cohort study single-center prospective observational. recruitment period: 15/11/2014 to 15/12/2014 approximately (50 records necessary). then follow a month is required. either theoretical study end: 01/15/2015. acquisition of data: pre inclusion of patients in the study by sorting cae emergency department on the following host pattern: traumatic brain injury with loss of consciousness, traumatic brain injury without loss of consciousness, with loss of consciousness discomfort, discomfort without a loss of consciousness peripheral vascular accident pva. collection address, telephone number and an e-mail address of the patient (after delivery of a newsletter). call the patient and questionnaire submitted between 0 and j15 and j15 and j30 between.

Eligibility criteria:
before inclusion criteria: * traumatic brain injury * head injury with loss of consciousness * cranio facial trauma * peripheral vascular accident * discomfort * discomfort with loss of consciousness before inclusion criteria: * head trauma notion and at least one of the following criteria: * loss of consciousness \<30 minutes * glasgow between 13 and 15 * post traumatic amnesia \<24h * altered mental status at the time of the accident (dizziness, confusion, disorientation) * transient focal neurological deficit exclusion criteria: * \<18 * major trust * context of acute alcohol (\> 3 glasses) or toxic taking (drugs) * not understanding or communication * patient refusal
assessment of short-term effect of l-citrulline on endothelial function and vasodilation in known cad patients

Conditions: Vascular Disease

Summary: the purpose of this study is to determine the efficacy of oral l-citrulline on endothelial function and vasodilation in patients with coronary artery disease(cad) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. the brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. then the brachial artery diameter (as an estimation of fmd) was measured and recorded. after 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of nmd) was measured. after 15 days treatment with the l-citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done. improvement of fmd to nmd ratio (before l-citrulline prescription) to fmd to nmd ratio (after l-citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

Eligibility criteria:
inclusion criteria: * history of documented cad; flow mediated dilation to nitroglycerin dependent vasodilation (fmd/nmd)ratio less than 1 exclusion criteria: * no documented cad; flow mediated dilation to nitroglycerin dependent vasodilation (fmd/nmd)ratio equal /more than 1

Keywords: vascular disease endothelial function l-citrulline
clinical evaluation of freeo2 (version 4) in all patients receiving oxygen

Conditions: Respiratory Disease; Respiratory Failure; COPD Exacerbation; Asthma; Pneumonia

Summary: evaluation of automatic titration of oxygen with a new version of freeo2 (v4)

in the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (freeo2 device) with a prototype develop in our lab in collaboration with laval university. in this study, we want to evaluate the new version of the freeo2 device (v4)

Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * patient receiving oxygen between 1 to 6 lpm for medical pathology * admitted to a medical service for less than 72 hours (emergency room not included) exclusion criteria: * unreliable spo2 signal * emergency or intensive care hospitalization * absence of niv or intubation criteria at baseline * sleep apnea not paired * long-term oxygen therapy * active delirium and cognitive impairment preventing informed consent
a gardening program to assess unhealthy lifestyle contributions to summer weight gain in children

Conditions: Overweight

Summary: the purpose of this study is to examine the impact of a summer gardening program on summer weight gain in overweight middle school children.

in the past two decades, the combination of unhealthy eating and physical inactivity has contributed to doubling the percentage of children and adolescents who are overweight. childhood overweight is known to lead to increased risk for several morbidities in childhood and into adulthood including type 2 diabetes mellitus, hypertension, and cardiovascular disease. recent data shows that children experience greater and more variable increases in bmi during summer vacation than during the school year. our project aims to determine whether summer weight gain is due to a decrease in physical activity or an increase in daily calories as well as to assess the effectiveness of a summer gardening program on preventing summer body fat gain. we will randomize 40 middle-school children who are above the 95th percentile for bmi into either a control or intervention group. the control group will receive the standard of care and the intervention group will participate in garden fit, a summer gardening project at troy gardens in madison, wi. as part of garden fit, subjects will participate in weeding, landscaping and trail maintenance activities as well as preparing meals twice a week with fresh foods from the gardens. we hypothesize that summer weight gain is due to a worsening of healthy lifestyle (decreased physical activity from school to summer and increased eating of high calorie snacks). additionally, we hypothesize that an intervention that increases physical activity and provides increased access to healthy foods will reduce the trend of summer bmi increase.

Eligibility criteria:
inclusion criteria: * middle school child aged 10-14 years * bmi at or above the 85th percentile for height and weight * able to attend 8-week summer program and clinic visits exclusion criteria: * any known metabolic disorder * any physical disability that prevents or limits physical activity * claustrophobia

Keywords: childhood overweight gardening summer weight gain
pharmacokinetics of ceftaroline in normal and obese subjects

Conditions: Drug Safety

Summary: the purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.

this study is planned to be a phase i, open-label, single period, single-dose pharmacokinetic study conducted in 32 healthy adult male and female subjects. adult subjects will be recruited and assigned to one of four groups based on their body mass index and total body weight. subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion. serial blood and urine samples will be collected over the next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy testing (female subjects only), monitoring of adverse events, and recording of concomitant medications.

Eligibility criteria:
inclusion criteria: * healthy adult subjects * nonsmokers within the last 1 year * body mass index and total body weight within specific categories exclusion criteria: * history of significant hypersensitivity reaction or intolerance to ceftaroline or beta-lactam agents or heparin * aspartate or alanine aminotransferase \>3 times the upper limit of normal * estimated creatinine clearance \ 1.5 mg/dl * female subjects who are pregnant or breast feeding * history of alcohol or substance abuse or dependence within the last 1 year * use of prescription or nonprescription drugs within last 7 to 14 days * participations in a clinical trials within last 30 days * donated blood (\>500 ml) within the last 56 days

Keywords: ceftaroline pharmacokinetics obesity
dual mobility cup in total hip arthroplasty preventing dislocation in patients at risk

Conditions: Femoral Neck Fracture; Osteoarthritis

Summary: retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between january 2009 and june 2012 at sundsvall hospital. hypothesis: the dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.

retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between january 2009 and june 2012 at sundsvall hospital. indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture. patients are followed recording complications, reoperations, functional outcome (harris hip score and eq5d) in june 2012.

Eligibility criteria:
inclusion criteria: * operated with an cemented dual mobility socket at sundsvall hospital

Keywords: hip surgery dual mobility cup dislocation total hip arthroplasty
sleep disturbances as a risk factor in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: this study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.


Eligibility criteria:
inclusion criteria: * mild to moderate ckd * healthy controls age and gender matched to ckd subjects * regular bedtimes of at least 6h/night, sedentary lifestyle exclusion criteria: * diabetes * current or previous dialysis for more than 1 month * uncontrolled hypertension * heart failure * liver disease * hiv * hemoglobin \< 10.5 g/dl * treatment with eprocrit, epogen, or aranesp * bone or organ transplant, * use of immunosuppressive drugs within past 6 months * current oral contraceptive use * current pregnancy * chemotherapy for malignancy within past 2 years

Keywords: chronic kidney disease poor sleep ckd kidney failure
dual antiplatelet therapy adherence with reminder app usage

Conditions: Aneurysm Cerebral (Unruptured)

Summary: the purpose of this study is to evaluate dual antiplatelet therapy adherence in patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. patients will be randomized on a 1:1 basis to either a medication reminder app group or a control group, with patients in both groups receiving the standard of care. the app in question, endovascular neurosurgery, is available on the app store. the app does not collect user data and has not been officially deemed hipaa compliant. the only data inputted into the app are the patient's procedure date and the antiplatelet medications the patient has been prescribed. the app does not possess sensitive patient data. patients will input the time notifications will be sent and the app will be available in both spanish and english. the investigators will be assessing medication adherence via the adherence barriers questionnaire.

this will be a randomized control trial, with patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. informed consent will be obtained from participating patients. patients will be assigned to either the app group or the control group. the particular stent-based therapy, either flow-diverter devices (fdd) placement or stent-assisted coiling, will be chosen for each patient by the clinical team. during the study consultation, the app group will have the app installed on their smart phones and will be trained in its usage. thromboelastography (teg) and aspirin inhibition percentage will be determined for each patient following the procedure. patients with teg less than 60% will have dual antiplatelet therapy (dapt\] changed from 81 mg aspirin and 75 mg clopidogrel to 81 mg aspirin and 10 mg prasugrel. patients with aspirin inhibition percentages of less than 20% will have their aspirin doses increased to 325 mg. medication compliance of all participants will be assessed on the day of the procedure via a medication compliance questionnaire. the same questionnaire will be administered during follow-up appointments 2-4 weeks and 6 months post-procedure.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * must speak either english or spanish fluently * physically able to come to the research site location. * elective stent-based procedures for unruptured cervical, and intracranial, intradural aneurysms * endovascular therapy must be deemed appropriate by clinical team. exclusion criteria: * presence of aneurysm where treatment plan does not include dual anti-platelet therapy * presence of comorbidities that preclude the possibility of treatment. * presence of contraindications to dual antiplatelet therapy. * presence of certain vessel anatomical characteristics. * lack of iphone.

Keywords: aneurysm unruptured antiplatelet adherence reminder medication dapt
long-term effects of coronavirus disease 2019 on the cardiovascular system: cv covid-19 registry

Conditions: Sars-CoV2; Covid19; Cardiovascular Diseases; Cardiovascular Risk Factor

Summary: patients presenting with the coronavirus-2019 disease (covid-19) have a very high risk of cardiovascular adverse events, including death from cardiovascular causes. unfortunately, there are no reliable statistics on the frequency and severity of these complications during the index hospitalization. moreover, the long-term cardiovascular outcomes of these patients are entirely unknown. the investigators aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for sars-cov-2 and determine their long-term cardiovascular outcomes.

coronavirus disease 2019 (covid-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus-2 (sars-cov-2) that has posed a significant threat to global health. angiotensin-converting enzyme 2 (ace2) has been identified as a functional receptor for coronaviruses, including sars-cov and sars-cov-2. sars-cov-2 infection is triggered by the binding of the virus spike protein to ace2, which is highly expressed in the heart and lungs. there are multiple connections between covid-19 and the cardiovascular system. first, covid-19 patients and pre-existing cardiovascular disease are at increased risk for serious adverse events. second, the infection has been associated with multiple direct and indirect cardiovascular complications, such as acute myocardial injury, myocarditis, arrhythmias, and thromboembolism. third, the therapies under investigation for covid-19 may have cardiovascular side effects. there is clear scientific evidence linking covid-19 with cardiac damage, with a subsequent impact on mortality from any cause. the reasons for increased mortality in patients with covid-19 and heart damage are not fully understood. the long-term prognosis for patients who have had covid-19 is entirely unknown. previous experience with sars-cov suggests that both the underlying disease and its treatment could be associated with a worse cardiovascular prognosis. in a study of 25 survivors of sars-cov, at 12 years of follow-up, altered lipid metabolism was found. similarly, viral diseases such as influenza a are associated with increased cardiovascular mortality after infection. for the reasons stated above, the investigators consider that patients who presented covid-19 have a high risk of long-term cardiovascular adverse events such as cardiac death, myocardial infarction, stroke, heart failure, and cardiac arrhythmias. to test this hypothesis, the investigators aimed to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for sars-cov-2 and determine their long-term cardiovascular outcomes.

Eligibility criteria:
inclusion criteria: * ≥ 18 years exclusion criteria: * none

Keywords: sars-cov2 covid19 cardiovascular death cardiovascular diseases cardiovascular risk factor