Kornimate/medical-research-clean huggingface dataset:
the restore-sirio randomized controlled trial

Conditions: Percutaneous Coronary Intervention; No-reflow Phenomen; Acute ST-segment Elevation Myocardial Infarction

Summary: primary percutaneous coronary intervention (ppci) is the preferred reperfusion strategy for treating acute st-segment elevation myocardial infarction (stemi). the main goals are to restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as early as possible. no-reflow is the term used to describe inadequate myocardial perfusion of a given coronary segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels and it refers to the high resistance of microvascular blood flow encountered during opening of the infarct-related coronary artery. despite optimal evidence-based ppci, myocardial no-reflow can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. several strategies have been tested to revert the no-reflow including the use of thrombectomy, glycoprotein iib/iiia inhibitors and the use of intracoronary adenosine, but none has been demonstrated to effectively counteract the phenomenon. the trial aims to show the effect of the administration of intracoronary adrenalin on myocardial reperfusion assessed by magnetic resonance in patients with stemi undergoing pci and with persistent coronary angiographic the thrombolysis in myocardial infarction (timi) 0-1 flow during the interventional procedure after failure of standard therapy.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * presentation within 6-7 h of symptom onset of stemi * eligibility for reperfusion by primary-pci * timi flow grade 0-1 during the interventional procedure in the culprit vessel after the initial opening of the vessel with the coronary wire exclusion criteria: * evident clinical arrhythmias (ventricular tachycardia/ventricular fibrillation) * evidence of coronary dissection or spasm * parkinson symptoms * closed angle glaucoma * thyroid disorders * known history to hypersensitivity to the drug * pregnancy * stage 4 or 5 ckd (egfr \<30 ml/min/1.73 m2)
hemodynamic effects of stored blood transfusion in intensive care patients

Conditions: Pulmonary Hypertension

Summary: transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. the investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.


Eligibility criteria:
inclusion criteria: 1. the patient has a pulmonary artery catheter in place 2. transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy 3. the patient has an arterial catheter exclusion criteria: 1. age \< 18 years 2. clinical prediction that the patient will not survive at least 48 hours 3. acute bleeding: \> 2 units of packed red blood cells/hour 4. vasopressor use: noradrenalin \> 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study 5. therapy with inhaled no, inhaled prostacyclin, or phosphodiesterase-5-inhibitors 6. sepsis

Keywords: transfusion pulmonary hypertension intensive care medicine
ph ii bevacizumab + etoposide for pts w recurrent mg

Conditions: Glioblastoma; Gliosarcoma

Summary: primary objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with etoposide + bevacizumab. secondary objectives to evaluate safety \& tolerability of etoposide + bevacizumab among patients with recurrent malignant glioma (rmg). to evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with etoposide + bevacizumab.

exploratory, single-arm, ph ii study designed to assess anti-tumor activity of combinatorial regimen consisting of etoposide + bevacizumab among patients with rmg. primary endpoint of study is probability of progression-free survival at 6 months. important secondary objective is to further assess safety of etoposide \& bevacizumab for patients with recurrent malignant glioma. if study demonstrates that combinatorial regimen of etoposide + bevacizumab is associated with encouraging anti-tumor activity among patients with rmg, further assessment of regimen in additional phase ii \& possibly phase iii studies, will be considered.

Eligibility criteria:
inclusion criteria: * pts have confirmed diagnosis of recurrent/progressive who gr iii \& iv mg * age \>18 rs * interval of \>4 wks since prior surgery * interval of \>4 wks since prior xrt/chemo, unless there is unequivocal evidence of progressive disease \& pts have recovered from all anticipated toxicity of most recent therapy; * karnofsky performance status score \>60 * hematocrit \>29 percent, anc \>1,500 cells/microliter, platelets \>100,000 cells/microliter * serum creatinine \<1.5 mg/dl, bun \<25 mg/dl, serum sgot \& bilirubin \<1.5 x uln * for pts on corticosteroids, they have been on astable dose for 1wk prior to entry * signed informed consent approved by irb prior to pt entry * if sexually active, pts must agree to take contraceptive measures for duration of treatments. exclusion criteria: * prior therapy w either bevacizumab/etoposide * \>3 prior recurrences * pregnancy/breast feeding * co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil * evidence of cns hemorrhage on baseline mri on ct scan * pts who require therapeutic anti-coagulation * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring iv antibiotics \& psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state * pts w another primary malignancy that has required treatment \<past year

Keywords: glioblastoma gliosarcoma gbm mg brain tumor bevacizumab avastin etoposide vp-16 etopophos toposar vepesid glioblastoma multiforme recurrent gbm anaplastic astrocytoma malignant glioma
accuracy of lactate meter in gsdia

Conditions: Glycogen Storage Disease Type Ia

Summary: the goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the accu chek guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

the goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the accu chek guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

Eligibility criteria:
inclusion criteria: * patients with diagnosed/confirmed (by liver biopsy or genetic testing) glycogen storage disease type ia (icd 10 code: e74.01). * connecticut children's emergency department visit and/or admission to connecticut children's during time study is active * for pediatric participants: ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document * for adults: ability to understand and the willingness to sign a written informed consent exclusion criteria: * patients with glycogen storage disease unspecified 74.00, or ib * patients not meeting inclusion criteria

Keywords: glycogen storage disease type ia blood lactate glycogen storage disease ia blood glucose gsd i gsdia blood glucose accu chek glucometer lactate plus
a study of the effectiveness of pomegranate pills in men with prostate cancer before prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare the effects of pomegranate polyphenol pills (pom-x) and a placebo (sugar pill) on prostatic oxidative stress. the placebo is a pill that looks like the pom-x pill but does not have an active ingredient.

subjects will receive pom-x or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. biomarkers in the blood, urine, and prostate tissue will be assessed.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs. 2. radical prostatectomy scheduled at duke or johns hopkins. 3. initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review. 4. age ≥ 18 years of age. 5. willingness and ability to sign an informed consent document. 6. agreement with complete abstinence from other commercially available pomegranate products during the course of the study. 7. no prior allergy to pomegranate dietary agents. 8. no significant medical or psychiatric condition that would make the patient a poor protocol candidate. 9. the patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin e, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study. 10. the patient is not taking lhrh agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy. 11. patient has not received experimental medications within the past six months. exclusion criteria: 1. significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate. 2. concomitant or antecedent hormonal therapy. 3. known allergy to pomegranate juice. 4. subjects unable or unwilling to comply with protocol requirements. 5. evidence of metastatic disease on physical examination or on ct or bone scan. 6. use of finasteride, dutasteride at any point during the study. 7. clinically significant abnormal laboratory value \>2x the upper limit of normal (2xuln).
evaluation of the use of the renuvion apr system in the labia

Conditions: Labia Enlarged; Labium; Hypertrophy

Summary: labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.

while traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with rf energy has shown minimal complication rates with high patient satisfaction. this study aims to evaluate the use of the renuvion apr system for use as a minimally invasive alternative to surgical labiaplasty.

Eligibility criteria:
inclusion criteria: * female subjects, ages 35 - 70 years old. * asa physical status classification system class i and class ii subjects. * labial protrusion class ii and class iii (motakef scale)12. * females who do not desire traditional invasive surgery. * understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. * absence of physical conditions unacceptable to the investigator. * females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. * willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. * willing to release rights for the use of study photos, including in publication. * able to read, understand, sign, and date the informed consent. exclusion criteria: * labial protrusion class i (motakef scale). * subjects presenting with asa physical status classification system classes iii or higher. * pregnant, lactating, or plans to become pregnant during study participation. * known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). * previous treatment in the study treatment area. * active systemic or local skin disease that may alter wound healing. * significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. * known susceptibility to keloid formation or hypertrophic scarring. * cancerous or pre-cancerous lesions in the area to be treated. * possesses a surgically implanted electronic device (i.e., pacemaker). * serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. * participation in any other investigational study within 30 days prior to consent and throughout study participation. * subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
assessing the immediate increase in serum ferritin after oral iron doses: an experimental study in iron-deficient women

Conditions: Iron Deficiency Without Anemia

Summary: serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. however, oral iron doses can acutely elevate sf levels, potentially biasing assessments of iron stores during supplementation. this study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin following the administration of a daily iron dose for two months.


Eligibility criteria:
inclusion criteria: * low iron stores (sf levels \< 30 µg/l), * no anemia (hb \> 120 g/l) * no inflammation (crp \< 5 mg/l) * 18 to 45 years old. * body weight \<70 kg * normal body mass index (18.5-26.5 kg/m2) exclusion criteria: * any chronic or acute disease * consumption of mineral and vitamin supplements since screening and over the study period * blood transfusion, blood donation or significant blood loss over the past 4 months, * pregnant or breastfeeding, * continuous/long-term use of medication during the whole studies (except for contraceptives) * therapeutic iron infusion over the past 6 months, * known hypersensitivity or allergy to iron supplements, * intention to become pregnant over the course of the study

Keywords: serum ferritin oral iron supplementation
prevention of ovarian function damage by a gnrh analogue during chemotherapy in hodgkin lymphoma patients

Conditions: Hodgkin Lymphoma; Hodgkin Disease

Summary: chemotherapy as one of the basic modalities of oncology treatment often leaves permanent implications and among the most common is infertility as a result of irreversible gonadal damage. this project sets the primary target to verify the protective effect gnrh analogues administration to protect ovarian tissue during three different regimens of chemotherapy in patients with hodgkin disease (hd) in reproductive age.

during the first two years of the project duration the curative anti-tumorous combined treatment in fertile patients with hodgkin disease diagnosis will be carried out. patients are to be divided into three groups according to the clinical stage of the disease and treated with the three types of the chemotherapeutic regimens comparable with toxicity. patients will receive gnrh analogues during the chemotherapy for the gonadal protection by the mechanism of foliculogenesis inhibition in pre-pubertal stage. at the end of successful treatment according to stated criteria the ovarian function of every patient will be repeatedly evaluated in relation with toxicity of chemotherapy used. these ovarian function results will be compared with control group of patients without gonadal protection, which reproductive functions will be evaluated according the same method.

Eligibility criteria:
inclusion criteria: * diagnosis of hodgkin lymphoma * fsh and lh levels in peripheral blood below 15 iu/l * fertile age from 18 to 35 years * female * presence of both ovaries exclusion criteria: * ovarian tumours or cysts over 40 mm in diameter

Keywords: hodgkin lymphoma hodgkin disease
evaluation of the "pupillary pain index" in neurological prognosis after cardiac arrest

Conditions: Cardiac Arrest; Post-Anoxic Coma; Anoxic Brain Injury

Summary: two-thirds of patients admitted to the intensive care unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome. this study will evaluate the pupillary pain index (ppi) in the neurological prognosis after cardiac arrest. the ppi is determined by recording of pupillary dilatation with a videopupillometer after a calibrated and incremented nociceptive stimulus on a cutaneous metamere.

cardiorespiratory arrest is associated with high mortality and morbidity rates. the direct consequence of a cardio-circulatory arrest is the absence of blood flow allowing oxygenation of the organs and consequently formation of ischemic lesions. anoxic cerebral lesions are common in the aftermath of a cardiac arrest and often lead to the death of patients when active therapies are stopped after a multimodal prognostication that indicates that a poor outcome is very likely. it is of paramount importance to optimize the sensitivity of the prognostication strategy in detecting good neurological outcome. a multimodal approach to the prognostic assessment is essential, and must include at least clinical examination, electrophysiology exploration (electroencephalography and/or evoked potentials) and biomarker analysis. although the most reliable predictors did not give false positives in most studies, none of them, considered individually, can establish an unfavorable prognosis with an absolute degree of certitude. for these reasons it is interesting to evaluate new prognostication tools. the videopupillometry allows precise, reproducible and repeated measurement of changes in pupil diameter in response to a painful or a luminous stimulus. pupillary pain reflex analysis is usually used to assess the degree of analgesia in a non-communicative patient during general anesthesia and neuromuscular blockade. the ppi score is determined at the bedside by recording pupillary dilatation after a calibrated and incremented nociceptive stimulus (electrical current between 5 and 60ma) applied to a skin metamere with two electrodes. automated pupillometry measurement has been recently developed to help support prognostication, with a quantitative pupillary light reflex measurement. the aim of this study is to evaluate the pupillary pain index in the neurological prognosis after a cardiac arrest by correlating the ppi at 48h from the patient's arrival to the cpc score at 3 months.

Eligibility criteria:
inclusion criteria: * admission to the icu after cardiac arrest * age \> 18 years * presenting a glasgow score of \<8 at admission exclusion criteria: * pregnancy * ocular pathology making pupillometry impossible. * patient under guardianship or curatorship

Keywords: pupillometry pupillary pain index brain ischemia heart arrest neuroprognostication
light treatment for sleep/wake disturbances in alzheimer's disease

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

1. efficacy: up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy. 2. predictors of response: we expect the primary predictor of treatment response will be initial mmse score. secondary predictors include baseline sleep/wake and circadian parameters and age. 3. effectiveness: bright light treatment will be more effective than dim light in improving quality of life. 4. an understanding of some of the genetic markers of memory and/or sleep problems.

Eligibility criteria:
inclusion criteria:alzheimer's disease patients: * stanford alzheimer's disease core center member or potential member, with diagnostic criteria met for probable ad, living with caregiver willing to participate in the protocol * non-institutionalized caregivers: * living in home of ad patient and willing to participate in protocol exclusion criteria:alzheimer's disease patients: * history of manic or bipolar disorder * prior bright light treatment * irregular or non-24 hour sleep/wake cycle * positive result on multi-staged rls/plmd * medical/ophthalmologic exclusions * rdi \>20 on overnight edentrace® recording caregivers: * history of manic or bipolar disorder * medical/ophthalmologic exclusions
effect of furlow palatoplasty with buccal myomucosal flap on the speech development

Conditions: Cleft Palate

Summary: about 20 patient will be collected according to the eligibility criteria and grouped into group i : 10 patients were treated with furlow with buccinators flap group ii : 10 patients were treated with 2 flap palatoplasty all patients will be examined by an expert phoniatrician by recording of speech samples in arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. the records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors


Eligibility criteria:
inclusion criteria: * 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic. * lip and palate repair performed by one craniofacial surgeon exclusion criteria: * patients with syndromic cleft lip. * redu cases * bilateral cleft lip * patient older 5years or younger 3 years. * associated cardiac anomalies. * any systemic condition
non-invasive brain stimulation to enhance treatment of dysarthria post-stroke

Conditions: Dysarthria; Stroke

Summary: the proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.

a total of 60 cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tdcs and sham groups. all the participants will receive individualized speech therapy based on the results of their speech assessment. for the real tdcs group, an anodal high-definition tdcs of 2 milliamperes (ma) lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (sm1) during speech therapy. for the sham tdcs group, stimulation given during speech therapy will only last for 30 seconds in order to cause a similar sensation on the scalp as the real stimulation group. there will be a total of 10 daily sessions during a 2-week period.

Eligibility criteria:
inclusion criteria: * cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke. * both acute and chronic stroke participants will be recruited. exclusion criteria: * individuals with a personal or family history of epilepsy or seizures; * individuals with a history of another neurological condition (which is not a result from the initial stroke); * individuals with a history of speech disorders, voice disorders, oro-maxillo-facial surgery involving the tongue and/or lip, severe cognitive impairment, severe aphasia; * in an unstable or serious medical condition; * have a cardiac implant metallic foreign body implant and/or any medications that lower neural thresholds (e.g. antidepressants, neuroleptic agents, etc.).