Kornimate/medical-research-clean huggingface dataset:
a study of apatinib in recurrent or recurrent high-grade glioma

Conditions: Glioma

Summary: the purpose of this study is to determine the effectiveness and safety of apatinib for patients with recurrent or recurrent high-grade glioma.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years old, male or female; * 2. the histologically confirmed first-line after the surgical resection of the whoiii / iv glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of whoiii / iv glioma; * 3. ecog score: 0-2 points; * 4. the main organs function properly, that is, meet the following criteria:(1) blood test:a. hgb≥90 g / l;b. anc ≧ 1.5 × 109 / l;c. plt ≥80 × 109 / l;(2) biochemical examination:a. alb≥30g / l;b. alt and ast \<2\*uln;c. tbil≤1.5\*uln; d. plasma cr≤1.5 \*uln; * 5. no history of mental illness in patients; * 6. thyroid function is normal; * 7. subjects volunteered to join the study, signed informed consent, good compliance, with follow-up. exclusion criteria: * 1. pregnant or lactating women; * 2. hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure\> 150 mmhg and diastolic blood pressure\> 100 mmhg); those with grade i or greater myocardial ischemia or myocardial infarction, arrhythmia (including qt period ≥ 440 ms) and grade i cardiac insufficiency, grading reference nci-ctc ae 3.0; * 3. unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption; * 4. have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding; * 5. have mental illness, or history of substance abuse; * 6. patients treated with anticoagulants or vitamin k antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an international normalized ratio (inr) ≤1.5 farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 u daily for adults), or low dose aspirin (80 to 100 mg daily); * 7. researchers think it is not suitable for inclusion. all patients underwent ct or mri of the head one week prior to the start of the protocol, with intracranial hemorrhage.
comparison of enteral versus intravenous potassium supplementation

Conditions: Acute Hypokalemia

Summary: null hypothesis: there is no difference in the efficacy of ivpr and epr during an episode of hypokalemia. alternate hypothesis: there is a mean difference of 15% in serum potassium levels between the two groups. objective: to compare the efficacy epr and ivpr for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/l after potassium replacement)

hypokalemia is frequently encountered in daily clinical practices of cardiac intensive care unit (cicu). the development of ventricular arrhythmias related to hypokalemia can lead to sudden cardiac death. thus, potassium replacement therapy is the cornerstone therapy for hypokalemia.though intravenous potassium replacement (ivpr) in hypokalemia is the preferred route in most intensive care settings, it is associated with known safety risks. inappropriately administered, ivpr can lead to arrhythmias, cardiac arrest and death 1, 7, 8. given these risks, ivpr is considered a "high-alert medication" by institute of safe medication practice. enteral potassium replacement (epr), with its superior safety profile may be a better alternative to ivpr. a retrospective review showed that the efficacy of epr was comparable to ivpr in pediatric patients after congenital heart disease. the investigators seek to explore this comparison between epr and ivpr in a randomized prospective trial

Eligibility criteria:
inclusion criteria: * • all patients undergoing surgical repair/palliation of congenital heart lesion at the aga khan university hospital and admitted to the pediatric cardiac intensive care unit (pcicu) for post-operative management. * serum potassium levels (\<4.39 meq/l) immediate post operatively * patients/parents willing to participate in the study * have a central venous line for ivpr and an arterial line for monitoring and blood draws. * able to tolerate oral or nasogastric administration of medication for epr. exclusion criteria: * • patients with acute renal failure (estimated clearance creatinine - eccr \<50) * patients with paralytic ileus, necrotizing enterocolitis or gi bleeding. * patients with nausea, vomiting or diarrhea prior to randomization. patients will not be excluded if these symptoms develop during the trial after the initial recruitment. based on clinical decision the route of potassium supplementation may be changed if these symptoms. intention to treat analysis will be used for the primary end point. * patient with symptomatic hypokalemia (manifested as a rhythm disturbances). * initial serum k level (post surgery) \< 2.0 meq

Keywords: hypokalemia intravenous enteral post-cardiac surgery
arteriovenous fistula tissue bank for pre- and post-fistula placement specimens

Conditions: Kidney Failure, Chronic

Summary: this project will bank sera, dna and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

hemodialysis patients utilizing an arteriovenous fistula (avf) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. because of this, a great focus has been on placing avf in all patients undergoing hemodialysis. while avf are relatively simple to place from a surgical standpoint, 30-60% of avf will not mature adequately to be used for hemodialysis. in order to be utilized for hemodialysis, the blood flow in the vein used to create the avf will need to increase by over 100 fold. in order to do so, the vein will need to dilate by more than 150%. avf which fail to mature do not dilate, and the major histologic finding in these avf has been neointimal hyperplasia. the factors (both circulating and tissue) which contribute to avf maturation or failure are poorly understood, and investigations in this area are limited. current studies in the literature have either described pre-avf vein characteristics, or have looked at serum or tissue specimens following avf failure. to date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. this project will bank sera, dna and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Eligibility criteria:
inclusion criteria: * age 19 years of age or greater * arteriovenous fistula placement for hemodialysis access scheduled within 30 days exclusion criteria: * incompetent to provide informed consent

Keywords: hemodialysis vascular access arteriovenous fistula
cardiac involvement in patients with duchenne/becker muscular dystrophy

Conditions: Duchenne / Becker Muscular Dystrophy

Summary: this study evaluates the function of the heart in young patients with muscular dystrophy type duchenne or becker. participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.

muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. the usual method to evaluate the heart is echocardiography, emphasizing few parameters. cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. in this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.

Eligibility criteria:
inclusion criteria: * boys aged 8 to 18 years with dmd/bmd confirmed genetically or by muscle biopsy * informed consent exclusion criteria: * other clinically significant concomitant disease states (e.g., renal failure) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers, * inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and cmr) * mr-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging
trim tots pre-school obesity prevention programme

Conditions: Overweight; Obesity

Summary: randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.


Eligibility criteria:
inclusion criteria: * children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.

Keywords: obesity overweight bmi ifestyle diet nutrition physical activity pre-school toddlers children prevention of overweight and obesity in pre-school children
comparing primary with secondary repair of based on electrodiagnostic assessment and clinical examination

Conditions: Peripheral Nerve Injury

Summary: the purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.

treatment of injuries to major nerve trunks in the hand and upper extremity remains a major and challenging reconstructive problem. our goal was to compare primary versus secondary repair of median and\\or ulnar nerve by electrodiagnostic assessment and clinical examination.

Eligibility criteria:
inclusion criteria: * patients with confirmed clean transection injury between shoulder and wrist exclusion criteria: * crush injuries

Keywords: ulna median repair primary
biomarkers and volumetric capnography in bpd

Conditions: Bronchopulmonary Dysplasia

Summary: the purpose of this study is to assess the association of biomarkers on day 7 of life with the development of bronchopulmonary dysplasia in very preterm infants. additionally a short lung function test at 36 weeks postmenstrual age (pma) will be performed to investigate whether certain capnographic indices are able to reflect the degree of lung disease. protocol was amended (under others: additional enrollment of 70 subjects).

this is a two-centre prospective cohort study in very preterm infants born below 32 0/7 weeks pma and hospitalised in the neonatal intensive care units at the university children's hospital basel and the inselspital berne during two years. after informed consent a sample of 0.5 ml ethylenediaminetetraacetic acid (edta) full blood will be taken on day 7 of life (+/- 2 days) during routine blood sampling. the biomarkers which are planned to measure include the c-terminal portion of the proendothelin-1 precursor (ct-proendothelin (proet)-1) and other plasma biomarkers of respiratory distress. at 36 weeks pma, lung function testing will be performed during quiet unsedated sleep in supine position approximately 30 minutes post feeding. after placement of a facemask, tidal breathing will be recorded at the bedside using a commercially available ultrasonic flow meter (spiroson, exhalyzer d, ecomedics, ch) according to american thoracic society (ats) and european respiratory society (ers) standards of infant lung function testing. different capnographic indices will be calculated to investigate if they reflect the degree of lung disease at 36 weeks pma.

Eligibility criteria:
inclusion criteria: * parental consent, born below 32 weeks pma exclusion criteria: * no parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)

Keywords: bronchopulmonary dysplasia, preterm infant
migraine and body composition

Conditions: Migraine With and Without Aura; Chronic Migraine; Healthy Controls

Summary: this research is being done to look at the association between migraine and obesity.

research into the role of inflammatory markers and other obesity related proteins and chemicals may help us understand migraine and lead to new treatment.

Eligibility criteria:
inclusion criteria: * premenopausal women (18-55 years) * normal weight (bmi = 18.5 - 24.9) or obese (bmi ≥ 30) * diagnosis of episodic or chronic migraine or pain free control exclusion criteria: * evidence of pain disorder other than migraine (e.g. irritable bowel syndrome) * chronic conditions known to alter risk or pattern of migraine (e.g. hypothyroidism) * illnesses that may affect adipokine levels (e.g. diabetes) * clinically relevant abnormal glucose/cholesterol levels * pregnant women * potential participants who are unable to undergo mri based on standard screening questionnaire (those with brain aneurysm or surgical clips, certain types of artificial heart valves, heart defibrillator or pacemaker, cochlear implants, eye implants, blood vessel coil, recently placed artificial joints, certain types of vascular stents, history of bullets, pellets, bbs, history of any implanted metal or device or who have worked with sheet metal in the past)

Keywords: migraine episodic migraine chronic migraine obesity non-obese
vnrx-5133 with vnrx-5022 in subjects with varying degrees of renal impairment

Conditions: Pharmacokinetics

Summary: this is a multi-center, open-label, pk and safety study of vnrx-5133 and vnrx-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.


Eligibility criteria:
inclusion criteria: * bmi: 18.5-40.0 kg/m2 with a minimum weight of 45 kg * able and willing to abstain from alcohol from 48 h before admission until the follow-up visit * suitable veins for cannulation/multiple venipunctures, as assessed by the investigator at screening * males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration. * laboratory values meeting defined entry criteria subjects with normal renal function (group 1) must also meet the following criteria: * match to one or more subjects with renal impairment by gender, age, and weight subjects with renal impairment (groups 2-5) must also meet the following criteria: * stable, pre-existing renal impairment. exclusion criteria: * employee of the study site, contract research organization (cro) or the ind sponsor * female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration * male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration * use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent) * the subject has a congenital or acquired immunodeficiency syndrome * screening or day -1, clinically significant abnormal ecg values * active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted * history of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an emergency department * known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug * history of donation of more than 450 ml of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug * plasma or platelet donation within 7 days of dosing and throughout the study * consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year * oral temperature \>38.5˚c or acute illness on day -1 * previous participation in a study of vnrx-5133 * excluded concomitant medication
endometriosis - mri

Conditions: Endometriosis; Mobility Limitation; Magnetic Resonance Imaging; Diagnosis; Pelvis; Comparative Study

Summary: endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. there is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. it therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. the clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. the persistence of hypo-mobility could also help to understand treatment failures.


Eligibility criteria:
inclusion criteria: * patient referred for suspected pelvic endometriosis requiring pelvic mri * female, nulliparous, * patient with signed written consent, patient with health insurance, * patient willing to comply with all study procedures and duration exclusion criteria: * bmi \> 35, * history of hereditary collagen and elastic tissue disease, * history of pelviperitonitis, * history of major pelvic surgery, * inability to receive informed information, * inability to participate in the entire study, * lack of social security coverage, * refusal to sign consent

Keywords: endometriosis ; mobility limitation magnetic resonance imaging, cine pelvis comparative study
effects of the addition of uterosacral ligament plication to pectopexy operation on anatomical and subjective symptoms

Conditions: Pelvic Organ Prolapse

Summary: the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

in this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Eligibility criteria:
inclusion criteria: * patients with stage ii-iv apical compartment defect according to the pop-q classification exclusion criteria: * having severe chronic disease that makes the operation dangerous * patients under 25 and patients over 75 years old

Keywords: pelvic organ prolapse pectopexy laparoscopy uterosacral ligaments plication
pet imaging ccr2 in lung inflammation

Conditions: Lung Inflammation

Summary: the primary objective of this study is to assess the lung distribution of the positron emission tomography (pet) imaging radiotracer cu-dota-ecl1i, which binds to the specific population inflammatory cells, in patients with fibrotic lung diseases. this objective includes sub-studies to assess radiotracer distribution in the lung, the reproducibility of pet scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue. the overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases.

this is a single site, pilot phase 0/1 clinical trial to establish the uptake of cu-dota-ecl1i in additional patients with ild fibrotic lung disease (n=60). healthy volunteers without known pulmonary disease will be recruited as controls (n=5). all subjects will be recruited and undergo one dynamic pet/ct scan to characterize the lung uptake of cu-dota-ecl1i. among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second pet/ct within two months. a third subgroup of subjects (n=10) who undergo lung transplant will have analysis of ccr2+ cells in their explanted lungs.

Eligibility criteria:
inclusion criteria: * men or women 21 years of age or older who have never smoked or current smokers who smoked at least 10 cigarettes per day (1/2 pack) and have smoked at least 100 cigarettes (5 packs) over the past month. * screening fev1 and fvc \> 80% of predicted * capable of lying still and supine within the pet/ct and pet/mr scanner for \~1 hour and follow instructions for breathing protocol during the ct portion * no illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year * no known history of cardiac, pulmonary, hepatic or renal disease or diabetes * no history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions * able to comprehend and willing to follow instructions for the study procedures as called for by the protocol * bmi ≤ 35 exclusion criteria: * currently enrolled in another study using an investigational drug * pregnancy (confirmed by urine pregnancy test) * active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes * currently taking any prescription medications * presence of an implanted device that is incompatible with ct or mri scanning * creatinine \> 1.30 mg/dl, ast \> 50 units/l, alt \> 55 units/l, or total bilirubin \> 1.2 mg/dl
relapse prevention, row: study to evaluate prevention of relapse in patients in stable chronic schizophrenia receiving either seroquel or placebo

Conditions: Schizophrenia

Summary: this study is being carried out to see if quetiapine (seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.


Eligibility criteria:
inclusion criteria: * stable schizophrenic patients who have provided written informed consent * patients 18 to 65 years old who remain clinically stable after switching to a stable dose of seroquel (quetiapine). exclusion criteria: * patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate, * expected non-compliance to treatment * known diabetes mellitus, * contraindications, * intolerance or non-responsiveness to seroquel or other safety issues.

Keywords: schizophrenia