Kornimate/medical-research-clean huggingface dataset:
comparative study of fosaprepitant and aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric caner patients

Conditions: Chemotherapy Induced Nausea and Vomiting; Pediatric Cancer Patients

Summary: children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-a (fosaprepitant) or arm-b (aprepitant). children recruited to arm-a received intravenous granisetron plus dexamethasone followed by fosaprepitant infusion. children recruited to arm-b received the same drugs as those given to children in arm-a, except that fosaprepitant was substituted with aprepitant. granisetron and dexamethasone were given continuously until 48 hours after completion of chemotherapy. the primary end point of the study was to determine the proportion of patients who achieved a cr, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a cr during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. secondary end points were the proportion of patients who achieved a cr during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy.


Eligibility criteria:
inclusion criteria: children aged 2-12 years at the time of study entry with documented cancer scheduled to receive mec or hec (more than 30% emetogenic potential) with karnofsky score of 60 or more (for patients aged greater than 10 years) or lansky play performance score of 60 or more (for patients aged 10 years or less) predicted life expectancy of at least 3 months; and written informed consent provided by parent or guardian exclusion criteria: vomiting 24 hours before treatment day 1 known history of qt prolongation or allergic reaction to any of the study drugs symptomatic primary or metastatic cns malignancy causing nausea or vomiting patients who received radiation therapy to the abdomen or pelvis in the week before treatment; active infection or any uncontrolled concurrent illness except for malignancy abnormal laboratory values at screening (peripheral absolute neutrophil count \ 5 times of the upper limit of normal for age, bilirubin or serum creatinine \>1.5 times of the upper limit of normal for age) initiation of systemic corticosteroids within 72 hours before study drug administration or as part of the chemotherapy regimen; benzodiazepines or opioids initiated within 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam use of antiemetics within 48 hours of treatment use of cyp3a4 substrates or inhibitors within 7 days or cyp3a4 inducers within 30 days of treatment

Keywords: fosaprepitant aprepitant pediatric cancer vomiting efficacy safety
safety, tolerability and immunogenicity of ino-4500 in healthy volunteers

Conditions: Lassa Fever

Summary: this is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of ino-4500 administered by intradermal (id) injection followed by electroporation using the cellectra® 2000 device in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening; * negative tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody; * screening electrocardiogram (ecg) deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); * use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile. exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose; * is currently participating in or has participated in a study with an investigational product within 30 days preceding day 0; * previous receipt of an investigational vaccine product for prevention of lassa fever; * fewer than two acceptable sites available for id injection and ep considering the deltoid and anterolateral quadriceps muscles; * audiometry testing that demonstrates a hearing level threshold of 30 db or greater for any frequency tested between 250 hz - 8000 hz; * recent (within 6 months) or planned travel to lassa-endemic region; * current or anticipated concomitant immunosuppressive therapy.

Keywords: healthy volunteer
respiratory sarcopenia in older adults

Conditions: Sarcopenia

Summary: the objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic. a sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the virgen de la arrixaca hospital, murcia, will participate in the study. in the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. in the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). sociodemographic and clinical variables, physical function (palm grip, 5sts, 4mgs), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). descriptive statistics, univariate and multivariate logistic regression models, cox proportional hazards model and kaplan-meier curves will be used to analyze the data from the longitudinal study. to compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. a p-value \<0.05 will be considered significant in all analyses. the recording and analysis of the data will be carried out with the ibm spss statistics 24® program.


Eligibility criteria:
inclusion criteria: * have functional ambulation (even with technical aids) * be able to obey simple commands, such as taking deep breaths * have sufficient oral occlusion capacity to perform respiratory tes exclusion criteria: * presence of acute respiratory diseases * serious orthopedic diseases that interfere with measurements * diagnosis of severe dementia * those who present any contraindication for performing respiratory pressure measurement tests, as established in the guidelines of the spanish society of pulmonology and thoracic surgery (separ).

Keywords: sarcopsarcopenia geriatrics respiratory function
role of surgery in management of pineal region tumors in children

Conditions: Brain Tumor

Summary: the aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : how can surgery affect the outcome in children with pineal region tumors ?


Eligibility criteria:
inclusion criteria: * all patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention exclusion criteria: * patients with pineal region tumors older than 18 years old * and pediatric patients younger than 18 years ild and unfit for surgical intervention

Keywords: pineal region
clinical trial for the use of a novel cell collector device to retrieve cells from the uterine cervix

Conditions: Uterine Cervical Dysplasia; Uterine Cervical Intraepithelial Neoplasia; Uterine Cervical Neoplasia; Uterine Cervical Cancer

Summary: this study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely

this study tested the feasibility, safety and efficacy of the new e2tm collector, and compared its performance with the standard method for obtaining cervical cells for pap test of endocervical cytobrush and ayer's spatula

Eligibility criteria:
inclusion criteria: women ages \>14 being followed for a previous abnormal pap all patients will have signed an informed consent form prior to being enrolled in this study exclusion criteria: patients who have had a hysterectomy

Keywords: cervix uterus dysplasia cancer collector
clinical trial assessing 5-ht3 receptor antagonist (ramosetron) for the treatment of anterior resection syndrome

Conditions: Anterior Resection Syndrome

Summary: poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. but, currently there has been no specific treatment for ars and symptom based empirical management is tried recently, 5-ht3 receptor antagonists can be used for treatment of ibs-d, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency. we performed the clinical trial with using ramosetron (irribow®) for the treatment of ars


Eligibility criteria:
inclusion criteria: * the patients who undergo sphincter saving surgery for rectal cancer exclusion criteria: * recurred rectal cancer * rectal cancer with distant metastasis * permanent stoma formation * postoperative concurrent chemoradiotherapy * uncontrolled medical disease * inflammatory bowel disease * uncontrolled constipation * preoperative incontinence (lars score, more than 20) * allergic to intervention drug
effect of incentive spirometer and pursed lip breathing after whipple procedure.

Conditions: Hospital Stay

Summary: whipple procedure is one of the most complex surgeries among hepatobiliary surgeries. it has named as pancreaticoduodenectomy. it can cause many ppcs. lung volumes are reduced due to atelectasis and pneumonia. incentive spirometer (is) is used to prevent ppcs. due to general anesthesia, atelectasis is among most frequent ppcs. pursed lip breathing (plb) supports the patient to control the breath. the shriveling lips provide resistance to the air flowing out of the lungs. airway collapse can be prevented by prolonged exhalation. dyspnea occurs during 6mwt when patient performs walk in corridor. the aim of this study is to check the effect of incentive spirometer and pursed lip breathing to improve dyspnea, oxygen saturation and hospital stay after whipple procedure. this research of rct will check the effect of is and plb by taking sample size of 60 post-operative patients through convenient sampling technique by allocating them randomly in group a and group b. group a will receive plb and group b will receive is with baseline treatment chest percussions up to the duration of every day till discharge (reading will be collected on every 4rth day), dyspnea will be assessed through 6mwt and measured by modified mrc dyspnea scale. the data will be analyzed through spss 26.


Eligibility criteria:
inclusion criteria: * age (45 to 70) * type of abdominal surgery (whipple procedure) (11) * gender (male and female) * patients who has no history of pulmonary disease * smokers and nonsmokers exclusion criteria: * copd (copd patient with postoperative whipple procedure) * heart patient (patients who had history of heart disease along with whipple procedure) * uncontrolled hypertension (patients who has have history of uncontrolled hypertension in postoperative whipple procedure)

Keywords: dyspnea, incentive spirometer oxygen saturation whipple procedure
genotype expression and phenotype of endothelial cells, carrying an acvrl1, eng or smad4 mutation, in response to bmp9 for the identification of new therapeutic targets in hereditary haemorrhagic telangiectasia

Conditions: Hereditary Haemorrhagic Telangiectasia

Summary: hereditary hemorrhagic telangiectasia (hht) or osler-weber-rendu syndrome patients are carriers of a heterozygous mutation of the activin receptor-like kinase 1 (acvrl1), endoglin (eng) or mothers against decapentaplegic homolog 4 (smad4) gene. hht involves the bone morphogenetic protein 9 (bmp9)/activin receptor-like kinase 1 (alk1)-endoglin signalling pathway. bmp9 is a growth factor that binds to alk1 receptor and to endoglin its co-receptors and physiologically activates smad signaling pathway. endothelial cells in hht patients display half expression of functional alk1 receptors or endoglin co-receptors or of the transcription factor smad4, which should lead to effects on the functions of these cells. the identification of differences in gene expression between endothelial cells from hht patients and healthy donors will allow the identification of new functions or new target pathways for therapy. circulating endothelial cells are rare in the bloodstream in adults, but are present in greater quantities in cord blood.


Eligibility criteria:
inclusion criteria: * newborn whose parents : * are adults * are affiliated to a social security or similar * are not subject to any legal protection measures * newborn child with one parent who has monitored for hht confirmed by molecular biology (carrier of a mutation of the smad4, eng or acvrl1 gene). * consent signed by the two representatives of parental authority exclusion criteria: * one of the two parents opposes donating the umbilical cord blood and the umbilical cord for research * one of the two parents opposes genetic testing * patient for whom it was not possible to obtain umbilical cord blood after delivery for technical or medical reasons.

Keywords: hereditary haemorrhagic telangiectasia endothelial cell
vasopressor support, mean arterial pressure and capillary refill time in critically ill patients

Conditions: Critical Illness

Summary: the goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (crt) value in crtically ill patients. the main questions it aims to answer are: * how do vasopressor drugs determine crt value * how does mean arterial pressure (map) determine crt value * how often crt value is normal (\< 3 sec) despite hypotensive map (\<65 mmhg) participants will have the crt measured over the course of the icu hospitalization. at the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence crt value.

the goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (crt) value in critically ill patients. the main questions it aims to answer are: * how does norepinephrine dose influence crt value * how does epinephrine dose influence crt value * how does argipressin dose influence crt value * how does dobutamine dose influence crt value * how does mean arterial pressure (map) determine crt value * how often crt value is normal (\< 3 sec) despite hypotensive map (\<65 mmhg) participants will have the crt measured over the course of the icu hospitalization. at the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence crt value. crt will be a dependent variable. independent variables will be as follows: age, map, norepinephrine dose, epinephrine dose, argipressin dose, dobutamine dose. crt measurements will be performed in a standarized rigor (light, chronometer, pressure and ambient temperature will be the same in all patients)

Eligibility criteria:
inclusion criteria: * critical illness requiring vasopressor support * invasive blood pressure monitoring exclusion criteria: * finger distal phalanx not available * patient in a room of suboptimal ambient temperature

Keywords: capillary refill time norepinephrine epinephrine argipressin dobutamine mean arterial pressure
mr-guided cryoablation of prostate bed recurrences

Conditions: Prostate Tumors

Summary: the purpose of this research is to see if mr-guided cryoablation can effectively treat prostate tumor recurrences.


Eligibility criteria:
inclusion criteria: * patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa * surgery is not a desirable alternative therapy at the time of enrollment * radiation therapy has failed or not indicated or can be safely postponed * tumor size is \< 5 cm at its largest diameter * tumor does not encompass the rectal wall or external urethral sphincter * patient is able to undergo mri exclusion criteria: * n/a
the safety and efficacy of single antiplatelet therapy after pipeline flex with shield for intracranial aneurysms

Conditions: Treatment

Summary: the objective of this study was to evaluate the safety and efficacy of single antiplatelet therapy after pipeline flex with shield stent implantation for intracranial aneurysms.

title：a single-center, prospective, cohort study of the safety and efficacy of single antiplatelet therapy after pipeline flex with shield stent implantation for intracranial aneurysms. purpose：to assess the safety and efficacy of single antiplatelet therapy after pipeline flex with shield stent implantation for intracranial aneurysms. follow up:the follow-up period was 6 months.

Eligibility criteria:
inclusion criteria: 1. patients with unruptured intracranial aneurysms who received the intracranial pipeline flex with shield stent. 2. vascular conditions: 1) there was no obvious calcification and stenosis of the parent artery. 2) the curvature of the bearing artery is minimal. 3) the parent artery diameter ≥2.5mm 3.according to the committee's assessment, only one pipeline flex with shield is needed for aneurysm treatment. 4.before the stent implantation procedure, standard dual antiplatelet therapy should be administered for at least 3 days. 5.patients with an modified rankin scale(mrs) score of less than 2 on the day of registration. 6.the operation was successful, and immediate postoperative angiography indicated good wall apposition. exclusion criteria: 1. patients with recurrent aneurysms after interventional treatment or surgical clipping. 2. the patient after stent placement surgery. 3. aneurysms can have irregular shapes, such as fusiform, blister-type, or dissecting aneurysms. 4. the patient had no history of stroke or aneurysm rupture in the last 3 months. 5. abnormal platelet function, or platelet count \< 100,000 cells/mm³. 6. known history of allergy to clopidogrel or heparin.

Keywords: intracranial aneurysm
the effect of atorvastatin on renal function in healthy subjects during normal and high sodium intake

Conditions: Healthy Subjects

Summary: we wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

we wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake. we wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and hr under acute treatment with atorvastatin depends on sodium intake.

Eligibility criteria:
inclusion criteria: 1. age 20-50 yr 2. bmi\<30 3. females had to use oral contraceptive treatment or iud. exclusion criteria: 1. clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or endocrine organs 2. abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine, blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase) 3. albuminuria or glucosuria 4. cancer 5. arterial hypertension 6. alcohol abuse 7. medical treatment, except contraceptives 8. pregnancy or breast feeding 9. blood donation one month before the study.

Keywords: atorvastatin healthy sodium excretion hemodynamics tubular function
molecules associated with the presence and severity of nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver; Metabolic Syndrome

Summary: non-invasive diagnosis and treatment of nonalcoholic fatty liver disease (nafld) remain unmet medical needs. aim of this study is to investigate the blood levels of three hormonal systems related to obesity, insulin resistance and inflammation in patients with different stages of nafld, in order to identify potential diagnostic markers. study aim: to compare the blood levels of: a) proglucagon-derived hormones (glucagon-like peptide \[glp\]-1, glp-2, glicentin, oxyntomodulin, glucagon, major proglucagon fragment \[mpgf\]), b) follistatins-activins (follistatin-like (fstl)3, activin b), c) igf axis (insulin-like growth factor (igf)-1, total and intact igf binding protein (igfbp)-3 and igfbp-4, in 18 individuals with early stage nafld vs. 14 controls to explore the levels of gdf-15, total and intact, in nafld versus obese controls (oc) at baseline and during oral glucose tolerance tests (ogtts)


Eligibility criteria:
inclusion criteria: * individuals with liver ultrasound imaging * adults exclusion criteria: * the presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
tumoral circulating cells and colorectal cancer progression

Conditions: Colorectal Cancer

Summary: prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

this study aims at allowing a better understanding of which circulating tumor cells (ctc) have the higher risk of metastasis of in the overall population of ctc. prospective monocenter open-label study. in the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage ii/iii, metastatic non resectable, metastatic potentially resectable). tissue samples will be collected for patients scheduled for surgery.

Eligibility criteria:
inclusion criteria: 1. patient of more than 18 years old 2. histological diagnosis of colic adenocarcinoma metastatic or not 3. before any treatment with systemic chemotherapy 4. patient affiliated to, or beneficiating of the national security 5. patient having signed informed consent exclusion criteria: 1. patient with previous chemothrapy treatment 2. patient with more than one evolutive tumoral pathology 3. patient under long-term immunosuppressor treatment 4. patient with severe infection 5. pregnant or breasting woman 6. person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
insulin sensitivity and beta cell function after carbohydrate loading in hip replacement surgery

Conditions: Insulin Sensitivity

Summary: the purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.


Eligibility criteria:
inclusion criteria: * elective hip replacement exclusion criteria: * known diabetes mellitus * kidney failure (creatinine clearance \<40 ml/min * liver failure (aspartate and alanine aminotransferases x 2 above reference) * hb \<110 g/l * ongoing severe bacterial or viral infection * malignancies * psychiatric disease

Keywords: insulin sensitivity beta cell function carbohydrate preload elective hip replacement double-blind randomized control study