Kornimate/medical-research-clean huggingface dataset:
antiangiogenic peptide vaccine therapy in treating patient with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating hla-a\*2402 restricted patients with advanced hepatocellular carcinoma.

it has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. immunotherapy is one of the encouraging modalities for patients. we have to assess its toxicities, clinical response and immune responsiveness.

Eligibility criteria:
inclusion criteria: * unresectable or treatment-resistant patients with hepatocellular carcinoma * measurable disease by ct scan * ecog performance status 0-2 * life expectancy \> 3 months * laboratory values as follows: 2,000/mm3 \ 75,000/mm3, total bilirubin \< 1.5 mg/dl, asparate transaminase \< 150iu/l, alanine transaminase \< 150 iu/l, creatinine \< 3.0mg/dl * hla-a\*2402 * able and willing to give valid written informed consent exclusion criteria: * pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) * brest-feeder * active or uncontrolled infection * steroids or immunosuppressing agent dependent status * active or uncontrolled other malignancy * serious or uncured wound * decision of unsuitableness by principal investigator or physician-in charge

Keywords: hepatocellular carcinoma peptide vaccine vegfr
vaginal preparation with chlorhexidine-alcohol vs. povidine-iodine vs. saline

Conditions: Cesarean Section; Infection; Surgical Site Infection

Summary: the purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.

this is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late preterm and term pregnancies admitted to labor \& delivery unit for cesarean delivery with three arms. randomization allocation would be performed in 1:1:1 fashion for vaginal preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. a saline wash group is included to determine if the act of cleansing the vagina with a sponge alone reduces bacterial colony counts.

Eligibility criteria:
intervention group (vaginal preparation) inclusion criteria: * pregnant women admitted for cesarean delivery * gestational age greater than or equal to 34 weeks exclusion criteria: * rupture of membranes or active labor * chorioamnionitis (prior to enrollment) * recent (within 4 weeks) antibiotic exposure * maternal hiv infection or immunocompromised state * known allergy to shellfish, iodine, or chlorhexidine

Keywords: vaginal preparation antisepsis c-section
first human dose trial investigating safety, tolerability and pharmacokinetics of nnc0194-0499 in male subjects with overweight or obesity

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america. the aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of nnc0194-0499 in male subjects with overweight or obesity.


Eligibility criteria:
inclusion criteria: * male, aged 22-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 34.9 kg/m\^2 (both inclusive). overweight should be due to excess adipose tissue, as judged by the investigator exclusion criteria: * any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol * subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ascvd according to acc/aha (american college of cardiology /american heart association) guideline) risk above or equal to 5% * male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (pearl index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening (visit 1) until 3 months following administration of the investigational medical product * use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid
comparison between lung ultrasound and chest radiography for acute dyspnea

Conditions: Dyspnea; Congestive Heart Failure

Summary: for patients presenting to the emergency department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (lus) for lus arm or after chest radiography (cxr) and natriuretic peptide (nt-pro bnp) results for cxr arm. all patients will undergo cxr, those enrolled in the lus arm, after sonographic evaluation. after discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. in case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.

study protocol after the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ecg, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as adhf or non-cardiogenic dyspnea. then, the patient will be assigned to one of the experimental arms. in the lus arm, the same emergency physician will perform lus, and express the new integrated presumptive etiology ("lus-implemented" diagnosis). all patients will then undergo cxr. in the cxr arm, patients will undergo cxr, and the new integrated etiology will be record after cxr and nt-probnp results will be available. after hospital discharge, two expert emergency physicians, blinded to lus results, will independently review the entire medical record, and indicate the final diagnosis. in case of disagreement, a cardiologist will review the medical records, and adjudicate the case. statistical analysis the accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "positive" and "negative" results will be considered, for each test, the diagnosis of adhf or non-cardiac dyspnea, respectively. receiver operating characteristic (roc) and area under curve (auc) statistics will be also shown.

Eligibility criteria:
inclusion criteria: * acute dyspnea as chief complaint * presence of an emergency physician skilled in lung ultrasound at evaluation time exclusion criteria: * mechanical ventilation ongoing at enrolment time * dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
transthoracic needle biopsy using 3d printed navigational template: a phase i feasibility trial

Conditions: Lung Neoplasms

Summary: this study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.

in previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. it was reported that localizer deviation was 10(0-20)mm.in this trial,investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.

Eligibility criteria:
inclusion criteria: ct confirmed peripheral lung nodule; nodule size larger than or equal to 3 cm; ecog performance status 0-2 ; informed consent. exclusion criteria: nodule located in the scapula region wherein biopsy needle is impeded; nodule within 3 cm above diaphragmatic dome.

Keywords: biopsy, needle printing, three-dimensional image-guided biopsy
effect of short term adrenal suppression on androgen overproduction in overweight girls with androgen excess

Conditions: Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome

Summary: short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries

this study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. the investigators hypothesize that one month of oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. specifically, this intervention will improve androgen levels after adrenal stimulation testing with adrenocorticotropin hormone (acth).

Eligibility criteria:
inclusion criteria: * overweight(\>85th bmi%) females * early to late puberty (expected age range 7-18) * hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same tanner stage) * screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (lh), lipids, testosterone, prolactin, dheas, e2, glucose, and insulin; and decreased follicle-stimulating hormone (fsh) and/or sex hormone-binding globulin (shbg) exclusion criteria: * screening labs outside of age-appropriate normal range * hemoglobin \<12 mg/dl and hematocrit\<36% (subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. if still \<36%, they will be excluded.) * morning cortisol \<5 g/dl * 17-hydroxyprogesterone \>295 ng/dl * history of cushing's syndrome or adrenal insufficiency * pregnant
empagliflozin and anakinra for the treatment of postprandial hypoglycemia in patients with prediabetes

Conditions: Postprandial Hypoglycemia

Summary: this study is to analyze whether the sglt2-inhibitor empagliflozin or the il-1 receptor antagonist anakinra may improve postprandial hypoglycemia in subjects with prediabetes.

subjects with prediabetes may develop postprandial hypoglycemia. this is probably due to a dysfunction of the insulin producing β-cell characterized by a delayed and exaggerated insulin secretion leading to an initial peak in glycaemia followed by a rapid fall and eventually resulting in hypoglycemia. the latter occurring typically within 1 to 3 hours after food intake. in patients with gastric bypass surgery and postprandial hypoglycemia the sglt2-inhibitor empagliflozin and the il-1 receptor antagonist anakinra reduced postprandial insulin release and prevented hypoglycemia. this study is to analyze whether a similar therapeutic approach using empagliflozin and anakinra may also improve postprandial hypoglycemia in subjects with prediabetes.

Eligibility criteria:
inclusion criteria: * subjects with prediabetes defined by glycosylated haemoglobin a1c (hba1c) 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l) or plasma glucose 2 h following 75 glucose ingestion of 7.8-11.0 mmol/l. * hypoglycemia occuring 1 to 3 h following ingestion of a standardized liquid mixed-meal (75 g carbohydrates) and fulfilling the whipple's triad (glucose below 3.0 mmol/l). * age ≥ 18 years * for subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study exclusion criteria: * upper gastrointestinal surgery * diagnosis of any type of diabetes mellitus * signs of current infection * use of investigational drug up to one week prior to start of treatment phase * glucocorticoid therapy * neutropenia (leukocyte count \< 1.5 × 109/l or absolute neutrophil count (anc) \< 0.5 × 109/l) * anemia (hemoglobin \< 11 g/dl for males, \< 10 g/dl for females) * clinically significant kidney or liver disease (creatinine \> 1.5 mg/dl, aspartate aminotransferase (ast)/alt \> 2 × uln, alkaline phosphatase \> 2 × uln, or total bilirubin \[tbili\] \> 1.5 × uln) * uncontrolled disease * currently pregnant or breastfeeding * no subjects meeting the criteria for vulnerability * participation in another study with investigational drug within the 30 days preceding and during the present study.

Keywords: sglt2-inhibitor empagliflozin il-1 receptor antagonist anakinra prediabetes insulin clearance proinsulin
a study of nab-paclitaxel and carboplatin plus necitumumab (ly3012211) in participants with stage iv squamous nsclc

Conditions: Carcinoma, Non-Small Cell Lung Cancer (NSCLC)

Summary: the purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage iv squamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed squamous nsclc. * have stage iv disease at the time of study entry (american joint committee on cancer \[ajcc\] staging manual, 7th edition). * have measurable disease at the time of study enrollment as defined by response evaluation criteria in solid tumors, version 1.1 (recist 1.1). * have tumor tissue available for biomarker analysis. * have an eastern cooperative oncology group (ecog) performance status of 0 to 1. * have adequate organ functions. exclusion criteria: * are currently enrolled in another clinical trial. * have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (egfr), vascular endothelial growth factor (vegf), or vegf receptor. * have received previous chemotherapy for advanced nsclc. participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry. * have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry. * have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry. * have symptomatic central nervous system (cns) malignancy or metastasis (screening not required). * have a history of arterial or venous embolism within 6 months prior to study entry. * have clinical evidence of concomitant infectious conditions. * have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments. * are pregnant or breastfeeding. * have a known history of drug abuse. * have a concurrent active malignancy. participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible. * have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.
automated visual monitoring for improving patient safety (vipsafe)

Conditions: Postoperative Confusion

Summary: after an operation many patients are in a confused mental status at the intensive care unit. in this status they possibly fall out of their bed or pull out endotracheal tubes or central venous catheters accidentally. for this, they need permanently monitoring and control through intensive care personnel. the goal of the vipsafe project is to develop robust techniques for automated patient monitoring, that rely on data from a small number of untethered sensors, which are nonetheless flexible enough to cope with a large variety of demands.


Eligibility criteria:
inclusion criteria: * patients with planned postoperative stay at intensive care unit after previous written consent to the study * patients with not-planned postoperative stay at intensive care unit with written consent after admission to intensive care unit * patients unfit to plead with admission to intensive care unit with written consent of the officially appointed agent exclusion criteria: * absent written consent * age \< 18 years old

Keywords: postoperative delirium
prostatic artery embolization for obstructive uropathy due to prostate cancer

Conditions: Prostatic Neoplasm; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases

Summary: the aim of this study is to investigate the safety and efficacy of prostatic artery embolization of patients with recurrent symptoms secondary to locally advanced prostatic cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit for or refuse surgical treatment.

this is a prospective study investigating the safety and efficacy of pae for patients with prostate cancer who suffers from acute urinary retention, severe luts and/or recurrent complications such as haematuria. our hypothesis is that pae will eliminate the need for indwelling catheter and improve ipss and qol 12 months post-procedure. 1, and 6 months follow-up. main outcome ability to void after removal of indwelling catheter secondary outcomes international prostate symptom score (ipss) quality of life (qol) international index of erectile function (iief) prostate volume peak void flow (qmax) post-void residual (pvr) classify complications according to society of interventional radiology (sir) guidelines for reporting prostate-specific antigen (psa)

Eligibility criteria:
inclusion criteria: * indwelling catheter secondary to locally advanced prostate cancer (pca) or * moderate-severe obstructive luts secondary to pca * unsuitable for or refuse surgery exclusion criteria: * bladder dysfunction(and known neurological conditions affecting bladder function) * urethral strictures * bladder neck contracture * known sphincter anomalies * big bladder diverticulum or stones * kidney insufficiency (egfr \< 45) * coagulation disturbances * severe atheromatous or tortuosity of arteries * allergy to contrast medium * unable to undergo mr imaging * bladder malignancy

Keywords: ipss quality of life dan-pss complications prostate cancer
urox biomarker bladder cancer study

Conditions: Bladder Cancer

Summary: this is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy. the study aims to test if the urox™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. the study aims to assess the value of the biomarker as a screening tool for bladder cancer. patients with and those without bladder cancer are required for the study.

patients who undergo investigation for bladder cancer will have a cystoscopy and biopsy as part of their routine care. these patients are then brought back to urology outpatient clinic for their biopsy results within two weeks. a urox biomarker bladder cancer study patient information leaflet will be sent to all patients who are booked for these investigations, explaining the study aims and the requirements for participation. on the day of their cystoscopy, potential participants will be approached and after signing a study specific consent form, the urine sample will be accepted, given a study number and sent for urox biomarker testing. these results will then be returned to the study team for comparison against the biopsy histology result to assess for sensitivity and specificity. while cystoscopy and biopsy are the current gold standard for diagnosis of bladder cancer, it has been shown to have false-negatives of between 10-40%, due to factors such as operator error or small areas of malignancy(15-17). the possibility of a screening/outpatient test for bladder cancer with high positive predictive value would help with reduction or prioritisation of further investigations and early diagnosis of disease thus potentially allowing alternative treatment options.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years of age * patients under investigation for bladder cancer due to undergo investigative standard of care biopsy exclusion criteria: * patients aged \< 18 years of age * patients who are currently undergoing radiation therapy. * proposed subject has no bladder (due to surgical removal). * no cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results) * patients unable or unwilling to provide consent * patients currently on investigational drug trials * patients with catheter in situ
efficacy of acupressure versus traditional treatment on reducing ankle edema during pregnancy

Conditions: Gestational Edema

Summary: incidence of ankle edema is high during pregnancy, if left untreated, it may lead to difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable. acupressure promotes the condition of the circulatory and lymphatic system leading to the elimination of edema. the aim of this study is to investigate the efficacy of acupressure versus traditional physical therapy treatment on ankle edema during pregnancy.

sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. they will be assigned into three equal groups, group a will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and group b will receive the same traditional treatment as group a in addition to circulatory exercises, 3times per week for 4 weeks; while group c will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.

Eligibility criteria:
inclusion criteria: * pregnant women in their third trimester, * age ranged from 25-35 years and * bmi was ≥30kg/m2. exclusion criteria: * pregnant women with skin diseases * irremovable bracelet, * decreased functional active range of motion in the affected lower extremity * any mental or physical disorders.

Keywords: edema leg
metacognitive beliefs in adolescents with eating and nutrition disorders

Conditions: Feeding and Eating Disorders

Summary: the present study aims to study the presence of metacognitive beliefs in adolescent subjects with eating and nutrition disorders (end) compared with a control group composed of subjects of the same sex and age belonging to the general population.


Eligibility criteria:
eating and nutrition disorders (end) inclusion criteria: * female sex * age: 12 to 17 years * italian nationality * diagnosis relating to the end framework according to the diagnostic criteria of the diagnostic and statistical manual of mental disorders (dsm-5). exclusion criteria: * absence of signed informed consent control group inclusion criteria: * female sex * age: 12 to 17 years * italian nationality exclusion criteria: * absence of signed informed consent

Keywords: metabeliefs metacognition brooding rumination anorexia nervosa bulimia nervosa binge eating disorder