Kornimate/medical-research-clean huggingface dataset:
neonatal non-invasive hemoglobin determination

Conditions: Surgical Procedures; Infant, Newborn; Infant, Low Birth Weight

Summary: the purpose of this study is to evaluate hemoglobin (hgb) measurement by masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (kg).

this collaborative study with masimo corporation will involve 2 phases. in the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for hgb analysis using the cyanomethemoglobin method (advia 2121). masimo corporation will use this data to calibrate or modify the hemoglobin reading (sphb®) sensors and monitors. all results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (sphb®) measurements.

Eligibility criteria:
inclusion criteria: 1. males or females weighing 0.5 kg to 3 kg. 2. neonates and infants and children admitted to the children's hospital of philadelphia (chop)operating room (or), picu and nicu where hemoglobin measurements are anticipated. 3. parental/guardian permission (informed consent) exclusion criteria: 1. subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous). 2. subject weighing more than 3 kg. 3. subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor. 4. any skin rash on the intended site of measurement. severe allergy to adhesive tapes.

Keywords: hemoglobin monitoring, physiologic blood gas monitoring, transcutaneous
italian multicenter study comparing folfoxiri versus gemcitabine as adjuvant treatment for resected pancreatic cancer

Conditions: Pancreatic Cancer

Summary: patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: gemcitabine, the standard arm, or folfoxiri (the combination of 5-fluorouracil/folinic acid, oxaliplatin and irinotecan), the experimental arm. a total of 310 patients will be enrolled in about 50 italian centers.

patients with resected stage i-iii pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: gemcitabine, the standard arm, or folfoxiri (the combination of 5-fluorouracil/folinic acid, oxaliplatin and irinotecan), the experimental arm. a total of 310 patients will be enrolled in about 50 italian centers. all the patients will be followed up during and after the treatment until disease progression and death or for a minimum of 60 months. main objective: to show an increase in disease-free survival with an hr of 0.70 for patients enrolled into the experimental arm compared with standard arm. secondary objectives: to show an increase in overall survival with an hr of 0.70 for patients enrolled into the experimental arm compared with standard arm. to show the tolerability of the experimental treatment in this setting. principal inclusion criteria: * histological diagnosis of pancreatic cancer * surgical resection with curative intent within 10 weeks before of enrollment (stage i-iii) * absence of evidence of metastases (cm0) * age 18-75 * ecog performance status 0-1 * adequate bone marrow, liver and renal function * written informed consent principal exclusion criteria: * evidence of metastases * ca19.9 higher than 2.5 x uln (upper limit of normal range) * precedent chemotherapy or radiotherapy * coexisting malignancies * relevant coexisting diseases that could contraindicate the participation to the study * hypersensitivity/intolerance to the drugs in study * pregnancy or breastfeeding * neurotoxicity of grade \> 1 * malabsorption syndrome primary end-point: disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death. secondary end-points: overall survival, defined as the time from enrollment to the evidence of death. toxicity, defined according to nci-ctc

Eligibility criteria:
inclusion criteria: * histological diagnosis of pancreatic cancer * surgical resection with curative intent within 10 weeks before of enrollment (stage i-iii) * absence of evidence of metastases (cm0) * age 18-75 * ecog performance status 0-1 * adequate bone marrow, liver and renal function * written informed consent exclusion criteria: * evidence of metastases * ca19.9 higher than 2.5 x uln (upper limit of normal range) * precedent chemotherapy or radiotherapy * coexisting malignancies * relevant coexisting diseases that could contraindicate the participation to the study * hypersensitivity/intolerance to the drugs in study * pregnancy or breastfeeding * neurotoxicity of grade \> 1 * malabsorption syndrome
assessment of myocardial tissue damage in aortic stenosis

Conditions: Aortic Stenosis

Summary: aortic stenosis (as) is the most common valve disease in the united states and most common indication for valve replacement surgery. anatomical and hemodynamic severity of as is insufficient for elucidating patients' prognosis. therefore, the decision about the optimal timing of surgical intervention remains critical. however, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ecg). degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in as patients and have a negative impact on patient outcomes. in this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (ib), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (lv) load as measured by zva, and ecg analysis of the duration of the qrs interval have a role in risk stratification for as patients and to apply those methods to identify which patients would benefit from surgical intervention. the investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with as, and 2) ib, zva, and qrs interval can be diagnostic measures of the severity of myocardial damage. the investigators will measure the severity of myocardial fibrosis using mri (reference) in 50 patients and will test the diagnostic significance of ib (testing method). zva, qrs duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.


Eligibility criteria:
inclusion criteria: * moderate or severe aortic stenosis determined by echocardiography * adults \> 65 years old exclusion criteria: * ejection fraction \< 50% * valvular diseases of more than or equal to moderate degree other than aortic stenosis * prior myocardial infarction or coronary artery disease needs revascularization * atrial fibrillation (chronic) * pacemaker/defibrillator implanted * previous valve replacement performed * cardiomyopathy(hcm, infiltrative cardiomyopathy, constriction) * renal dysfunction (estimated gfr \< 30ml/min/1.73m² or end stage renal failure) * patients with contraindication for mri * patients with poor echocardiographic images

Keywords: aortic stenosis myocardial tissue echocardiography mri
a phase iii trial of z-338 in paediatric patients with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to evaluate pharmacokinetics, efficacy and safety of z-338 of pediatric patients with functional dyspepsia (fd). in part 1, the pharmacokinetics and safety of single oral dose of z-338 100 mg are evaluated. in part 2, the efficacy and safety of z-338 100 mg orally 3 times daily before meals are evaluated. part 2 is comprised by the double-blind phase and the open-label phase. in the double-blind phase, subjects will take z-338 or placebo for 28 days. in the open-label phase, all subjects will take z-338 for 28 days.


Eligibility criteria:
main inclusion criteria: part 1\& part 2 * subjects aged from nine to 17 years (from nine to 14 years in part 1), on the day the informed consent is signed. * subjects with a diagnosis of fd as defined by the rome iv criteria. * subjects who have postprandial fullness, upper abdominal bloating or early satiation. part 2 only * subjects who have postprandial fullness, upper abdominal bloating or early satiation during with a certain severity during a week prior to the day of randomization. main exclusion criteria: part 1\&part 2 * subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent. * subject who have received helicobacter pylori eradication therapy within 24 weeks prior to informed consent, or subjects who is defined as helicobacter pylori-positive within 4 weeks prior to or on the day the informed consent is signed. * subjects who have alarm symptom on the day the informed consent is signed. * subjects who have food allergy of unknown origin or uncontrolled food allergy. part 2 only * subject taking drugs used for fd within 2 weeks prior to the day of randomization (excluding proton pump inhibitors) * subject taking proton pump inhibitors within 4 weeks prior to the day of randomization.
18f-fluciclovine pet/mri imaging for the detection of tumor recurrence after radiation injury to the brain

Conditions: Metastatic Intracranial Malignant Neoplasm; Recurrent Intracranial Neoplasm

Summary: this phase i trial studies the ability and amount of fluciclovine positron emission tomography (pet) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). f-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. the results of this study may also help investigators understand all the ways that f-18 fluciclovine may affect patients.

primary objective: i. to determine the static fluciclovine f18 (fluciclovine) pet imaging tumor-to-background ratios (tbrmax; tbrmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (mri) findings suggesting recurrent disease, using histopathology as proof of disease. secondary objectives: i. to determine static fluciclovine pet standardized uptake value (suv)peak, suvmean values and metabolic tumor volumes (mtv) which distinguish true tumor recurrence from radionecrosis in patients with mri findings suggesting recurrent disease, using serial mri as a surrogate marker of disease. ii. to determine early dynamic fluciclovine pet time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with mri findings suggesting recurrent disease, using histopathology or serial mri as a marker of disease. iii. to correlate the determined static fluciclovine pet suvpeak, suvmean, tbrmax, tbrmean, and mtv values with progression free survival. iv. in patients with true tumor progression, suv values will be correlated with ki67 staining on final pathology. outline: patients receive fluciclovine intravenously (iv) and undergo brain dynamic pet/mri imaging over 50 minutes. after completion of study, patients are followed up every 3 months for up to 1 year.

Eligibility criteria:
inclusion criteria: * clinical evidence of intracranial metastatic disease which underwent radiation and who presents with mri findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion') exclusion criteria: * contraindication to contrast enhanced mri * females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm) * inability to lie still for 50 minutes during fluciclovine pet-mri imaging * inability or refusal to consent * allergy or anaphylaxis to any of the reagents used in this study * inability or unwillingness to return for required visits and follow-up exams
eras on postoperative recovery after laparoscopic distal gastrectomy

Conditions: Enhanced Recovery After Surgery

Summary: this prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (eras) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. we hypothesize that our eras protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.

adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the eras protocol (n=49) or conventional protocol (n=49). the conventional groups receive our current perioperative management. the eras groups receive our new eras protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. the primary outcome measure was the postoperative quality of recovery evaluated using the korean version of quality of recovery-15 at 24, 48, and 72 hours postoperatively. the secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the i-feed score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the clavien-dindo classification during hospitalization, and length of hospital stay.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective laparoscopic distal gastrectomy * american society of anesthesiologists (asa)physical classification i-ii * ecog performance status scale 0 or 1 * willingness and ability to sign an informed consent document exclusion criteria: * patients with chronic pain * gastrectomy with combined resection of other organs * patients with history of upper abdominal surgery * allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, nsaids) * medical or psychological disease that can affect the treatment response

Keywords: enhanced recovery after surgery stomach neoplasms gastrectomy pain, postoperative
is routine cervical dilatation necessary during elective caesarean section? a randomised controlled trial

Conditions: Failure of Cervical Dilatation; Complications; Cesarean Section; Wound Infection,; External Causes of Morbidity and Mortality

Summary: the purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity

participants with indication for elective caesarean section were randomly allocated to two groups. group a (n = 200) women with intraoperative cervical dilatation; group b (n = 200) women with no intraoperative cervical dilatation.patients were randomised using computer-generated random numbers in sealed envelopes, to place them in one of the groups: group a (n = 200) women with intraoperative cervical dilatation; group b (n = 200) women with no intraoperative cervical dilatation. the investigator was not blinded to the procedure allocation. the allocated envelope was opened by the clinician just before the surgery. the procedure allocation was recorded in the women's charts.antibiotic prophylaxis of 1 g of intravenous cefazolin or clindamycin 600 mg was given to each woman when the umbilical cord was clamped. in group 1 patients, the surgeon inserted his or her double-gloved index digit in the cervical canal to dilate it and removed the outer gloves after digital dilatation of the cervix.

Eligibility criteria:
inclusion criteria:patients eligible for inclusion were those who had elective caesarean delivery. they had to be more than 37 weeks gestation. - exclusion criteria:use of antibiotics during the last 24 h, pathology that should be treated with antibiotics, pre-existing maternal diseases, chorioamnionitis, fever on admission, need of transfusion before or during the caesarean section,ruptured membranes, emergency caesarean section and preterm caesarean section. -

Keywords: cervix uteri, cesarean section, infection, dilatation
role of lung function for exercise capacity in well-trained individuals

Conditions: Exercise Performance

Summary: the purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate


Eligibility criteria:
inclusion criteria: * age 18-39 * physically active \> 5 h weekly * maximal oxygen consumption classified as high or very high exclusion criteria: * diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid * ecg abnormality * acq score \> 1.5 * severe bronchial hyperreactivity as determined by mannitol test * fev1/fvc ratio \< 0.7 determined with spirometry * chronic illness determined to be a potential risk for participant during study * in chronic treatment with medication that may interfere with study results * pregnancy * smoker * blood donation during the past 3 months
wound irrigation comparative effectiveness study

Conditions: Cutibacterium Acnes Contamination

Summary: the primary objective of this study is to compare the presence of c acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either normal saline irrigation (group 1) or irrisept irrigation (group 2). secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to c acnes presence among subjects in the two groups.


Eligibility criteria:
inclusion criteria: • ault patients requiring total shoulder arthroplasty exclusion criteria: * age younger than 18 years * history of shoulder infection * antibiotic therapy within 2 weeks of surgery * cortisone infiltration within 3 months prior to surgery * allergy to chg * diagnosis of rheumatoid arthritis * immunocompromised patients
prevention of pacemaker lead induced tricuspid regurgitation by transesophageal echo guided implantation (place)

Conditions: Tricuspid Regurgitation; Pacemaker Complication

Summary: this is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. patients are randomized 1:1 in the two groups and followed up for up to 3 years.

lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and icd-implantation that is associated with increased mortality and hospitalizations for heart failure. transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. this is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. patients are randomized 1:1 in the two groups and followed up for up to 3 years. echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.

Eligibility criteria:
inclusion criteria: * indication for right ventricular lead implantation according to current guidelines exclusion criteria: * preexisting tricuspid regurgitation ≥ grade 2 * other severe heart valve disease * history of tricuspid valve treatment * preexisting right ventricular lead * chronic dialysis * contraindication for transesophageal echocardiography
bone mineral density in adults with hyperphenylalaninemia

Conditions: Phenylketonurias

Summary: hyperphenylalaninemia (hpa) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (pah). elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems. the foundation of this diet is a phe-free medical product/formula made from free amino acids. based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. despite the obvious benefits of the diet, it has been suggested that the dietary restrictions may be associated with poor bone health in these patients. however, data supporting this has been reported in studies with small sample sizes and/or inadequate sample populations that include children. there is a paucity of data on bone health in adults with hpa. the investigators propose an observational study to describe the bone health status among adults with a diagnosis of hpa and to compare them to established normative age and gender-specific values among healthy individuals. the investigators hypothesize that adults with hpa will have lower bone density as measured by a dual x-ray absorptiometry (dxa) scan compared to the established normative values.


Eligibility criteria:
inclusion criteria: * diagnosis of hpa at birth * aged 18 or older exclusion criteria: * peri-menopausal women * menopausal women * patients taking bisphosphonates * pregnant women * women who have been pregnant within one year of study enrollment * women who have breastfed within one year of study enrollment

Keywords: bone mineral density adults
oxytocin via intramuscular injection and intravenous bolus or infusion for prevention of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: the study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (iv) infusion or iv bolus reduces the rate of postpartum hemorrhage compared to intramuscular (im) injection.

the study will compare the effect of iv infusion or iv bolus to im oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.

Eligibility criteria:
inclusion criteria: * all women who present in active labor for a live birth at the study hospital will be considered for participation in the study exclusion criteria: * planned or transferred for delivery via cesarean section * administration of a pre-delivery uterotonic to induce or augment labor * unable to provide informed consent due to mental impairment, distress during labor or other reason

Keywords: postpartum hemorrhage oxytocin prevention third stage of labor hemoglobin intravenous intramuscular bolus