Kornimate/medical-research-clean huggingface dataset:
myocardial function assessment in patients with coronary artery disease using noninvasive myocardial work

Conditions: Noninvasive Myocardial Work; Coronary Artery Disease

Summary: noninvasive pressure-strain loop (psl) derived myocardial work (mw) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. the aim of this study was to assess left ventricular (lv) myocardial function in symptomatic patients with coronary artery disease using the promising method. methods: transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. images were stored and imported into the software for further offline analysis of psl-based mw. mw analysis were carried out on each patient for global and regional myocardial function assessment.


Eligibility criteria:
inclusion criteria: patients who were hospitalized for coronary angiography with angina or equivalent symptoms. - exclusion criteria: acute coronary syndrome, left main stem coronary disease, left ventricular ejection fraction (lvef) below 55%, observed resting regional wall motion abnormalities (rwmas), non-sinus rhythm, intraventricular block, previous cardiac surgery, severe valvular heart disease, hypertrophic cardiomyopathy, myocarditis, pericardial diseases, pulmonary hypertension, and poor image quality. -
the efficacy of topical bupivacaine and triamcinolone acetonide injection in the relief of pain after endoscopic submucosal dissection for gastric neoplasia: a randomized double-blind, placebo-controlled trial

Conditions: Gastric Cancer; Gastric Adenoma

Summary: although pain is a common complication of endoscopic submucosal dissection (esd), management strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and in pain associated with surgery in clinical practice. further, triamcinolone, a type of steroid, is often mixed with bupivacaine to lengthen the analgesic effect. the aim of this study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for abdominal pain relief and as a potential method of pain control after esd for gastric neoplasia. we hypothesized that topical bupivacaine and/or triamcinolone acetonide injection after esd would be effective for pain relief. for this, we designed randomized, double-blind, placebo-controlled trial. eligible patients with early gastric neoplasm were randomized into one of three groups: bupivacaine (bv) only, bupivacaine with triamcinolone (bv-ta), or placebo. to evaluate the pain after esd, the present pain intensity (ppi) score and the short-form mcgill pain questionnaire (sf-mpq) were used to evaluate pain at 0, 6, 12 and 24 h after esd.


Eligibility criteria:
inclusion criteria: * age, between 20 and 80 * patients who were scheduled to undergo esd for gastric epithelial neoplasm at severance hospital between july 2012 and april 2013 exclusion criteria: * not providing written informed consent * a history of any cardiac arrhythmias * current or regular use of analgesic medication for other indications * known other disease such as peptic ulcer disease or reflux esophagitis which could induce upper gastrointestinal pain * multiple lesions requiring esd in a single patient * evidence of infectious disease or antibiotics therapy within 7 days prior to enrollment * participation in another clinical trial within 30 days prior enrollment * current pregnancy or breast feeding.

Keywords: bupivacaine, triamcinolone acetonide, endoscopic submucosal dissection patients
progesterone on the day of ovulation induction is associated with pregnancy outcome

Conditions: Female Infertility

Summary: progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. the hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity.


Eligibility criteria:
inclusion criteria: * ivf/icsi following controlled ovarian stimulation * progesterone measured on the day of ovulation induction * informed consent exclusion criteria: * missing consent

Keywords: ivf progesterone ovulation induction pregnancy rates female infertility due to nonimplantation
senior adult hepatobiliary prehab study

Conditions: Hepatobiliary Cancer; Cholangiocarcinoma; Liver Metastases

Summary: the purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.


Eligibility criteria:
inclusion criteria: * age ≥65 years * resectable hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis with liver resection planned ≥4 weeks * ecog 0-2 * able to sign consent exclusion criteria: * does not meet inclusion criteria
more options available with a quadripolar lv lead provide in-clinic solutions to crt challenges

Conditions: Postoperative Cardiac Complication; Heart Failure; Left Ventricular Cardiac Dysfunction; Inappropriate Phrenic Nerve Stimulation; Perioperative/Postoperative Complications

Summary: this investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and phrenic nerve stimulation (pns), both at implant and during follow-up, compared to standard bipolar left ventricular leads.


Eligibility criteria:
inclusion criteria: * patients are indicated for cardiac resynchronization therapy with defibrillation backup device (crt-d) implantation, as per current international certified guidelines * patients age is 18 years or greater * patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form * patients must be willing and able to comply with all study requirements exclusion criteria: * patients with a life expectancy \<12 months. * patients who are or may potentially be pregnant. * patient has suffered any of the following in the 4 weeks prior to enrolment: * myocardial infarction (mi) * coronary artery bypass graft (cabg) * unstable angina pectoris * patient has primary valvular disease which has not been corrected

Keywords: cardiac resynchronization therapy, heart failure, left ventricular lead, quadripolar left ventricular lead, phrenic nerve stimulation, intra and post operative related complications
can shear wave elastography predict the success of eswl: a prospective study

Conditions: Kidney Stone

Summary: can shear wave elastography predict the success of shock-wave lithotripsy used in renal stones treatment ? a prospective study

extracorporeal shock-wave lithotripsy (eswl) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones. this study is a trial to determine the predictive role of shear wave elastography in the success of eswl management of kidney stones.

Eligibility criteria:
inclusion criteria: * patients more than 18 years * with single radiopaque renal stone * ranging in size from (1-1,5 cm) for eswl. exclusion criteria: * any urological abnormal anatomy * lower calyceal stone more than 1cm * impaired renal functions * uncorrected coagulopathy. * active uti pregnancy single kidney multiple stones
17-ohpc in pregnancy: im vs sc routes

Conditions: Preterm Birth

Summary: this study will compare the plasma concentration x time curve or area under the curve (auc) and the side effects reported with 250 mg intramuscular (im) and 275 mg subcutaneous (sc) injections of 17-hydroxyprogesterone caproate (17-ohpc).

17-hydroxyprogesterone caproate (17-ohpc) is used in women with a prior preterm birth (ptb) as it reduces recurrences by a third. the drug is administered intramuscularly (im) but that creates discomfort and in many instances requires repeated office visits as the drug is administered weekly from 16-20 weeks until 36 weeks or delivery. amag pharmaceuticals obtained fda approval to administer the drug subcutaneously (sc) based on demonstration of bioequivalence of a dose of 275 mg sc to a dose of 250 mg im. that bioequivalence study was performed in postmenopausal women who received a single dose. this study will be performed in pregnant women with repeated injections both to demonstrate that equivalent exposure is seen and to assess the side effects and acceptance of each route of administration. a pharmacokinetic (pk) study will be performed after participants have reached steady state (after 9 injections). participants will receive their injections from research personnel up until the time of completion of the pk study. home injections will be an option for all participants after the pk study is completed.

Eligibility criteria:
inclusion criteria: 1. pregnant female with documented prior birth between 16 0/7- 36 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes 2. gestational age (ga) \< 22 weeks, based on study determined ga (as treatment must start between 16 0/7 and 21 6/7 weeks) 3. singleton gestation 4. age between 18 - 45 years 5. able to give informed consent and undergo all study procedures including a single seven day pharmacokinetic study which requires daily venipunctures and willingness to answer questions about side effects and discomfort at each study visit. exclusion criteria: 1. known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery 2. malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus) 3. medical or obstetrical complication that might affect gestational age at delivery, such as active ulcerative colitis, liver tumors, liver disease/failure, renal disease/failure, undiagnosed vaginal bleeding unrelated to pregnancy, or hypertension requiring 2 or more agents 4. current or history of thrombosis or thromboembolic disorders 5. known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions 6. moderately severe depression (patient health questionnaire-9 (phq-9) score ≥15, edinburgh postnatal depression scale (epds) score of \>13, or suicidal ideation)

Keywords: 17-hydroxyprogesterone caproate
protocol for evaluation of quarter-time cardiac imaging: 5-minutes rest and 3-minutes stress wide beam reconstruction (wbr) versus full-time filtered back projection (fbp)

Conditions: Cardiac Diseases

Summary: a new, innovative software image processing method, wide beam reconstruction (wbr), utilizes resolution recovery and incorporates poisson noise-reduction into the reconstruction process of nm images. this method facilitates the reconstruction of low count density myocardial perfusion spect images. preliminary research indicates that spect acquisition time consequently can be reduced by 60% (less than 5 minutes) for rest and by 75% (just over 3 minutes) for stress, while tomographic image quality is maintained, or even improved. such a decrease in image acquisition time decreases patient discomfort during the tomographic acquisition, decreases the opportunity for patient motion, and improves laboratory efficiency.

standard full-time spect will be processed using fbp and compared to 3-minute stress and 5-minute rest scans processed with wbr. the following scan parameters will be evaluated: image quality; perfusion defect extent, severity, and reversibility; transient ischemic dilatation; left ventricular end-diastolic volume; left ventricular end-systolic volume; left ventricular ejection fraction; and regional wall motion and wall thickening abnormalities. these parameters will be assessed visually by experienced nuclear physicians (at least 2 blinded readers) and quantitatively using several different commercially available software programs.

Eligibility criteria:
inclusion criteria: * patient is clinically stable * patient is able to tolerate additional 8 minutes of scanning * patient is willing to undergo additional 8 minutes of scanning exclusion criteria: * unstable patient * non-consenting patient
antiplatelet effect of low doses of aspirin taken every 12 hours in patients undergoing coronary artery bypass graft and/or aortic valve surgery

Conditions: Coronary Arteriosclerosis

Summary: this study is a randomized open label study that implies the administration of asprin according to three different regimens. the aims of the study are: * to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane a2. * to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet cox-1. the endpoints of this study are: - to evaluate the changes in the levels of txb2 and 12-hete in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro txb2 urinary 8-iso-pgf2 alpha urinary, 2-3 dinor-6-chetopgf1 alpha, verify-now aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin


Eligibility criteria:
inclusion criteria: * informed consent of the study signed * coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses * age between 55 and 80 * ejection fraction \> 30%. exclusion criteria: * excessive bleeding (\> 1000ml / 6 h) or the need of re operation for bleeding * perioperative myocardial infarction * stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation * patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention * patients undergoing off-pump coronary artery bypass graft * overt kidney or liver disease * therapies that influence the coagulation * fertile women
incagn01876 in combination with immune therapies in subjects with advanced or metastatic malignancies

Conditions: Advanced Malignancies; Metastatic Cancer

Summary: the purpose of this study is to determine the safety, tolerability, and efficacy of incagn01876 when given in combination with immune therapies.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * phase 1: subjects with advanced or metastatic solid tumors. * phase 1: subjects who have disease progression after treatment with available therapies. * phase 2: subjects with advanced or metastatic melanoma, rcc, and urothelial carcinoma. * presence of measurable disease based on recist v1.1. * eastern cooperative oncology group performance status of 0 or 1. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range * prior treatment with any tumor necrosis factor super family agonist. * receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * has not recovered to ≤ grade 1 from toxic effects of prior therapy. * active autoimmune disease. * known active central nervous system metastases and/or carcinomatous meningitis. * evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * evidence of hepatitis b virus or hepatitis c virus infection or risk of reactivation. * known history of human immunodeficiency virus (hiv; hiv 1/2 antibodies).

Keywords: cervical cancer endometrial cancer gastric cancer (including stomach and gastroesophageal junction (gej)) esophageal cancer hepatocellular carcinoma (hcc) melanoma (mucosal or cutaneous) merkel cell carcinoma mesothelioma microsatellite instability-high (msi-h) solid tumors non-small cell lung cancer (nsclc) ovarian cancer squamous cell carcinoma of the head and neck (scchn) small cell lung cancer (sclc) renal cell carcinoma (rcc) triple-negative breast cancer (tnbc) urothelial carcinoma glucocorticoid-induced tumor necrosis factor receptor (gitr)
a study to assess disintegration of the new aspirin disintegrating tablets

Conditions: Moderate Pain

Summary: the aim of this study is to assess disintegration of the new aspirin disintegrating tablets


Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18 to 65 years included * verified diagnosis of "healthy" * non-smokers or passive smokers * bmi in the range of 18.5 to 30 kg/m2 * subject has given written informed consent to participate in the trial prior to admission to the trial exclusion criteria: * blood donation within the last 90 days prior to planned randomization * any previous medication within 10 days before the planned administration of the radiolabelled investigational medicinal product (rimp) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety * subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct. * vegetarian * subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 millisievert), or will exceed 10 millisievert over any three year period
dental plaque removal evaluation and comparison of kid's battery-operated toothbrush and manual toothbrush

Conditions: Plaque, Dental

Summary: to evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

this is a single use, examiner blinded, randomized, two-period, cross-over, irb-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. this study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. qualified subjects with sufficient plaque, according to rustogi modified navy plaque index (rmnpi) will be randomly assigned to one of two sequence treatment groups. after the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.

Eligibility criteria:
inclusion criteria: 1. 5 to 8 years 2. be a regular manual toothbrush user. exclusion criteria: 1. have any physical limitations or restrictions which might preclude normal tooth brushing. 2. have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments. 3. have fixed or removable orthodontic appliances.
68ga-nota-rm26 pet/ct in glioma patients

Conditions: Glioma

Summary: the aim of this study was to investigate the value of 68ga-nota-rm26, an antagonist targeting gastrin-releasing peptide receptor (grpr) pet tracer, in the diagnosis of high who grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (pet/ct).

the gastrin-releasing peptide receptor (grpr), also known as bombesin receptor subtype ii (bb2), is a member of the g protein-coupled receptor family of bombesin receptors. grpr is over-expressed in various types of human tumors including breast cancer. rm26, a grpr antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.to target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide nota-rm26 was synthesized with a peg3 linker between nota and rm26, and then labeled with 68ga. an open-label brain pet/ ct study was designed to assess its clinical diagnostic value in patients with glioma.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated glioma patients * signed written consent. exclusion criteria: * pregnancy * breastfeeding * known allergy against pentixafor * any medical condition that in the opinion of the investigator,may * significantly interfere with study compliance
validation of betalactam ml prediction models - tdmaide

Conditions: Infections

Summary: the goal of this study is to learn about the real wold behavior of developed machine learning models that predict the plasma concentration of piperacillin-tazobactam and meropenem in critically ill patients admitted to the intensive care unit (icu). the main aim of the study is to validate the performance of these machine learning models. to this end, daily measured plasma concentrations of the investigated antimicrobials will be compared with the predicted concentration by the machine learning algorithms. additional goals of the study include: * to describe the total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the icu. * to quantify the correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of side effects. * to evaluate the perceived necessity of therapeutic drug monitoring (tdm) of consultants and physicians in training working in the icu. * to evaluate the perceived added value of daily tdm. samples (where possible taken routinely) from participating patients will be analyzed for meropenem and piperacillin-tazobactam plasma concentration. participating physicians will be asked to fill in a short daily questionnaire during the time a patient under their care is treated with the antimicrobial under investigation.


Eligibility criteria:
patients inclusion criteria: * admission to the icu. * age above 18 years old. * treatment with piperacillin-tazobactam or meropenem for less than 48 hours. exclusion criteria: * pregnant or lactating patients. * limitation of therapy beyond "do not resuscitate". * expected demise within 48 hours after inclusion. * haemoglobin \< 7 g/dl. * previous inclusion in this study for a treatment course with the same antimicrobial. consultants and physicians in training inclusion criteria: * consultant or physician in training working in the icu. exclusion criteria: * none

Keywords: artificial intelligence machine learning pk/pd piperacillin-tazobactam meropenem intensive care unit