Kornimate/medical-research-clean huggingface dataset:
glutamate and diastolic function in patients undergoing aortic valve repair

Conditions: Hypertrophy, Left Ventricular; Aortic Stenosis; Myocardial Ischemia; Cardiopulmonary Bypass

Summary: purpose: the effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy . methods: 25 patients will be included in this double-blind randomized placebo-controlled study. glutamate was administered intravenously immediately after aortic cross-clamp release. the patients receive either a low dose of 30mg kg-1 h-1 (lg-group) or high dose of 60 mg kg-1 h-1 (hg-group) or placebo (p-group) at a rate of 3.3ml kg-1h-1 for 2h. transesophageal echocardiography (tee) is used to measure diastolic and systolic ventricular function before sternotomy (t0), and 2h (t2), 3h (t3) and 6h (t4) after release of cross clamp. additionally routine hemodynamic parameters are measured intraoperatively.


Eligibility criteria:
inclusion criteria: * severe aortic stenosis * left ventricular hypertrophy of more than 10mm ivs thickness * normal ejection fraction * sr exclusion criteria: * moderately or severely reduced systolic left ventricular function (ejection fraction \<30%) * atrial fibrillation or flutter * intolerance to glutamate.
quantitation of cardiac output change by impedance cardiography in subjects undergoing exercise gated stress/rest tc-99m czt-spect mpi

Conditions: Coronary Artery Disease

Summary: the aim of this study is to test for an early post-stress cardiac output (co) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (czt) spect camera.

single photon emission computed tomography (spect) myocardial perfusion imaging (mpi) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (cad) (1). however, it has been recognized that in certain patients spect mpi is unable to detect the presence of or underestimates the extent of cad. the fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease (2) has stimulated studies to improve the diagnostic accuracy of spect mpi. such studies have analyzed post-stress parameters such as left ventricular (lv) ejection fraction (ef) (3, 4), wall motion abnormalities (5) and transient lv dilation (6) with images acquired on conventional anger cameras as long as 60 minutes after the stress tracer injection. such delayed assessment may miss early ischemic stunning as a result of its transient nature. however, detection of an early post-stress decrease in cardiac output (co) may serve as a potential marker for the presence of significant or extensive ischemia. the aim of this study is to test for an early post-stress co change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (czt) spect camera.

Eligibility criteria:
inclusion criteria: * patients referred to the nuclear cardiology center for a clinically indicated exercise stress mpi study exclusion criteria: * known standard contraindications for ergometry * anemia * hyperthyroidism * intra- and extra-cardiac shunts * significant arrhythmia * hemodialysis
a study of montelukast (mk-0476) compared with fluticasone in pediatric participants with chronic asthma (mk-0476-303)

Conditions: Asthma, Bronchial

Summary: a study to determine the effects of montelukast (mk-0476) on pediatric participants with chronic asthma compared with fluticasone. the primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. this trial was stopped at a time before any participants had actually entered the trial. based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

this study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Eligibility criteria:
inclusion criteria: * between 6 months and 5 years, 4 months of age * diagnosed with asthma by a doctor * at least 3 episodes of asthma symptoms within the last 6 months exclusion criteria: * active or chronic breathing disease, other than asthma * required insertion of a breathing tube for asthma * major surgery within the last 4 weeks * currently in the hospital * allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
cochlear implant low power strategy

Conditions: Hearing Loss

Summary: reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. the commercial mp3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ace strategy. however in order to develop smaller sound processors, further battery life power savings are required. the aim of this study is to evaluate three experimental sets of mp3000 parameter sets, compared against the default ace program. in the background for each of the four strategies, experimental noise reduction programs (spatialnr and nr3) will also be in use. in an additional phase of the study, low stimulation rate ace programs will also be evaluated against the default stimulation rate.


Eligibility criteria:
inclusion criteria: 1. adult (\>18 years) cochlear implant recipients 2. implanted with the ci500, ci24re and nucleus 24 series and ci422 cochlear implants. 3. user of commercially available freedom, cp810 or cp900 series sound processor 4. user of the ace strategy or mp3000 strategy 5. at least 3 months experience with the cochlear implant 6. native speaker in the language used to assess speech perception performance 7. willingness to participate in and to comply with all requirements of the protocol exclusion criteria: 1. additional handicaps that would prevent participation in evaluations 2. unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Keywords: cochlear implants, power consumption,
an efficacy and tolerability study of travatan® versus lumigan®

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study is evaluate effects of travatan® versus lumigan® on intraocular pressure (iop) and ocular surface and inflammatory biomarkers.


Eligibility criteria:
inclusion criteria: * diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment. * intraocular pressure (iop) between 19 mmhg and 35 mmhg in at least one eye, which would be the study eye. * iop considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * able to follow instructions and be willing and able to attend all study visits. * best corrected snellen visual acuity of 6/60 (20/200, 1.0 logmar) or better in each eye. * must read, sign, and date an ethics committee-approved informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the principal investigator. * any abnormality preventing reliable applanation tonometry in either eye. * concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * prior treatment of dry eye with punctal plugs, punctal cautery, restasis® or topical ocular corticosteroids. * history of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications). * contact lens wear. * intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the screening visit. * use of any systemic medications known to affect iop (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to screening visit or an anticipated change in the dosage during the course of the study. * women of childbearing potential not using reliable means of birth control, are pregnant, or lactating. * unwilling to risk the possibility of darkened iris or eyelash changes. * participation in any other investigational study within 30 days prior to the screening visit. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma ocular hypertension
to determine if sleep deprivation results in increased esophageal acid exposure

Conditions: Gastroesophageal Disease

Summary: the purpose of this study is to determine if sleep deprivation results in increased esophageal acid exposure in healthy controls and gastroesophageal reflux disease (gerd) patients.

to determine if increased esophageal acid exposure is mediated by altering appetite regulation. to assess if there is any relationship between sleep deprivation and the serum level of tnf-alfa (a protein that can be elevated in inflammation).

Eligibility criteria:
inclusion criteria: * male/female - 18-80 * 2 or more episodes of heartburn a week for last 3 months exclusion criteria: * previous upper gi surgery * underlying co-morbidity * narcotic medications * psychotropic's and benzodiazapines medications * hx of psychological abnormalities * hx of etoh in previous 6 mos. * diabetes mellitus * neuropathy * seizures * sleep apnea * co-morbidity that interfere w/sleep * women who are pregnant, or childbearing yrs, not on bc

Keywords: gerd sleep deprivation appetite regulation ghrelin leptin
an open label treatment use protocol for ibrutinib in subjects with relapsed or refractory mantle cell lymphoma

Conditions: Relapsed or Refractory Mantle Cell Lymphoma

Summary: the purpose of this study is to provide patients who have relapsed or refractory mantle cell lymphoma (mcl) with early access to an investigational medication called ibrutinib (pci-32765) and to collect safety information about the drug.


Eligibility criteria:
inclusion criteria: * patients, 18 years of age and older, with mantle cell lymphoma who have relapsed or refractory disease after prior therapy are eligible. exclusion criteria: * patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible. * patients previously treated with ibrutinib are not eligible. * patients enrolled in another interventional clinical study with therapeutic intent are not eligible.

Keywords: mantle cell lymphoma ibrutinib
treatment of olfactory dysfunction in seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: people with allergies frequently complain of a loss or reduction in the sense of smell. in this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.


Eligibility criteria:
inclusion criteria: 1. males and females between 18 and 59 years of age. 2. seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction. 3. positive skin or rast test to allergen. 4. symptoms of olfactory dysfunction. 5. no significant history of chronic sinusitis. exclusion criteria: 1. women of childbearing potential not using the contraception method(s) (birth control pills, depo provera, double barrier) as well as women who are breastfeeding. 2. patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 3. use of any other investigational agent in the last 30 days. 4. absence of olfactory or nasal symptoms. 5. use of medications that may affect olfaction. 6. medical conditions that may affect olfaction. 7. smoking. 8. uri at the time of screening.
maintenance electroconvulsive therapy (ect) versus aripiprazole in clozapine-resistant schizophrenia

Conditions: Clozapine Resistant Schizophrenia

Summary: the pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. few studies have found ect as beneficial in trs, including crs. however, literature on the role of m-ect in maintaining the therapeutic gains of acute ect in crs is lacking. the objective of the study is to compare the efficacy of m-ect vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with crs.


Eligibility criteria:
inclusion criteria: 1. patients clinically diagnosed with crs (currently under clozapine) 2. patients aged 18-60 years of either sex. 3. lar giving voluntary written consent for participation in the study exclusion criteria: 1. patient already on ect or aripiprazole. 2. history of psychoactive substance abuse or dependence. 3. co-morbid psychiatric, major medical or neurological disorders. 4. history of organicity or significant head injury. 5. pacemaker or metal in any body part, excluding the mouth. pregnant and breastfeeding females.

Keywords: clozapine resistant schizophrenia aripiprazole m-ect
physical exercise and telephone follow-up mediated by telerehabilitation

Conditions: Cardiac Failure

Summary: cardiovascular diseases are the leading cause of death and disability globally, accounting for approximately 31% (17.9 million) of all deaths each year. the covid-19 pandemic has led to the total suspension of most cardiac rehabilitation programs at the highest peaks of the spread, forcing people not to leave home, enhancing metabolic conditions and generating further complications due to sedentary lifestyle. physical exercise is an essential component in the rehabilitation of patients with heart failure disease, evidencing improvements in quality of life, functional capacity, in addition to reducing the mortality rate, number of rehospitalizations, and levels of depression. it is necessary to carry out interventions adapted to the needs of patients who have difficulties traveling to health centers, however, some authors report that remotely oriented exercise could present results similar to those of traditional rehabilitation in a center or therefore, promoting a cardiac telerehabilitation program together with telephone educational follow-up could cause greater improvements compared to other cardiac rehabilitation and telerehabilitation programs. objective: to determine the effects of a physical exercise program and telephone educational follow-up mediated by cardiac telerehabilitation in patients with heart failure on functional capacity, depression, and health-related quality of life.

a randomized controlled clinical trial type study will be carried out, in a period of 6 months between the year 2022, in patients with a diagnosis of heart failure who enter a cardiac rehabilitation program in the city of santiago de cali, colombia, linking to the research after the consultation with cardiology in three groups: physical exercise program and conventional educational component with telephone follow-up (intervention), physical exercise program and conventional educational component mediated by cardiac telerehabilitation, to which measurements of sociodemographic variables and clinical before-after measurements (physiological, paraclinical, anthropometric) functional capacity, quality of life and state of depression.

Eligibility criteria:
inclusion criteria: * patients previously diagnosed by a cardiology specialist with heart failure. * patients who present an indication to exercise. * patients who have digital equipment such as a computer, tablet or cell phone with access to virtual platforms to carry out exercise sessions mediated by technology. * participants who accept and sign the informed consent. exclusion criteria: * patients with respiratory comorbidity or who present some limitation to perform active and resisted movements (recent fractures, recent hemodynamic alterations, coronary disease event after the diagnosis of cardiovascular disease, infectious diseases and neuromuscular limitation).

Keywords: rehabilitation telerehabilitation
medical antiarrhythmic treatment or radiofrequency ablation in ischemic ventricular tachyarrhythmias

Conditions: Myocardial Infarction; Ventricular Tachyarrhythmia

Summary: the study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.

the study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (icd). the patients have not been using using chronic antiarrhythmic medication. primary end point is number of icd therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several icd and arrhythmia related issues. total length of the follow-up is at least two years.

Eligibility criteria:
inclusion criteria: * patients 18-80 years of age with prior myocardial infarction and icd (single chamber, dual chamber icd or icd with biventricular pacing capability (crt-d)) for primary or secondary prevention of sudden cardiac death (scd), who have had at least two documented episodes of sustained vt or vf and no chronic amiodarone treatment for ventricular tachyarrhythmias exclusion criteria: * age less than 18 years or more than 80 years * non-ischemic cardiomyopathy * ongoing chronic treatment of ventricular tachyarrhythmias with amiodarone, intolerance/contraindication to all class iii antiarrhythmic drugs (i.e., intolerance/contraindication to one class iii agents is not excluding the patient if another one can be used) * contraindication to endocardial catheter ablation (e.g., intracavitary thrombi, contraindication to perioperative anticoagulation) * previous vt/vf ablation * open heart surgery within 3 months * prosthetic heart valve * planned revascularization (pci or cabg) * surgery for structural heart disease or heart transplantation * pregnancy or planned pregnancy within the follow-up period * secondary cause for vt/vf (e.g., acute myocardial infarction) * patient does not want to participate * life expectancy less than 12 months

Keywords: implantable cardioverter defibrillator antiarrhythmic medication catheter ablation
a rct study of eras in infants with choledochal cyst

Conditions: Enhanced Recovery After Surgery; Infant ALL; Cholangiectasis

Summary: recently, with reference to the successful experience of accelerated rehabilitation surgery in the field of adult surgery, the investigators have conducted studies on eras in pediatric and even infant cholangiectasia surgery to discuss its feasibility and safety. the results showed that some items of eras could be safely applied in perioperative management of cbd, and could reduce traumatic stress and promote postoperative recovery. therefore, the investigators assumed that the eras protocols could be safely applied in the treatment of cbd in children and even infants, reducing traumatic stress in children with cbd, promoting postoperative rehabilitation, reducing complications and hospitalization time, reducing hospitalization costs, and saving medical resources.

1. optimize preoperative, intraoperative and postoperative perioperative management by learning from the successful experience of accelerated rehabilitation surgery model in other fields. for example: necessary and sufficient preoperative education of children and guardians; short fasting before surgery; oral carbohydrate at 2h before surgery; breast feeding at 4h before surgery (formula feeding at 6h before surgery); improved intestinal preparation; irregular placement of nasogastric tube; the use of general anesthesia plus epidural or sacral block anesthesia during surgery; attention to the whole process of heat preservation; strict control of infusion volume; and selection of minimally invasive hands methods of operation; early postoperative activity, multi-mode analgesia, etc. 2. according to the pathophysiological characteristics of infants with cholangiectasia, several aspects were studied: minimally invasive surgery；promote gastrointestinal motor function recovery；develop principles and plans for early postoperative feeding；rational placement of abdominal drainage tube; precise choice of anesthesia method, etc.

Eligibility criteria:
inclusion criteria: * infants aged 0-12 months * according to the clinical manifestations and preoperative imaging examination, the children admitted to hospital were diagnosed with choledochal cyst * the legal guardian of the child signs the informed consent exclusion criteria: * have potentially life-threatening diseases of various organ systems * preoperatively associated with other diseases that interfere with the treatment process of the child * caroli's disease was diagnosed * any other condition that the investigator deems unsuitable for participation in the trial