Kornimate/medical-research-clean huggingface dataset:
clevidipine bolus administration in the treatment of hypertensive patients undergoing cardiac surgery (sprint)

Conditions: Hypertension

Summary: this study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective l-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.

study participants were screened up to 14 days prior to their elective cardiac surgery. for the purpose of this study, hypertension was defined as systolic blood pressure (sbp) ≥140 mm hg immediately prior to initiation of study drug. on the day of surgery, an iv bolus dose of clevidipine (bolus 1 - pre-anesthesia) was administered to each eligible study participant during treatment period 1 to decrease bp before induction of general anesthesia. the dose (either 125 μg, 250 μg or 500 μg) given was based on the assigned cohort for each participant, listed in the 'arms' section below. at the discretion of the investigator, a second iv bolus dose of clevidipine (bolus 2 - with anesthesia) could have been administered during treatment period 2 at either 125 μg, 250 μg or 500 μg, based upon the earlier observed response to bolus 1. this dose was administered after the induction of anesthesia, to decrease bp prior to cannulation of the ascending aorta for initiation of cardiopulmonary bypass. assessment of safety was performed throughout treatment periods 1 and 2 with adverse events (aes) followed 6 hours post final bolus dose and serious adverse events (saes) followed 24 hours post final bolus dose.

Eligibility criteria:
inclusion criteria: * require elective cardiac operation involving the use of cardiopulmonary bypass * age 18 years or older * a history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator * written informed consent * pre-anesthesia baseline sbp ≥140 mm hg just prior to bolus, measured using an arterial line exclusion criteria: * receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing * critical left main coronary artery stenosis * critical aortic valve (\<0.5 cm3) or mitral valve (\<1.0 cm3) stenosis * acute myocardial infarction within the prior 14 days * fully paced cardiac rhythm * known or suspected aortic dissection * requiring preoperative intra-aortic balloon pump counterpulsation therapy * contraindication to transesophageal echocardiography * positive pregnancy test or breast feeding * intolerance or allergy to calcium channel blockers * allergy to soybean oil or egg lecithin * any condition(s) that in the investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study * participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

Keywords: hypertension antihypertensive agent calcium channel blocker
risk factors of individuals with coronary artery disease

Conditions: Coronary Artery Disease

Summary: it would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. environmental and genetic factors may play a role in the progression of coronary artery disease. the goal of this project is to establish a series of cross-sectional / case-control studies to evaluate risk factors of coronary artery disease in china.

this study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with coronary artery disease. the study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. the diagnosis of coronary artery disease will be confirmed by coronary angiography performed with the judkins technique using a quantitative coronary angiographic system. coronary artery disease will be considered to be present if there is a diameter stenosis of at least 50% in at least one of the three major epicardial coronary arteries. the number of diseased vessels will be determined and a classification of 1-, 2-, and 3-vessel disease will be used. coronary artery segments will be defined according to the coronary artery surgery study classification. blood samples from vein and coronary artery will be collected. we will study coronary arteriovenous difference of various markers. urinary samples will be obtained the day of coronary angiography. we will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress factors, angiogenic factors, and inflammatory markers, etc.) and genetic (including oxidative stress factors and inflammatory factors, etc.) risk factors. we will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of coronary artery disease.

Eligibility criteria:
inclusion criteria: * this is a study only of chinese. * subjects will be allowed to participate if they self-identify as chinese. * the age range of the participants will be between 18 and 89 years. * the study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. exclusion criteria:
monitoring in congestive heart failure study

Conditions: Congestive Heart Failure

Summary: this is a multi-center, non-randomized study designed to develop an external monitor for chf patients.

heart failure patients will be externally monitored. the collected information will be used to assess patient status.

Eligibility criteria:
inclusion criteria: 18 years of age or older

Keywords: congestive heart failure
prospective single center open label study of shoulder oa pain

Conditions: Osteoarthritis

Summary: open label, prospective, single cohort study of durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients

subjects 19-85 years old will receive a single intra-articular (ia) injection of durolane® 3ml given for the relief of pain in the treatment of symptomatic osteoarthritis (oa) of the shoulder followed over a 26-week time period.

Eligibility criteria:
inclusion criteria: * diagnosis of glenohumeral osteoarthritis * spom score greater than or equal to 50 in study shoulder * willing to discontinue oral and topical analgesia other than rescue acetaminophen * abstinence from any other ia or per-articular injections for the shoulder during the course of the trial * patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month * pain at least 50% of the days during previous month * patients who have failed conventional therapy of nsaids or steroid injections * patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder * cooperative and able to communicate effectively * agree not to participate in any other studies during trial exclusion criteria: * significant pain from other joints requiring chronic analgesic therapy * presence of one or more conditions besides oa that could confound pain and functional assessments * clinically apparent tense effusion, malalignment or instability in study shoulder * shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity * inability to abstain from analgesic use other than rescue acetaminophen * ia injections of steroids to the study shoulder within 3 months or any other joint within the prior month * ia injection of hyaluronic acid in the study shoulder within 9 months of baseline * allergic reaction to ha * any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder * uncontrolled hypothyroidism * pregnant or breastfeeding women * planned surgical procedure * history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site * treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline

Keywords: degenerative arthritis
continued access study of adefovir dipivoxil (adv) for patients w/chronic hbv infection.

Conditions: Hepatitis B

Summary: provide adefovir dipivoxil (hepsera) 10 mg once daily to patients with chronic hepatitis b virus (hbv) infection who have completed a gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.

the objective of this study is to provide adefovir dipivoxil 10 mg once daily to patients with chronic hepatitis b virus(hbv) infection who have completed a gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil. the secondary objective of this study is to evaluate the safety of chronic therapy with adefovir dipivoxil 10 mg.

Eligibility criteria:
inclusion criteria: * must have completed one of the following gilead-sponsored studies as indicated: gs-96-412, gs-98-437, gs-98-438, gs-00-461 and gs-00-481. if the patient has participated in another gilead-sponsored study, the cro or sponsor's medical monitor will evaluate for participation in this study on a case by case basis. exclusion criteria: * any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements. * currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin b, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine or competitors of renal excretion such as probenecid and sulfinpyrazone. these agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil. * currently receiving investigational agents with activity against hepatitis b virus. * hypersensitivity to any of the components of the drug product. * pregnant or lactating females. * inability to comply with study requirements. * experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.

Keywords: chronic hepatitis b
postural re-education in low back pain

Conditions: Low Back Pain

Summary: the global postural re-education is a global approach for the treatment of musculoskeletal disease. using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular breathing pattern to maintain a correct posture and feeling it.

in some countries there is a physical therapy method called "global posture reeducation" (gpr), which was developed by philippe emmanuel souchard based on 20 years of clinical experience.the method consist to balance the miofascial tension probably responsible for an articular overloading. the method stretches the shortened antigravity muscles that are inside a different static muscles chains. gpr is a global approach that search the biomechanics cause in the near areas, and involves actively the patient in the postural and gestural changes.

Eligibility criteria:
inclusion criteria: * lumbalgia diagnosis * age 18-80 exclusion criteria: * migrated hernia * calcified disc hernia * spondylolisthesis * other physiotherapeutic interventions within 6 months of the baseline assessment. * surgical operation within six months of baseline * cancer syndrome, neurological and rheumatic diseases

Keywords: exercise low back pain posture rehabilitation
a multiple myeloma trial in patients with bone metastases

Conditions: Multiple Myeloma

Summary: the purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (iv) every 3 - 4 weeks for 2 years. patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * confirmed diagnosis of multiple myeloma * stable renal function defined as two serum creatinine determinations of \< 3 mg/dl * calculated creatinine clearance of greater than or equal to 30 ml/min * ecog performance status of 0 or 1 * life expectancy of greater than or equal to 9 months * if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * ability to comply with trial requirements and give informed consent. exclusion criteria: * iv bisphosphonate therapy for more than 3 years. * patients with a diagnosis of amyloidosis. * known hypersensitivity to zoledronic acid or other bisphosphonates * pregnant patients or lactating patients. * women of childbearing potential not on a medically recognized form of contraception * patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.

Keywords: z-max, multiple myeloma, zoledronic acid, bone metastases
maternal high blood pressure and newborn's blood profile

Conditions: Maternal-Fetal Exchange

Summary: maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. the purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.

pregnancy induced hypertension (pih) and preeclampsia (pree) are caused by gestation and have an onset after 20 weeks of pregnancy. although the exact etiology of pih and pree remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. the endothelium has been identified as the target tissue of the disease. endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. the neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. this study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. the current retrospective observational study was conducted at the clinic of obstetrics, gynecology and neonatology of the emergency county hospital, timisoara over a period of three years, from january 2014 to december 2016. all inborn patient files were analyzed as anonymised limited data sets from archived records of the neonatology department.

Eligibility criteria:
inclusion criteria: * age: 0-28 days * newborns of healthy mothers; * newborns of mothers with pregnancy induced hypertension; * inborn patients; * written informed consent signed by legal guardian. exclusion criteria: * maternal disease other than pih; * syndromal, chromosomal or infectious diseases of the newborns; * causes other then pih for perinatal asphyxia.

Keywords: maternal pih neonatal thrombocytopenia neonatal neutropenia
evaluation of diasorin liaison® ptx3 (long pentraxin 3) assay in patients with pneumonia

Conditions: Pneumonia

Summary: liaison® ptx3 is an in vitro chemiluminescent immunoassay (clia) intended for the quantitative determination of long pentraxin 3 (ptx3) in human plasma samples. liaison® ptx3, in conjunction with clinical evaluation and other laboratory findings, may serve as an aid in the determination of disease severity and prognosis of patients with community-acquired (cap) and hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap).

long pentraxin 3 (ptx3) is an essential protein of innate immunity, produced by myeloid cells, endothelial cells and respiratory epithelial cells, and involved in resistance to selected pathogens and in inflammation. in different pathological conditions (infections of bacterial and viral origin, sepsis, and cardiovascular diseases) and in patients requiring admission to intensive care units (icus), ptx3 was detected in high concentrations in the circulation and was associated with disease severity and mortality. ptx3 plasma concentration was found to be an independent prognostic indicator of short-term mortality (28 days) in hospitalized patients with coronavirus disease 2019 (covid- 19) and higher ptx3 levels were found in icu patients compared to ward patients. moreover, ptx3 significantly correlated with the inflammatory molecules c-reactive protein (crp), procalcitonin (pct), and interleukin (il)-6. given the association between ptx3 and inflammatory conditions, especially in the context of lung infections, the study aims to investigate the potential of ptx3 to be used as a severity marker and a prognostic predictor for outcome in patients with community-acquired (cap) and hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap).

Eligibility criteria:
inclusion criteria: * subjects willing and able to sign the approved informed consent form in accordance with international and national regulations * patients diagnosed with pneumonia, either cap, hap, vap * collection of plasma samples within 24 hours from pneumonia diagnosis (for cap diagnosis is usually made at ed presentation and for hap and vap diagnosis is made during hospital stay) * k2 edta plasma samples dedicated to the study have a minimum volume of 3 ml exclusion criteria: * patients who are currently pregnant * samples collected and/or stored in an inappropriate way
obstructive sleep apnea master protocol gpif: a study of tirzepatide (ly3298176) in participants with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Obesity

Summary: the purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use positive airway pressure (pap) therapy in gpi1 and those who are and plan to stay on pap therapy in gpi2.


Eligibility criteria:
inclusion criteria: for gpi1 participants: - participants who are unable or unwilling to use pap therapy. participants must not have used pap for at least 4 weeks prior to screening. for gpi2 participants: - have been on pap therapy for at least 3 consecutive months prior to screening and plan to continue pap therapy during the study for both gpi1 and gpi2 participants: * have an ahi ≥15 on psg as part of the trial at screening * have a body mass index (bmi) ≥30 kilogram/square meter (kg/m²) * have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight exclusion criteria: for gpi2 participants: * have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop pap therapy for 7 days prior to psg testing during the course of the study * are unwilling to stop pap therapy for 7 days prior to polysomnography (psg) testing during the course of the study for gpi1 and gpi2 participants: * female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. * have type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm), history of ketoacidosis, or hyperosmolar state/coma. * have hba1c ≥ 6.5% (≥ 48 mmol/mol) at baseline * any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline * have significant craniofacial abnormalities that may affect breathing at baseline * have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of cheyne stokes respiration * diagnosis of obesity hypoventilation syndrome or daytime hypercapnia. * active device treatment of osa other than pap therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study. * respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. * have a self-reported change in body weight \>5 kg within 3 months prior to screening * have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening) * have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
screening hepatitis positive women for congenital anomalies

Conditions: Hepatitis C

Summary: hepatitis c virus is one of the virulent viruses

hepatitius positive women should be screened for congenital anomalies

Eligibility criteria:
inclusion criteria: * pregnant women with hepatitis c virus received treatment during first trimester exclusion criteria: * pregnant women with hepatitis c virus who didnot receive treatment during first trimester
tolerance of myocardium to ischemia injury

Conditions: Reperfusion Injury; Myocardial Ischemia

Summary: this study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.


Eligibility criteria:
inclusion criteria: * patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation * patient in sinus rhythm at the time of surgery * patient older than 18 * patient able to understand the information and consent forms exclusion criteria: * medical history of type 2 diabetes, atrial fibrillation or use of class iii anti-arhythmic drug * left ventricle ejection fraction \< 40% * pregnancy * patient in emergency condition
double ligation and topical silver nitrate

Conditions: Umbilical Granuloma

Summary: to study and compare the efficacy and safety of double ligation and topical silver nitrate solution while treating children with umbilical granulomas

the patients underwent one treatment option and then followed up for three weeks and the results noted in terms of success/failure and complications specific to each treatment option and analysed accordingly

Eligibility criteria:
inclusion criteria: 1. patients of umbilical granuloma, less than 1 year age exclusion criteria: 1. patients who already had any treatment 2. parents refused to give consent for enrollment 3. patients lost in follow up

Keywords: double ligation, topical silver nitrate