Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of tranexamic acid in patients with varying renal function undergoing cardiac surgery with the use of cardiopulmonary bypass

Conditions: Cardiac Disease; Renal Disease

Summary: cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of patients. tranexamic acid (txa) is a routinely administered antifibrinolytic agent that reduces blood loss and blood transfusion requirement. however, standard dosing of txa in patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may lead to higher blood concentration of txa when compared to the patients with normal renal function. solid phase microextraction (spme) is a fast and simple method to measure txa levels. this prospective study on cadiac surgical patients undergoing cardiopulmonary bypass aims to study the pharmacokinetics of txa in patients with renal dysfunction. two patient groups will be studied who will receive either txa 50mg/kg bolus or bart regimen (30 mg/kg, 16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and bleeding risk. hypothesis: standard dosing of txa used in cardiac surgery result in higher blood concentration of txa in patients with renal dysfunction when compared to patients with normal renal function.


Eligibility criteria:
inclusion criteria: * cardiac surgical patients above 18 years of age with renal dysfunction (stage 1, 2 ,3, 4 and 5 of the kidney disease outcome quality - initiative classification of chronic kidney disease) exclusion criteria: * all patients under 18 years of age or unable to give consent * documented drug allergy to tranexamic acid * deep hypothermic circulatory arrest * pre-existing coagulopathy * pregnancy * advanced liver disease * renal transplant recipients * concomitant treatment with contraceptives, tretinonin

Keywords: cardiac surgery renal dysfunction pharmacokinetics tranexamic acid
dietary phytoestrogens and bone metabolism

Conditions: Osteoporosis

Summary: the purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.

osteoporosis in postmenopausal women is one of the most important public health challenges of our time. with millions of women affected and billions of dollars being spent for its complications, we need to develop effective approaches to this disease. postmenopausal women are at particular risk because the loss of estrogen associated with the menopause leads to bone loss of much greater magnitude than one would expect on the basis of age alone. estrogen replacement therapy, a logical and effective therapeutic approach, has been associated with serious concerns about adverse events and, thus, limited use. the recent development of selective estrogen receptor modulators (serms) may help if they continue to show promise. interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is an expected outgrowth of the general interest in alternative medicinals for a wide variety of human disorders. concerns about the potential for adverse consequences of the conventional use of estrogen replacement therapy, and limited knowledge about long term use of serms- add support to this quest. no systematic investigation of the role of dietary phytoestrogens on bone mass and skeletal dynamics has yet been conducted. with the dramatic increase in interest in these sources of estrogenic activity, it is important for us to determine whether these agents are efficacious. otherwise, this field will be plagued for years to come by incomplete, anecdotal and scientifically poorly documented actions of these agents on bone metabolism. it is our expectation that this study will begin to provide the documentary information that the field so clearly needs. the rationale for exploring the potential for phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and compelling. women will be randomly assigned to one of three healthy eating plans and, over the course of the year-long study, will learn to choose and cook foods to help optimize health as they go through menopause and beyond.

Eligibility criteria:
inclusion criteria: * postmenopausal * weight within 90% to 120% of ideal body weight * 12 or more months since last menstrual period * new york metro area resident exclusion criteria: * history of cancer, diabetes, or heart disease * smoker
an exploratory study of bps804 treatment in adult patients with type i, iii or iv osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: the purpose of this study is to investigate the effect of bps804 on strength/quality of bone in patients with type i, iii or iv osteogenesis imperfecta using a special type of ct scanner. participants will be treated for 1 year.

this study was previously posted by mereo biopharma and was transferred to ultragenyx in february 2021.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of oi type i, iii or iv * capable of giving signed consent exclusion criteria: * history of skeletal malignancies or other bone diseases (other than oi) * history of endocrine or thyroid/parathyroid conditions that could affect bone metabolism * treatment with bisphosphonates within 3 months of randomisation * treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation
transcatheter aortic valve replacement (tavr) double balloon valvuloplasty

Conditions: Aortic Valve Stenosis

Summary: in this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. the investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. the investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion. the primary objective of this study is to determine if double valve inflation during a tavr procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age 2. diagnosis of severe native valve aortic stenosis 3. meets the standard of care indications to undergo tavr procedure (aortic valve area \ 40 mmhg or peak velocity \>4.0 m/s or aortic valve area index \<0.6). 4. provided informed consent. exclusion criteria: 1. history of prior aortic valve replacement 2. pre-existing moderate to severe aortic regurgitation 3. lacking pre-procedure echocardiogram 4. patients planning to undergo multiple valve replacements simultaneously 5. intraoperative arrhythmia 6. intraoperative hemodynamic instability 7. intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection) 8. at the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.

Keywords: tavr balloon valvuloplasty
kinesio taping in cerebral palsy upper extremity functionality

Conditions: Cerebral Palsy

Summary: purpose: the aim of this study is to investigate the effects of kinesio taping on upper extremity functionality in participants with cerebral palsy. methods: this study included 14 children aged 6-16 years, diagnosed with cerebral palsy. the children with cerebral palsy were divided into 2 groups, the study group and the control group. assessments were done three times for each group (beginning - 45min later - 1 week later). frenchay arm test was used to evaluate upper extremity functionality in participants with cerebral palsy. kinesio taping was applied to study group to improve posture and function in shoulder area.


Eligibility criteria:
inclusion criteria were as follows; * to have a cognitive level to comprehend the instructions * not having a cooperative problem that may prevent communication * continuing special education regularly exclusion criteria were as follows; * those with orthopedic problems * any surgical procedure * participants with cognitive problems * participants who do not regularly receive physiotherapy

Keywords: kinesiotape cerebral palsy upper extremity functionality
non-invasive neurally adjusted ventilatory assist (nava) prone vs supine in premature infants

Conditions: Neonatal Oxygen Desaturation; Premature; Ventilator Lung; Newborn; Apnea of Prematurity

Summary: this research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.


Eligibility criteria:
inclusion criteria: * viable infants born at ≤32 weeks of gestation on non-invasive nava. * infant must be stable on nava for at least 24 hours prior to the study exclusion criteria: * infants with congenital heart disease (chd) * infants with persistent pulmonary hypertension (pphn) * infants with contraindications to using nava (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an ng/og catheter cannot be placed.

Keywords: apnea of prematurity nava
dermal suturing only versus layered cutaneous closure

Conditions: Wound Closure Techniques

Summary: the purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.

the purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. this will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.

Eligibility criteria:
inclusion criteria: * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure with predicted linear closure * willing to return for follow up visits exclusion criteria: * mentally handicapped * incarceration * pregnant women * wounds with predicted closure length less than 3 cm * wounds unable to be fully closed via primary closure
an intervention study to reduce the use and impact of potentially inappropriate medications among older adults

Conditions: Polypharmacy; Incontinence; Insomnia; Anxiety

Summary: an educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin). cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.

this study tests the effectiveness of a knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician

Eligibility criteria:
inclusion criteria: * 65 year old human adults * who fill a prescription for at least 5 medications * community dwelling * chronic use (3 months or longer) of at least one potentially inappropriate medication (e.g. benzodiazepine, oxybutynin) exclusion criteria: * patients with severe mental illness, dementia and epilepsy * concomitant consumption of any other antipsychotic medication (including lithium, olanzapine, clozapine, quetiapine, risperidone, haloperidol etc.) * concomitant consumption of any antiepileptic (including carbamazepine, valproate, gabapentin, lamotrigine, topiramate, oxcarbazepine etc.) * concomitant consumption of a cholinesterase inhibitor or memantine

Keywords: polypharmacy benzodiazepine use oxybutynin use cognition disorders/drug therapy incontinence
international registry of coronavirus (covid-19) exposure in pregnancy

Conditions: Covid-19

Summary: the international registry of coronavirus exposure in pregnancy (ircep) is a prospective cohort study of pregnant and recently pregnant women who have been tested for sars-cov-2 (regardless of the result) or have been clinically diagnosed with covid-19 by a health care professional. data from the ircep will be used to evaluate the impact of covid-19 on pregnancy and birth outcomes.

the international registry of coronavirus exposure in pregnancy (ircep) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for sars-cov-2 (regardless of the result) or have been clinically diagnosed with covid-19 by a health care professional. as this is an international registry, women from all countries are welcome to participate. women will enroll and provide information to the ircep via website and mobile app. after signing the electronic informed consent document, registrants will answer questions on the following modules: demographics, reproductive history, height and weight, habits, health conditions, medications, current pregnancy, covid-19 infection test, and covid-19 infection symptoms. monthly follow-up modules will continue until the pregnancy outcome. in case of a live birth, the registry participant will continue with the post-partum outcomes module until the newborn is 90 days of age. medical records from the mother and neonate will also be requested.

Eligibility criteria:
inclusion criteria: * pregnant women or women who have been pregnant within the last 6 months * able to give electronic informed consent * tested for sars-cov-2 (regardless of the result) or clinically diagnosed with covid-19 by a health care professional exclusion criteria: * \<18 years of age
oxygen concentration should be kept at the lowest possible level during recruitment

Conditions: Laparoscopic Surgery

Summary: in this study, our goal is to compare the effects of recruitment manoeuvre which is applied with different oxygen concentrations on oxygenation and respiratory mechanics during pneumoperitoneum

detailed description: "recruitment manoeuvre" which has been defined and become popular in the recent years is nowadays widely accepted and applied. the positive effects of the recruitment manoeuvre during and after surgery on respiratory mechanics and oxygenation have been reported. the duration and the applied pressure values of recruitment manoeuvre have been defined well and in detail regarding the definitions for this manoeuvre (1-3). despite these definitions, no detailed information has been provided on the effects of the oxygen and oxygen concentration during recruitment manoeuvre . atelectasis develops after the induction of anaesthesia, even in healthy subjects, and is associated with an increase in intraoperative shunt leading to impairment of gas exchange (4). it is well known that in patients, who have undergone mechanical ventilation with high oxygen concentration levels, oxygen replaces the less insoluble nitrogen. partial oxygen pressure increases with the implementation of oxygen in high concentrations, and the oxygen flow into the blood increases. but when the gas flow into the blood is more than inspired, absorption atelectasis develops in lungs - due to appliance of high oxygen concentration. atelectasis may also develop due to different reasons such as failure in secretion clearance during the surgery, replacement of nitrogen with inhalation anaesthetics and appliance of pneumoperitoneum. in the recent years, many studies have analyzed the effects of recruitment manoeuvre during pneumoperitoneum and laparoscopic surgery on respiratory mechanics and oxygenation, and reported the benefits of recruitment in these operations (4-6). in this study, our goal is to compare the effects of recruitment manoeuvre which is applied with different oxygen concentrations on oxygenation and respiratory mechanics during pneumoperitoneum.

Eligibility criteria:
exclusion criteria: * patients, who were older than 65 years, * had respiratory system and cardiovascular diseases, * used medication that could affect the respiratory function or smokers have been excluded.

Keywords: recruitment oxygen concentration pneumoperitoneum laparoscopy
a phase 1 study of hec88473 injection in healthy subjects, obese subjects and t2dm subjects

Conditions: Healthy Subjects; Obesity; T2DM (Type 2 Diabetes Mellitus)

Summary: this is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hec88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (t2dm).

this study is divided into two parts, part a is an escalating single-dose study in healthy subjects and obese subjects, and part b is an escalating multiple-dose study in subjects with t2dm.

Eligibility criteria:
inclusion criteria: part a 1. males or females, between 18 and 45 years of age, inclusive, at screening. 2. body weight ≥ 50 kg for males and body weight ≥ 45 kg for females. 18≤body mass index (bmi)\<28 kg/m2 for nonobese subjects and 28≤bmi≤45 kg/m2 for obese subjects. part b 1. males or females, between 18 and 65 years of age, inclusive, at screening. 2. 24 kg/m2≤bmi≤35 kg/m2. 3. subjects diagnosed with t2dm, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for ≥ 3 months before screening. 4. 7.0%≤ hba1c ≤10.5% at screening. exclusion criteria: part a 1. smoked more than 5 cigarettes per day within 3 months before the study. 2. immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study. 3. positive alcohol breath test result or positive urine drug screen. 4. blood donation (\> 300 ml) or massive blood loss (\> 400 ml) within 3 months before screening. part b 1. have type 1 diabetes mellitus. 2. have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months). 3. have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>5 times the upper limit of the reference range at screening. 4. have serum calcitonin ≥20 ng/l at screening. 5. have a personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce mtc. 6. fasted triglycerides \> 5.7 mmol/l at screening. if the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.
phase 2b evaluation of efficacy and safety of ar882 in gout patients

Conditions: Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic

Summary: this study will assess the serum uric acid lowering effect and safety of ar882 in gout patients at two doses compared to placebo over 12 weeks.


Eligibility criteria:
inclusion criteria: * history of gout * sua \> 7 mg/dl * estimated glomerular filtration rate (egfr) ≥ 30 ml/min/1.73m2 exclusion criteria: * malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * history of cardiac abnormalities * history of kidney stones
a study to compare the efficacy of nivolumab and relatlimab plus chemotherapy vs pembrolizumab plus chemotherapy for stage iv/recurrent non-squamous non-small cell lung cancer with pd-l1 expression ≥ 1%

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to compare the efficacy of nivolumab and relatlimab in combination with chemotherapy to pembrolizumab with chemotherapy in participants with stage iv or recurrent non-squamous non-small cell lung cancer with pd-l1 expression ≥ 1%


Eligibility criteria:
inclusion criteria * participants must have histologically confirmed stage iv or recurrent non-small cell lung cancer (nsclc) of non-squamous (nsq) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * participants must have measurable pd-l1 ≥ 1% tumor cell (tc) score by the investigational pd-l1 immunohistochemistry (ihc) assay ventana pd-l1 (sp263) cdx assay conducted by central laboratory during the screening period prior to randomization. * participants must have measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per recist v1.1 criteria. * participants must have an easter cooperative oncology group (ecog) performance status of ≤ 1 at screening. * participants must have a life expectancy of at least 3 months at the time of randomization. exclusion criteria * participants must not be pregnant and/or breastfeeding. * participants with epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk), or ros-1 mutations that are sensitive to available targeted inhibitor therapy. participants with unknown egfr, alk, or ros-1 status are excluded. * participants with known brafv600e mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (ret) mutations or neurotrophic tyrosine receptor kinase (ntrk) fusion gene alterations are excluded. participants with unknown or indeterminate braf mutation, activating ret mutations or ntrk fusion gene alterations are eligible. * participants must not have untreated central nervous system (cns) metastases. * participants must not have leptomeningeal metastases (carcinomatous meningitis). * participants must not have concurrent malignancy requiring treatment. * participants must not have an active autoimmune disease. * participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (iv) glucocorticoids to assist with management. * participants must not have a history of myocarditis. * participants must not have had prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or other antibody or drug targeting t-cell co-stimulation or checkpoint pathways. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: non-squamous pdl-1 ≥ 1%