Kornimate/medical-research-clean huggingface dataset:
study of biomarkers of airway inflammation (0000-128)

Conditions: Airway Inflammation

Summary: this study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.


Eligibility criteria:
inclusion criteria: * female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study * male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study * subject is a nonsmoker * subject is in generally good health * subject is willing to comply with the diet, alcohol, and caffeine study restrictions exclusion criteria: * subject is a nursing mother * subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening * subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection * subject has a recent history of allergic rhinitis at screening * subject has any respiratory disease at screening * subject has daily phlegm or a chronic cough * subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study * subject consumes excessive amounts of alcohol or caffeine * subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening * subject has a history of stroke, seizures, or major neurological disorders * subject regularly uses illicit drugs or has a history of drug/alcohol abuse * subject received a vaccination within 3 weeks of screening

Keywords: sputum inflammatory biomarkers
incretin effect in lean and obese subjects

Conditions: Incretin Effect; Insulin Resistance; Type 2 Diabetes

Summary: the incretin effect is markedly reduced in patients with type 2 diabetes. data support the notion that this deficiency is a consequence of the diabetic state. however, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (ngt) despite their insulin resistant state remains to be elucidated. the primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 3 months * normal blood hemoglobin * informed consent exclusion criteria: * liver disease * diabetic nephropathy * treatment with medication that can not be stopped for 12 hours
genetic causes of discrepant clinic in monogenic twins

Conditions: Rare Diseases; Genetic Predisposition to Disease

Summary: in the disco-twin study (prospective, open-label molecular-genetic study), twin pairs with one healthy and one affected twin with molecularly undiagnosed diseases will be analysed by means of omics technologies and/ or re-analysed using existing datasets. phenotype and omics data will be shared within the university hospital tübingen and with external collaborators to improve the diagnostic rate of the subjects included in the study.


Eligibility criteria:
inclusion criteria: * twin pair monozygotic clinically (phenotypic) discordant twins * unclear diagnosis * suspected (mono-)genetic cause of the disease in one twin exclusion criteria: * missing informed consent of both twin/ legal representative * no distinct phenotype

Keywords: rare diseases genetic predisposition omics technology next generation sequencing (ngs)
spect myocardial blood flow quantification for diagnosis of ischemic heart disease determined by fraction flow reserve

Conditions: Coronary Artery Disease

Summary: recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (cad) when myocardial blood flow (mbf) is quantified in absolute terms using single photon emission tomography (spect) compared to conventional myocardial perfusion imaging (mpi). however, there are no uniformly accepted cutoff values of mbf and mfr derived from spect for diagnosing hemodynamically significant cad. particularly, the diagnostic performance for quantitative spect has not been validated using fractional flow reserve (ffr). the aim of this prospective study is to determine optimal cutoff values of absolute mbf and mfr derived from nai (tl)-based spect and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ica) in combination with ffr results as the reference standard in patients with suspected or known cad.


Eligibility criteria:
inclusion criteria: * age 18 \~ 79 years old * at least one cad risk factor * intermediate to high pre-test likelihood for cad * suspected or known cad, clinically referred for invasive coronary angiography * able and willing to comply with the study procedures * written informed consent exclusion criteria: * history or risk of severe bradycardia * history of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease * wheezing asthma or copd * known second- or third-degree av block * known hypersensitivity to dipyridamole or adenosine * known coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci) prior to screening * breastfeeding or pregnancy * claustrophobia or inability to lie still in a supine position * unwillingness or inability to provide informed consent

Keywords: spect myocardial blood flow myocardial flow reserve
phase 1 study to assess the safety, pk and pd of inbrx-101 in adults with alpha-1 antitrypsin deficiency

Conditions: Alpha-1 Antitrypsin Deficiency; AATD

Summary: this is an open-label, 2-part, dose-escalating, phase 1 study of inbrx-101 (rhaat-fc). part 1 will consist of single ascending dose (sad) administration of inbrx-101 and part 2 will consist of multiple ascending dose (mad) administrations of inbrx-101. the planned dosing schedule is iv every 3 to 4 weeks.


Eligibility criteria:
inclusion criteria: * documented alpha-1 antitrypsin (aat) serum concentration \<11 μm. * diagnosis of alpha-1 antitrypsin deficiency (aatd) with any allelic combination with exception of the null/null genotype. * for subjects in part 2 80 and 120 mg/kg cohorts only: post-bronchodilator fev1 of at least 40% of predicted normal value. * for subjects in part 2 80 and 120 mg/kg cohorts only: subjects eligible for bronchoscopy per judgment of investigator. * nonsmoker for at least 6 months prior to study and must remain nonsmoking for the entire study duration. * adequate hepatic and renal function as defined per protocol. * willing to undergo current augmentation therapy washout (if applicable) and refrain from initiating augmentation therapy, other investigational drug trials for aatd, therapy with iv immunoglobulins or monoclonal antibodies during the entire study, including follow-up. exclusion criteria: * known or suspected allergy to components of inbrx-101 (aat or human igg) or pdaat. * participation in any investigational drug trial within 30 days prior to this trial, or subjects receiving iv immunoglobulins or monoclonal antibodies within 30 days prior to this trial. * history of and/or on the waiting list for lung or liver transplant, lobectomy, or lung volume reduction surgery. * acute respiratory tract infection or copd exacerbation that required antibiotic treatment and/or increase in systemic steroid dosage within the 4 weeks prior to screening. subjects are permitted to continue to receive steroids if the investigator judges the subject to have a history of stable dosing. * subjects with ongoing or history of unstable cor pulmonale. * infection with hepatitis a, b, or c or human immunodeficiency virus (hiv). * active autoimmune disease or documented history of autoimmune disease that 1) required systemic steroids or immune-suppressive medications and 2) tested positive for auto-antibodies. exception: endocrinopathies managed with hormone replacement therapy (hrt). * current substance and/or alcohol abuse with protocol defined exceptions. * current narcotics abuse with protocol defined exceptions.

Keywords: alpha-1 antitrypsin deficiency aatd alpha-1 disease aat
balance and executive function in middle-age and older patients with heart failure in post-acute care program

Conditions: Heart Failure

Summary: this trial is a single-center clinical trial in taiwan with an expected enrollment of 60 people in taiwan. the purpose of this trial is to compare the performance of middle-aged and elderly patients with subacute heart failure with that of a healthy control group in terms of balance function and executive function, as well as to investigate whether there is a correlation between balance function and executive function in middle-aged and elderly patients with heart failure and to track the changes in balance and executive function one month and three months after discharge from the hospital. please think carefully before deciding whether to participate in this trial.


Eligibility criteria:
inclusion criteria: * diagnosed with heart failure and receiving post-acute care program for heart failure * left ventricular ejection fraction≦40% * age ≥ 45 * no cognitive impairment * ambulate independently or with the use of aids * clinical symptoms are stable * voluntary participation exclusion criteria: * use of medications that cause dizziness or interfere with balance * have other diagnoses that may affect balance, such as stroke, parkinson's disease * color blindness, severe hearing or visual impairment that prevents reading questions and listening to instructions

Keywords: heart failure balance function executive function
continuous popliteal nerve blocks: effect of perineural catheter tip location relative to the sciatic nerve bifurcation on postoperative analgesia

Conditions: Popliteal Nerve Block; Foot Surgery; Ankle Surgery; Popliteal Bifurcation

Summary: research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.

hypothesis: during a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.

Eligibility criteria:
inclusion criteria: * undergoing surgery with a popliteal perineural catheter for postoperative analgesia * age 18 years or older exclusion criteria: * pregnancy * inability to communicate with the investigators and hospital staff * incarceration * clinical neuropathy in the surgical extremity * chronic high-dose opioid use * a history of opioid abuse * surgery outside of ipsilateral sciatic and saphenous nerve distributions

Keywords: popliteal ucsd postoperative pain foot surgery ankle surgery popliteal catheter popliteal nerve block lower extremity surgery bifurcation catheter insertion site
comparison of intraoperative best practice advisory reminders to protocolize insulin administration versus standard care in patients at high risk of hyperglycemia

Conditions: Diabetes; Hyperglycemia

Summary: this study will assess the implementation of a glucose management clinical decision support tool. the specific objective is to determine if supplementing the existing glucose check reminder with a best practice advisory (bpa), an actionable insulin dosing calculator, providers will be influenced to improve the control of hyperglycemia.

poor intraoperative glucose control has been linked to multiple types of infections including surgical site infections and urinary tract infections. several studies suggest maintaining glucose at less than 180 mg/dl effectively prevents infections, and minimizes risks of hypoglycemia as compared to stricter blood glucose targets. the insulin dosing protocol that will be used in the study is available for use throughout the vanderbilt university medical center (vumc) department of anesthesiology. the insulin calculator (bpa) automates the protocol guidelines. when a patient meets the study criteria, the bpa will provide an automated notification through the electronic health record system. these automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. the provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department. the specific objective is to determine if supplementing the existing glucose check reminder with a bpa, an actionable insulin dosing calculator, will influence providers to improve the control of hyperglycemia. study results will guide the future integration of the bpa at vumc.

Eligibility criteria:
patient participants inclusion criteria: * all patients having surgery at vanderbilt university medical center main operating rooms (ors), vanderbilt medical center children's hospital, medical center east or gynecological (4s) ors, who qualify for the glucose check best practice advisory (bpa). to qualify for the glucose bpa, the patient must meet the following criteria: 1) a documented diagnosis of diabetes, without a recorded measurement of glucose within the last 2 hours, or 2) the patient had an insulin administration within the last twelve hours and did not have a recorded measurement of blood glucose within the last hour. exclusion criteria: * patients having surgery at other locations * patients not qualifying for the vumc glucose check bpa provider participants: any provider of eligible patients may receive the bpa while providing care for these patients.
pharmacogenetic prediction of metoprolol effectiveness

Conditions: Hypertension

Summary: the investigators will prospectively follow a population of patients with uncontrolled high blood pressure beginning metoprolol succinate therapy to determine the drug effect in an observational clinical trial. the investigators will determine each individual's genotype for both cyp2d6 and adrenoceptor beta 1 (adrb1). metabolomic markers will be identified to determine if specific metabolites are associated with drug response. the investigators' overall objective is to determine if genetics predicts metoprolol succinate response better than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.


Eligibility criteria:
inclusion criteria: 1. subjects between age \>30 years and \< 80 years 2. subjects have diagnosis of uncontrolled essential hypertension. exclusion criteria: 1. end stage liver disease, 2. end stage renal disease, 3. pregnant females, 4. american society of anesthesiologists (asa) classification of \>3, 5. wards of the state, prisoners, 6. decisionally challenged, 7. hr\<60 bpm, 8. av block\>240 msec, 9. active reactive airway disease, 10. illicit drug abuse in the preceding 30 days, 11. hypersensitivity to metoprolol or its derivatives 12. severe peripheral arterial circulatory disorders. subjects will have a screening physical exam performed by dr. monte prior to enrollment in the study.

Keywords: genotype cyp2d6 adrb1
pteye in parathyroid adenoma

Conditions: Parathyroid Adenoma

Summary: identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. the aim of the present study is to evaluate the correlation of pteye autofluorescence device with biochemical data of parathyroid adenoma patients.

identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. two approaches are available to surgeons to perform near-infrared autofluorescence: (i) camera-based systems (cbs) and (ii) probe-based systems such as pteye™ (medtronic, minneapolis, mn).the aim of the present study is to evaluate the correlation of pteye autofluorescence device with biochemical data of parathyroid adenoma patients.

Eligibility criteria:
inclusion criteria: * age \>18 years old * primary hyperparathyroidism caused by adenoma * patient's informed consent acquired exclusion criteria: * secondary and tertiary hyperparathyroidism * re-operation for adenoma * previous neck surgery * patient enrolled in another study that may affect the results of this study

Keywords: parathyroid adenoma near-infrared autofluorescence
the swiss venous thromboembolism cohort 65+

Conditions: Venous Thromboembolism

Summary: the purpose of this prospective multicenter cohort study is to examine long-term medical outcomes, quality of life, and medical resource utilization in elderly patients (\>= 65 years) with acute venous thromboembolism (i.e., acute pulmonary embolism and/or deep vein thrombosis)


Eligibility criteria:
inclusion criteria: * objectively confirmed acute pulmonary embolism and/or deep vein thrombosis * age \>=65 years exclusion criteria: * thrombosis at a different site than lower limb * catheter-related thrombosis * insufficient spoken language ability in german or french * follow-up not possible (e.g., terminally ill patients) * informed consent not possible (e.g., severe dementia) * prior enrolment in the study
external ventricular drainage post-market clinical follow-up registry

Conditions: Cerebrospinal; Disorder

Summary: this post-market follow-up registry will capture clinical data specific to the safety and performance of the integra external ventricular drainage systems and accessories.

the purpose of this study is to investigate whether the integra external ventricular drainage system listed as part of this study do perform to clinical expectations. additionally, this study will focus on the safety of these devices by collecting any device-specific adverse events (aes) or device deficiencies (dds) seen when used during standard of care procedures.

Eligibility criteria:
inclusion criteria: 1. patient and/or legally authorized representative has agreed to participate in the study by signing the ec-approved consent form, where applicable. 2. patients (of any age) who underwent or who plan to have a procedure with one of the integra or codman external ventricular drainage system. 3. for patients who have had the evd system removed prior to study enrollment, have available follow-up data from implant until the evd system is no longer required for drainage and monitoring of csf. exclusion criteria: 1. the patients in whom more than one evd system were or are intended to be placed. 2. the patient has sepsis. 3. the patient has a history of poor wound healing. 4. the patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the ifu. 5. the patient is otherwise determined by the investigator to be medically unsuitable for participation in this registry. 6. the patient is currently enrolled in another device trial or has been previously entered in this trial. 7. the patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator. 8. the patients known to have uncorrected coagulopathy. 9. the patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of bactiseal catheters)
surgical outcomes after routine cataract extraction & implantation of a conventional or spheric intraocular lens

Conditions: Cataract Extraction

Summary: to determine quality of vision post cataract extraction and intraocular lens (iol) implantation of 2 different acrylic intraocular lenses: acrysof® single-piece iol and acrysof® wf, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral cataract * eligible for phacoemulsification with primary implantation of a posterior chamber iol. if bilateral, patient will receive the same iol than the fellow eye. * expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral. * best corrected visual acuity (bcva) should be no better than 20/40 in the presence of a glare source using snellen visual acuity. in the snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line. * naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes. exclusion criteria: * preoperative ocular pathology potentially affecting visual acuity * previous intraocular or corneal surgery. * keratometric astigmatism exceeding 1.5 diopters. * planned postoperative refraction for mono-vision. * current contact lens usage. * other ocular surgery at the time of the cataract extraction. * uncontrolled diabetes. * any neurological condition that might interfere with performance of required test. * auto-immune deficiency disease. * other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. * use of any systemic or topical drug known to interfere with visual performance. surgical exclusion criteria * significant anterior chamber bleeding. * detached descemet's membrane * iris damage * posterior capsule rupture * radial tear in capsulorhexis * vitreous loss * zonular rupture. * use of corneal sutures for more than 1 week. post-implantation exclusion criteria * haptic not in the capsular bag. * descentration of the iol of more than 1.0 mm * ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.