Kornimate/medical-research-clean huggingface dataset:
anesthesia and motor evoked potential (mep) recruitment

Conditions: Idiopathic Scoliosis

Summary: test the hypothesis to recruit larger motor responses to transcranial stimulation.

the study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.

Eligibility criteria:
inclusion criteria: * age 12 through 17 years * diagnosis of idiopathic scoliosis * scheduled for posterior spinal fusion with neurophysiological monitoring * no known allergies to propofol or remifentanil * no contraindication to total intravenous anesthesia * no contraindications to the administration of volatile agents exclusion criteria: * failure to consent or assent to study * diagnosis other than idiopathic scoliosis * poorly controlled seizures or the presence of a cochlear implant * patient history or family history of malignant hypothermia or mitochondrial myopathies

Keywords: intra operative neurophysiologic monitoring transcranial motor evoked potential anesthesia pulses
enhance: a prospective evaluation of permacol™ in the repair of complex abdominal wall cases

Conditions: Hernia, Abdominal; Abdominal Injuries

Summary: the objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of permacol™ biological implant in the treatment of complex abdominal wall defects

this will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on permacol™ biological implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). the subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery. the study will enroll up to 200 subjects at up to 20 sites. enrollment is anticipated to take between 18 and 24 months.

Eligibility criteria:
inclusion criteria: subjects who meet all of the following criteria will be eligible for study enrollment: 1. subjects who are 18 years of age and older 2. subjects of either sex 3. subjects who require complex abdominal repair using permacol™ biological implant. 4. subjects who are willing and able to adhere to protocol requirements and provide written informed consent exclusion criteria: all subjects who meet any of the following criteria should not be enrolled into the study: 1. subjects who are pregnant 2. subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. ehlers danlos syndrome) or interfere with completion of study follow-up 3. subjects may not participate in any other clinical study that clinically interferes with this study while enrolled 4. concomitant use of a synthetic or another biologic mesh 5. subjects who require use of permacol™ as only temporary closure with planned reoperation, or permacol™ used as a temporary dressing in an open abdomen 6. subject who has systemic sepsis at the time of permacol™ implantation 7. subject with ongoing necrotizing pancreatitis 8. subject who requires use of permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair 9. subject who requires prophylactic use of permacol™ in the formation of stoma with anterior wall repair 10. permacol™ used in pelvic floor reconstruction

Keywords: complex abdominal wall reconstruction awr hernia
progression of hematopoietic diseases in shanghai, china

Conditions: Hematologic Diseases

Summary: the purpose of this study is to identify and characterize blood diseases presenting at shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility.

the purpose of this study is to identify and characterize blood diseases presenting at shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility. the format for these studies is a set of clinical series superimposed on a case-control design that enables integration of detailed clinical and molecular characterizations of disease pathogenesis together with an evaluation of potential confounding and interacting factors within a structured statistical analysis of benzene exposure.

Eligibility criteria:
inclusion criteria: men and women 18 years or older diagnosis of hematologic abnormality exclusion criteria: children non hematologic diseases

Keywords: aplastic anemia myelodysplastic syndromes cytopenias acute myeloid leukemia myelodysplastic/myeloproliferative diseases benzene poisoning
patients with renal impairment and diabetes undergoing computed tomography (ct)

Conditions: Kidney Diseases

Summary: the main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of isovue (iopamidol) or visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (mdct). serum creatinine will be measured before and up to 48-72 hours post dose.


Eligibility criteria:
inclusion criteria: * referred for contrast enhanced mdct * documented predose egfr of greater than or equal to 20 and less than 60 ml/min/1.73m2 * diagnosed as having diabetes mellitus exclusion criteria: * unstable renal function * unstable diabetes * concurrent administration of nephrotoxic drugs * undergoing dialysis

Keywords: contrast induced nephropathy
validation of a tear-based screening assay for breast cancer

Conditions: Healthy; Breast Cancer; Breast Cancer Female; Health Care Utilization; Health Knowledge, Attitudes, Practice; Health Personnel Attitude; Health Care Acceptability

Summary: this study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms. this tear-based screening test was developed and validated by namida lab, inc., a high complexity clinical laboratory improvement amendments (clia) certified lab.

the primary objective of this study is to determine if a tear-based biological test is an effective option in breast cancer screening. this will be assessed by comparing the score and classification produced from the assay to the current gold standard, screening mammograms. the primary endpoint will be assessed by calculating the sensitivity, specificity, ppv, and npv for the biological assay compared to the results of imaging. the secondary objective of this study is to obtain provider insight and recommendation as to the potential clinical utility of a tear-based biological test as a breast cancer screening option. the secondary endpoint will be achieved through a provider roundtable discussion. after completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the test scores determined for the sites patient population. providers will be allowed to verbally review the process and give their thoughts on the utility of a tear-based biological test within their clinic and how they feel it should be used. a member of the namida lab clinical team will be present to take notes. after the discussion a report will be generated and the site providers will be allowed to review it for accuracy. sites will be given a copy of their participants' scores as well as a summary of the provider roundtable discussion. sites may request to have the participants' results blinded if prior to review if preferred.

Eligibility criteria:
inclusion criteria: female over the age of 18 able to undergo the informed consent process willingness to comply with all study procedures exclusion criteria: currently diagnosed or are receiving treatment for breast cancer have an active eye infection under 18 years of age

Keywords: preventative screening protein biomarkers lacrimal tear fluid mammography primary care elisa assay clia laboratory lab developed test clinical utility high complexity underserved populations health disparities tear collection mammogram improved patient outcomes reduces gap in access health equity total cost of care trust from patient increased compliance affordable non-invasive women's health and wellness breast health breast cancer screening test
a single-dose, open-label, parallel-group study to assess the pharmacokinetics of baf312 in subjects with renal impairment compared to subjects with normal renal function

Conditions: Renal Impairment

Summary: to quantify the effect of different degrees of renal impairment on the pharmacokinetics of baf312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment


Eligibility criteria:
inclusion criteria: all subjects: * at least 50 kg and body mass index (bmi) within 18-38 kg/m2. * cyp2c9 wild-type (cyp2c9\*1 homozygous carriers) renal impairment: - subjects must have either mild, moderate or severe renal impairment exclusion criteria: all subjects * use of other investigational drugs within certain timelines * donation or loss of 400 ml or more of blood or plasma within eight (8) weeks prior to initial dosing * history of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h holter ecg recording including episodes of bradycardia (hr \ 100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than av-block grade 1) or bradycardia or tachycardia. * women of child-bearing potential * history of malignancy of any organ system * history or presence of symptomatic postural hypotension or syncope. * total wbc or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count \< 30,000/μl at screening or baseline. * clinically significant infection or recent vaccination with live-attenuated vaccines. * history or presence of hepatitis b or c and/or positive hepatitis b surface antigen (hbsag) or hepatitis c test result at screening. renal impairment: * history or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk. * any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. * treatment with certain drugs healthy subjects: * history or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases. * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study. other protocol-defined inclusion/exclusion criteria may apply

Keywords: renal impairement pharmacokinetics
exophthalmometry with 3d face scanners

Conditions: Exophthalmos; Graves Ophthalmopathy; Orbital Tumor; Orbital Fractures

Summary: this study investigates diagnostic methods to measure eyeball protrusion with a smartphone face scanner compared to the traditional hertel exophthalmometer. the study aims to validate a new reliable, fast and convenient smartphone app to measure the protrusion of the eyeball in different diseases such as graves' disease, orbital tumors, orbital fractures or orbital inflammation, as well as other rare diseases.

background: accurate and reproducible measures of abnormal eyeball protrusion are important for diagnosing different causes of exophthalmos, as well as following patients with grave's orbitopathy and retroorbital tumors. the current clinical gold standards for measuring abnormal eyeball protrusion is the hertel exophthalmometer, which is prone to reading errors and inconvenient to use. objective: the purpose of the ex3d-project is to replace the historic hertel exophthalmometer with a state-of-the-art mobile smartphone app that every ophthalmologist can carry in his pocket. methods: the investigators developed an accurate and easy to use method for measuring abnormal eyeball protrusion using the truedepth camera of the iphone 11 in comparison with a high-resolution 3d scanner as a reference to compare with the hertel exophthalmometer. outcomes: 1. accuracy and precision of 3d face-scanner and iphone in comparison to hertel exophthalmometer. 2. test re-test reliability in comparison to hertel exophthalmometer. 3. inter-operator reliability against hertel exophthalmometer. 4. patients before and after exophthalmos changing treatment. 5. applicability in daily clinical practice. broader impact: the invention makes exophthalmometry quick, easy and objective. a mobile smartphone application would replace measurements with the traditional hertel exophthalmometer, which are cumbersome, prone to reading errors and have a poor inter-rater reliability as well as test-retest reliability.

Eligibility criteria:
inclusion criteria: * written informed consent * able to cooperate with the study investigations (hearing, comprehension) * exophthalmos (grave's disease, orbital tumors, orbital inflammation, orbital fractures, rare causes (congenital, e.g. microphthalmos) * health controls exclusion criteria: * unable to sign informed consent * unable to cooperate with the examinations (hearing loss, neurological deficits)

Keywords: hertel exophthalmometer exophthalmos face scanner smartphone
b-cell reconstitution after hematopoietic stem cell transplantation

Conditions: Hematologic Malignancy

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) is a potentially curative treatment for a variety of hematological malignancies. however, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. to date, the design of new therapeutic strategies to improve immune recovery in allo-hsct patients is still hampered by the fact that post-transplant regenerative hematopoiesis has never been studied, and more generally by our currently limited knowledge on the development and function of human b lymphocytes. the main objective of our study is to study early b-cell progenitor reconstitution after allogeneic hematopoietic stem cell transplantation.


Eligibility criteria:
inclusion criteria: patients : * 18 years of age and older * with hematological malignancies and subject to allogeneic hsct * with health insurance coverage (bénéficiaire ou ayant droit) * having signed a written informed consent. inclusion criteria of donor * 18 years of age and older * with health insurance coverage (bénéficiaire ou ayant droit) * having signed a specific written informed consent. exclusion criteria of recipient and donor * absence of written informed consent * patient or donor on ame * patient or donor on ame or under protection by law, tutorship or curatorship * pregnant women
respiratory rate accuracy verification clinical: pulmonary rehabilitation patients

Conditions: Respiratory Insufficiency

Summary: study design: this study is a comparative, single-center study. this is a minimal risk study (as defined in 21 cfr part 56) using a non-significant risk device (as defined in 21 cfr part 812.3). a minimum of 60 subjects will be enrolled in the study. subject participation will last approximately 1 hour.

study design: this study is a comparative, single-center study. this is a minimal risk study (as defined in 21 cfr part 56) using a non-significant risk device (as defined in 21 cfr part 812.3). a minimum of 60 subjects will be enrolled in the study. subject participation will last approximately 1 hour. objective(s): the primary objective of this study is to evaluate the two fingertip respiratory rate (ftrr) algorithms performance of nonin's onyx 3 by attempting to demonstrate a mean error for ftrr \< 1.0 bpm during spontaneous breathing.

Eligibility criteria:
inclusion criteria: * the subject is at least 18 years old; * the subject has given written informed consent to participate in the study; * the subject is both willing and able to comply with study procedures. exclusion criteria: * the subject has a history of or current atrial fibrillation; * the subject has a documented history of frequent premature ventricular contractions (pvcs), defined as \>3 per 30 seconds; * the subject has an implanted pacemaker; * the subject has had any relevant injury at the sensor location site (self-reported); * the subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination); * the subject is currently or trying to get pregnant (self-reported); and/or * the subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
gamma-irradiated corneal inlay for keratoconus

Conditions: Keratoconus

Summary: study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (visiongraft, corneagen, usa) within the cornea of patients with keratoconus, a procedure called corneal tissue addition for keratoconus (ctak).

using e gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. preserved corneal tissue is currently available commercially from corneagen (visiongraft,1200 6th ave., ste.300, seattle, wa 98101). such tissue is currently used in a number of eye surgical procedures. it is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. the goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.

Eligibility criteria:
inclusion criteria: * at least 18 years of age, male or female, of any race * provide written consent and sign a hipaa form * willingness and ability to follow all instructions and comply with schedule for follow-up visits * for females: must not be pregnant * having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following: * moderate keratoconus: axial topography consistent with keratoconus, maximum keratometry on pentacam greater than or equal to 51.01 d * severe keratoconus: axial topography consistent with keratoconus with marked areas of steepening, maximum keratometry on pentacam greater than or equal to 56.01 d * presence of central or inferior steepening on the pentacam map * bscva less than or equal to 20/25 * contact lens wearers only: remove contact lenses one week prior to the screening refraction exclusion criteria: * contraindications, sensitivity or known allergy to the use of the test article(s) or their components * if female, be pregnant * eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme * previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. for example: a) history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.) * a history of delayed epithelial healing in the eye to be treated * have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
budesonide 3x3mg/d versus prednisone in active autoimmune hepatitis

Conditions: Autoimmune Hepatitis

Summary: this is a multicentre, multinational clinical study. it comprised two consecutive segments (a and b). segment a was designed as a randomized, double-blind, double-dummy, active-controlled, two-arm parallel-group study. the patients received either budesonide or prednisone for 6 months. during segment b all patients received budesonide as an open treatment for additional 6 months. in this confirmatory study the proportion of patients with complete response was compared between the two treatment groups. complete response was defined as biochemical remission (=serum levels of asat and alat within normal ranges) at the individual last visit of segment a and lack of steroid specific side effects throughout segment a.


Eligibility criteria:
inclusion criteria: * age 10 to 70 years * diagnosis of acute aih according to alvarez score * normal range of tpmt activity * normal acth test * negative pregnancy test at screening for females of childbearing potential * written informed consent exclusion criteria: * presence of hepatitis a, b, c, e or g virus infection * liver cirrhosis or clinical signs of portal hypertension * pbc * psc * history of hypersensitivity to the study medication
the hospital elder life program at the jewish general hospital

Conditions: Delirium; Fall Injury; Mortality

Summary: older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. the hospital elder life program (help) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. the overall objective of this study is to examine in a quantitative fashion the effects of the help program on adverse health events in geriatric inpatients admitted to the orthopedic ward at jgh for surgery after a hip fracture.

delirium and mobility impairment with high risk of falls are important medical complications after a hip surgery. more than 95% of hip fractures are caused by falling and the risk of a new fall after a hip surgery may be up to 50%. both postoperative delirium and fall are associated with increased length of stay and high perioperative mortality. the hospital elder life program (help) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital. the primary goals of the help program are: maintaining cognitive and physical functioning of high risk older adults throughout hospitalization, maximizing independence at discharge, assisting with the transition from hospital to home, and preventing unplanned hospital readmissions. these goals have been accomplished using a multicomponent intervention strategy. in addition to targeted interdisciplinary geriatric assessment, the program uses an innovative volunteer model to provide personal, supportive attention to vulnerable older inpatients.

Eligibility criteria:
inclusion criteria: * age 65 and over * admitted to orthopedic ward for hip surgery after a fracture exclusion criteria: * younger than 65 years of age * palliative care

Keywords: older, hospital, program