Kornimate/medical-research-clean huggingface dataset:
implementation of tele-exercise for management of knee osteoarthritis in older rural primary care patients

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (oa) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. clinical practice guidelines recommend physical exercise for managing symptoms of knee oa. as a result, several evidence-based exercise programs have been implemented in community centers. however, access to these programs is severely limited in rural settings. considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee oa. accordingly, we aim to engage rural primary care practices (including medical directors, clinicians, and staff) to develop a clinical pathway that refers patients to an evidence-based exercise program, called enhance fitness® (ef), which we have adapted for remote delivery (tele-ef). enhance fitness is a group exercise program that is recommended by the cdc for oa management. it is available in over 800 sites nationally and is covered by medicare advantage plans, but it is generally not available in rural communities. in addition, we will assess the feasibility and acceptability of implementing the clinical pathway that identifies physically inactive older patients with knee oa, facilitates exercise prescription, and streamlines referral to tele-ef in a rural primary care clinic over a 5-month period.


Eligibility criteria:
inclusion criteria: * age ≥65 years * community-dwelling * english-speaking * physician diagnosed knee osteoarthritis * physically inactive as determined by the 2-item physical activity vital sign questionnaire exclusion criteria: * cognitive impairment determined by a mini montreal cognitive assessment score of \<11 * significant, non-corrected visual or hearing impairment * plans to move out of the area in the next 6 months * cancer requiring treatment (except for non-melanoma skin cancer) in the past 6 months * heart attack in the past 6 months * stroke in the past 6 months * hip fracture in the past 6 months * hip/knee replacement in the past 6 months * spinal surgery in the past 6 months * heart surgery in the past 6 months * deep vein thrombosis in the past 6 months * pulmonary embolus in the past 6 months * hospitalization within the last month * ≥3 falls within the past month
safety and efficacy of punctum plug delivery system in subjects with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine if the punctum plug delivery system (ppds) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * over 18 yrs with open-angle glaucoma or ocular hypertension * subjects who have a best-corrected visual acuity of 20/100 or better. exclusion criteria: * uncontrolled medical conditions. * subjects who wear contact lenses. * subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications. * subjects who have a history of chronic or recurrent inflammatory eye disease.

Keywords: glaucoma, ocular hypertension, iop
dose ranging study to evaluate the safety, efficacy, and pharmacokinetics of budesonide rectal foam in pediatric patients aged 5 to 17 years with active, mild to moderate distal ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to \<12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: 1. male and female (non-pregnant and non-lactating) 5 to ≤17 years of age at screening. 2. established diagnosis of uc, based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies. 3. disease limited to the distal colon and rectum, (disease involving only the first 15 centimeters or less proximal to the anal verge). 4. active, distal uc of mild or moderate severity, defined as a modified mayo clinic score (mmcs) between 4 and 8, inclusive, that includes an endoscopy subscore ≥ 2 and a rectal bleeding subscore ≥ 1. 5. if on a background oral 5-asa, the dose and formulation have remained unchanged for at least 6 weeks prior to visit 2 (run-in) and the subject is willing to remain on the same dosage form and regimen for the duration of the study. exclusion criteria: 1. current or prior diagnosis of crohn's disease or indeterminate colitis. 2. ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum; 3. severe uc, defined as an mmcs \> 8. 4. infectious colitis (based on positive microbiologic tests at screening) or any recent history of infectious colitis (within 30 days of screening). 5. prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical). note: prior cholecystectomy is not exclusionary if more than 1 year prior to screening. 6. evidence or history of toxic megacolon or bowel resection. 7. active proctologic pathology such as hemorrhoids, fistulas and fissures or other historical anatomic problems which would impair rectal administration (e.g., cloaca, imperforate anus history)
measurement of total hemoglobin by pulse oximetry in neonatal population

Conditions: Anemia

Summary: assess ability of masimo sphb sensor to demonstrate robust performance on various sensor application sites on neonates/infants


Eligibility criteria:
inclusion criteria: * male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care. * ages: newborn infants less than 16 weeks postnatal age. * weight: range from 500 g to 10 kg. * able to obtain written informed consent from parents or legal guardians exclusion criteria: * neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.
simultaneous quantification of elexacaftor/tezacaftor/ivacaftor via reverse phase high performance liquid chromatography

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to support the clinical validation of a new assay to measure the levels of ivacaftor, tezacaftor, and elexacaftor (the components of trikafta) in the bloodstream in order to achieve greater understanding of the effectiveness of this medication in all people with cystic fibrosis. blood will be drawn at 3.0, 4.5, and 6.0 hours after taking the medication in the morning.

blood samples will be collected to measure steady state blood levels for participants who are being treated with elexacaftor/tezacaftor/ivacaftor (eti). this study is being conducted to evaluate drug dosing in people with cystic fibrosis. the aim of this study is to support clinical validation of pharmacokinetics launch of the elexacaftor/tezacaftor/ivacaftor blood serum level assay to demonstrate instrument capabilities to pass adx validation criteria.

Eligibility criteria:
inclusion criteria: * written informed consent obtained from subject * diagnosis of cf * aged 18 years and older * use of eti that has reached steady state dosing levels of eti, defined as a continuous dosing regimen for a minimum of 14 days. exclusion criteria: * a person with cf (pwcf) that is either not taking eti or dose not follow a continuous dosing regimen for a minimum of 14 days. * use of prohibited medications as outlined by package insert * pregnant or lactating people with cf * acute, severe deterioration in health requiring intensive care unit admission

Keywords: trikafta elexacaftor/tezacaftor/ivacaftor (eti) eti cystic fibrosis
stroke and traumatic acute brain injury line indicator system for emergent recognition (stabiliser-i)

Conditions: Ischemic Stroke; Hemorrhagic Stroke; Traumatic Brain Injury

Summary: in the search for a novel marker of stroke that could be rapidly assessed in blood, the investigators developed a point-of-care (poc) lateral flow device (lfd) that rapidly (\< 15 min) detects levels of a biomarker that is released into blood following neuronal injury associated with stroke and traumatic brain injury. the protein's expression in human brain should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.

the use of a lateral flow device (lfd) to indicate the presence of a blood biomarker is feasible and may provide an important diagnostic tool for stroke and traumatic brain injury (tbi). primary objectives: 1. determine the first-in-humans feasibility using the investigators' biomarker lateral flow device on whole blood samples to diagnose patients with acute stroke (both ischemic and hemorrhagic) and traumatic brain injury being evaluated in the emergency department and inpatient services at university of kentucky. provide initial pilot data for estimating sensitivity and specificity of the assay. 2. establish a visual ordinal grading scale that is easy to use clinically to judge the severity of injury, from the lateral flow device result. verify that the visual scale has inter-rater reliability, and evaluate it against a digital detection assay. 3. examine the correlation between clinical and radiographic parameters of injury severity and blood levels of the biomarker. the investigators will correlate the results of the test with nih stroke scale and with mri infarct volume for ischemic stroke, with hemorrhage volume on ct for hemorrhagic stroke, and with glasgow coma scale for traumatic brain injury (tbi).

Eligibility criteria:
inclusion criteria: 1. patients 21-85 years old, male or female. 2. suspected tbi, acute ischemic stroke, or nontraumatic/nonlesional intracerebral hemorrhage (ich) based on clinical and radiographic evidence as determined and documented by the appropriate service (trauma service or neurosurgery service for tbi; neurology or neurosurgery service for stroke) at university of kentucky. 3. patients with impaired capacity may be included; as the pathology to be studied (stroke or tbi) may impair their capacity (please see attached required documentation regarding impaired capacity). exclusion criteria: 1. pregnant women as the effect of pregnancy on the biomarker testing result is as yet unknown. 2. while patients may be included with the above listed diagnoses, they may be excluded later if an alternate unlisted diagnosis is found to be the root cause of their presentation. an example would be a patient initially thought to have a stroke, who is discovered to be suffering from a seizure instead.

Keywords: lateral flow device (lfd) acute stroke traumatic brain injury (tbi) point of care (poc) biomarker
drug-drug interaction study between edp-235, itraconazole, carbamazepine and quinidine in healthy subjects.

Conditions: COVID-19

Summary: a drug-drug interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the pharmacokinetics and safety of edp-235.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 90 days after the last dose of edp-235. a male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection * a positive urine drug screen at screening or day -1 * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * history of regular alcohol consumption * participation in a clinical trial within 30 days prior to the first dose of study drug * for part 2 participants: * participants of asian ancestry, given association of carbamazepine and severe rash (stevens-johnson syndrome \[sjs and toxic epidermal necrolysis \[ten\]) with hla-b 1502 in this population * platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine. * for part 2 and part 3 participants, the following cardiovascular abnormalities: * qrs duration \>110 ms * incomplete right bundle branch block or any complete bundle branch block * heart rate \ 90 beats per minute (per vital sign capture while rested) * history of unexplained syncope, structural heart disease, or clinically significant arrhythmias * personal or family history of long qt syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or brugada syndrome * pr interval \>220 ms or any 2nd or 3rd degree av block * ventricular pre-excitation * history of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives \[e.g. oxcarbazepine\]; known hypersensitivity to drugs structurally related to carbamazepine \[e.g.: tricyclic antidepressants\] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine

Keywords: drug-drug interaction
evaluation of the performance of chembio diagnostics systems, inc. dpp® hiv 1/2 rapid test

Conditions: HIV Infections

Summary: this study has been designed to evaluate the performance of the chembio diagnostics systems, inc. dpp® hiv 1/2 rapid test. the device is intended to qualitatively detect the presence of antibodies against hiv-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. this study will assess the dpp® hiv 1/2 screen assay's ability to detect hiv-1.


Eligibility criteria:
inclusion criteria: * must be at least 2 years of age (no upper age limit). * must be willing and able to receive post-test counseling, if applicable. * must sign (and be given) a copy of the written informed consent form and or assent form (if applicable). * must be able to sustain fingersticks and venipuncture from the arm or hand only. exclusion criteria: * am in a life threatening condition at the time of enrollment * have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-hiv immunosuppressive illness, etc.). * have participated or are participating in a clinical trial for an hiv vaccine. * have previously participated in this clinical trial.

Keywords: human immunodeficiency virus rapid test hiv hiv seronegativity
the duration of effects of massage in healthy participants

Conditions: Healthy; Pressure Pain Threshold; Massage

Summary: massage is a common rehabilitation treatment for musculoskeletal pain. prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage. the investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity.


Eligibility criteria:
inclusion criteria: • pain-free exclusion criteria: * non-english speaking * systemic medical condition known to affect sensation (i.e. uncontrolled diabetes) * regular use of prescription pain medication * current or history of chronic pain condition * currently taking a blood-thinning medication * any blood clotting disorder, such as hemophilia * contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines * contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture * investigator is unable to locate myofascial trigger point in the upper trapezius during testing session
osseous resective surgery vs conservative surgery with or without papilla preservation technique

Conditions: Periodontitis

Summary: the primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (fibreors) or conservative surgery with or without ppt in the treatment of deep residual pockets ≥ 6 mm in stage iii-iv periodontitis patients after cause related therapy (step ii) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility criteria:
inclusion criteria: * diagnosis of stage iii/iv periodontitis. * completed steps i-ii periodontal therapy at least 6 weeks before. * full mouth plaque score less than 15% at re-evaluation. * full mouth bleeding score less than 15% at re-evaluation. * posterior sextant with residual ppd ≥ 6 mm at ≥ 2 natural teeth (third molars excluded). * signed informed consent. exclusion criteria: * compromised general health which contraindicates the study procedures (asa iii-vi patients). * systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives). * pregnant or nursing women. * presence of tooth mobility ≥ class 2. * presence of furcation involvement ≥ ii degree (hamp 1975) at the affected teeth. * presence of deep infrabony defects (≥ 3 mm) at the involved sextant.
effects of nasal ventilation on cerebral and pulmonary function in orally intubated patients

Conditions: Hypoxemic Acute Respiratory Failure

Summary: the passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation. the hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.

the effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. the first condition consists of nociceptive stimulation of the left upper limb as a negative control. in three conditions, the inspired fraction of oxygen (fio2) will remain at 21% while applying three different rates of humidified nasal air at 0l/min, 30l/min and 60l/min respectively. the last two conditions consist of applying humidified nasal air at 30l/min and 60l/min with a fio2 of 100%. the primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. the secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. hypoxemic acute respiratory failure 3. intubation and mechanical ventilation since less than 4 days 4. pao2/fio2 ratio less than 200 5. rass\<-4 6. consent obtained from next of kin 7. patient with health insurance exclusion criteria: 1. central nervous system diseases (stroke, ms, epilepsy) 2. psychiatric illnesses (psychosis, depression) (indicated on patient's medical record) 3. hemodynamic instability (noradrenalin\>2mg/h) 4. patient on ame 5. patients under legal protection (guardianship/curators) 6. pregnant or breast-feeding women

Keywords: nasal ventilation orotracheal intubation brain activity
timing of endoscopy in cirrhotic patients with acute variceal bleeding

Conditions: Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding

Summary: endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (augib), especially acute variceal bleeding (avb), in patients with liver cirrhosis. however, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. herein, a multicenter randomized controlled trial (rct) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with avb.

a total of 368 cirrhotic patients presenting with augib that is highly suspected to be from avb will be enrolled. they will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. the primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. the secondary outcomes include 6-week mortality and incidence of adverse events.

Eligibility criteria:
inclusion criteria: 1. patients with augib which is highly suspected to be caused by gastroesophageal variceal rupture; 2. patients with a diagnosis of liver cirrhosis based on imaging and pathology; 3. patients and/or their relatives who sign informed consents; 4. patients' age ≥18 years. exclusion criteria: 1. patients who have undergone endoscopy at other hospitals before admissions; 2. patients' hemodynamics are unstable after resuscitation; 3. patients with severe cardiovascular or cerebrovascular diseases or renal injury; 4. patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases; 5. patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases; 6. patients with mental illness; 7. pregnancy.

Keywords: liver cirrhosis variceal bleeding gastrointestinal bleeding endoscopy survival randomized controlled trial