Kornimate/medical-research-clean huggingface dataset:
real-world evaluation of brolucizumab for the treatment of neovascular (wet) age-related macular degeneration (amd) (komodo health)

Conditions: Age-related Macular Degeneration (AMD)

Summary: this study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet amd patients initiating brolucizumab. evidence was generated to describe their patient characteristics and clinical outcomes. the study was conducted using the komodo healthcare map.

komodo healthcare map claims data from 08-oct-2016 to the date of most recent data from patients with wet amd who initiated brolucizumab were analyzed in this study. * identification period of the index date (index period): the patients fulfilling the selection criteria were identified during the period from 08-oct-2019 to 30-apr-2020. * index date: defined as the date of the earliest brolucizumab injection during the index period. * study period: the period from 08-oct-2016 to the most recent data extraction date (05-jun-2020). o note since 05-jun-2020 was the date data was pulled, claims data from recent months (e.g. may) may be incomplete (relative to the final db state) as well. * pre-index period: the period 36 months prior to the index date o note: data within 36 months prior to the index date will be used to assess baseline characteristics. * post-index period: the period of 180 days after the index date

Eligibility criteria:
inclusion criteria: 1. ≥1 healthcare common procedure coding system (hcpcs) code (j code) or national drug code (ndc) for treatment with brolucizumab during the index period (date of earliest code = index date) 2. ≥18 years old on the index date 3. ≥1 international classification of diseases, clinical modification-9/10 (icd-9/10) code for wet amd in the 36 months prior to or on the index date * note: off-label use of brolucizumab is not expected given payer access restrictions in the us 4. ≥24 months of continuous enrollment prior to the index date 5. ≥1 follow-up visit related to their wet amd after the index date exclusion criteria: 1. use of brolucizumab prior to 08-oct-2019 (e.g. clinical trials) 2. unknown laterality of the index eye on the index date 3. patients with no data throughout the 12 months immediately prior to the index date

Keywords: brolucizumab, intravitreal injection, neovascular age-related macular degeneration
impact of integrated care pathways for prevention of post-operative urinary retention (pour)

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Urinary Retention

Summary: a prospective randomized control trial will be conducted at good samaritan hospital and trihealth evendale hospital. subjects will receive total hip or knee surgery and follow-up via standard care at the discretion of the treating physician or the experimental study arm in which all patients will undergo the integrated care pathway.

patients will be randomized to the control group or the experimental group. patients in the control group will receive the treating physician's standard of care, and undergo bladder scans in the post anesthesia care unit (pacu), upon admission to the unit, and prior to discharge from the hospital. patients in the experimental group will undergo a multimodal pain control care pathway that minimizes opioid consumption. the primary endpoint will be the presence of or absence of post-operative urinary retention (pour) between discharge from the pacu and prior to discharge from the hospital. pour will be defined as bladder volume of greater than 500cc and the inability to void for at least 2 hours within the first 24 hours. pour, once identified will be treated with intermittent straight catheterization (isc). secondary endpoints will include opioid consumption (in morphine milligram equivalents; mme), genito-urinary consultation, type (knee or hip) and duration of surgery, type of anesthesia, duration of anesthesia, total amount of iv fluids, blood loss, length of hospital stay (los), discharge status (home with early outpatient physical therapy, etc.), time of first spontaneous voiding, and the number of iscs and any necessary indwelling catheterization and adverse events of interest including pour, post-operative nausea and vomiting (ponv), severe pain of 7 or greater on the numeric rating scale(nrs), blood loss requiring transfusion, and lower urinary tract symptoms (luts).

Eligibility criteria:
inclusion criteria: * asa grade i- iii * bmi under 36 kg/m\^2 * scheduled surgery for primary total hip or knee replacement * age 18+ years exclusion criteria: * contraindications or failure of neuraxial anesthesia * patients must not be outpatient total hip or knee procedure * known intercurrent uti, incontinence, or urinary retention not addressed by pre-operative urologic consultation and correction * pregnancy * current nicotine, alcohol or drug abusers * pre-operative narcotic use (any narcotic consumption within 3 days prior to surgery) * post- operative parenteral narcotic administration * allergy or intolerance to liposomal bupivacaine, bupivacaine, celecoxib, dexamethasone and/or pregabalin
temporal trends of coronary artery disease and peripheral artery disease (cope) in korea

Conditions: Coronary Artery Disease; Peripheral Artery Disease; Cardiovascular Diseases

Summary: cardiovascular disease (cvd) is caused by atherosclerosis of the artery and is classified into coronary artery disease, cerebrovascular disease, and peripheral arterial disease, depending on the location of the artery and the target organs. however, since cvd share a similar pathophysiology and the probability of incidence of other cvd in cvd patients is very high. it is thought that cvd incidence and mortality can be reduced by predicting the degree of incidence of other cvd in cvd patients. the aim of this study is to investigate the incidence and mortality of other cvd diseases in cvd patients.


Eligibility criteria:
inclusion criteria: * koreans who diagnosed with coronary artery disease between 2009 and 2018 * koreans who diagnosed with peripheral artery disease between 2009 and 2018 * koreans who diagnosed with cerebrovascular disease between 2009 and 2018 * more than 18 years old exclusion criteria: * less than 18 years old
role of angiotensin ii in insulin-induced microvascular activity

Conditions: Insulin Sensitivity; Microcirculation

Summary: in this study we hypothesize infusion of angiotensin ii improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. objectives: does infusion of angiotensin ii increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects?


Eligibility criteria:
inclusion criteria: 1.18-60 years 2.caucasian 3.blood pressure \<140/90 mmhg. exclusion criteria: 1. obesity (bmi\>27kg/m2) 2. cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure) 3. impaired glucose tolerance or diabetes mellitus according to the criteria of the ada 4. smoking 5. alcohol use \>4u/day 6. use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, nnsaids) 7. pregnancy 8. wearing contact lenses

Keywords: angiotensin ii
correlation study between sma blood flow reactivity and acute gastrointestinal injury in critically ill patients

Conditions: Intestinal Ischemia; Critical Illness; Enteral Nutrition Feeding; Hemodynamics; Ultrasonography, Doppler

Summary: this study aims to address the challenges of enteral nutrition support in critically ill icu patients with varying gastrointestinal function. we'll use bedside doppler ultrasound to monitor superior mesenteric artery (sma) blood flow changes post - feeding, exploring its correlation with acute gastrointestinal injury (agi) and other hemodynamic indicators. our goals are to identify the patterns of sma blood flow changes, establish a predictive model linking sma blood flow reactivity to agi risk, and propose individualized enteral nutrition strategies based on intestinal hemodynamics. through this innovative approach, we hope to enhance the safety of enteral nutrition, reduce agi incidence, and improve patient outcomes.


Eligibility criteria:
inclusion criteria: * adults aged ≥18 years and ≤80 years. * admitted to the study with a expected stay of more than 72 hours. * require initiation of enteral nutrition support. exclusion criteria: * pre-existing severe gastrointestinal diseases. * patients with gastrointestinal bleeding. * patients with bowel obstruction. * pregnant or lactating women. * patients with contraindications to bedside doppler ultrasound.

Keywords: enteral nutrition critical illness intestinal ischemia hemodynamics
1% alendronate gel in treatment of chronic periodontitis among smokers

Conditions: Chronic Periodontitis

Summary: * locally delivered alendronate (aln) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients * till date no study has reported the effect of local delivery of aln in chronic periodontitis patients among smokers. hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered aln as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.


Eligibility criteria:
inclusion criteria: * systemically healthy subjects with probing depth (pd) ≥ 5 mm or periodontal attachment level (pal) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm * no history of periodontal therapy in preceding last 6 months * no use of antibiotics in the preceding 6 months exclusion criteria: * subjects with known systemic disease * known or suspected allergy to the aln/bisphosphonate group * those on systemic aln/bisphosphonate therapy * subjects with aggressive periodontitis, * use of smokeless tobacco in any form, * alcoholics * immunocompromised subjects * pregnant or lactating females
robot-assisted stroke rehabilitation based on patient-therapist interactions

Conditions: Stroke; Hemiplegia; Healthy

Summary: our study goal is to assess natural patient-therapist interactions in order to map such human-human activities to robot-human interactions. critical to accomplishing this mapping will be determining the feasibility of a humanoid robot interacting with a patient in a more intuitive and flexible way, while concomitantly investigating the issue of safe contact and release.

stroke survivors with varying levels of motor deficit impairment in their upper extremity (ue) will be assessed using standardized clinical scales for cognition and motor impairment. following assessment, the patient and therapist will complete a therapy session consisting of activities of daily living (adl). during the therapy session, visual 3d motion tracking will be used via kinect, audio will be recorded, and basic measurements (i.e. the distance between a participants wrist and elbow) will be taken. after the patient-therapist interaction has been mapped, members of the research team will build computer based models of the therapist and patient using the insights gained from the human-human interaction. the models developed in this proposed study will be used as a template for programming safe and intuitive humanoid-patient interactions for future study. the model of the therapist will be implemented on the robot (w/o a patient involved) and in a simulation environment where it will be tested with a computer-based model of the patient.

Eligibility criteria:
inclusion criteria: * stroke survivors 18 years of age with hemiplegia and varying levels of impairment * healthy subjects greater than 18 years of age with no motor disabilities exclusion criteria: * under 18 years of age

Keywords: stroke hemiplegia healthy robotics rehabilitation therapy
evaluation of myocardial perfusion reserve

Conditions: Coronary Artery Disease

Summary: the proposed study is to validate a non-invasive imaging technique to evaluate the myocardial perfusion reserve in comparison with a validated invasive technique, the measure of coronary flow reserve (crf) with thermodilution.

coronary artery disease is a public health problem. the measurement of myocardial perfusion reserve is a prognostic factor supplemental. its measure should influence the treatment and the follow up of the patients. the measurement of crf by by one pressure-temperature sensor-tipped guide wire is a validated technique to evaluate the myocardial perfusion reserve but it is an invasive technique. in this study, the investigators will compare this method with a non-invasive method: completely automated analysis and quantification of myocardial blood flow from dicom files corresponding to stress and rest images was developed with a new camera czt spect.

Eligibility criteria:
inclusion criteria: * myocardial scintigraphy with pharmacologic stress and abnormal results * coronarography indicated * informed consent exclusion criteria: * pregnant woman * patient with terminal illness * terminal renal failure * allergy to iodine * informed consent impossible * patient under legal protection * history of coronary artery bypass surgery * contraindications for adenosine: asthmatic patients, second or third-degree av block without pacemaker or sick sinus syndrome. systolic blood pressure less than 90 mmhg. recent use of dipyramidole or dipyramidole-containing medications. methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. known hypersensitivity to adenosine. unstable acute myocardial infarction or acute coronary syndrome.
early effects of intensive lipid lowering treatment with ezetimibe/ simvastatin (vytorin®) assessed by virtual histology-intravascular ultrasound (vh-ivus) and optical coherence tomography (oct) on plaque characteristics in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: objective: to evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (vytorin®) for each component of coronary plaques. study design * prospective, randomized, single-center study of each 80 subjects enrolled * subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled. * eligible subjects will be randomized 1:1 to a) ezetimibe/simvastatin (n=80) vs. b) pravastatin (n=80), and each group of patients will be randomized further in a ratio of 1:1 to a) zes (n=40) vs. b) ees (n=40), according to the type of stent used. * all subjects will undergo vh-ivus at initial procedure. * follow-up vh-ivus will be performed at 3 months after index procedure. oct at initial procedure and 3-months will be performed in available cases.


Eligibility criteria:
inclusion criteria: general inclusion criteria 1. acute coronary syndrome including unstable angina, acute non-st elevation myocardial infarction and acute st elevation myocardial infarction 2. age of 20 years or older 3. patients with signed informed consent angiographic inclusion criteria 1. de novo lesion without significant plaque (angiographic lumen diameter stenosis \< 50%) 2. reference vessel diameter ?\> 3.0 mm by operator assessment 3. segment length of 10-20 mm 4. distance from the pci site \> 5.0mm (either proximal or distal) 5. available for serial high quality ivus studies of the entire segment. exclusion criteria: 1. failed pci 2. recommended coronary artery bypass grafting (cabg) 3. cardiogenic shock 4. administration of lipid lowering agents before enrollment 5. significant hepatic dysfunction (3 times normal reference values) 6. significant renal dysfunction (serum creatinine \> 2.0 mg/dl) 7. significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis 8. pregnant women or women with potential childbearing 9. saphenous vein graft
the epidemiology and etiology of acute gastroenteritis among estonian children after introduction of rotavirus vaccines

Conditions: Rotavirus Infection

Summary: this study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the estonian national immunization program in july 2014.

the two-year study period started in february 2015. the study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (age) to seven estonian hospitals participating in this study. expected sample size is about 2000 patients. hospitals that participate in this study are tartu university hospital, west-tallinn central hospital, tallinn's children hospital, pärnu central hospital, south-estonian hospital, kuressaare hospital and ida-viru central hospital. before enrollment all patients are asked to give an informed consent. after enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. specific database for our study has been created by company vision 5d. after completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into eppendorf tubes produced by our study laboratory. the samples are transported to our study laboratory where they are tested for rotavirus, norovirus g1, g2, astrovirus, adenovirus and sapovirus with fast-track diagnostics real-time assay kit ftd viral gastroenteritis. the samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

Eligibility criteria:
inclusion criteria: * children aged \< 18 year * hospitalized due to acute gastroenteritis exclusion criteria: * children aged \> 18 years * gastroenteritis due to known non-infectious causes

Keywords: rotavirus, acute gastroenteritis vaccination estonia impact severity scales
effects of levothyroxine supplementation in patients with systolic heart failure and subclinical hypothyroidism

Conditions: Systolic Heart Failure; Sub-clinical Hypothyroidism

Summary: the purpose of this study is to determine whether levothyroxine supplementation is beneficial in patients with systolic heart failure and subclinical hypothyroidism on the functional class evaluated with a 6 minute walk test.

forty patients with systolic heart failure and subclinical hypothyroidism will be include in a open label trial. they will receive levothyroxine supplementation to determine if their functional class will be affect.

Eligibility criteria:
inclusion criteria: * biochemical diagnosis of subclinical hypothyroidism (tsh between 3.5 and 10 with a normal t4) * systolic heart failure with new-york heart association (nyha) class ii or iii * left ventricular ejection fraction under 40% * stable heart failure for the past 3 months (no iv furosemide or hospital admission) * beta-blockers and ace inhibitors titrated to the maximum tolerated dose exclusion criteria: * isolated diastolic heart failure * awaiting cardiac resynchronisation therapy * impossibility to perform the 6 minutes walk test * active cancer / life expectancy under 18 months * treatment with amiodarone
evaluation of efficacy of ophthalmic solution in induced allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to establish the efficacy of r89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis


Eligibility criteria:
inclusion criteria: history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logmar or better in each eye; positive bilateral conjunctival allergy challenge reaction - exclusion criteria: narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis

Keywords: ocular, allergic conjunctivitis, ophthalmic
rtpa in in the prevention of cvad-associated thrombosis and infection in pediatric patients with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: the primary research question is, in patients with short bowel syndrome requiring central venous access device (cvad) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtpa) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.

central venous access devices (cvad) are used routinely in chronically ill pediatric patients for administration of medications, parenteral nutrition and laboratory testing. several complications resulting from the use of long-term cvads, namely venous sepsis and thrombosis, can significantly increase associated morbidity and mortality. cvad-associated thrombosis occurs in up to 50% of children with long-term cvad use and this is especially common in patients requiring life-sustaining long-term total parenteral nutrition (1). catheter thrombosis may arise from fibrin sheath formation around the catheter tip, intraluminal blood clot within the catheter, or venous thrombosis obstructing the vein and occluding the catheter tip. within 24 hours and typically within 2 weeks of placement of a cvad, a fibrin sheath forms around its tip (2-5). development of intraluminal thrombosis or venous thrombosis is less predictable. there is a growing body of evidence linking the development of cvad-associated thrombosis and line-related infection. it is known that proteins within the thrombus including fibronectin and fibrinogen attract bacteria, specifically staphylococcal species. the bacteria bind to ligands associated with the thrombus thus allowing for bacterial proliferation (6-8). the clinical relevance of line thrombus in development of line infection is underscored in a study of pediatric patients with hickman catheters, of whom 18% with catheter thrombosis developed a line-associated bloodstream infection, while none developed a catheter infection that did not also have a catheter clot (7). thus, we hypothesize that prevention of catheter-related clot formation with use of a local thrombolytic agent will also prevent infection in the catheter. the primary research question we pose is, in patients with short bowel syndrome requiring central venous access device (cvad) for long-term total parenteral nutrition, is once weekly recombinant tissue plasminogen activator (rtpa) lock therapy more effective than routine care using heparin flushes in reducing the incidence of line-associated thrombosis and infection.

Eligibility criteria:
inclusion criteria: 1. subjects with short bowel syndrome 2. requirement for central venous access device (cvad) for long-term tpn administration 3. age \>/= 6 months to \< 16 years 4. ability to initiate rtpa during hospitalization for newly inserted cvad 5. ability to be enrolled within 48 hours of cvad placement. exclusion criteria: 1. platelet count \<50,000 2. active bleeding 3. age =/\> 16 years at time of consent.