Kornimate/medical-research-clean huggingface dataset:
effect of different ventilatory strategies on cardiac function in patients with acute respiratory failure

Conditions: Respiratory Distress Syndrome

Summary: mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ali/ards patients respect to high tidal volume ventilation (about 12 ml.kg-1). this finding is usually explained by alveolar tidal overdistension associated to high tidal volume. stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. this may contribute to the development of systemic inflammatory response and multiple system organ failure and death. high tidal volume strategies might affect organ function by pathways not mediated by inflammatory response. it is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ali/ards patients. the study hypothesis is that high tidal volume ventilation reduces cardiac output in ali/ards patients respect to low tidal volume strategy. thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation. if study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).


Eligibility criteria:
inclusion criteria: * diagnosis of ards/ali exclusion criteria: * mean arterial pressure lower than 65 mmhg * beginning or change of vasoactive agents infusion rate in the last 2 hours

Keywords: respiratory distress syndrome, adult tidal volume cardiac output respiration, artificial protective ventilation
a study of shr-1701 plus bevacizumab and chemotherapy in non-small-cell-lung-cancer

Conditions: Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Summary: evaluate efficacy and safety of shr-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with egfr mutation after failure of tkis


Eligibility criteria:
inclusion criteria: - a subject must satisfy all of the following criteria to be considered for inclusion in the study: 1. histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer. 2. failed with prior egfr-tkis treatments. 3. measurable disease, as defined by recist v1.1 4. the eastern cancer cooperative group (ecog) performance status of 0 or 1 5. life expectancy ≥ 3 months 6. adequate hematologic and end-organ function as defined in the protocol exclusion criteria: - a subject who meets any of the following criteria will be excluded from study entry: 1. histologically or cytologically confirmed mixed sclc and nsclc. 2. symptomatic, untreated or active central nervous system metastases. 3. systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment 4. with any active autoimmune disease or history of autoimmune disease. 5. inadequately controlled hypertension. 6. tumour infiltration into the great vessels on imaging. 7. history of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment. 8. uncontrolled tumour-related pain. 9. patients with active hepatitis b or hepatitis c 10. severe infections within 4 weeks prior to initiation of study treatment. active tuberculosis within one year prior to initiation of study treatment.
canine guidance vs bilateral balanced occlusion in complete denture

Conditions: Edentulous Mouth; Edentulous Jaw

Summary: the objective of this study is to compare the canine guidance (cg) and bilateral balanced occlusion (bbo) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: bbo followed by cg, or cg followed by bbo.

reference for published version of the complete study: paleari ag, marra j, rodriguez ls, de souza rf, pero ac, de a mollo jr f, compagnoni ma. a cross-over randomised clinical trial of eccentric occlusion in complete dentures.j oral rehabil. 2012 apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. \[epub ahead of print\]

Eligibility criteria:
inclusion criteria: * adult patients needing new complete dentures * mentally receptiveness * absence of dysfunctional disorders of the masticatory system * normal volume and resilience of residual edentulous ridges * absence of debilitating systemic diseases exclusion criteria: * use of cardiac pacemaker * refusal to participate or inability to provide informed consent

Keywords: bilateral balanced occlusion canine guidance complete denture denture retention dental occlusion edentulous edentulism mandibular movement mastication patient acceptance of health care patient satisfaction
study of efficacy and safety of avtr101 in sarcopenic elderly

Conditions: Sarcopenia

Summary: the goal of this clinical trial is to primarily evaluate the efficacy of avtr101 to placebo on physical performance in sarcopenia patients. participants will: take avtr101 or a placebo three times daily for 12 weeks visit the clinic once every 4 weeks for checkups and tests


Eligibility criteria:
inclusion criteria: * men and women aged 65 years or older at the time of screening * appendicular skeletal muscle mass (asm) measured by dual-energy x-ray absorptiometry (dxa), men \< 7.0 kg/m2, women \< 5.4 kg/m2 * handgrip strength, men \< 28 kg, women \< 18 kg or 5-times sit-to-stand ≥ 12 second or 6 meter walking speed \< 1.0 m/s * nutrition status confirmed by mini nutritional assessment (mna) is higher than 8 at the time of screening * body weight ≥ 35 kg and bmi is between 15\~30 kg/m2 at the time of screening * after fully understanding the written consent, which includes compliance with the requirements and restrictions listed in the trial protocol and describes the overall nature and purpose of the clinical trial, including potential risks and side effects, the subject (or representative) voluntarily a person who signed a written consent form as exclusion criteria: * patients with neuromuscular or nervous system diseases (e.g. parkinson's disease, lou gehrig's disease, stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.

Keywords: sarcopenia
safety and tolerability of intravenous lfg316 in wet age-related macular degeneration (amd).

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (iv) doses of lfg316 in eligible patients with neovascular age-related macular degeneration (amd)


Eligibility criteria:
inclusion criteria: - active choroidal neovascular amd in at least one eye. exclusion criteria: * retinal disease other than amd that, in the investigator's opinion, would interfere with safety or study conduct. * choroidal neovascularization due to a cause other than amd. * in the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct. * any disease or concomitant (or recent) medication expected to cause systemic immunosuppression. * history of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis. * history of hospitalization for pneumococcal pneumonia within the past 3 years. * history of serious systemic infection within the past 12 months. * any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (lucentis), bevacizumab (avastin), pegaptanib (macugen), or other vegf inhibitor. other protocol-defined inclusion/exclusion criteria may apply

Keywords: amd age-related macular degeneration wet amd neovascular amd
stopping tsc onset and progression 2: epilepsy prevention in tsc infants

Conditions: Tuberous Sclerosis Complex; Epilepsy

Summary: this phase i/ii clinical trial is an open-label clinical trial design to verify safety and dosing for tavt-18 (sirolimus) powder for oral solution in tsc infants (n=5).

tuberous sclerosis complex (tsc) is caused by genetic mutation in tsc1 or tsc2, resulting in dysregulation of the mechanistic target of rapamycin (mtor) signaling pathway. age at time of seizure onset in tsc infants has been linked to long-term neurodevelopmental outcome in this high-risk population. tavt-18 is a novel formulation of sirolimus, an mtor inhibitor. this study evaluates tavt-18 as a targeted, disease-modifying drug therapy for preventing or delaying seizure onset in tsc using a rational, mechanism-based therapeutic approach.

Eligibility criteria:
inclusion criteria: * 0-6 months of age at the time of enrollment (randomization and treatment initiation must occur before 7 months of age and infants born prematurely must have a corrected age of at least 39 weeks, calculated by subtracting the number of weeks born before 40 weeks gestation from the actual chronological age, in weeks) * has a confirmed diagnosis of tsc based on established clinical or genetic criteria exclusion criteria: * prior history of seizures (clinical or electrographic) at the time of enrollment or identified on baseline eeg * has been treated in the past or is currently being treated at the time of enrollment with conventional anticonvulsant medications (aeds), systemic (oral) mtor inhibitors (such as rapamycin, sirolimus, or everolimus), ketogenic-related special diet, or another anti-seizure therapeutic agent, device, or procedure * has taken any other investigational drug as part of another research study, within 30 days prior to the baseline screening visit * has a significant illness or active infection at the time of the baseline screening visit * has a history of significant prematurity, defined as gestational age \<30 weeks at the time of delivery, or other significant medical complications at birth or during the neonatal period that other than tsc would convey additional risk of seizures or neurodevelopmental delay (i.e. hie, severe neonatal infection, major surgery, prolonged ventilatory or other life-saving supportive care or procedures) * abnormal laboratory values at baseline (i.e., renal function, liver function, or bone marrow production) that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject * prior, planned or anticipated neurosurgery within 3 months of the baseline visit * has a tsc-associated condition for which mtor treatment is clinically indicated (i.e. sega or aml) * subjects who are, in the opinion of the investigator, unable to comply with the requirements of the study
a study of a developmental,individual-difference,relationship-bases/floortime intervention for children with autistic

Conditions: Autism Spectrum Disorders

Summary: thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. the new treatment intervention is based on the dir model. parents will be coached at the start and then every 3-4 months for 1 year. outcome will be measured at the first session and at the end of the study using functional emotional assessment scale and childhood autism rating scales, functional emotional level, and parent satisfaction rating. hypothesis of the study: children who get additional treatment of dir/floortime show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.


Eligibility criteria:
inclusion criteria: * clinical criteria for autistic disorders according to dsm iv * child is 2 - 6 years of age exclusion criteria: * children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures) * children who are geographically inaccessible for follow-up visits * their parents are not literate or known chronic psychiatric or physical illness in the parents
aortic wall and left ventricular mechanics: echocardiographic and hemodynamic analysis

Conditions: Coronary Disease; Cardiac Valve Disease

Summary: the purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery.

the purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. measurements of the aorta are obtained by an ultrasound-based imaging technique called transesophageal echocardiography (tee), which is routinely performed during cardiac surgery. tee is an instrument used to monitor the heart and is standard of practice at weill cornell medical college.

Eligibility criteria:
inclusion criteria: * elective cabg, valvular procedure exclusion criteria: * non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.

Keywords: tee cardiac surgery pulse pressure
new york city (nyc) health ehearts pay for quality pilot

Conditions: Hypertension; Diabetes; Smoking; Ischemic Cardiovascular Disease

Summary: do monetary incentives in small independent primary care practices improve the delivery of preventive services as recommended by u.s. preventive services task force (uspstf) guidelines for cardiovascular health?

the nyc dohmh received a private donation from the robin hood foundation to provide monetary incentives to small practices for improving their delivery of preventive services in neighborhoods experiencing health disparities. practices recruited by nyc dohmh to adopt an electronic health record will be randomized to receive monetary incentives for improving both patient outcomes and delivery of care on: aspirin therapy, blood pressure control, cholesterol control, and smoking cessation intervention. the set of quality measures are referred to the abcs. the nyc dohmh will be collecting provider surveys on their experience on quality measurement and participation in other pay-for-performance programs, as well as transmit aggregated information on their performance on the abcs to dohmh on a monthly basis.

Eligibility criteria:
inclusion criteria: * primary care providers exclusion criteria: * specialists * pediatricians * obstetricians * gynecologists

Keywords: pay for quality provider clinical decision support quality reporting quality measurement
effect of systemic ropivacaine on hyperalgesia, flare reaction and peripheral nerve excitability

Conditions: Healthy Volunteers

Summary: the purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed. \*trial with medicinal product


Eligibility criteria:
inclusion criteria: 1. male 2. age: 18 - 65 years 3. weight: 50-100kg 4. height: 155-195cm 5. signed and dated informed consent 6. sufficient command of german language exclusion criteria: 1. contraindications to the class of drugs under study 2. vulnerable subjects (intellectually or mental impaired) 3. known hypersensitivity to class of drugs or the investigational product 4. drug abuse 5. known peripheral neuropathies 6. diabetes mellitus 7. chronic alcohol consumption 8. congestive heart disease 9. participants of other studies during study period 10. smoker
pressure-volume loop during high-risk pci

Conditions: Coronary Artery Disease

Summary: this study will examine the physiologic effects on loading conditions and contractility of the left ventricle during high-risk primary coronary intervention (hrpci) in the cardiac cath lab. this will be performed through analysis of real-time left ventricular (lv) pressure-volume loops (pvl) by continuously recording pvl during hrpci with the inca® pressure-volume loop system that will be temporarily placed in the left ventricle during the procedure.

given the complexity of patients treated by high risk percutaneous coronary interventions (hrpci), mechanical circulatory support (mcs) devices are increasingly used to maintain hemodynamic stability during these procedures. it is crucial to have a better understanding of the hemodynamic effects during hrpci and of mcs devices to guide appropriate device selection and utilization for hrpci. clinical studies evaluating different mcs devices are not all consistent in terms of patient selection, outcomes examined and overall findings. therefore, the role of mcs devices in hrpci is still widely debated. this is reflected in a variable clinical practice pattern and recommendations from professional society guidelines. the investigators believe that having a clear scientific understanding of mcs devices in terms of hemodynamic effects during different stages of these complex procedures may prove helpful in refining the process of appropriate mcs device selection in appropriate clinical setting. one especially insightful method of examining the mcs devices effect is analyzing the left ventricular (lv) pressure-volume loops (pvl). continuously recording pvl during hrpci can provide valuable data on the device effects on loading conditions and contractility of the left ventricle. in this study, the investigators will collect hemodynamic data in real-time during hrpci being performed as standard of care and continuously recording left ventricular pressure-volume loop (pvl) throughout the procedure via the inca® pressure-volume loop system (cd leycom, hengelo, the netherlands).

Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) with known coronary artery disease and planned elective hrpci procedures. exclusion criteria: * any patient not considered appropriate for elective hrpci procedures.

Keywords: high risk percutaneous coronary intervention pressure-volume loop
peg (polyethylene glycol)versus lactulose for treatment of overt hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the current standard of care for patients with he includes non-absorbable disaccharides(lactulose);the chemical name for lactulose is 4-o-β-d-galactopyranosyl-d-fructofuranose.the exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. this favors conversion of ammonia (nh3) to ammonium (nh4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.

polyethylene glycol electrolyte solution (peg) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. it is used safely to clean the bowel before colonoscopy.

Eligibility criteria:
inclusion criteria: * adult patients with overt hepatic encephalopathy. exclusion criteria: 1. patients with active git bleeding. 2. patients with history of bowel obstruction, perforation. 3. patients with history of allergy to peg. 4. treatment with rifaximin or neomycin in the previous 7 days. 5. patients with major psychiatric illness. 6. patients receiving benzodiazepines and narcotics. 7. patients with compromised renal. 8. patients receiving medications highly bound to plasma proteins eg. warfarin. 9. pregnant or lactating women. 10. fulminant hepatic failure.
optical coherence tomography angiography (octa) - directed pdt triple therapy

Conditions: Exudative Age Related Macular Degeneration

Summary: optical coherent tomography angiography (octa)-directed pdt triple therapy for treatment-naïve patients with exudative age-related macular degeneration (armd) versus standard of care anti-vegf monotherapy

this study is a 48 week, single center, randomized controlled clinical trial. approximately 150 subjects will be randomized into three separate arms. this study compares the efficacy of standard of care lucentis (ranibizumab) monotherapy versus octa-directed pdt triple therapy with lucentis (ranibizumab), pdt with visudyne (verteporfin), and triescence (triamcinolone acetonide) in treatment-naïve patients with exudative age-related macular degeneration. octa-directed pdt double therapy with lucentis (ranibizumab) and pdt with visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.

Eligibility criteria:
inclusion criteria: * willing to give written informed consent * willing and able to comply with all study procedures for the duration of the study. * presence of exudative armd with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain oct, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography * visual acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or early treatment diabetic retinopathy study * intraocular pressure less than or equal to 25mmhg * females of childbearing potential that are willing to use medically acceptable methods of birth control. exclusion criteria: * exudation maculopathies without drusen * previous treatment with macular photocoagulation, anti-vegf medication or pdt with visudyne * myocardial infarction or cerebrovascular accident within the last 6 weeks * previous vitrectomy * optic neuropathy * diabetic retinopathy * traction maculopathies * allergies to fluorescein and indocyanine, dilating agents or anti-vegf medications * have received previous treatment for armd * any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study

Keywords: macular degeneration lucentis triescense photodynamic laser treatment
effect of local infiltration anesthesia with ropivacaine on pain after primary total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: background: the local infiltration analgesic (lia) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (tha). however, the evidence for lia in tha remains to be clarified. purpose: to evaluate whether a single shot lia in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after tha.


Eligibility criteria:
inclusion criteria: * all patients receiving total hip arthroplasty in the study period exclusion criteria: * contraindications to receive spinal anesthetic, dexamethasone or acetaminophen. * patients who received general anaesthetic * patients who will get a different operation than standard direct lateral surgery * patients with osteosynthesis to be removed in the same operation

Keywords: arthroplasty, replacement, hip anesthesia, local ropivacaine randomized controlled trial