Kornimate/medical-research-clean huggingface dataset:
measures of pain relevant to knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: the aim is to improve understanding of the assessment of pain experience in patients with osteoarthritis (oa) of the knee. the current study will be divided into two parts. in study 1, the investigators will analyse existing questionnaires relevant to the mechanisms and therapeutic targets of knee oa to establish discrete dimensions that discriminate between the different mechanisms of pain. on the basis of this analysis, the investigators will refine the questionnaires to maximise their sensitivity to knee oa. in study 2, the investigators will seek to confirm the factor structure identified in the questionnaires in study 1 and explore potential mediator and moderator variables between pain and quality of life using the refined measures. the investigators will also evaluate quantitative sensory testing as a predictor of oa knee pain.


Eligibility criteria:
inclusion criteria: * participants in study 1 will have oa of the knee defined and scored radiologically and will report knee pain. participants in study 2 will also have oa of the knee, but a clinical diagnosis will suffice. exclusion criteria: * inability to speak or understand english * under the age of 18 years old * knee joint surgery within three months prior to participation * diagnosed rheumatoid arthritis, psoriatic arthritis, gout or any other inflammatory arthritis disorder * the participants in study 2 will also be excluded if they participated in study 1
role of statins in slowing rheumatic heart disease (rhd) progression

Conditions: Rheumatic Heart Disease; Valvular Disease

Summary: the goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (rhd) valvular pathology progression. this feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. these results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in rhd. successful treatment of rhd would fundamentally shift the rhd management paradigm world-wide, improve the lives of millions afflicted with rhd, and subsequently, decrease health care spending on rhd management.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * history of rhd as evidenced by at least one echocardiographic examination * no history of cardiac surgery exclusion criteria: * ≥ 75 or \< 18 years old * absence of rhd or rf history * active liver disease * impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal * history of previous statin intolerance or muscle disorders * current pregnancy (by history or lab assessment of beta hcg) or plans for pregnancy in the next 18 months). current lactation / breast feeding. * ldl \<60
a study of tildrakizumab in the treatment of genital psoriasis (czatch-genital-pso)

Conditions: Genital Psoriasis

Summary: the main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (smpc) and to access overall treatment safety and quality of life assessed on multiple scales.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., spga-g greater than or equal to (\>=) 3. * need for systemic biologic therapy based on the local country specific regulations. tildrakizumab, in accordance with the smpc, must be the anti-il23p19 selected therapy before including the patient in the study. * age 18 - 99 years. * informed consent in writing in accordance with applicable country regulations * patient must have plaque psoriasis affecting a body surface area (bsa) \>= 1% in a non-genital area at baseline. * patient willing and able to fill out study questionnaires. exclusion criteria: * patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the investigator, should not participate in the study. * patient exposed to any experimental treatment in the past 3 months prior to baseline. * any condition preventing prescription of tildrakizumab according to the smpc, including but not restricted to any contraindication or history of hypersensitivity or intolerance. * patient dependent on the investigator, including but not restricted to employees of the study site. * previous treatment with tildrakizumab.

Keywords: psoriasis plaque psoriasis skin diseases tildrakizumab
effect of hepa air filters on subclinical markers of cardiovascular health

Conditions: Endothelial Function; Oxidative Stress; Systemic Inflammation

Summary: the purpose of this study is to evaluate the ability of portable high efficiency particle air (hepa) filters to reduce exposures to pm2.5 and woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.

the investigators will use portable hepa filters in a single-blind randomized crossover design. each participant's home will be monitored for two consecutive seven-day periods, during which time two hepa units (one in the bedroom and one in the main living room) will be operated indoors. during one 7-day period the hepa filters will be operated normally, and during the other period the hepa unit will be operated without the internal filter in place (i.e., "placebo filtration"), thus blinding participants to the filters' status. the order of filtration or non-filtration will be random. at the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.

Eligibility criteria:
inclusion criteria: * 19 years or older * non-smoking household * lives in study region (smithers or telkwa british columbia) exclusion criteria: -
second eframngham heart study

Conditions: Cardiovascular Diseases

Summary: in the electronic framingham heart study (efhs), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the framingham research clinic for the fhs. participants enrolled in efhs receive a series of digital surveys modules to complete on a regularly occurring schedule. the objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates. there will be 4 survey periods. period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).

participants in efhs are invited to enroll from the fhs offspring and omni group 1 cohorts during the in-person examination 10/5 at the fhs research center in framingham, massachusetts (ma), usa or remotely from home after the in-person examination. all efhs participants have the efhs mydatahelps mobile app (developed by fhs investigators with careevolution our industry partner) installed on their smartphone. the efhs app allows communication with participants through notifications and data collection. participants are asked to answer health surveys administered through the app. survey assessments will include 6 modules: cognition, pain, mood, physical function and performance, physical activity, and events. the interventions are defined by the patterns of administration of survey modules to the experimental and control groups. the administration of the cognition, pain, mood, and psychosocial modules follow the same pattern for both groups. however, the administration of the physical function, physical activity, and events modules is delayed by 2 weeks in the experimental group as compared to the control group.

Eligibility criteria:
inclusion criteria: * invited to enroll from the fhs offspring and omni group 1 cohorts during the in-person examination 10/5 at the fhs research center * english speaking * english language reading proficiency * owns an iphone with compatible ios (version 10.0 or higher) or android (version 5.0 or higher) * residence in the united states * provision of permissions for notifications and data sharing with the research center * provision of signed and dated informed consent (within the efhs mobile app) exclusion criteria: * limited and non-readers

Keywords: framingham heart sudy efhs mhealth patient provider communication user engagement
molecular markers in predicting lung cancer development using tissue samples from healthy participants

Conditions: Healthy, no Evidence of Disease; Lung Cancer

Summary: rationale: studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors learn more about the development of cancer. purpose: this laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

objectives: * to obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression. * to identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung. outline: serum, urine, sputum, and buccal cell samples are collected. patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. the samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

Eligibility criteria:
disease characteristics: * healthy participant * no history of smoking * no history of cancer patient characteristics: * swog performance status 0 * no clinically apparent bleeding diathesis prior concurrent therapy: * not specified

Keywords: squamous cell lung cancer non-small cell lung cancer small cell lung cancer healthy, no evidence of disease
a study of hbi-8000 (tucidinostat) with pembrolizumab in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this phase 2 study evaluates hbi-8000, a histone deacetylase inhibitor (hdaci) in combination with pembrolizumab for the treatment of patients with advanced or metastatic non-small cell lung cancer who possess programmed death ligand 1 (pd-l1) expression tumor proportion score (tps) of 1% or greater.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of nsclc with pd-l1 expression of ≥1% based on fda-approved test * no prior treatment with checkpoint inhibitors or more than one regimen of chemotherapy including epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) mutation directed therapy for advanced or metastatic disease * disease must have at least 1 measurable target lesion by recist 1.1 * adequate major organ functions as evidenced by laboratory findings within 14 days prior to first dose * eastern cooperative oncology group (ecog) ≤2 and must have a life expectancy of ≥12 weeks exclusion criteria: * history of grade ≥3 hypersensitivity reactions to monoclonal antibodies * participation in another interventional clinical trial within 28 days or less than 5 half-lives of investigational agent before the first dose * recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry (except patients with a pleurx™ port) * active, known or suspected autoimmune disease or history of immune-mediated toxicity leading to discontinuation of previous checkpoint inhibitor treatment should be administered in (neo)adjuvant setting. exceptions are for type i diabetes mellitus, hyperthyroidism requiring hormone-replacement or skin only disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy * active pneumonitis, history of non-infectious pneumonitis that required treatment with steroids, or history of interstitial lung disease * received approved live vaccines within 30 days of planned first dose. intranasal influenza vaccines (e.g. flu-mist) are not allowed, however inactivated viral vaccines or vaccines based on subviral component are allowed * any condition requiring chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications. and any steroids use within 14 days of first dose except for inhaled or topical steroids. note: other protocol-defined inclusion/exclusion criteria may apply

Keywords: hbi-8000 pembrolizumab nsclc
multimodal imaging in the study of disorientation in the hospital

Conditions: Mild Cognitive Impairment; Dementia; Disorientation; Older Adults; Magnetic Resonance Imaging

Summary: the purpose of this study is to investigate whether markers of brain structure and function from mri are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to alzheimer's disease when walking through a real world environment.

this is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. the features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors. additionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.

Eligibility criteria:
inclusion criteria: * 50 years and above * mini mental state examination (mmse) ≥ 12 \< 28 points for experimental group * mini mental state examination (mmse) ≥ 28 points for control group * sufficient knowledge of german to understand participant information, declaration of consent and questionnaires * dated and signed declaration of consent * sufficient mobility and motivation to participate in the study exclusion criteria: * less than 50 years * significantly impaired vision or hearing * severely reduced mobility: cannot move around independently (even with aids)
renal arterial denervation in sympathetic dysautonomia

Conditions: Hypertension; Renal Denervation; Increased Variability; Blood Pressure Disorders; Blood Pressure Variability; Sympathetic Dysautonomia

Summary: the ransom registry is considered as a collection of data with the ultimate purpose of gathering information about the effect of renal denervation in patients of the investigator's center and evaluating the results within the usual clinical practice. the general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation\> 10 mmhg for systolic bp and\> 5 for diastolic bp of its blood pressure levels, measured by abpm.


Eligibility criteria:
inclusion criteria: * all patients included in a prospective manner must sign an informed written consent and meet all of the following criteria that are typical of the procedure according to the protocol of our center: * be considered adequate and eligible by the group of doctors responsible for the patient and by the multidisciplinary team of the study. over 18 years, not pregnant. * poorly controlled arterial hypertension, under treatment with at least one antihypertensive drug. * in addition, poorly controlled hypertension + increased variability, considering as such a standard deviation\> 10 mmhg for systolic bp and\> 5 for the diastolic bp of patient´s blood pressure levels, measured by abpm. * renal arteries anatomy suitable for the procedure, considered by ct, mri, ultrasound or angiography. * some criteria of dysautonomia, following the consensus of the american autonomous society (aas) and the european federation of autonomous societies (efas) of 2018. or supine htn. defined as sbp ≥ 140 mmhg and / or dbp ≥ 90 mmhg, measured at least after 5 minutes of supine rest. moderate forms (160-179 mmhg or dbp of 100-109 mmhg) or severe will preferably be included. (sbp≥ 180 mmhg and / or dbp ≥ 110 mmhg). mild forms will be considered in conjunction with symptoms or other findings (abpm) or nighttime htn. considered as such one that does not fall more than 10% compared to the daytime bp or even rises (riser). they will be considered in conjunction with symptoms or other findings (eg abmp). * if the foregoing is not fulfilled, marked orthostatism (\> 30 mmhg in sbp and / or\> 10mmhg in dbp). * life expectancy exceeding one year (not presenting terminal illness or any health condition for which a survival of less than one year is estimated). exclusion criteria: * egfr \<30 ml / min / 1.73m2. * monoxidin treatment. * impossibility of informed consent by the patient or legal representative. * impossibility for follow-up at least 1 year. * do not fulfill inclusion criteria, assessed by the multidisciplinary team.

Keywords: sympathetic dysautonomia blood pressure variability hypertension renal denervation
adapting and implementing the i-home intervention in caregivers of patients with adrd

Conditions: Caregiver Burden

Summary: the purpose of this study is to pilot test the adapted improving home hospice management of end-of-life issues through technology (i-home) intervention with family caregivers of patients with advanced alzheimer's disease and related dementia. data will be collected regarding intervention feasibility and acceptability.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old and \< 100 years * english speaking * providing care to an adrd patient who is age ≥ 65 years old and \< 105 years who is a stage 7a-f on the functional assessment staging tool (fast) scale exclusion criteria: * non-english speaking * \ 100 years old
a clinical trial of oral midazolam plus oral ketamine for sedation during laceration repair

Conditions: Lacertaions

Summary: background: sedation is often needed for young children undergoing minor procedures in the emergency department (ed). oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. in a few studies oral ketamine has been used successfully for procedural sedation as well. the efficacy of using a combination of oral midazolam and oral ketamine for procedural sedation has been studied only for invasive procedures in children with malignancies. no randomized controedll studies were performed using this sedative combination in children requiring laceration repair. objectives: to determine the efficacy of adding oral ketamine to oral midazolam for procedural sedation in children requiring laceration repair compares to oral midazolam plus placebo. design: a randomized, double blind, placebo-controlled study. setting: pediatric emergency department. participants: children 1 to 10 years with laceration requiring sedation. interventions: eligible patients will be randomly assigned to one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral ketamine group. both groups will be given the same volume of medications. midazolam will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with oral ketamine in a dose of 5 mg/kg. the medical staff will be blinded to the treatment given. patient monitoring will be conducted according to the american academy of pediatrics (app) and the israeli health ministry guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. main outcome measures: pain score: visual analog score (vas) - by parent. data analysis: descriptive statistics will be used to describe the study population. data will be analyzed using t- tests for continuous data and fisher exact test for categorical data. key words: sedation, children, ketamine, midazolam, emergency department.


Eligibility criteria:
inclusion criteria: * age: 1 years - 10 years * any child with laceration requiring sedation exclusion criteria: * major trauma * closed head injury associated with loss of consciousness * abnormal neurologic examination in a previously normal child * significant developmental delay or baseline neurological deficit * a patient with seizures * elevated intra-cranial pressure * hypersensitivity to midazolam or ketamine * hypertension * hyperthyroidism or a patient receiving thyroid replacement * alcohol intoxication or a history of alcohol abuse * acute or chronic respiratory, cardiac, renal or hepatic abnormalities * glaucoma * known psychiatric disease * asa score of more than 2 * informed consent cannot be obtained from legal guardian
acute effects of exercise combined with ketone ester supplement

Conditions: Overweight and Obesity; Cognitive Change; Ketoses, Metabolic

Summary: to examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults.

the prevalence of excess body weight and associated medical burdens (i.e., cardiometabolic and neurocognitive impairments) have been rising over the past several decades globally. the combination of exercise and ketone supplementation has been recently proposed as one of the solutions with potential clinical value, of which the interventional effects and underlying mechanisms remain unclear. the current study aims at (1) investigating the additive effects of ketone ester supplements to exercise in aspects of cardiorespiratory fitness, metabolism, and neurocognitive status, and (2) examining how the exercise type (hiie \[high-intensity interval exercise\] vs. mice \[moderate-intensity continuous exercise\]) influences the cardiometabolic and neurocognitive responses of the exercise-diet regime. for each of the 30 participants, six experimental trials will be performed in a randomized trial with a counterbalanced order: (1) hiie-kt condition (hiie with ketone supplements); (2) mice-kt condition (mice with ketone supplements); (3) ne-kt condition (non-exercise with ketone supplements); (4) hiie-pla condition (hiie with taste-matched placebo); (5) mice-pla condition; and (6) ne-pla condition. cardiometabolic and neurocognitive parameters will be assessed before and after 30, 60, and 90 min subsequently ketone ester supplements.

Eligibility criteria:
inclusion criteria: * body mass index \> 25 kg/m\^2; * right-handed. exclusion criteria: * psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus; * addicts to alcohol, nicotine, or drugs; * oral contraceptive or any medication intake during the past 6 months; * current engagement in any resistant exercise.

Keywords: overweight obesity exercise nutrients neurocognition metabolism