Kornimate/medical-research-clean huggingface dataset:
effect of small interfering rna inclisiran on carotid plaques as assessed by carotid ultrasound

Conditions: Carotid Plaque; Hyperlipidemia; Echocardiography

Summary: current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. nonetheless, the impact of pcsk9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. this investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in asia. the primary aim is to evaluate the effects of small interfering rna (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.

in a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. the assessment encompassed:blood samples: analyzed at baseline (month 0) and subsequently at months 1, 2, 3, 5, 9, 11, and 12, examining biochemical markers, lipid profiles, and liver and kidney function tests.carotid ultrasound: conducted at months 0, 3, 9, and 12, monitoring the carotid intima-media thickness, maximum carotid plaque thickness, carotid plaque area, carotid plaque volume, and carotid lumen stenosis area for thorough analysis.clinical records: documented in detail the baseline clinical information, biochemical markers, imaging findings, and any adverse cardiovascular or cerebrovascular events that occurred throughout the study period. this approach ensures a comprehensive understanding of inclisiran\&#39;s effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.

Eligibility criteria:
inclusion criteria: * patients with carotid plaques as indicated by ultrasound * men and women aged 18-75 years; * ldl-c \&gt;3.4 mmol/l without regular statin therapy or ldl-c \&gt;1.8 mmol/l after 4 weeks of statin lipid-lowering therapy. exclusion criteria: * - known allergies or contraindications to pcsk9 inhibitors and/or statin therapy; * prior use of pcsk9 inhibitors; * prior history of hemorrhagic stroke; * prior coronary artery bypass grafting or coronary intervention; * inability to perform oct imaging or unclear imaging; * severe renal insufficiency (creatinine clearance \&lt; 30 ml/min); * severe hepatic dysfunction; * baseline triglycerides \&gt; 5.6 mmol/l; * pregnant or lactating women; * life expectancy not exceeding 1 year; * in the judgment of the investigator, unsuitable for this study for any reason.

Keywords: inclisiran carotid plaque echocardiography hyperlipidmia
prognostic and diagnostic value of biomarkers and cardiac functional parameters in patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: the study aims to investigate whether disease progression in patients with chronic heart failure (chf) can be assessed by new biomarkers, and determine their diagnostic value. the study also intends to describe comparison of echocardiography with cardiopulmonary function test in chf patients, and relating these cardiac functional parameters to clinical outcome.


Eligibility criteria:
inclusion criteria: * age ≥18 years * with symptoms and signs in nyha ⅱ\~ⅳ * with cardiac structural changes confirmed by echocardiography exclusion criteria: * with other severe diseases combined and will be alive for less than 12 months * hard to participate in the investigation or accept the follow-up visits * pregnant or lactating women * during the acute phase of st-elevation acute myocardial infarction, stroke, severe infection and other critical conditions

Keywords: heart failure biomarkers echocardiography cardiopulmonary function tests
pilot study to evaluate magnetic marker imaging on diabetic polyneuropathy and gastroparesis

Conditions: Diabetic Polyneuropathy; Diabetic Gastroparesis; Diabetes Mellitus

Summary: the purpose of this study is to determine whether magnetic marker monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.


Eligibility criteria:
inclusion criteria: * age \> 50 years * written informed consent * diabetes mellitus (only diabetes mellitus group) * symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only diabetes mellitus group) * actually measured hba1c (only diabetes mellitus group) exclusion criteria: * subject who is pregnant or breast feeding. * subject unwilling or unable to comply with study requirements. * any investigational agent or participation in another clinical trial within 28 days prior to randomization * any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures. * history of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results. * known allergy to the investigational product, to any of its excipients * active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease * implanted cardiac cardioverter-defibrillator or cardiac pacemaker * stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy * long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) \< 3 days before randomisation and before magnetic marker monitoring
european safety registry in ulcerative colitis (p04808)

Conditions: Ulcerative Colitis

Summary: this is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (uc).

this is a prospective, observational, post-marketing safety surveillance registry of uc participants treated with remicade or another standard therapy. registry centers are targeted to enroll a total of 2000 participants (1000 remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. participants who started the registry on standard therapy may switch over to remicade.

Eligibility criteria:
inclusion criteria: * 18 years of age, of either sex, and of any race. * moderate-to-severe active uc, as defined by assessment by the treating physician. * must, within 30 days of baseline, either: * initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (aza), or methotrexate (participants in this category must be remicade naïve) or * initiate remicade. participants who have been treated in the past with remicade, but who have discontinued for any reason and who are scheduled to receive remicade within 30 days of the baseline visit must have a remicade-free interval of no less than 90 days from the date of the next expected infusion * must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry. * must be evaluated for active and inactive (latent) tuberculosis (tb) as suggested by local guidelines or as required by the remicade label for participants starting remicade. exclusion criteria: * female who is known to be pregnant or nursing. * previously treated with any other (investigational) biological drug for uc( other than remicade) prior to baseline. * in a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry. * participating in a blinded trial. in addition, participants with conditions that are contraindicated in the remicade summary of product characteristics (spc) should not be treated with remicade.
influenza reminder text-messaging

Conditions: Influenza

Summary: through a large, population-level quality improvement effort within the children's hospital of philadelphia care network, we will evaluate text message reminders on flu vaccination rates for both patients with and without a scheduled well child care visit during flu season.

this is a randomized control trial with two patient cohorts: patients with and without a scheduled well child care visit during the upcoming 2024 flu season. patients with a scheduled well child visit will be randomized into one of three groups (control, intervention message #1, or intervention message #2). patients within the intervention groups will receive a one-time text message reminder to get their flu shot for their child at their child's upcoming well visit. intervention groups will be texted at the same time, the same month as their child's well visit. the text message language will differ between groups. patients without a scheduled upcoming well child visit during the 2024 flu season will also be randomized into one of three groups (control, intervention message #1, or intervention message #2). intervention groups will be texted at the same time, at the start of flu season. the text message language will differ between groups. flu vaccine uptake will be measured within each patient cohort.

Eligibility criteria:
inclusion criteria: * all patients between ages 6 months-18 years old who have an upcoming well visit during the fall of 2024 (september through december 2024) or had a completed well visit from january 2023 through august 2024 * patients have a mobile phone number within their medical record * patients have opted-in to text communications from chop * english-speaking exclusion criteria: * subjects who do not meet the above inclusion criteria will be excluded
brain circuits in schizophrenia and smoking

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the principle aim of the project is to identify the key brain circuits associated with smoking and especially smoking in high risk population. the investigators hope that the study will provide concrete biomarkers for new therapeutic development and ultimately reducing the smoking related health burden.

there are several studies and hypotheses to be tested. this project includes (1) a cross-sectional study design that measures brain imaging, smoking, clinical diagnosis and symptoms, cognitive functional assessments, distress tolerance, and genetic information, which is also the baseline for the longitudinal study; and (2) a longitudinal study design for smoking cessation option for 1 year in some smokers and a longitudinal follow-up for all available subjects. during the baseline portion of the study, subjects are expected to complete clinical symptom assessments, a computer challenge task to measure distress tolerance, mri scan, role-play test to measure cognitive and functional abilities, and blood draw. subjects who are eligible will participate in the longitudinal follow-up study where the research team will call subjects regularly regarding smoking related information (smoking risk and treatment options).

Eligibility criteria:
inclusion criteria: * male and female between ages 12-above (clinical assessments and blood draw only above 62) * ability to give written assent (age below 18) * ability to give written informed consent (age 18 or above) * individuals fulfilled other criteria but over age 62, with major medical illnesses, significant alcohol or other drug use, or unable to undergo mri may participate in clinical assessments and blood draw if his/her participation forms a family unit (i.e., if at least one of the family member has participated). * subjects above age 62 will not participate in mri measurements although they may still participate in clinical assessments and blood draw. exclusion criteria: * inability to sign informed consent/assent * for patient participants, evaluation to sign consent (esc) below 10. * any major medical illnesses that may affect normal brain functioning. examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, cns infection or tumor, other significant brain neurological conditions. * significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence. * woman who are pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test before mri) * can not refrain from using alcohol and/or marijuana 24 hours or more prior to experiments. * for mri, unable to undergo mri scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobic to the scanner

Keywords: mri smoking schizophrenia
a study comparative of formoterol/fluticasone foraseq® and fluticasone in asthma patients

Conditions: Asthma

Summary: the primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.


Eligibility criteria:
inclusion criteria: * sign the icf * age ≥ 12 years * persistent asthma diagnosis, as per the gina classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the acq-745 test (see appendix c) ≤ 3.0 * current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent) * initial fev1 of at least 40% of the predicted normal value * serum cortisol assessment within normal values. exclusion criteria: * use of oral or parenteral corticosteroid within the 3 months prior to study beginning * requirement of admission due to asthma within the 3 months prior to study beginning * presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months * presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma * recent (\< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma * intolerance or allergy to any of the components of the drugs assessed in the study * pregnancy or lactation * chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance

Conditions: Bacterial Meningitis; Augmented Renal Clearance

Summary: the investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.

the investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. in this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.

Eligibility criteria:
inclusion criteria: * children have been diagnosed with bacterial meningitis with augmented renal clearance (egfr ≥ 160 ml/(min\*1.73m2)); * age: 2 months-18 years; * meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment; * meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously. exclusion criteria: * patients who die within the treatment cycle; * severe congenital malformation; * receive other systemic experimental drug therapy; * other factors that the researchers consider unsuitable for inclusion.
trial to assess the effects of an antimicrobial mouthwash on the esophageal microbiome

Conditions: Esophageal Adenocarcinoma; Barrett's Esophagus; Reflux Esophagitis

Summary: this is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. there will be 2-3 study visits, at day 0 and day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the day 21 visit. subjects will be required to fast overnight prior to the visits on days 0 and 21.

Eligibility criteria:
inclusion criteria: * age \>18 * scheduled for upper endoscopy for clinical indications * no allergy or other contraindication to chlorhexidine exclusion criteria: * use of proton pump inhibitors or h2 receptor antagonists within 1 month of enrollment. acid suppressant medications raise the gastric ph and can dramatically alter the gastric and esophageal microbiome. * history of upper gastrointestinal cancer * history of histologically proven barrett's esophagus * history of antireflux or bariatric surgery, or other gastric or esophageal surgery * use of antimicrobial mouthwash within 1 month of enrollment * use of antibiotics or immunosuppressant medications within 3 months of enrollment * use of steroid inhalers or nasal sprays within 1 month of enrollment * hiv or other immunosuppressed states or conditions (e.g. active malignancy) * pregnant or breast feeding * inability to give informed consent

Keywords: microbiome esophagus endoscopy mouthwash
evaluation of two treatments for chronic post concussion syndrome

Conditions: Post Concussion Syndrome; Head Injury

Summary: this study is designed to investigate factors that are associated with prolonged recovery from mild head injury. the investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms. a further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. the investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.


Eligibility criteria:
inclusion criteria: * mild head injury at least 3 months prior to treatment * age 19 to 65 years * grade 12 education * proficiency with english language exclusion criteria: * current litigation

Keywords: post concussion syndrome cognitive behavioral therapy anxiety sensitivity mild head injury psychotherapy chronic post concussion symptoms
carotid plaque assessment using 18fluorine (18f) -sodium fluoride positron emission tomography (pet) /mr

Conditions: Carotid Artery Plaque

Summary: carotid plaque can lead to ischemic stroke. treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. the aim of the study is to assess 18f-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. investigators conduct a pilot case-control study. twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% nascet) will have a 18f-sodium fluoride pet/mr. standardized uptake value (suv) and tissue-to-background ratio (tbr) will be measured among carotid plaques.


Eligibility criteria:
inclusion criteria symptomatic patients: * age\>18 * carotid plaque ≥ 50% symptomatic (ischemic stroke on ct or mr) during the last 15 days or asymptomatic * ability to give informed consent * affiliation to social security exclusion criteria: * modified rankin score ˃ 3 * contraindication to mri * renal failure (creatinine clearance by cockcroft ˂ 50 ml / min) * pregnancy / breastfeeding * hypersensitivity to the active substance or excipients

Keywords: stroke carotid plaque 18f-sodium fluoride pet/mr
aliskiren and renin inhibition in diastolic heart failure

Conditions: Diastolic Heart Failure

Summary: this study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. additionally, the investigators will investigate any differences that may exist between hispanics and non-hispanics. the investigators hope to find that hispanic americans will have a greater response to this new regimen compared to non-hispanic americans.

our main hypothesis is that in contrast to non hispanic whites, the degree of raas system activation is more pronounced in mexican americans with diastolic hf and consequently their response to raas inhibition therapy is greater. blocking the raas with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. these changes should be greater appreciated in mexican americans if the central pathophysiologic influence of hf in this population was raas maladaptation.

Eligibility criteria:
inclusion criteria: 1. chronic stable diastolic hf documented by clinical diagnosis and echocardiogram within the last 2 years 2. nyha classes i-iii, symptomatically stable (for \>1month) 3. age 21-70 years 4. either of hispanic ethnicity (mexican american origin) or non-hispanic white 5. patients on ace inhibitor therapy (lisinopril) 6. blood pressure \>100/75 mmhg 7. adequate birth control 8. patients seen in ttuhsc cardiology or internal medicine clinic for at least two visits since january 2008 exclusion criteria: 1. acute coronary syndrome (within the last month). 2. recent acute diastolic or systolic hf (within the last month) 3. pancreatic disease 4. renal artery stenosis 5. pregnancy 6. history of angioedema 7. severe hypotension (systolic bp\<90mmhg or mean arterial pressure \<65mmhg) 8. hyperkalemia (defined by k+\>5 meq/l) 9. chronic kidney disease (stage 3 and above) 10. systolic dysfunction (ejection fraction below 50%) 11. ethnicity other than mexican american or non-hispanic white

Keywords: diastolic heart failure hispanic americans aliskiren spironolactone lisinopril diastolic heart failure in hispanic americans
cognitive and emotional processing of social stimuli in children and youth with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: children and youth diagnosed with autism spectrum disorder (asd) have been shown to react abnormally to social stimuli, especially to human faces. children and youth with asd show less interest in social stimuli, and may even avoid looking at or interact with such stimuli. it has been proposed that social stimuli elicit reactions like fear and stress in individuals with asd, and this explains the lack of interest and avoidance. the present project investigates this hypothesis.


Eligibility criteria:
for asd group: inclusion criteria: * diagnosed with autism spectrum disorders

Keywords: asd startle