Kornimate/medical-research-clean huggingface dataset:
one-year trajectory of cognitive changes in patients with late-life depression in the short term

Conditions: Late Life Depression

Summary: the purpose of this study was to investigate the one-year trajectory of cognitive change in elderly patients with depression, to explore the transfer characteristics and transfer rules of various states of cognitive impairment in patients, to predict the relevant risk factors of cognitive decline, and to find possible influencing factors affecting state change, so as to provide a theoretical basis and reference for subsequent targeted intervention research on geriatric depression.

the 1-year prospective longitudinal study involved 400(prospective)subjects who met criteria for geriatric depression,the whole cognitive function was assessed by mini-mental state examination(mmse),montreal cognitive assessment scale-moca)and subjective cognitive decline scale(scd-9).cognitive function was monitored at 6 and 12 months.gain factors related to cognitive function(e.g.,age,gender,education,cognitive function,anxiety level,sleep,social support,resilience,social networks,etc.).by studying the longitudinal changes of cognitive function in the elderly patients with depression,a time-discrete and state-discrete multistate markov model was constructed,namely,state 1(normal cognitive， nc),state 2(subjective cognitive decline， scd),state 3(mild cognitive decline，mci) and state 4(alzheimer's disease，ad).in-depth analysis of some factors and indicators on the impact of the transfer between the states, the transfer between the states estimated probability.

Eligibility criteria:
inclusion criteria: 1. meeting the criteria for major depression in the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) 2. age at first onset ≥60 years 3. informed consent exclusion criteria: 1. relevant past history affecting cognitive function: various types of stroke, traumatic brain injury, severe brain atrophy, mental abnormalities 2. perennial alcohol addiction, or long-term use of various drugs that affect mental state 3. survival time of malignant tumors and tumors 4. patients with language, vision, and hearing impairments
markers of carnitine acetyltransferase (crat) protein activity and carnitine availability

Conditions: Metabolism and Nutrition Disorder; Metabolic Disturbance

Summary: this study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive magnetic resonance spectroscopy (mrs) technique. specifically, phosphocreatine (pcr) kinetic and acetylcarnitine levels will be determined at resting, during exercise and during the recovery post exercise. the target population is adult healthy men, with a wide range of maximal physical capacity.

skeletal muscle mitochondrial activation during the transition from resting metabolism to exercise may modulated by crat activity. furthermore, dynamic changes in acetylcarnitine during the transition from exercise to resting metabolism (acetylcarnitine off-kinetic) may also reflect the action of crat protein. to date, the only possibility to get information on crat activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. by dynamic mrs scanning, it might be possible to deduce information that reflects crat activity, thereby making the biopsy sampling unnecessary.

Eligibility criteria:
inclusion criteria: * males, generally healthy * age 18-40 years old * bmi 18 - 25 kg/m2 * no medication use that interfere with the aims of the study * stable level of daily physical activity or training for at least 6 months exclusion criteria: * females * regular smokers, drug abuse * participation in other studies * weight gain/loss \> 3 kg in the last 6 months * contraindications for mrs scans: * vegetarian eating behavior

Keywords: acetylcarnitine kinetic phosphocreatine (pcr) kinetic
psychological ressources, anxiodepressive symptoms, well-being and therapeutical observance in parkinson's disease

Conditions: Parkinson's Disease

Summary: anxiodepressive symptoms are frequently observed in parkinson's disease patients. these non motor psychiatric charateristics of the disease negatively impairs quality of life, and may impair well-being or therapeutical observance. the objective of this study is to determine if psychological ressources are associated to anxiodepressive symptoms, to parkinson well-being and therapeutical observance. it will be interesting to determine if the presence of some - or multiple- psychological ressources could prevent patients from anxiety, depression, impaired well-being and impaired observance. this study will analyse retrospectively psychological scalescompleted by 30 parkinson's disease patients through previous psychological interviews. the scales investigate anxiety, depression, well-being, psychological ressources, and therapeutical observance. the results will highlight the importance of working on psychological ressources with parkinson's disease patients through psychotherapy, in order to improve their well-being, positive emotions and maybe contribute to better therapeutical observance.

the scales used are : * the spane * the pas * the lot-r * the scs * the brief bdi * the ssam * the had * the maas * an observance scale

Eligibility criteria:
inclusion criteria: * patients with diagnosis of parkinson's disease exclusion criteria: * patients with any other parkinsonian syndrome

Keywords: psychological ressources well-being depression anxiety therapeutical observance parkinson's disease
study to evaluate a single intranasal dose of sti-2099 (covi-drops™) in outpatient adults with covid-19 (uk)

Conditions: Covid19

Summary: this is a double-blind study designed to investigate the efficacy, safety and pk of a single dose of covi-drops or matched placebo in outpatient adults who have tested positive for covid-19 and are either asymptomatic or have mild symptoms.

subjects will be randomized 2:2:1 to receive a single dose of covi-drops 10 mg, covi-drops 20 mg or matched placebo in a double-blind manner. investigational product (covi-drops or matched placebo) will be administered once as two separate 0.5 ml instillations (0.5 ml up each nostril). subjects will be followed to day 60.

Eligibility criteria:
inclusion criteria: * positive for covid-19 with any locally approved rt-pcr within 7 days of planned treatment. * either have no covid-19 symptoms (asymptomatic) or mild illness/symptoms * must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol * subject must have provided written informed consent * willing to follow contraception guidelines exclusion criteria: * moderate or severe illness/symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) * any medical condition that, in the investigator's opinion, could adversely impact subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process * documented acute infection other thand covid-19 * pregnant or lactating women who are breast feeding or planning to during the study * has participated, or is participating, in a clinical research study evaluating covid-19 convalescent plasma, mabs against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Keywords: covid-19
preoperative therapy with oxaliplatin/docetaxel/capecitabine and radiation in resectable esophagus cancer

Conditions: Esophagus Cancer

Summary: in this phase i/ii trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. in the brief phase i portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. if the 3-drug regimen is tolerated, the phase ii portion will proceed with this regimen. if the 3-drug combination is considered too toxic, the phase ii study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

upon determination of eligibility, patients will be receive: oxaliplatin + docetaxel + capecitabine + radiation therapy if the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase ii portion of the trial. if the three-drug regimen is too toxic, the phase ii portion will proceed with the two-drug regimen oxaliplatin + docetaxel + radiation therapy

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * adenocarcinoma or squamous cell carcinoma of the esophagus or g/e junction. * must be surgical candidates * no previous treatment for esophageal cancer * must have measurable or evaluable disease * able to perform activities of daily living with minimal to no assistance * adequate bone marrow, liver and kidney function * provide written informed consent exclusion criteria: you cannot participate in this study if any of the following apply to you: * tumor location in the proximal esophagus * metastatic disease or locally advanced cancer * moderate to severe peripheral neuropathy * serious pre-existing medical illnesses * significant heart disease * treated for an invasive cancer within the previous 5 years * women who are pregnant or breast-feeding * age \< 18 years please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: esophagus cancer
diagnostic, risk stratification and prognostic value of novel biomarkers in patients with heart failure

Conditions: Heart Failure

Summary: the objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.

blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased nt-probnp. the objective of this work is to investigate and then to sequence new proteins or micrornas in the blood of these patients for diagnostic, risk stratification and prognostic purpose.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years of age 2. symptomatic (nyha class ii-iv) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level) 3. hospital admission, emergency department visit, or outpatient diuretic escalation of therapy for destabilized hf at least once in the 6 months prior to enrollment exclusion criteria: 1. life expectancy \<1 year due to causes other than hf such as advanced cancer 2. cardiac transplantation or revascularization indicated or expected within 6 months 3. severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 l (when diagnosed as standard of care) 4. subject unable or unwilling to provide written informed consent 5. coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months 6. progressive neurological disease 7. pregnancy
pediatric zylet safety and efficacy study

Conditions: Chalazion; Hordeolum

Summary: a multicenter study to evaluate the safety and efficacy of zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)


Eligibility criteria:
inclusion criteria: * child, 0 to 6 years of age, any sex and race * subject must have a clinical diagnosis of lid inflammation (e.g. chalazion/hordeolum) in at least one eye. if both eyes are diagnosed with lid inflammation, both eyes will be treated * in good health (no current or past relevant medical history), based on the judgment of the investigator * parent/guardian is able and willing to follow instructions and provide informed consent exclusion criteria: * known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication * known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication * use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (nsaid), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study * use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study * use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration * use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study * history of ocular surgery, including laser procedures, within the past six months * anticipation that surgical intervention for lid inflammation will be required prior to completion of the study * subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication * history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study * participation in an ophthalmic drug or device research study within 30 days prior to entry in this study * unlikely to comply with the protocol instructions for any reason
optical coherence tomography examination in acute myocardial infarction

Conditions: Myocardial Infarction; Optical Coherence Tomography

Summary: different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (ami), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. the primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with ami.

acute myocardial infarction (ami), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for ami, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. the erosion study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with ami. optical coherence tomography (oct), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo. in this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by oct.

Eligibility criteria:
inclusion criteria: * patients with st-segment elevation myocardial infarction (defined as continuous chest pain lasted \>30 min, st-segment elevation \>0.1 mv in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ecg), and an elevated troponin i level) * age ≥18 years * provide written informed consent exclusion criteria: * cardiac shock * history of coronary artery bypass graft * left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion * inability to obtain thrombolysis in myocardial infarction flow grade ≥ 2

Keywords: biomarker plaque morphology
the use of cell free fetal dna in the maternal blood in the evaluation of intrauterine fetal demise and miscarriage

Conditions: Circulating Cell Free Fetal DNA; Intrauterine Fetal Demise; Miscarriage

Summary: women presenting to washington hospital center with fetal loss would be offered participation in the study. the objective is to determine if ccffdna obtained from maternal blood is present in the setting of missed abortion or fetal demise. the investigators primary hypothesis is that cell free fetal dna will be present in maternal blood in the presence of a failed pregnancy.


Eligibility criteria:
inclusion criteria: * women diagnosed with intrauterine fetal demised or missed abortion exclusion criteria: * patients diagnosed with threatened abortion with cardiac activity present * patients with iufd who have delivered the fetus (the induction process may already be in process, however, the fetus and placenta must be in situ at the time of blood sampling) * patients with known genetic abnormalities or mental retardation as a result of chromosomal abnormalities 13, 18, 21, or sex chromosomes. * children under the age of 18 * patients not fluent in or unable to consent to the study in english

Keywords: circulating cell free fetal dna intrauterine fetal demise miscarriage
virtual visits in heart failure care transitions

Conditions: Heart Failure

Summary: this study evaluates the use of virtual visits in the post-discharge care of patients with heart failure. participants admitted to the hospital with a primary diagnosis of heart failure will be randomized at discharge to either a virtual visit or outpatient visit for their 7-day post discharge follow up visit.

published guidelines recommend that patients being discharged home after hospitalization for hf should be offered a 7-day post-discharge outpatient clinic visit as a way to increase engagement with care and reduce risk of poor outcomes. unfortunately no-show rates for the 7-day post-discharge outpatient visit in this population are high, suggesting poor engagement. the investigators have previously observed a 76% no-show rate at the cleveland clinic main campus. this study is to evaluate whether use of 7-day post-discharge virtual visit versus in-person visit can improve adherence with post-discharge appointment.

Eligibility criteria:
inclusion criteria: 1. hospitalized for primary diagnosis of hf; 2. anticipated to be discharged home; 3. agreeable to longitudinal post-discharge care at cleveland clinic main campus in the first few weeks after hospital discharge; 4. patient or an individual in their social support network has the ability (equipment and connectivity) to do a virtual visit after hospital discharge; exclusion criteria: 1. being transferred to another hospital, or being discharged to an inpatient facility or nursing home; 2. being discharged to hospice; 3. subject currently enrolled in an interventional research study that requires an in-person clinical visit within 7 days post-discharge.

Keywords: heart failure distance health virtual health
comparison of different botulinum toxin a injection patterns in the treatment of blepharospasm

Conditions: Blepharospasm

Summary: to evaluate the efficacy of different botulinum toxin a injection patterns in treating benign essential blepharospasm and to compare their influence on condition of eye surface .

the authors performed a prospective double-blinded randomised clinical trial of 60 patients with an established diagnosis of benign essential blepharospasm from february 2013 to december 2015. patients received a full injection pattern of 5 sites on one eye and a medial lower eyelid waived injection pattern of 4 sites on the other eye randomly. they were surveyed on ocular surface disease index (osdi), jankovic rating scale (jrs), blepharospasm disability index (bsdi) prior to injection and 1week, 1month and 3 months after injection. at these time points, closure of the eyelid, tear break up time (but), schirmer test ｉ, and lower lid tear meniscus height (tmh) were also measured.

Eligibility criteria:
inclusion criteria: * had a confirmed diagnosis of bilateral beb * a minimum of 24-week period since the last injection was required for all patients who had previously received multiple injections of bont-a. exclusion criteria: * blepharospasm of known etiology (caused by medication, injury, etc.) * history of surgical intervention for beb (myectomy or neurectomy) * current ophthalmologic infection * apraxia of eyelid opening associated with levator palpebrae dysfunction

Keywords: blepharospasm botulinum a injection pattern tear
mace cds software master enrollment protocol

Conditions: Cardiac Events

Summary: this protocol will collect real world ehr data to support the product development life cycle activities associated with developing the major adverse cardiac events (mace) clinical decision support (cds) software. the data will also be utilized in subsequent clinical validation to support an fda application and/or applications to other regulatory agencies as needed.

the primary objective is to develop a machine learning tool which predicts risk of 30-day mace (major adverse cardiac event) risk stratification among patients visiting ed with suspicion of acs (acute coronary syndrome). the data will also be utilized in subsequent clinical validation. in addition to retrospective electronic health record (ehr) data, health information exchange (hie) data and patient reported outcomes will be collected to capture 30-day mace outcomes, as applicable.

Eligibility criteria:
inclusion criteria: * all genders, races, ethnicities exclusion criteria: * ≤ 18 years old presenting to the ed and for clinical validation only, adults \< 22 years old

Keywords: emergency department major adverse cardiac events