Kornimate/medical-research-clean huggingface dataset:
heart attack research program- imaging study

Conditions: Myocardial Infarction

Summary: the harp study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with minoca (mi with non obstructive coronary arteries) to determine the underlying diagnosis in each participant. participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.

harp is a multi-center, observational study which enrolls men and women with mi who are referred for cardiac catheterization. eligible participants with minoca (defined as no stenosis of \>50% in any major epicardial vessel) will undergo optical coherence tomography (oct) at the time of diagnostic angiography and cardiac magnetic resonance imaging (cmr). participants will also have the option to enroll in the harp-platelet sub-study.

Eligibility criteria:
inclusion criteria: * acute ischemic symptoms compatible with diagnosis of mi, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms * objective evidence of mi (either or both of the following): * elevation of troponin to above the laboratory upper limit of normal * st segment elevation of ≥1mm on 2 contiguous ecg leads * willing to provide informed consent and comply with all aspects of the protocol * age ≥ 21 years exclusion criteria: * stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac catheterization * history of known obstructive coronary artery disease at angiography, including history of percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) * recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month) * alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma * coronary dissection apparent on angiography * excessive coronary tortuosity which, in the angiographer's opinion, increases the risks of oct * egfr\<45 or contraindication to additional contrast needed for oct in the opinion of the angiographer or treating physician * contraindication to mri (including but not limited to ferromagnetic implants) * pregnancy * thrombolytic therapy for stemi (qualifying event)

Keywords: myocardial infarction imaging
ischemic preconditioning claudication study

Conditions: Intermittent Claudication; Ischemia Vascular; Peripheral Arterial Disease; Peripheral Vascular Disease

Summary: this study proposes ischemic preconditioning (ipc) as a novel intervention to improve walking distance in patients with intermittent claudication.

this study proposes ischemic preconditioning (ipc) as a novel intervention to improve walking distance in patients with intermittent claudication. peripheral arterial disease (pad) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. ipc protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear. the investigators predict that ischemic preconditioning (ipc) will delay claudication onset time (cot), increase peak walking time (pwt) and improve muscle strength in patients with intermittent claudication. the investigators will determine whether ipc improves claudication onset time (cot) and peak walking time (pwt) in patients with intermittent claudication. a motorized treadmill will be employed to assess cot and pwt. the investigators will determine whether ipc can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. these metrics will be assessed quantitatively using a biodex™ dynamometer.

Eligibility criteria:
inclusion criteria: 1. between ages of 18-80 2. able to give informed consent 3. presence of vascular disease with intermittent claudication exclusion criteria: 1. age \ 80 2. unable to give informed consent 3. presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene 4. pregnancy 5. unable to walk on a treadmill 6. unable to perform or tolerate ischemic preconditioning 7. unable to follow commands 8. exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by pi 9. patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg 10. history of major lower extremity amputation 11. history of major psychiatric disorder 12. history of uncontrolled hypertension

Keywords: ischemic preconditioning
comparison of engerix b vaccine versus sci-b-vac vaccine in celiac patients

Conditions: Celiac Disease

Summary: celiac disease and infection with hepatitis b virus (hbv) are very prevalent worldwide and carry a high morbidity rate. it has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for hbv during infancy. in this study, we will evaluate whether a second vaccination series with a different vaccine, sci-b-vac, results in a better immunological response in celiac patients. eligible patients will be randomized to receive a 3-dose vaccination series with engerix or sci-b-vac vaccines.. rate of responders and level of immunity will be compared. this study will facilitate better protection of celiac patients to this potentially deadly virus.


Eligibility criteria:
inclusion criteria: * patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy. * completion of the im hbv vaccine series in infancy. * hbsab titer of \<10miu/ml at the time of enrollment. exclusion criteria: * immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-mp, steroids). * inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.

Keywords: celiac disease hepatitis b vaccination
epidemiology of sepsis at yuetan subdistrict in beijing

Conditions: Sepsis

Summary: the purpose of this study is to determine the epidemiology and outcome of sepsis at yuetan subdistrict in beijing in mainland china).

1. questionnaires were used to collect the characteristic information of people living in yuetan subdistrict in beijing and select people who had been hospitalized because of any reasons between july 2012 and june 2014. 2. data were collected on all patients admitted into different hospitals during the study period. the following information was recorded:demographic characteristics and admission category (whether medical, scheduled surgery, nonoperative trauma, or unscheduled surgery), presence of preexisting organ insufficiency,using definitions included in the acute physiology and chronic health evaluation (apache) ii score11; co- morbidities and the estimated prognosis of any preexisting underlying disease, following the classification of mccabe and jackson. 3. patients were included in the study cohort when having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock:2012".

Eligibility criteria:
inclusion criteria: * age≥18 years; * having lived in yuetan subdistirct for at least 1 year * having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "surviving sepsis campaign:international guidelines for management of severe sepsis and septic shock:2012" exclusion criteria: * age\<18 years * lived in yuetan subdistrict less than 1 year

Keywords: sepsis, severe sepsis, septic shock, epidemiology, outcome
feasibility of preoperative inspiratory muscle training for patients with peritoneal metastases

Conditions: Peritoneal Metastases

Summary: the goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases. the main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by thabane et al 2010. participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.


Eligibility criteria:
inclusion criteria: * scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy exclusion criteria: * surgery scheduled less than two weeks from the date of inclusion * inability to speak and understand swedish
pet imaging of systemic sclerosis using fdg and 68ga-dota-siglec-9

Conditions: Systemic Sclerosis

Summary: this study evaluates the potential of positron emission tomography (pet)/computed tomography (ct) imaging to monitor disease activity in patients with systemic sclerosis (ssc). pet/ct imaging will focus on two pathological features of ssc, i.e. metabolic activity evaluated by glucose analog 18f-fdg, and expression of inflammation-inducible vascular adhesion protein 1 (vap-1) evaluated by 68ga-dota-siglec-9 tracer.

in patients with systemic sclerosis (ssc), the quantitative assessment of disease activity is still difficult. identification of patients who unlikely respond to therapy before or early in a course of the treatment could reduce morbidity and produce cost-savings. this project will evaluate the potential of advanced functional imaging techniques to monitor disease activity. functional imaging will focus on two pathological features of ssc, i.e. metabolic activity evaluated by glucose analog 18f-fdg positron emission tomography (pet)/computed tomography (ct), and expression of inflammation-inducible vascular adhesion protein 1 (vap-1) evaluated by new 68ga-dota-siglec-9 tracer. if successful, the resulting techniques may prove invaluable as tools in the clinical practice and in drug research aiming to find new targets to the treatment of ssc.

Eligibility criteria:
inclusion criteria: * adults with active systemic sclerosis (ssc). * onset of ssc (defined as first non-raynaud symptom) not more than 5 years ago. * clinically active disease with proximal nailfold capillary abnormalities detected with videocapillaroscopy and/or raised inflammatory markers (crp or esr). exclusion criteria: * underage, pregnant, breastfeeding, handicapped or prisoner * history of or current inflammatory joint disease or autoimmune disease other than ssc. * history of treatment with, prior to this study, immunosuppressives or disease-modifying anti-rheumatic drugs (dmards) such as methotrexate, leflunomide, azathioprine, mycophenolate, cyclophosphamide or biologic agents such as anti-tnf inhibitors, abatacept, or rituximab. hydroxychloroquine is allowed in the history (≥3 months prior to pet study). * intra-articular or parenteral corticosteroids ≤4 weeks prior to pet/ct study. * prostanoids or other vasoactive treatments like phosphodiesterase-5 inhibitors or endothelin receptor antagonists ≤4 weeks prior to pet/ct study (the use of calcium channel inhibitors is allowed).
dynamic substrate mapping (dsm) for ischemic vt

Conditions: Ischemic Ventricular Tachycardia

Summary: this is a prospective, non-randomized study to determine the feasibility of using a new technique called dynamic substrate mapping (dsm) to help guide the treatment of ischemic ventricular tachycardia (ivt). we hypothesize that dsm will lead to simpler, more effective ablation of ivt. results from this study will be used to determine if further clinical investigation is warranted.


Eligibility criteria:
inclusion criteria: * have an icd or crt-d device * had at least 3 documented device therapies to treat vt over last 3 months * clinical vt is confirmed or suspected to be of ischemic origin * scheduled for vt ablation procedure * lvef \> or = 20% exclusion criteria: * inadequate aad washout (amiodarone should be maintained at current dose) * unstable angina * active ischemia * cardiac surgery within prior 2 months * evidence of infection * prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention * history of embolic event * myocardial infarction within prior 6 weeks * enrolled in another study * recurrent sepsis or otherwise not a candidate for catheterization * hypercoagulable state or inability to tolerate heparin therapy during procedure * has had an atriotomy or ventriculotomy within prior 4 months * life expectancy \< 6 months * class iv nyha classification
efficacy and safety of shr-1314 by subcutaneous injection in active moderate to severe graves' orbitopathy patients

Conditions: Active Moderate to Severe Graves' Orbitopathy

Summary: this is a single-arm, prospective, open-label, phase ii study that explored the efficacy and safety of shr-1314 in active moderate to severe graves' orbitopathy. the study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. eighteen adult patients with active moderate to severe graves' orbitopathy will be enrolled. eligible subjects will receive shr-1314 subcutaneously. the primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.


Eligibility criteria:
inclusion criteria: 1. patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. 2. male or female between the ages of 18 and 70 (including boundary values) 3. onset of active go symptoms fewer than 9 months prior to baseline. 4. clinical diagnosis of graves' disease associated with active go with a cas ≥ 3 (on the 7-item scale) for the most severely affected eye(study eye) at screening and baseline. 5. moderate-to-severe active go (not sight-threatening but has an appreciable impact on daily life). 6. does not require immediate surgical ophthalmological intervention. exclusion criteria: 1. pregnant or lactating women. 2. allergy to the study drug or to any component of the study drug. 3. significant abnormalities in laboratory and ecg. 4. decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months. 5. corneal decompensation unresponsive to medical management. 6. decrease in cas of ≥ 2 points between screening and baseline. 7. decrease in proptosis of ≥ 2 mm between screening and baseline. 8. previous orbital irradiation or surgery for ted. 9. any other ophthalmic disease that might interfere the study or the study result confirmed by investigator. 10. patients with serious, progressive and uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic, endocrine, nervous and psychiatric diseases, or other conditions that considered inappropriate for patients to participate this study.
psma pet/mri-guided prostate biopsy for pi-rads ≤3 and prior negative biopsy

Conditions: Prostate Cancer Screening; PSMA-PET

Summary: the goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for cspca and reducing missed diagnoses.

this research intends to prospectively enroll patients with prior negative biopsies, a pi-rads score ≤ 3, and persistent psa or phi elevation, randomly assigning them to the psma pet/mri group (experimental group) and the trus-guided transperineal saturation biopsy group (control group). the research aims to evaluate the application of psma pet/mri in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in cspca detection rates between psma pet/mri-trus guided prostate targeted biopsy and trus-guided saturation biopsy.

Eligibility criteria:
inclusion criteria: * serum psa \> 4 ng/ml * at least one prior negative prostate biopsy * at least two consecutive increases in psa and/or phi * negative digital rectal examination * multiparametric mri (mpmri) indicating a pi-rads score ≤ 3 exclusion criteria * age ≤ 30 years or \> 85 years * concurrent presence of other malignant tumors * previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy) * inability to comply with psma pet/mri examination (e.g., contrast allergy, claustrophobia, etc.) * contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.) * severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment) * incomplete clinical or pathological data

Keywords: imaging examinations psma pet/mri prostate cancer
sjogren-larsson syndrome: natural history, clinical variation and evaluation of biochemical markers

Conditions: Sjogren-Larsson Syndrome (SLS)

Summary: sjogren-larsson syndrome (sls) is a rare genetic disease in which patients typically exhibit ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a distinctive maculopathy. the purpose of this study is to define the clinical spectrum and natural history of sjogren-larsson syndrome, and identify biomarkers that correlate with disease phenotype while establishing a registry for future investigations of biochemical pathogenesis and therapy.

the study will consist of a clinical component and a scientific component consisting of laboratory investigations of potentially useful biochemical (lipid and protein) markers. up to 50 sls patients of all ages, gender and ethnic origins will be enrolled. a detailed clinical evaluation will be performed to determine the presence and extent of disease involving the skin, nervous system and eyes. clinical testing will include brain magnetic resonance imaging (mri) and spectroscopy (mrs), electroencephalography (eeg), neurocognitive tests, ophthalmologic examination with retinal photographs and optical coherence tomography (oct), photographs of the skin and tests of cutaneous transepidermal water loss. laboratory investigations will include lipid analyses (e.g. fatty alcohols, farnesol, fatty acids, ether glycerolipids, etc.) of blood, skin and urine; proteomic analysis of skin (stratum corneum); and measurements of leukocyte fatty alcohol and farnesol oxidation. a skin biopsy (optional) will be obtained for electron microscopy, measurement of lanthanum perfusion (transepidermal water loss), and/or establishing keratinocyte cultures. correlations between clinical abnormalities and laboratory measurements will be tested to identify the most useful biomarkers for future diagnostic and therapeutic studies. to characterize the progression of phenotypic features over time, patients \<6 years of age will be followed yearly and patients ≥6 years of age will be followed every 3 years. in addition, a sls patient registry will be established as a resource for future investigations in sls.

Eligibility criteria:
inclusion criteria: * the only eligibility criterion is that subjects have a genetically or biochemically confirmed diagnosis of sjogren-larsson syndrome. exclusion criteria: * the primary exclusion criteria are the patients' failure to consent or inability to travel to a stair site.

Keywords: ichthyosis spasticity spastic diplegia intellectual disability
allergy and covid-19 vaccines

Conditions: Anaphylactic Reaction; Vaccine Reaction

Summary: prospective and retrospective multicenter study to estimate the proportion of patients who tolerated continuation of covid-19 vaccination (absence of anaphylactic manifestations). secondly, to determine the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis following administration of a covid-19 vaccine. comprehensive allergological investigations involving clinical, skin and biological tests will enable us to determine whether or not vaccine components, and in particular excipients (peg2000, ps80 and tromethamine), are responsible for anaphylactic reactions to covid-19 vaccines. a biological collection will be set up during this clinical study to study the immunological mechanisms, effector cells and signalling pathways involved in these reactions.

eligible patients will be identified via the pharmacovigilance centers and allergology hotlines set up in each center, according to the organization specific to each hospital site. . the patient identified in this way will be contacted by the secretariat of each allergology center to schedule an allergology consultation at least 3 to 5 weeks after the reaction (the usual delay before exploring an anaphylactic reaction to avoid the risk of false negatives). then, in the framework of a collegial meeting ,the patient's file will be reviewed in order to specify the history of the allergic disease and the modalities of subsequent covid-19 vaccination. a follow-up telephonique call at 6months will be made systematically for patients who have continued vaccination to ensure that there are no significant adverse events related to the covid-19 vaccine.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * anaphylactic reaction to a covid-19 vaccine administered by pfizer-biontech or janssen or vaxzevria or moderna, at least 3 weeks old at the time of the allergology consultation. an anaphylactic reaction is defined as the occurrence of any of the following systemic manifestations within a few hours of administration of a covid-19 vaccine: * skin rash with urticaria and/or angiodema, * and/or associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (intense abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of malaise), and/or hypotension, tachycardia. * affiliation to a social security system * signature of the informed consent * stop taking antihistamines at least 3 days before skin allergy tests are performed exclusion criteria: * other non-anaphylactic systemic reactions after administration of covid-19 mrna vaccine (serum sickness, vasculitis, guillain-barré syndrome) * pregnancy and lactation * disorders of hemostasis or severe bleeding considered a contraindication to intramuscular injection

Keywords: anaphylactic reactions covid-19 vaccines peg2000 tromethamine