Kornimate/medical-research-clean huggingface dataset:
optimizing infarct size by transforming emergent stenting into an elective procedure study

Conditions: Myocardial Infarction

Summary: the goal of primary pci is to restore anterograde myocardial flow. stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.

in the setting of largely thrombotic lesions such as those treated in the context of primary pci, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. interestingly in some of these studies comparing bms versus balloon angioplasty an early hazard associated to the use of stent has been reported. thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of st segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.

Eligibility criteria:
inclusion criteria: * chest pain for \>30 min with st-segment elevation of one mm or more in 2 or more contiguous ecg leads or with presumably new left bundle-branch block * admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia exclusion criteria: * the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel * inability to assume an oral p2y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin * uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmhg or 120, respectively, despite medical therapy) * limited life expectancy, e.g. neoplasms, others * inability to obtain informed consent * pregnancy * patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to cmr (claustrophobia, pacemakers, or implantable defibrillator devices)

Keywords: st-segment elevation myocardial infarction primary angioplasty stent
metformin add-on regimen comparison study in japanese participants with type 2 diabetes mellitus (mk-0431a-136)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in japanese participants with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. the primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin a1c (hba1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in hba1c at 24 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (t2dm) * currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (aha) in the prior 8 weeks, and hba1c ≥ 6.0% and ≤ 9.0%; or * currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral aha in the prior 8 weeks, and hba1c ≥ 6.5% and \< 10.0% exclusion criteria: * type 1 diabetes mellitus, * secondary diabetes mellitus, or * gestational diabetes mellitus
long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the dietary intervention study in children

Conditions: Breast Cancer

Summary: rationale: the amount and type of fat in the diet may affect hormone levels, bone mineral density, and breast density later in life. this may affect the risk of developing breast cancer. learning about the long-term effects of diet on hormone levels, bone mineral density, and breast density may help the study of breast cancer in the future. purpose: this clinical trial is studying the long-term effect of adolescent diet on hormones and breast cancer risk in women previously enrolled in the dietary intervention study in children.

objectives: primary * determine the long-term effect of the dietary intervention study in children (disc) to lower total fat and saturated fat intake during adolescence on serum progesterone levels in young women previously enrolled in the disc study. secondary * determine the long-term effect of the disc intervention on serum estradiol levels in these women. * determine the long-term effect of the disc intervention on bone mineral density in these women. * determine the long-term effect of the disc intervention on breast density in these women. * determine the long-term effect of the disc intervention on the prevalence of metabolic syndrome in these women. outline: this is a multicenter study. patients undergo fasting blood collection on day 1 for assessment of serum hormones (progesterone, estradiol), lipids, lipoproteins, and fasting glucose. patients also undergo blood pressure, height, weight, and waist circumference measurements. patient then receive a snack and complete the modifiable activity questionnaire, center for epidemiological studies depression scale short form, spielberger state-trait anxiety inventory, and dietary intervention study in children medical history questionnaire (including demographics, medical history, menstrual history, medications, reproductive history, dietary supplements, alcohol and tobacco use, and family history of cancer). patients also undergo dual-energy x-ray absorptiometry (dexa) and mri to measure bone and breast density. patients complete an in-person 24-hour dietary recall using the nutrition data system for research on day 1 and via telephone once in weeks 2 and 3. day 1 is scheduled during the patient's luteal phase of menstrual cycle. after completion of study, patients contact the clinic to report start of next menses. projected accrual: a total of 301 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * previously enrolled on a clinical trial titled, "dietary intervention study in children" patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: breast cancer
waveform periodicity analysis in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: study design a prospective study. objective a single center clinical trial on the analysis of intracardiac atrial electrogram waveform periodicity for catheter ablation of persistent atrial fibrillation with octaray™ mapping catheter, as prospective randomized controlled study. hypothesis: the critical atrial substrates in maintaining persistent atrial fibrillation could be identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic mapping. based on the previous study, atrial substrate with high-similarity electrogram regions correlated with procedural af termination and better long-term af-free (1). therefore, we proposed that the degree of waveform similarity plus the beat-to-beat sequential morphology (2) (duration of how many similar waveforms can maintain in sequence) would be even better to characterize the atrial substrate and could be potentially critical atrial substrate in prediction of sources of af. as additional substrate mapping provided benefits compared to pvi alone in patients with persistent af, we hypothesize that waveform periodicity adjuvant to electrogram similarity and phase mapping could be used to guide radiofrequency ablation in real time. the used of the octaray™ mapping catheter could collected more af electrogram and facilitate the mapping resolution and driver identification.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * refractory or intolerant to medication exclusion criteria: * previous af ablation * la thrombus * previous maze procedure * poor renal function * can't follow-up for one year

Keywords: persistent atrial fibrillation ablation driver
the evaluation of training an emergency reflex action drill in the emergency surgical airway in dutch paramedics

Conditions: Emergency Medical Services; Airway Management; Cricothyroidotomy; Prehospital; Prehospital Emergency Medical Services; Prehospital Setting; Self Confidence

Summary: the goal of this observational study is to learn about the effects of training an emergency reflex action drill (erad) for emergency surgical airway (esa) in dutch paramedics. the main question it aims to answer is: - does training an erad improves self-confidence in performing an esa in dutch paramedics participants will fill out a questionnaire directly before and after the training. to investigate long-term effects, they will be asked to fill out a questionnaire after 2 till 3 months and after one year.


Eligibility criteria:
inclusion criteria: * registered dutch paramedic * ambulance driver on advanced life support ambulance * participant in the two-day trauma course. exclusion criteria: * medium care ambulance paramedic

Keywords: emergency reflex action drill emergency surgical airway emergency medical services prehospital cricothyrotomy coniotomy porcine model 3d model self-confidence
objective measurement with tcm pattern for aiddes

Conditions: Sjögren's Syndrome; Systemic Lupus Erythematosus; Dry Eye Syndrome

Summary: to explore the association with tcm pattern and tcm tongue diagnosis for autoimmune disease and dry eye syndrome.

objective: to explore the association with tcm pattern and tcm tongue diagnosis for autoimmune disease and dry eye syndrome. method: this study wants to include the 1000 autoimmune disease (aid) subjects as 800 sjögren's syndrome (sjs) and 200 systemic lupus erythematosus (sle) for comparing with the 500 dry eye syndrome (des) subjects. aid and des subjects will be enrolled to evaluate at v1 baseline and follow-up for 6 times evaluation with one month interval during one year. and the non-aid-non-des healthy control subjects will be also included in our study for comparison with the dry eye syndrome and healthy control. this study want to use objective measurement and questionnaires as tcm pattern, osdi, esspri, sf-36, schirmer's test, tcm heart rate variability, and tcm tongue diagnosis to differentiate aid, des and healthy control. expected results: 1. to evaluate the difference among tcm pattern, osdi, esspri, sf-36, schirmer's test, tcm heart rate variability, and tcm tongue diagnosis to differentiate between aid and des. 2. to evaluate the difference among tcm pattern and tcm tongue diagnosis among the aid groups, des group, and healthy control. keyword: autoimmune disease, sjögren's syndrome, systemic lupus erythematosus, dry eye syndrome, tcm pattern, tcm tongue diagnosis.

Eligibility criteria:
sjögren's syndrome * inclusion criteria: 1. aged between 20 and 75 years 2. fulfilled the 2002 american-european consensus criteria for ss (aecg) * exclusion criteria: na systemic lupus erythematosus * inclusion criteria: 1. aged between 20 and 75 years 2. fulfilled the 1982 and 1997 acr revised systemic lupus erythematosus criteria * exclusion criteria: na dry eye syndrome * inclusion criteria: 1. aged between 20 and 75 years 2. schirmer's test less than 10 mm/5 min * exclusion criteria: na non aiddes healthy controls * inclusion criteria: 1. aged between 20 and 75 years 2. without any chronic disease * exclusion criteria: any sjögren's syndrome, systemic lupus erythematosus, or dry eye syndrome.

Keywords: sjögren's syndrome systemic lupus erythematosus dry eye syndrome
symphony il-6 reference range study

Conditions: Sepsis

Summary: symphony il-6 is a device that quantitates human il-6 by fluorescence enzyme immunoassay (feia) from whole-blood specimens. use of symphony il- 6 removes the need for plasma separation before testing. symphony il-6 comprises two components, the symphony fluorescence immunoanalyzer and the symphony il-6 cartridge. whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. after 20 minutes a readout and printout are given with a quantitative il-6 concentration. the used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. given the nature of this device and its portability, there is potential for future deployment as a point-of-care (poc) device. the objective of this study is to establish a reference range for symphony il-6 in a cohort of apparently healthy individuals.


Eligibility criteria:
inclusion criteria: * subject is willing and able to provide informed consent * \> 18 years of age * whole blood specimen collected in edta anticoagulant tubes * minimum volume of 100µl for symphony il-6 testing * specimen is available for testing within 12 hours from collection * c-reactive protein (crp) \< 10 mg/l exclusion criteria: * subjects presenting with a fever * subjects with a diagnosis of covid-19 or other respiratory illness at the time of collection * subjects otherwise self-reported as unhealthy * hemolyzed specimens
safety and feasibility study of the shockwave lithoplasty system

Conditions: Vascular Disease

Summary: to study the early safety and performance of the shockwave medical system in subjects to demonstrate that the device can safely and effectively deliver localized energy for the treatment of vascular disease.

shockwave medical, inc. intends to conduct a prospective, single-arm, single-center, first in human study designed to evaluate the early safety and feasibility of the shockwave lithoplasty system in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at target site. the shockwave lithoplasty system is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. up to 10 subjects will be enrolled to undergo lihtoplasty.

Eligibility criteria:
inclusion criteria: * age \>18 * patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form. * female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure. * patient is able and willing to comply with all assessments in the study. * peripheral arterial disease of rutherford category 2, 3, 4, and 5. * ability to tolerate an antiplatelet agent (i.e. aspirin, clopidigrel or prasagrel). * meets angiographic inclusion criteria exclusion criteria: * patients with peripheral arterial disease of rutherford category 6. * severe or infected gangrene of the lower extremity. * planned major amputation. * previously implanted stent at the treatment site. * patient with an externally-connected intracardiac catheter or pacemaker. * patient with an implantable pacemaker or defibrillator. * patient has connective tissue disease (e.g., marfan's syndrome). * patient has a hypercoagulable disorder. * patient has allergy to imaging contrast media for which they cannot be premedicated. * patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of \>19.5 µmol/l. * patient has active systemic infection. * patient has less than a one year life expectancy. * patient is pregnant or nursing. * patient is participating in another research study involving an investigational agent that has not reached the primary endpoint. * patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. * chronic total occlusion of target vessel. * chronic total occlusion of inflow vessel. * highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon) * patients requiring concurrent intervention below the most distal target lesion. * inflow disease: stenosis of \>50% in vessel proximal to the target lesion which requires treatment with drug eluting balloon (deb) or atherectomy. * prior procedure in target leg within past 3 months.
efficacy of the aspen intervention program in low-resource communities

Conditions: Autism Spectrum Disorder

Summary: the asd screening and parent engagement (aspen) program is a culturally adapted, parent-mediated intervention program. the aspen program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. the aspen program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. coaching is also provided to train parents on using evidence-based strategies within the home setting. the aspen program is delivered by a student clinician and a peer leader. we hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. we hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.


Eligibility criteria:
inclusion criteria: * child is between 18 months through 6 years of age * child has a medical diagnosis or educational classification of autism or autism spectrum disorder (asd) or child is at-risk for autism/asd as determined by the modified-checklist for autism in toddlers - revised/follow-up interview (m-chat-r/f) and/or social communication questionnaire (scq) * child resides in a low-resource household as determined by at least one of the following criteria: * -child or family has medicaid as an insurance provider * -child's primary caregiver has achieved a high school or lower education * -child resides in a household with an annual income of 200% of the federal poverty level exclusion criteria: * primary caregiver does not speak/understand english or spanish * child is younger 18 months or older than 6 years of age * child does not have a medical diagnosis or educational classification of autism/asd or does not meet at-risk criteria on the m-chat-r/f and/or scq * child does not reside in low-resource household

Keywords: autism parent-mediated intervention naturalistic developmental behavioral intervention low resource households
psychodynamic therapy for treating panic disorder

Conditions: Panic Disorder

Summary: this study will determine the effectiveness of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training in treating adults with panic disorder.

this is a randomized controlled trial of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training, a less active form of treatment in other studies, for adults with primary diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) panic disorder. forty nine patients who have signed written consent who have primary dsm-iv panic disorder have been entered into the study. randomization has been stratified by presence of major depression and use of psychoactive, anti-panic medications. medications, if present, have been held constant. all patients have received 24 sessions of either psychodynamic psychotherapy, or applied relaxation training for panic disorder. this study is currently closed for recruitment, although final follow-up assessments have yet to be completed.

Eligibility criteria:
inclusion criteria: * 18-55 years old * primary dsm-iv panic disorder with or without agoraphobia * severity 5/8 minimum on the anxiety disorders interview schedule exclusion criteria: * psychosis * unstable medication dosage * unwilling to discontinue ongoing psychotherapy * organic mental syndrome * substance use or abuse

Keywords: panic disorder, psychodynamic psychotherapy, efficacy trial
efficacies of entecavir add on hbeag positive patients with hbv dna positive during peginterferon alpha 2a treatment

Conditions: Chronic Hepatitis B

Summary: the aim of interferon therapy in hbeag positive chronic hepatitis b was to make patients obtain immune control to hepatitis b virus defined as occurred hbeag seroconversion and hbsag loss with sustained viral response after treatment. however this target could not be get if patients keep hbv dna positive during interferon treatment and offend relapse after withdraw of treatment. in this trail, nucleoside(acid) analogues(na) will add on patients with hbv dna load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of hbeag seroconversion and hbsag loss after 48 weeks of combined therapy, compared with control group.

hbeag positive patients with hbv dna load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will be enrolled randomized into two groups, in intervention group, patients will receive entecavir combine with peginterferon alpha 2a(peg-ifn a-2a) treatment for 48 weeks and follow 24 weeks. patients in control group will be continue treated with peg-ifn a-2a for 48 weeks and followed 24 weeks. serum hbv dna load, hbsag/anti-hbs level, hbeag/anti-hbe will be tested at enrollment and every 3 months during the treatment course. parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. the efficacies of the combined therapy were evaluated by the rates of hbeag seroconversion and hbsag loss after 48 weeks of combined therapy, compared with control group.

Eligibility criteria:
inclusion criteria: * hbeag positive patients with hbv dna load ≥1000copies/ml after 6 months of peginterferon a-2a treatment exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitic b peginterferon hbsag entecavir