Kornimate/medical-research-clean huggingface dataset:
supplementation of lycopene in carotid atheroma

Conditions: Carotid Atherosclerotic Disease

Summary: stroke is the second leading cause of death worldwide. one of the causes of stroke which can be treated is narrowing of the carotid artery. currently the only definite treatment option is surgery or endovascular treatment. all patients not qualified for or awaiting surgery are, therefore, left with best medical therapy and with a yearly risk of stroke anywhere between 1% - 35% depending on the severity of the disease. the study will use the properties of a tomato extract containing lycopene. previously studies have demonstrated beneficial properties of tomato extracts: 1. it decreases lipid oxidation 2. it decreases dna damage 3. it has properties that reduce the speed and amount of cell divisions that inflammatory and smooth muscle cells undergo (both of these cell types contribute to atheroma formation). the investigators wish to assess whether long-term food supplementation with a tomato extract containing lycopene could influence atherosclerotic plaque characteristics. the investigators will assess this using magnetic resonance imaging of the plaque and transcranial doppler ultrasonography for counting the number of blood clots that go to the brain's arteries. furthermore the investigators wish to examine the effect of long-term food supplementation with a tomato extract containing lycopene on blood cholesterol levels and lipid oxidation and blood markers of inflammation and injury of the inner lining of the arteries. this will be a single center, double blind, randomised, placebo controlled study.


Eligibility criteria:
inclusion criteria: * age 40 - 90 years old, * clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms: 1. amaurosis fugax 2. transient ischemic attack (tia) 3. stroke (ipsilaterally to the stenotic artery) * \>30% stenosis on initial b-mode ultrasonography imaging, * written, informed consent. exclusion criteria: * age \ 90 years old, * time from symptom to recruitment \> 2 months * \<30% stenosis on b-mode ultrasonography imaging, * scheduled for surgical/endovascular intervention within 3 months, * high-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 21), * other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements), * chronic use of high dose aspirin \>325 mg/day, * allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin), * contraindications for mri studies including claustrophobia, any mri non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.), * known renal impairment with creatinine clearance \<50 ml/min (as per departmental policy), * women of childbearing potential, * inability to consent

Keywords: carotid atheroma plaque vulnerability stroke risk
undiagnosed sleep apnea and bypass operation

Conditions: Sleep Apnea

Summary: sleep apnea is a prevalent disorder in patients with coronary artery disease. previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events after percutaneous coronary intervention. in the sabot study, the investigators used a fda-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.

the sabot study is an observational study designed to study the impact of sleep apnea on cardiovascular outcomes after non-urgent coronary artery bypass surgery (cabg). patients between the ages of 18 and 90 who are scheduled undergo an non-urgent cabg were eligible for the study the recruited patients participants were scheduled to undergo a hospital-based overnight sleep study using a us food and drug administration-approved portable monitoring devices: the watch-pat (itamar medical, caesarea, israel). watch-pat is a four-channel unattended sleep monitoring device that measures peripheral arterial tone (pat), pulse oximetry, heart rate, and actigraphy from a built-in actigraph. respiratory events are identified by digital vasoconstriction mediated by α-adrenergic receptors that are sensitive to surges in sympathetic activity. respiratory events are considered to be present when one of the following three criteria was met: a reduction in pat amplitude with an acceleration of the pulse rate or an increase in wrist activity; a reduction in pat amplitude with ≥3% oxyhemoglobin desaturation; and ≥4% oxyhemoglobin desaturation only. although manual scoring and editing of the watch-pat signals are possible, we adopted results generated by the device algorithm alone with no intervention by the operator. the diagnosis of sleep apnea is confirmed if the ahi was greater than 15 events/h. end points the pre-specified primary end point is a major adverse cardiac and cerebrovascular event (macce), defined as a composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization. the secondary end point comprised sudden cardiac death or resuscitated cardiac arrest, all-cause mortality, and hospitalization for heart failure.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery exclusion criteria: * known sleep apnea on cpap therapy * cardiogenic shock on mechanical hemodynamic support * intubated on mechanical ventilation * heart failure on oxygen therapy * long -term alpha blocker therapy * severe chronic pulmonary disease * recurrent malignant arrhythmia * inability to provide informed consent

Keywords: sleep apnea coronary artery bypass grafting outcomes
group b streptococcus (gbs) infection and in preterm labor women conceived through ivf

Conditions: Preterm Labor

Summary: this is a cross - sectional study to determine the prevalence of gbs infection and associated factors in preterm labor women conceived through art. 221 subjects will be involved.

pregnant women at 20 0/7 to 36 6/7 weeks of gestation, conceived through art, with signs and symptoms of preterm labor will be recruited. anal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. digital examination will be performed after that. only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire. the samples will be sent immediately to my duc hospital laboratory or will be stored in stuart-amies medium in \< 4 hours. all culture results are interpreted based on clinical and laboratory standards institute (clsi) in 2012. statistical analysis was performed by statistical package for the social sciences (spss) v.20 and chi-square test. a p-value of \< 0.05 was considered as statistically significant.

Eligibility criteria:
\* inclusion criteria: to be eligible for enrolment into this trial, subject must fulfil all of the following criteria, unless specified otherwise * being conceived through ivf * moderate uterine contractions (2 contractions per 10 minutes, duration \< 30 seconds) * 20 0/7 to 36 6/7 weeks of gestation * intact membrane * cervical dilation ≤ 3 cm * willing to participate into the study * exclusion criteria: to be eligible for enrolment in this study each subject must not meet any of the following criteria: * having had intercourse during 24 hours before * being suspected of amniotic leakage * rupture of membrane identified by direct observation through speculum examination of amniotic fluid flow from cervix * vaginal bleeding * being suspected of placenta abruption, placenta previa * having been treated with antibiotics within 1 week before * vaginal douche within 48 hours before * having used vaginal medicines during 48 hours before * having vaginal ultrasound shortly before * urine culture positive with gbs
building a multidisciplinary research program to address hypertension disparities: exploring the neurocognitive mechanisms of a self-management intervention for african american women

Conditions: Hypertension

Summary: the goal of this project is to develop and pilot test a research protocol to assess the influence of a health information behavior enhanced intervention on self-management, blood pressure control, and brain activity in african american women with hypertension. this work will identify characteristics of african american women that are associated with improved self-management and decreased blood pressure, and subsequent reduction of risk of heart disease and premature death. the results of this project will have direct impact in informing interventions to improve blood pressure control, by advancing our knowledge of brain activity associated with behavior change in african american women with hypertension in the metro-detroit area, and ultimately everywhere.


Eligibility criteria:
inclusion criteria: inclusion criteria are (a) aged \>18, (b) clinically diagnosed with hypertension, and (c) right-handed (due to potential differences in brain morphology compared to left-handed individuals). - exclusion criteria: exclusion criteria are (a) history of renal insufficiency, (b) score less than 22 on the montreal cognitive assessment (moca), and (c) having one of the following contraindications for fmri: heart pacemaker, heart defibrillator, metal in the eye, and some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices, pregnant. we require a score of \>22 on the moca to assure that subjects are able to participate cognitive procedures. -
ureteral stenting after retrograde intrarenal surgery for renal stones

Conditions: Kidney Stone; Retrograde Intrarenal Surgery; Ureteral Stent

Summary: several studies evaluated the benefit of a short-term external ureteral catheter (uc) compared to double-j (dj) ureteral stent after flexible ureteroscopy (urs); the results were controversial. these studies had combined analyses of ureteral and renal stones with a high risk of selection bias. studies comparing external uc and dj stent after flexible urs for isolated renal stones are lacking. in the present study, the investigators will compare the outcomes of using a one-day external uc versus a dj internal ureteral stent for ureteral drainage after retrograde flexible urs (retrograde intrarenal surgery "rirs") for renal stones. the investigators aim to identify the best ureteral drainage method after rirs regarding stone clearance, complications, and stent-related symptoms.


Eligibility criteria:
inclusion criteria: • adult patients of either gender in whom rirs was the primary modality. exclusion criteria: * pregnant women * active urinary tract infection * solitary kidney * concomitant pathology that need intervention in the same setting * patients with surgical incidents that indicate double-j stenting (residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).
goal directed fluid therapy

Conditions: Goal Directed Fluid Therapy

Summary: intraoperative fluid demand will be monitored by esophageal doppler in lean and obese patients.

to our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. consequently, we want to compare lean patients (bmi \ 25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Eligibility criteria:
inclusion criteria: * female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis) exclusion criteria: * cardiac insufficiency (ef\< 35%) * renal insufficiency (creatinin clearance \<30ml/min, dialysis) * insulin dependant diabetes mellitus * coagulopathy * nyha iv * infection * sepsis * history of suspect malignant hyperthermia * porphyria

Keywords: goal directed fluid therapy lean patients obese patients crystalloids esophageal doppler tissue oxygenation fluid management during surgery fluid management
myocardial protection with adenosine during primary percutaneous coronary intervention in pts with stemi

Conditions: Acute Myocardial Infarction

Summary: objective: to evaluate the safety and efficacy of a brief intracoronary infusion of ado applied at the time of reperfusion to limit infarct size and lv remodelling in patients with acsst submitted to primary actp. design: multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. patients: 200 patients older than 18 with acsst and without prior myocardial infarction receiving primary ptca within 6 hours after symptom onset.

the main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with st segment elevation (acsst). in most of these patients, performing ptca or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. intracoronary adenosine (ado) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with acsst receiving early reperfusion therapy. objective: to evaluate the safety and efficacy of a brief intracoronary infusion of ado applied at the time of reperfusion to limit infarct size and lv remodelling in patients with acsst submitted to primary actp. design: multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. patients: 200 patients older than 18 with acsst and without prior myocardial infarction receiving primary ptca within 6 hours after symptom onset. protocol: intracoronary ado (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, nmr between 6 and 14 days and after 6 months. end-points: major: infarct size as measured by nmr, secondary: changes in lv volumes and ef, and major cardiac events during the follow-up.

Eligibility criteria:
inclusion criteria: * patients older than 18 years. * patients with acute coronary syndrome with st segment elevation within six hours of the onset of symptoms. exclusion criteria: * patients younger than 18 years and pregnant women. * patients with previous transmural infarction. * patients with clinical evidence of bronchospastic lung disease or prior bronchodilator therapy. * patients with pacemakers. * patients with timi flow higher than 1 and lower than 3.

Keywords: adenosine angioplasty acute myocardial infarction acute coronary syndrome with st segment elevation infarct size rescued myocardium
action - anticoagulation treatment influence on post-operative patients

Conditions: Heart Valve Disease

Summary: the primary objective of this study is to compare two different regimens of therapy, avk and asa (aspirin), in the early postoperative period after aortic valve replacement with sjm epic™ or sjm epic™ supra porcine bioprosthetic heart valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).


Eligibility criteria:
inclusion criteria: 1. patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed) 2. patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements. 3. patient is of legal age in the host country 4. the patient is in sinus rhythm before implantation exclusion criteria: 1. patient already has a prosthetic valve, other than the valve being replaced at this time. 2. patient requires double valve implantation 3. patient requires concomitant cabg 4. patients requires intra aortic balloon pump at intervention 5. patient has a medical condition which contraindicates implantation of the sjm epic and/or sjm epic supra porcine bioprosthetic heart valve (e.g. patient on dialysis) 6. patient requires asa or avk therapy, i.e. not suitable for randomization 7. patient is pregnant or nursing. 8. patient is affected by active endocarditis. 9. patient is affected by aortic dissection. 10. patient has history of cerebral ischemia 11. patient is affected by coagulopathy, history of gi bleeding or increased bleeding risk 12. patient is affected by peripheral vascular disease requiring treatment 13. patient has previous chronic anticoagulation therapy 14. patient is allergic to asa and/or avk
effect of adductor-canal-blockade on high pain responders after total knee arthroplasty

Conditions: Pain After Total Knee Arthroplasty

Summary: the purpose of this study is to determine whether adductor-canal-blockade (acb) is superior to placebo when it comes to analgetic efficacy in high pain responders after total knee arthroplasty (tka). high pain responders are defined as patients reporting vas \> 60 during knee flexion the 1. or 2. day after surgery.

the patients will be included the 1. or 2. day after surgery. all tka patients will be screened. those reporting vas \> 60 during active 45 degrees knee flexion will be asked to participate. included patients will receive 2xacb (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). there will be 45 minutes between the two blockades. the blockades will be ultrasound guided.

Eligibility criteria:
inclusion criteria: * tka within 48 hours and vas\>60 during active 45 degrees knee flexion despite conventional pain medication. * informed consent * asa 1-3 * bmi 18-40 exclusion criteria: * unable to communicate in danish * allergic reactions toward drugs used in the * abuse of alcohol/drugs * unable to cooperate

Keywords: total knee arthroplasty adductor canal blockade (acb) high pain responders us-guided nerve block
octaplas adult ttp trial

Conditions: Thrombotic Thrombocytopenic Purpura

Summary: to assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (ffp) and other approved plasma products used within 24 hours of thawing) used in the treatment of ttp, in patients undergoing therapeutic plasma exchange, with a special emphasis on the occurrence of thromboembolic events (tees).


Eligibility criteria:
inclusion criteria: 1. patient is a male or female at least 18 years of age or older. 2. patient has a diagnosis of ttp or suspicion of ttp that is planned on being treated with tpe within 3 days of study entry. 3. patient has thrombocytopenia (platelets \< 100 x 10p9p/l). 4. patient is willing to give voluntary written informed consent before any study-related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. exclusion criteria: 1. patient has a history of severe hypersensitivity reaction to plasma-derived products or to ffp. 2. patient has an already known iga deficiency with documented antibodies against iga. 3. patient is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion. 4. patient has severe deficiencies of protein s. 5. patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of ttp prior to randomization. 6. patient is currently taking ace-inhibitors; in case patient is under ace-inhibitor treatment a wash-out period of at least 24 hours has to elapse prior the first plasma infusion.

Keywords: plasma exchange thrombotic thrombocytopenic purpura ttp
distribution of immune cells and their subtypes in peripheral blood of gout

Conditions: Gout Flare; Intercritical Gout; Advanced Gout; Asymptomatic Hyperuricemia

Summary: the purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

a number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from msu deposition in the joint or tissue, leading to release nlrp3 inflammasome-mediated production of bioactive il-1β. further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. however, a global understanding of blood immune responses underlying gout is still unclear. thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Eligibility criteria:
inclusion criteria: * gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the acr board of directors and the eular executive committee in 2015 * intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(all of these gout remission patients underwent dual-energy ct test within one month, and were detected to have msu crystal deposition in local joints) * advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(all of these gout remission patients underwent dual-energy ct test within one month, and were detected to have msu crystal deposition in local joints) * asymptomatic hyperuricemia: hyperuricemia in men was defined as sua ≥ 420 mmol/l without any complications exclusion criteria: * primary osteoarticular diseases * unwilling participation in the study * corticosteroids or indomethacin use in the past 3 months; * septic arthritis or another joint disease (such as rheumatoid arthritis); * impaired renal function (creatinine clearance \<30 ml/min) and other conditions which may increase the level of blood uric acid

Keywords: pbmc monocyte treg