Kornimate/medical-research-clean huggingface dataset:
prediction of vulnerable plaque using coronary ct angiography and computational fluid dynamic in acute coronary syndrome

Conditions: Acute Coronary Syndrome; Plaque, Atherosclerotic

Summary: the aim of the pvcfd trial is to predict vulnerable plaque confirmed by oct using coronary ct angiography and computational fluid dynamics in patients with acute coronary syndrome.

acute coronary syndrome（acs）mainly includes unstable angina, non-st-segment elevation myocardial infarction, and st-segment elevation myocardial infarction, which is the leading cause of death around the world. the main pathophysiological feature of acs is the rupture of vulnerable plaque, which can be recognized by coronary artery angiography (cag), intravascular ultrasound (ivus) and optical coherence tomography (oct). compared with cag and ivus, oct is the best intravascular imaging technique so far. but all these examinations are invasive and expensive. recently, coronary ct angiography derived adverse plaque characteristics (apc) and hemodynamic forces defined by computational fluid dynamics (cfd) can reflect plaque vulnerability and hemodynamic forces acting on the plaque, which are important factors in the progress of the rupture of vulnerable plaque. so, we want to explore predictive value of coronary ct angiography (cta)and computational fluid dynamics for vulnerable plaque in acs. the pvcfd trial is a prospective and single center study, patients with acs will be arranged to complete coronary cta before cag. oct will be used to detect the characteristics of coronary atherosclerotic plaques confirmed by cag. lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection are defined as vulnerable plaque. patients will be divided into vulnerable plaque group and stable plaque group according to this. the coronary cta images will be screened for apc and cfd analyses at core laboratories of shanghai tenth's hospital. lesions with diameter stenosis (ds) \>30% based on coronary cta evaluation were included for subsequent apc (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) analysis and hemodynamic forces (ffrct,δffrct, wss and pws) defined by cfd. three prediction models (model 1: percent diameter stenosis + lesion length, model 2: model 1 + apc, model 3: model 2 + hemodynamic force) will be constructed to identify vulnerable plaque confirmed by oct.

Eligibility criteria:
inclusion criteria: 1)acute coronary syndrome was diagnosed according to universal definition of acs; and 2) coronary cta was completed before cag; and 3) definitely culprit lesion can be recognized by cag; 4) oct was done to detect coronary atherosclerotic plaques confirmed by cag. exclusion criteria: 1) previous history stent implantation; 2) previous history of coronary artery bypass graft surgery; 3) acs without clear culprit lesion; 4) poor image quality of coronary cta for apc and cfd analysis; 5) myocardial infarction secondary to other reasons
study of chlorhexidine gluconate as a preoperative antisepsis

Conditions: Surgical Site Infection

Summary: the purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.


Eligibility criteria:
inclusion criteria: 1. resection of following organs (clean-contaminated open surgery) * liver, pancreas, bile duct, duodenum * stomach * colon, small bowel 2. aged 20 - 85 years old 3. use prophylactic antibiotics 4. use preoperative bowel preparation 5. elective operation 6. asa classification 1-2 asa i : no known systemic disease asa ii : single systemic disease \& mild or well controlled asa iii : multiple systemic diseases or moderately controlled systemic disease asa iv : poorly controlled systemic diseases 7. adequate organ functions defined as indicated below: * wbc 3000 \~ 12 000/mm3 * \> hb 8.0 g/dl * \> plt 100 000/mm3 * \< cr 1.2 mg/dl exclusion criteria: 1. allergy to chlorhexidine or povidone 2. clean surgery or contaminated surgery 3. patients who cannot be followed up during 1 month 4. patients taking immunosuppressant drugs or chemotherapy agents 5. emergent surgery and reoperation 6. uncontrolled diabetes, bmi \> 30 kg/m2 7. vulnerable patients

Keywords: surgical site infection chlorhexidine gluconate povidone iodine
weight gain after cpap treatment in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this trial is to investigate the mechanisms leading to weight gain during cpap treatment for obstructive sleep apnea (osa).

obesity and obstructive sleep apnea share a bidirectional relationship. while obesity is a major risk factor for osa, osa may contribute to weight gain. recent evidence suggests that osa treatment is associated with weight gain. the mechanisms involved in weight gain after osa treatment are not known. the purpose of this study is to determine the mechanisms of weight gain during cpap treatment for severe osa leads. the investigators hypothesis is that cpap leads to a decrease in energy expenditure and prevents the elimination of extracellular fluid that is accumulated during the day. in order to test this hypothesis, 20 patients with severe osa aged between 50 and 80 years old, under regular treatment with cpap, will be invited to participate. using a cross-over design, the investigators will perform bioelectric impedance 5 times over 24 hours in order to assess the circadian effect of fluid accumulation in two different conditions: during cpap treatment and 7 days after cpap withdrawal. a full polysomnography will be performed during cpap withdrawal to confirm severe osa and during cpap treatment to confirm adequate control of respiratory events. in addition, basal metabolic rate, hematocrit, serum bnp, urinary sodium, creatinine and osmolality will be determined in the morning during the cpap and cpap withdrawal periods.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of severe osa (ahi\>30 events/h) * 50 and 80 years old * regular treatment with cpap with an average daily use of \>4hours exclusion criteria: * congestive heart failure * renal insufficiency * hepatic failure * urinary incontinency * diuretic therapy

Keywords: cpap weight gain obstructive sleep apnea
lornoxicam versus etoricoxib in postoperative pain after total knee arthroplasty

Conditions: Postoperative Pain

Summary: the purpose of this study is to assess efficacy and safety of lornoxicam compared with that of etoricoxib after total knee replacement.

total primary knee arthroplasty (tka) remains a model of severe pain for major orthopedic surgery. the concept of multimodal analgesia for the postoperative pain therapy is a routine in many hospitals but the question is still under debate about the ideal combination between techniques and drugs regarding early mobilization and low risk of complications. after obtaining ethical committee approval and informed consent, 110 patients american society of anesthesiologists score (asa ) i-ii undergoing knee replacement under spinal anesthesia were randomized to receive postoperative either lornoxicam (8 mg per os (po) /12 hours (h) for 48 h) or etoricoxib (120mg po/24 h for 48 h) both administered in the postoperative care unit, at the end of surgery. the groups received postoperative analgesia when numeric rating scale (nrs) over 3 with iv perfalgan in fixed dose 1g every 8 h and morphine (loading dose 0,1mg/kg and titration until nrs under 3, followed by subcutaneous (sc) administration of ½ of the total loading dose on demand for the following 48 h).the lornoxicam group received gastric protection with iv pantoprazole. the effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at nrs over 3, the total amount of morphine in the first 24 and 48 h postoperative, the side effects and necessary amount of adjuvant medication.

Eligibility criteria:
inclusion criteria: * asa i-iii * weight (kilos) over 40 kg * height (centimeters) over 155 cm * non-anemic * indication for primary tka exclusion criteria: * history of asthma * peptic ulcer * severe hepatic or renal dysfunction * neuropathies * bleeding disorders * uncooperative * drugs abuse * sensibility to the drugs used * long acting nonsteroidal antiinflammatory drugs (nsaid) in the last 4 days preoperative * cerebrovascular and peripheric vascular disease * arterial hypertension (hta) not adequately controlled * congestive heart failure

Keywords: postoperative pain lornoxicam etoricoxib total knee arthroplasty
an observational study of patients with primary mitochondrial disease (spimm-300)

Conditions: Primary Mitochondrial Disease

Summary: this is an observational study of patients with primary mitochondrial disease with either signs or symptoms suggestive of myopathy. the investigator will identify potential patients through existing medical records and one on-site visit.

an observational study of patients with presumed primary mitochondrial disease designed to better characterize and correlate symptoms and signs of myopathy and genetic test results and the use of commonly prescribed treatments. the study will help define and identify a subject population for a future trial of an investigational product to treat primary mitochondrial disease associated with signs and symptoms of myopathy.

Eligibility criteria:
inclusion criteria: * willing and able to provide a signed informed consent form (icf) prior to participation in any-trial related procedures * patient has clinical presentation of pmd with either signs or symptoms suggestive of myopathy * patient is ambulatory and able to attempt 6mwt exclusion criteria: * patient has symptoms of pmd due to secondary mitochondrial dysfunction * patient has had prior exposure to elamipretide * patient does not have the cognitive capacity to understand and complete all study assessments * patient has a medical history of severe renal impairment * history of active alcoholism or drug addiction during the year before enrollment

Keywords: primary mitochondrial disease stealth myopathy exercise intolerance muscle pain mitochondrial myopathy primary mitochondrial myopathy
symptom burden in patients treated with ocrelizumab for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study is designed to determine whether symptom burden differs by time to infusion.


Eligibility criteria:
inclusion criteria: * age 18-80 * diagnosis of multiple sclerosis (revised 2017 criteria) * edss 0-7 * plans to initiate treatment with ocrelizumab within 6 months or has been on an approved regimen of ocrelizumab for \>12 months as part of their clinical care * individual must be able to provide consent, read/write/comprehend english language exclusion criteria: * clinical relapse within 3 months of first on-study infusion * cognitive impairment limiting the ability to consent or fill out the electronic survey * currently pregnant, planning to become pregnant during the study period, or currently breastfeeding * untreated psychiatric illness (such as major depressive disorder, bipolar disorder, psychotic disorder, schizophrenia) * active substance abuse disorder * significant medical comorbidities (such as history of severe traumatic brain injury, stroke, systemic cancer or chronic infection) * chemotherapy use within 6 months of first study infusion * prior treatment with alemtuzumab within 12 months of first study infusion * prior treatment with a b-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion
safety and efficacy of intrathecally administered magnesium sulfate

Conditions: Abdominal Cancer; Abdominal Pain

Summary: magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.

spinal anesthesia is commonly used for the major abdominal cancer surgery because of decreasing the risks of general anesthesia.the quality and duration of sensory and motor block and decrease post operative pain is important in the major abdominal cancer surgery and patient's content satisfaction. opioids in high doses and other drug such as clonidine and neostigmine added to local anesthetics to this purpose, but significant side effects. magnesium sulfate block the n- methyle -d- aspartate (nmda) channels in a voltage-dependent way to be improve the quality and duration of spinal block. however, the use of magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. systemic delivery of magnesium sulfate decrease postoperative opioid requirements. in experimental studies, spinal injection of magnesium sulfate reduces the respond to painful stimulus in rats.

Eligibility criteria:
inclusion criteria: * patients with asa physical status ii or iii, 21-year-old or older with major abdominal cancer surgery exclusion criteria: * significant coexisting, hepatorenal, or other end organ disease, obesity (bmi \> 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs
enhancing educational and vocational recovery in adolescents and young adults with early psychosis through supported employment and education.

Conditions: Persistent Delusional Disorder; Acute and Transient Psychotic Disorder, Unspecified; Schizophrenia; Schizoaffective Disorder; Other Nonorganic Psychotic Disorders; Unspecified Nonorganic Psychosis

Summary: psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. however, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. the aim of the present study is to explore the effects of supported employment and education (see) following the individual placement and support (ips) model in people with early psychosis. the investigators compare treatment as usual (tau) in an outpatient psychiatric setting to tau plus see.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of early psychosis (dsm 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients * sufficient linguistic and intellectual abilities to take part in the study * interest in competitive employment or/and mainstream education * written informed consent exclusion criteria: * learning disability or mental retardation as well as insufficient german language abilities (\< a2) * physical or organic handicap that seriously impede work or educational functioning
cystatin c and beta 2 microglobulin in thalassemic children.

Conditions: Blood Disease

Summary: beta thalassemia has many complications on many systems as the renal system.so early detection of renal impairment is required in those children to decrease complications of this nephropathy.

thalassemia syndromes are the most common single gene disorders worldwide especially in developing countries. the use of regular and frequent blood transfusions in patients with beta thalassemia major has improved patients' life spans and quality of life, but can lead to chronic iron overload. many factors contribute to the functional abnormalities found in beta thalassemia patients such as decreased red cell life span, rapid iron turnover, tissue deposition of excess iron and also, specific iron chelators can affect kidneys. the success in management of patients of beta thalassemia has led to chronic hemosiderosis in different organs like liver and heart and long-term complications in other organs like pancreas and kidneys have recently been studied. the evidence of proximal tubular damage has been observed in beta thalassemia patients. also, low-molecular-weight proteinuria has been found in almost all patients. unlike other organs, it is unclear whether kidney damage results solely from intravascular haemolysis, chronic transfusion or as a complication of iron chelation therapy. although the early identification of patients at high risk of renal impairment is of great importance as it may allow specific measures to be taken to delay renal impairment, there are limited studies about renal dysfunction in pediatric thalassemic patients. thus, in this study we will use different measurements for early detection of renal impairment even if the patients have no symptoms to handle with the disease in its reversible stage before being irreversible. beside the usual investigations of renal function we will measure cystatin c and beta2 microglobulin as early markers of renal impairment.

Eligibility criteria:
inclusion criteria: * children with beta thalassemia from the age of 1 year to 18 years. exclusion criteria: * children who have other hematological or chronic disease.

Keywords: renal impairment
humira® long-term treatment in patients with non-infectious intermediate-, posterior-, or pan-uveitis

Conditions: Uveitis

Summary: this study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in japan.


Eligibility criteria:
inclusion criteria: * participants receiving adalimumab for the treatment of non-infectious intermediate-, posterior-, or pan-uveitis exclusion criteria: * participants previously treated with adalimumab

Keywords: humira adalimumab non-infectious intermediate-, posterior-, or pan-uveitis
a humanitarian device exemption treatment protocol of therasphere for treatment of unresectable hepatocellular carcinoma

Conditions: Liver Cancer

Summary: to provide therasphere treatment for patients diagnosed with unresectable liver cancer.


Eligibility criteria:
inclusion criteria: patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. patients must have an ecog performance status score of \ /= 3 months, non-pregnant with an acceptable contraception in premenopausal women. patients must be \>4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy. exclusion criteria: * contraindications to angiography and selective visceral catheterization * evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs * evidence of any detectable tc-99m maa flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels) * significant extrahepatic disease representing an imminent life-threatening outcome * severe liver dysfunction or pulmonary insufficiency * active uncontrolled infection * significant underlying medical or psychiatric illness * pregnancy patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of therasphere treatment and place the patient at undue risk.
quality of life outcomes following treatment for esophageal cancer

Conditions: Esophageal Cancer

Summary: the goal of this study is to evaluate how treatment for esophageal cancer affects your quality of life. the findings of this study may help us understand how this disease and its treatment affect your lifestyle, diet, exercise, support system and overall quality of life. we hope this study will provide important information that can be used to develop programs to improve the quality of life of patients with esophageal cancer.

in order to determine the impact of esophageal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals, evaluating their physical symptoms, physical and social functioning and overall quality of life. medical and sociodemographic factors as well as health behaviors that might be predictive of adaptation will be tested. this is a preliminary investigation and it is hoped that we will be able to base future research questions on the results of this study.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of esophageal cancer. * anticipated to undergo surgical resection (ivor lewis, trans hiatal, mckeown procedure) of esophageal cancer. (group 1 patients only) * underwent esophagectomy for esophageal cancer at least 18 months prior to consent, with no evidence of disease. (group 2 patients only) * ability to speak, read and write english. exclusion criteria: * inability to give informed consent. * patients anticipated to require a laryngectomy as part of their surgical resection.

Keywords: esophageal canceresophagus
cortical effects of peripheral nerve injury at birth

Conditions: Peripheral Nerve Injury

Summary: cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with obpi.

peripheral nerve injury results in a number of cortical changes due to the lack of sensory and motor stimuli. although functional magnetic resonance imaging (fmri) studies that revealed the changes in the cortical activation exist, the cortical activation changes in obstetrical brachial plexus injury is poorly known. for this reason, the aim of this study is to investigate the cortical activity during rest and with stimulation by fmri in patients with obpi. patients with obpi diagnosis in the cervical 5-6 (c5-6) (upper trunk) who are followed up in gazi university faculty of health sciences department of physiotherapy and rehabilitation division of hand rehabilitation will participate in the study. patients with a surgery history at least 5 years ago and over 10 years age will be included. clinical motor and sensory assessments will be performed to help in explaining the analyses of cortical activation. in their first visit, clinical assessments including active movement scale, modified mallet classification (mmc) and sensory tests will be performed; while fmri scanning will be carried out in the second visit. patients will be scanned for 3 paradigms at one single fmri session: at rest and during sensory stimulation and watching videos of motor movements. video images will include the 5 movements used in mmc and will be watched by glasses integrated in the mri device. images obtained from mr scanning will be analyzed with analysis programs like leonardo, fresurfer, spm, brainvoyager and clinical results will be compared to mr images.

Eligibility criteria:
inclusion criteria: * upper trunk (cervical 5-6) involvement * cooperated exclusion criteria: * illiterate * surgical history for his arm in the previous 5 years * other than only c5-6 involvement * any impairment that prevents positioning in mri machine