Kornimate/medical-research-clean huggingface dataset:
cordimax china post market surveillance

Conditions: Coronary Artery Stenosis

Summary: study purpose: this study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of cordimax and xience v drug-eluting stents as they dealing with all kinds of complex lesions in the real world. study group experimental group: cordimax® rapamycin eluting coronary stent system control group: xience v® everolimus eluting coronary stent system

the purpose of the post market clinical trial is to evaluate the safety and efficacy of the cordimax rapamycin eluting coronary stent system (recs). the cordimax will be compared to an active control group represented by the fda approved commercially available abbott vascular xience v® eecs everolimus eluting coronary stent system. the post market clinical trial consists of a randomized clinical trial (rct) in china which will enroll approximately 3660 subjects (2:1 randomization cordimax® recs : xience v® eecs) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 4 mm. all subjects in the rct will be screened per the protocol required inclusion/exclusion criteria. the data collected will be compared to data from the subjects enrolled into the xience v® arm of us rct. all subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .

Eligibility criteria:
inclusion criteria: 1. age 18 years old or more 2. patients with symptomatic coronary artery disease 3. adapt to the des treatment according to guide 4. with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5\~4.0 mm) in diameter ;has the objective basis of myocardial ischemia 5. patients willing to participate and sign in research exclusion criteria: 1. women in pregnancy or lactation 2. patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation 3. patients were banned to use the antiplatelet and/or anticoagulant therapy 4. patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project 5. patients who must stop clopidogrel to accept a elective surgery 6. patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system

Keywords: stents coronary artery disease
a randomized study of temperature-controlled and bipolar radiofrequency for inferior turbinate reduction

Conditions: Patients With Chronic Rhinitis Who Failed Medical Treatment

Summary: currently, there are several alternative treatments for patients with chronic rhinitis (cr) who failed medication. although, most of the researches have been focusing on temperature-controlled rf (tcrf), the cost is a major limitation for applying it worldwide. the investigators objective of this study is to compare the subjective and objective outcomes of bipolar rf (brf) with the more popular tcrf for cr treatment. the investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.


Eligibility criteria:
inclusion criteria: * adults with snoring and chronic nasal obstruction. * respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant * consent to the protocol. exclusion criteria: * chronic active sinusitis, severe deviated nasal septum (dns), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation. * uncontrolled bleeding disorders, hypertension, or cardiovascular diseases * not complete the protocol

Keywords: radiofrequency turbinate reduction nasal obstruction temperature-controlled radiofrequency bipolar radiofrequency chronic rhinitis.
tolerability, safety and efficacy of the h1-coil deep transcranial magnetic stimulation in subjects with negative symptoms and cognitive deficits of schizophrenia

Conditions: Schizophrenia

Summary: objectives:the purpose of the study is to explore the efficacy and safety of h1-coil deep brain rtms in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics. patient population: the intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). the patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have panss negative≥21 and panss positive\<24. patients will be recruited from both academic and private research centers. structure: the study is a randomized, prospective, 8 weeks, double blind study. blinding: the treatment administrator and the study personnel and patients will be masked to the treatment being administrated. concurrent control: the study group will receive active rtms treatment and the control group will receive an inactive, sham treatment.


Eligibility criteria:
inclusion criteria: 1. patients between the ages of 18-65 (male and female), diagnosed in the past as suffering from schizophrenia. the diagnosis will be reaffirmed according to icd criteria. 2. right hand dominant. 3. scores in panss negative questionnaire above 21. 4. gave informed consent for participation in the study. 5. negative answers on safety screening questionnaire for transcranial magnetic stimulation 6. stable on the same antipsychotic medication for at least two months prior to entering the study. 7. negative answers to all questions in the tms safety questionnaire (attached ). exclusion criteria: 1. diagnosed as suffering from another axis 1 disorder . 2. scores in panss positive questionnaire above 24. 3. history of epilepsy, seizure, or hot spasm. 4. history of epilepsy within first-degree relatives. 5. history of head injuries. 6. history of metal in the head (outside the mouth space). 7. history of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump. 8. history of migraines. 9. history of hearing loss (not due to aging) or cochlear implants. 10. history of drug or alcohol abuse during the last year. 11. women - pregnancy or not using a reliable method of birth control. 12. inability to achieve satisfying level of communication with the subject. 13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire 14. custodians. 15. participation in another medical study during the experiment.

Keywords: schizophrenia tms brain stimulation negative symptoms clinical improvement cognitive improvement
automatic evaluation of the severity of gastric intestinal metaplasia with pathology artificial intelligence diagnosis system

Conditions: Gastric Intestinal Metaplasia; Artificial Intelligence; Pathology; Gastric Cancer

Summary: the olgim staging system is highly recommended for a comprehensive assessment of gim severity to evaluate patients' gastric cancer risk. however, its need to take at least 4 biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population. we plan to develop a digital pathology artificial intelligence diagnosis system (dpaids), to automatically identify tumor areas in whole slide images(wsi) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas.

gastric cancer is the fifth most prevalent malignancy and the third most deadly worldwide, and intestinal metaplasia (im) is a common precancerous state that is closely associated with gastric carcinogenesis .the olgim staging system is highly recommended for a comprehensive assessment of gim severity to evaluate patients' gastric cancer risk. however, its need to take at least four biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population. developing automated screening methods can reduce the heavy diagnostic workload. with advances in digital pathology scanning devices and deep learning technologies, whole-slide images (wsi) have been used to develop automated cancer diagnostic systems. we plan to develop a digital pathology artificial intelligence diagnosis system (dpaids), to automatically identify tumor areas in whole slide images(wsi) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas. then biopsies will be prospectively collected and prepared as wsi for model validation.

Eligibility criteria:
inclusion criteria: * patients aged 40-75 years who undergo the gastroscopy examination and biopsy exclusion criteria: * patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy * patients with previous surgical procedures on the stomach * patients with contraindications to biopsy * patients who refuse to sign the informed consent form

Keywords: gastric cancer gastric intestinal metaplasia digital pathology whole slide image
a study of once monthly intravenous or subcutaneous mircera in participants with chronic kidney disease on hemodialysis.

Conditions: Anemia

Summary: this 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. participants will be randomized to receive either monthly intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice a week).


Eligibility criteria:
inclusion criteria: * regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks * continuous iv or sc maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose exclusion criteria: * transfusion of red blood cells during previous 2 months * significant acute or chronic bleeding * poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months * weekly dose of epoetin beta greater than (\>) 16000 international units (iu), or weekly dose of darbepoetin alfa \>80 micrograms during previous month
impact of evolocumab as an additional lipid-lowering therapy to changes in lipid core burden index of non-culprit vulnerable plaque in patients who underwent percutaneous coronary intervention for the acute coronary syndrome

Conditions: Clinical Trial; Acute Coronary Syndrome

Summary: this study aimed to investigate the impact of intensive cholesterol-lowering therapy (including evolocumab), drug treatment for high-risk plaques (vulnerable plaques) with a high probability of developing acute coronary syndrome. the purpose of this study is to determine the effect of the change in the lipid core burden index and compare the rate of cardiac events over 12 months following cholesterol therapy.


Eligibility criteria:
inclusion criteria: 1. over 19 years old 2. patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information 3. patients who underwent nirs-ivus guided coronary stent surgery for acute coronary syndrome 4. patients who did not meet the ldl-cholesterol level (\<70mg/dl) even after receiving the maximum dose of combined cholesterol therapy for 2 months exclusion criteria: 1. subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel and contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) 2. pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 3. subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration 4. those whose surviving life is expected to be less than 1 year 5. subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment 6. subjects participating in a randomized study on cholesterol therapy

Keywords: evolocumab spectroscopy, near-infrared
positron emission tomography of infection and vasculitis

Conditions: Infection; Vasculitis

Summary: the purpose of this study is to evaluate the value of positron emission tomography/computed tomography in various inflammatory conditions caused by bacterial infection or vasculitis. glucose analog fdg is sensitive to detect inflammation foci but we hypothesize that other imaging agents such as pk11195 and ga-citrate may have added value in certain applications.

the purpose of this study is to evaluate the value of pet/ct in various inflammatory conditions caused by bacterial infection or vasculitis. our aim is to: 1. investigate whether fdg (18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose) pet/ct and 68ga-(gallium-68) citrate pet/ct enable the early and accurate detection of metastatic infection foci in staphylococcus aureus bacteremia. 2. study the usefulness of fdg pet/ct in detection of endovascular infection in bacteremia caused by salmonella spp. 3. find an optimal fdg pet/ct protocol for detection of infectious endocarditis and metastatic infection foci related to endocarditis. 4. study the value of fdg pet/ct in the diagnosis of infection of pacemaker or implantable cardioverter defibrillator. 5. investigate the usefulness of fdg pet/ct, 68ga-citrate pet/ct, and 11c- (carbon-11) translocator protein ligand (pk11195) pet/ct in diagnosis of vasculitis and in imaging of the magnitude of the vascular changes.

Eligibility criteria:
inclusion criteria: adults with * staphylococcus aureus bacteremia or * salmonella spp. bacteremia or * infective endocarditis or * infection of pacemaker or implantable cardioverter defibrillator or * vasculitis exclusion criteria: * underage, pregnant, breastfeeding, handicapped or prisoner

Keywords: pet/ct infection vasculitis
a clinical study of curcuminoids in the treatment of oral lichen planus

Conditions: Oral Lichen Planus

Summary: a phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with olp presenting to the oral medicine clinic at the university of california, san francisco, will be enrolled. study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. a side-effects questionnaire will be administered at the 2-week follow-up. the numeric rating scale (nrs) will be used to measure symptoms and the modified oral mucositis index (momi) to measure clinical signs of olp. primary outcome is change in symptoms from baseline. secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum c-reactive protein and serum interleukin-6 levels.


Eligibility criteria:
inclusion criteria: * patients presenting to the ucsf oral medicine clinic diagnosed with either the atrophic or the erosive form of oral lichen planus * study subjects must have a symptom score between 3 to 8 at the time of entry into the study. (range of scale: zero to ten with zero being no symptoms and ten being the worst imaginable symptoms. * study subjects will have discontinued systemic and/or topical steroids and/or curcuminoids for at least 2 weeks before entry into the study. exclusion criteria: * pregnancy, lactation or unwillingness to use an effective method of contraception. an attempt will be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. if pregnancy cannot be ruled out, a pregnancy test will be provided to the women before enrollment into the study. - patients younger than 21 years of age. * patients who cannot return for a follow-up visit at two weeks after enrollment. * patients who have a medical contraindication to discontinuation of systemic steroids eg. those on long term corticosteroid therapy. - patients with a history of gastro-esophageal reflux disease, gastric / duodenal ulcers, or gallstones. * patients with elevated liver enzymes; * patients on anticoagulants or antiplatelet medications. * patients undergoing orthodontic treatment. * patients who don't read, speak or understand english.

Keywords: curcuminoids oral lichen planus c reactive protein interleukin 6
hysteroscopic myomectomy for submucosal myomas without energy instruments

Conditions: Hysteroscopic Myomectomy

Summary: uterine fibroid are the most common benign tumor in the female reproductive system. although many patients with uterine fibroid do not need to be treated because they are asymptomatic, some patients can experience compression, menorrhagia, pain, irregular bleeding or infertility. the symptoms caused by uterine fibroid are related to its location and size. submucous fibroids constitute 5-10% of all uterine fibroids.the submucous hysteromyoma is the most likely to cause symptoms, often leads to menorrhagia, irregular bleeding or infertility. hysteroscopic myomectomy is a commonly used minimally invasive procedure. the submucous myoma can be resected out by endoscopic resectoscope with electricloop (unipolar and bipolar) . it can preserve the uterus and fertility, also effectively alleviate symptoms. however, some specific complications have also followed，such as： hemorrhage，uterine perforation， pneumonedema，infections，adhesions，etc. uterine perforation occurs when the electrode is working, there is a high risk of injury to adjacent anatomical structures. and even without perforation, sometimes thermal injury to adjacent organs may still be discovered in a few days after surgery.in addition，many scholars have found that hysteroscopic electromyectomy has a higher risk of intrauterine adhesion than other intrauterine operations. in order to reduce the damage caused by energy source, especially the adverse effects of thermal damage on the endometrium, the new methods of hysteroscopic myomectomy currently include: the hysteroscopic tissue removal (htr) system, the cold loop myomectomy， the hysteroscopy endo operative system (heos)，etc. existing studies show that，these manipulation techniques did not cause the myometrium damage by radiofrequency energy source, greatly reducing the risk of postoperative intrauterine adhesions. the cold knife hysteroscopic myomectomy in this study is a series of procedures using cold instruments（mechanically, with scissor, grasping or morcellation） to remove uterine submucosal fibroids. the purpose of this surgical technique is to make the operation safe and effective, with greater emphasis on the anatomical and physiological integrity of the myometrial and endometrial layers. this study aims to evaluate the safety and efficacy of cold knife hysteroscopic myomectomy.

according to the inclusion and exclusion criteria，collecting the data of participants who have undergone cold knife hysteroscopic myomectomy. the investigators will analyze the safety and efficacy of cold knife hysteroscopic myomectomy through the collected data.

Eligibility criteria:
inclusion criteria: all patients who underwent cold knife hysteroscopic myomectomy and excised tissue that showed pathology confirmation of leiomyoma. exclusion criteria: patients has gynecologic malignancy.

Keywords: hysteroscopy cold knife myomectomy submucous myoma
preemptive lung impedance-guided therapy in evolving acute heart failure in acute myocardial infarction patients

Conditions: Heart Failure

Summary: it is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. as a result, the investigators have no way of preventing acute heart failure. treatment of these patients only begins after appearance of clinical signs of acute heart failure. lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. this study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility criteria:
inclusion criteria: * patients hospitalized in the iccu for acute myocardial infarction and developing acute heart failure exclusion criteria: * patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
osteoarticular infections with pneumococcal

Conditions: Bone and Joint Infection

Summary: osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. they represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. they represent 0.3% at 0.6% of the bacteraemia at streptococcus peumoniae.


Eligibility criteria:
inclusion criteria: * patients having had a bone and joint infection with s pneumoniae, with or without device. exclusion criteria: * none

Keywords: bone and joint infection streptococcus peumoniae
investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type ii diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate clinical efficacy and safety of sodium glucose co-transporter 2 (sglt2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for type ii diabetes under usual care. it is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. diabetes mellitus, type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs 2. patients with changes within +- 0.5% of hba1c 3. patients with the variation of 6.5% =\< hba1c =\<10% 4. patients with written informed consents 5. patients whose bmi is =\>20kg/m2 exclusion criteria: 1. patients with diabetes mellitus, type 1, other types of diabetes or pregnancy diabetes 2. patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months 3. patients with severe infection, in the perioperative period or severe trauma 4. patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dl、female with greater than or equal to1.3mg/dl) 5. patients with severe hepatic impairment (judged by the attending doctor) 6. patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent 7. patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy 8. patients with neuropathic bladder or dysuria 9. patients under treatment with diuretic 10. patients under sglt2 treatment at the kickoff point of the study 11. patients with a history of hypersensitivity to sglt2 inhibitors 12. patients who are judged ineligible by the principal investigator