Kornimate/medical-research-clean huggingface dataset:
everolimus stent in myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: randomized trial to test the efficacy and safety of newer drug eluting stent generation in patient with acute myocardial infarction treated with primary percutaneous coronary intervention (pci)

the efficacy and safety of drug-eluting stents (des) in the treatment of coronary artery disease is well established. it is well known that drug eluting stent (des) have dramatically decreased restenosis rates for both on-label and off-label indications. however, the concern for increased (late) stent thrombosis is still present des implantation in patient with acute myocardial infarction is still controversial because acute coronary lesion presents the highest possible thrombotic burden newer des with new antiproliferative drugs and more biocompatible polymers have shown a significant reduction of (late) stent thrombosis in patients in stable condition. aim of the study was to asses the long term efficacy and safety on second generation everolimus eluting stent compared with first generation sirolimus eluting stent

Eligibility criteria:
inclusion criteria: * all st segment elevation myocardial infarction (stemi) patients eligible for primary pci exclusion criteria: 1. contraindication to dual antiplatelet therapy for 12 months 2. known allergy to sirolimus or everolimus 3. major surgical procedure planned within 1 month. 4. history, symptoms, or findings suggestive of aortic dissection. 5. participation in other trials 6. pregnancy.

Keywords: primary pci drug eluting stent
myocardial ischaemia after exposure to diesel exhaust

Conditions: Coronary Heart Disease

Summary: exposure to particulate air pollution is associated with increases in cardiovascular mortality and morbidity. the pathophysiological mechanisms underlying this observation are emerging, and exposure to particulate air pollution has been shown to result in increases in blood pressure and arterial tone, impaired vascular function and an increased tendency for blood to clot as well as an increase in atherosclerotic plaque burden. recent evidence from panel studies and controlled exposure studies have suggested an increase in myocardial ischaemia (a reduction in blood flow to the heart) following exposure. in this study we aim to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust (as a model of urban air pollution) using ct/pet myocardial perfusion imaging in male patients with stable coronary disease and healthy male controls. we hypothesize that following exposure to dilute diesel exhaust: 1. myocardial blood flow will be reduced 2. coronary flow reserve will be impaired 3. the magnitude of impairment will be higher in patients with coronary disease as compared to healthy controls


Eligibility criteria:
inclusion criteria: * healthy volunteers will be taking no regular medication, have a normal electrocardiogram and exercise stress test * patients with a previous history of myocardial infarction or successful coronary revascularization (ptca or coronary artery bypass grafting) but without symptoms of angina pectoris will be recruited exclusion criteria: * healthy volunteers: * regular medication * abnormal 12-lead electrocardiogram * abnormal exercise stress test * patients with coronary disease * acute coronary syndrome within past 3 months * impaired left ventricular function * significant valvular heart disease * left ventricular hypertrophy * resting conduction defect * digoxin use * renal impairment (egfr \<60 ml/min) * hepatic impairment * asthma

Keywords: air pollution myocardial ischaemia coronary blood flow diesel exhaust troponin electrocardiography
impact of 18f-fes pet on the therapeutic treatment of patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a multi-center study in france to evaluate the impact of estrotep pet/ct results on the therapeutic management of patients with metastatic breast cancer (mbc). each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. after inclusion, a standardized pre estrotep pet/ct questionnaire will be completed by the investigators to evaluate the initial management plan. patient will perform the estrotep pet/ct examination at visit 2. a standardized post estrotep pet/ct questionnaire will then be completed by the investigators. patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.


Eligibility criteria:
inclusion criteria: 1. female aged at least 18 years old at the time of enrolment 2. oestrogen-receptor positive primary breast cancer in ihc (er ≥10%) 3. her2-negative primary breast cancer (0, 1+, 2+ fish negative) 4. metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion 5. patient relapsing under first-line treatment combining a cdk4/6inhibitor and hormone therapy 6. patient having undergone an fdg pet/ct during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline fdg pet/ct seeking the relapse during 2nd line staging (according to the recommendations of the guide to correct use (gbu) for medical imaging tests). a period of 2 to 28 days will be respected between the 2 pet/ct scans (fdg/fes). 7. ecog 0, 1 or 2 8. life expectancy of at least 12 months 9. patient registered with a social security scheme 10. patient having signed an informed consent form 11. patient able to follow the study procedures and fill in the quality of life questionnaires exclusion criteria: 1. isolated hepatic metastases (taking into account the high physiological hepatic uptake of fes) 2. patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer 3. person presenting a known allergy to one of the components of estrotep 4. patients having been treated with a cdk4/6 inhibitor in combination with an serm or serd as first-line metastatic therapy 5. atients suffering from severe or known chronic liver or renal failure 6. patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of estrotep, according to the investigator's opinion 7. woman of childbearing age with no effective means of contraception according to the investigator's opinion 8. severe intercurrent disease or comorbidity assessed at risk 9. persons referred to in articles l. 1121-5 to l. 1121-8 and l11222 of the french public health code
phase 2 study of isis 681257 (akcea-apo(a)-lrx) in participants with hyperlipoproteinemia(a) and cardiovascular disease

Conditions: Elevated Lipoprotein(a); Cardiovascular Disease

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of isis 681257 and to assess the efficacy of different doses and dosing regimens of isis 681257 for reduction of plasma lipoprotein(a) \[lp(a)\] levels in participants with hyperlipoproteinemia(a) and established cardiovascular disease (cvd).


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of cvd defined as documented coronary artery disease, stroke, or peripheral artery disease * lp(a) plasma level ≥ 60 mg/dl * must be on standard-of-care preventative therapy for other than elevated lp(a) cvd risk factors key exclusion criteria: * within 6 months of screening: acute coronary syndrome, major cardiac surgery, or stroke/tia * within 3 months of screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis * heart failure new york heart association (nyha) class iv

Keywords: ionis-apo(a)-lrx akcea-apo(a)-lrx dyslipidemia dyslipoproteinemia hyperlipidemia hyperlipoproteinemia hyperlipoproteinemia(a) hyperlipoproteinemia a lipoprotein lipoprotein(a) lipoprotein a lp(a) lp a
the impact of a personalized care intervention on 90-day post-discharge care

Conditions: Cardiovascular Diseases

Summary: the purpose of this 90 day study is to demonstrate the extent to which participants with cardiovascular conditions can improve their recovery at home through a mobile app, support and resources made available to them after hospitalization. the study will evaluate the effectiveness of personal care intervention support, including one-on-one guidance, educational information, check-ins, and laguna's mobile app to help participants recover better after hospitalization.

this study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. laguna integrated hospital provided clinical guidance and laguna's personalized contextual care protocols, with the goal of improving health outcomes and reducing readmissions within 90 days post-discharge. particiants in the intervention group received support from laguna health via laguna's mobile app, phone, video, text, or web chat. laguna provided contextual support to remove recovery barriers to these intervention participants.

Eligibility criteria:
inclusion criteria: * admitted to the hospital with a diagnosis of a cardiovascular disorder as defined by the coded diagnoses for that admission * discharged to home * converse in english * uses a telephone (landline or cell phone) exclusion criteria: * participant unable to provide informed consent * participant lacks cognitive ability to participate in the study interventions as judged by the individual initiating the consenting process

Keywords: readmissions behavioral health care transitions social determinants of health contextualizing healthcare virtual coaching
isolated deficits of the lateral semicircular canal

Conditions: Peripheral Vestibular Disorder

Summary: there are only a few cases of isolated lateral canal deficit described in the literature. this study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature. in addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile. the population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the university hospitals of strasbourg for an acute unilateral vestibular deficit whose examination at the vhot shows a reduced and isolated gain of a lateral semicircular canal.


Eligibility criteria:
inclusion criteria * major patient * man or woman * patient who has given their consent to the use of their data. * patient treated in the ent department for dizziness between june 2020 and july 2021. non-inclusion criteria * patient who expressed his opposition to participating in the study * inability to provide the subject with enlightened information (difficulties in understanding the subject, cognitive disorders) * subject under safeguard of justice * subject under guardianship or guardianship * neurological signs on clinical examination

Keywords: peripheral vestibular disorder lateral semicircular canal video head impulsed test
rectal bacteriotherapy, fecal microbiota transplantation or oral vancomycin treatment of recurrent clostridium difficile infections

Conditions: Clostridium Difficile

Summary: the purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent clostridium difficile infections.

clostridium difficile infection (cdi) is the most common nosocomial infection in the western world. cdi is associated with high morbidity and mortality and is a great burden for the health care system leading center of disease control and prevention (cdc) to identify it as one of three most important/urgent threats to public health. despite antimicrobial treatment of cdi, 20% of the patients have recurrence of cdi. due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective. fecal microbiota transplantation (fmt) is an alternative treatment for recurrent cdi. studies have shown a cure rate up to 90% in patients with recurrent cdi. one alternative to fmt is rectal bacteriotherapy (rbt) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. rbt has never been investigated in a clinical trial. the project is a randomized controlled trial including 450 patients with recurrent cdi will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either fmt or rbt. the patients will be followed up for 180 days. cure is defined as resolution of cdi symptoms 90 days after treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * verified recurrent cdi with symptoms of cdi and microbiological verification (pcr). * previously treated for cdi with at least 10 days of vancomycin or metronidazole. * be able to read and understand danish. exclusion criteria: * life expectancy \< 3 months. * allergy toward vancomycin * other infection in the gi tract with clinical symptoms similar to cdi. * other illness in the gi tract with clinical symptoms similar to cdi. * use of antibiotics for more than 14 days treating other infections * planning pregnancy, pregnancy or breast feeding. * severe immune suppression which makes fmt/rbt relatively contraindicated

Keywords: recurrence infection
dose ranging study with the probiotic combination (vsl#3) in diarrhea ibs

Conditions: IBS

Summary: to evaluate the effects of vsl#3 on symptoms associated with diarrhea predominant ibs

the study will evaluate 2 doses of vsl#3 and placebo over a 4 week period in patients presenting with diarrhea predominant ibs symptoms.

Eligibility criteria:
inclusion criteria: * ibs diarrhea exclusion criteria: * \< 18 years of age * pregnancy/breast feeding * concomitant medications to reduce bowel function

Keywords: ibs functional bowel disorder diarrhea probiotic
how to treat opiate withdrawal in neonates

Conditions: Neonatal Abstinence Syndrome

Summary: three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. major objective is to investigate the duration of drug treatment based on the finnegan score. secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

background: neonatal narcotic abstinence syndrome is an important medical, social and financial problem. several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best. goal: three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. major objective is to investigate the duration of drug treatment based on the finnegan score. secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions. methods: neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. infants with severe malformation are excluded. each infant is assessed every eight hour by a modified finnegan score. when 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. the masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. when the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way. a total of 120 infants, 40 in each group will be included in the study.

Eligibility criteria:
inclusion criteria: * neonates of mothers who consumed opiates during pregnancy * born after 34 completed weeks of pregnancy * parents' informed consent exclusion criteria: * preterm birth before 34 0/7 gestational weeks * severe malformation * illness requiring respiratory assistance or catecholamines * negative meconium drug test

Keywords: opiate dependence withdrawal newborn
hydroxychloroquine sulfate tablets for radiation-induced oral mucositis

Conditions: Radiation-induced Oral Mucositis

Summary: evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy


Eligibility criteria:
inclusion criteria: * patients pathologically diagnosed with non-metastatic head and neck malignant tumors * aged 18-80 years * eastern cooperative oncology group performance status of ≤2 * planning to receive definitive rt or postoperative adjuvant rt * normal liver, kidney and bone marrow function * sign informed consent exclusion criteria: * those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution * had a history of head and neck radiotherapy * patients with non head and neck parts in the radiotherapy area * poor oral hygiene or severe periodontitis * suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, parkinson's disease or epilepsy * recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets * retinopathy * other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
gemcitabine (gff) in patients with pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: the purpose of this study is to examine the efficacy and safety of the drug combination gff in patients with advanced pancreatic cancer (apc).

this open-label, multi center phase ii study was conducted to investigate the efficacy and safety of the combination of 5-fluorouracil (5-fu)/folinic acid (fa) plus gemcitabine (gff) in patients (pts) with advanced pancreatic cancer (apc). we consequently started this study after completing the phase i trial accomplished by our conko- study group.

Eligibility criteria:
inclusion criteria: * histological proved pancreatic cancer * inoperable disease * informed consent * adequate bone marrow reserve exclusion criteria: * under 18 years * brain metastasis * lactating woman * life expectancy under 3 months

Keywords: pancreatic cancer gemcitabine combination
efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase ii study

Conditions: Metastatic Nasopharyngeal Carcinoma; Chemotherapy Effect

Summary: to evaluate the efficacy and safety of pd-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

to evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (npc) after platinum-based chemotherapy failure. the primary end point is objective response rate (orr), the secondary end points are overall survival (os), progression-free survival (pfs), duration of response (dor), adverse effects and quality of life.

Eligibility criteria:
inclusion criteria: * patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment. * previous failure of first-line platinum-containing chemotherapy (single drug or combination). * previously diagnosed who classification type ii or iii by histological pathology. * at least one measurable lesion (according to recist1.1). * age between 18 and 70. * eastern cooperative oncology group (ecog) 0-1, and life expectation at least 3 months. * enough blood test. * participate voluntarily and sign the informed consent. exclusion criteria: * previously diagnosed who classification type i by histological pathology. * prior exposure to anti-pd-1/pd-l1 antibodies plus anti-vegf antibodies. * necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding. * a history of interstitial pneumonia or other autoimmune diseases. * sever infection. * sever heart disease. * hiv infection. * allogeneic organ transplantation * malignancy other than nasopharyngeal carcinoma. * pregnancy or breast feeding. * received other test drugs.
mouth odor on preventing pneumonia by oral frailty

Conditions: Breathing, Mouth; Pneumonia; Frailty

Summary: this research plan aims to first collect data on the oral function and oral hygiene status of the elderly population in the community and to understand the normal model of oral frailty among the older adults in the community. subsequently, a comparison will be made between the oral status of hospitalized patients and the community-dwelling elderly population. the goal is to verify whether oral odor can be used as an objective biological indicator following intervention.

the first stage will aim to examine the relationships between the level of oral frailty and pneumonia-associated pathogens, as well as to establish a mouth odor database among community-dwelling people; the second stage will compare the differences of the level of oral frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older healthy people and 160 hospitalization patients. the third stage will confirm whether the mouth odor is an effective biological maker to show the changes of oral frailty, pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years old, * alert and oriented, * with sufficient comprehension and cooperation, * willing to participate in oral assessment. exclusion criteria: * patients who score below 5 on the general practitioner assessment of cognition (gpcog), * patients with oral treatments such as oral cancer treatment, * patients with oral treatments such as periodontal disease treatment.

Keywords: mouth odor pneumonia oral bacteria oral frailty oral management rehabilitation