Kornimate/medical-research-clean huggingface dataset:
pathogen detection and community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: study to compare the number of community-acquired pneumonia (cap) pathogens detected using current diagnostic tests to the number detected using the biofire diagnostics investigational polymerase chain reaction (pcr) platform.

patients diagnosed in the emergency department with cap that requires hospitalization provide a sputum sample for culture and sensitivity testing, urine for detection of s. pneumonia and l. pneumophila, an anterior nasal swab for s. aureus pcr, a nasopharyngeal swab for s. pneumonia pcr and the filmarray lrti v.2.0 iuo panel, and blood for procalcitonin testing and, in cases in which the patient is suffering rigors and hypotension, cultures. as part of this study, sputum or sputum equivalent will be acquired for testing using the filmarray lrti v.2.0 iuo panel.

Eligibility criteria:
inclusion criteria: * emergency department physician diagnosis of cap requiring hospitalization exclusion criteria: * inability to obtain sputum or sputum equivalent
post-marketing surveillance of donepezil hydrochloride - investigation of long term safety and efficacy of aricept as well as its proper use information in patients with dementia with lewy bodies (dlb).

Conditions: Dementia With Lewy Body Disease

Summary: to investigate long term safety (especially about parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with dlb.


Eligibility criteria:
inclusion criteria: 1. naive participants diagnosed as dlb exclusion criteria: 1. participants with a history of donepezil hydrochloride product administration in the past 2. participants who have already been registered in this surveillance 3. participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives

Keywords: donepezil hydrochloride aricept dementia lewy bodies dementia with lewy bodies post-marketing surveillance
prevention of atrial tachycardia after a right atriotomy ii

Conditions: Atrial Flutter

Summary: the investigators performed a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. conduction time between electrodes placed on both sides of the lesions is measured on the second postoperative day. coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line are performed three month after the operation.

we perform a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy (surgical dissection plus cryoablation) and the atriotomy with the inferior caval vein (cryoablation alone) to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. conduction times between electrodes placed on both sides of the lesions are measured on the second postoperative day. coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line and to try to induce atrial flutter are performed three month after the operation.

Eligibility criteria:
inclusion criteria: 1. clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy, 2. age \>18 years, 3. ability to give an informed consent. exclusion criteria: 1. acute operation 2. chronic atrial fibrillation 3. indication for maze procedure
optimize heart failure care during transitional period in patients with acute heart failure.

Conditions: Heart Failure With Reduced Ejection Fraction; Acute Heart Failure

Summary: the period of about a month after the discharge of acute heart failure patients is defined as a transition time. during this period, the patient has a high mortality rate and a readmission rate because the patient is not stabilized. in the united states and europe, the readmission rate is more than 25% within 30 days, and the mortality rate within 30 days after discharge is three times that of patients with chronic heart failure. the trans-hf is a prospective, randomized, multi-center, controlled study, which enrolls patients with acute heart failure with reduced ejection fraction. the objective of trans-hf is to improve gai at six months through three interventions: pre-discharge checklist, heart failure education, and telephone monitoring before the first outpatient visit.


Eligibility criteria:
all consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and satisfy 4-5 simultaneous inclusion criteria: 1. symptoms of heart failure 2. signs of heart failure 3. lung congestion in chest-x-ray 4. objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels 5. left ventricular ejection fraction less than 40% exclusion criteria: 1. patients younger than 19 years old 2. patients who do no consent

Keywords: acute heart failure
magnetic resonance imaging in treating children with progressive low-grade astrocytoma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: new imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma. purpose: phase ii trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.

objectives: i. determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. ii. improve the quality of life without use of aggressive surgery or radiotherapy in this patient population. outline: patients undergo magnetic resonance spectroscopic imaging (mrsi) over 60 minutes prior to surgery and/or radiotherapy. patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. arm i: patients undergo conventional surgery. arm ii: patients with inaccessible tumors undergo focal radiotherapy. following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with mrsi or mri for tumor response and growth. projected accrual: a total of 24 patients will be accrued for this study over 2 years.

Eligibility criteria:
disease characteristics: diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on t2 weighted scans incomplete surgical resection previously treated with evidence of tumor progression no hemispheric or cerebellar masses patient characteristics: age: 12 and under performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: see disease characteristics

Keywords: childhood low-grade cerebral astrocytoma childhood low-grade cerebellar astrocytoma recurrent childhood cerebral astrocytoma
iv acetaminophen for acute post operative pain in c-section patients

Conditions: Post-operative Pain

Summary: post-operative pain management after c-section is an important topic as the number of elective c-sections increases each year. pain is managed either by giving opioids or by using non-opioids. the purpose of this study is to evaluate the effectiveness of iv acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. the hypothesis is that four doses of iv acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

most of the opioids used are centrally acting drugs like morphine or its derivatives. the most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. one of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (nsaids). frequent use of nsaids is also associated with complications, such as gastric ulcer and platelet dysfunction. when compared to other non-nsaids, iv acetaminophen is a relatively safer drug with quicker onset of action. in an earlier conducted study, the onset of action of analgesia for a bolus dose of iv acetaminophen is 3 minutes. iv acetaminophen is fda approved for management of mild to moderate pain. an adverse reaction associated with the prolonged usage of iv acetaminophen is hepatic injury. the most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.

Eligibility criteria:
inclusion criteria: * elective full term cs patients * age 18 and above * asa i-iii exclusion criteria: * allergic reaction to iv acetaminophen * not able to understand and sign the research consent * pregnancy induced hypertension or pre-eclampsia patients * planned intensive care admission patients * patients with severe hepatic impairment or active liver diseases (two fold increase in any of the liver enzymes) * patients with serum creatinine\>2mg/dl * for nursing mothers, any evidence of hepatic dysfunction of the new born

Keywords: opioid usage requirements pain iv acetaminophen opioid usage c-section
the safety and efficacy of etanercept (enbrel®) for the treatment of discoid lupus erythematosus

Conditions: Discoid Lupus Erythematosus (DLE)

Summary: a 20 week study to assess the safety and efficacy of etanercept(enbrel®)for the treatment of discoid lupus erythematosus


Eligibility criteria:
inclusion criteria: * subjects with discoid lupus erythematosus .subjects require to have confirmation of diagnosis by a skin biopsy .this can be undertaken at the screening visit if no previous biopsy confirmation available. and; * having failed steroids (topical, intralesional, systemic) and are candidates for antimalarial therapy * negative ana have no history of latent or active tb prior to screening. exclusion criteria: * subjects allergic to sunscreens * prior treatment with anti-tnf therapies * subjects who do not have a previous skin biopsy result confirming a dle diagnosis and who are unwilling to undergo this procedure at screening. * subjects currently receiving systemic steroid therapy (or have received in the last 3 months) * known hypersensitivity to enbrel® (etanercept) or any of its components or known to have antibodies to etanercept. * prior or concurrent use of cyclophosphamide therapy * concurrent sulfasalazine therapy. * known hiv-positive status or known history of any other immuno-suppressing disease. * any mycobacterial disease or high risk factors for tuberculosis (tb), such as family member with tb, positive purified protein derivative (ppd) or taking anti-tuberculosis medication * active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits. * severe comorbidities (diabetes mellitus requiring insulin; chf of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic bp \ 160 or diastolic bp \> 100 mm hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years \[other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer\]) * systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
in vivo succinate detection after external beam radiation therapy in sdhx- paragangliomas

Conditions: Paraganglioma of Head and Neck

Summary: qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. we aim at assessing the added value of 1h-srm for the evaluation of early response to ebr therapy in patients with cervical sdhx pgl.

paragangliomas (pgl) are rare neuroendocrine tumors inherited in 40% of cases. sdhx genes (sdha, sdhb, sdhc, sdhd), encoding the 4 subunits of the mitochondrial enzyme succinate dehydrogenase (sdh), are the most frequently involved. accumulation of succinate, the substrate for sdh, is a very specific biomarker for these mutations. recently, we have demonstrated the feasability of detecting and quantifying succinate in tumors in vivo, by magnetic resonance spectroscopy (1h-srm). patients carrying these mutations frequently develop cervical pgl for which the treatment of choice is external beam radiation therapy (ebr). the objective of this project is to determine the feasibility of using 1h-srm for the evaluation of early response to ebr therapy in patients with cervical sdhx pgl.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * patient with cervical pgl with planning of treatment with ebr * patient with an sdhx mutation or unknown genetic status * patient affiliated to a social security scheme exclusion criteria: * pregnant woman * contraindication to mri (implantable device, etc.) * impossibility of lying down without movement for 45 minutes (hyperalgesic patient, claustrophobia, etc.) * ppgl having previously been the subject of local (excluding surgery) or systemic treatment * ppgl \<1 cm longest axis * patient under guardianship or curatorship

Keywords: paraganglioma,sdhx genes, 1h-spectroscopy mri
asymptomatic bacteriuria, urinalysis abnormality at the initiation of sglt2 inhibitors and uti risk

Conditions: Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Summary: the sglt2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. however, the association between sglt2 inhibitors and urinary tract infection (uti) risk is controversial. moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of sglt2 inhibitors are risk factors for uti in women. there is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of sglt2 inhibitors. the aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of sglt2 inhibitors on uti risk in a prospective cohort of women with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * female * \>18 years old * type 2 diabetes mellitus * initiated sglt2 inhibitors * available informed consent exclusion criteria: * having urinary tract or genital tract symptoms at the enrollment * treated for urinary tract or genital tract infection in the last 3 months
a study to assess the safety, tolerability and effects of single ascending doses of asp3652 in healthy subjects

Conditions: Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Safety

Summary: the purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the central nervous system (cns), as well as the cns side effect profile of single ascending doses of asp3652 in healthy, caucasian male and female subjects.

each subject receives 3 single ascending doses of asp3652 and a single dose of matching placebo during one randomly selected investigational period. randomization is conducted separately for males and females. the washout period between dosing occasions is at least 7 days. screening takes place from day -22 to day -2. subjects are admitted to the clinic in the afternoon of day -1 of investigational period 1, 2, 3 and 4 for pre-dose assessments. on day -1 of all investigational periods, subjects do not take any food or drink for at least 10 hours before the anticipated dosing time on day 1. for the duration of their stay in the clinic, subjects are not allowed to consume caffeine or other xanthine-containing drinks. the subjects are discharged on day 4 of each investigational period. the end of study visit (esv) is planned to take place 7-14 days after early discharge or after day 4 of investigational period 4.

Eligibility criteria:
inclusion criteria: * subject is white and of caucasian origin. * body mass index more than or equal to 18.5 and less than 30.0kg/m2. * male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy. * female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy. exclusion criteria: * pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only). * known or suspected hypersensitivity to asp3652, or any components of the formulation used. * a mean qtc(f) interval of \>430 ms (for males) and \>450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of long qt syndrome (lqts). in case of an abnormal qtc(f) interval, the assessment may be repeated once (in triplicate). if the qtc(f) interval exceeds the limits, two additional electrocardiogram (ecg)s can be recorded and the average of the three qtc(f) values should be used to determine the subject's eligibility.

Keywords: phase i asp3652 dose escalation maximum tolerated dose (mtd)
delirium, agitation/sedation, pain and dyspnea in respiratory intensive care unit (nivilium)

Conditions: Respiratory Failure; Delirium; Agitation,Psychomotor; Pain; Dyspnea; Mechanical Ventilation Complication

Summary: non-invasive mechanical ventilation (niv) has been increasingly used in the treatment of acute respiratory failure. notwithstanding failure rates still remains high, ranging from 5% to 60%. the onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. the aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to respiratory intensive care unit undergoing non-invasive mechanical ventilation for acute respiratory failure.


Eligibility criteria:
inclusion criteria: * patients with acute respiratory failure admitted to the respiratory intensive care unit of the university hospital of modena undergoing non invasive mechanical ventilation exclusion criteria: * age lower than 18 * glasgow coma scale lower than 10 within 24 hours from respiratory intensive care unit admission * need for immediate orotracheal intubation * pregnancy * previously established psychiatric disease or dementia
comparison between perineural and systemic effect of dexamethasone as an adjuvant for prolongation of four nerve blocks with bupivacaine in total knee arthroplasty

Conditions: Analgesia; Pain, Postoperative

Summary: the addition of dexamethasone (dxam) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. the aim of this study is to determine whether this is a systemic or local effect.


Eligibility criteria:
inclusion criteria: * pre-surgical total knee arthroplasty patients exclusion criteria: * skin infection near block site * allergy to local anesthetics * peripheral neuropathy * proven opioid dependency * coagulopathy * dementia
decision aid in chronic total occlusion (cto) patients

Conditions: Coronary Occlusion

Summary: the aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.

this is a parallel, 2-arm, randomized trial to compare an intervention group receiving cto choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. the investigators will measure the effect of cto choice on five outcomes: (a) patient knowledge regarding cto of pci or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (pci) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). to capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. these video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.

Eligibility criteria:
patient: inclusion criteria: 1. at least one lesion occluding the coronary artery detected by angiography or mscta. 2. left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement. 3. no major barriers to provide written consent. exclusion criteria: 1. severe coexisting conditions, such as severe renal insufficiency (gfr \< 30 ml/min•1.73m2), severe hepatic dysfunction \[elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation\], acute or chronic heart failure (nyha iii-iv), acute infectious diseases, immune disorders, malignancy, etc. 2. patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey. cardiologist: inclusion criteria: 1. doctors who work in the department of cardiology for more than 1 years. 2. no major barriers to provide written consent. exclusion criteria: none.

Keywords: chronic total occlusion decision aid