Kornimate/medical-research-clean huggingface dataset:
study on the efficacy of phenytoin in the prophylaxis of seizures of patients with pneumococcal meningitis at least 50 yrs old.

Conditions: Seizures; Pneumococcal Meningitis

Summary: to evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. hypothesis: administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.

background: bacterial meningitis has still a high morbi-mortality despite the global improvement in therapy. among complications, the presence of seizures may contribute to increase the morbi-mortality. prophylactic phenytoin is used in clinical practice in high risk patients but this use is variable because there are not controlled clinical trials demonstrating efficacy along with antibiotics and corticosteorids. pneumococcal episodes are associated to a higher number of seizures and a higher mortality especially in elderly patients. objectives: to evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. hypothesis: administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs. methodology: multicentre, randomized, double blind placebo controlled clinical trial. patients will be included mostly from hospitals from reipi and caiber and randomly assigned to receive phenytoin or placebo. sample size has been estimated in 61 patients per group. antibiotic therapy and icp prophylaxis will be standardized in all centres. phenytoin administration will be maintained during antibiotic therapy. end point will be incidence of seizures during hospital stay and overall mortality will be a secondary end-point. followup visits at 1 and 3 month will be performed.

Eligibility criteria:
inclusion criteria: adult patients \> or = 50 years old. diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive csf gram stain and/or a detection of pneumococcal antigen or pcr or suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy. exclusion criteria: to have seizures prior to arrive to the hospital or the inclusion in the study. pregnancy or breastfeeding. to have conduction abnormalities in ecg. history of allergy or intolerance to phenytoin. patients with meningitis as a complication of neurosurgical procedures. epileptic patients taking usually anticonvulsivants. refusal by the patient or family to participate and/or to sign the informed consent.

Keywords: phenytoin prophylaxis pneumococcal meningitis randomized placebo-controlled double blind patient 50 years or older
cdk4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer

Conditions: Breast Cancer

Summary: this is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for cdk4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.


Eligibility criteria:
inclusion criteria: * aged ≥18 and older * confirmed diagnosis of hormone receptor-positive breast cancer. * subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy. * subjects have received or plan to receive cdk4/6 inhibitors for advanced disease. * ecog 0-2 * adequate organ function exclusion criteria: * subjects disable to swallow pills. * history of immunodeficiency disease

Keywords: locoregionally recurrent metastatic cdk4/6 inhibitors
a prospective investigation of the vwf-adamts 13 axis in acute ischaemic brain injury (tias and stroke).

Conditions: Stroke

Summary: in patients presenting with acute stroke or transient ischaemic attacks (tia), von willebrand factor related parameters, including vwf antigen, activity, fviii:c and propeptides, adamts13 levels and vwf multimers in cases where adamts 13 was reduced will be measured. global haemostasis will be assessed using thrombin generation and the relation between increase thrombin generation and vwf explored. thrombin generation will be performed pre and post filtration for the presence of procoagulant microparticles. these parameters will be investigated acutely, at presentation and in convalescence; in addition, the effect on these parameters of treatment such as thrombolysis may be informative. correlation between measured parameters and adverse clinical outcome would be used to identify markers of severity and progression of ischaemic stroke and identification of potential novel approaches to therapy that might improve outcome.


Eligibility criteria:
inclusion criteria: * patients aged \>18 years of age presenting within 9 hours of onset of symptoms will be recruited from the hyperacute stroke unit at uclh. * patients in whom stroke has been excluded or in whom intracerebral haemorrhage has been diagnosed are to be included as 'controls'. the definitive diagnosis will not be immediately obvious at presentation. * written consent will be obtained from patients or their nearest relative, particularly in patients with aphasia/dysphasia. exclusion criteria: * patients \<18 years old * patients with systemic vasculitis or active malignancy will be excluded. * patients not wishing to participate

Keywords: presentation with
cardiac blood flow patterns associated with left ventricular myocardial damage

Conditions: Cardiomyopathies; Myocardial Injury; Healthy

Summary: various factors affect the performance of the heart: the contractile properties of myocardial muscle cells are the fundamental devices for translating tension-generation and shortening of the cardiac muscle into pressure-generation and blood volume ejection from the heart into the body. on the other hand, the performance of heart can be analyzed with respect to input and output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance of a pump: with every heartbeat blood is sucked from a low-pressure system (veins) and pumped to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood volume, blood flow and pressures are linked by hemodynamic laws. cardiac magnetic resonance (cmr) is the "gold standard technique" to determine cardiac function and muscle mass, as well as for non-invasive diagnosis of myocardial necrosis/fibrosis. furthermore, new cmr imaging techniques enabling the measurement of myocardial magnetic relaxation times for characterization of myocardial morphology and the acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and surrounding vessels, represent promising tools for the evaluation of the interaction between myocardial morphology and cardiac function. aim of this explorative study is to 1. identify myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation dynamics ...) with myocardial injuries.


Eligibility criteria:
inclusion criteria: * patients age 20-80 years, * patients with and without ischemic or non-ischemic myocardial injuries scheduled for routine cardiac magnetic resonance imaging, * ability to hold the breath, * ability to give informed consent exclusion criteria: * patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for magnetic resonance investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, colored contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body), * patients with tendency toward claustrophobia, * hemodynamically unstable patients, * patients with (major) arrhythmia * pregnancy, * impaired kidney function indicated by creatin clearance lower than 60 ml/min (creatin clearance will be calculated according to cockroft-gault formula)
safety and efficacy of qax576 in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of qax576 in patients with idiopathic pulmonary fibrosis.


Eligibility criteria:
inclusion criteria * diagnosis of idiopathic pulmonary fibrosis (ipf), based on an appropriate clinical definition of ipf as detailed in the ats/ers/jrs/alat statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management diagnosis must be confirmed by a diagnostic hrct or surgical lung biopsy. * a 6-minute walk test (6mwt) distance ≥50 meters at screening (use of supplemental oxygen allowed). exclusion criteria * smokers (use of tobacco products in the previous 3 months). urine cotinine levels will be measured during screening for all subjects. smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab. * lung residual volume \> 120% predicted at screening.

Keywords: interstitial lung disease usual interstitial pneumonia fibrosis, pulmonary fibrosis, respiratory disease, interstitial lung disease, biological therapy, therapeutic uses,
thrombus aspiration in patients with stemi

Conditions: ST-segment Elevation Myocardial Infarction

Summary: this is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute st-segment elevation myocardial infarction (stemi) underwent percutaneous coronary intervention (pci).

this is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute st-segment elevation myocardial infarction (stemi) underwent percutaneous coronary intervention (pci). patients who are diagnosed as stemi and referred for pci will be enrolled. they will be randomized 1:1 to either manual thrombus aspiration with pci group or pci alone group.the primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (mi), cardiogenic shock, stroke, new or worsening nyha class iv heart failure during 1 year follow-up. the secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.

Eligibility criteria:
inclusion criteria: * age between 18-80; * diagnosed as stemi for presenting symptoms or definite ecg and myocardial markers changes; * patients presenting with definite ecg changes indicating stemi: st elevation of 0.1 mv in 2 contiguous limb leads or ≥0.2 mv in 2 contiguous precordial leads; * referred for pci for presenting symptoms, and the coronary angiogram (cag) shows that the initial timi thrombus grade ≥2; * informed consent. exclusion criteria: * previous history of myocardiopathy, valvular heart disease or severe heart failure; * severe hepatic or renal dysfunction; * life expectancy less than 1 year; * prior pci or cabg; * contraindications of using anticoagulation or antiplatelet drugs.
intravenous ganaxolone as adjunctive therapy to treat subjects with status epilepticus

Conditions: Status Epilepticus; Convulsive Status EPILEPTICUS; Non Convulsive Status Epilepticus; Epilepsy

Summary: this study will evaluate the effectiveness and safety of an investigational drug, iv ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.

this is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive iv ganaxolone in subjects with se. study drug will be added to standard of care before iv anesthetic during the treatment of se. subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous iv. subject's will be followed up for 3 weeks post-treatment. subjects who are known to be at risk for se may be consented and/or assented prior to an se event.

Eligibility criteria:
inclusion criteria: * subjects 12 years of age and older * clinical and/or electrographic seizures exclusion criteria: * life expectancy of less than 24 hours * anoxic brain injury as primary cause of se * recent (\<24 hour) traumatic brain injury as the primary cause of se * administered anesthesia for the treatment of se
retrospective study evaluating the current utilization of desvenlafaxine succinate sustained-release (pristiq) among psychiatrists and primary care physicians in the treatment of patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the goal of this observational study is to learn about how pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (mdd).

it is retrospective patient chart study among psychiatrists and primary care physicians (pcps) treating patients suffering from major depressive disorder (mdd). physicians will be asked general medical questions in order to quantify their prescribing behavior and their perception of treatment performance. a retrospective patient chart review will then be performed and patient data will be collected to document patient characteristics and actual treatment outcomes. upon qualification, specific instructions for chart review will be provided. once the identified charts are pulled, the physicians are instructed to continue with the on-line survey. in total, there will be approximately 450 psychiatrists and 450 primary care physicians participating in this trial.

Eligibility criteria:
inclusion criteria: * patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy. * physicians must be either a psychiatrist or a primary care physician, a prescriber of pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company. exclusion criteria: * patients who have not been treated for depression.

Keywords: retrospective chart review study desvenlafaxine utilization psychiatrists and primary care physicians treatment of major depressive disorder
ultrasound versus magnetic reseonance imaging(mri) in the assessment of anterior knee pain

Conditions: Anterior Knee Pain

Summary: anterior knee pain , often known as patellofemoral pain syndrome (pfps), is a prevalent orthopedic ailment. it usually happens while you're bending your knees. it can affect people of all ages, although it is most common among teenagers, young adults, and athletes . the actual etiology of anterior knee pain might be complicated, encompassing a variety of conditions; it causes disability, discomfort and a negative impact on the quality of life . a number of diagnostic techniques, including plain radiography, computed tomography, mri, arthroscopy and ultrasound are used to identify the pathologies causing anterior knee pain. arthroscopy, though accurate, is invasive and can cause complications. palin radiographs and computed tomography expose patients to radiations


Eligibility criteria:
inclusion criteria: * adults who presented by knee pain , limitation of movement at knee. exclusion criteria: * knee trauma, non-cooperative patients and those who refuse to participate, contraindications to magnetic resonance imaging, such as patients with cardiac pacemakers, metallic plates, and claustrophobia.
the usefulness of the hyperq stress system in routine annual screening testing

Conditions: Cardiovascular Diseases

Summary: the main objective of this study is to compare the sensitivity and specificity of a new system for analyzing the electrocardiogram (ecg) to the sensitivity and specificity of a conservative treadmill test in asymptomatic subjects, classified by framingham score as moderate to high risk. subjects will perform a routine exercise test with the addition of another set of electrodes to record high resolution ecg. all subjects will perform a stress echocardiography. the result of the routine ecg analysis will be compared to the new system and to the echocardiography results.


Eligibility criteria:
inclusion criteria: * a patient referred to annual screening check * classified as being at intermediate or high risk for the development of cardiovascular disease by the framingham score. * signed an informed consent form exclusion criteria: * a subject who cannot or should not perform an exercise test.

Keywords: asymptomatic subjects moderate to high risk for cardiovascular event
eus-coeliac plexus block versus radiofrequency ablation in pain relief of patients with malignancy

Conditions: Cancer of Pancreas; Pancreatic Neoplasms; Pain; Cancer-Associated Pain; Pain Management

Summary: many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. coeliac plexus neurolysis (cpn) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. it can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. the effect of cpn has been well established by some retrospective series. the overall response rate to cpn ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. it is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection. recently, radiofrequency ablation (rfa) of coeliac plexus has been introduced as another mode of cpn. so far, only one small single center randomized controlled trial (rct) suggesting superior performance in favour to cpn using rfa. this result has to be validated and by a rct with larger sample size. in addition, data concerning the quality of life (qol) improvement and cost-effectiveness need to be further elucidated. therefore, the aim of this study is to perform a rct to look into these issues.

the aim of this study is to compare the efficacy of eus-guided cpn versus radiofrequency ablation in patients with pain related to pancreatic cancer. by performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new rfa treatment approach can be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥18 year-old * patients who give informed consent to the study * suboptimal pain control with regular analgesics * inoperable cancer of pancreas exclusion criteria: * patients who refuse to give consent * patients aged \<18 years * eus not possible due to: problem related to scope insertion such as trismus, stenosis of the upper gi tract coagulopathy with inr \>1.5 or platelet count \< 70 * low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe

Keywords: endoscopic ultrasound guided radiofrequency ablation coeliac plexus neurolysis pancreatic cancer pain relief chemical coeliac plexus neurolysis coeliac plexus ablation cancer pain
human urine sample collection for alport nephropathy biomarker studies

Conditions: Alport Syndrome

Summary: this is a prospective cross-sectional, observational, single-center study of alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function. the purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as alport nephropathy.


Eligibility criteria:
inclusion criteria: * alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping) * physically able to provide a single first-morning urine sample of at least 30 ml exclusion criteria: * diagnosis of chronic kidney disease * receiving chronic phosphate-lowering therapy or erythropoietin therapy * ongoing chronic hemodialysis therapy and/or renal transplant recipient * nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments other protocol-defined inclusion/exclusion criteria may apply

Keywords: alport syndrome proteinuria glomerular disease hereditary nephropathy nephropathy
a study of xolair to evaluate effectiveness and long-term safety in patients with moderate to severe asthma

Conditions: Asthma

Summary: this study is a multicenter, prospective, observational cohort study of \~5000 xolair-treated and \~2500 non-xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.


Eligibility criteria:
inclusion criteria: * signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative) * ≥12 years of age * physician diagnosis of moderate to severe persistent asthma * evidence or history of positive skin test or in vitro reactivity to an aeroallergen * willingness to participate fully for the duration of the study (5 years) * for patients in the xolair-treated cohort, have received at least one dose of xolair therapy at the time of enrollment exclusion criteria: * contraindication to xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to xolair) * acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization * acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months * use of an experimental drug within 30 days prior to study screening * diagnosis of cystic fibrosis * for patients in the non-xolair-treated cohort, any prior treatment with xolair

Keywords: moderate to severe asthma
accuracy of non invasive hemoglobin measure by sphb device in post operative anemia diagnosis

Conditions: Anemia

Summary: non invasive hemoglobin monitoring by sphb device had been developed to assess hemoglobin level during hemorrhagic surgery. it's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. this study aims to valid these finding on a cohort of post operative patients from gynaecological department.


Eligibility criteria:
inclusion criteria: * being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy * \> 18 years exclusion criteria: * non french speaker * being under a legal individual protection measure * not being able to consent * being opposed to data collection

Keywords: post operative screening anemia iron deficiency diagnosis