Kornimate/medical-research-clean huggingface dataset:
prospective study to optimize vancomycin dosing in children and adults using computer software

Conditions: Bacterial Infections

Summary: we will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. we will also include therapeutic outcomes and costs in the analysis.

recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. the hypothesis for this study is that dosing vancomycin assisted by computer software and bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. this study will enroll 90 patients per year for three years, totaling 270 patients. eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. participants in the first group of 90 will be treated according to standard care. the second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the bestdose software developed by the usc laboratory of applied pharmacokinetics. the second group will be dosed with the software in its current form, and the third group with funded updates. for all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. the primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy.

Eligibility criteria:
inclusion criteria: 1. hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment. 2. participants will of any age. 3. participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent. exclusion criteria: 1. prior receipt of vancomycin for the same clinical event (e.g. the same fever of unknown origin in a neutropenic patient defined as \<24 hours of no fever) 2. known colonization or infection with a vancomycin resistant organism (mic \> 2 mg/l) 3. known hypersensitivity or intolerance to vancomycin 4. patients on any form of dialysis 5. not expected to survive \>72 hours.

Keywords: vancomycin pharmacokinetics pharmacodynamics decision support
lucinactant for treatment of acute hypoxemic respiratory failure in children up to two years old

Conditions: Acute Hypoxemic Respiratory Failure

Summary: treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Eligibility criteria:
inclusion criteria: * ≥ 38 weeks (corrected age) to 2 years (24 months) * intubated and mechanically ventilated (mv) for ≥ 6 hours and anticipated need for mv for ≥ 24 hours * persistent hypoxia * written informed consent exclusion criteria: * mechanical ventilation for \> 48 hours * oxygenation index ≥ 25, if arterial line was avialable * pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange * neuromuscular disease or hypotonia * upper airway disease * baseline requirment for supplemental oxygen * untreated pneumothorax * off-label use of commercially available surfactant outside neonatal period * history of prematurity and passive immunoprophylaxis with humanized monoclonal antibody * head injury with glasgow coma scale \< 8 * brain death or impending brain death * do not resuscitate orders * cardiopulmonary resuscitation within 6 hours of meeting entry criteria * experimental therapy in which the intervention potentially affects respiratory outcomes * any transplant recipient * meconium aspiration syndrome * bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection
amlodipine/atorvastatin combination to reduce the health risk of high blood pressure and high cholesterol levels

Conditions: Hypertension; Hyperlipidemia

Summary: the purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines


Eligibility criteria:
inclusion criteria: * clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication exclusion criteria: * patients with blood pressure adequately maintained at goal with or without medication * patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively
cortical plasticity after motor cortex stimulation in healthy subject and chronic pain patients

Conditions: Neuropathic Pain

Summary: the primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional mri. as a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect. in healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 hz and theta-burst rtms, in a cross-over randomized study. two sessions of 5 consecutive days of rtms are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 hz and theta-burst stimulation in a cross-over randomized order. cortical plasticity of the motor cortex is evaluated via functional mri (motor activation) performed before the first rtms session and the last day of each session of rtms.


Eligibility criteria:
inclusion criteria: * healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent. * patients : * aged from 18 to 80 years, male or female, with social protection , fully informed and having given their written consent. * unilateral pharmacoresistant neuropathic pain during at least one year, * without any change of the pharmacological treatment since at least one month exclusion criteria: * for healthy subjects only: * history of chronic pain * analgesic medication within 24h before stimulation for patients only: new analgesic treatment within 1 month before consent for both: * drug addiction, headache, epilepsy history * ferromagnetic intracranial device * implanted stimulator * absence of contraceptive method for women of childbearing age

Keywords: neuropathic pain stimulation of the motor cortex (scm) pharmacoresistant rtms
changes of the single limb standing balance after total knee arthroplasty in degenerative osteoarthritis

Conditions: Knee Osteoarthritis

Summary: it was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. most current researches have been focused on the change of the proprioception. however, the evaluation of the proprioception is based on the surrogated end. double or single limb standing balance is considered functional scale. it is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis. unfortunately, few study have been performed for figuring proprioceptive change after surgery out. considering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.


Eligibility criteria:
inclusion criteria: * medial compartment degenerative knee osteoarthritis showing the varus deformity exclusion criteria: * history of surgery on the lower extremity except for arthroscopy or menisectomy * hip arthritis or, hip or back pain disturbing the standing * history of participation in sport rehabilitation program within less than 6 months * presence of neurological or musculoskeletal disease disturbing the standing * patient to reject the participation

Keywords: knee osteoarthritis arthroplasty postural balance
acute cardiorespiratory effects of e-cigarette inhalation

Conditions: Healthy

Summary: according to the world health organization cigarette smoking is today one of the leading single causes of preventable death and morbidity. the electronic cigarette (e-cigarette) has been marketed as a safer alternative to conventional cigarettes, and its global sales continue to grow exponentially each year. despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. therefore the current study is designed to investigate the effects of active e-cigarette inhalation on the cardiovascular and respiratory systems.

it is estimated that 6 million people worldwide lose their lives due to tobacco use yearly. on average, cigarette smokers are estimated to die 10 years earlier than non-smokers. ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers have all been linked to tobacco use. in recent years the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. e-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting women and adolescents. with limited knowledge of e-cigarette vaping health effects in humans it has been challenging for governments and health officials to give advice and regulate the use of this novel product. in the current study investigators aim to investigate acute cardiovascular and respiratory effects after active inhalation of e-cigarette in healthy human subjects.

Eligibility criteria:
inclusion criteria: * intermittent/sporadic cigarette smoking * normal clinical examination * normal ekg * normal blood tests * normal lung function exclusion criteria: * cardiovascular disease * respiratory disease * systemic or chronic disorders or disease * symptoms of infection or inflammation within 2 weeks of the study * bmi≥30 * pregnancy * current habitual cigarette smokers

Keywords: nicotine electronic cigarette
assessment of bladderlight surveillance

Conditions: Bladder Cancer

Summary: is bladderlight® (bl) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.

there are three arms to the proposed performance evaluation of the integrated test - arms 1 and 2 are cross-sectional studies examining the accuracy of the bladderlight® test in the detection of cancer of the urinary bladder in patients attending either gross haematuria clinic for a potential primary (first time) diagnosis (arm 1) or patients attending cystsoscopic surveillance clinic as follow up to a previous, treated case of bladder cancer (arm 2). arm 3 is a longitudinal examination of disease state following a negative cystoscopy with a positive bladderlight® test - this will examine whether bladderlight® can predict progression to overt disease. arm three will not involve any further requirement for physical sampling, but will involve result checking on subsequent cystoscopies

Eligibility criteria:
inclusion criteria: 1. aged 18 years of age or above. 2. patients attending cystoscopic surveillance clinic for monitoring of recurrence of urothelial carcinoma after having been treated for urothelial carcinoma / bladder cancer (arm 1) or patients attending gross haematuria clinic (or equivalent) for cystoscopy/biopsy (if appropriate) relating to symptoms suggestive of possible urothelial cancer (arm 2). patients that will receive a cystoscopy as per standard practice. 3. able to understand and sign the written informed consent form. 4. able and willing to follow the protocol requirements exclusion criteria: 1. participation in any clinical study of an investigational medicinal product during the 8 weeks preceding the sampling period of the study. 2. patients that have a urinary tract stent, kidney stones or catheter

Keywords: urine haematuria flexible cystoscopy recurrence cytology
treatment of knee osteoarthritis with bone marrow aspirate matrix: prospective, randomized trial

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (koa) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. conservative treatment of osteoarthritis should be the first approach to patients with this disease. the interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of oa and its natural history. the aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (iha), bone marrow aspirate (bma) and bma matrix in the treatment of knee osteoarthritis. the sample will consist of 90 patients with osteoarthritis of the knee followed up at the into, who will be divided into three groups: group a, treatment with bma; group b, treatment with iha ; and group c, treatment with bma matrix. patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. we believe that treatment with bma and the bma matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.


Eligibility criteria:
inclusion criteria: bilateral knee oa according to the american college of rheumatology criteria kellgren-lawrence ≤ iii in both knees full range of movement (0 a 120°). exclusion criteria: 1) history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus\> 10° or valgus \>15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index \>35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) hip oa \> tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside rio de janeiro metropolitan area

Keywords: osteoarthritis knee hyaluronic acid bone marrow aspirate bone marrow aspirate matrix
effect of xolair on airway hyperresponsiveness

Conditions: Allergic Asthma

Summary: the purpose of this study is to determine if xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. another purpose is to determine if xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

xolair, a recombinant humanized monoclonal anti-ige antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. in moderate to severe allergic asthmatic patients, xolair reduced asthma exacerbations and improved symptoms. however, there is limited data on the effects of xolair on airway hyperreactivity, an important component of asthma.

Eligibility criteria:
inclusion criteria: * female patients must have a negative urine pregnancy test at visit 1 and a negative urine pregnancy test at subsequent visits. in addition, female patients must be using a medically acceptable form of birth control. * history of mild to moderate asthma * a positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus) * a pc20 value for methacholine \< 5 mg/ml * a pc15 value for hypertonic saline at \< 4 minutes * capable of faithfully attending regularly scheduled study visits * willing to avoid prohibited medications for the periods indicated in the protocol * a baseline serum ige level of \> 30 iu/ml and \< 700 iu/ml exclusion criteria: * women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding * known sensitivity to study drug or class of study drug * any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit * patients with a history of severe anaphylactoid or anaphylactic reactions * patients taking beta-adrenergic antagonists in any form * patients previously exposed to xolair * patients with a known hypersensitivity to trial drug excipient ingredients or related drugs * chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations * use of immunosuppressive medications * history or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

Keywords: asthma
french aquablation clinical investigation using waterjet ablation therapy for endoscopic resection of prostate tissue

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the aquabeam system in the treatment of benign prostatic hyperplasia (bph) in men 45 to 80 years of age.


Eligibility criteria:
inclusion criteria: * subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. * history of inadequate response, contraindication or refusal to medical therapy for bph. * age from 45 through 80 years. * prostate volume between 30ml and 80ml by transrectal ultrasound (trus) measured at baseline. exclusion criteria: * bmi ≥ 42. * ipss total score \<12. * history of prostate cancer or clinically significant elevated psa value. * history of bladder cancer actively treated within 2 years prior to the surgical procedure. * bladder calculus or clinically significant bladder diverticulum (e.g., pouch size \>20% of full bladder size). * active infection, including urinary tract infection within 72 hours of the treatment procedure. * prostatitis treated with antibiotics within 1 year of the surgical procedure. * subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter. * subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use. * clinically significant abnormal serum creatinine measured within 30 days of treatment. * maximum urinary flow rate (qmax) \>15 ml/s or pvr \> 300 ml measured by uroflowmetry test at baseline. * subject has been catheterized due to retention within 14 days prior to the surgical procedure. * subject has a history of intermittent self-catheterization. * previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis * subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d) * any severe illness or psychiatric condition that would prevent study completion or confound study results. * subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (nsaids, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg). * participants using medications specifically for bladder muscle problems (e.g., irritability). use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications. * participating in another investigational study that could affect responses to the study device. * subject is unwilling to accept a transfusion should one be required.

Keywords: lower urinary tract symptoms (luts) benign prostatic hyperplasia (bph) aquabeam aquablation
confocal microscopy dual band in the management of bladder cancer

Conditions: Urinary Bladder Neoplasm

Summary: bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. the photodynamic diagnosis technique (pdd) currently used (hexvix®) has improved tumor detection but with a high false positive rate. indeed, the main limitation of the pdd is its lack of specificity, ranging from 35 to 66%. the association of this technique with new technologies such as the cellvizio dual band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. the objective of this study is to demonstrate the efficacy of cellvizio dual band technique for the diagnosis of tumors bladders.


Eligibility criteria:
inclusion criteria: * patients having 18 years old or more * patients with a bladder carcinoma and with indication of tumor resection under hexvix procedure. * patients giving consent to participate in the study exclusion criteria: -no consent to participate in the study

Keywords: urinary bladder cancer diagnosis cellvizio dual band