Kornimate/medical-research-clean huggingface dataset:
low dose of midazolam is superior to conventional dose for rapid sequence intubation in emergency department (ed)

Conditions: Intubation

Summary: midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. in some studies, however, the reduced dose has been used with the concern of hemodynamic instability. we would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.


Eligibility criteria:
inclusion criteria: * patients who need rapid sequence intubation in emergency room exclusion criteria: * in hypotension(systolic blood pressure less than 90 mmhg * severe trauma patients * pregnant * allergic to midazolam, etomidate

Keywords: intubation
start: sensipar treatment algorithm to reach k/doqi targets in chronic kidney disease subjects with secondary hyperparathyroidism

Conditions: Kidney Disease; Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: the purpose of this research is to study the effects and safety of sensipar approved by the food and drug administration (fda) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism (hpt).

the purposes of this study are: - to assess the effectiveness of a treatment algorithm that includes sensipar on bio-intact parathyroid hormone (bipth), adjusted serum calcium (ca), serum phosphorus (p), and calcium-phosphorus product (ca x p) levels in the management of shpt in ckd subjects on dialysis by determining achievement of national kidney foundation kidney disease outcomes quality initiative (k/doqi) guideline targets. - to assess the use of vitamin d sterols and phosphate binders when sensipar is incorporated in the treatment of shpt. - to assess the safety and tolerability of sensipar.

Eligibility criteria:
inclusion criteria: - subjects with chronic kidney disease who have received dialysis for at least one month before the first dose of study medication and are clinically stable. - adults at least 18 years of age who have given written informed consent. - out of target pth values, defined as the most recent historical measurement of bipth \> 160 pg/ml within 3 months prior to informed consent signature. - serum calcium \>/= 8.4 mg/dl within one month prior to informed consent signature. exclusion criteria: - unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgement of the investigator. hospitalization solely for dialysis vascular access revision does not qualify as an unstable medical condition. - parathyroidectomy in the 3 months before day 1. - current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets. - use of investigational drug or device or participation in trial of investigational drug or device (except experimental dialysis machines) within 30 days of enrollment into the study. any investigational procedures. - females of child-bearing potential who are pregnant (e.g., positive serum pregnancy test) or are breast feeding. females of child bearing potential who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. - hypersensitivity to sensipar or any of its components. - previously participated in this or any other sensipar study, or received/is receiving sensipar as a commercially available product. - disorder that would compromise the ability of the subject to give written informed consent and/or to comply with study procedures.

Keywords: calcimimetic cinacalcet hemodialysis secondary hyperparathyroidism chronic kidney disease
dual point pet scan in early stage hodgkin lymphoma patients with bulky lesions

Conditions: Hodgkin's Lymphoma

Summary: to assess specificity and overall accuracy of interim dual-point acquisition pet in predicting treatment outcome. the study is aimed at assessing the specificity of interim dual-point pet performed after 2 abvd cycles to predict treatment outcome in early-stage hodgkin's lymphoma patients presenting bulky lesions at baseline.

the proposed study is an non-interventional survey of a cohort of patients in whom interim pet scan is performed only for prognostic aims. pet with 18f-fdg is a standard staging procedure for most lymphoma subtypes. performed early during the therapy for hodgkin's lymphoma (hl) its results have a high prognostic value and is the main predictor of treatment outcome. from 2006 onward, interim-pet after 2 abvd courses has been increasingly performed in the daily clinical practice as a routine test for disease prognosis, and now it can be considered as a standard prognostic tool. the novelty of the study relies on a new method for interim-pet scan execution: a dynamic study, with 2 different time points of image acquisition. this could potentially enable us to discriminate between unspecific, inflammatory dg uptake, from a "true" uptake form persisting viable neoplastic cells. therefore, the main aim of the study is reducing false positive results in the interim-pet scan interpretation. since dynamic changes of fdg uptake in hodgkin's lymphoma are still unknown we propose, in the present study, to assess the by the same acquisition technique the pattern of fdg uptake at baseline in untreated patients affected by this neoplasm. the institutions equipped with a magnetic resonance scanners and a diffusion weighted imaging analysis technique (dw-mri), could participate to the dw-mri sub-study.

Eligibility criteria:
inclusion criteria: * hodgkin lymphoma diagnosis according all the who classification subtype but lymphocyte predominance. * age 18 - 60 years old * stage ia- iia (by fdg-pet scan) * presence of bulky tumour (either in mediastinum or other site) * treatment with abvd x 4 (early stage) * consolidation radiotherapy on bulky lesion * signed the informed consent form exclusion criteria: * diabetes mellitus uncompensated * lymphocyte predominance histology * pregnancy or lactation * implanted biomedical devices (for dw-mri sub study)

Keywords: early stage
defining the operating characteristics of nirs in the diagnosis of pediatric traumatic intracranial hemorrhage

Conditions: Craniocerebral Injuries; Head Injuries; Head Injury, Minor; Head Trauma; Traumatic Brain Injury; Traumatic Brain Hemorrhage; Hematoma of Head; Intracranial Hemorrhages

Summary: in this study, investigators look at a different type of technology that might help to avoid having to perform ct scans in certain patients suspected of having a head injury. near-infrared spectroscopy (nirs) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. investigators will study nirs, using a device called the infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as ct scan, which is the current gold standard. investigators will try to determine if nirs can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. investigators will also study how easy it is to use nirs so that it might become a standard part of the workup for children with suspected head injury.

patients that present to dayton children's hospital with a head ct order for suspected tbi will be approached for enrollment. an alert will notify study personnel as ct scans are ordered. the goal is to obtain nirs data within four-hours before or after the ct scan. informed consent will be obtained according to institutional protocols. nirs data will be obtained using infrascanner model 2000 (infrascanner inc.). eight data points will be collected for each subject in standard fashion from right to left frontal, temporal, parietal, and occipital locations. study personnel will be trained by the manufacturer and will be blinded to the results of the ct scan. data stored on the infrascanner will be subsequently transferred to a password-protected database for storage and analysis. for each participant scanned with the infrascanner 2000, they will be de-identified with a subject number, with patient demographics, mechanism of injury, gcs presentation, time of ct scan, and time of nirs recorded. ct scan results comprise presence of epidural hematoma and/or subdural hematoma and its maximal thickness if present; presence of intraparenchymal hematoma; presence of skull fracture; and any other traumatic injuries contained in the ct scan report. the length of time required to acquire nirs data will also be recorded for quality improvement purposes. the specific aims of this study are to better understand the epidemiology of traumatic brain injury (tbi) at dayton children's hospital, to establish the operating characteristics of nirs for suspected traumatic intracranial hemorrhage at dayton children's hospital, and to study the implementation of a new diagnostic modality in a busy tertiary care emergency department.

Eligibility criteria:
inclusion criteria: * 0-18 years old * glasgow coma score (gcs) 3-15 * undergoing head ct scan for suspected tbi exclusion criteria: * post-operative patients

Keywords: trauma traumatic brain injury infrascanner near-infrared spectroscopy pediatric
investigation of dental plaque and gingival index

Conditions: Dental Plaque

Summary: investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.


Eligibility criteria:
inclusion criteria: * be aged 18 to 65 years inclusive * have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present * give written informed consent * be in good general health * must discontinue oral hygiene for 24-hrs.after initial appointment. * no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study exclusion criteria: * medical condition which requires pre-medication prior to dental visits/procedures * advanced periodontal disease * 5 or more decayed, untreated dental sites * diseases of the soft or hard oral tissues * orthodontic appliances * abnormal salivary function * use of drugs that can currently affect salivary flow * use of antibiotics one (1) month prior to or during this study * use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn) * pregnant or breastfeeding. * participation in another clinical study in the month preceding this study * allergic to common dentifrice ingredients. * immune compromised individuals (hiv, aids, immuno suppressive drug therapy)
mri biomarkers predictive of disability progression in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Magnetic Resonance Spectroscopy

Summary: the transition from relapsing-remitting multiple sclerosis to secondarily progressive multiple sclerosis (spms) is difficult to identify. typically, spms is diagnosed retrospectively, with a significant delay, on the basis of a clinical history of progressive worsening, independent of relapses. thus, spms is often associated with a considerable period of diagnostic uncertainty. the use of ultra-high field imaging can shed light on the mechanisms of disability progression thanks to its better spatial resolution and advanced imaging techniques. the new morphological imaging techniques make it possible to visualize chronic inflammatory lesions and to evaluate their evolution. it also allows for the precise measurement of brain atrophy, a reference in the evaluation of neurodegeneration. metabolic imaging via proton spectroscopy allows the analysis of several promising cerebral metabolites that can provide information on cellular energy metabolism, mitochondrial function, or oxidative stress, and can help identify tissues at risk of neurodegeneration. sodium imaging can provide information on axonal energy metabolism before the occurrence of stable and irreversible axonal damage. this technique is promising as an early marker of neurodegeneration.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * duration of disease ≤ 25 years, * irreversible disability ≤ 7 (permanent wheelchair use) on the edss scale exclusion criteria: * other progressive neurological disease, * isolated radiologic syndrome (ris), * severe psychiatric pathology not in balance, * change in dosage, discontinuation or initiation of a psychotropic treatment within the last month, * change in background ms treatment for less than 3 months, * a course of corticosteroids (oral or intravenous) for less than one month, * patient with a contraindication to mri: pregnancy, metallic ocular foreign body (accidental splinters or others), pacemaker, implantable defibrillator, neurostimulator not compatible with mri 7.0 t, cochlear implants and in general any electronic medical equipment implanted in an irremovable way: metallic cardiac valve, vascular clips (formerly implanted on cranial aneurysm), metallic prosthesis...), * illiterate and non-french speaking patient: patient who is partially or completely unable to read and write french. * patient benefiting from reinforced protection, i.e. minor, subject deprived of liberty by a judicial or administrative decision, subject staying in a health or social establishment, adult under legal protection and finally patient in emergency situation, * pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)

Keywords: multiple sclerosis ultra-high field 7t magnetic resonance spectroscopy sodium imaging predictive mr biomarker of ms
analysis of the pulmonary microbiome

Conditions: Pneumonia; Microbial Colonization; Microbial Disease

Summary: the purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia.

the purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia with severe acute respiratory failure, requiring admission to the intensive care unit, and to compare it with that of patients diagnosed with pneumonia but who do not develop severe acute respiratory failure and subsequent admission to the intensive care unit.

Eligibility criteria:
inclusion criteria: * patients with acute respiratory failure * patients with suspect of pneumonia exclusion criteria: * pregnancy * age \< 18 years
proactive evaluation of function to avoid cardiotoxicity

Conditions: Cardiotoxicity; Breast Cancer; Lymphoma; Sarcoma; Leukemia; Myeloma; Lung Cancer

Summary: this study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac mri to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.


Eligibility criteria:
inclusion criteria: * participant in the survive registry * signed informed consent form for proact * histological diagnosis of any cancer type (patients with treated and clinically stable brain metastasis are acceptable) * scheduled to receive anti-cancer therapy (radiation therapy is permitted) exclusion criteria: * contraindication to magnetic resonance imaging (mri) * unable to comply with study investigations (in the judgment of the investigator) * life expectancy less than 1 year * note: if a patient develops a temporary contraindication (e.g. temporary tissue expanders in breast cancer patients) after the baseline mri, follow up mris will be discontinued for safety for the duration in which the patient has the contraindication. however, once the patient is no longer contraindicated to receiving mris, the study schedule may resume with their next scheduled mri time point from the date of enrollment. therefore, some time points may be skipped during the patient's enrollment in the study. also, if a patient needs a repeat mri at any time point for any reason (i.e. panic attack during the mri causing them to not be able to continue, unreadable images, etc.), we may repeat the mri as long as the patient is willing.
futility of exhaled breath condensate ph measurements in ventilated patients in intensive care unit (icu)

Conditions: Ventilator Associated Pneumonia; Death

Summary: measurement of ph in exhaled breath condensate has been mentioned as a robust variable from lung inflammation. it is non-invasive and reproducible. the investigators measured ph in the water condensed in the trap of expiratory arm of ventilator.in icu the investigators measured ph in condensed water without interfering with patients treatment. a group of critically ill patients mechanically ventilated due to non pulmonary cause were followed until successful weaning, death or pneumonia. the investigators found that ph did not change along the study and it did not predict worsening condition.

collection of exhaled breath condensate (ebc) became a promising method for obtaining samples from the lungs. in this prospective clinical trial we aimed to answer if spontaneous ebc in the trap of the expiratory arm of the ventilator could replace ebc collected by coolant chamber with gas standardization with argon as an inert gas. second, if ebc ph could predict ventilator associated pneumonia (vap) and mortality. we included a group of critically ill patients, that required mechanical ventilation due to non-pulmonary cause. the patients were followed up until development of vap, successful weaning or death.ebc ph spontaneously collected in the trap of expiratory arm of the ventilator. we measured ph with a blood gas analyzer, named radiometer abl5 copenhagen. for the coolant chamber ebc ph measurement, the expiratory arm was passed through the chamber at -3ºc and in 10 min at least 2 ml was collected. the rest of the ebc was collected in ependorff tube and ph was measured after de-aeration of the condensate with argon (350 ml/min) for 10 min as a gas standardization procedure as previously described by hunt and colleagues. \[hunt jf, fang k, malik r, snyder a, malhotra n, platts-mills tae, gaston b. endogenous airway acidification: implications for asthma pathophysiology. am j resp crit care med 2000; 161: 694-699. \]

Eligibility criteria:
inclusion criteria: * endotracheal intubation and mechanical ventilation for at least 48 hours due to non-pulmonary cause * for whom their close acquaintances gave the informed consent exclusion criteria: * pregnancy, denied surrogate decision-makers to give informed consent. * patients that required mechanical ventilation due to: pneumonia, severe respiratory infection, massive haemoptysis, acute severe asthma, bronchiectasis, copd exacerbation, or acute lung injury. finally, patients that expected to be ventilated less than 2 days.

Keywords: exhaled breath condensate ph predictive value of ph
role of interleukin-13 pathways on pain and itch sensitivity ( il-13 )

Conditions: Itching

Summary: atopic dermatitis (ad) is as chronic, inflammatory skin disorder affecting 20% of the world's population. intense itch and skin pain are the main symptoms. research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. the medicinal product called lebrikizumab, used for treatment of ad, has shown to block the interleukin called il-13. the purpose of this experiment is to evaluate the role of il-13 in itch in people with atopic dermatitis.

atopic dermatitis (ad) is as chronic, inflammatory skin disorder affecting 20% of the world's population. intense itch and skin pain are the main symptoms. research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens. however, the physiological mechanisms by which il-13 increases the itch sensitivity are unclear. the aim of this project is to use, for the first time in humans, the monoclonal antibody lebrikizumab that inhibits il-13 with high affinity as a novel experimental tool to modulate the il-13 pathway and evaluate its role in the transmission and processing of itch and pain.

Eligibility criteria:
inclusion criteria: * 18-60 years • the patients should have an ad according to diagnosis by a board-certified dermatologist, with an eczema area and severity index (easi), a validated scoring tool that grades the physical signs of ad of at least 7. the project team will be specifically trained and evaluated in the easi assessment to ensure interindividual consistency. exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other drugs moles, wounds, scars, or tattoos in the area to be treated or tested * treatment within two weeks before start of the experiment with topical corticosteroids or calcineurin inhibitors. * treatment within two weeks before start of the experiment with topical treatments (excluding emollients) on the skin areas selected for testing (eight weeks if treated with systemic treatments for ad such as methotrexate or azathioprine) * treatment with antihistamines 72 hours before start of the experiment * previous or current history of neurological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.) * current use of medications that may affect the trial such as antihistamines and painkillers (use of antihistamines must be discontinued 72 hours before the experiment and all topical agents and emollients must be discontinued 24 hours before the experiment). * use of systemic corticosteroids * consumption of alcohol or painkillers 24 hours before the study days and between these * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials) * lack of ability to cooperate
effects of whole body vibration in parkinson's disease symptoms

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to know the effects of an intervention in parkinson's disease symptoms. the main question it aims to answer are: * is whole body vibration able to reduce rigidity in parkinson's participants? * can whole body vibration modify gait abilities and other parkinson's symptoms? participants (subjects with parkinson's disease) will do habitual therapy treatment. experimental group will also carry out whole body vibration sessions and control group will do placebo whole body vibration sessions.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease, in phase i and ii according to hoehn \& yahr phases. * able to maintain independently standing position. * able to understand instructions and score \>24 in minimental test. exclusion criteria: * changes in pharmacological treatment for pd symptoms during the study. * recent injuries in the last 12 weeks in lower limbs or trunk. * other neurological conditions not related to parkinsonism.

Keywords: parkinson disease, whole body vibration rigidity
rixubis drug use-result survey (japan)

Conditions: Hemophilia B

Summary: the purpose of this survey is to understand the following items observed in the actual clinical use of rixubis. 1. unexpected adverse drug reactions 2. occurrence of adverse drug reactions in the actual clinical use 3. factors that may affect safety and effectiveness 4. occurrence of factor ix (fix) inhibitor development in patients with coagulation fix deficiency 5. safety and effectiveness for hemophilia b patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy


Eligibility criteria:
inclusion criteria: * patients with hemophilia b scheduled to receive treatment with rixubis exclusion criteria: * patients not administered rixubis