Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of a monovalent conjugated vaccine against haemophilus influenzae type b

Conditions: Haemophilus Influenzae Type b

Summary: this study will investigate safety and immunogenicity of a monovalent conjugated vaccine against haemophilus influenzae type b in healthy children aged 2 to 4 months in china.


Eligibility criteria:
inclusion criteria: * infants of either sex, aged 2 - 4 months * in good health as determined by: * medical history * physical examination * clinical judgment of the investigator; * available for all visits scheduled in the study and able to comply with all study regulations * for whom written informed consent has been obtained from at least one parent or legal guardian exclusion criteria: * parent or legal guardian is unwilling or unable to give written informed consent to participate in study * infants who have received any other haemophilus influenzae type b immunization dose before * infants who presented a previous disease potentially related to haemophilus influenzae type b * infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained haemophilus influenzae type b disease * premature (before 37th week of gestation) or birth weight less than 2500 g * history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component * fever ≥ 38.0 °c (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment * subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease * known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder * subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder * subjects with a clinically significant genetic anomaly * treatment with corticosteroids or other immunosuppressive drugs * any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives * any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the chinese routine vaccination program. * participation in any other investigational trial simultaneously * planned surgery during the study period * any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective

Keywords: vaccine prevention haemophilus influenzae type b children
efficacy of antibiotic treatment for patients with chronic low back pain and modic type i changes - randomized placebo-controlled trial

Conditions: MSK Conditions; Chronic Low Back Pain (CLBP); Modic Changes

Summary: the goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. in some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "modic type i change." the main questions the trial aims to answer are: * what is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and modic type i changes? * what is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and modic type i changes? researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain. participants in the trial will: * be invited for an mri scan to determine if they have a modic type i change; those who do will be included in the study. * take either amoxicillin or a placebo daily for 100 days. * take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics. * attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests. * complete questionnaires at baseline, 3 months, 6 months, and 12 months.


Eligibility criteria:
inclusion criteria: * aged 18-65 years. * chronic low back pain (i.e. duration \>6 months) after a previous (mri confirmed) disc herniation within the past 6 months to 2 years. * at least 2 of the following questions should be answered with "yes": * does training and/or exercise increase your pain? * is your sleep during the night disturbed due to your back pain? * is it painful to turn over in bed at night? * do you suffer from morning pain? * the mean pain intensity should be at least 5 points on a 0-10 nrs-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks. * modic type i changes visible on the mri-scan in the vertebrae adjacent to the previous herniated disc. exclusion criteria: * received antibiotic treatment in the past month. * current pregnancy, lactation or pregnancy-wish. * severe physical or psychiatric co-morbidities. * lbp resulting from a specific cause such as a tumor or fracture. * surgery or epidural injection in the past 6 months. * previous antibiotic course of 100 days. * contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (pku) * contra-indication for mri. * current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid. * hepatic or renal (egfr≤30) impairment. * inability to swallow capsules.

Keywords: antibiotics amoxicillin low back pain (lbp) modic changes randomized controlled trial
pilot study: is overactive bladder caused by subacute urinary tract infections?

Conditions: Overactive Bladder

Summary: the purpose of this study is to look for evidence of bacteria in the urine or bladder of people with overactive bladder. because you do not have overactive bladder, your participation in this study will be used as a comparison to those who have overactive bladder.


Eligibility criteria:
inclusion criteria: * urge urinary incontinence based on clinical history and bladder diary; subjects must have 3 or more urge incontinence episodes/day and 10 or more voids/day. * 21 years or older * healthy volunteers for control subjects exclusion criteria: * active cystitis performed on a catheterized urine specimen * known or suspected correctable etiology for her urge incontinence * history of urinary tract stones, foreign bodies or malignancy * history of recurrent urinary tract infections * pregnant women, children * evidence of urge urinary incontinence or more than 1 episode of stress incontinence/day by control subject
determinants of functional ability, perceived health, and interaction with multimorbidity in hip and knee osteoarthritis

Conditions: Osteoarthritis

Summary: hip and knee osteoarthritis (oa) is an important health problem with a high prevalence and significant consequences on functional ability, perceived health, restriction of autonomy and handicap. the weight of multimorbidities and their interaction on functional ability and perceived health are left unexplored. this project will rely on the cohort khoala, representative, multiregional, of 881 prevalent cases (symptomatic hip and knee oa). main objective: * to describe the evolution over time of pain, functional ability, social participation and quality of life in subjects with hip and knee oa * to identify prognosis factors of disease evolution (socio-demographic, clinical, and other health parameters) * to determine interactions with comorbidities, other personal and environmental factors (icf model). concurrent objective: to improve measurement of perceived health specific to hip and knee oa by the oakhqol by improving its metrologic performances based on item response theory. task 1: to prepare an improved measurement scale, available as a judgment criteria for the 3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-oakhqol task 2: evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design to best assess the evolution of perceived health and functional ability over time, and to identify stability of deterioration of autonomy. perspectives: this project targets to provide public health deciders with information of good quality to help them manage determinants of perceived health in oa subjects, as essential factors to health care resource utilization in their various modalities.


Eligibility criteria:
inclusion criteria: * hip or knee osteoarthritis (tibiofemoral), uni or bilateral, symptomatic, with confirmed diagnosis according to american college of rheumatology acr and european league against rheumatism (eular) * kellgren and laurence radiological stage at least 2 exclusion criteria: * knee or hip prosthesis on painful joint * preceding osteotomy * serious comorbidity (affecting quality of life, or leading to a high care consumption) * according to x-ray : knee pain with isolated patello-femoral osteoarthritis (i.e without an associated tibiofemoral osteoarthritis) * other pathology on knee or hip * adults getting a legal protection or with the incapacity to give their consent

Keywords: health determinants epidemiology maintaining autonomy psychology osteoarthritis perceived health
lung volume change between noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula

Conditions: Respiratory Failure

Summary: the difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.

electrical impedance tomography can effectively monitor the lung volume change in icu patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. continuous positive airway pressure (cpap) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . however, the extent of lung volume change or functional residual volume (frc) change by using these two devices were never surveyed before in extubated patients. the investigators will check end-expiratory lung volume (eelv) ,anterior, medio-anterior, medio-posterior and posterior eelv by electrical impedance tomography after use of these two devices in extubated patients.

Eligibility criteria:
inclusion criteria: * \>20 y/o * any extubated patients after tolerating spontaneous breathing trial exclusion criteria: * presence of tracheostomy * recent facial trauma * active gastro-intestinal bleeding * do-not-intubate status and * planned use of bipap after extubation. * patients with unstable spinal lesions or fractures. * bmi\> 50 * patients with a cardiac pacemaker * burn injury with skin defect

Keywords: electrical impedance tomography nasal pillow continuous positive airway pressure(cpap) high flow nasal cannula extubation
to investigate the prevalence of children asthma in china

Conditions: Asthma

Summary: asthma is the most common chronic respiratory disease in children and has much effect on their life and study, which leads to huge economic burden and pressure to the whole families. some children will develop into adult patients so that asthma can be the life-long vigorous trouble. in recent years, the prevalence rate of children asthma is increasingly going up worldwide. the prevalence rate in last 12 months reported in usa, united kingdom, australia, new zealand was between 12% to 30%. center for asthma prevention and education of capital institute of pediatrics investigated the national asthma prevalence in 900 thousands children in 27 provinces and cities, which average rate was 0.11% to 2.03% in 1990. in 2000, we investigated it again in 31 provinces(43 cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%) which was much higher than that in 1990.

1. objectives 1. to investigate the national children(0-14 years old)asthma prevalence; 2. to compare the prevalence rate between that in 1990 and 2000; 3. to analyse the asthma manifestations including the ages, seasons, causes, trigger and hereditary factors and their impact on the asthma patients, families and society; 4. to identify the risk factors by questionnaires in case-control research. 2. study design / clinical plan 1. the screening stage: to distinguish suspected asthma from the children age from 0 to 14 years old. 2. to obtain identified asthma from the suspected asthma. 3. to evaluate the prevalence and severe degree of 0 to 14-year-old children asthma and gain the main risk factors by case-control research.

Eligibility criteria:
inclusion criteria: * children age from 0 to 14 years exclusion criteria: * none
the influence of tramadol on platelet function

Conditions: Drug Toxicity; Platelet Dysfunction; Clotting Disorder

Summary: the aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.

the aim of this study is to quantify the effect of tramadol on platelet aggregation. to this end, the effect of tramadol on platelet function will be demonstrated in an ex-vivo study using optical aggregometry (lta) on whole blood of 15 patients. the main objective variable is to use platelet function assays (lta) as well as thrombelastography (teg) to determine this effect on platelet function. the null hypothesis of this study is that tramadol does not affect platelet aggregation in healthy patients. in addition, two further questions will be addressed: * using a titration series, to attempt to plot a dose/response curve of the effect of tramadol on platelet function. * tramadol is often administered together with other drugs such as nsaids (ibuprofen), novalgin, ssris or other opioids such as morphine or in the surgical setting fentanyl and remifentanil. a series of studies will be conducted to determine whether these combinations alter the effect of tramadol on platelet function.

Eligibility criteria:
inclusion criteria: * 18y and older, healthy volunteers exclusion criteria: * age \< 18 years * pregnant women * history of addiction (especially opiate abuse) * pre-existing general addictive disease * ongoing pain therapy with opiates * taking antidepressants (snri, ssri) * history of thrombocytopathy or coagulation disorders * therapy with drugs that influence thrombocyte function (ass, clopidogrel, prasugrel, ticagrelor or similar) * known intolerance to opiates
evaluation of etafilcon a daily disposable lenses

Conditions: Myopia

Summary: to evaluate the clinical performance of daily disposable etafilcon a lenses.


Eligibility criteria:
inclusion criteria: * the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * the subject must be at least 18 and not more than 70 years of age. * the subject's refractive cylinder must be \< 1.00 diopters (d) in each eye. * the subject must have best corrected visual acuity of 20/25 or better in each eye. * the subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 d in each eye. * the subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes. * the subject must self-report their race as asian * the subject must have normal eyes (i.e., no ocular medications or infections of any type). * the subject must demonstrate adequate mobility and 20/30 vision oculus dexter (od) and oculus sinister (os) with the study contact lenses. exclusion criteria: * currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). * any ocular or systemic allergies or diseases that may interfere with contact lens wear. * any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. * entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia. * any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (prk), laser in-situ keratomileusis (lasik), etc.). * any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the fda classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * monovision or multi-focal contact lens correction. * participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. * history of binocular vision abnormality or strabismus. * any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., hiv, by self report). * suspicion of or recent history of alcohol or substance abuse. * history of serious mental illness. * history of seizures. * employee of investigational clinic (e.g., investigator, coordinator, technician)
usefulness of contrast enhanced harmonic endoscopic ultrasound for pancreatic cysts

Conditions: Pancreatic Cyst

Summary: the study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (ch-eus) for the differentiation of the pancreatic cysts and their malignant potential.

due to the increase use of cross-sectional imaging techniques for varied medical conditions more and more pancreatic cysts are incidentally found. magnetic resonance imaging revealed a prevalence of incidental pancreatic cystic neoplasm (pcn) in adults between 2,4-49,1% and autopsy studies showed that half of the individuals had pancreatic cysts. there is a great variety of pancreatic cysts, they are mainly divided in neoplastic or non-neoplastic (i.e pseudocyst). pseudocysts appear after acute or chronic pancreatitis and represent only 20% of all pancreatic cysts.. pcn include a diverse group of pancreatic cysts including mucin-producing (intraductal papillary mucinous neoplasm (ipmn), mucinous cystic neoplasm (mcn)) and nonmucin-producing lesions (serous cystadenoma (scn), solid pseudopapillary neoplasm(spn) cystic neuroendocrine tumor(cnet)) with different morphology and progression to malignancy. spn's,cnet are considered premalignant or malignant conditions and require surveillance or surgical resection. scn instead are benign and surveillance is not necessary. resection is considered only if symptoms are present. the discrimination between the different cyst types is crucial for the therapeutic approach. their morphology can be similar and sometimes it's a challenge to diagnose them.there are many tools but none is good enough to be used alone. contrast-enhanced harmonic endoscopic ultrasound using low mechanical index (0.12-0.4) is an additional test to assess the vascularization of the cystic wall and the septa and solid component for the differential diagnosis of pcn. our aim was to identify specific imaging characteristics using ch-eus in order to increase the diagnostic accuracy for potential malignant pancreatic cysts.

Eligibility criteria:
inclusion criteria: * presence of an undetermined pancreatic cyst \>10mm (computer tomography, magnetic resonance imaging); * written informed consent. exclusion criteria: * platelet count under 50.000 platelets per microliter (mcl) * patients with cardiorespiratory instability * refuse of the patient to participate.

Keywords: contrast-enhanced harmonic endoscopic ultrasound (ch-eus) eus-fna pancreatic cyst pancreas
a comparison study of two respiratory physical therapy methods and standard medical treatment for treating copd patients during acute exacerbation

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Summary: one of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs. chronic obstructive pulmonary disease (copd) patients are often hospitalized with an acute exacerbation of their medical condition. those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment. the study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay. in order to do so we will compare three groups of copd patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or intrapulmonary percussive ventilator (ipv) in addition to standard medical care and the third group will get standard medical care alone.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute exacerbation of copd or acute exacerbation of chronic bronchitis * respiratory rate\>25 * paco2\> 45 mmhg * 7.35 \< ph \< 7.38 exclusion criteria: * intubation * apnea * glasgow coma scale \< 8 * pneumothorax * fev1 \< 50% predicted * ischemic hearth disease
smartphone utilization for glucose monitoring and antenatal reporting

Conditions: Gestational Diabetes; Pregestational Diabetes

Summary: this project will utilize mhealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.

this will be a prospective single center randomized trial piloting the use of mhealth applications in an obstetric population with diabetes. participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. participants will be randomized to traditional care or mhealth intervention. outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in hemoglobin a1c.

Eligibility criteria:
inclusion criteria: * pregnant, english speaking, diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees urmc obgyn for obstetric care in pregnancy. exclusion criteria: * not english speaking, does not have smartphone, unable to consent.