Kornimate/medical-research-clean huggingface dataset:
effects of minocycline on cytokine levels in severe meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: one of the important factors in obtaining successful outcomes when treating severe meibomian gland dysfunction (mgd) is to control the existing ocular and eyelid inflammation. thus, in previous studies, topical and systemic antibiotics with anti-inflammatory function, such as topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to treat severe mgd. in this study, minocycline which had the fewest side effects was used to evaluate the effect on cytokine levels in severe mgd. at study initiation, all patients completed an ocular surface disease index (osdi) questionnaire and had an ocular surface, tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time (tbut), schirmer test, corneal and conjunctival fluorescein staining, microscopic examination of lid margins and meibomian glands, and tear cytokine levels. all measurements except tear cytokine levels were conducted in the same manner before treatment, after 1 month, and after 2 months of treatment. tear cytokine levels were evaluated before treatment and after 2 months of treatment. the aim of this research was to determine the concentration of inflammatory cytokines in the tears of patients with mgd and to compare the cytokine levels, corresponding clinical responses, and ocular symptoms before and after 2 months of treatment with oral minocycline.


Eligibility criteria:
inclusion criteria: * patients with stage 3 or 4 meibomian gland dysfunction * moderate or marked symptoms of ocular discomfort, itching, or photophobia with limitations of activities * moderate or severe meibomian gland dysfunction clinical signs * mild to moderate conjunctival and peripheral corneal staining or increased conjunctival and corneal staining, including central staining * increased signs of inflammation : moderate or severe conjunctival hyperemia, phlyctenulae exclusion criteria: * history of previous ocular or intraocular surgery * evidence of acute or chronic infections or inflammation of the cornea and conjunctiva * ocular allergy * autoimmune disease * history of intolerance or hypersensitivity to any component of the study medications * use of topical ocular medications * wearing contact lenses during the study period * presence of current punctal occlusion * pregnancy * lactating women * children

Keywords: meibomian gland dysfunction inflammatory tear cytokine minocycline
safety study for bepotastine besilate ophthalmic solution in normal volunteers

Conditions: Allergic Conjunctivitis

Summary: safety study for bepotastine besilate ophthalmic solution in normal volunteers


Eligibility criteria:
inclusion criteria: * subjects must be at least 3 years of age, and have ocular health within normal limits exclusion criteria: * no active ocular disease
tryptophan depletion in acute mania

Conditions: Bipolar Disorder

Summary: serotonin (5-ht) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (md). selective serotonin reuptake inhibitors (ssris) are currently the most widely used drugs for the treatment of depression. patients with bipolar disorder (bd) who are treated for depression with ssris might develop mania, which is believed to be triggered by antidepressant treatment. rapid tryptophan depletion (rtd) has been shown to induce transient depressive symptoms in remitted depressed patients treated with ssris. in remitted manic patients treated with lithium, rtd does not seem to have clinical effects. however, rtd was not studied in acutely manic patients and could theoretically have antimanic properties. in this double blind randomized placebo controlled study rtd will be used as a tool to assess the role of 5-ht in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.


Eligibility criteria:
inclusion criteria: * acute mania * ability to provide written informed consent exclusion criteria: * mixed affective states * suicidal ideation * uncontrolled systemic illness

Keywords: bipolar disorder acute mania tryptophan depletion placebo controlled add-on bipolar disorder- manic type
the effect of liposomal lidocaine on perceived pain in children during percutaneous interosseous pin removal in the outpatient setting

Conditions: Pain

Summary: the removal of smooth, percutaneous pins (perc pins), which are used for fracture fixation, occurs once adequate bone healing has taken place. at the stollery children's hospital (sch), this frequently performed procedure is currently done without anesthetic, making it a painful and uncomfortable experience for the child and their caregiver(s). liposomal lidocaine is a relatively new effective and "needle-free" topical anesthetic. the investigators were interested in examining its effectiveness in pain reduction in children undergoing perc pin removal. objective: to determine if liposomal lidocaine is effective in reducing pain in a pediatric population undergoing perc pin removal compared to a placebo. hypothesis: the investigators hypothesize that liposomal lidocaine would significantly reduce pain during perc pin removal compared to a placebo. research design: this was a triple-blinded, randomized placebo-controlled clinical trial with 281 patients (140 patients each in the maxilene and 141 in the placebo groups). pain measurements, using the oucher scale (children) and a 10-cm visual analog scale (parents and caregivers) were collected prior to randomization and immediately after perc pin removal. data was analyzed using a student's t-test and the wilcoxon signed ranks test.


Eligibility criteria:
inclusion criteria: * children between 3 and 16 years of age (i.e. up to but not including the 17th birthday) who present to the pediatric plaster room at the sch for perc pin removal were eligible for inclusion in this study. exclusion criteria: * any patient with perc pins that are threaded (not smooth), as these pins require a more difficult removal process, oftentimes in the operating room instead of the orthopedic clinic. * infection around the perc pins: this is considered a relative contraindication to the use of topical anesthetic as it is usually less effective in this situation. * any parents/patients unable to exhibit understanding of the oucher/vas -- due to language barriers or developmental delay in the patient (e.g. severe cerebral palsy). * the presence of an open wound in the vicinity of the pins that could not be excluded from the area to which the topical anesthetic cream is to be applied. * present use of analgesic or anxiolytic medications (within 24 hours prior to pin removal) * known allergies or adverse reactions to maxilene

Keywords: patients aged 3 to 16 years presenting for removal of smooth percutaneous interosseus pins after orthopeadic surgery
minimally invasive esophagectomy (mie) in prone versus left decubitus position

Conditions: Esophageal Cancer; Esophagectomy

Summary: the purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of minimally invasive esophagectomy (mie). * comparing morbidities from the two groups * comparing short-term quality of life from the two groups * comparing oncological results (3,5 year survival) from the two groups

thoracoscopic esophagectomy is routinely performed in two positions. the left decubitus position is the most commonly used position at most centers. however prone position is another alternative. the left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .however, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. they are regarded as potential causes leading lung injury. prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. but it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. a longer learning curve may be needed. a few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. until now, no prospective randomized study has been carried out in this field.

Eligibility criteria:
inclusion criteria: * clinical stage i/ii esophageal cancer * normal blood test of basic metabolism panel * pulmonary function: fev1 \> 1.2l, fev1% \> 50%, dlco \> 50% * heart function: ny grade i and grade ii * sign informed consent exclusion criteria: * patients who received neoadjuvant therapy * mental disorders

Keywords: minimally invasive esophagectomy
evaluating the effects of eecp on circulation, blood glucose level and blood pressure in type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this proposed department of defense study is to evaluate the effect of enhanced external counterpulsation (eecp) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving eecp therapy.


Eligibility criteria:
inclusion criteria: 1. age equal to or greater than 18 2. diagnosis of type 1 or type 2 diabetes mellitus 3. prescribed eecp therapy in the dgmc eecp clinic 4. medically cleared for eecp therapy 5. tricare beneficiary exclusion criteria: 1. dgmc eecp clinic patient withou a diagnosis of type 1 or type 2 diabetes mellitus

Keywords: hypertension diabetes mellitus hemoglobin a1c peripheral vascular resistance eecp blood pressure angiogenesis coronary artery disease coronary disease heart diseases cardiovascular diseases
icotinib at different doses in second-line treatment for non-small cell lung cancer patients with wild type egfr

Conditions: Non-small Cell Lung Cancer

Summary: this study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.


Eligibility criteria:
inclusion criteria: * recurrent or progressive non-small cell lung cancer stage iv or iiib patients with histologic or cytologic confirmation. * wild type epidermal growth factor receptor status. * progressed after first-line chemotherapy. * no previous systemic anticancer therapy. * measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated. * provision of written informed consent. exclusion criteria: * evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * positive epidermal growth factor receptor mutation. * known severe hypersensitivity to icotinib or any of the excipients of this product. * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
safety issues of peribulbar injection of uc-msc in patients with retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the study will perform uc-mscs and cm transplantation. the first group will be injected by ucmsc+nacl. the 2nd group will be injected by uc-msc+cm. the 3rd group will be injected by cm. each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of uc-msc is 1 million cells for each subject. all groups will be observed until 6 months.

the eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. sterile cover attached to other parts of the face except for the eyes. 1.8 ml cell preparations are suspended in physiological nacl until it reaches a total of 2 ml volume of cell suspension (for uc-msc + nacl group). stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. on day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of eye pressure. on day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and optical coherence tomography examination. the observation results will be written in the observation table and analyzed by a statistic. after the data was completed, then make a discussion, conclusion, and suggestion of the study.

Eligibility criteria:
inclusion criteria: * visual field defects at initial examination with humhprey perimetry are between 25% to 50% * willing to sign informed consent as research subjects * willing to do peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue * willing to do visual field checks with humphrey's perimetry, vision tests with snellen boards, optical coherrent tomography (oct) examinations, electroretinogram examinations and fill out a quality of life questionnaire exclusion criteria: * pregnant or nursing women * positive result of hiv test * have a history of eye tumors * in immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells * have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma * do not come to control according to the schedule determined by the researcher (loss to follow up)

Keywords: allogeneic mesenchymal stem cell umbilical cord mesenchymal stem cell conditioned medium allogeneic umbilical cord mesenchymal stem cell
concurrent chemoradiation with or without dc-cik immunotherapy in treating locally advanced esophageal cancer

Conditions: Esophageal Carcinoma

Summary: the purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (cik) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.


Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed locally advanced esophageal carcinoma * age: \> 18 * karnofsky performance status ≥ 70 * at least one measurable tumor lesions according to the recist criteria. * normal functions of heart, lung, liver, kidney and bone marrow * blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/l and platelet (plt) ≥100×109/l, creatinine ≤1.5 unl * informed consent signed exclusion criteria: * patients with metastatic disease in the central nervous system (cns). * patients who are pregnant or nursing. * patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable * patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis * coexisted morbidities that investigators believed not suitable for chemoradiation

Keywords: locally advanced esophageal carcinoma dc-cik immunotherapy
safety and efficacy of bay1192631 in japanese patients with methicillin-resistant staphylococcus aureus (mrsa) infections

Conditions: Skin Diseases, Infectious

Summary: the aim of this study is to see the efficacy and safety of bay1192631 in japanese patients with methicillin-resistant staphylococcus aureus (mrsa) (skin and soft tissue infections (ssti) and ssti-related bacteremia).


Eligibility criteria:
inclusion criteria * suspected or confirmed methicillin-resistant staphylococcus aureus (mrsa) infection * japanese male and female patients aged 18 years or above * diagnosis of skin and soft tissue infection with mrsa either suspected or confirmed as the major cause of infection, with/without ssti (skin and soft tissue infection)-derived mrsa bacteremia suspected exclusion criteria: * having received any systemic antibacterial potentially effective against mrsa for \>/=24 hours within 3 days prior to the first infusion of a study drug, or having received/expected to receive the medication within 24 hours prior to the first infusion, unless antibacterial therapy for \>/=72 hours proves to be ineffective on or lack appropriate potency (resistant) to mrsa. * moribund clinical condition such as death likely within the first 3 days of a study drug treatment * history of significant allergy or intolerance to linezolid or bay1192631 * known or suspected human immunodeficiency virus (hiv) infection with a cd4+ t-cell count \< 200/μl * chronic treatment with immunosuppressive drugs * active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments * current or anticipated neutropenia with neutrophil count \< 1,000/ mm\^3 * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>/= 8 times the upper limit of reference range or moderate to severe hepatic disease with child pugh score \>/=10.

Keywords: methicillin resistant staphylococcus aureus, skin and soft tissue infection, bacteremia, tedizolid
absorption, distribution, metabolism and excretion study for gsk221149a

Conditions: Obstetric Labour, Premature; Premature Labor

Summary: this is a phase one study investigating the absorption, distribution, metabolism and excretion of gsk221149a in six healthy women of non-child bearing potential.


Eligibility criteria:
inclusion criteria: * healthy adult, non-smoking females * aged between 30 - 55 years old, and bmi of between 19 and 32 * not of child-bearing potential exclusion criteria: * no clinically significant findings on clinical examination, medical examination and blood tests. * radiation exposure over previous 3 years is greater than 10msv * history of bleeding or gastric problems

Keywords: absorption, metabolism, excretion distribution,
prognosis related to induced thrombopenia with heparin under venoarterial ecmo in reanimation

Conditions: Heparin-induced Thrombocytopenia

Summary: thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (va-ecmo) for refractory cardiogenic shock. similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (hit) could represent the causative underlying mechanism. however, the epidemiology as well as related mortality regarding hit and va-ecmo remains largely unknown. the investigators aimed to define the prevalence and associated 90-day mortality of hit diagnosed under va-ecmo.this retrospective study included patients under va-ecmo from 20 french centers between 2012 and 2016.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ecmo-va * ecmo-va duration ≥ 3 days * hit confirmed by immunological tests * patient affiliated to a social security scheme exclusion criteria: * known antecedent of tih prior to cannulation * pregnant woman * ecmo-va following cardiopulmonary arrest or septic shock
clinical score usefulness and ehr integration

Conditions: Sepsis

Summary: the sofa score is a severity of illness and prognostic score used in the icu. it has also recently been adopted as part of the definition of sepsis. this study will prospectively evaluate the usability of automated sofa scoring for icu patients within an electronic patient monitoring dashboard. it will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.


Eligibility criteria:
inclusion criteria: * patients admitted to the medical intensive care unit within 2 months of automated sofa scoring module activation. exclusion criteria: * refusal to allow medical records to be used for clinical research.

Keywords: sepsis sofa score automated calculation
rapid acclimatization to hypoxia at altitude

Conditions: Physiological Function in Low Oxygen Environment

Summary: in low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). the purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. the drugs are methazolamide and aminophylline.


Eligibility criteria:
inclusion criteria: * normotensive (i.e. \<140/90 mmhg) exclusion criteria: * pregnancy * nursing mother * current tobacco use or regular use within the previous two years * use of prescription medication other than birth control * asthma or any other type of lung/respiratory dysfunction * resting oxygen saturation \<95% * unwillingness to abstain from exercise for 48 hours prior to laboratory testing * use of anticoagulant therapy or have a known or suspected bleeding disorder * identification of contraindication during screening (i.e. positive stress test) * any history of mountain sickness (altitude sickness) * any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives * history of clinically significant illness within 4 weeks prior to day 1 * subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1 * receipt of a transfusion or any blood products within 30 days prior to visit 1.

Keywords: hypoxia altitude exercise
long-term follow-up study of patients receiving onasemnogene abeparvovec-xioi

Conditions: Spinal Muscular Atrophy Type I; Spinal Muscular Atrophy Type II; Spinal Muscular Atrophy Type III; SMA

Summary: this is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (sma) who were treated with onasemnogene abeparvovec-xioi. participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.


Eligibility criteria:
inclusion criteria: * any participant with sma who received onasemnogene abeparvovec-xioi gene replacement therapy in a novartis gene therapies-sponsored clinical study * participant/parent/legal guardian willing and able to complete the informed consent process and comply with study procedures and visit schedule exclusion criteria: * parent/legal guardian unable or unwilling to participate in the long-term follow-up safety study

Keywords: gene replacement