Kornimate/medical-research-clean huggingface dataset:
safety of rg2077 in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: multiple sclerosis (ms) is an autoimmune disorder. in this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. this study will test the safety of a new drug called rg2077 that is designed to treat ms. the study will not determine whether rg2077 is effective in treating ms, only whether it is safe to use in patients with ms. study hypothesis: rg2077 will arrest ms if administered early in the course of ms and decrease accumulation of lesions on mri.

effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. rg2077 may block a t cell costimulation pathway central to the pathophysiology of ms. a total of 20 patients with ms will be enrolled in this study. each patient participates in the study for 4 months. the dose-escalation portion of this study evaluated the safety of a single infusion of rg2077 (ctla4-igg4m) in 16 patients with ms and is now complete. patients who participated in the single infusion portion of the study were assigned to one of four groups. each group received a different dose of rg2077. the second portion of the study will evaluate the safety of 4 doses of rg2077 in 4 additional patients. in the multiple infusion portion of the study, all patients will receive the same dose of rg2077. patients will be monitored for possible side effects of rg2077.

Eligibility criteria:
inclusion criteria * confirmed diagnosis of ms, defined as an mri consistent with ms plus two separate clinical events, or one clinical event and mri consistent with demyelination plus a second mri demonstrating new lesions * have declined all fda approved therapies for ms

Keywords: ataxia mri ms ctla4-igg4m costimulatory signals autoimmune disorders
different crystalloid coload volumes on the 90% ed of norepinephrine

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. in addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. the purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥180 mmhg * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine postspinal anesthesia hypotension coload cesarean section
comparison of 133xe scintigraphy with 19f mri

Conditions: Lung Diseases

Summary: the central hypothesis and current observation is that pfx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. this is a pilot proof of concept study to demonstrate the non-inferiority of 19f mri gas ventilation imaging compared to 133xe ventilation scintigraphy in subjects with lung disease. the secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19f mri gas ventilation imaging compared to 133xe ventilation scintigraphy

aim 1: compare measures of lung ventilation performance obtained using 133xe scintigraphy with performance using 19f perfluorinated gas mri using two independent readers. 133xe scintigraphy will be scored using the methods described in the statistics section and 19f images will be scored using the methods described in the statistics section. scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent. the outcomes of the work proposed is expected to show the non-inferiority of 19f perfluorinated gas mri to 133xenon scintigraphy

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial 1. outpatients of either gender, age \> 18. 2. willing and able to give informed consent and adhere to visit/protocol schedules. (consent must be given before any study procedures are performed.) 3. women of childbearing potential must have a negative urine pregnancy test. this will be confirmed before participation in this investigational protocol. 4. completion of 133xe ventilation scintigraphy after referral for ventilation imaging for any reason in pro00081987 a comparison of technegas® and xenon 133 planar lung imaging in subjects referred for ventilation scintigraphy. the mri will be accomplished in a timely fashion after the scintigraphy study based on scheduling availability in the center for advanced magnetic resonance development (camrd). exclusion criteria: subjects presenting with any of the following will not be included in the trial: 1. conditions that will prohibit mri scanning (metal in eye, claustrophobia, inability to lie supine)

Keywords: 19f mri gas ventilation 133 xe ventilation scintigraphy
observational study to evaluate the real-life effectiveness of benepali following transition from enbrel

Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis

Summary: the primary objective is to evaluate the effectiveness of benepali in participants with rheumatoid arthritis (ra) and axial spondyloarthritis (axspa), including participants with ankylosing spondylitis (as) and non-radiographic axspa, following their transition from treatment with enbrel. the secondary objectives of this study are to describe clinical characteristics of patients transitioned from enbrel® to benepali® in routine practice, to evaluate safety during and following the transition from enbrel to benepali and to evaluate patient-reported outcomes during and following the transition from enbrel to benepali.


Eligibility criteria:
key inclusion criteria: * must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice * transition from enbrel to benepali at the physician's (investigator's) discretion prior to enrolment into the study * must have been treated with the same dose of enbrel for at least 6 months prior to transition to benepali and have at least 1 efficacy data value including but not restricted to das-28 or basdai during that period * must have a stable disease throughout the 2 month prior to enrolment based on the investigator's judgement * women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during benepali therapy and for three weeks after discontinuation of therapy key exclusion criteria: * have any medical conditions that precludes administration of benepali according to summary of product characteristics (smpc), such as the following: * hypersensitivity to the benepali active substance, or to any of the associated excipients * sepsis, or risk of sepsis * active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment * show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the investigator * treatment with another biologic agent * are currently receiving or have previously received any therapies that would preclude administration of benepali, such as the following: * immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period * treatment with investigational agents within the last 6 months prior to transition point and during the period of observation. * any other unspecified reasons that would, in the opinion of the investigator, make the patient unsuitable for enrollment. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: observational biosimilar etanercept benepali enbrel
comparison of thermometry in canada for pediatrics

Conditions: Healthy; Febrile Illness

Summary: compare and assess the accuracy and reliability of the instatemp md® device to techniques presently in use for measuring temperature in infants and children in a canadian clinical setting.

this study is designed as a multi-center study. this study will involve collecting temperatures on patients using the instatemp md® device and the traditional method used in the clinical setting. reliability and agreement of the instatemp md® will be compared to the current canadian paediatric society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children.

Eligibility criteria:
inclusion criteria: * children age 1 month to ≤ 10 years old * male or female * subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed * subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent exclusion criteria: * subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures * subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes. * subjects with signs or recent history of inflammation or infection of the forehead or at the reference clinical test site. * subjects currently using cooling blankets or fans * subjects with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for instatemp md and definitive comparator (e.g. rectal or oral) measurements. * subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead) * subjects currently alcohol intoxicated * subjects with documented illicit durg use in the previous 5 days * subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading * subject is taking any medication that in the opinion of the investigator may alter the temperature of the child * subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.
evaluation of store-and-forward teledermatology versus a face-to-face assessment during a skin cancer screening event

Conditions: Skin Cancer; Screening; Telemedicine

Summary: the purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event. the investigators' hypotheses include the following: 1. compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance. 2. compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance. 3. the sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.


Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of consent, may be male or female. * able to provide a brief medical history and have/allow an examination of their skin including photographs. * capable of giving informed consent. * will be able to receive notification of follow-up recommendations exclusion criteria: * patients who will not provide informed consent * patient who are unable to fulfill tasks of this study

Keywords: skin cancer teledermatology screening store-and-forward
fevertext: assessing fever rates after vaccination during the 2011-12 influenza season using text messaging

Conditions: Fever

Summary: in this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (tiv) and 13-valent pneumococcal conjugate vaccine (pcv13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (tiv) or 13-valent pneumococcal conjugate vaccine (pcv13) administered non-concomitantly. the investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (tiv) and 13-valent pneumococcal conjugate vaccine (pcv13) are given concomitantly than when tiv or pcv13 is administered non-concomitantly.


Eligibility criteria:
inclusion criteria: 1. are 6 through 23 month olds, 2. have a visit at a study site during the study period of nov. 1, 2011 through march 31, 2012, 3. receive trivalent inactivated influenza vaccine (tiv)/13-valent pneumococcal conjugate vaccine (pcv13)concomitantly, trivalent inactivated influenza vaccine (tiv)/without 13-valent pneumococcal conjugate vaccine (pcv13) or 13-valent pneumococcal conjugate vaccine (pcv13) without trivalent inactivated influenza vaccine (tiv)/(4) parent has a cell phone with text messaging capabilities; and (5) parent speaks english or spanish. exclusion criteria: 1. presence of fever \>=100.4 at time of vaccination; 2. administration of any antipyretic in the 6-hour period prior to vaccination 3. stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever; 4. stated intention to move away from the nyc area \<6 month; 5. parent only speaks a language other than english or spanish; 6. inability to read text messages; 7. children who received live attenuated influenza vaccine (laiv) this visit; 8. children who received trivalent inactivated influenza vaccine (tiv) or 13-valent pneumococcal conjugate vaccine (pcv13) in the seven days prior to enrollment date note: patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (tiv)/13-valent pneumococcal conjugate vaccine (pcv13)
comprehensive risk assessment and prevention plan of osteoporosis and sarcopenia for the elderly participating in community-based long-term care services

Conditions: Osteoporosis; Sarcopenia; Frailty

Summary: the purpose of this project is: 1. provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas. 2. screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia 3. construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas

detailed description: investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups: 1. screening group: inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment. 2. multi-disciplinary team intervention group: introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion. 3. control group (delayed intervention): receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. after two year's follow-up, multi-disciplinary team intervention service will be implemented.

Eligibility criteria:
inclusion criteria: * age≥ 50 old and lived in the community exclusion criteria: * life expectancy less than two years

Keywords: osteoporosis sarcopenia quality of life intrinsic capacity frailty
of androgen receptor expression in breast cancer with or without brca mutation

Conditions: Breast Cancer

Summary: androgen receptor is extensively expressed in brca and its role in the disease may differ depending upon molecular subtypes and stages. androgen receptor (ar) may act as an antagonist of estrogen receptor α (erα), in erα induced effect, whereas in the absence of estrogens, ar may act as an agonist, of erα- promoting tumor. thus, depending on the brca micro-environment, both agonists and antagonists of the ar have been suggested for therapeutic approaches.

the rate of ar positivity in breast cancer is about 60% to 80%. biologically the ar pathway has cross talk with several other key signaling pathway, including the pi3k/akt/mtor and mapk pathways, and with other receptor, including estrogen receptor and human epidermal growth factor receptor-2. in clinical trials in patients with breast cancer, ar targeted therapies such as ar agonists, ar antagonists, parp inhibitors, and pi3k inhibitors have shown promising results. the use of ar targeted therapies in conjunction with other agent has been investigated for overcoming resistance to ar focused treatments. thus, the value of ar positivity as a prognostic marker has not been identified. several retrospective clinical studies have shown that ar might be a prognostic or predictive factor in breast cancer. brca1 mutation accounts for the progress of hereditary breast cancers and is in connection with unique clinicopathological characteristics compared with sporadic breast cancers. the database is still evolving and newer mutation and their significance is being found every day. also, there were several limitations to these previous studies. first, the cut-off for ar positivity was arbitrary. in most of the studies, the cut-off points were 1% or 10% and weren't enough to predict carcinoma survival. moreover, quite 90% of the studies were conducted in non-asian regions. most of the studies involving asian patients studied the prognostic role of ar in tnbc patients, with inconclusive results. there are only a few studies from indian continents and none has correlated the ar expression with brca. after the written inform consent in case of fresh recruitment the blood will be collected and tissue blocks will be obtained, use of already available blocks of patients who earlier participated in another study is also proposed. (a) samples will be stored for dna study and will be frozen in liquid nitrogen and stored at -80 °c until further processing. (samples will store in 10% formalin at room temperature (rt) for immunohistochemistry

Eligibility criteria:
inclusion criteria: * histology proven cases of breast cancer exclusion criteria: * patients with prior treatment * pregnant and lactating women
an investigation of ball rolling effects on trigger points

Conditions: Trigger Point Pain, Myofascial

Summary: the current study aims to examine the potential effects of rolling a myostorm ball on the trigger points in the upper back muscles.

the investigators will ask the participants to attend the laboratory in two sessions. they will seek the tender spots on the trapezius muscle. then the participants will be asked to roll a myostorm ball ( a small hard ball made of plastic with a layer of soft material cover) on their affected muscles. they will be tested for pain-pressure threshold (ppt), shoulder range of motion, electromyography (emg), and force before and after the manipulation.

Eligibility criteria:
inclusion criteria: * trigger points on the trapezius muscle exclusion criteria: * back injury
telaxman - laser lithotripsy with automatic real-time stone recognition

Conditions: Lithotripsy, Laser

Summary: urolithiasis is an extremely common disease affecting about 12% of the world population with increasing tendency. urinary stones are sediments that form in the kidney from crystals, such as calcium oxalate. currently, urological endoscopy with laser lithotripsy represents the leading and most frequently used method for the treatment of urinary stones of different localization, size and composition. surgical urology, including interventional stone treatment, is highly inﬂuenced by technology. with regard to fragmentation properties and effectiveness for all stone types holmium:yttrium-aluminium-garnet (ho:yag) laser lithotripsy has become the standard technology to disintegrate urinary calculi. in addition, other kinds of lasers are emerging, such as the thulium fiber laser (tfl); a new solid-state, diode-pumped laser that may provide urologists with increased options for stone treatment. while urolithiasis treatment in general and laser lithotripsy in specific rarely goes along with major complications, recent studies have shown that there are possible indirect risks to the treatment with lasers, such as thermal damages to the urinary tract even at low-power settings if inadequate irrigation is applied. sufficient irrigation is mandatory to perform safe ho:yag laser lithotripsy. the revolix htl+ automatic real-time stone detection module was developed to overcome these limitations and improve the safety of the patient with regard to potential thermal damages. the objective of this clinical investigation is to assess the feasibility of stone recognition and disintegration with the revolix htl+ in clinical conditions and to identify hypotheses to be used in future clinical investigations.


Eligibility criteria:
inclusion criteria: * subject scheduled for laser lithotripsy * subject aged 18 or older * subject able to give consent * informed consent documented by signature exclusion criteria: * subject pregnant or nursing * subject requiring emergency lithotripsy * contraindication for the surgical procedure: * positive urine culture, * unfit for general anesthesia, * therapeutic anticoagulation, or systemic infection