Kornimate/medical-research-clean huggingface dataset:
a 24-week prospective, open-label, multicenter, single-arm rpms study in real-world setting for atectura®

Conditions: Asthma

Summary: this surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of atectura inhalation capsule for up to 24 weeks under routine clinical practice.

the three different doses of atectura inhalation capsule via breezhaler will be prescribed according to the approved label information in korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study

Eligibility criteria:
inclusion criteria: 1. adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 μg) via breezhaler, as per the approved label information 2. patients who participate in the study after signing the consent form for data collection and use (data privacy icf) after receiving a clear explanation of the objectives and nature of the study from the investigator (for patients under the age of 18, consent and signature of a legal representative is required) exclusion criteria: 1. patients who are contraindicated for this medicinal product as described in the precautions for use in the label information (package insert) a. patients with hypersensitivity reaction to this medicinal product or any of its constituents b. because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the lapp lactose deficiency or glucose-galactose malabsorption, etc. 2. patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required 3. patients participating in other interventional clinical trials

Keywords: korea ics/laba combination
effectiveness of rtms on pain and quality of life in patients with cancer neuropathic pain. clinical trial.

Conditions: Neuropathic Pain

Summary: the purpose of this study is to evaluate the effectiveness of repetitive transcranial magnetic stimulation (rtms) on pain and quality of life in patients with cancer neuropathic pain. although there are currently different therapeutic options for neuropathic pain, most are limited or restricted to pharmacotherapy. transcranial magnetic stimulation (tms) is a tool recently incorporated into neuroscience in the management of neuropathic cancer pain. the study will include 10 patients with oncologic neuropathic pain who will receive 20 sessions of rtms and the effect on pain and quality of life.

neuropathic pain is defined as pain caused by a primary lesion or transient dysfunction of the central or peripheral nervous system. in cancer, it is generated as a consequence of multiple factors such as: direct compression of nerve structures, post-surgical nerve injuries, and nerve injuries secondary to chemotherapy. at least 3.5 million people around the world suffer from this symptom associated with cancer; of this population, 38% experience pain in all stages and 80% in advanced stages, negatively impacting quality of life.

Eligibility criteria:
inclusion criteria: * patients with neuropathic pain of oncological origin * patients of legal age (18 years old) * patients using their cognitive faculties exclusion criteria: * pregnancy * history of negative reaction to tms * history of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.

Keywords: transcranial magnetic stimulation, repetitive neuropathic pain quality of life cancer
tens and taping for older people

Conditions: Postural; Defect

Summary: aim: to examine the acute effects of transcutaneous electrical nerve stimulation (tens) and kinesio taping (kt) on lower limb joint proprioception, static standing balance, limits of stability and functional balance performance in community-dwelling older adults. design: a one-group experimental study with a repeated-measures design. sample: 24+ community-dwelling older adults interventions: tens and kt, tens and sham taping, kt and sham tens, and sham tens and sham taping (30 minutes each) major outcomes: outcomes will be evaluated during each of the intervention conditions. lower limb joint active repositioning error will be evaluated using a joint position sense test; a force platform will be used to assess the single-leg standing body sway path length and velocity; a functional reach test will give a score that reflects the limits of stability of the participants; and the timed up-and-go test will be used to quantify functional balance performance of the participants. anticipated results and significance: it is predicted that both tens and kt, when applied together, may best improve lower limb joint proprioception and facilitate all balance performances among the community-dwelling older adults. these interventions could be applied in clinical settings to improve joint proprioception and postural control of the elderly people.


Eligibility criteria:
inclusion criteria: * between 60 and 75 years old * able to ambulate independently and safely without using any walking aid * able to follow instructions exclusion criteria: * known unstable medical condition (e.g., uncontrolled hypertension) * known sensorimotor or neurological disorders (e.g., stroke and epilepsy) * significant musculoskeletal disorder of the lower limbs (e.g., osteoarthritis of the knee) * cognitive disorder * presence of an implanted electrical device (e.g., cardiac pacemaker) * cancer * a change in skin sensation * wound around the lower limb joints * a recent injury that may affect test performance * allergy to adhesive tapes
a phase 3 study to evaluate the safety and tolerability of dimebon patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. in cohort 1, subjects with alzheimer's disease (n=250) will receive dimebon 20 mg or placebo tid for 26 weeks. in cohort 2 ad subjects (n=500) will be treated with dimebon 20 mg or placebo tid for 12 weeks after completion of the randomized portion of the study, subjects in both cohorts will have the opportunity to enroll in a dimebon open label extension study.


Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease. * mmse 12-26 inclusive. * if on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study. * if not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study. exclusion criteria: * have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region \[e.g., thalamus, hippocampus\]). * have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions. * have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study. * reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

Keywords: alzheimer's disease dimebon safety tolerability
study of health personnel and the assistance to patients with tuberculosis in hospital environment

Conditions: Tuberculosis; Health Care Professionals; Hospital Environment

Summary: the purpose of this study is to evaluate in hospital environment the knowledge of the health care professionals about fundamental concepts on tuberculosis and the accomplishment to respiratory isolation practices for patients with pulmonary tuberculosis hospitalized in a public hospital in fortaleza, ceará, brazil.

a cross-sectional study of health care professionals using a study instrument with questions to evaluate the knowledge of basic concepts about tuberculosis. a retrospective study reviewing medical records of patients with suspected tuberculosis hospitalized in the units of adult and pediatric clinics and in the critical care unit in a general hospital in fortaleza-ce.

Eligibility criteria:
inclusion criteria: * health care professionals working in a public hospital (hgwa) in the units of adult and pediatric clinics and in the critical care unit in a general hospital in fortaleza-ce exclusion criteria: * health care professionals working in hgwa but in units other than adult and pediatric clinics and in the critical care unit

Keywords: tuberculosis disease transmission exposure to biological agents health personnel
enhancing the health extension workers capacity for promotion of maternal and child

Conditions: Behavior Problem

Summary: background: maternal and child nutrition is a lingering public health concern, affecting the lives of the most vulnerable individuals, in particular mothers and children. to counteract the burden, the ethiopian government has applied various strategies, including incorporating the promotion of nutrition as one package of primary health care provided by the health extension workers (hews). however, the provider's knowledge, promotion skill, and competency for promoting maternal and child nutrition have not been examined. moreover, health extension workers have been promoting using the traditional model of education and indicating the need for continuous professional development to strengthen the workforce. thus, the study is aimed to assess and enhance the health extension worker's capacity in promoting maternal and child nutrition through comprehensive and evidence-based capacity-building training. methods: a quasi-experimental study will be employed among 92 health extension workers. a baseline study, involving both qualitative and quantitative studies will be conducted to identify the gaps in maternal and child nutrition promotion. the knowledge, promotion as well as counseling skills of the hews will be assessed using a self-administered questionnaire and observational checklist, respectively. the intervention will involve training, supportive supervision, and coaching in a real environment. a four-day training will be given, which will be followed by supportive supervision of expert supervisors. further, the greet, ask, listen, identify, discuss, recommend, and agree counseling model with pender's health promotion model will be applied to enhance hews promotion skill. a post-test aimed at assessing the knowledge and counseling competency will be conducted and the pretest and posttest results will be compared using a t-test. factors affecting both knowledge and counseling capacity will be assessed using binary logistic and linear regression, respectively. similarly, a qualitative study will be used to explore promotion skills. discussion: given there are problems associated with the knowledge and counseling skills of hews in ethiopia, nutrition education using a well-designed and comprehensive strategy would bring a positive impact on professionals' promotion capacity thereby improving mothers/caregivers' behavior regarding child and maternal nutrition. the evidence will also enforce nutrition programmers and the amhara regional health bureau to end maternal and child undernutrition.


Eligibility criteria:
inclusion criteria: -all health extension workers working in the study area will be included. exclusion criteria: * not any

Keywords: community health workers maternal and child nutrition
dupixent in adults with refractory post-burn pruritus in an ambulatory clinic

Conditions: Pruritis

Summary: the goal of this study is to test the efficacy of dupixent in improving post-burn itching symptoms versus the current standard of care.

participants will receive six injections of dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that). in addition, participants will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference. individual participants will require 13 weeks to complete all study visits.

Eligibility criteria:
inclusion criteria: • persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak english sufficient to participate in the study. exclusion criteria: * currently taking dupixent for any other diagnosis * known allergy to dupixent * pregnant and or lactating mothers * anyone treated for pruritus using laser therapy * currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications * currently taking steroids * persons with developmental delays or otherwise unable to complete measures * prisoners or anyone otherwise unable to give their own consent or who is not their own guardian * one or more of the following existing disorders: conjunctivitis; any co-existing dermatological condition except burns; any type of cancer; requiring dialysis; chronic stage 3 or higher kidney disease; biliary disorder; gall bladder disorder; or another renal or hepatic disorder which, in the opinion of study physician, deems this study inappropriate for an eligible individual. * persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical trials at this site * we further exclude persons with other dermatological conditions (other than burn) , which may have pruritis or pain associated with them and who may be treated with medications other than dupixent, and whose perceived benefit could confound our results. * we similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.

Keywords: itching, itch
panchromoendoscopy using oral indigo carmine mixed with polyethylene glycol prep

Conditions: Colonic Polyps

Summary: this study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. it then will use this adequate staining concentration of indigo carmine to study whether this dye will increase the detection of polyps during colonoscopy.

colon cancer occurs in 5% of the us population. currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. colonoscopy is considered the gold standard test for colon cancer screening. this is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. it is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. it has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. it is however cumbersome and time consuming, which has discouraged its use. indigo carmine, one commonly used dye, is actually fda approved as a food colorant and can be consumed orally. it is minimally absorbed. in addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. the investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer.

Eligibility criteria:
inclusion criteria: * patients presenting for screening or surveillance colonoscopy * must be aged 50 to 75 yrs * must be able and willing to sign informed consent exclusion criteria: * known creatinine \>1.2 * cirrhosis * pregnancy or breast feeding * history of anaphylaxis to any dye * history of bowel surgery or small bowel obstruction * history of aspiration * history of dysphagia * american society of anesthesia class \>2 * history of abnormal liver function test in the last year * history of any degree of cytopenia in the last year

Keywords: polyp
virtual reality immersive method for spider (phobia) exposure therapy (vimse)

Conditions: Phobia, Specific

Summary: the aim of this study is to examine the efficacy of virtual reality exposure therapy as a treatment for specific phobia (spiders). a gamified virtual reality simulation of one-session therapy (vr-ost) will be compared to the gold-standard treatment in the form of traditional one-session phobia treatment (ost) using in-vivo stimuli. this study was powered to detect a non-inferiority margin of a 2-point difference between groups.


Eligibility criteria:
inclusion criteria: * score of 10 or less in behavioral approach test * individual meeting dsm-5 criteria according to interview for primary diagnosis of specific phobia, spider * swedish residency * fluent in swedish exclusion criteria: * ongoing psychotherapy * ongoing psychotropic medication (unless stabilized for three months) * indication of suicidal ideation, as assessed by item 9 of the phq-9 * meets criteria for alcohol or substance use disorder * meets criteria for serious mental disorder, such as bipolar disorder, schizophrenia or psychosis * balance and/or eyesight problems (such as lack of stereoscopic vision) that could interfere with vr treatment

Keywords: specific phobia exposure therapy virtual reality randomized controlled trial
use of gm-csf supplemented ivf medium in patients with recurrent implantation failure

Conditions: Infertility

Summary: the purpose of this study is to determine whether in assisted reproductive technologies the use of culture medium supplemented with gm-csf, a growth factor working on stem cells, may improve the embryo implantation in patients experiencing recurrent implantation failure in ivf cycles.

in assisted reproductive technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. in particular there are a group of patients, in young reproductive age, experiencing recurrent implantation failure, nevertheless the good embryos produced and transferred. recently, it has been showed that culture medium supplemented with gm-csf, may improve the embryo outcomes in ivf. in this trial the investigators will test the potential benefits of this culture medium on embryos of patients experiencing recurrent implantation failure. 100 women with recurrent implantation failure, at least three failed previous ivf attempts with at least 8 good embryos transferred no more than 40 years old will be selected. these patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. after the oocyte retrieval and fertilization by icsi procedure, the fertilised oocyte (2pn)will cultured with the gm-csf supplemented culture medium (embryogen, origio, denmark), or in normal culture in micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage embryos). a maximum of three embryos will be transferred. the pregnancy rate the implantation rate will be the outcomes considered

Eligibility criteria:
inclusion criteria: * woman age 40 years old or less, * 3 or more consecutive previous failed ivf cycles with a total of at least 8 good embryos replaced in uterus exclusion criteria: * chromosomal defects in the couple, * metabolic diseases (diabetes, etc), * other genetic diseases (thalassemia, cystic fibrosis, etc.)

Keywords: gm-csf recurrent implantation failure pregnancy rate ivf
residual inflammation and plaque progression long-term evaluation

Conditions: Atherosclerosis; Myocardial Infarction; Coronary Artery Disease; Inflammation

Summary: inflammation drives atherosclerotic plaque rupture triggering most acute coronary syndromes. despite advances in diagnosis and management of atherosclerosis, patients with myocardial infarction (mi) remain at increased risk of recurrent events. the ripple study aims to examine the relationship between residual coronary inflammation detected by 68ga-dotatate pet in patients treated for mi to long-term plaque progression measured by ct coronary angiography (ctca). the association between infarct-related myocardial 68ga-dotatate pet and myocardial function and viability will also be assessed.

while vascular inflammation can be detected using 18f-fdg pet, this method lacks inflammatory cell specificity and is unreliable for coronary imaging because of high background signals from the myocardium. upregulation of somatostatin receptor subtype-2 (sst2) occurs in activated macrophages, offering a novel inflammation imaging target. 68ga-dotatate, an sst2 pet tracer with low myocardial binding, shows promise for imaging coronary inflammation. having previously demonstrated increased 68ga-dotatate signals in coronary atherosclerotic lesions post-mi, we now aim to study the natural history of residual arterial inflammation in non-culprit arteries and better understand how 68ga-dotatate signals relate to plaque morphology, progression and rupture. residual infarct-related myocardial inflammation and its association with ischemic myocardial remodelling will also be examined.

Eligibility criteria:
inclusion criteria: * male or female participants \>18 years old * able to give written, informed consent and to lie flat * first-presentation of myocardial infarction within \~2 weeks * at least mild non-culprit coronary artery disease on angiography, managed medically exclusion criteria: * women of child bearing potential not using adequate contraception * contrast allergy or contrast-nephropathy * uncontrolled atrial fibrillation * chronic kidney disease (egfr \<30 ml/min/1.73 m2) * any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study * uncontrolled chronic inflammatory disorder * history of recent malignancy deemed relevant to the study by the investigator * current use of systemic corticosteroids * previous coronary artery bypass grafting surgery (cabg) or percutaneous coronary intervention (pci) before the index event * contraindication to coronary angiography * requires cabg or staged non-culprit artery pci