Kornimate/medical-research-clean huggingface dataset:
a study based on health insurance data about the treatment of patients who have been newly diagnosed with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a retrospective analysis study in copd patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period.


Eligibility criteria:
inclusion criteria: * all patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death * a patient will be included as an incident copd patient if either a hospital documented at least one copd diagnosis (international statistical classification of diseases and related health problems (icd-10 j 44.-) or a specialist (pneumologist) documented at least 2 confirmed copd diagnoses (above icd-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017 * patients should not have received any copd diagnosis (icd-10 j44.-) or any copd-associated medication in the 12 months pre-index period * patient should have, at date of incident copd diagnosis (index date), an age of at least 40 years exclusion criteria: * patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (icd-10: j45) by pneumologists
early detection of atherosclerosis: a randomized trial in the primary prevention of cardiovascular diseases.

Conditions: Atherosclerosis; Cardiovascular Diseases

Summary: the incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. the main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

we will perform non-invasive techniques (carotid intima-media thickness, cac score and ankle-brachial index) to individuals at intermediate cardiovascular risk.with these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. the end-point will be the course of atherosclerosis measured by cimt/cac score (2 years) and the incidence of cvd at 5 years of follow-up.

Eligibility criteria:
inclusion criteria one or more of the following: * familiar history of early-onset cardiovascular disease (male \< 55 or female \< 65). * type 2 diabetes mellitus or type 1 with microalbuminuria. * essential high blood pressure. * chronic kidney disease. * primary hyperlipidemia. the presence of two or more of the following: * current smoker. * physical inactivity. * high blood pressure (recently diagnosed). * abdominal perimeter: \> 102 cm. males; \> 88 cm. females. * total cholesterol \> 240 mg/dl. * hdl cholesterol ≤ 40 mg/dl males, ≤ 50 mg/dl females. exclusion criteria: * age \ 74 years old. * previous cardiovascular event.

Keywords: atherosclerosis cardiovascular prevention carotid intima-media thickness ankle-brachial index
japanese idiopathic interstitial pneumonias registry

Conditions: Idiopathic Interstitial Pneumonia

Summary: an objective of jips registry is to examine disease behavior of idiopathic interstitial pneumonias (iips), considering classification, background, and diagnostic methods based on american thoracic society (ats)/ european respiratory society(ers) /japanese respiratory society (jrs)/ latin american thoracic association (alat) guidelines for diagnosis and the ats/ers classification of 2002 and 2013.

jips registry is a multi-site, non-interventional, prospective observation study of patients with newly diagnosed iips in japan. at least 600 patients will be registered for 16 months at approximately 80 sites in japan. primary research question is to determine the natural history of each category of iips at registration, patient background and diagnosis methods will be considered. furthermore, the present treatment patterns and disease behavior (ct and forced vital capacity (fvc) changes, as well as changes in interstitial pneumonia markers, etc.) will also be investigated.

Eligibility criteria:
inclusion criteria: 1. patients aged between 20 and 84 years 2. patients with idiopathic pulmonary fibrosis (ipf) and other iips diagnosis within 6 months before registration at each facility 3. patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation exclusion criteria: 1. patients for whom the tests (such as the lung function test) conducted in this study could not be performed 2. patients who underwent pulmonary resection 3. patients undergoing dialysis 4. patients with cancer treated at the time of registration or those planning to receive treatment in the future

Keywords: iips
intraoperative boost radiotherapy with electrons (ioert) followed by hypofractionated whole-breast irradiation (wbrt)

Conditions: Invasive Lobular and Ductal Carcinoma

Summary: hypofractionated intraoperative boost (hiob) is defined as hypofractionated wbrt (40.5 gy in 2.7 gy per fraction) preceded by an intraoperative boost to the tumor bed (10 gy ioert). the hiob study concept will test whether such a combined schedule is superior or iso-effective standard rt in terms of local control and cosmetic outcome.

the purpose of this research study is to find out the effects (good and bad) of adding a dose of radiation to the area of the cancer during surgery to whole breast radiation therapy (wbrt) after surgery. ioert is the application of electron radiation directly to the residual tumor or tumor bed during cancer surgery. wbrt is a type of radiation therapy used to treat patients who have cancer in the breast covering the entire breast tissue. both immediate and long-term effects will be measured. for patients with certain types of breast cancer, one standard treatment is removal of the area of cancer and a small amount of normal tissue around it followed by breast radiation. the radiation treatment in this situation usually lasts 3 to 5 1/2 weeks of wbrt followed by 5-8 daily radiation treatments at the site where the lump was removed called a "boost". during this study, the single dose of electron irradiation (ioert) given at the surgical site during the operation will replace the usual 5-8 days of localized radiation and the whole breast radiation will last 3 weeks.

Eligibility criteria:
inclusion criteria: * histological proven invasive breast carcinoma (ductal and lobular) * age \> 40 years * karnofsky performance status \>70% * single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci) * nodal status: no-1 * clear surgical margins: r0; min 2mm. re-excision after ioert is permitted but not required to achieve (-) margin. * all grades g1 - g3 * any hormonal receptor and her-2 status * informed consent exclusion criteria: * in-situ carcinoma without invasive component or multifocal disease \> 4 cm * tumor stage: t3 or 4 * nodal status \> n1 pathologically * surgical margins \< 2mm * multicentricity * previous radiotherapy to the involved breast * karnofsky index \< 70% * mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus. * distant metastases * unable to provide written consent

Keywords: breast cancer radiation therapy mobetron ioert iort hypofractionated radiation therapy partial breast radiation
analysis of the microbiome in the healthy smokers and copd patients

Conditions: Pulmonary Disease, Chronic Obstructive; Microbiota

Summary: this study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (copd) patients. the aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and copd patients.

after the introduction of the gut-lung axis theory, extensive studies revealed the diversity of microbiomes among healthy smokers and copd patients form the respiratory samples or lung tissues. in the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and copd patients was reported. this study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (copd) patients who are being followed up by asan medical center. the aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and copd patients. this study would help establishing gut-lung axis model in humans.

Eligibility criteria:
inclusion criteria: * patients with smoking history at least 10 pack-year * patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) \<0.7) exclusion criteria: * patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension) * patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)

Keywords: chronic obstructive pulmonary disease microbiome
effectiveness and safety of edaravone dexborneol in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.

the study lasts a total of 90 days and includes three phases: screening, treatment, and follow-up. treatment period: patients are divided into exposure group and non-exposed group based on the use of edaravone dextrol after ischemic stroke. the exposure group: edaravone dextrol is used according to reference to clinical practice, without specific restrictions. the non-exposed group: edaravone dextrol is not used, and concomitant therapy is at the clinician's discretion. follow-up period: all patients continue to be followed up to 90 days after stroke onset.

Eligibility criteria:
inclusion criteria: * age≥18 years old； * clinically diagnosed as acute ischemic stroke； * time from symptom onset to admission≤14 days (symptom onset time is defined as last known well time)； * pre-stroke mrs ≤1； * have been informed of the content of the informed consent form and agree to participate. exclusion criteria: * acute intracranial hemorrhagic diseases confirmed by images: parenchymal hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc. * patients who are pregnant or lactating and who are planned to become pregnant within 90 days; * patients with severe renal failure (egfr\<30ml/min); * patients with concurrent malignancy or severe systemic disease with an estimated survival of less than 90 days; * patients with severe mental disorders or unable to complete the informed consent and follow-up due to dementia; * patients who are judged unsuitable for participation in the study.

Keywords: acute ischemic stroke edaravone dextrol real-world study
effectiveness and safety of omalizumab in children with allergic asthma.

Conditions: Allergic Asthma

Summary: the study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in china, and described patient profiles and treatment patterns of omalizumab in real-world practice.

this non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in china, and described patient profiles and treatment patterns of omalizumab in real-world practice. this study was designed to use secondary data from medical charts of 25 hospitals. medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and aes for retrospective analysis. patients with allergic asthma aged 6 -\<12 years treated with omalizumab from july 6, 2018 to september 30, 2020 were identified for medical chart extraction.

Eligibility criteria:
inclusion criteria: * aged between 6 -\<12 years * diagnosed with allergic asthma and could be treated using omalizumab. comorbidities included allergic rhinitis, atopic dermatitis, nasal polyp, chronic urticaria, and food allergy * received omalizumab during the identification period * had at least one documented follow-up data after omalizumab treatment * provided informed consent if required by ethics committee (ec) of hospital exclusion criteria: * current participation in a clinical trial of any investigational treatment

Keywords: omalizumab, allergic asthma, children, real-world study
ccro044: quality of life assessments associated with a physician communication intervention for prostate cancer patients

Conditions: Prostate Adenocarcinoma

Summary: a generic cancer health-related quality of life measure will be used to assess the impact of the patient-specific radiation therapy plan review using the european organisation for research and treatment of cancer (eortc) quality of life questionnaire (qlq)-c30. patient psychosocial adjustment will be assessed by the memorial anxiety scale for prostate cancer and the eortc qlq-c30 subdomain. physician communication will be assessed with the uc davis physician communication adapted from the cologne patient questionnaire. the study will characterize the above health-related quality of life (hrql) scores (eortc qlq c-30, the memorial anxiety scale, and the uc davis physician communication) prior to initiation of radiation (baseline), during the first week of treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment), and 12 months after treatment ends.

the primary purpose of this pilot study is to assess the feasibility of administrating a battery of hrql measures after the planned intervention is administered. because distributional information on the proposed hrql measure has not been previously collected in prostate cancer patients, this pilot study will provide the necessary descriptive statistical information for the planned endpoint measures (summary scores for the hrql battery) to help plan a randomized trial evaluating the efficacy of the patient-provider communication intervention. men who are receiving definitive or post-operative radiation therapy for management of prostate cancer at the university of california (uc) davis will be recruited. the study will administer a validated quality of life instrument (eortc qlq-c30), a previously validated psychosocial instrument (memorial anxiety scale), and assessment of physician-patient communication using a new uc davis physician communication assessment adapted from the validated cologne patient questionnaire. the study will administer these questionnaires prior to initiation of radiation (baseline), during the first week of treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment), and 12 months after treatment ends.

Eligibility criteria:
inclusion criteria: 1. diagnosis of prostate adenocarcinoma over the age of 18 years 2. low, intermediate or high risk as defined by d'amico risk groups treated with dose escalated conventional fractionated radiation therapy 3. patient deemed clinically appropriate for definitive, adjuvant or salvage radiation. 4. patient most provide study specific informed consent prior to study entry. 5. androgen deprivation allowed 6. pelvic lymph radiation therapy allowed for high risk disease exclusion criteria: 1. metastatic prostate cancer 2. positive pelvic nodes 3. patients treated with radiation for palliative intent 4. prior radiation therapy to the pelvis
the study of mechanism of chronic insomnia disorder using acupuncture based on changes of brain gaba and fmri

Conditions: Insomnia Disorder

Summary: insomnia disorder is one of the major neuropsychiatric diseases which received more attention in recent years. disturbances in the amino acid neurotransmitter, gama-amino butyric acid (gaba) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of insomnia. both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on insomnia symptom. however, the underlying mechanism remains unclear. the principal objective of this project is to use magnetic resonance spectroscopy (mrs) as well as acupuncture to provide the first in vivo characterization of cortical gaba levels between pro- and post-acupuncture treatment in individuals with chronic insomnia disorder (cid), and use resting state functional magnetic resonance imaging (fmri) to determine whether cid patients have altered brain connectivity and network parameter changes. the investigators are also exploring the correlation between cortical gaba levels, fmri parameter changes and abnormalities in sleep parameters and neuropsychology test in cid patients.

three groups of subjects (cid accepted true acupuncture, cid accepted sham acupuncture and healthy) will participate in the study. all subjects will undergo a laboratory blood test, physical and neurological examination, polysomnography (psg) and an extensive battery of neuropsychological assessments. all subjects meeting eligibility criteria for the study will complete a baseline mrs and fmri to evaluate differences in multi-modality brain gaba and fmri parameters between the patients and healthy. after randomized acupuncture treatment, investigators will compare brain metabolic and functional parameters to elucidate the neural mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the perspective of neurotransmitters and brain network.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic insomnia disorder (cid) met the criteria of the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5) * subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months * must be able to cooperate with cognitive testing and mri scan exclusion criteria: * known pre-existing sleep disorder other than chronic insomnia disorder * circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation) * severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems * clinical diagnosis of ad or parkinson's neurodegenerative diseases * moderate or severe psychological illness * clinical history of stroke or other severe cerebrovascular disease * clinical history of malignancies disease * active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. trazodone, mirtazapine, zolpidem, zaleplon) * alcohol or drug abuse
the massachusetts general hospital optical coherence tomography registry

Conditions: Coronary Artery Disease

Summary: information will be collected prospectively in about 3,000 patients having optical coherence tomography during cardiac catheterization. subjects will be initially enrolled at sites outside of the united states, where optical coherence tomography is approved by regulatory agencies. subjects will be followed for up to 5 years.

this project will create a prospective registry of 3,000 patients with follow-ups of up to 5 years. the aims of the project will be: 1. identify plaque characteristics on oct that are associated with adverse cardiac events including myocardial infarction 2. to identify characteristics of stented arteries that are associated with adverse events including restenosis and stent thrombosis because detailed clinical, angiographic and intravascular imaging data will be gathered from a large number of patients with clinical follow-ups, we anticipate that the registry will be a tremendous resource for additional research questions going forward.

Eligibility criteria:
inclusion criteria: * subjects who have had oct imaging performed during cardiac catheterization and have provided written consent exclusion criteria: * none
protein and magnesium in ulcerative colitis

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Magnesium Deficiency; Nutritional Deficiency; Protein Deficiency

Summary: the aim of the study is to improve the quality of nutritional therapy for patients admitted with acute severe ulcerative colitis (asuc) treated with high-dose steroids. this study consists of two randomized interventions and one observational part regarding protein, magnesium, and metabolic stress. first an interventional part aims to explore the effect of a high-protein diet during and after admission on different parameters regarding protein turnover.second the study aims to explore the degree of magnesium depletion in asuc. in case of magnesium depletion, the study aims to investigate whether oral magnesium supplementation can regain body stores of magnesium. last the study aims to observe the degree of metabolic stress, including, the degree of insulin resistance, in asuc during admission and under treatment with high-dose steroids compared to three weeks after discharge.

patients with acute severe ulcerative colitis (asuc) may have an altered protein turnover due to inflammation, reduced dietary intake and/or accelerated protein loss. despite this the level of dietary protein needed to maintain nitrogen balance has never been described in patients with asuc. clinical symptoms of asuc include frequent and bloody diarrhea which alone or simultaneous with a risk of reduced dietary intake and weightloss can lead to magnesium depletion. magnesium depletion can cause severe symptoms including cardiac arrhythmia and neuromuscular dysfunction which might worsen the disease further. the prevalence of magnesium depletion in asuc has never been described and furthermore it is not known whether oral supplementation are able to reverse the condition in patients with asuc.

Eligibility criteria:
inclusion criteria: * age 18 years or older * cognizant * must speak or read danish or participate in relevant communication in interpreting or translating the study material. * diagnosed with acute severe ulcerative colitis (asuc) (documented in the patient journal) * admitted at "lever-, mave-, og tarmsygdomme/ lmt" at aarhus university hospital and in medical treatment with high-dose intravenous steroid (solumedrol 40 mg x 2 daily) exclusion criteria: * pregnant and/or lactating women * plasma creatinine \> 200 µmol/l (protein intervention only) * patients receiving tube- or parenteral feeding (protein intervention only) * receiving any kind of magnesium supplementation 6 months prior to inclusion (magnesium intervention only) * diagnosed with type 1 or type 2 diabetes mellitus (observational part only)