Kornimate/medical-research-clean huggingface dataset:
social media-based bundle care of aecopd patients.

Conditions: Acute Exacerbation of COPD; Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive; Readmission Rate; Mobile Medical; Bundle Care; Mobile Telemedicine

Summary: chronic obstructive pulmonary disease(copd) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. acute exacerbation (ae) of copd can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of copd patients, alleviate clinical symptoms, improve the quality of life. while a number of copd applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. therefore, the investigators aim to establish a bundle care mode based on the mode of "hospital-home-community-patient", clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. in this randomized controlled trial(rct), aecopd patients will be divided into interventional or control groups randomly. patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). while patients in the control group will receive standard of care only (traditional management mode). this study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for aecopd patients after discharge in china.


Eligibility criteria:
inclusion criteria: * aecopd patients with pulmonary function grade gold2-4; * aged between 45 and 70 years old; * have a smartphone, and can skillfully use mobile wechat official account; * willing to use wechat official accounts to manage copd; * willing to accept outpatient follow-up; * signed informed consent. exclusion criteria: * patients with asthma, bronchiectasis, tuberculosis, or other diseases; * patients with malignant tumors, liver and kidney failure, limb dyskinesia, and other diseases; * unstable angina pectoris in recent one month, myocardial infarction within a half year, severe arrhythmia, uncontrollable congestive heart failure, or poor blood pressure control (systolic blood pressure \> 140mmhg and/or diastolic blood pressure \> 90mmhg); * cognitive impairment; * combined with respiratory failure; * with a life expectancy of less than one year; * plan to or participating in a copd management project or mobile wechat official account project; * completed another trial within 30 days.

Keywords: readmission rate chronic obstructive pulmonary disease randomized controlled trial bundle care mobile telemedicine mobile medical acute exacerbation of chronic obstructive pulmonary disease
a trial to compare biochaperone insulin lispro formulations with us approved humalog® and with eu approved humalog® in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: this is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with type 1 diabetes mellitus (t1dm). each subject will be randomly allocated to one of four treatment sequences. each sequence comprises one single dose of each of four imps. imp1 and imp2 are biochaperone lispro formulations. they have the same composition and correspond to different development stages of a unique product which is biochaperone insulin lispro; between them, improvements were made to prepare industrial production. comparators (imp3 and imp4) are us-approved humalog® and eu-approved humalog®. all imps will be dosed at 0.2 u/kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days. the trial will compare the characteristics of biochaperone insulin lispro fully liquid (imp2) formulation to us-approved humalog and eu-approved humalog.


Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus * body mass index (bmi) between 18.5 and 28.5 kg/m\^2, both inclusive * hba1c \<= 75 mmol/mol (\<=9.0%). * fasting negative c-peptide (\<= 0.30 nmol/l). * total insulin dose of \< 1.2 (i)u/kg/day. * stable insulin regimen (with respect to safety of the subject and scientific integrity of the study) using continuous subcutaneous insulin infusion (csii) or multiple daily insulin injections (mdi) for at least 2 months. exclusion criteria: * known or suspected hypersensitivity to imp(s) or related products. * receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial. * history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. * any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator. * any history or presence of clinically relevant comorbidity capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data. * signs of acute illness as judged by the investigator. * any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator. * clinically significant abnormal screening laboratory tests, as judged by the investigator. * proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination. * use of oral antidiabetic drugs (oads) and/or glp-1 receptor agonists within 3 months prior to screening.
a study for pregabalin in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.


Eligibility criteria:
inclusion criteria: * male or female patients, at least 18 years of age * meeting the acr (america college of rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) * at screening (v1) and randomization (v2), patients must have a score of no less than 40 mm on the pain visual analog scale (vas) * at randomization (v2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4 exclusion criteria: * patients with no less than 30% decrease on the pain visual analog scale (vas) at randomization (v2) as compared to screening (v1) * patients with other severe pain due to other conditions (eg, dpn or phn) that may confound assessment or self-evaluation of the pain associated with fibromyalgia * patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders * clcr less than 60 ml/min (estimated from serum creatinine)

Keywords: pregabalin fibromyalgia
intradermal vaccination with stabilized tumor mrna - a clinical phase i/ii trial in melanoma patients

Conditions: Malignant Melanoma

Summary: vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mrna coding for the corresponding antigen

vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mrna coding for the corresponding antigen. antigens used are melan-a, mage-a1, mage-a3, survivin, gp100 and tyrosinase. gm-csf is used as an adjuvans. phase i/ii clinical trial to analyse safety and immune respones in stage iii/iv melanoma patients.

Eligibility criteria:
inclusion criteria: * stage iii/iv * fresh frozen tumor-tissue * age 18-75 * informed consent given * karnofsky \>= 70% exclusion criteria: * systemic glucocorticoids * brain metestasis * other malignancies
effect of buffered local anesthesia on pain in areteriovenous fistula

Conditions: Pain, Procedural; Pain, Postoperative; Satisfaction, Patient

Summary: pain and satisfaction score will be assessed at the end of surgery and compared in either of two groups

all patients meeting inclusion criteria will be randomly enrolled in two groups. intervention group will receive buffered lignocaine . at the end of procedure data will be recorded regarding pain vasscore and satisfaction score

Eligibility criteria:
inclusion criteria: * asa i to iii * brachiocephalic arteriovenous fistula * radiocephalic arteriovenous fistula exclusion criteria: * basiic vein transposition * redo surgery emergency surgery * failure to understand the questionnnare
effect of barley supplemented wheat bread on markers of cardiovascular and renal health

Conditions: Cardiovascular Diseases; Kidney Diseases

Summary: the disruption of colonic microbiota has been linked to a number of diseases, mainly cardiovascular and kidney diseases. one possible means to improve the microbiota is to increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from proteolytic saccharolytic fermentation. beta-glucans are soluble dietary fibers mainly found in oats and barley. results from previous studies suggest that the consumption of barley reduces the risk of cardiovascular and kidney diseases. therefore, this study will explore the effect of barley beta-glucans on markers of cardiovascular and renal health.


Eligibility criteria:
inclusion criteria: * healthy individuals of age 18 years or older * bmi ranged between 18.5 and 24.9 exclusion criteria: * celiac disease, cancer, diabetes , cardiovascular diseases * gastro intestinal tract disease * pregnant women * use of pre-, pro- or antibiotics 15 days before the enrollment into the study * food allergy to food used in the trial

Keywords: tbars tac pcs barley beta-glucan e-selectin no
cervical occlusion for the prevention of preterm birth

Conditions: Uterine Cervical Incompetence

Summary: the aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.

cervical weakness and ascending infection have long been considered important causes of preterm birth. cervical occlusion could theoretically be used for the treatment of cervical weakness and to protect the cervix against infection. a cervical cerclage could be placed to increase the cervical resistance, and occlusion of the external os could be performed to retain the cervical mucus plug thereby preventing infection. the aim of this multicentre, stratified, randomised controlled trial was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with prophylactic and therapeutic cervical cerclages.

Eligibility criteria:
inclusion criteria: * the physician in charge considered that a cerclage was indicated. * gestational age between 12 and 27 completed weeks. * previous late mid-trimester miscarriage, or spontaneous preterm labour and delivery before 28 weeks with or without previous cerclages. * previous cerclage because of short cervix. * confirmed gestational age defined as gestational age estimated by ultrasound at less than or equal to 22+0 weeks, and/or certain last menstrual period. * vaginal infection treated before cerclage. * ability to read and understand the relevant national language. * consent obtained in accordance with specifications of the local research ethics committee. * 18 years or more of age and legally competent. exclusion criteria: * demonstrated cervical infection. * obstetrical complications in the current pregnancy. * multiple pregnancies. * history of a significant abruptio placenta in a previous pregnancy.

Keywords: cervical cerclage uterine cervical incompetence
the added-value of psma pet in detecting clinically significant prostate cancer lesions in patients undergoing mri-targeted biopsy. (pandora)

Conditions: Multiparametric MRI; Lesion PI-RADS 3

Summary: prostate specific membrane antigen (psma) positron emission tomography/computed tomography (pet/ct), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. indeed, several studies have shown that psma pet/ct outperformed choline pet/ct with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low psa level. moreover, the propsma trial reported that psma pet/ct had 27% greater accuracy than that of ct and bone scanning when staging patients with high-risk localised prostate cancer. more recently, availability of integrated pet/mri scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. it also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions. in the light of current issues, the next question is whether psma pet imaging could add to the detection of prostate cancer. several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic psma pet/ct . recently, in the primary trial, 291 men received successively mri, psma pet/ct and systematic ± mri-targeted biopsies. despite similar ppv between imaging methods, the main advantage of psma was in men with equivocal mri. indeed, they found that 90% of cspca was identified by psma pet/ct in this subgroup and paved the way for further investigation. this finding was confirmed in the most recent systematic review and meta-analysis. the aim of this prospective study is to evaluate the added-value of psma pet in detecting prostate cancer in patients who are candidates for biopsy with equivocal mri.


Eligibility criteria:
inclusion criteria: subjects must meet the following criteria for inclusion in the study: * men ≥ 18 years of age * multiparametric mri within the previous 6 months * at least one lesion pi-rads 3 * able to provide written informed consent exclusion criteria: eligible subjects must not meet any of the exclusion criteria listed below: * previous prostate cancer diagnostic on mri-targeted biopsy * at least one lesion pi-rads 4-5 * negative mri (pi-rads 1-2) * previous treatment for prostate cancer 11 * contraindication to psma pet and/or mri and/or prostate biopsy * low quality of mri defined by a pi-qual score of 1 or 2 * any medical condition that may interfere with the study procedures.

Keywords: psma pet mri-targeted biopsy
autologous regeneration of tissue (art) for wound healing

Conditions: Wound of Skin

Summary: the purpose of this research study is to learn about a new device, autologous regeneration of tissue (art), for collecting skin grafts from participant's own skin.


Eligibility criteria:
inclusion criteria: * adults from 18 to 90 years of age. * patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration. * able and willing to give consent for the study. exclusion criteria: * pregnant women (urine hcg test will be performed at baseline on women of child bearing potential). * adults unable to consent. * prisoners. * subjects requiring concurrent systemic antimicrobials during the study period for any infection. * subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease. * subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents. * subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin). * subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).

Keywords: chronic wound
evaluating in vivo parp-1 expression with 18f-fluorthanatrace positron emission tomography (pet/ct) in breast cancer

Conditions: Breast Cancer

Summary: up to 30 evaluable participants with known or suspected breast cancer (birads 5 by imaging) will undergo ftt pet/ct imaging before primary surgery or neoadjuvant therapy. patients undergoing neoadjuvant therapy may choose to have a second ftt pet/ct scan after the start of therapy (1 days to 3 weeks). ftt pet/ct uptake will be correlated with pathology measures and treatment response, in subjects undergoing neoadjuvant therapy


Eligibility criteria:
inclusion criteria: * participants will be ≥ 18 years of age * known or suspected (birads 5 on imaging) primary breast cancer * at least one breast lesion one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast mri). only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study. patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included. * willing to allow use orcollection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy * participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening. * inability to tolerate imaging procedures in the opinion of an investigator or treating physician * any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
a clinical study for evaluating the safety of excessive consumption of a plant sterol-enriched yoghurt drink

Conditions: Healthy; Mild Hypercholesterolemia

Summary: the purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.


Eligibility criteria:
inclusion criteria: * male/female subjects, * aged 20-65 years old, * triglycerides (tg) levels under 400 mg/dl, * total cholesterol plasma level under 240 mg/dl (with half the subjects at entry under 200 mg/dl), * ldl-cholesterol plasma level under 160 mg/dl (with half the subjects at entry under 120 mg/dl), * non diabetic and non hypertensive, * accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (japan atherosclerosis society guidelines), * effective contraceptive methods used for female subjects, * having given written consent to take part in the study exclusion criteria: * subjects with sitosterolemia, * subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months, * taking any hypocholesterolemic treatment, * presenting known allergy or hypersensitivity to plant sterols, * dairy products and lactose, subject with heavy alcohol intake (\> 60g/day), * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, * subjects receiving a transplant or under immunosuppressor treatment, * receiving treatment for any serious pathology. * for female subject: * pregnancy, * breast feeding or * intention to be pregnant during the study

Keywords: plant sterol hypercholesterolemia dairy
effect of weight loss on psoriasis

Conditions: Psoriasis

Summary: controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. no controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting. patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type ii diabetes and in severe psoriasis there is an increased risk of early death. lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. this leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. in summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.


Eligibility criteria:
inclusion criteria: * moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy * bmi \> 27 exclusion criteria: * pregnancy/breast feeding * diabetes requiring insulin treatment * severe heart/kidney/liver disease * gout * high potassium intake * obesity due to medical conditions/medications * use of medical treatment for obesity * previous bariatric surgery * intentional/unintentional weight loss up to 3 months prior to inclusion
follow-up study to assess visual function in subset of patients who have previously participated in the tg-mv-006 and tg-mv-007 ocriplasmin studies

Conditions: Symptomatic Vitreomacular Adhesion

Summary: the primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin phase iii studies (tg-mv-006 or tg-mv-007).

non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function

Eligibility criteria:
inclusion criteria: * written informed consent obtained from the patient prior to inclusion in the follow-up study * previous participation in either of the placebo controlled, ocriplasmin phase iii studies (tg-mv-006 or tg-mv-007) exclusion criteria: * n/a
magseed magnetic marker localization

Conditions: Disorders of Breast; Breast Lesions

Summary: the purpose of this post-marketing study is to provide prospective evidence that the magseed and sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

this is a post-market, prospective, open label, single arm study of magseed and sentimag in patients undergoing surgical excision of a breast lesion. subjects will have the magseed marker deployed under imaging guidance up to thirty days prior to surgery. the magseed marker will be localized using the sentimag system during surgery and removed with the lesion. after the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Eligibility criteria:
inclusion criteria: * subjects with a breast lesion requiring image-guided localization prior to excision. * subjects aged 18 years or more at the time of consent. exclusion criteria: * the subject is pregnant or lactating. * subject has pacemaker or other implantable device in the chest wall. * subject has current active infection at the implantation site in the breast (per investigatordiscretion)