Kornimate/medical-research-clean huggingface dataset:
cardiorespiratory fitness in prediabetic,type 2 diabetic and healthy individuals

Conditions: Prediabetic State; Diabetes Mellitus, Type 2; Cardiorespiratory Fitness; Inflammation; Exercise Test

Summary: the aim of this study to investigate and compare cardiorespiratory fitness (crf) parameters of prediabetic, type 2 diabetic and healthy individuals. crf assessed with cardiopulmonary exercise test (cpet) which is gold standard measure of crf. pulmonary functions, inflammation, disease specific parameters such as hba1c, fasting plasma glucose etc affect crf in prediabetic and type 2 diabetics.all parameters examine in this study.

this study will be participated with type 2 diabetic,prediabetic and healthy patients. patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise capacity, physical activity level, quality of life, cardiorespiratory fitness levels will assess and record. pulmonary function test will be assesed with cpet system, respiratory muscle strength will be evaluated with mouth pressure. exercise capacity will be evaluated using six minute walking test, incremental shuttle walk test. and cardiorespiratory fitness will assess cpet system. physical activity level will be evaluated trial accelerometer and international physical activity questionnaire.

Eligibility criteria:
inclusion criteria: * cooperation, * no assistance for ambulation, * body mass index\<40 * diagnose of prediabetes/type 2 diabetes and health exclusion criteria: * any cardiac problems, * uncontrolled hypertension, * any neurologic disease, * uncontrolled diabetes, * any orthopedic disease impairs walking, balance * any respiratory disease affects cardiorespiratory fitness

Keywords: prediabetes type 2 diabetes cardiorespiratory fitness pulmonary functions functional capacity exercise capacity
nasal airway stent (nastent®) study in osa

Conditions: Obstructive Sleep Apnea

Summary: this study intends to assess the effect of nasal airway stent (nasten®) as a treatment modality in patients with sleep-disordered breathing (sdb) including snoring and/or obstructive sleep apnea (osa). nastent®, a distally perforated soft silicon nasal tube, is a mechanical splint against collapse of the upper airway at multiple levels. nastent® might be able to prevent the vibrations caused by fluttering of various parts of the upper airway which leads to snoring. furthermore, it also potentially secures a patent airway throughout the night securing airflow.

patients with an established diagnosis of osa with apnea/hypopnea-index (ahi)\< 20/ hour sleep from the ent department are recruited and informed about the study. after obtaining informed consent and patient inclusion, a baseline portable sleep monitoring at home using watchpat™300 for one night is performed. during the next visit the objective size and position of the stent is determined under direct visualization using fiberoptic nasolaryngoscopy. subsequently, the patients will receive a nastent® starter kit (containing 6 different stent sizes of nastent®, 130, 135, 140, 145, 150 and 155mm) to gradually get accustomed to the stent and to find the right size for them. during the following consultation, a nastent® classic kit (containing 7 stents of the same size, each can be used for two consecutive nights) is given to the patients to be used for 14 consecutive nights. during the last night of this 14-night period, a follow-up home portable sleep monitoring evaluation using watchpat™300 is performed with nastent® in situ. afterwards, during the final visit at the outpatient clinic, acceptance of the therapy with nastent® by the patients is evaluated, and the decision of whether to continue the therapy and to proceed to the purchase of this product as a long-term treatment for the patient or not, is made.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * ahi ≤ 20 per hour of sleep * complaints of socially disturbing snoring by the partner of the patient * capable of giving informed consent exclusion criteria: * craniofacial deformities * acute nasal trauma, fracture (during the past 3 months) * nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis * cerebrospinal fluid leaks * history of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia\< 100/µl), lower respiratory tract disorders. * pregnancy or willing to become pregnant * excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs) * history of sleep medication use

Keywords: obstructive sleep apnea snoring stent
examining adolescent assessment, feedback, incentive, and exchange (afix) in north carolina

Conditions: Adolescent Health Services; Immunization

Summary: the north carolina immunization branch will evaluate the use of the cdc program to improve adolescent vaccination practices (called assessment, feedback, incentives, and exchanges, or afix). this evaluation is the first of its kind in the nation and may have a profound impact on prevention. afix has four major components: 1) assessment of a provider's current immunization practices and vaccination levels, 2) feedback of the assessment results and strategies to improve coverage levels, 3) incentives to improve coverage levels, and 4) exchange of information and resources necessary to facilitate improvement. this program will evaluate the effectiveness of afix visits on affecting provider practices to increase adolescent (age 11-18) immunization. visits include discussion of that practice's immunization rates and strategies for improving rates. the investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). thirty practices will be randomly assigned to each intervention type. the main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (tdap, hpv, and mcv4) as well as pre- and post-afix visit surveys focusing on recall tactics utilized by each practice. data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).


Eligibility criteria:
inclusion criteria: * pediatric and/or family practices participating in the north carolina immunization program * a minimum of 200 active adolescent patients

Keywords: diphtheria-tetanus-pertussis vaccine measles-mumps-rubella vaccine meningococcal vaccines hepatitis b vaccines chickenpox vaccine papillomavirus vaccines
a study to evaluate a modified contact lens

Conditions: Myopia

Summary: this study is being conducted to evaluate the product performance of soflens daily disposable contact lenses packaged in an investigational test solution versus soflens daily disposable contact lenses packaged in the currently marketed solution (control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.


Eligibility criteria:
inclusion criteria: * subjects must be free of any anterior segment disorders. * subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. * subjects must be myopic and require contact lens correction from -0.50 d to -6.00 d in each eye. * subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses. * subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study. * subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment. * subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog). * subjects must feel that being in an urban environment has a negative effect on their lens wearing experience. * subjects must have access to an internet connection and be able to send and receive email. exclusion criteria: * subjects who have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or who are using any ocular medication. * subjects with any grade 2 or greater finding during the slit lamp examination * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects with any scar or neovascularization within the central 4 mm of the cornea. subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * subjects who are allergic to any component in the study care products.

Keywords: ocular irritation
injection of cyanoacrylate+lipiodol vs cyanoacrylate+lauromacrogol in gastric varices

Conditions: Gastric Varices; Portal Hypertension

Summary: the purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. when a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). it has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. however, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. we conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Eligibility criteria:
inclusion criteria: * patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis. * the age of the patients range from 18 to 80 years old. exclusion criteria: * patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy. * patients who have abnormal portosystemic shunt according to the imaging results. * patients who have no previous upper gastrointestinal bleeding history. * patients who have multiple endoscopic treatments for esophagogastric varices before.
effect of acupuncture dry needle in treatment of chronic mechanical low back pain

Conditions: Low Back Pain

Summary: low back pain affects about 60% to 90% of the working-age population in modern industrial society. chronic mechanical low back pain (cmlbp) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. the purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain.

low back pain affects about 60% to 90% of the working-age population in modern industrial society. chronic mechanical low back pain (cmlbp) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. the purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain. thirty patients their age ranged from 20 - 45 years participated in our study and divided randomly into two equal groups suffering from nonspecific low back pain. the first group (a) consist of 15 patients receiving acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, the second group (b) consist of 15 patients receiving only stretching and strengthening exercises for back muscles. the following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending and left side bending) were measured before and after treatment.

Eligibility criteria:
inclusion criteria: 1. age ranges from 20 to 45 years old. 2. pain of at least 30 mm to 70 mm on a visual analogue scale (vas) from 0 mm (no pain) to 100 mm (worst imaginable pain). 3. presence of mtrps at least in 4 muscles on any side. 4. patients had lower back myofascial pain syndrome for at least 3 months ago. exclusion criteria: a history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.

Keywords: acupuncture dry needle chronic mechanical low back pain
study of recombinant factor ix fc fusion protein (rfixfc) in participants with hemophilia b

Conditions: Severe Hemophilia B

Summary: the primary objectives of the study were: to evaluate the safety and tolerability of rfixfc; to evaluate the efficacy of rfixfc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rfixfc on each prevention (prophylaxis) regimen and participants receiving rfixfc on an episodic regimen. the secondary objectives of the study were: to evaluate and assess the pharmacokinetic (pk) parameter estimates of rfixfc and rfix (benefix®) at baseline in the sequential pk subgroup as well as rfixfc at week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rfixfc consumption.


Eligibility criteria:
inclusion criteria: * male and 12 years of age and older and weigh at least 40 kg * diagnosed with hemophilia b (baseline factor ix level less than or equal to 2%) * history of at least 100 exposure days to any factor ix product * platelet count ≥100,000 cells/μl exclusion criteria: * history of factor ix inhibitors * kidney or liver dysfunction * diagnosed with another coagulation defect other than hemophilia b * prior history of anaphylaxis associated with any factor ix or intravenous (iv) immunoglobulin administration
easytrak 4 steerable lv lead

Conditions: Heart Failure

Summary: the primary objective of this clinical investigation is to evaluate the safety and effectiveness of the easytrak 4 steerable lv lead.

this is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the easytrak 4 steerable lv lead.

Eligibility criteria:
inclusion criteria: * must receive a commercially available guidant crt-p or crt-d device * creatinine \< 2.5 mg/dl obtained no more than two weeks prior to enrollment * age 18 or above, or of legal age to give informed consent specific to state and national law * willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol * geographically stable residents who are available for follow-up exclusion criteria: * have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate * have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement * have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads) * currently requiring dialysis * have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment * have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) * documented life expectancy of less than six months or expected to undergo heart transplant within the next six months * enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study * have a pre-existing unipolar pacemaker that will not be explanted/abandoned * have a mechanical tricuspid heart valve * women who are pregnant or plan to become pregnant note: women of childbearing potential must have a negative pregnancy test within seven days of enrollment.

Keywords: left ventricular lead pacing heart failure
immunogenicity and safety of an adjuvanted inactivated subunit influenza vaccine to those of a non-adjuvanted inactivated subunit influenza vaccine, when administered to adults affected by chronic diseases

Conditions: Influenza Disease

Summary: this phase iii is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of novartis vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.


Eligibility criteria:
inclusion criteria: * 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases:moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstructive pulmonary disease (copd) or moderate to severe asthma, moderate to severe hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus exclusion criteria: * hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine; * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; * known or suspected impairment/ alteration of immune function; * any condition which might interfere with the evaluation of the study objectives

Keywords: influenza influenza vaccine adjuvanted influenza vaccine h5n1 influenza antigen
pedometer assisted physical activity in individuals with copd. a multicenter randomized controlled trial.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: home based and tele-rehabilitation programs may be potentially useful to deliver and to maintain the benefits in difficult-to-reach areas. tele-health technologies allow for distribution of healthcare services and exchange of information between healthcare providers and patients in different geographical locations and provide an important tool to reach people living in rural communities. in a previous single center study, we had shown that a home pedometer assisted program to enhance physical activity was as effective as and cheaper than a standard outpatient supervised exercise training program.13 we wondered whether the results of that study 13 might be confirmed in a larger multicenter randomized controlled trial (rct). therefore the aim of this multicenter rct was to evaluate the benefits and costs of a program of pedometer assisted physical activity as compared to standard hospital outpatient supervised exercise training program.

a multicenter rct was conducted in moewardi (surakarta, central jawa, indonesia) and mohammad rabain (muara enim, south sumatra, indonesia) hospitals from february the 1st, 2019 to february the 29th 2020. the study was performed according to the helsinki declaration, approved by the committee of moewardi hospital, surakarta, central jawa, indonesia (number 713/ix/hrec/2018, september 26th, 2018 and indonesian ministry of health).participants with copd as defined by the global initiative for chronic obstructive pulmonary disease (gold) guidelines and eligible for this study were allocated into two groups using a randomly generated sequence. before and after the program, the following outcome measures; 6mwt, bode, physical activity, mrc and cat score.

Eligibility criteria:
inclusion criteria: * individuals with copd as defined by the global initiative for chronic obstructive pulmonary disease (gold) guidelines,2 40-80 years old, were recruited from the outpatient clinics of moewardi and mohammad rabain hospitals. * all subjects had to be in stable conditions as assessed by absence of worsening in symptoms, i.e. no change in cough, and/or sputum beyond day-to-day variability which would have been sufficient to warrant a change in the management prescribed at discharge from hospitals or prescribed at home by their gp, and stability in blood gas values (e.g. no respiratory acidosis). exclusion criteria: * individuals refusing to participate, participated in a pulmonary rehabilitation program during the previous 6 months, or with active malignancy, previous lung surgery, unstable cardiovascular diseases, orthopaedic and/or neuromuscular diseases interfering with their ability to walk, or inability to connect with internet and operate whatsapp video call applications were excluded.

Keywords: pulmonary rehabilitation; tele-medicine; exercise capacity; dyspnoea; quality of life
exercise training on metabolic syndrome severity in employees

Conditions: Metabolic Syndrome

Summary: hypothesis: an occupational 6 months physical exercise training will lead to better health behaviour and improve the severity of the metabolic syndrome. 312 subjects will be assigned to either an intervention or a waiting-control-group. the intervention group will receive instructions with the aim to perform 150 min exercise training per week. exercise consists of endurance, strength and coordination training. a feedback system guided by sports scientists will be installed for all subjects in the intervention group using activity monitoring (wearable). after 6 months training subjects from the intervention group will be assigned to one of the following groups for follow-up observation from month 6 to months 12: * training with personal/individual feedback from sport scientist * training with automated feedback using activity monitoring tools (wearable) * training without further feedback subjects assigned to the control group will be provided with information on low intensity motion exercises. after 6 months in the control group subjects will be provided with the same exercise intervention as the intervention for a duration of 6 months. study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at month 24..


Eligibility criteria:
inclusion criteria: * 3 out of 5 parameters of the metabolic syndrome exclusion criteria: * ongoing participation in occupational health service * clinical relevant acute or chronic infections * pregnancy * surgery dating back less than 8 weeks * artificial joint replacement dating back less than 6 months * tumor disease dating back less than 5 years * every other disease or relevant functional disorder not allowing to participate in regular physical exercise

Keywords: metabolic syndrome exercise training employees workplace operational health service