Kornimate/medical-research-clean huggingface dataset:
a study to assess safety, tolerability and pharmacokinetics of of azd6553 in healthy volunteers and patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: azd6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (copd). copd refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. this leads to a limitation of the flow of air to and from the lungs causing shortness of breath. in contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. there is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with copd. azd6553 acts by reducing the activity of a protease found to be involved in the disease process in copd. azd6553 is being developed as a novel oral treatment to control the symptoms and exacerbations of copd, and reduce the progression and severity of the disease. the purpose of this research study is to determine how safe and well-tolerated azd6553 is and how much azd6553 enters blood circulation by collecting blood and urine samples during the study. we are also investigating what azd6553 is broken down into, when given orally, how much of the drug is cleared from the body via the kidneys, and the effect of taking the drug after food. this will all be done by analysis of blood and urine samples taken at various point during the study.


Eligibility criteria:
inclusion criteria: * parts a and b only; body mass index (bmi) between 18 and 30 kg/m2. * parts a and b only; normal physical examination, laboratory values, and vital signs (blood pressure and pulse) unless the investigator considers an abnormality to be clinically irrelevant. * part c only; clinical diagnosis of copd for at least one year and post-bronchodilator fev1 30 - 80% predicted, fev1/fvc ratio \< 70% exclusion criteria: * participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to visit 2, or participation in a method development study one month prior to visit 1 * part c only: an acute exacerbation or acute respiratory infection (upper or lower) in the 4 weeks prior to visit 1 or visit 2. * part c only: concomitant diagnosis of significant pulmonary disease other than copd, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis

Keywords: azd6553 chronic obstructive pulmonary lung respiratory disease placebo-controlled copd healthy volunteers copd patients
the effect of vitamin d repletion on small low density lipoprotein (ldl) particle number in subjects at elevated cardiovascular risk

Conditions: Atherosclerosis

Summary: vitamin d is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. it is also produced in the body when ultraviolet rays from sunlight strike the skin and trigger vitamin d synthesis. vitamin d is essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and bone growth. without sufficient vitamin d, bones can become thin, brittle, or misshapen. vitamin d sufficiency prevents rickets in children and osteomalacia in adults. together with calcium, vitamin d also helps protect older adults from osteoporosis. many people have low levels of vitamin d. replacing vitamin d is thought to help lower the risk of heart disease. vitamin d may be helpful, but it could also be harmful. the investigators are studying the effect of vitamin d on the level of a harmful kind of cholesterol. participants will have their cholesterol levels measured and then receive either vitamin d or a placebo. after 2 months of treatment, the investigators will measure their cholesterol levels again.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years and \< 85 years 2. vitamin d 25-oh level \<20 ng/ml 3. one of the following risk factors: * known coronary artery disease (cad) or a cad equivalent (e.g. diabetes, chronic kidney disease, etc) * bmi \> 30 kg/m2 * random glucose level \> 200mg/dl * increased waist circumference (male: \> 40in; females: \> 35in.) * decreased hdl (male: \< 40mg/dl; female: \< 50mf/dl) * framingham risk score \> 10% * hscrp \> 2 mg/l exclusion criteria: 1. serum phosphorus level \> 5.5 mg/dl 2. estimated gfr \<30 ml/min/1.73m2 3. use of vitamin d \>400 iu/day within 1 month of most recent vitamin d 25-oh determination 4. use of calcitriol or other "activated" vitamin d 5. change in statin, ezetimibe, niacin, fibrate dose within 1 month 6. concurrent participation in an investigational drug study 7. have any other condition, which in the opinion of the investigator, should prohibit the participation in the study 8. serum calcium level \>10.5 mg/dl 9. anti-epileptic medication 10. triglycerides \> 400 mg/dl 11. bmi \> 40 kg/m2 12. evidence of cirrhosis as evidenced by ast \> 3 x upper limit, alt \> 3 x upper limit, bilirubin \> 1.5 mg/dl , albumin \ 14.5 sec 13. pregnant or lactating females
investigating the pharmacokinetics of subcutaneous injections with 1 mg/ml, 3 mg/ml, and 10 mg/ml semaglutide strengths and the absolute bioavailability of semaglutide

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator) * age between 18 and 55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 20 and 30 kg/m\^2 (both inclusive) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner * any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide * history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test * history of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 ml of beer or lager, one glass (120 ml) of wine, or 20 ml spirits) * smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test
effectiveness of telemedicine home assessments for identification and reduction of asthma triggers

Conditions: Asthma in Children

Summary: the study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. interactive video (iav) defines telemedicine. it allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. it is similar to using face time on a mobile device. asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. reducing these triggers in the home can improve asthma.

in this study, supplies will be given to some participants to help reduce or remove triggers from the home. one example is dust mites. these are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. this study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.

Eligibility criteria:
inclusion criteria: 1. age ≥ 5 years and ≤ 18 years 2. have a diagnosis of persistent asthma as defined by national guidelines criteria1 3. patient receives care in arkansas children's hospital (ach) primary care, in patient and/or specialty clinics 4. patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids 5. english speaking participants/parents 6. access to wifi, smartphone or mobile device (tablet) exclusion criteria: 1. age \ 18 years 2. non-english speaking participants/parents 3. patients not receiving primary and/or asthma specialty care or inpatient services at ach 4. inability of patient or family to participate in tm evaluation due to lack of access to wifi or smartphone or mobile device

Keywords: asthma telemedicine
a study of pulmonary arterial hypertension participants treated with macitentan or selexipag

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: world health organization functional class (who/fc), 6-minute walk distance (6mwd), brain natriuretic peptide (bnp) or n-terminal pro-brain natriuretic peptide (nt-probnp).


Eligibility criteria:
inclusion criteria: * participants in the clinical classification of pulmonary hypertension group 1 (pah) * participants with idiopathic, heritable and associated forms of pah (connective tissue disease, congenital heart disease corrected at least 1-year ago, human immunodeficiency virus infection, drug use or toxin, and porto-pulmonary) * confirmed diagnosis of pah with hemodynamic study right heart catheterization (rhc) at enrolment or at latest follow-up (not later than twelve months from enrolment date) * participants with a low or intermediate mortality risk profile, as per clinical judgement based on a multiparametric approach including clinical, functional exercise, right ventricular function and hemodynamic parameters * participants currently in treatment with selexipag and/or macitentan (in monotherapy or in combination therapy) exclusion criteria: * participants in group 1 that are responders to the vasoreactivity test * participants with pulmonary veno-occlusive disease (pvod), defined on the basis of the following chest findings at high-resolution computed tomography (hrct): centrilobular ground-glass opacities, smooth thickening of interlobular septa, mediastinal lymph node enlargement * participants already in treatment with subcutaneous/intravenous prostanoids. iloprost interventional (iv) (treatment of digital ulcers in systemic sclerosis \[ssc\] participants according to european league against rheumatism \[eular\] guidelines) is allowed * participants currently enrolled in an interventional study
the relationship between brain volume and sensory integration in autistic and attention deficit hyperactivity disorder.

Conditions: Sensory Integration Dysfunction

Summary: the relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study

detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. also detect relationship between changes in brain and sensory disintegration in each group.

Eligibility criteria:
inclusion criteria .diagnosis of autism spectrum disorders /adhd verified and confirmed on a clinical basis. . willing of the parents or the caregivers to participate in the study. exclusion criteria: .children with intelligence quotient below 70. .children with history or current substance use. .children with medical or other neurological conditions. .children with history of preterm labour (as brain volume lower than term delivery). -

Keywords: sensory disintegration
functional goat cheese effect in lipid profile change

Conditions: Obesity and Overweight

Summary: the purpose this study was to evaluate the therapeutic effect of a functional goat cheese on obese and overweight people with altered lipid profile. the functional goat cheese containing polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit cardiovascular health of people who need to normalize lipid profile; which in the long term can contribute to the prevention of cardiovascular diseases.

a randomized, parallel, double-blind, controlled is being performing to evaluate the effect of a functional goat cheese on lipid profile in overweight or obese volunteers who need a special diet. were included 60 volunteers (men and women) aged between 18 and 65 years (imc ≥27\<40 kg/m2) with a cardiovascular risk (\<10%). the volunteers are being followed at la paz university hospital of madrid. for 12 weeks, the volunteers should consume 60 g of cheese daily (functional cheese or control cheese) and to receive advice to follow a balanced and individualized hypocaloric diet as well as physical activity.

Eligibility criteria:
inclusion criteria: * volunteers with overweight type ii or obesity type i or ii (imc ≥27\<40 kg/m2). * cardiovascular risk \< 10% and almost two of follow factors: men ≥ 45 years old or women ≥ 55 years old; familiar background of premature cardiovascular disease; hdl cholesterol \<40 mg/dl for men and \<50 mg/dl for women; total cholesterol ≥ 200 mg/dl; triglycerides ≥ 150 mg/dl and \< 200 mg/dl; ldl ≥ 130 mg/dl and \< 160 mg/dl; smoker * accept advises to perform a balanced hypocaloric diet and regular practice of physical activity. * signed informed consent. exclusion criteria: * individuals with diabetes mellitus type 1; * individuals with diabetes mellitus type 2, using medication; * individuals with dyslipidemia, using drug; * individuals with high blood pressure, using medication; * individuals with allergies to dairy protein; * individuals with severe diseases (hepatic, kidney, cancer...); * individuals with drugs or supplements consumption to weight lost; * individuals that consume drugs, ω-3 supplements or supplement that can modify the lipid and / or glucose profile (statins, fibrates, diuretics, corticosteroids, insulin...); * individuals who have participated in programs and / or clinical trials of weight control in the last 6 months; * individuals with increased alcohol consumption 30g/day; * individuals that stop smoking in the next 20 weeks (during the study); * individuals with mental disease or low cognitive function; * pregnant women or breastfeeding; * individuals with intensive physical activity; * individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
assessing the usability and reliability of the prototype prosthesis devices

Conditions: Amputation; Traumatic Amputations; Leg Amputation

Summary: the aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. the prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years; * lower limb amputation at the transfemoral or transtibial level; * functional medical classification: level k3-k4 \[25\]; * subjects wearing a prosthesis for at least 1 year (experienced wearers); * maximum body weight 100 kg. exclusion criteria: * significant medical comorbidities: presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits. * implanted cardiac devices: individuals with implanted pacemakers or cardioverter-defibrillators. * cognitive impairment: individuals with a mini-mental state examination (mmse) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation. * severe depressive symptoms: individuals with a beck depression inventory-ii (bdi-ii) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research. * severe anxiety symptoms: individuals with a state-trait anxiety inventory (stai-y) score less than 50, indicating clinically significant anxiety that may interfere with research participation. * inability or unwillingness to provide informed consent: individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.
pilot study of tearcare system - long-term extension

Conditions: Dry Eye Syndromes

Summary: the objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the tearcare™ system in adult patients with dry eye syndrome who had previously been treated with the tearcare system.


Eligibility criteria:
inclusion criteria: * previously enrolled in the tearcare arm of the tearcare pilot study * reports dry eye symptoms within 3 months of the baseline examination with a standard patient evaluation for dryness (speed) score ≥ 6 * tbut of \<10 seconds in at least one eye * willing to comply with the study, procedures, and follow-up * willing and able to provide consent exclusion criteria: * any active ocular or peri-ocular infection or inflammation * recurrent eye inflammation within the past 3 months * ocular surgery, oculoplastic surgery, ocular injury, ocular herpes simplex, or herpes zoster * ocular surface abnormalities that may affect tear film distribution or treatment * abnormal eyelid function in either eye * diminished or abnormal facial, periocular, ocular or corneal sensation * ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies * systemic diseases resulting in dry eye (e.g. sjogren's syndrome) * allergies to silicone tissue adhesives * an absence or fibrosis of the meibomian glands (e.g. ectodermal dysplasia). * unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. accutane, antihistamines, etc.) * anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days. * unwillingness to washout and remain off certain dry eye medications for the duration of the study. * participation in another ophthalmic clinical trial within the past 30 days * co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)
efficacy and safety of dwj1252 in the treatment of functional dyspepsia (part 2)

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to evaluate the efficacy and safety of dwj1252 in treatment of functional dyspepsia.


Eligibility criteria:
inclusion criteria: * male and female of at least 19 years old * patient with functional dyspepsia met the rome iii criteria exclusion criteria: * patients with previous gastrointestinal surgery * patients with history of gastrointestinal bleeding, mechanical obstruction, perforation * patients with history of gastrointestinal cancer
efficacies of entecavir add on hbeag negative patients with hbv dna positive during peginterferon alpha 2a treatment

Conditions: Chronic Hepatitis B

Summary: the aim of interferon therapy in hbeag negative chronic hepatitis b was to make patients obtain immune control to hepatitis b virus defined as sustained viral response after treatment. however this target could not be get if patients keep hbv dna positive during interferon treatment and offend relapse after treatment withdraw. in this trail, entecavir will add on patients with hbv dna load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

hbeag negative patients with hbv dna load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks and followed 24 weeks after treatment. serum hbv dna load, hbsag/anti-hbs level, hbeag/anti-hbe will be tested at enrollment and every 3 months during the treatment course. parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. the efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.

Eligibility criteria:
inclusion criteria: * hbeag negative patients with hbv dna load ≥1000copies/ml after 3 months of peginterferon a-2a treatment exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b peginterferon sustained viral response entecavir hbeag