Kornimate/medical-research-clean huggingface dataset:
a real world experience of dapagliflozin in type 2 diabetes

Conditions: Type2 Diabetes

Summary: type 2 diabetes mellitus (t2dm) is creating a health pandemic globally. management of type 2 diabetes involves combination of lifestyle intervention and drug intervention, which includes sodium-glucose transporter 2 (sglt-2) inhibitors, such as dapagliflozin. dapagliflozin (forxiga®) was approved by the malaysian drug authority for the treatment of type 2 diabetes in 2014. this study will describe the characteristics of patients who are prescribed dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe their glycaemic control, weight, and renal function at baseline and during use of dapagliflozin.

the prevalence of type 2 diabetes among adults \>18 years old is 17.5% in malaysia, where half of them are undiagnosed. diabetes also accounts for 14.5% of all-cause mortality worldwide, with close to half of the deaths are in subjects \<60 years old. these highlight the importance of early diagnosis of disease, timely intervention with appropriate therapy, and treating type 2 diabetes patients to goal to prevent the development of complications. asian type 2 diabetes phenotypes are different than caucasians, i.e. significant pancreatic beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal complications. although clinical trials of sglt-2 inhibitors have been published, real-world data on the use of this new class of antidiabetic medication is still lacking, in particularly among asians.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm prior to the first prescription of dapagliflozin * patients with t2dm who are initiated with dapagliflozin from march 2014 till december 2015 * patients need to be on dapagliflozin therapy for at least six consecutive months from the index date * patients need to have diabetologists/endocrinologists' follow up for at least six months after the initiation of dapagliflozin exclusion criteria: * patients with t2dm who are initiated with dapagliflozin after december 2015 * patients with incomplete electronic medical records * patients with type 1 diabetes * patients with latent autoimmune diabetes of adults (lada) * female patients with t2dm who are found to be pregnant during the treatment period of dapagliflozin

Keywords: pragmatic, sodium-glucose transporter 2 inhibitor, malaysia
actual use trial of atorvastatin calcium 10 mg

Conditions: Hypercholesterolemia

Summary: the purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.


Eligibility criteria:
inclusion criteria: * at least 18 years of age (19 in alabama). * provide written informed consent. * never participated in a study about cholesterol medicines. exclusion criteria: * females subjects who are pregnant or breastfeeding. * subjects with active liver disease. * subjects taking cyclosporine. * subjects with a known allergy to atorvastatin calcium.

Keywords: atorvastatin hypercholesterolemia
clinical & community approaches to weight management

Conditions: Overweight and Obesity

Summary: this project seeks to build on innovative strategies to optimize the care of low-income children with a bmi ≥ 85th percentile. to accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the integrated clinical and community systems of care model, to address obesity through optimized screening and management known to be effective, e-referrals, healthy weight clinics, and the ymca's healthy weight and your child weight management program (originally known as mend). the study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of \>7 million children with obesity covered by the children's health insurance program or medicaid.

this is a 2-arm rct. enrolled patients are randomized to a pediatric weight management intervention (pwmi): 1)a healthy weight clinic based at a federally-qualified health center (fqhc), or 2) a modified healthy weight and your child intervention delivered in ymcas. a comparison sample of children receiving care in eight demographically similar fqhcs serve as a comparison group.

Eligibility criteria:
inclusion criteria: * child is age 6.0 through 12.9 years at referral * child's bmi meets or exceeds the 85th percentile for age and sex * parent can read and respond to interviews and questionnaires in english and spanish exclusion criteria: * children who do not have at least one parent who is able to follow study procedures for 1 year * families who plan to leave their primary care health center within the study time frame * families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties * children who were taking medications that substantially interfere with growth * children who have a sibling enrolled in the study.
a study to investigate the safety and tolerability of ly3938577 in healthy participants and participants with type 2 diabetes mellitus

Conditions: Healthy; Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to assess the safety and tolerability of a single dose of ly3938577 in healthy participants and participants with type 2 diabetes mellitus (t2dm) (part a) and multiple doses of ly3938577 in participants with t2dm (part b). the study will last approximately 6 weeks for part a and approximately 10 weeks for part b respectively.


Eligibility criteria:
inclusion criteria: * male and female participants who are overtly healthy as determined by medical evaluation (part a) * participants with t2dm diagnosed greater than 1 year before enrollment (part a and part b) * have a body mass index within the range of 18.5 to less than or equal to (\<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for t2dm participants. * male or female participants of nonchildbearing potential exclusion criteria: * have proliferative retinopathy or maculopathy and/or severe neuropathy * have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or insulin within the previous 3 months * have received chronic systemic glucocorticoid therapy in the past 3 months * are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.
a study to assess the safety and efficacy of enantone (leuprorelin) in central precocious puberty (cpp) among chinese participants

Conditions: Central Precocious Puberty

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of enantone in the treatment of cpp in chinese participants.

the drug being evaluated in this study is called enantone (leuprorelin). enantone is used to treat children who have cpp. this study will look at long term safety and efficacy of leuprorelin in the treatment of chinese participants with cpp. the study will enroll approximately 300 participants. all participants who have received leuprorelin 30 mcg/kg to \<90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from september 1st 1998 to september 30th 2018 will be observed. this multi-center trial will be conducted in china. data will be collected over period of 20 months.

Eligibility criteria:
inclusion criteria: 1. has diagnosis of idiopathic cpp. 2. has been treated with leuprorelin acetate (enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to \[\>=\] 90 mcg/kg up to 180 mcg/kg) or low dose (\< 90 mcg/kg down to 30 mcg/kg). 3. has initiated and completed treatment during the index period from september 1st 1998 to september 30th 2018. 4. have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: tanner staging, estradiol or testosterone level, and fsh and lh level. the participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (gnrha) therapy with enantone to support the diagnosis of cpp. in addition, should have at least one record of bone age during treatment with enantone. exclusion criteria: 1. has been treated with leuprorelin acetate or any other gnrha for conditions other than cpp. 2. has used any other gnrha products for cpp treatment prior to initiation of enantone therapy. 3. cpp participants with identified etiology, such as brain tumor or cranial irradiation.

Keywords: drug therapy
comparison of microbiota and quality of life for a low fodmaps and standard dietary in irritable bowel syndrome patients

Conditions: Food Habits

Summary: ibs is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.at present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (fodmaps) can induce ibs symptoms.data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

ibs is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.at present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (fodmaps) can induce ibs symptoms.data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence. this study will compare the effect of low fodmaps diet and usual diet instruction on intestinal flora, intestinal short chain fatty acids and quality of life by two groups.the results will answer the effect and long-term safety of low fodmaps diet.

Eligibility criteria:
inclusion criteria: * diagnostic criteria for rome ⅲ * ibs patients with diarrhea type * by endoscopy, x-ray, b ultrasound and laboratory examination to exclude organic disease * patients be able to communicate well with the researchers and be willing to participate in the study exclusion criteria: * stomach, small intestine, colon surgery history * irritable bowel disease (ibd) active period, celiac disease * alcoholics or drug abuse * pregnant or lactating women * recent drug users who use defecation * have a special diet
a study to test the design, functionality, and ergonomic features of the autoinjector

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Psoriasis

Summary: the main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. however, no active medicine is given by the autoinjector.

this device (called an autoinjector) automatically injects medicine under the skin with a sterile needle, and is similar to other types of autoinjectors currently being used for this purpose. this trial has been designed to make sure that people, who are likely to use this device, are able to self-inject and understand the training material. a total of 68 subjects took part in the study. about half (30 patients) will have either rheumatoid arthritis (ra), psoriatic arthritis (psa) or ankylosing spondylitis (as) and the other half will have psoriasis (a type of skin disease), since this device will be used by patients with one of these diseases to inject their medication. the study is designed to have each patient complete 2 self-injections with the autoinjector in 2 different sites-one in the front of the thigh and one in the abdomen 2 inches away from the navel. the order of the first injection location is decided by randomization. the patient will have an equal chance of having the thigh or the abdomen as the first injection. the study staff will assess the subject's safety prior to the patient leaving the clinic. two prefilled, 1ml placebo autoinjectors for subcutaneous injection

Eligibility criteria:
inclusion criteria: * have the capacity to understand and sign an informed consent form * have one of the following diagnoses: rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis, or psoriasis * be willing and able to self-inject exclusion criteria: * have a recent history of (within 6 months prior to study entry) or current diagnosis of a major bleeding or coagulation disorder * have a prior history of a inability to use an autoinjector * have an allergy to latex or any component of the autoinjector * female participants who are pregnant * are unwilling to complete the study assessments

Keywords: rheumatoid arthritis psoriatic arthritis ankylosing spondylitis psoriasis autoinjector
clinical performance of cre8 drug eluting stent in all comer population

Conditions: Stable Angina; Unstable Angina; Acute Myocardial Infarction

Summary: the aim of this study is to evaluate safety and efficacy performances of cre8 drug eluting stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * patients with symptoms of stable angina or documented silent ischemia; * patient with coronary artery disease ranging between 0 and 22 according to the syntax score; * patients with acute coronary syndrome, including unstable angina, nstemi and stemi; * patient is eligible for percutaneous coronary intervention (pci) and is an acceptable candidate for surgical revascularization (cabg); * left ventricular ejection fraction \> 30%; * target de-novo lesions with diameter stenosis \> 50% (including total occlusion); * target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm; * patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee of the respective clinical site. exclusion criteria: * female with childbearing potential or lactating; * known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium; * acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis); * thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder; * known significant gastro-intestinal or urinary bleeding within the past 6 months; * patient refusing blood transfusion; * patient currently under immunosuppressant therapy; * patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period; * co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; * participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; * patient underwent target vessel revascularization with a des within 3 months prior to the index procedure; * target lesion is located or supplied by an arterial or venous bypass graft.

Keywords: coronary artery disease drug eluting stent all comers patients
effect of pd-1 /pd-l1 inhibitor therapy before liver transplantation on acute rejection after liver transplantation in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Acute Rejection

Summary: this study is a single-center, prospective, non-interventional cohort study based on the real world data.in this study, 30 patients with a history of pd-1/pd-l1 monotherapy prior to liver transplantation and 30 patients without a history of pd-1/pd-l1 monotherapy prior to liver transplantation were recruited from the group of patients with hepatocellular carcinoma who had undergone allogeneic liver transplantation.collected patient data included demographics, oncology and immunotherapy history, evaluated index before liver transplantation, laboratory, pathological and imaging results at specific time points after transplantation (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 16 weeks, 24 weeks), as well as the occurrence of acute rejection (ar) , grading of severity, and anti-rejection treatment plan at the same time. endpoints included relapse-free survival and overall survival (os). these data aims to assess: 1) the incidence of acute rejection after liver transplantation in patients with hepatocellular carcinoma; 2) the time of acute rejection, banff classification, and acute rejection-related mortality after liver transplantation in patients with hepatocellular carcinoma; 3) the cellular immune function after liver transplantation;; 4) the dose and drug concentration of tacrolimus after liver transplantation in patients with hepatocellular carcinoma; and 5) the overall survival (os) and relapse-free survival(rfs) after liver transplantation in patients with hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years, 2. eastern cooperative oncology group (ecog) performance score ≤3, 3. voluntarily participate, totally understand in the study and sign the informed consent form (icf), 4. hepatopathology confirmed hepatocellular carcinoma after liver transplantation, 5）patients with hepatocellular carcinoma treated with pd1/pd-l1 monoclonal antibody prior to liver transplantation, 6）pd-1/pd-l1 monotherapy needs to be used ≥ 2 times (the patients were divided into observation and control group according to whether received pd-1/pd-l1 monoclonal antibody treatment before liver transplantation) exclusion criteria: 1. patients with incomplete clinicopathological data, 2. post-transplantation ≥6months, 3. pd-1/pd-l1 monotherapy required for oncological reasons after liver transplantation.
effects of synergy on nutrient intake and acceptability in phenylketonuria (pku)

Conditions: Phenylketonurias

Summary: phenylketonuria (pku) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (pah), which leaves them unable to convert phenylalanine (phe) into tyrosine (tyr). patients with mild pku or partly responsive to the drug synthetic tetrahydrobiopterin (bh4) (kuvan®) can change to a more relaxed diet. however due to difficulty to adapt their diet, these patients are at risk of an imbalanced nutritional status and an insufficient intake of specific micronutrients, essential amino acids and dha (docosahexaenoic acid). the study product is designed to improve the nutritional status of the patients. the study investigates if the nutritional status is indeed improved following 24 week use of the study product, and also the study aims to evaluate product acceptability.


Eligibility criteria:
inclusion criteria: 1. pku subjects identified by newborn screening and started low-phe diet before 3 months of age 2. pku subjects (with or without current aam use) with an increased phe-tolerance/intake due to: * mild pku phenotype * bh4 treatment 3. if treated with bh4, pku subjects should be on a stable bh4 treatment for at least 26 consecutive weeks up to start test product intake 4. age≥12 years 5. if subjects (irrespective whether bh4 users or mild pku) use amino-acid mixture(s; aam), then a maximum of 25 protein equivalents (pe) derived from the aam per day applies and usage on a daily basis for at least 26 consecutive weeks up to visit 1 6. if subjects (irrespective whether bh4 users or mild pku) use aams they should be capable and willing to substitute their current aam(s; maximum of 25 pe per day) with one portion of the test product per day 7. if subjects (irrespective whether bh4 users or mild pku) use omega-3, antioxidant, and/or vitamin supplements, to stop usage of the supplements and be able and willing to substitute with the test product 8. willing and able to comply with study procedures 9. willing and able to provide informed consent (and assent in case of minors if required by local law/regulations) 10. for women of childbearing potential: not to have the intention to become pregnant during the study exclusion criteria: 1. for women: currently pregnant or lactating 2. current or prior use of the test product within six weeks prior to entry into the study 3. concurrent conditions (including renal failure and severe hepatic failure) and medication that could interfere with participation, outcome parameters or safety (as determined by investigator) 4. psychotropic medication (i.e. medication affecting the nervous system) and inotropic medication 5. any condition creating high risk of poor compliance with study 6. participation in any other studies involving investigational or marketed products concomitantly or within six weeks prior to entry into the study. except for studies related to kuvan® (synthetic tetrahydrobiopterin (bh4)) without diagnostic, therapeutic or experimental intervention.
effects of exercise and cognitive training on cognitive function in older adults

Conditions: Aging; Alzheimer's Disease

Summary: the purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing alzheimer's disease.


Eligibility criteria:
inclusion criteria: * first or second-degree relative of someone with alzheimer's disease * not currently engaging in regular exercise * able to undergo an mri * fluent in english exclusion criteria: * neurological illnesses/conditions * medical illness/conditions that may affect brain function * any unstable or severe cardiovascular disease or asthmatic condition * severe depressive symptoms * inability to walk unassisted

Keywords: healthy aging
sleep quality, job satisfaction, quality of life, occupational burnout levels in individuals

Conditions: Physical Activity

Summary: the aim of this study is to compare sleep quality, job satisfaction, quality of life, occupational burnout levels among individuals who do or do not do exercise.

physical activity is very important in terms of healthy growth and development, protection from unwanted bad habits, socialization, protection from chronic diseases, and providing an active aging period. at the same time it increases the quality of life throughout life.especially in individuals who work in sitting position, the risk of physical activity decrease due to intensive working hours, time constraint, social insufficiency is even more risk.therefore, it is aimed to compare sleep quality, job satisfaction, quality of life, occupational burnout levels among individuals who do or do not do exercise.

Eligibility criteria:
inclusion criteria: healthy individuals; * between the ages of 25-65 years, * those who are in the profession group working for at least 8 hours, * who do the same job for at least 5 years, * individuals with no doctor-diagnosed skeletal system disease will be included. exclusion criteria: individuals; * below the age of 25 years and above the age of 65 years, * individuals with doctor-diagnosed skeletal system disease will be excluded.