Kornimate/medical-research-clean huggingface dataset:
a pilot study exploring the efficacy and safety of herbal medicine on korean obese women with metabolic syndrome risk factors - double blinded, randomized, multicenter, placebo controlled clinical trial -

Conditions: Metabolic Syndrome; Obesity

Summary: the purpose of this trial is to investigate the efficacy and safety of daesiho-tang and taeeumjowi-tang on korean obese women with metabolic syndrome risk factors


Eligibility criteria:
inclusion criteria: * female aged 18 to 65 years * subject must included at least one or more of the following symptoms below * bmi of 30 kg/㎡ or more; * bmi between 25 and 29.9kg/㎡ with hypertension, taking medication or sbp ≥ 140mmhg or dbp ≥ 90mmhg at the screening visit * bmi between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose \> 126mg/dl at the screening visit * bmi between 25 and 29.9kg/㎡ with hyperlipidemia, taking medication or total cholesterol ≥ 200mg/dl or triglyceride ≥ 150mg/dl at screening visit * agreed to low-calorie diet during the trial * written informed consent of the trial exclusion criteria: * endocrine diseases associated with weight gain, such as hypothyroidism, cushing's syndrome, etc. * heart disease (heart failure, angina pectoris, myocardial infarction) * cholelithiasis * severe renal disability (scr \> 2.0 mg/dl) * severe liver disability (2.5 fold of normal high range value on alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], alkaline phosphatase) * history of narrow angle glaucoma * history of stroke or temporary ischemic cardioplegia * history of eating disorder such as anorexia nervosa or bulimia nervosa, etc. * use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion) * use of cns stimulant medication for weight loss * forbidden treatment (insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse) * history of weight loss surgery, such as bariatric surgery, etc. * subjects who are judged to be inappropriate for the clinical study by the researchers * women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, iud, spermicide, condom, abstinence, etc.) * use of other investigational product within last 1 month * 10 percent reduction in body weight over 6 months * decided to quit smoking over the last 3 months or have irregular smoking habits

Keywords: metabolic syndrome daesiho-tang taeeumjowi-tang korean medicine
the avoiding diabetes thru action plan targeting pilot randomized control trial

Conditions: Prediabetes

Summary: the goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.

the adapt (avoiding diabetes thru action plan targeting) trial is an innovative study that leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy of primary care providers. using principles of behavior change theory and persuasion technology, the multidisciplinary design team utilized in-depth interviews and in-vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. the core element of the tool is a streamlined shared goal setting module within the electronic health record system. the system also utilizes a pre-encounter patient behavior change goals elicitation survey to help tailor the goal setting session to patient preferences and encourage shared decision making. the patients also interact with a website that collects their longitudinal behavior change data and visualizes their progress over time and in comparison to other study members. the adapt system utilizes the influential powers of goal setting, tailoring, reminders, social comparisons, testimonials and other methods to integrate evidence based behavior change principles and persuasion techniques into routine primary care clinical encounters. if successful, the adapt system may represent an adaptable and scalable technology-enabled behavior change tool for all primary care providers.

Eligibility criteria:
inclusion criteria: * prediabetes exclusion criteria: * age\<18 * diabetes
post-cholecystectomy quality of life

Conditions: Gallstone

Summary: the study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.


Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy patients * indication for operation symptomatic gallstones exclusion criteria: * previous complication of gallstone disease * indication for cholecystectomy other than symptomatic gallstones * illness significantly lowering quality of life * inability to fill in questionnaires * denies participation

Keywords: cholecystectomy quality of life
fish oil for the treatment of depression in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Depression

Summary: this study will determine whether fish oil can reduce depression in people with multiple sclerosis (ms) who are mild to moderately depressed and are currently taking antidepressant medication. study hypothesis: three months of fish oil supplementation will improve depression scores on the montgomery-asberg depression rating scale (madrs) or beck depression inventory (bdi) better than placebo.

depression occurs in 50% to 60% of all individuals with ms. evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. this study will determine the effectiveness of fish oil supplements in reducing depression in ms patients who are taking antidepressant medication. this study will last 3 months. participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. at the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. participants will do no respond to treatment will be excused from the study. all participants will remain on their antidepressants and ms medication throughout the study. participants will have weekly study visits. at each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. blood collection will occur at study start and at study completion.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting ms * diagnosis of depressive disorder * score between 11 and 30 on the montgomery-asberg depression rating scale (madrs) * score of 25 or greater on the mini-mental state examination (mmse) * currently taking antidepressant medication for at least 3 months prior to study entry exclusion criteria: * currently taking fatty acid supplements * consume more than 6 oz of fish per week within 1 month prior to study entry * severe depression * suicidal thoughts * other psychological disorders * currently taking more than two types of antidepressants * any serious medical condition that would interfere with the study * worsening of ms symptoms or corticosteroid treatment within 1 month prior to study entry * current enrollment in another fish oil study * pregnancy

Keywords: fatty acids, omega-3 fish oils complementary therapies
nsaids versus opioids in acute ser ii ankle fractures

Conditions: Ankle Fracture

Summary: this study is being conducted to evaluate whether nsaids are more or less effective in bone healing than opioids in acute fracture pain. participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

pain management in acute fractures is challenging and influenced by several factors contributing to pain perception. these factors include but are not limited to tissue damage by the local impact, mechanical stress at the fracture ends, and central perception of the noxious stimulus. tissue damage and mechanical stress leads to inflammation and further to local swelling. swelling itself is significant contributor in pain development. ideal pain management would attack pain development at most sites possible. the current clinical practice in the us applies a derivate of an opioid analgesic combined with acetaminophen, thereby influencing pain development at central perception by the opioid analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. the exact mechanism of the peripheral effect is not known. this clinical practice disregards the positive effect of medications influencing the peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (nsaids). nsaids affect pain development by blocking the synthesis of arachidonic acid metabolites, inhibiting peripheral inflammatory response and central pain perception. the major reason for not applying nsaids in the treatment of acute fracture pain is an experimental animal study showing decreased bone healing in relation to nsaid usage. however, clinical data thus far is inconclusive, whether bone healing is affected in humans and whether nsaids should be avoided in the setting of bone fractures. this proposed study will give an answer whether the usage of nsaids in acute fractures has a negative effect on bone healing.

Eligibility criteria:
inclusion criteria: * age \> 18 to \< 60 * isolated ankle fracture type ser ii * ability to speak and understand english * bmi\< 35 exclusion criteria: * asa\>3 * previous or acute gastric bleeding * renal insufficiency (creatinine: \>1.27mg/dl) * liver insufficiency (child-pugh-wert: 10-15) * malignant tumor * rheumatoid arthritis * heart failure (nyha iii-iv) * high frequency absolute arrhythmia * patients with known psychiatric illness * coagulopathy * asthma * function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria * adults unable to consent * pregnant women * prisoners * workers comp patient * early fracture displacement (within first 2 weeks) indicating need for surgery * polytrauma * concurrent participation in another clinical trial
phase ii safety and efficacy study of 18fdopa pet-ct in children with hyperinsulinemic hypoglycemia

Conditions: Congenital Hyperinsulinism (CHI); Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)

Summary: children with congenital hyperinsulinism (chi) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. in this study, researchers will test how well a radioactive drug, 18-labeled l-fluorodeoxyphenylalanine (called f-dopa) can detect a form of hyperinsulinism (focal hi) that may be cured by surgery. eligible participants in this study will have positron emission tomography/computerized tomography (pet/ct) scans with f-dopa prior to surgery.

for children with congenital hyperinsulinism (chi), low blood sugar is caused by cells in the pancreas that release too much insulin. some children with chi have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). children who have focal disease located in specific areas of the pancreas may be cured with surgery. f-dopa is a radioactive drug that is picked up by these cells and used for positron emission tomography (or pet), an imaging technique used in nuclear medicine departments. in this study, researchers will validate the efficacy and safety of using pet/ct with f-dopa in the pre-operative localization of focal disease in children with hyperinsulinism.

Eligibility criteria:
inclusion criteria: * infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy exclusion criteria: * pregnant or lactating females * any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.

Keywords: congenital hyperinsulinism (chi) hyperinsulinism persistent hyperinsulinemic hypoglycemia of infancy (phhi) chi phhi pancreatectomy 18f-dopa pet/ct scan
galectin-3 as a biomarker in patients with chagas disease

Conditions: Chagas Disease

Summary: the purpose of this study is to analyze the efficacy of galectin-3 as a biomarker on the chagas disease prognosis. this analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

previous studies indicate that activated macrophages secrete galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. its plasmatic levels are increased on patients with acute decompensated heart failure. these observations suggest that measuring levels of galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. to investigate the role of this new biomarker in chagas disease, we will study a chagas disease population (including patients with the indeterminate and cardiac form of the disease). the assessment of the prognostic value of galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests. the patients included in the study must at first sign the written consent. they shall be accompanied in the specialized outpatient clinics for chagas disease - hospital são rafael - centro de biotecnologia e terapia celular. they will be submitted to several tests, including: * collection of blood samples for biochemical analysis; * electrocardiogram; * holter electrocardiogram; * echocardiogram; * treadmill test; * x-ray imaging; * magnetic resonance imaging; * evaluation of the quality of life through the application of questionnaires (sf 36 and the minnesota living with heart failure questionnaire).

Eligibility criteria:
inclusion criteria: * chagas disease diagnosis confirmed by 2 different serologies * diagnosis of indeterminate form or cardiac form, with and without ventricular dysfunction. exclusion criteria: * significant valve disease defined as aortic stenosis with a gradient of ve/ao \> 50 mmhg * mitral stenosis with a valve area inferior than 1,5 cm2 * severe or moderate aortic and/or mitral regurgitation * chronic use of immunosuppressive agents * dialysis treatment of terminal renal failure * fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the accp/sccm (american college os chest physicians/society of critical care medicine) * current abusive use of alcohol or illicit drugs (based on the dsm iv) * any other comorbidities that impact patient's survival within the next 2 years * liver disease in activity * continuous use of steroids as treatment for copd * hematologic, neoplastic or bone diseases * homeostasis disturbances * inflammatory diseases or chronic infectious diseases

Keywords: galectin-3 chagas disease biomarkers
a study of the effects of canagliflozin (jnj-28431754) on renal endpoints in adult participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Albuminuria

Summary: the purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with type 2 diabetes mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

the study will be conducted in adult participants with type 2 diabetes mellitus (t2dm), receiving standard of care for hyperglycemia and cardiovascular (cv) risk factors, who have either a history of a prior cv event or 2 or more risk factors for a cv event. participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. canagliflozin will be provided at a dose of 100 mg/day through week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose. the study consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between canvas and canvas-r. a total of 5,700 participants are targeted to be recruited into the study. participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels. the completion target was reached in february 2017.

Eligibility criteria:
inclusion criteria: * must have a diagnosis of type 2 diabetes mellitus * must have inadequate diabetes control (as defined by glycosylated hemoglobin level \>=7.0% to \<=10.5% at screening) * greater than or equal to (\>=) 30 yrs old with history of cardiovascular (cv) event, or \>= 50 yrs old with high risk of cv events * must be either not on antihyperglycemic agents (aha) therapy, or on aha monotherapy, or combination aha therapy with any approved agent for the control of blood glucose levels. exclusion criteria * history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * history of one or more severe hypoglycemic episode within 6 months before screening * history of hereditary glucose-galactose malabsorption or primary renal glucosuria * ongoing, inadequately controlled thyroid disorder * renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant * myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.

Keywords: albuminuria canagliflozin cardiovascular outcomes type 2 diabetes mellitus t2dm jnj-28431754 antihyperglycemic agent
investigation of fatigue, physical activity, sleep quality and anxiety levels

Conditions: Multiple Sclerosis; Covid-19

Summary: hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in wuhan, china. just like other members of the community, ms patients are uncomfortable with the emotional distress and health anxiety caused by the covid-19 outbreak. most ms patients receive immunosuppressive or immunomodulatory therapies. patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. moreover, ms patients lose social support. patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. we also know that increased anxiety and sleep disorders can cause ms patients to have an attack. when literature is examined, it is known that ms patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. ms patients lose social support during the covid-19 outbreak. for all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the covid-19 outbreak will be further affected for these reasons.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of clinically definite ms, physician-administered expanded disability status scale (edss) range of 1-5, and following the instructions. exclusion criteria: * patients with acute attacks (three months prior to the study) and those included on the physiotherapy program during the covid-19 pandemic.

Keywords: multiple sclerosis covid-19 pandemic fatigue physical activity sleep quality anxiety
pharmacokinetic study of aprepitant in bep treatment of patients with testis carcinoma (a-bep)

Conditions: Nausea; Vomiting

Summary: the purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard bep regimen. also to determine how long treatment with aprepitant is necessary in bep regimen for 5 consecutive days.

aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.more recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with bep. there are, however, no published data available for the use of aprepitant in this situation.

Eligibility criteria:
inclusion criteria: * between 18 and 75 years of age * able and willing to sign informed consent form * subject has an indication for treatment with bep regimen * subject is expected to receive at least 2 cycles of bep regimen * subject is able to swallow capsules exclusion criteria: * documented history of sensitivity/idiosyncrasy to aprepitant or excipients * relevant history or condition that might interfere with drug absorption * history of or current abuse of drugs, alcohol or solvents * inability to understand nature and extent of the trial and the procedures * participation in a drug trial within 30 days prior to the first dose * febrile illness within 3 days before the first dose * use of agents that are known to interfere with aprepitant pharmacokinetics * abnormal liver or renal function

Keywords: nausea and vomiting after using cytostatic drugs