Kornimate/medical-research-clean huggingface dataset:
intensive instruction on the use of aricept

Conditions: Alzheimer's Type Dementia

Summary: the purpose of this study is to examine the influence of the instruction on the use of aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.

to examine the influence of the instruction on the use of aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.

Eligibility criteria:
inclusion criteria: * diagnostic evidence of probable alzheimer's type dementia consistent with dsm-iv. * written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to japanese regulations as appropriate) prior to beginning screening activities. * patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution. * outpatients in their own home. exclusion criteria: * patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment. * known hypersensitivity to donepezil or piperidine derivatives. * involvement in any other investigational drug clinical trail during the preceding 12 weeks.
francelevo - zimino registry (fzr)

Conditions: Acute Heart Failure

Summary: the french national authority for health (haute autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with zimino®. this study is designed to provide real-life data on the use, safety and clinical outcomes of zimino® in routine clinical practice in france.

this is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving zimino® in france. the patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. the follow-up can be a phone call or a visit to the hospital. patients who meet the eligibility criteria will be identified consecutively at each hospital. the participating hospitals will vary in size and medical activities, depending on their location and the population size they serve. the physician will determine the patient's treatment strategy. drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians. the estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months.

Eligibility criteria:
inclusion criteria: * patients receiving zimino® treatment * patients or patient's families not objecting to the patient's participation in the study. exclusion criteria: * none

Keywords: low cardiac output syndrome cardiogenic shock
safety study in adolescent and adult patients with asthma

Conditions: Asthma

Summary: e004-c2 is a continuation of e004-c for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for e004 (epinephrine inhalation) versus placebo in a double-blinded manner.


Eligibility criteria:
inclusion criteria: * only subjects who have successfully completed the e004-c study within the last 135 days or those who are actively enrolled in the current study e004-c at the time of the study extension initiation * male and female asthma patients aged 12 - 75 years * patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment * no significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to screening * demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter * female patients of child-bearing potential must be non-pregnant and non-lactating at screening and throughout the study, and must use an acceptable method of contraception during the study exclusion criteria: * a smoking history of 10-pack years, or having smoked within 12 months of screening * any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma * concurrent clinically significant diseases * known intolerance or hypersensitivity to any component of the study drugs * recent infection of the respiratory tract, before screening * use of prohibited medications * having been on other investigational drug/device studies in the last 30 days prior to screening * known or highly suspected substance abuse

Keywords: asthma bronchial asthma shortness of breath
immunosuppressants to postoperative infection and death

Conditions: Organ Transplantation; Immunosuppressive Agents; Cohort Study

Summary: the goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in taiwan. the main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant. the study enrolled patients who underwent solid organ transplant (sot), kidney (icd-9-cm code v42.0), liver (icd-9-cm code v42.7), or lung (icd-9-cm code v42.6) transplants. we employed propensity score matching (psm) to establish a matched cohort. the study will compare sot patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.

this study used secondary data from the longitudinal health insurance database (lhid), a subset of the nhird provided by the health and welfare data science center (hwdc) of the ministry of health and welfare in taiwan. the hwdc encrypts personally identifying data to protect the privacy of beneficiaries. the database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of taiwan's national health insurance program. this program has provided coverage for up to 99% of the country's population since 1995. the nhird can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making. diagnostic data within the nhird from before 2016 and from 2016 or later are respectively coded using international classification of diseases, ninth revision, clinical modification (icd-9-cm) and international classification of diseases, tenth revision, clinical modification (icd-10-cm) codes. the database was provided by the hwdc under license and so cannot be made freely available. requests for access to these data should be made to hwdc (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html).

Eligibility criteria:
inclusion criteria: * patients who underwent solid organ transplant (sot) exclusion criteria: * patients who received more than one sot, had an infectious disease diagnosis before their sot or had incomplete medical information in the database.
assessing the benefits of a painless lancing device among diabetes patients

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and hba1c compared to the conventional lancing device.

self-monitoring of glucose forms the cornerstone of diabetes management. there are multiple limiting factors towards efficient self- monitoring of blood glucose, including cost barriers, inconvenience, investment of time, pain associated with pricking etc. pain has perceived as a major impediment to the self-monitoring of blood glucose. genteel lancing device offers a painless pricking experience and hence helps to report blood sugar values at least 4 times a day. the perceived pain sensitivity of the study subjects would be assessed using the 4- point pain screening questionnaire during the course of the study. the aim of this study is to gather information on the percentage reduction in hba1c values in diabetes patients as compared to the baseline values after three months and six months respectively brought about by percentage smbg adherence, defined as the percentage of total recorded smbg values as compared to the ideal number of readings over the 24-week period. smbg adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice weekly in type 2 subjects). smbg adherence can be provisionally attained by multiple pricking using painless genteel lancing device compared to the conventional lancing device. additionally, the subject is asked about the likelihood they would use the device if available for routine smbg practice in the future.

Eligibility criteria:
inclusion criteria: 1. less than or equal to 70 years of age. if minor (\<18 years), accompanied by caretaker. 2. diagnosed with either type 1 or type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects 3. presenting with an uncontrolled glycemic status (hba1c \>8.0%). 4. ready for self-monitoring of blood glucose (smbg) practices. 5. attending physician prescribed testing at least 2 times per day 6. judged by the study trainer to be competent to correctly use genteel and demonstrated to the trainer that the subject can use the genteel device properly. exclusion criteria: 1. more than 70 years and less than 5 years 2. hba1c \< 8.0% 3. unwilling for smbg.

Keywords: lancing device hba1c painless lancing smbg adherence
the effects of broccoli sprout extract on obstructive lung disease

Conditions: Asthma; COPD

Summary: the purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and copd.

asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. the economic burden for 2010 is estimated to run $20.7 billion. although steroids are the mainstay of treatment, they do not "cure" the disease. while inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. thus, the continuing focus on simply treating the inflammation is a barrier to progress. it is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks. one compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. preliminary data demonstrate that broccoli sprout extract (bse), rich in sulforaphane, improves airflow measures in asthmatics. we plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of bse, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by bse.

Eligibility criteria:
inclusion criteria: * asthma * copd exclusion criteria: * currently on chronic oral steroid medications * current respiratory symptoms * pregnant * fev1 less than 40% predicted at baseline * extreme degrees of bronchial hyperreactivity * recent respiratory infection (\<3 weeks) * unstable symptoms in the prior month * a history of intubation for respiratory symptoms within the past year * any history of cardiac disease.
a pilot study of the therapeutic potential of stem cell educator therapy in type 1 diabetes

Conditions: Diabetes Mellitus Type 1

Summary: this is a prospective, single arm, open-label, single-center pilot study to assess the safety, feasibility, and efficacy of stem cell educator therapy for the treatment of patients with type 1 diabetes.

our previous work demonstrated that human cord blood-derived multipotent stem cells (cb-scs) are a unique type of stem cell identified from human cord blood, distinct from other stem cell types including hematopoietic stem cells (hscs), and mesenchymal stem cells (mscs). the stem cells and harnessed some of their unique properties with stem cell educator therapy by using cb-scs in a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent cb-scs in vitro, and returns the "educated" lymphocytes (but not the cb-scs) to the patient's circulation . this treatment leads to global immune modulations and immune balance as demonstrated by clinical data and animal studies. the stem cell educator therapy may revolutionize the clinical treatment of diabetes and other immune-related diseases through cb-scs' immune education and induction of immune balance, without the safety and ethical concerns associated with conventional stem cell-based approaches

Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years * must have a diagnosis of type 1 diabetes mellitus based on the 2015 american diabetes association criteria for the clarification and diagnosis of diabetes * must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells (iaa, ia2, gad 65, znt8) * fasting c-peptide level \> 0.3 ng/ml * adequate venous access for apheresis * ability to provide informed consent * must agree to comply with all study requirements and be willing to complete all study visits exclusion criteria: * ast or alt 2 \> x upper limit of normal. * creatinine \> 2.0 mg/dl. * known coronary artery disease or ekg suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist. * known active infection * pregnancy or breastfeeding mothers * use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy. * presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.) * anticoagulation other than asa. * hemoglobin \< 10 g/dl or platelets \< 100 k/ml * is unable or unwilling to provide informed consent * presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

Keywords: diabetes
the predictive value of tmprss2-erg fusion in high risk prostate cancer patient

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate the predictive value of tmprss2-erg gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

the objective of this study is to evaluate the predictive value of tmprss2-erg gene fusion in prostate patients who have been treated with hormonal and radiation treatment after biochemical failure original biopsy slides of 65 patients will be collected and reviewed. a tissue used to test and map dna fragments will be constructed from patients who underwent radiation therapy. rna and dna will be extracted from each slide. this study, if positive, will establish the predictive value of tmprss2-erg gene fusion in prostate cancer patients. it can lead to believe that high-risk prostate cancer patients will benefit from a more aggressive treatment. an endpoint of this study is to evaluate the relation between the gleason score and the tmprss2-erg gene fusion. another is to evaluate the relation between the t-stage and tmprss2-erg gene fusion.

Eligibility criteria:
inclusion criteria: one of the following * t3a + * psa \> 20 * gleason 8 or higher * karnofsky performance status ≥ 70. * signed study-specific informed consent
a study of ly3209590 in japanese participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the safety of a study drug known as ly3209590 in japanese participants with type 2 diabetes. side effects and tolerability will be documented. blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. the study will last about four weeks, not including screening. screening is required within 4 weeks before the start of the study.


Eligibility criteria:
inclusion criteria: * have t2dm diagnosed at least 1 year ago * have hemoglobin a1c (hba1c) ≥7.0% and ≤10.0% with fasting plasma glucose (fpg) ≥126 milligrams per deciliter (mg/dl) or hba1c ≥6.5% and \<7.0% with fpg ≥144 mg/dl at screening * have body weight ≥54 kilograms and a body mass index \>18.5 and ≤40.0 kilograms per square meter at screening exclusion criteria: * have received a total daily dose of insulin \>1.2 units per kilogram at screening * have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-iv inhibitor, in the past 3 months before screening * have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction * have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study
the effect of abdominal binder use on postoperative pain and mobility in patients undergoing pelvic surgery

Conditions: Pelvic Organ Prolapse; Abdominal Surgery; Laparoscopic Surgery; Post Operative Pain

Summary: to determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. to determine if abdominal binder usage results in decreased visual analog scale (vas) pain scores and shorter time to first ambulation post operatively.


Eligibility criteria:
inclusion criteria: * patients must be 18 years or older. * willing and able to provide informed consent. * patients must be undergoing scheduled pelvic surgery. * patients must be admitted overnight (at least one night) after surgery. exclusion criteria: * patients who are younger than 18 years old. * patients who are unable or unwilling to provide informed consent. * patients who are illiterate. * patients who are non-english speaking or reading. * patients who are unwilling to be contacted by phone after surgery. * patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night. * patients who are having surgery for any other indication other than pelvic surgery. * patients with a chronic pain syndrome (as evidenced by daily intake of opioids).
metabolic response to 3-day fast versus carbohydrate-free diet in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.

in addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. these include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * c-peptide \> 1.5 ng/ml exclusion criteria: * body mass index \> 40 * hematological abnormalities * liver disease * kidney disease * congestive heart failure * life threatening malignancies

Keywords: diabetes
postprandial profiles of metabolites and appetite-regulating hormones in plasma and cerebrospinal fluid

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: overweight and obesity are rising in prevalence and becoming a growing threat to public health. obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals. the purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (csf) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.


Eligibility criteria:
inclusion criteria: * 10 male patients with obesity (bmi \>30) and type 2 diabetes * 10 male volunteers with normal weight (bmi 20-24) matched by age * 10 male volunteers with obesity (bmi \>30) matched by age exclusion criteria: 1. unwillingness to participate or wish to withdraw from ongoing protocol 2. hepatic disease or hemorrhagic diatheses (including abnormal international normalized ratio (inr), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (alat)) 3. anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant) 4. anaemia (p-hemoglobin below normal range) 5. nephropathy (se-creatinine \>130 μm and/or albuminuria) 6. suspected difficult access to the spinal canal (e.g. pronounced scoliosis, spinal stenosis, osteoporotic coincidence in the lower back, spina bifida, meningocele after surgical intervention) 7. lumbar skin infection (e.g. herpes zoster, pustules or ulcers) 8. medical history with headaches - both in connection with dura puncture and frequent headaches of other types 9. central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.) 10. clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.) 11. patients with type 2 diabetes: treatment with dpp-4 inhibitor or glp-1 receptor agonist. late diabetic complications including proliferative diabetic retinopathy (anamnestic), arteriosclerotic cardiovascular disease (heart failure or previous ischemic event/myocardial infarction)