Kornimate/medical-research-clean huggingface dataset:
study of early pharmaceutical intervention for cardiovascular disease prevention in stage 1 hypertension

Conditions: Cardiovascular Diseases

Summary: step-pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmhg and evaluate the health economics. step-pre is a multi-center randomized clinical trial. the cohort will be randomized into the treatment group or control group with a 1:1 ratio. the treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmhg. both groups will take health care education. step-pre will last 4 years.


Eligibility criteria:
inclusion criteria: * stage 1 hypertension (blood pressure is in 130-139/80-89 mmhg); * 35 - 64 years old * without taking antihypertensive medicine during screening * signed the written informed consent exclusion criteria: * took antihypertensive medicine within the last 1 month; * history of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack \[tia\]); * history of myocardial infarction or unstable angina or history of coronary revascularization (pci or cabg); * lab tests indicating abnormal liver or kidney function (alt ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2); * history of sustained atrial fibrillation or ventricular arrhythmias at entry influencing the measurement of electronic blood pressure； * severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial; * dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease; * severe somatic disease such as cancer; * severe cognitive impairment or mental disorders; * pregnant or breastfeeding, or planning to be pregnant; * having organ transplantation; * participating in other clinical trials.

Keywords: stage 1 hypertension
a multiple-dose study of mk-1006 (mk-1006-004)(terminated)

Conditions: Type 2 Diabetes

Summary: this study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of mk1006 in participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * participant has a bmi less than or equal to 42 kg/m\^2 at the screening visit * participant has been diagnosed with type 2 diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications * participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study * participant is a nonsmoker and has not used nicotine containing products for \~ 6 months before start of study exclusion criteria: * participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or ppar-gamma agonists * participant has a history of stroke, chronic seizures, or a major neurological disorder * participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug * participant has glaucoma or is blind * participant has a condition known to be related to cataract development * participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than lasik) within 3 months of screening * participant has a history of type 1 diabetes or ketoacidosis * participant cannot stop taking certain current medications during the study * participant consumes greater than 3 alcoholic beverages per day * participant consumes more than 6 servings of caffeinated beverages per day (1 serving is \~ 120 mg caffeine) * participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food * participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study
a study of flortaucipir pet in healthy volunteers and cognitively impaired subjects

Conditions: Alzheimer's Disease

Summary: this study will test if two flortaucipir pet scans up to 4 weeks apart in healthy volunteers, mci and ad subjects provide the same results.


Eligibility criteria:
inclusion criteria: * healthy volunteers * male or female subjects ≥ 50 years of age * mini-mental state examination (mmse) ≥ 29 * mci subjects * male or female subjects ≥ 50 years of age * mmse ≥ 24 * have mci consistent with national institute on aging-alzheimer's association (nia-aa) working group's diagnostic guidelines for ad * have a study partner that can report on subject's activities of daily living * probable ad subjects * male or female subjects ≥ 50 years of age * mmse \> 10 * meet clinical criteria for probable ad based on the nia-aa working group's diagnostic guidelines for ad * have a study partner that can report on subject's activities of daily living exclusion criteria: * current clinically significant psychiatric disease * evidence of structural brain abnormalities * evidence of dementing illness other than ad * current clinically significant cardiovascular disease or ecg abnormalities, or additional risk factors for torsades de pointes * current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * history of alcohol or substance abuse or dependence * females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * have received or participated in a trial with investigational medications in the past 30 days * have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
penicillin allergy delabeling among surgical patients

Conditions: Penicillin Allergy

Summary: penicillin allergy testing among surgical patients


Eligibility criteria:
inclusion criteria: * surgical patients with reported penicillin allergy exclusion criteria: * missing consent
a retrospective study in chinese good prognosis patients undergoing assisted reproductive technology (art) treatment

Conditions: Infertility

Summary: this is a multicenter retrospective study in good prognosis chinese patients. data will be collected from infertile women who underwent first in vitro fertilization (ivf)/intra cytoplasmic sperm injection (icsi) using a gonadotropin releasing hormone (gnrh) antagonist (cetrotide) protocol at about 4 ivf centers to investigate the factors associated with clinical pregnancy rate. the definition of the good prognosis subjects is, age not more than 35 years old, baseline serum follicle-stimulating hormone (fsh) level no more than 10 milliinternational units (miu)/milliliter (ml), body mass index (bmi) not more than 30 kilogram per meter square (kg/m\^2), previously underwent no more than 3 ivf/icsi cycles, and the total dose of gonadotropin used no more than 2500 iu in current cycle. no intervention(s) will be administered on the subjects. data required to investigate the factors associated with the pregnancy outcome of gnrh antagonist ivf cycle will be collected from the subjects' medical records into database through electronic data capture system and analyzed.


Eligibility criteria:
inclusion criteria: * infertile women who underwent the first gnrh antagonist ivf/icsi-et (embryo transfer) cycle with an available art outcome * used cetrotide in a fixed or flexible antagonist protocol * age not more than 35 years old * baseline serum follicle-stimulating hormone (fsh) level not more than 10 milliinternational unit per milliliter (miu/ml) * body mass index (bmi) not more than 30 kilogram per meter square (kg/m\^2) * normal uterine cavity exclusion criteria: * previously underwent 3 or more ivf/icsi cycles * the total dose of gonadotropin used was more than 2500 iu in current cycle * administration of daily 0.125 milligram (mg) cetrotide * received an agonist trigger * use of clomiphene citrate or letrozole during cycles * presence of endometriosis grade 3 to 4, confirmed or suspected * presence of uni-or-bilateral hydrosalpinx * known history of recurrent miscarriages

Keywords: infertility cetrotide assisted reproductive technology (art)
phase 2 safety and efficacy study of at-101 in combination with rituximab in patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is an open-label phase 2 study to evaluate the safety and efficay of at-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * diagnosis of cll as defined by the nci-working group * previous treatment with standard systemic chemotherapy or immunotherapy. * disease progression or relapse after treatment. * indication for treatment as defined by the nci working group guidelines (cheson, 1996) * ecog performance status ≤ 2 * adequate liver and renal and bone marrow function exclusion criteria: * treatment of cll with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. acute toxicities from prior therapy must have resolved to grade ≤ 1. * class 3 or 4 cardiac disease as defined by the new york heart association functional classification * severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, copd) * active secondary malignancy or history of other malignancy within the last five years * active symptomatic fungal, bacterial and/or viral infection including active hiv or viral hepatitis (a, b or c). * patients who are contraindicated for treatment with rituximab * diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-hodgkin's lymphoma, or other non-b-cll b-cell malignancy; * t-cll or other t-cell malignancy

Keywords: at101 at-101 cancer lymphoctic lukemia rituximab
the study on profile and genetic factors of aspirin resistance (progear study)

Conditions: Coronary Disease; Cerebral Infarction; Ischemic Attack, Transient

Summary: the purpose of this study is to determine the clinically meaningful definition and prevalence of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent vascular events in cardiovascular patients taking aspirin.

primary outcomes: the primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboembolism, and death caused by cardiovascular disease. secondary outcomes: platelet aggregation induced by collagen and arachidonic acid, serum thromboxane b2, urine 11-dehydrothromboxane b2, platelet thrombus formation under flow conditions (sub-study only at the national cardiovascular center) the primary objective of this study is to determine the markers for aspirin resistance. to achieve this objective, platelet aggregation, serum thromboxane b2, and urine 11-dehydrothromboxane b2 are measured in patients receiving usual therapeutic doses of aspirin, who experienced acute coronary syndrome, cerebral infarction, or transient ischemic attack occurred in a period between the past 1 month and the past 2 years. this is a multi-center, prospective study.

Eligibility criteria:
inclusion criteria: adult males or females who met the criteria listed below: * patients who had acute coronary syndrome, cerebral infarction (except cardioembolic stroke), or transient ischemic attack between past 28 days and the past 2 years * patients who receive long-term aspirin therapy (at least 28 days) * patients who are \>=20 years of age * patients willing and able to give written informed consent exclusion criteria: * malignancy or suspected malignancy * patients who showed platelet counts less than 100,000/ul or more than 450,000/ul * congenital bleeding tendency * patients who receive other antiplatelet drugs or warfarin * patients with atrial fibrillation * patients who received surgical operation or catheter intervention within the past 2 weeks * patients who received anticoagulation drug therapy including heparin ( low-molecular weight heparin) and danaparoid. * patients with more than modified rankin scale 4

Keywords: aspirin platelet aggregation inhibitors
mesalamine 2 g sachet for the maintenance of clinical and endoscopic remission in ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (qd) for maintenance of clinical and endoscopic remission in subjects with uc. the duration of treatment for each subject was 6 months.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 75 years, with ulcerative colitis in remission exclusion criteria: * evidence of other forms of inflammatory bowel disease * infectious disease (including human immunodeficiency virus \[hiv\], hepatitis b virus \[hbv\], or hepatitis c virus \[hcv\]) * disease limited to proctitis \<15 cm * short bowel syndrome * prior colon resection surgery * history of severe/fulminant uc * intolerant or allergic to aspirin or salicylate derivatives * use of rectal formulations (5-aminosalicylic acid \[5-asa\], steroids) within ≤7 days * women who are pregnant or nursing * history of known malignancy * history of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial
aqt90 flex ntprobnp2 test kit - 23004 - reference interval study

Conditions: Heart Failure

Summary: the purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (url) of the ntprobnp2 test kit on the aqt90 flex analyzer.

the ntprobnp2 test is an in vitro diagnostic assay for the quantitative determination of n-terminal pro-b-type natriuretic peptide {nt-probnp) in edta or lithium heparin whole blood or plasma specimens on the aqt90 flex analyzer in point of care/ near-patient testing and laboratory settings. it is intended for use as an aid in the diagnosis of heart failure. the test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure. the ntprobnp2 cal cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the ntprobnp2 test on the aqt90 flex analyzer by establishing points of reference to estimate nt-probnp values. the aqt90 flex analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. it is intended for use in point of care/ near-patient testing and laboratory settings.

Eligibility criteria:
inclusion criteria: * subject must have given their valid consent to donate their sample in the sample bank * subjects must have been 18 years of age or older at the time of sample collection * subject must have answered yes, to being generally healthy, in the health questionnaire * subjects must, as a minimum, have completed questions regarding age, gender, race, and ethnicity exclusion criteria: answered yes to any of the conditions below (information gathered from a self-reported health questionnaire or results from blood sample tests): * current medications for treating cardiovascular diseases at the time of sample collection * current antibiotics (indicates ongoing infections) * known to suffer from any of the illnesses below at the time of sample collection: * disease(s) of/or affecting the cardiovascular system * congestive heart failure * hypertension * previous history of any heart disease * diabetes (either self-reported in questionnaire or a glycosylated hemoglobin (hba1c) in the diabetic range (above 6.4%) * renal dysfunction or failure (an estimated glomerular filtration rate (egfr) below 60 ml/min/1.73m2.) this is to be calculated using information on age, sex and creatinine using the 2021 chronic kidney disease epidemiology (ckd-epi) creatinine equation. * cancer or history of cancer
real-time data monitoring for shared adaptive, multi-domain and personalised prediction and decision making for long-term pulmonary care ecosystems (re-sample)

Conditions: Pulmonary Disease, Chronic Obstructive; Exacerbation Copd; Comorbidities and Coexisting Conditions

Summary: the main objective of this re-sample cohort study is to identify from a real-world data (rwd) set that will be collected, a subset of data that can be potentially used as important predictors and parameters for disease progression of copd and complex chronic conditions, and multi-morbid exacerbations. the secondary objective is to evaluate the feasibility of rwd collection from a patient's perspective. study design: this is a prospective observational cohort study to collect rwd in patients with copd and complex chronic conditions, with a maximum of 38 months of follow-up. measurements are performed and rwd are collected by using the healthentia mobile phone application at baseline (e.g. patient characteristics), daily (e.g. symptom diary), during follow-up visits and at deterioration, and from hospital data (e.g. healthcare visits). the choice of parameters and measurement tools that will be collected during the cohort will be updated every three months during the first year of the cohort (via protocol amendments). these updates are based on citizen-design sessions and on new literature insights. prognostic models will be developed including predictors derived from the rwd collection.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd according to the gold criteria \[5\] (fev1 \< 80% of the predicted value and fev1/fvc \< 0.70); * patients can be included both at stable state and during exacerbation/hospitalization; * at least one comorbidity: diabetes mellitus (glucocorticoid-induced, or stable type 1 or 2), chronic heart failure (clinical diagnosis according to the esc guidelines), ischaemic heart disease (history of myocardial infarction, angina pectoris), active symptoms of anxiety and/or depression (≥11 hospital anxiety and depression scale , and/or anxiety or depression symptoms being treated at the time of inclusion); * under treatment at one of the pilot sites (mst, tuk, gem); * \>40 years of age; * smoker or ex-smoker; * able to understand, read and write the language spoken in the country of the pilot site. * accessibility to internet; * written informed consent from the subject prior to participation. furthermore, 25% of the patients should also have ≥ 2 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or ≥ 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or modified mrc (mmrc) score of 3 or 4 (copd patients with these scores have a higher chance of exacerbating). exclusion criteria: * serious other diseases with a low survival rate; * presence of any other active lung disease (e.g., sarcoidosis); * severe psychiatric illness, diagnosed by anamnesis; * maintenance therapy with antibiotics * patients with cognitive impairment (mini mental state examination (mmse) \< 24)
autologous conditioned serum: functional and clinical results

Conditions: Knee Osteoarthritis; Osteoarthritis, Knee; Cartilage Degeneration

Summary: the purpose of this study was to investigate the potential ability of autologous conditioned serum (acs) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (oa).

fifteen patients with clinical and radiological signs of oa of the hip or knee were recruited for this study. each patient received 4 injections of acs (orthokine®) at the site of oa once per week for 4 weeks. clinical and functional evaluation were performed using vas scale for pain, womac scale and kss functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. statistical analysis was done with the wilcoxon signed-rank test.

Eligibility criteria:
inclusion criteria: * knee osteoarthritis \>3 months in clinical and radiographic signs * vas for pain \>50mm exclusion criteria: * hepatitis b * hepatitis c * hiv * pregnancy * drug abuse * other intra-articular injections \<6 months * surgery on affected knee \<12 months

Keywords: knee osteoarthritis inflammation joint autologous conditioned serum
d2212c00002 j-phase ii study

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in japanese patients with idiopathic pulmonary fibrosis.

this is a phase ii, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in japanese patients aged ≥ 50 years with mild to moderate idiopathic pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * confirmed ipf diagnosis for ≤ 5 years prior to visit 1 (screening). confirmation of diagnosis of ipf * mild to moderate ipf to include all of the following at visit 1 1. fvc ≥ 50% and ≤ 90% predicted normal 2. partial pressure of oxygen in arterial blood (pao2) of ≥ 55 mmhg on room air, or oxygen saturation by pulse oximetry (spo2) of ≥ 90% on room air at rest 3. hemoglobin-corrected diffusion capacity for carbon monoxide (dlco) ≥ 30% and ≤ 90% predicted normal exclusion criteria: * history of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis * diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease * a suspected ipf exacerbation not fully resolved and treatment completed ≤ 14 days prior to visit 1 * a suspected ipf exacerbation during the screening period * a fev1/fvc ratio \< 0.70 at the time of visit 1 (postbronchodilator) * the extent of emphysema on the hrct is greater than the extent of fibrosis

Keywords: japan phase2 safety tolerability idiopathic pulmonary fibrosis ipf cat-354 tralokinumab