Kornimate/medical-research-clean huggingface dataset:
biochemical recurrence rate of radical prostatectomy combined with neoadjuvant and adjuvant chemotherapy in high risk prostate cancer

Conditions: Prostate Cancer

Summary: effect of radical prostatectomy combined with neoadjuvant and adjuvant chemotherapy in patients with high risk prostate cancer. the purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

the purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Eligibility criteria:
inclusion criteria: * prostate cancer * psa \> 20 or * clinical stage \> t2c or * gs \> 7
effect of metabolic control at onset of diabetes on progression of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to find out if very tight blood glucose control from the onset of type 1 diabetes can preserve beta cell function. study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

the specific aim of this study is to determine if early restoration of metabolic control will improve c-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process. following completion of the baseline procedures (mixed meal tolerance test and blood sample collection), participants are randomized to either the standard treatment group or the intensive treatment group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management. all subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.

Eligibility criteria:
inclusion criteria: * age 6.0 to \<46.0 years * diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy) * if participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative. * willing to accept randomization to either the intensive diabetes management group or the standard care group. * willing to complete the planned 2 years of follow-up. * able to electronically transmit data monthly. * investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing. exclusion criteria: * currently pregnant or lactating, or anticipate getting pregnant in the next one year. * currently anemic (hematocrit level will be obtained at the screening visit). * chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study. * complicating medical issues that might interfere with study conduct. * inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver). * currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.

Keywords: type 1 diabetes closed loop therapy continuous glucose monitor
comparison study of drugs for symptom control and complication prevention of atrial fibrillation (af) (code-af trial)

Conditions: Atrial Fibrillation

Summary: this study is prospective cohort study which was performed in multicenter (general hospital) in korea. inclusion criteria is all patients with atrial fibrillation who visit hospital. the purpose is to analyze complication, composite outcome (all cause mortality, hospitalization, the incidence of stroke, heart failure and cardiovascular event (mace)) according to the 1) the use of anti-arrhythmic drugs (aads), 2) use of medication for rate control (beta blocker, calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin, coumadin, an noac)


Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation * patients with age more than 19 * patients who agree with study inclusion exclusion criteria: * patients who do not agree with study inclusion * patients with age less than 19 * pregnancy, breastfeeding

Keywords: atrial fibrillation anti arrhythmic drug noac warfarin coumadin
a retrospective study of transbronchial cryobiopsy in the diagnosis of progressive pulmonary fibrosis

Conditions: Pulmonary Fibrosis; Transbronchial Cryobiopsy

Summary: the goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（tblc） in progressive pulmonary fibrosis.

the goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（tblc） in progressive pulmonary fibrosis. the main question it aims to answer are: • the diagnostic rate of mdd1 or mdd2 based on tblc. • the rate of hemorrhage, pneumothorax, acute ild exacerbation and mortality. participants' medical records will be collected by us.

Eligibility criteria:
inclusion criteria: patients with ppf, ≥18 years of age, unclassified ild, hrct ≤3 months, forced vital capacity (fvc)≥50% predicted value, pulmonary carbon monoxide diffusion (dlco)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmhg, body mass index (bmi)≤35 kg/m2. exclusion criteria: patients with platelet counts below 50,000e+9/l or international normalized ratio of prothrombin time (inr) above 1.5 are not eligible for tblc
post-marketing surveillance of atrovent® in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to obtain further information on the tolerability and efficacy of atrovent® inhalets in the treatment of chronic obstructive pulmonary disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * patients of both gender older than 40 years, who suffer from chronic obstructive pulmonary disease * only patients who have not been treated with atrovent® within the last year are to be considered for inclusion exclusion criteria: * contraindications listed in the instructions for use/summary of product characteristics for atrovent® metered dose inhaler
effect of the molecular weight of oat β-glucan on its ability to lower serum cholesterol

Conditions: Hypercholesterolemia

Summary: the purposes of this study were: 1. to determine if a breakfast cereal containing 3g of high molecular weight oat beta-glucan fiber would lower low-density lipoprotein (ldl) - cholesterol (the "bad" cholesterol) compared to a control cereal containing wheat fiber. 2. to determine if the ldl-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.

the fda allows a health claim that oat products may reduce the risk of heart disease, based on meta-analyses showing a cholesterol-lowering effect of oat beta-glucan, if the product delivers at least a 3g daily dose of oat beta-glucan. however, not all studies have demonstrated a lowering of oat products. this may be due to variable bioactivity of the beta-glucan in the oat products. the bioactivity of oat beta-glucan is believed to depend upon its viscosity in the gut. factors influencing viscosity include the molecular weight (mw) of the beta-glucan molecule and the amount of soluble beta-glucan in the product, which, in turn determines its concentration (c) in solution. in finished food products both mw and c can be modified by beta-glucanase enzymes present in other ingredients in the food (eg. wheat flour), processing (eg. extrusion) and storage (eg. freezing of moist products such as muffins). the effect of altering the mw and solubility of beta-glucan in foods on glycemic responses has been shown, but a role for mw and c in cholesterol lowering has not been established. to address this issue, this study was designed with 2 primary objectives: 1. an extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce ldl cholesterol compared to a control wheat bran cereal. 2. a significant correlation exists between ldl cholesterol and log(c×mw), where c is the amount of soluble β-glucan in the daily dose of cereal and mw is the molecular weight of the β-glucan in the cereal.

Eligibility criteria:
inclusion criteria: * body mass index 18.5 to 40.0 kg/m\^2 * no intention to lose or gain weight * fasting total cholesterol 5.0 to 8.0 mmol/l * fasting ldl cholesterol 3.0 to 5.0 mmol/l * consuming diet containing \<15% energy from saturated fat exclusion criteria: * use of any cholesterol-lowering drug, herbal or nutritional supplement * regular consumption of oatmeal, oat bran or psyllium - containing cereals * fasting serum triglycerides \>4.0mmol/l * serum aspartate transaminase \>1.5 times upper limit of normal * serum urea or creatinine \>1.8 times upper limit of normal * presence of diabetes or fasting glucose \>6.9mmol/l * presence or recent major surgical or medical event * allergy to wheat or oats * presence of condition or drug which alters digestion or absorption of foods

Keywords: humans randomized clinical trial dietary fiber nutrition beta-glucan oats ldl cholesterol coronary heart disease
an examination of the blood pressure lowering ability and safety of olmesartan medoxomil in patients with type ii diabetes

Conditions: Hypertension

Summary: this study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with type ii diabetes and high blood pressure. the medication being tested has been approved by the fda for the treatment of high blood pressure.


Eligibility criteria:
inclusion criteria: * patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents * patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but \<200 mmhg and a msdbp less than or equal to 114 mmhg following a 3 to 4-week single-blind placebo run-in period * the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg * patients with a mean daytime (8am - 4pm) sbp \> 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period * if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study exclusion criteria: * history of stroke or transient ischemic attack (tia) within the last one year * history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months * presence of overt proteinuria at screening * severe hypertension (dbp greater than or equal to 115 mmhg or sbp greater than or equal to 200 mmhg) * patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome * type i or type ii diabetes requiring insulin * evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease * presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter

Keywords: hypertension angiotensin receptor blocker calcium channel blocker angiotensin converting enzyme inhibitor hydrochlorothiazide stage i and ii hypertension type ii diabetes
observational study of lenalidomide in subjects with mantle cell lymphoma who failed ibrutinib treatment

Conditions: Lymphoma, Mantle-Cell

Summary: the objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory mantle cell lymphoma (mcl) following ibrutinib treatment. mcl subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. it is therefore of benefit to have data on the outcomes of treatment options available in this patient population. an observational study design was chosen to collect the clinical data already existing or being collected for mcl subjects being treated with lenalidomide. mcl subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. lenalidomide does not need to be the next subsequent treatment after ibrutinib.


Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign an informed consent document (icd), if applicable, prior to any collection of study-related data. 2. males or females ≥ 18 years of age at the time of signing the icd (if informed consent is applicable) 3. diagnosis of mantle cell lymphoma (mcl) as assessed by the investigator. a copy of a pathology report establishing the diagnosis of mcl must be available 4. must have received at least one dose of ibrutinib and must have met at least one of the following criteria: a. relapse: subjects with relapse following initial response of cr to ibrutinib (or an ibrutinib-containing regimen). subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. b. progressive disease (pd): subjects with pd following initial response of pr to ibrutinib (or an ibrutinib-containing regimen). subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. c. refractoriness: subjects with i. best response of stable disease (sd) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had pd, or ii. best response of pd at anytime while on ibrutinib (or an ibrutinib-containing regimen) d. intolerance: subjects requiring premature discontinuation of ibrutinib for reasons other than pd prior to the planned end of treatment. potential reasons for premature discontinuation may include adverse event (ae) attributed to ibrutinib or inability to continue ibrutinib for other reasons. subjects responding to ibrutinib treatment must have documented pd/relapse following discontinuation of ibrutinib. the reason for the premature discontinuation of ibrutinib will be recorded. exclusion criteria: * no exclusion criteria.

Keywords: mantle cell lymphoma multicenter observational lenalidomide (revlimid®) relapsed or progressed ibrutinib
comparison between propess and cook double-balloon catheter for cervical priming

Conditions: Delivery Problem

Summary: the investigators aimed to compare efficacy and safety of propess versus cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.

previous studies focused on use of pge2 instead of propess, which is a preparation of pge2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. compared with pge2, propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. however local studies comparing the efficacy and satisfaction of cervical priming between cook double-balloon catheter and propess were lacking. the investigators aimed to compare efficacy and safety of propess versus cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.

Eligibility criteria:
inclusion criteria: * viable singleton pregnancy * cephalic presentation * bishop score \<7 * at term (\>=37+0 weeks of gestation) * nulliparous women exclusion criteria: * gestation \<37weeks * multiple pregnancy * bishop score \<7 * malpresentation * contraindication to vaginal delivery * previous caesarean section * history of myomectomy * maternal fever * suspected infection * abnormal fetal heart-rate patterns * rupture of membranes * intrauterine growth restriction * not fit for giving consent * allergic to propess or pge2
optimized treatment and regression of hbv-induced liver fibrosis

Conditions: Liver Fibrosis

Summary: patients with chronic hepatitis b histologically confirmed of liver fibrosis s2/s3 (similar to metavir f2/f3, ishak 2/3/4) are randomly assigned in a 1:1 ratio. one arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus pegylated interferon (peg-ifn) for 1 year, entecavir for another additional 0.5 year. patients will be assessed at baseline, at every six months for blood count, liver function test, hbvdna, afp, prothrombin time, thyroid function, liver ultrasonography, and fibroscan. the second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.


Eligibility criteria:
inclusion criteria: 1. ages from 18 to 65 years old; 2. male or female; 3. treatment-naive patients with chronic hbv-induced fibrosis s2/s3 (similar to f2/f3, ishak 2/3/4), who consent to undergo liver biopsy before and after treatment; 4. patients with hbeag-positive, hbvdna\>2×10\ iu/ml or with hbeag-negative, hbvdna\>2×10\ iu/ml; 5. agree to be follow-up regularly; 6. signature of written inform consent. exclusion criteria: 1. patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. patients who are allergic to entecavir, interferon, or their components, and those considered not suitable for medications used in this study; 3. patients coinfection with hcv or hiv, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. patients with baseline afp level higher than 100 ng/ml and possible malignant lesion on image, or afp level higher than 100 ng/ml for continuous three months; 5. creatinine \>1.5×uln; 6. patients with other uncured malignant tumors; 7. patients with severe diseases of heart, lung, kidney, brain, blood system or other organs; 8. patients with severe neurological or psychological disease (e.g. epilepsy, depression, mania and schizophrenia); 9. patients with poorly controlled diabetes, hypertension or thyroid disease; 10. patients with any other reasons not suitable for the study.

Keywords: hepatitis b liver fibrosis regression efficacy
a phase iii clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops

Conditions: Myopia

Summary: this study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase iii clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.a total of 526 subjects were planned to be enrolled。 statistical analyses were performed with the use of sas software, version 9.4, without any specific description. all statistical tests were two-sided at a 0.05 level.

Eligibility criteria:
inclusion criteria: 1. child (female or male) aged 6 to 10 years. 2. myopia (ser of at least -0.50 d and no more myopic than -6.00 d) in each eye as measured by cycloplegic autorefraction. 3. if present, astigmatism of ≤1.50 d in each eye as measured by cycloplegic autorefraction. 4. anisometropia ser of \< 1.50 d as measured by cycloplegic autorefraction. exclusion criteria: 1. history of any disease or syndrome that predisposed the subject to severe myopia (e.g.,marfan syndrome, stickler syndrome, retinopathy of prematurity). 2. history in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia). 3. chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year). use of cycloplegic drops for dilated ocular exam was allowable. 4. heart rate persistently (for more than 10 minutes) \> 120 beats per minute. 5. allergy to study drugs.
evaluation of housing first initiative for chicago homeless with chronic medical illness

Conditions: Unstable Housing

Summary: the study hypothesizes that early housing after hospitalization with case management integrated into the health and housing systems, will results in decreased use of costly health services (i.e., hospitalizations and emergency room visits) with no negative affect on health. to address this hypothesis the investigators implemented a randomized controlled trial of 407 homeless adults with chronic medical illness in chicago. eligible homeless adults were enrolled during a hospitalization to intervention - early housing with case management - or usual care - usual case management and housing options. the investigators followed the sample for 18 months with assessments at baseline, 1,3,6,9,12 and 18 months are enrollment. study measures include quality of life, health service use, alcohol and substance use, housing and social and demographic characteristics.

the chicago housing for health partnership (chhp) was developed to meet the challenge of providing housing to the most disadvantaged homeless people in the city: those with chronic illnesses who are being discharged from a hospital. the program model was community based and collaboratively created and monitored by an oversight committee composed of the leadership of all involved partner agencies. the chhp was a group of 8 nonprofit agencies that provided supportive housing and 2 agencies that provided interim housing or respite care. supportive housing was defined by the intervention as housing without time limits combined with services to help participants to live more stable, productive lives. to evaluate this new service model, a prospective randomized trial was designed to examine the effect of supportive housing and intensive case management on health service utilization. the investigators enrolled homeless patients with at least 1 of 15 chronic illnesses from 2 urban hospitals that were members of the partnership and known to have large numbers of unstably housed patients. the chronic illnesses were associated with increased mortality in the homeless21 and were verified through review of physician hospital notes. this trial is the health outcomes portion of chhp.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english or spanish speaking * presence of at least one chronic medical illness * unstable housing

Keywords: early housing after hospitalization