Kornimate/medical-research-clean huggingface dataset:
a study in which non-metastatic castration-resistant prostate cancer (nmcrpc) patients for whom a decision to treat with darolutamide has been made before enrollment are observed and certain outcomes are described

Conditions: Prostate Cancer

Summary: the purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. when a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.


Eligibility criteria:
inclusion criteria: * men over the age of 18 years * histologically or cytologically confirmed adenocarcinoma crpc defined by disease progression despite adt and may present as a confirmed rise in serum psa levels (as defined by pcwg3: rising psa values at a minimum of 1-week intervals, and a baseline psa value ≥ 1.0 ng/ml). for patients with a prior ari treatment (enzalutamide or apalutamide), there is no baseline psa value required * no evidence of metastasis based on conventional imaging. an imaging assessment needs to be obtained prior to the 1st dose of darolutamide. for patients with a prior ari treatment (enzalutamide or apalutamide) for nmcrpc, m0 status with no evidence of disease progression should be confirmed within 3 months of ari discontinuation * decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study * signed informed consent * life expectancy of ≥3 months * for a patient with a prior ari treatment (enzalutamide or apalutamide) for nmcrpc for less than one year, all toxic effects from prior use of any ari treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * contraindications according to the local marketing authorization * previous treatment with darolutamide (more than 3 days prior to enrollment) * patient with a prior ari treatment (enzalutamide or apalutamide) for nmcrpc for more than one year
initiating mealtime ultra-rapid acting insulin (afrezza) in uncontrolled type 2 diabetes patients

Conditions: Type2 Diabetes

Summary: to examine the effects of adding prandial afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or glp-1 use.

clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. the investigator proposes treating patients with afrezza who have an index hemoglobin a1c (hba1c) between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. the response to afrezza will be assessed with continuous glucose monitoring systems (cgms) studies and initial and follow-up hba1c's. the goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in hba1c improvement often occur.

Eligibility criteria:
inclusion criteria: * adult type 2 diabetes patients age 18 or older * hba1c ≥ 7.5% and ≤ 11.5% after at least 6 months treatment with diabetes medication. treatment may include oral agents, basal insulin or glucagon-like peptide-1 (glp-1) in any combination. * patient and provider agree not to add additional diabetes medications during the 14 weeks of the study (unless rescue treatment is indicated). exclusion criteria: * history of asthma, chronic obstructive pulmonary disease (copd) or smoking within 6 months * forced expiratory volume in one second (fev1) under 70% predicted * pregnancy * active malignancies and/or life expectancy of \< 12 months * major surgery planned during study period * currently using rapid acting insulins - novolog, humalog, apidra * prior use of afrezza in the last 3 months * unwilling to test blood glucose before or after each meal * exposure to systemic glucocorticoids within 6 weeks of screening * severe hypoglycemia in last 6 months or hypoglycemia unawareness * any medical condition which, in the opinion of the investigator, would interfere with ability to understand or respond to the administration of inhaled insulin

Keywords: inhaled insulin
a predictive model and scoring system for severe complications after endovascular thrombectomy

Conditions: Acute Ischemic Stroke; Endovascular Thrombectomy; Symptomatic Intracranial Hemorrhage; Malignant Cerebral Edema

Summary: to establish a predictive model and scoring system for predicting severe complications after thrombectomy. this scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials.

acute ischemic stroke (ais) accounts for about 80% of all strokes. the focus of ais treatment is to restore reperfusion of ischemic territory as soon as possible, promote neurological recovery, reduce disability rate and improve long-term survival rate. in recent years, a series of randomized clinical trials have proved that endovascular thrombectomy (evt) is safe and effective in the treatment of anterior circulation ais. evt has been recommend as the first-line treatment for anterior circulation large vessel occlusion (lvo) stroke by guidelines. symptomatic intracranial hemorrhage (sich) and malignant cerebral edema (mce) are the two most common severe neurological complications, leading to brain tissue hypoxia and neurological dysfunction. currently, there is a lack of prediction system to identify patients at high risk for severe complications, who can most likely benefit from adjuvant treatment after thrombectomy to improve patient functional independence and survival rate.

Eligibility criteria:
inclusion criteria: 1. symptoms and signs compatible with ischemia in the anterior circulation 2. internal carotid artery occlusion or middle cerebral artery m1 and m2 segment occlusion confirmed by computed tomographic angiography (cta)/ magnetic resonance angiography (mra)/ digital subtraction angiography (dsa) 3. premorbid mrs ≤1; 4. national institutes of health stroke score (nihss) ≥6 at admission; 5. onset to puncture time ≤24h; 6. treated with thrombectomy resulting in mtici score ≥2b at end of the procedure. exclusion criteria: 1. intracranial hemorrhage, aneurysm, and arteriovenous malformation before endovascular thrombectomy; 2. perioperative complications, including dissection and arterial perforation; 3. anticipated life expectancy \<3 months; 4. critical baseline clinical, laboratory and imaging data are missing; 5. lack of follow-up results within 72 hours and 90 days after thrombectomy; 6. pregnant or lactating women; 7. severe systemic diseases (e.g. advanced cancer), potentially interfering with prognosis; 8. allergy to contrast media and nitinol; 9. concurrent participation in a study that would interfere with the establishment of predictive models; 10. unable to complete the assessment due to mental disorders cognitive or emotional disorders before onset.

Keywords: acute ischemic stroke endovascular thrombectomy sich mce
a long-term extension study for the phase 3 study of nalmefene (339-14-001) in patients with alcohol dependence

Conditions: Alcohol Dependence

Summary: the long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.


Eligibility criteria:
inclusion criteria: * patients who have completed study 339-14-001 * patients who have signed the informed consent form for study 339-14-002 exclusion criteria: * the patient has a clinically significant unstable illness (eg, complication of new york heart association (nyha) class iii or iv heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (egfr) of \< 30 ml/min/1.73 m2, hepatic failure, and neoplastic disorder) * the patient has a clinically significant abnormal electrocardiogram (ecg) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator
comparative antimicrobial efficacy of two topical acne therapies for the treatment of facial acne

Conditions: Acne

Summary: the purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

to investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. clinical efficacy and tolerability will be assessed.

Eligibility criteria:
inclusion criteria: * outpatient at least 12 years of age. female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study. * mild to moderate facial acne vulgaris * able to understand the requirements of the study and sign informed consent/hipaa authorization forms. subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian. exclusion criteria: * female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control * allergy or sensitivity to any component of the test medication * known hypersensitivity to to any component of the investigational formulations * known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis * beards or sideburns * skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris * evidence of recent alcohol or drug abuse * participation in an investigational drug study within 30 days of the baseline visit

Keywords: acne vulgaris acne
clinical outcomes among non-valvular atrial fibrillation patients with renal dysfunction

Conditions: Atrial Fibrillation

Summary: the objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (nvaf) patients with renal dysfunction in routine clinical practice. the study has a retrospective design, and will be conducted in the us truven health marketscan commercial claims and medicare supplemental databases


Eligibility criteria:
inclusion criteria: * have to be adults (≥18 years of age) * newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug) * have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period) * have at least two diagnosis codes for nvaf (on outpatient or inpatient claims, at two different days) and * have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period exclusion criteria: * valvular af (at least one inpatient diagnosis in the baseline period) * pregnancy (inpatient or outpatient diagnosis in the baseline period) * transient cause of af (inpatient or outpatient diagnosis in the baseline period) * venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or * overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date) * have a pharmacy claim for an oral anticoagulation (oac) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period * receive both warfarin and rivaroxaban 15 mg on the index date * have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period). for the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. a sensitivity analysis, omitting this exclusion criterion, will be performed.

Keywords: real-world study atrial fibrillation renal dysfunction rivaroxaban warfarin
effects of polyphenols supplementation on cycling endurance

Conditions: Healthy

Summary: endurance performance during high intensive exercises is mainly determined by the capacity of the aerobic metabolism. it generally induces muscle fatigue defined as the reversible decline in skeletal muscle contractile performance. fatigue is multifactorial and is often associated with many physiological parameters including reduced neural input and disruptive metabolic changes in skeletal muscles such as lactic acidosis and the production of oxidative free radicals. moreover, it could lead to oxidative stress as a result of an imbalance between reactive oxygen species (ros) production and intrinsic antioxidant defense. to alleviate oxidative stress, some ergogenic strategies have been tested. numerous studies have reported that different types of supplementation such as selenium, vitamin e, vitamin c or polyphenols were of interest to protect against these mechanisms. indeed, although some studies demonstrated no or harmful effects, most studies observed positive effects of antioxidants on oxidative stress or performance. more particularly, polyphenols, have great antioxidant capabilities and protective effects and it increases the synthesis and bioavailability of nitric oxide (no)which is well known to be the most important mediator of vasodilation. to date, most of the studies exploring the effects of polyphenols on exercise investigated several days or weeks of supplementations on vascular, blood parameters (blood pressure, no concentration, oxidative stress markers) or endurance performance. conflicting results are often obtained. only few studies investigated the effects of a single intake on immediate performance and recovery capacity. therefore, the present work aimed to study the effects of an acute intake of a specific profile polyphenols from grape and apple on physical performances. more specifically, performance, in the present study, referred to high intensity cycling exercise until exhaustion revealing the capacity to maintain a constant strong effort hereafter named endurance. the hypothesis was that an acute of polyphenols would increase the time to exhaustion during a high intensity cycling exercise.


Eligibility criteria:
inclusion criteria: * body mass index lower than 27 and waist size lower than 94 cm * physical activity higher than 2 hours a week * written informed consent exclusion criteria: * more than 6 hours training a week, regularly trained in aerobic activities * asthmatic, smokers or under medicinal drugs * dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances

Keywords: polyphenols cycling endurance aerobic pain
dose-ranging study: safety, tolerability and immunogenicity of ino-4500 in healthy volunteers in ghana

Conditions: Lassa Fever

Summary: this is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of ino-4500 administered by intradermal (id) injection followed by electroporation (ep) using cellectra™ 2000 device in healthy volunteers in ghana.


Eligibility criteria:
inclusion criteria: * judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening; * negative tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody; * screening electrocardiogram (ecg) deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); * must meet one of the following criteria with respect to reproductive capacity: surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). in the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. use of medically effective contraception when used consistently and correctly from screening until three (3) months following last dose. exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until three (3) months following last dose; * positive serum pregnancy test during screening or positive urine pregnancy test prior to any dosing; * is currently participating in or has participated in a study with an investigational product within 30 days preceding day 0; * previous receipt of an investigational vaccine product for prevention of lassa fever; * audiometry testing that demonstrates a hearing level threshold greater than 30 db for any frequency tested between 500 hz - 8000 hz; * fewer than two acceptable sites available for id injection and ep considering the deltoid and anterolateral quadriceps muscles; * current or anticipated concomitant immunosuppressive therapy; * fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.

Keywords: healthy volunteer
a phase ib study of the selective pkc-β inhibitor ms-553 in patients with refractory or relapsed cll/sll

Conditions: CLL (Chronic Lymphocytic Leukemia); SLL (Small Lymphocytic Lymphoma)

Summary: a phase ib study of the selective pkc-β inhibitor ms-553 in patients with refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma


Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. diagnosis of cll or sll: 1. history of histologically documented cll or sll that meets iwcll diagnostic criteria according to the 2018 guidelines, and 2. indication for treatment as defined by the 2018 iwcll guidelines, or the need for disease reduction prior to allogeneic transplantation.- exclusion criteria: 1. current transformation of cll/sll non-hodgkin lymphoma or hodgkin lymphoma. 2. active and uncontrolled autoimmune cytopenia(s).
studying genes in samples from younger patients with rhabdomyosarcoma

Conditions: Sarcoma

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and find biomarkers related to cancer. it may also help doctors find better ways to treat cancer. purpose: this research trial studies genes in samples from younger patients with rhabdomyosarcoma.

objectives: * to obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions. * to provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma. outline: dna samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. dna is then eluted and sequenced by illumina platform.

Eligibility criteria:
disease characteristics: * matched genomic deoxyribonucleic acid (dna) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: alveolar childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma
an intervention to reduce inappropriate medications in long-term care residents with severe dementia

Conditions: Dementia; Inappropriate Prescribing

Summary: an education intervention to promote medication reviews and interdisciplinary discussions within long-term care facilities with the aim of improving medication regimen among residents with severe dementia

a quasi-experimental study in three long-term care facilities. the intervention comprises an information leaflet for families of residents, a 90-minute knowledge exchange session for general practitioners, pharmacists and nurses and a list of "generally", "sometimes", and "exceptionally" appropriate medications for severe dementia residents

Eligibility criteria:
inclusion criteria: * diagnosis of dementia of any etiology * severe dementia exclusion criteria: * admission less than 2 months before intervention

Keywords: quality improvement long term care polypharmacy
a prospective double-blind interventional study of tissue reaction to polyglycolic acid sutures in human skin

Conditions: Lower Eyelid Entropion

Summary: objective to investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response. design a prospective, double blind, randomized clinical trial using a novel ethical study design. both the patient and clinician analyzing the histology were blinded to the suture gauge used. participants a total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study. intervention patients were randomly allocated to 5/0 or 7/0 vicryl™ test suture groups. patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. after 28 days, entropion correction was achieved by a quickert procedure which includes excision of an eyelid wedge. histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture. main outcome measure defined histological parameters of suture-related granulomas were measured at multiple levels. data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.


Eligibility criteria:
inclusion criteria: * consecutive patients * involutional lower eyelid entropion * horizontal eyelid laxity associated * informed consent exclusion criteria: * inability to provide informed consent * previous eyelid surgery * poorly controlled diabetes * oral steroid use * addisons disease

Keywords: entropion suture granuloma tissue reaction
characterization of t-cell response in participants previously treated with jnj-54861911 (atabecestat)

Conditions: Alzheimer Disease

Summary: the purpose of this study is to determine t-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

this is an exploratory phase 0 study in participants who previously participated in studies (54861911alz2002 \[nct02260674\], 54861911alz2003 \[nct02569398\], or 54861911alz2004 \[nct02406027\]) with atabecestat. in this study, participants will only have blood drawn. the primary hypotheses for this study is that adverse event of elevated liver enzymes observed in some participants is caused by a t-cell dependent inflammatory response. participants will be monitored for adverse events and will be called 1 day after the blood draw to assess for any adverse events.

Eligibility criteria:
inclusion criteria: * participant who received and discontinued atabecestat in one of the following prior trials (54861911alz2002, 54861911alz2003, or 54861911alz2004) * must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * willing and able to adhere to the prohibitions and restrictions specified for this study exclusion criteria: * anemic based on the last blood draw in the prior atabecestat trial * donated more than (\>) 450 milliliter (ml) of blood in the past 3 months * currently participating in an atabecestat study (54861911alz2002, 54861911alz2003, or 54861911alz2004)