Kornimate/medical-research-clean huggingface dataset:
a study to assess the effects of pt001 and pt005 mdi on specific image based parameters in subjects with moderate to severe copd

Conditions: COPD, Chronic Obstructive Pulmonary Disease

Summary: to assess the effect of treatment with glycopyronnium (gp) mdi administered twice daily (bid) and formoterol fumarate (ff) mdi administered bid on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (copd) following chronic dosing after approximately two weeks treatment.


Eligibility criteria:
inclusion criteria: * non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or child bearing potential, has a negative urine pregnancy test at visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly * subjects with an established clinical history of copd as defined by the american thoracic society (ats)/european respiratory society (ers) * current or former smokers with a history of at least 10 pack-years of cigarette smoking. * at visit 1, fev1/fvc ratio must be \<0.70 * at visit 1, post-bronchodilator fev1must be \>30% and \<80% predicted normal value, calculated using the third national health and nutrition examination survey (nhanes iii) reference equations. exclusion criteria: * significant diseases other than copd, i.e., disease or condition which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. * women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception. * subjects, who in the opinion of the investigator, have a current diagnosis of asthma. * subjects who have been hospitalized due to poorly controlled copd within 3 months prior to visit 1 (screening) or during the run-in period (visit 1 to visit 2). * subjects who have poorly controlled copd, defined as acute worsening of copd that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to visit 1 (screening) or during the run-in period (visit 1 to visit 2). * subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. * subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the mdi.
cannabis inhalation: effects on cardiovascular function during rest and exercise

Conditions: Cannabis; Cardiovascular Risk Factor

Summary: this two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. these techniques will examine arterial stiffness, vascular function, and cardiac function. in phase i and ii, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. cannabis used in phase i of this study will consist of approximately 10% thc. on all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. phase ii of the study will implore a similar design. in favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (cbd: (\~10%)) and low delta-9-tetrahydrocannabinol (thc: (\<1%)), or a high thc (\~10%) and low cbd (\<1%) variant.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 19-45yr 4. in good general health as evidenced by medical history and free of chronic disease 5. must be experienced with cannabis use. this requires recreational cannabis use of a minimum of once per week in the past 30 days as confirmed by urine test 6. experience consuming cannabis recreationally by vaping dried cannabis exclusion criteria: 1. deemed unfit to exercise by the parq+. 2. current or past diagnoses of substance abuse disorder 3. failure of recreational substance urine screening test 4. current, past, or strong family history of psychosis, or has previously experienced a cannabis-related psychotic episode 5. current or past diagnoses of cannabis use disorder 6. current or past diagnoses of any mood or anxiety disorder 7. identified ecg abnormalities 8. systolic blood pressure exceeding 160mmhg 9. diastolic blood pressure exceeding 90mmhg 10. resting heart rate exceeding 100bpm, or lower than 40bpm 11. diagnosed with respiratory disease 12. diagnosed with cardiovascular disease 13. diagnosed with liver disease 14. diagnosed with kidney disease 15. is pregnant or planning to be pregnant 16. currently taking prescription medication (excluding contraceptive medication) 17. is a cigarette smoker
a study of niraparib as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive stage small cell lung cancer

Conditions: Extensive-stage Small Cell Lung Cancer

Summary: niraparib is a parp inhibitor. the study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of zl-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ed-sclc) to evaluate the efficacy and safety.


Eligibility criteria:
inclusion criteria: aged 18-75 years histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ed sclc) ongoing clinical benefit (partial response \[pr\], or complete response \[cr\] per recist version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide) eastern cooperative oncology group (ecog) performance status of 0 or 1 subjects must have adequate bone marrow, renal and hepatic function exclusion criteria: subjects with central nervous system (cns) metastases subjects receiving consolidative chest radiation after last dose of first-line chemotherapy. subjects with pleural effusions that cannot be controlled with appropriate interventions. all side effects attributed to prior anti-cancer therapy must have resolved to grade 1 or baseline
radiosurgery in treating patients with kidney tumors

Conditions: Kidney Cancer

Summary: rationale: radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. purpose: this phase i/ii trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

objectives: primary * to evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors. secondary * to evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates. serum blood marker objective: * to determine if serum markers collected before and after radiation may give a predictive indication of tumor response. outline: this is a phase i, dose-escalation study followed by a phase ii study. patients undergo placement of 2-3 fiducial markers in or near the renal tumor. patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. treatment may repeat at 6 months if tumor is still present. after radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months. projected accrual: a total of 32 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (no major psychiatric illnesses.) * patient is able to give and sign study specific informed consent * no prior radiation to the treatment field * negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential * patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor * karnofsky status of ≥ 60% * signed study-specific informed consent prior to study entry exclusion criteria: * any patient not meeting the eligibility criteria. * any patient with active connective tissue disease such as lupus, dermatomyositis. * any patient with active crohn's disease or active ulcerative colitis. * major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.

Keywords: stage i renal cell cancer stage ii renal cell cancer stage iii renal cell cancer stage iv renal cell cancer
efficacy and safety of basal-bolus therapy, comparing stepwise addition of insulin aspart versus complete basal-bolus regimen

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, and north and south america. the aim of this clinical trial is to investigate if the two treatments are equally effective.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 12 months * basal insulin treatment (nph once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months * hba1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) * bmi (body mass index) less than 40.0 kg/m\^2 exclusion criteria: * previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (visit 1) * use of glp-1 (glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (visit 1) * anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, mao (monoamine oxidase) inhibitors, etc.) * cardiovascular disease, within the last 12 months prior to screening visit (visit 1), defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg). for argentina: systolic blood pressure sitting at least 150 mmhg and/or diastolic blood pressure at least 90 mmhg * impaired liver function, defined as alat (alanine aminotransferase) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) * impaired renal function defined as serum creatinine above 135 micromol/l (above 1.5 mg/dl) for males and above 110 micromol/l (above 1.2 mg/dl) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the cockroft \& gault formula). one retest within a week is permitted with the result of the last sample being conclusive * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * proliferative retinopathy or maculopathy requiring treatment according to the investigator * treatment with oads (oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local oad label)
study to demonstrate the non-inferiority of olmesartan medoxomil versus candesartan cilexetil in reducing blood b-type (or brain) natriuretic peptide levels at week 24

Conditions: Chronic Heart Failure; High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

Summary: this study will compare olmesartan medoxomil to candesartan cilexetil in reducing bnp, a prognostic biomarker of heart failure, at week 24


Eligibility criteria:
inclusion criteria: * male or female, adult, out-patients aged between 18 and 85 years * patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of chf * patients with functional nyha class ii-iv with lvef \< 40% assessed within the last 3 months * patients with blood bnp levels \> 400 pg/ml or nt-probnp levels \> 1500 pg/ml * patients with chf due to ischemic heart disease, idiopathic dilated cardiomyopathy (idc), mitral or aortic insufficiency or hypertension * patients with stable conventional treatment with diuretics, acei and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance exclusion criteria: * females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. if a female becomes pregnant during the study, she has to be withdrawn immediately * patients with current hospitalisation due to heart failure * patients with stroke or transient ischemic attack (tia) within the last 3 months * patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months * planned cardiac surgery, revascularization or resynchronization within the study period * patients with operable valvular disease or significant obstructive cardiomyopathy * patients with bradycardia \[heart rate (hr) \< 50 bpm\] * patients with hypotension \[systolic blood pressure (sbp) \< 90 mmhg\] * patients with obstructive pneumopathy * patients with clinical significant renal failure (creatininemia \> 200 micromol/l)
pharmacokinetics of degarelix in chinese patients with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.


Eligibility criteria:
inclusion criteria: * has a histologically confirmed (gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated * has a prostate-specific antigen (psa) level ≥2.0 ng/ml at screening * has a screening serum testosterone level \>150 ng/dl * has an eastern cooperative oncology group (ecog) score of ≤2 exclusion criteria: * has had previous or is currently under hormonal management of prostate cancer. however, hormonal therapy for a maximum duration of 6 months is accepted. this treatment should have been terminated at least 6 months prior to the screening visit * is currently treated with a 5-alpha reductase inhibitor * is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy * is in need of neoadjuvant hormonal therapy * has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
source monitoring déficit in neuropsychiatric population

Conditions: Psychiatric Disorder

Summary: the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.the investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

source-monitoring abilities will be measured thanks to reality-monitoring testing (i.e. the ability to distinguish internal-generated events from external ones) and internal-monitoring testing (i.e. the ability to distinguish an imagined source from a performed one). a source-monitoring deficit have been demonstrated in patients with psychiatric conditions such as schizophrenia and seems linked to frontotemporal abnormalities (frontotemporal dysconnectivity and temporal hypoactivity). with a total of 150 patients, the investigators will include 30 patients per group: patients with pre-dementia stage alzheimer, alzheimer, fronto-temporal dementia, lewy body dementia or parkinson and bipolar disorder, with the hypothesis that bipolar disorder patients will present less marked deficit. the investigators will recruit 150 healthy controls.

Eligibility criteria:
inclusion criteria: * subjects who gave their free and informed consent; * men and women; * aged 18 to 80; * having normal or corrected vision; * mastering the french language (read and spoken); * all subjects will not have a working memory deficit preventing the test from being passed (mmse short version):am patients should have a score of \<mmse \<26; patients with pre-dementia ad will be diagnosed according to dubois criteria (dubois et al., 2016); patients with early ftd will be diagnosed according to rascovsky's criteria (rascovsky et al., 2011); patients with dcl will be diagnosed according to mckeith's criteria (mckeith et al., 2005), tbp patients will be diagnosed using dsm 5 criteria (arlington va, 2013). exclusion criteria: * inadmissibility of the consent or refusal of the subject. * patients under guardianship

Keywords: bipolar disorder source-monitoring
pathophysiologic study to understand and possibly treat nocturia

Conditions: Nocturia

Summary: this study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.

this study intends to investigate the different causes nocturia. patients with nocturia will be assigned to wearing knee high then thigh high compression stockings to assess the effect on weight gain during the day and the number of nocturia events. renin and aldosterone levels will also be assessed. furthermore, fluorescein dye will be used to to demonstrate vascular leakage of the fluorescent dye.

Eligibility criteria:
inclusion criteria: * age above or equal to 18 years at the time of signing informed consent * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures. exclusion criteria: * suspected or proven peripheral arterial disease, including history of peripheral arterial bypass grafting * any sensory impairment such as severe peripheral neuropathy as evidenced by patient reported intermittent claudication and/or signs of ischemia such as "blue toes". * allergy to stocking textile material. * leg edema or pulmonary edema from congestive heart failure. * local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis. * extreme deformity of the leg, or unusual leg shape or size that would prevent correct fit. * treatment with any diuretics such as furosemide or hydrochlorothiazide.
study of eyp-1901 in patients with diabetic macular edema (dme)

Conditions: Diabetic Macular Edema

Summary: a prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the eyp-1901 intravitreal insert compared to aflibercept

a study to evaluate efficacy and safety of two doses of eyp-1901 in subjects with dme

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the screening visit * previously treated with at least 1 intravitreal anti-vegf in the last 6 months in the study eye at least 8 weeks prior to the screening visit. * bcva letter score of 35 letters (20/200 snellen equivalent) to 75 letters (20/32 snellen equivalent) in the study eye at the screening visit and at baseline (day 1). exclusion criteria: * any current or history of ocular disease other than dme * bcva using etdrs charts \<30 letters (20/250 snellen equivalent) in the fellow eye. * active ocular inflammation or active infection in either eye at baseline (day 1).

Keywords: dme eyp-1901 eyepoint
blood based eyedrops from different sources in the treatment of severe keratopathy

Conditions: Keratopathy; Sjogren's Syndrome; GVHD - Graft-Versus-Host Disease

Summary: topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. the purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

the rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (growth factors, gf), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . the most used product so far is the eye drop prepared from serum (autologous serum, as) or from platelet-rich plasma (plasma rich platelet, prp) of peripheral blood taken from the patients themselves. more recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. in particular the homologous sources show: * not invasiveness to the patient, who could in time not like the repeated withdrawals * applicability even in patients with underlying systemic conditions. they may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye * reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation * conceptually unlimited availability of the product to be dispensed * versatility of therapeutic indications, based on different gf levels which are estimated in advance the purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies.

Eligibility criteria:
inclusion criteria: * diagnosis of severe dry eye , scored as level severity 3 according to the dry eye workshop grade (dews, ocular surf 2007) * corneal epithelial damage, stained with fluorescein as vital dye, nei (national eye institute) score\> 6 (estimated with imagej software) damage coverage\> 25% of total corneal area * good general health condition * ability to adhere to treatment and to the procedures provided by the study exclusion criteria: * concurrent treatment with hypotensive drugs * ocular surgery in the 12 months preceding enrollment .