Kornimate/medical-research-clean huggingface dataset:
impact of neuromonitoring during cardiac procedures

Conditions: Delirium; Stroke; Acute Kidney Injury

Summary: through a series of sequential analyses, retrospective database exploration looking for linkages and associations between the use of processed electroencephalogram (eeg) and/or cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be explored.

the purpose of this study is to mine the premier healthcare database to: 1. define the incidence of post-operative cognitive complications, acute kidney injury and stroke after specific cardiac surgical procedures (defined as: coronary artery bypass graft \[cabg\], aortic valve replacement, mitral valve repair, mitral valve replacement, thoracic aortic operation, combined cabg and valve replacement or repair ; and 2. determine the incremental increase in the length of hospitalization and cost of hospitalization among cardiac surgical patients who suffer postoperative cognitive complications, acute kidney injury and stroke; and 3. determine the effectiveness of intraoperative neuromonitoring with cerebral saturation and/or processed electroencephalogram (eeg) monitoring on the incidence of post-operative cognitive complications, acute kidney injury and stroke as a consequence of specific cardiac surgery procedures. the premier healthcare database is a privately owned database that represents approximately 1/5th of all united states hospitalizations annually. it includes all international classification of diseases-9th revision (icd-9) and international classification of diseases-clinical modification (icd-9-cm) diagnosis and procedure codes recorded by the hospital, as well as a limited set of current procedural terminology (cpt)-4 codes. within the database, discharge-level data include information on patient and provider characteristics, diagnoses and procedures, hospital resource utilization, and charges/cost data for all entries, including pharmacy charges.

Eligibility criteria:
inclusion criteria: * all adult (age \>=18 years) hospitalized patients who underwent major cardiac surgical procedure requiring cardiopulmonary bypass captured in the premier database from january 1, 2010 - december 31, 2014 (5 year period) exclusion criteria: * \<18 years of age * cardiac procedures not requiring cardiopulmonary bypass
knowledge and attitude towards fertility among emirati infertile patients

Conditions: Infertility, Female; Infertility, Male

Summary: infertility is on the rise worldwide due to multiple reasons. proper and timely diagnosis makes the treatment easier and more acceptable by the couple. lack of fertility knowledge however delays necessary investigations and sometimes reduces chances of success as a consequence of a delay in patients / couples approaching infertility clinics. assessing the fertility knowledge of the emirati infertility patients would help us to understand better the cultural aspects of fertility, the driving forces for having children and how much patients actually know about predisposing factors for infertility. this in turn would improve counseling and possible set knowledge campaigns to increase awareness.


Eligibility criteria:
inclusion criteria: * united arab emirates nationals coming for their first consultation in art fertility clinics * any age group * males and females exclusion criteria: - none kindly note that art is the name of the fertility clinic and not an abbreviation

Keywords: surveys and questionnaires
gen1029 (hexabody®-dr5/dr5) safety trial in patients with malignant solid tumors

Conditions: Colorectal Cancer; Non-small Cell Lung Cancer; Triple Negative Breast Cancer; Renal Cell Carcinoma; Gastric Cancer; Pancreatic Cancer; Urothelial Cancer

Summary: the purpose of the trial is to evaluate the safety of gen1029 (hexabody®-dr5/dr5) in a mixed population of patients with specified solid tumors

the trial is an open-label, multi-center first-in-human trial of gen1029 (hexabody®-dr5/dr5). the trial consists of two parts a dose escalation part (phase 1, first-in-human (fih) and an expansion part (phase 2a). the expansion part of the trial will be initiated once the recommended phase 2 dose (rp2d) has been determined.

Eligibility criteria:
inclusion criteria (main): * patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with gen1029 may be beneficial. * patient must be ≥ 18 years of age * patients must have measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1 * have an acceptable hematological status * have an acceptable renal function * have an acceptable liver function * have an eastern cooperative oncology group performance status of 0 or 1 * body weight ≥ 40kg * patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of gen1029 exclusion criteria (main): * acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first gen1029 administration * have clinically significant cardiac disease * have uncontrolled hypertension as defined in the protocol * any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke * history of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of investigational medicinal product (imp) * have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first gen1029 administration * history of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial * radiotherapy within 14 days prior to first gen1029 administration * any prior therapy with a compound targeting dr4 or dr5 * history of chronic liver disease or evidence of hepatic cirrhosis
atacicept in subjects with iga nephropathy

Conditions: IgA Nephropathy; Berger Disease

Summary: a phase 3 study with atacicept in subjects with iga nephropathy (origin 3)

this is a multi-part study comprising of the original phase 2b study and the addition of a separate pivotal phase 3 study. after the completion of the primary results for the ph 2b dose ranging study, the pivotal study will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with igan and persistent proteinuria despite being on a maximally tolerated dose (mtd) of a rasi. safety, egfr, serum immunoglobulins and gd-iga1 will also be clinically assessed. the clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. the upcr primary endpoint will be assessed after the first 200 patients are randomized.

Eligibility criteria:
key inclusion criteria: * must have the ability to understand and sign a written informed consent form * male or female of ≥18 years of age * total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (upcr) ≥1.0 mg/mg based on a 24-hour urine sample during the screening period * diagnosis of igan as demonstrated by renal biopsy conducted within 10 years * egfr ≥ 30 ml/min/1.73 m2, as per the chronic kidney disease epidemiology collaboration (ckd-epi) equation. * on a stable prescribed regimen of raasi for at least 12 weeks that is at the maximum labeled or tolerated dose at screening * systolic blood pressure ≤150 mmhg and diastolic blood pressure ≤90 mmhg key exclusion criteria: * igan secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial iga deposition including iga vasculitis (i.e., henoch-schonlein purpura), systemic lupus erythematosus (sle), dermatitis herpetiformis, ankylosing spondylitis * total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (upcr) ≥ 5 mg/mg based on a 24-hour urine sample during the screening period * evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of egfr within 3 months of screening) * evidence of nephrotic syndrome within 6 months of screening (serum albumin \ 3.5 mg/mg * renal or other organ transplantation prior to, or expected during the study * concomitant chronic renal disease in addition to igan * uncontrolled diabetes, defined as hemoglobin-a1c (hba1c) \>7.5% at screening * history of tuberculosis (tb), untreated latent tb infection (ltbi), or evidence of active tb determined by a positive quantiferon test * participation in the phase 2b (parts a and b) study or any previous treatment with atacicept

Keywords: berger disease berger's disease iga glomerulonephritis iga nephropathy iga nephropathy 1 immunoglobulin a nephropathy nephritis iga type nephropathy, iga
watchman implantation during hybrid ablation

Conditions: Atrial Fibrillation; Stroke

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia with a lifetime risk of developing af of 1 in 4 people aged over 40. stroke remains the most feared complication of af with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. the left atrial appendage (laa) is the origin for more than 90% of the emboli in non-valvular af. the watchman™ left atrial closure device (watchman device, boston scientific) reduces the risk of stroke by closing off the laa. during hybrid procedures for af, laa occlusion with epicardial devices is known to be difficult and not free of risks.it thus will be interesting to study the safety and feasibility of endocardial watchman device implantation in a hybrid ablation approach.


Eligibility criteria:
inclusion criteria: * documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation, * eligible at least for short-term oac therapy, * no other conditions that would require long-term oac therapy, suggested by current standard medical practice, and thus is eligible to stop oac if the laa is sealed, * calculated cha2ds2-vasc score of 1 or more, * 18 years of age or older, able and willing to provide written informed consent. exclusion criteria: * current new york heart association class iv congestive heart failure, * current thrombocytopenia (\< 100x10e9/l) or anemia (hemoglobin \<6.2 mmol/l), * active infection or sepsis, * resting heart rate \> 110 beats per minute, * cerebrovascular accident (cva) or transient ischemic attack (tia) within the last 30 days, * recent myocardial infarction (within 3 months), * transient case of af (i.e., secondary to recent cardiac surgery (within 3 months)), * planned cardioversion 30 days post implant of the watchman device, * implanted mechanical valve prosthesis, * history of obliterated laa, * history of heart transplantation, * symptomatic carotid disease (i.e., carotid stenosis \>50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric tias or ipsilateral stroke within 6 months), * necessity to use long-term oac, * contraindication for use of oac or dual anti-platelet therapy, * contraindication for use of aspirin, * pregnancy or planned pregnancy during the course of the investigation, * life expectancy less than 2 years, * participation in any other clinical study involving an investigational drug or device. echocardiographic exclusion criteria (as assessed via transthoracic echocardiography (tte) or tee) for this study are: * left ventricular ejection fraction (lvef) \< 30%, * intracardiac thrombus as visualized by tee within 2 days prior to implant, * high risk patent foramen ovale, * current atrial septal defect and/or previous atrial septal repair or closure device, * significant mitral valve stenosis (i.e., mv 4. 5 cm2), * existing pericardial effusion of \>3 mm, * complex atheroma with mobile plaque of the descending aorta and/or aortic arch, * cardiac tumor.

Keywords: watchman atrial fibrillation hybrid ablation safety feasibility stroke prevention
sex disparities in hypoxic sympatholysis and impact of obesity

Conditions: Obesity; Healthy; Vasoconstriction; Vasodilation

Summary: patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. this project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.


Eligibility criteria:
inclusion criteria: * 18-45 years of age (premenopausal) * healthy weight (bmi ≥18 and ≤25 kg/m2) * obese (bmi ≥30 kg/m2) exclusion criteria: * pregnancy, breastfeeding, oral hormonal contraceptive use * diagnosed sleep apnea or oxygen desaturation index \>10 events/hr * current smoking/nicotine use * increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy * nerve/neurologic disease * cardiovascular, hepatic, renal, respiratory disease * blood pressure ≥140/90 mmhg * diabetes, polycystic ovarian syndrome * communication barriers * prescription medications, sensitivity to lidocaine
kremezin study against renal disease progression in korea

Conditions: Chronic Kidney Disease

Summary: 1. to evaluate the effectiveness of ast-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe chronic kidney disease (ckd iii-iv), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of egfr 50% or more or doubling of serum creatinine (scr) when compared with standard-of-care group; 2. to evaluate the effectiveness of ast-120 (spherical carbon adsorbent) to gfr and proteinuria; 3. to evaluate the effectiveness of ast-120 (spherical carbon adsorbent) to health related quality of life; 4. to evaluate the safety and tolerability of long-term ast-120 therapy in patients with ckd; 5. to evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)


Eligibility criteria:
inclusion criteria: * informed consent * age 18 years or older * ckd stage 3,4 (estimated gfr by cockcroft-gault equation 15-59 ml/min/1.73m\^2) * followed up by responsible nephrologists more than 6 months * egfr checked 2 times or more during screening period * egfr declined or expected to decline \>= 5ml/min/year or \>=2.5ml/min/6 months * blood pressure \<= 160/100 mmhg * blood pressure checked 3 times or more during screening period * no significant change of medication for ckd exclusion criteria: * patients who took medicine ast-120 or ketosteril within 2 months * received any investigational agent or participated in a clinical study within the previous 2 months * history of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe gi dysmotility) * obstructive urologic disease and other reversible kidney diseases * chronic kidney disease due to autosomal dominant polycystic kidney disease, adpkd * severe nephrotic syndrome, 10g or more/day(or random urine pcr \>= 10.0) * history of previous kidney transplant * heart failure (nyha iii-iv), uncontrolled arrhythmia, unstable angina * liver cirrhosis (child-pugh b,c) * active infection, uncontrolled inflammatory disease * progressive malignant disease * cerebral infarction and intracranial hemorrhage within 6 months,except transient ischemic attack (tia) * uncontrolled blood sugar (hba1c \>10%) * severe anemia, hb \<7g/dl * life expectancy less than 12 months at the point of randomization * pregnant and willing to bear child during study * patients, inappropriate to study (researchers decided)
expanded access to provide selitrectinib for the treatment of cancers with a ntrk gene fusion

Conditions: Solid Tumors Harboring NTRK Fusion

Summary: selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (ntrk1, ntrk2, or ntrk3 gene fusion). the patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. expanded access is intended to treat individual patients with different types of cancers with a ntrk gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (trk) inhibitor therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer with a ntrk1, ntrk2, and ntrk3 gene fusion * previous treatment with a kinase inhibitor with known activity on trk inhibition * unable to participate in an ongoing selitrectinib clinical trial * medically suitable for treatment with selitrectinib exclusion criteria: * currently enrolled in an ongoing clinical study with a trk inhibitor

Keywords: metastatic cancer advanced cancer neurotrophic tyrosine receptor kinase (ntrk) ntrk1 ntrk2 ntrk3 fusion positive children loxo-195
leukocyte morphology and corticosteroids response in septic patients (mocorsep)

Conditions: Sepsis; Septic Shock; Sepsis Syndrome; Infection

Summary: non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.

sepsis is a major public health issue, caused by an organ disorder related to an immune response not controlled by the infection. several randomized trials have shown that the combination of glucocorticoids and mineralocorticoids improves the survival rate of patients in septic shock. the optimal use of this therapeutic approach requires identifying the pro-inflammatory phase patients likely to respond to corticosteroid therapy. hyperactivation of immune cells is accompanied by morphological changes likely to be characterized by modern hematology instruments, particularly the dxh900 (beckman coulter). the dxh900 is able to use specific techniques to determine a significant number of morphological characteristics (cpd or cell population data) for circulating leukocytes. recently, one of these leukocyte morphological parameters, mdw (monocyte distribution width), has been clinically approved for identifying septic patients or those at risk of developing sepsis. this mdw parameter currently has the ce ivd mark and is approved by the american fda. the aim of the study is to explore the hypothesis that leukocyte morphological parameters, including mdw, may constitute functional biomarkers of pro-inflammatory response and help to identify septic patients likely to optimally respond to a combination treatment of glucocorticoids and mineralocorticoids, and thus improve their chances of survival. the proposed study is a non-interventional, prospective, monocentric cohort study to explore the variation of leukocyte morphological parameters measured on the dxh900 hematology analyzer according to the different infectious conditions of patients ranging from a known or suspected infection to septic shock versus non-infected control patients, and possibly based on the response. this observational cohort study will consist of patients with a known or suspected infection, sepsis or in septic shock on their date of admission into one of the medical or surgical departments and monitored up to day 7 of the hospital stay or on the date of discharge from the hospital, whichever occurs first.

Eligibility criteria:
inclusion criteria: * an infection (known or suspected) * sepsis * sepsis + vasopressor * septic shock * responders to corticosteroid therapy * non-responders to corticosteroid therapy exclusion criteria: * pregnant women * patients with onco-hematological diseases with the presence of blasts.

Keywords: leukocyte morphology corticosteroid mdw cell population data dxh900
evaluation of immunogenicity, reactogenicity and safety of hbv-mpl vaccine vs engerix™-b, in haemodialysis patients

Conditions: Hepatitis B

Summary: this trial is designed to evaluate the immunogenicity, reactogenicity and safety of an mpl-adjuvanted recombinant hepatitis b vaccine in comparison with those of engerix™-b in haemodialysis patients with or without previous vaccination against hepatitis b

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * dialysis patients * a medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study. * age: from 18 years onwards * seronegative for anti- hepatitis antibodies exclusion criteria: * history of persistent hepatic, cardiac or respiratory disease * any acute disease at the moment of entry into the study * chronic alcohol consumption * hepatomegaly, right upper quadrant pain or tenderness * any treatment with coticosteroids or immunomodulating drugs * known hypersensitivity to any component of the vaccine * simultaneous participation in any other clinical trial

Keywords: hepatitis b engerix™-b recombinant hepatitis b vaccine adjuvant
comparative effects of aerobic exercises, resistance training and combined training on heart failure patients

Conditions: Heart Failure

Summary: to compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.


Eligibility criteria:
inclusion criteria: * heart failure patients with ejection fraction greater than 35% exclusion criteria: * patients with unstable angina * patients who had severe pain in the lower limbs * patients with blood pressure greater than 190/120mmhg were excluded * patients who had positive contraindication for cardiac rehabilitation were not admitted in this study

Keywords: aerobic exercises resistance training combined training
changes in heart rate variability and heart rate/activity slope after hospitalization for acute exacerbations of copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of copd.

the investigators will place a monitoring patch that continuously records electrocardiogram and activity. participants will switch this patch every 7 days for a total of 28 days. from these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of copd.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. at least moderate copd by global initiative for chronic obstructive lung disease spirometry criteria (fev1/fvc \< 0.7 and fev1 \< 80% predicted) 3. 10 pack year smoking history 4. hospitalized with one or more of: 1. increased dyspnea 2. increased sputum 3. change in sputum character 5. treated with corticosteroids and/or antibiotics for respiratory indications 6. age \> 40 years old exclusion criteria: 1. discharging home on hospice 2. inability to follow trial protocols 3. pacemaker 4. allergy to a component of the adhesive patches 5. breastfeeding 6. permanent/continuous atrial fibrillation