Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics and safety of loncastuximab tesirine in participants with relapsed or refractory diffuse large b-cell lymphoma or high-grade b-cell lymphoma with hepatic impairment (lotis-10)

Conditions: Diffuse Large B-Cell Lymphoma; High-grade B-cell Lymphoma

Summary: the primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large b-cell lymphoma (dlbcl) or high-grade b-cell lymphoma (hgbcl) participants with moderate and severe hepatic impairment.


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 years or older * pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) dlbcl not otherwise specified, dlbcl arising from low grade lymphoma, and high-grade b-cell lymphoma (2016 world health organization classification) who have received at least one systemic treatment regimen * measurable disease as defined by the 2014 lugano classification * normal hepatic function or hepatic impairment as defined by the national cancer institute organ dysfunction working group hepatic impairment classification: * arm a normal hepatic function: bilirubin and aspartate aminotransferase (ast) ≤ upper limit of normal (uln) * arm b moderate hepatic impairment: bilirubin \> 1.5 × to 3 × uln (any ast) * arm c severe hepatic impairment: bilirubin \> 3 × uln (any ast) * ecog performance status 0 to 2 for participants with normal hepatic function. ecog 0 to 3 for participants with moderate or severe hepatic impairment * adequate organ function * women of childbearing potential (wocbp)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug. exclusion criteria: * previous therapy with loncastuximab tesirine * allogenic or autologous stem cell transplant within 60 days prior to start of study drug (c1d1) * human immunodeficiency virus (hiv) seropositive * serologic evidence of chronic hepatitis b virus (hbv) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable hbv viral load * serologic evidence of hepatitis c virus (hcv) infection without completion of curative treatment or with detectable hcv viral load * history of stevens-johnson syndrome or toxic epidermal necrolysis * lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease * breastfeeding or pregnant * significant medical comorbidities * major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (c1d1), except shorter if approved by the sponsor

Keywords: loncastuximab tesirine lymphoma dlbcl hgbcl hepatic impairment
safety study of inhaled saline in acute lung injury

Conditions: Pulmonary Edema

Summary: to determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ards).

hypertonic saline (hs) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. safety concerns in mechanically ventilated patients with ards center primarily on hs's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. for that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. this narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.

Eligibility criteria:
inclusion criteria: * study participants will include consenting adult patients (age \> 18), who had been intubated and mechanically ventilated for \<72 hours and meet international consensus criteria for ards.

Keywords: acute lung injury mechanical ventilation
retrospective cohort study of the physiotherapy in critically ill covid patients

Conditions: COVID-19

Summary: retrospective cohort study that will include patients from the icu of the hospital de la santa creu i sant pau in barcelona during the period between march 11 and may 13, 2020. the cohorts are made up of two groups of patients admitted for severe covid during the first wave, according to whether or not they received physiotherapy and the possible impact of physiotherapy on the days of mechanical ventilation in the two study groups will be studied.


Eligibility criteria:
inclusion criteria: * patients diagnosed with covid-19 in critical condition * adults \>18 years * admission to the icu from march 11 to may 13, 2020 exclusion criteria: * patients readmitted on 2 occasions during the study period, the second will be omitted income.

Keywords: physical therapy covid mechanical ventilation
bayesian estimation of diagnostic performance of diabetic cardiovascular autonomic neuropathy without a gold standard

Conditions: Diabetic Cardiovascular Autonomic Neuropathy (DCAN)

Summary: this study aimed to estimate sensitivities and specificities of diabetic cardiovascular autonomic neuropathy (dcan) diagnostic tests using the bayesian approach without a gold standard in another independence dataset.the reference the values for the short-term hrv were calculated in the investigators' previous study (including 371 healthy subjects). this study dataset contained 200 diabetic patients who completed both the short-term hrv test and ewing's test. simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the bayesian approach without a gold standard.

the can prevalence is rapidly growing in all populations worldwide. no document has been reported diagnostic performance of short-term heart rate variability (hrv) for diabetic cardiovascular autonomic neuropathy (dcan) in the chinese population. this study aimed to estimate sensitivities and specificities of dcan diagnostic tests using the bayesian approach, in the absence of a gold standard in another independence dataset.the reference the values for the short-term hrv were calculated in the investigators' previous study (including 371 healthy subjects). this study dataset contained 200 subjects who completed both the short-term hrv test and ewing's test. simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the bayesian approach without a gold standard.

Eligibility criteria:
inclusion criteria: * survey diabetic participants with undiagnosed can, aged 30-90 years, were included in this study. exclusion criteria: * some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their ca function. briefly, the exclusion criteria were as follows: 1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism; 2. pregnancy or lactation; and/or 3. serious hepatic or renal dysfunctions.

Keywords: bayesian estimation, short-term heart rate variability, diabetic cardiovascular autonomic neuropathy, diagnostic performance diagnostic performance short-term heart rate variability diabetic cardiovascular autonomic neuropathy dcan
early detection of cognitive decline

Conditions: Cognitive Impairment

Summary: the goal of this clinical trial is to evaluate the impact of a brief cognitive screener on provider behavior in patients completing an annual wellness visit (awv). the main question\[s\] it aims to answer are: * do appropriate referrals increase for patients using the new screener? * do appropriate diagnostic orders increase for patients using the new screener? participants will respond to 4 questions about their cognitive abilities as part of a larger awv protocol. researchers will compare provider behavior for patients completing awvs before and after implementation of the new screener to see if referral, diagnostic and prescribing behaviors differ.

in the course of this two-year project, the rand team and partners (university of pittsburgh medical center \[upmc\] and northwestern university \[nu\]) will conduct secondary data analysis to establish the validity of scores from the pcf item bank; use the resulting data to derive meaningful scoring criteria and interpretation guidance, and determine the best short form item set from the pcf item bank to use for standardized cognitive impairment screening during the medicare annual wellness visit (awv); use qualitative methods to refine workflow for administering the screener in primary care; work with upmc to integrate the resultant brief self-reported promis cognition screener (pro-cis) into their workflows; and evaluate the effect of implementing brief standardized pro-cis with interpretive guidance on primary care providers' behaviors.

Eligibility criteria:
inclusion criteria: * has awv within study period exclusion criteria: * provider uses non-digital awv form
study to evaluate the ocular tolerance of syl1001 in healthy volunteers

Conditions: Ocular Pain; Dry Eye

Summary: the purpose of this study is to determine whether syl1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.


Eligibility criteria:
inclusion criteria: * subjects must provide signed inform consent prior to participation. * bmi between 19,5 y 29 kg/m2. * normal ocular test in both eyes: iop \ /=0,8 (20/25)snellen scale, or \</=0.1 logmar. * normal fluorescein clearance test in both eyes. * normal funduscopy in both eyes. exclusion criteria: * pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study. * current relevant disease. * previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment. * volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study. * having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route. * case history of hypersensitivity to meds or any other allergic process. * visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis). * volunteers with visual alteration with more than 3 dioptres in either eye. * volunteers who has participated in a clinical trial during the past fout months before study entry. * blood or derivate transfusion during the six previous months to study entry. * case history of drug or alcohol abuse or dependence. * positive result in test drug abuse during selection period. * positive serology results to hepatitis b virus(hbsag), virus c o vih. * analytic alterations medically relevant, at investigator's judgement.

Keywords: ocular pain dry eye sirna
effect of coaching on mid-career physician well-being, job satisfaction, and fulfillment

Conditions: Burnout, Professional

Summary: the study will assess the effect of individualized professional coaching for mid-career family medicine and general internal medicine physicians on burnout, job satisfaction, and professional fulfillment.


Eligibility criteria:
inclusion criteria 1. general internal medicine and family physicians 2. in practice for 5-30 years exclusion criteria: 1. physicians who specialize in areas other than general internal medicine and family medicine 2. physicians who have been in practice less than 5 years or more than 30 years
assessment of the safety and efficacy of brm421 ophthalmic solutions in dry eye subjects.

Conditions: Dry Eye Disease

Summary: the objective of this study is to compare the safety and efficacy of brm421 os to vehicle for the treatment of the signs and symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a reported history of dry eye prior to enrollment; * have a history of use or desire to use eye drops; exclusion criteria: * have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * be a woman of childbearing potential who is not using an acceptable means of birth control;
clinical study of probiotic treatment for androgenetic alopecia

Conditions: Androgenetic Alopecia; Female Pattern Baldness

Summary: the primary objective of the study is to assess the efficacy of da-001 as an oral supplement for treatment of female pattern hair loss.

da-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. the ingredients were tested in-vitro and have demonstrated the anti-androgen effect. this study aims to compare da-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).

Eligibility criteria:
inclusion criteria: * females age 18 or older * diagnosed with female pattern hair loss * willing and able to apply the treatment as directed, comply with study * otherwise healthy * able to give informed consent exclusion criteria: * a medical history that may interfere with study objectives * women who are pregnant, lactating, or planning to become pregnant during the study period * subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc) * subjects who have known allergies to any excipient in da-001 * subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation * subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation * subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation * subject is unable to provide consent or make the allotted clinical visits
hemostatic activity following laao

Conditions: Atrial Fibrillation; Stroke

Summary: the primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (laao).

this is a prospective cohort study of patients undergoing transcatheter laao at aarhus university hospital. hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 laao patients. platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.

Eligibility criteria:
inclusion criteria: * age \> 18 years * atrial fibrillation (paroxysmal, persistent, or permanent) * admitted and eligible for laao * signed written consent exclusion criteria: * known hereditary bleeding disorders (i.e. hemophilia a and b, von willebrand disease) * platelet count \< 75 x 109/ml
applying nutrient drink test in understanding pathophysiology of cvs

Conditions: Cyclic Vomiting Syndrome

Summary: cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. there is very little research on this field at this point and most doctors do not fully understand the disorder. the goal of this study is to assess how the stomach empties food. participants will be asked to participate in this study because either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past, or (b) they are physically healthy. the study seeks to compare how a healthy person's stomach empties to how the stomach of someone with cyclic vomiting disorder empties.

up to 14% of unexplained vomiting in adults is attributed to an under recognized and often misdiagnosed disorder termed cyclic vomiting syndrome (cvs). as cvs is better understood, gastroenterologists are increasingly recognizing the importance of timely diagnosis and early management for this chronic and debilitating disorder. currently, the only gold standard diagnostic strategy involves evaluating clinical criteria set by the rome foundation, such as vomiting frequency and duration of episodes. outside of these subjective criteria, no definitive and objective diagnostic strategy for cyclic vomiting syndrome exists. developing diagnostic strategies has been difficult given the exact etiology of cvs is still unknown. one physiologic theory includes rapid gastric emptying (ge)-or a dumping-like syndrome related to impaired gastric accommodation. a retrospective analysis observed rapid gastric emptying by standard 4-hour scintigraphic gastric emptying study in 80% of subjects, suggesting a relationship with cvs and rapid ge. in turn, rapid emptying has been hypothesized to relate with abnormal gastric accommodation - the reflex allowing storage of food through increased fundic volume. this physiologic abnormality can be readily and easily measured using non-invasive tools, but have never been tested in cvs. to explore this further, we aim to determine if cvs patients have abnormal gastric accommodation measured by nutrient drink test.

Eligibility criteria:
inclusion criteria: * diagnosed with cyclic vomiting (or healthy volunteer) * age 18 or greater exclusion criteria: * age under 18 * history of gastric surgery * history of marijuana use * history of gastroparesis * history of diabetes mellitus ii * upper endoscopy with known obstructive gastric disease * current pregnancy or lactation * active inflammatory bowel disease (crohn's disease, ulcerative colitis) * severe renal disease (gfr \<15/dialysis dependent) * active malignancy (diagnosed in last 5 years) * allergy/intolerance to liquid ensure®

Keywords: chronic nausea, intermittent vomiting, impaired accommodation
incidence, long- term outcome and factor related to non- cardiac postoperative delirium in elderly patients

Conditions: Postoperative Delirium

Summary: the purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.

the investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.

Eligibility criteria:
inclusion criteria: * age \>/ 60 years * american society of anesthesiologists (asa) physical status 1-3 * undergoing scheduled surgery * giving an informed consent exclusion criteria: * impaired visual and auditory disturbance * cannot communicate with thai language * undergoing neurosurgery

Keywords: delirium, postoperative delirium, elderly
prospective study on plasma pro-endothelin-1 in predicting bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm infants. comparing pro-endothelin-1 with established clinical indices of bronchopulmonary dysplasia (bpd). hypothesis: pulmonary-vascular remodeling in infants developing bpd is directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker of bpd.


Eligibility criteria:
inclusion criteria: * very preterm infants born before 32 weeks gestational age exclusion criteria: * severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops
single patient expanded access to ganitumab for metastatic ewing sarcoma

Conditions: Ewing Sarcoma

Summary: despite improvements in outcomes for patients with localized ewing sarcoma, patients with relapsed metastatic ewing sarcoma continue to have poor outcomes with current chemotherapy options. a large body of preclinical data supports a role for igf-1r inhibition in the treatment of ewing sarcoma. more recently, clinical trials of igf-1r monoclonal antibodies have demonstrated single- agent activity in patients with relapsed ewing sarcoma. ganitumab (amg 479) is a fully human monoclonal antibody directed against igf-1r. we are proposing this single-agent expanded access ind to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

despite improvements in outcomes for patients with localized ewing sarcoma, patients with relapsed metastatic ewing sarcoma continue to have poor outcomes with current chemotherapy options. a large body of preclinical data supports a role for igf-1r inhibition in the treatment of ewing sarcoma. more recently, clinical trials of igf-1r monoclonal antibodies have demonstrated single- agent activity in patients with relapsed ewing sarcoma. ganitumab (amg 479) is a fully human monoclonal antibody directed against igf-1r. we are proposing this single-agent expanded access ind to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Eligibility criteria:
inclusion criteria: diagnosis: confirmed translocation-positive ewing sarcoma organ function requirements: serum creatinine \< 1.4 adequate liver function * total bilitubin \<1.5x upper limit of normal for age * sgpt (alt) \ 50% by echocardiogram bone marrow * absolute neutrophil count \> 750 * platelet count \> 75 exclusion criteria: * female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy. sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy. * patients with known pre-existing diabetes mellitus will be excluded from study.