Kornimate/medical-research-clean huggingface dataset:
ruxolitinib for treatment of covid-19 induced lung injury ards

Conditions: ARDS, Human; COVID

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with covid-19 severe pneumonia.

this clinical trial is an open-label trial of ruxolitinib for the treatment of severe covid-19 to assess its efficacy and safety. ruxolitinib (incb018424 phosphate, inc424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of janus kinase (jak)1 and jak2, with modest to marked selectivity against tyrosine kinase (tyk)2 and jak3, respectively. ruxolitinib interferes with the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. ruxolitinib (jakavi®) is currently approved in the european union (eu) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (pmf) (also known as chronic idiopathic mf), post-polycythemia vera myelofibrosis (ppv-mf) or post-essential thrombocythemia myelofibrosis (pet-mf) and for the treatment of adult patients with pv who are resistant to or intolerant of hydroxyurea (hu). in the us, ruxolitinib has been approved in the treatment of steroid refractory graft versus host disease post allogeneic stem cell transplantation. because many patients with severe respiratory disease due to covid-19 have features consistent with the cytokine release syndrome (crs) and increased activation of the jak/stat pathway, it is postulated that ruxolitinib might have a useful role in treating these patients.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female adult ≥18 years of age at time of enrollment. 2. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay (result of the pcr is not necessary for inclusion, but has to approved latest within 48-72 hours after registration) 3. willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study 4. severe lung disease as defined by following: 1. recent intubation 2. requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (pao2/fio2) ≤ 200 mmhg at a peep ≥ 5mm h2o 3. serum ldh \> 283 u/l 4. ferritin above normal value 5. ct-scan: pulmonary infiltration compatible with covid-19 disease 5. patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed. exclusion criteria: 1. uncontrolled hiv infection 2. active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention) 3. chronic kidney disease requiring dialysis 4. alt/ast \> 5 times the upper limit of normal. 5. pregnancy or breast feeding. 6. allergy to study medication 7. simultaneous participation in another clinical trial with an experimental treatment

Keywords: covid-19 ards ruxolitinib janus kinase jak1 jak2
a research study for patients with end-stage renal disease (esrd)

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (pth) compared with the standard of care.


Eligibility criteria:
inclusion criteria: * esrd patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month * the mean of 2 ipth determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/ml (31.8 pmol/l) and less than 800 pg/ml (84.8 pmol/l). if bipth is determined, the mean levels must be greater than or equal to 150 pg/ml (15.9 pmol/l) and less than 410 pg/ml (43.5 pmol/l) * the mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the pth determinations must be greater than or equal to 8.4 mg/dl (2.1 mmol/l) exclusion criteria: * have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator * have had a parathyroidectomy in the 6 months before day 1 * have received vitamin d therapy for less than 21 days before day 1 or required a change in prescribed vitamin d brand or dose within 21 days before day 1. if subjects are not prescribed vitamin d therapy, they must remain free of vitamin d therapy for the 21 days before day 1. * received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme cyp2d6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). the tricyclic antidepressant amitriptyline is permitted. - experienced a myocardial infarction within 3 months prior to day 1 * are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) * have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets

Keywords: secondary hyperparathyroidism (shpt) dialysis, end stage renal disease (esrd) kdoqi, cinacalcet clinical trial, amgen
tongxinluo improve high on clopidogrel platelet reactivity patients with coronary heart disease

Conditions: Coronary Artery Disease

Summary: tongxinluo is a kind of chinese patent drug,which could promote blood circulation.recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.in this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive tongxinluo.all patients will be followed up for one year.

the primary endpoint is platelet reaction unit( by verifynow) at 30 days.the secondary endpoints include inflammation marker (hscrp、cd62p-cd41),tt,fib and pt at 30 days,and mi、ischemic stroke, target vessel revascularization and all-cause mortality 、bleeding events at 1 year.

Eligibility criteria:
inclusion criteria: - (1)acs (including unstable angina pectoris, non-st-segment elevation myocardial infarction and st-elevation myocardial infarction) （2）accept at least one coronary stent. （3）the age between18 and 75 . （4）high on-treatment platelet reactivity defined as an adp-induced platelet aggregation (by verifynow，pru≥236）at 24 hr after clopidogrel loading (300 \~ 600mg)or 24 hours after pci. （5）informed consent exclusion criteria: * （1）tongxinluo contraindication . （2）receiving gp iib / iiia receptor antagonist treatment （3）who complicate the known bleeding tendency and blood system diseases. （4）nyha grade iii \~ iv （5）aspirin or clopidogrel allergies （6）severe liver or kidney dysfunction （7）pregnancy （8）cann't accept 30 days supervision and blood proofer. （9）other serious illness, life expectancy less than 6 months. （10) planned surgery recently （11) pci again within 30 days. (12) mental diseases interfering understanding the informed consent form （13）accept other drugs or participate in other clinical research at the same time .

Keywords: high on-treatment platelet reactivity coronary heart disease tongxinluo
cardiac monitoring of post-operative cancer patients experiencing atrial fibrillation

Conditions: Post-Operative Cancer Patients Experiencing Atrial; Fibrillation

Summary: the purpose of this study is to assess whether it is possible and acceptable to monitor patients at a distance who experience a condition called atrial fibrillation after their cancer surgery. some patients have no other clinical reason for staying in the hospital after cancer surgery except in order to control their heart rhythm. being able to send these patients home earlier and monitor them at a distance from their home can be good for their quick recovery. studies have shown greater quality of life and patient satisfaction when patients are monitored at a distance for conditions like atrial fibrillation, however cancer patients have not been studied.


Eligibility criteria:
inclusion criteria: * post-operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged. * must attend two outpatient visits at mskcc's cardiology practice during the study period, as specified by the participant's attending. * must be older than 21 years of age. exclusion criteria: * non-english speaking patients

Keywords: atrial fibrillation ecg monitor blood pressure device remote cardiac monitoring
the interaction between metformin and physical training

Conditions: Impaired Glucose Tolerance; Diabetes Mellitus, Type 2

Summary: physical activity is a first line treatment for patients with type 2 diabetes (t2d), however, the vast majority of patients with t2d do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. it is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (ampk) in skeletal muscle and liver, and the activation of ampk results in many different metabolic effects, including improvements in glycemic control. because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. thus, the aim of this study is to assess the effects of training with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur. subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way. experimental days will be performed before randomisation (before initiation of metformin/placebo treatment), before initiation of the training period and after the training period.


Eligibility criteria:
inclusion criteria: * glucose-lowering-medication naïve t2d and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (pg) in the 75-g ogtt (7.8-11.0 mmol/l) and/or hba1c (39-47 mmol/mol) * caucasian * bmi \> 25 but \< 40 kg/m2 * low to moderate physically active (≤90 min of structured physical activity/week) exclusion criteria: * pregnancy * smoking * glucose-lowering treatment * treatment with steroids and other immunomodulating drugs * contraindication to increased levels of physical activity * liver disease (alat elevated more than 3 times above upper normal limit, or reduce levels of the liver function markers albumin and kf ii+vii+x) * renal insufficiency (egfr\<60 ml/min) * prior history of lactic acidosis * hba1c \>55 mmol/mol and/or 2-hpg in the 75-g ogtt \> 15 mmol/l
study of dasatinib in patients with chronic phase chronic myeloid leukemia and a suboptimal response to imatinib

Conditions: Leukemia, Myeloid, Chronic

Summary: the purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. the safety of these treatments will also be evaluated.

participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (cgr) less than a partial cgr (pcgr) after at least 6 months of monotherapy with 400-mg; a pcgr after at least 12 months of monotherapy with 400-mg imatinib; or less than a major molecular response with a complete cgr after at least 18 months of monotherapy with 400-mg imatinib. participants received either dasatinib or imatinib for 12 months or until disease progression, unacceptable toxicity, consent withdrawal, or study discontinuation. after 12 months, who had a confirmed major molecular response and were still receiving dasatinib, 100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months. participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study.

Eligibility criteria:
inclusion criteria: * chronic phase ph\^+ chronic myeloid leukemia (cml) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (cgr) that is less than a partial cgr (pcgr) after at least 6 months of monotherapy with imatinib, 400 mg; a pcgr after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete cgr after at least 18 months of monotherapy with imatinib, 400 mg. * either gender * age of 18 years or older exclusion criteria: * previous diagnosis of accelerated phase or blast crisis cml * uncontrolled or significant cardiovascular disease * history of significant bleeding disorder unrelated to cml * concurrent malignancies * intolerance of imatinib, 400 mg * prior treatment with imatinib at a dose higher than 400 mg * prior stem cell transplantation and/or high-dose chemotherapy for cml

Keywords: chronic phase cml, with a suboptimal response after treatment with imatinib
performance of rigid gas permeable (rgp) scleral contact lenses with a passive artificial iris

Conditions: Low Vision

Summary: data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (a, b and c). before the measuring days, each subject will undergo an extra fitting session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. the fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. during the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. during the first testing session data from the lens design a (reference lens without artificial iris) will be recorded. during the second testing session data from the lens designs b and c (lenses with artificial iris with different transmittances) will be recorded. in each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). a specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.

first, the participant will be subjected to an rgp scleral contact lens fitting session, then during the second and third visits the participant will be subjected to several non-invasive procedures specific to the study in order to assess contrast sensitivity and visual acuity using the fitted and uniquely fabricated investigational medical devices. the tests will be performed after eye drops are supplied to dilate the pupil of the subjects (eye drops: tropicamide and phenylephrine). besides the clinical experiments, the participant will be given a specific questionnaire in order to assess comfort, light sensitivity, horizontal visual angle and overall experience of the investigational medical device and in combination with a pair of sunglasses category 3-4. the investigators will document the occurrence of any adverse events and specific side effects during day 2 and 3 (testing sessions with the investigational devices) in order to effectively assess their safety.

Eligibility criteria:
inclusion criteria: - age between 18 and 45 years old exclusion criteria: * iris disorders (i.e. ocular albinism, coloboma, aniridia). * known disease-related ocular surface problem (i.e. microbial keratitis). * known ocular pathologies (except refractive disorders). * coexistent ocular diseases impeding contact lens correction (i.e. glaucoma, previous ocular surgery). * corneal scarring. * low corneal endothelial cell count (\< 1500 cells per mm2), with potential of corneal hypoxia-induced corneal edema induced by contact lens wear. * wearing of contact lenses in the last 24 hours (prior to the interventions).

Keywords: visual acuity contrast sensitivity scleral contact lens artificial iris
assessment of the effectiveness of iv and sc abatacept (orencia) patient alert cards in patients with rheumatoid arthritis in a sample of eu countries

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to determine a) if the implementation of abatacept (orencia®) patient alert card (pac) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

3 sub studies: 2 cross-sectional and 1 retrospective chart review

Eligibility criteria:
inclusion criteria: * patient survey (cohort 1): 1. patients has taken abatacept within the previous 3 months for rheumatoid arthritis 2. patient is 18 years of age or over * hcp survey (cohort 2): a) physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up) * retrospective chart review study (cohort 3): 1. patient survey questionnaire completed , informed consent form (icf) signed exclusion criteria: * patient survey: 1. patient has participated in a clinical trial for their arthritis in the previous 12 months 2. currently an employee of bms * hcp survey: 1. physicians or nurse who have recruited patients for the patient survey 2. currently an employee of bms
a study measuring asthma control in pediatric and adolescent subjects whose asthma is worsened by activity or exercise

Conditions: Bronchospasm; Activity/Exercise Induced Bronchospasm

Summary: during this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ecg) tests, and lung function tests. all study related medications and medical examinations are provided at no cost. all study drugs are currently available by prescription to patients 4 years and older.


Eligibility criteria:
inclusion criteria: * diagnosed with persistent asthma for 3 months or longer. * experience worsened asthma symptoms during physical activity. * using or used an inhaled steroid for the last 4 weeks or longer (such as aerobid, azmacort, flovent, pulmicort, qvar, or vanceril). exclusion criteria: * used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months. * have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma. * admitted to a hospital within the last 6 months due to asthma symptoms. * any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.). * the study physician will evaluate other medical criteria.

Keywords: bronchospasm asthma
a prospective observational study of the performance of zarin in kenya

Conditions: Contraceptive Usage

Summary: this will be a non-comparative prospective observational study of women using zarin as a primary method of contraception in kenya. it will be conducted in close collaboration with the kenya moh in several moh-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. the investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study: * a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and * a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant the main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with zarin services.

a non-comparative prospective observational study of women using zarin as a primary method of contraception in kenya. it will be conducted in close collaboration with the kenya moh in several moh-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. the investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study: * a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and * a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant the main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with zarin services.

Eligibility criteria:
inclusion criteria: * be aged 18-44 years, inclusive * be willing to sign an informed consent document * be willing to give contact information for follow up * agree to return for follow-up visits * have decided to receive zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Keywords: ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonisation ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot post-marketing monitoring safety efficacy acceptability
a pk similarity study of two sintilimab products produced by different processes in advanced or metastatic nsclc patients

Conditions: Advanced or Metastatic NSCLC

Summary: this is a phase i study comparing pk similarity of sintilimab by different production process (approved versus m1b) in chinese advanced or metastatic nsclc patients who have failed or been intolerant to at least one prior line of standard treatment


Eligibility criteria:
inclusion criteria 1. histologically or cytologically confirmed locally advanced, recurrent or metastatic nsclc patients who have received or been intolerant to at least one prior line of standard treatment. 2. no egfr mutation or alk rearrangement. 3. ecog ps score 0 or 1. 4. bmi ≥ 21.0kg/m2 and ≤ 26.0kg/m2 5. body weight ≥ 60.0kg and ≤ 75.0kg. 6. adequate organ function per protocol-defined criteria. exclusion criteria 1. exposure to any anti-pd-1, pd-l1, pd-l2 antibodies. 2. allergic to any component of sintilimab. 3. active autoimmune diseases. 4. clinically unstable central nervous system metastasis.