Kornimate/medical-research-clean huggingface dataset:
acp-196 (acalabrutinib) in combination with pembrolizumab, for treatment of hematologic malignancies

Conditions: Follicular Lymphoma (FL); CLL; Small Lymphocytic Lymphoma (SLL); Richter's Syndrome; Mantle Cell Lymphoma (MCL); Indolent Non Hodgkin Lymphoma; Waldenström Macroglobulinemia; Multiple Myeloma; Hodgkin Lymphoma; Burkitt Lymphoma; Marginal Zone Lymphomas; Mediastinal Large B Cell Lymphoma; Hairy Cell Leukemia

Summary: this study is evaluating the safety, pharmacodynamics (pd), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

this is a phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. in the first stage, part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of b-cell malignancies. in the second stage, part 2 allows for possible expansion cohorts into a wider range of b-cell malignancies, and part 3 will evaluate the combination in subjects with myelofibrosis (mf).

Eligibility criteria:
main inclusion criteria: * diagnosis of a hematologic malignancy as documented by medical records and with histology based on criteria established by the world health organization (who). * eastern cooperative oncology group (ecog) performance status of ≤ 1. * agreement to use contraception during the study and for 90 days after the last dose of acp-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children. * completion of all therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy. * anc ≥ 0.5 x 10\^9/l or platelet count ≥ 50 x 10\^9/l unless due to disease involvement in the bone marrow. main exclusion criteria: * a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk. * central nervous system (cns) involvement by lymphoma/leukemia * any therapeutic antibody within 4 weeks of first dose of study drugs. * total bilirubin \> 1.5 x uln; and aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3.0 x uln. * estimated creatinine clearance of \< 30 ml/min, calculated using the formula of cockcroft and gault (140-age) • mass (kg)/(72 • creatinine mg/dl); multiply by 0.85 if female.

Keywords: bruton tyrosine kinase inhibitor btk b-cell malignancies mantle cell multiple myeloma cll sll dlbcl follicular waldenstrom burkitt lymphoma marginal zone lymphomas hairy cell leukemia b cell acute lymphoid leukemia acalabrutinib acp-196
role of serum adiponectin in the ealy detection of renal impairment in patients with non alcoholic fatty liver disease

Conditions: Renal Impairment

Summary: early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum adiponectin level.

nonalcoholic fatty liver disease (nafld) includes different types of liver damage, ranging from simple steatosis and nonalcoholic steatohepatitis (nash) to liver cirrhosis and even hepatocellular carcinoma.(1) nafld is diagnosed by the presence of more than 5% fat accumulation in liver cells after excluding excessive alcohol intake in patients as well as other secondary causes of liver disease, such as drug-induced liver injury, viral and autoimmune hepatitis.(2) the diagnostic criteria for chronic kidney disease (ckd) are either the reduced estimated glomerular filtration rate (egfr) (\<60 ml/min/1.732) and/or abnormal albuminuria and/or overt proteinuria in patients for at least 3 months.(3) the association between nafld and ckd has recently attracted the attention of many experts. nafld and ckd share some common pathophysiological mechanisms as well as some metabolic risk factors for cardiovascular disease. some studies have confirmed that the presence of nafld increases the risk of ckd and that the degree of liver fibrosis is related to ckd stage,(4) it is crucial to detect early renal impairment in patients with nafld to prevent ckd progression, minimize complications, and improve survival (1) adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.(4) adiponectin is one of the key regulators involved in glucose and lipid metabolism. further analyses have shown its anti-inflammatory and anti-apoptotic roles in human cells. data from large cross sectional studies showed a positive correlation between serum adiponectin and mortality in chronic kidney disease.(5)

Eligibility criteria:
inclusion criteria: 1. patients with fatty liver aged from 18 to 60 yrs either diabetic or not . 2. patient with normal echogenic kidney in ultrasound and egfr more than 60 ml/min/1.73m2. 3. the control group are completely healthy subjects without any systemic or liver and kidney affection exclusion criteria: * 1)patients less than 18 yrs \& more than 60 yrs 2)all patients having any other causes of renal and hepatic disease rather than diabetes and having any other systemic problem.
sepsis post market clinical utility simple endpoint study - indiana university hospital

Conditions: Sepsis; Adult Disease; Severe Sepsis; Emergency Department

Summary: the purpose of this study is to demonstrate that addition of the monocyte width distribution (mdw) parameter to current standard of care improves a clinician's ability to recognize sepsis in the emergency department, resulting in earlier decision to administer antibiotics from time of ed presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

the objective of this study is to develop a method for identifying sepsis patients from electronic health records (ehr) based on sepsis-2 criteria. sepsis patients will be identified using a sepsis definition which includes meeting sirs score of ≥2 within 12 hours of ed presentation and any microbial testing ordered within 24 hours of ed presentation. the patient will be enrolled if it meets the sepsis definition and additional emr data elements will be extracted to complete case report form. furthermore, objectives include to confirm the clinical validity and performance of mdw in a control population of sepsis patients where mdw is measured but not reported to physicians. this study is an observational study which will simulate the decision impact of mdw on sepsis identification and patient management

Eligibility criteria:
inclusion criteria: * adult (18 to 89 years) * all race and ethnicities * presenting to the emergency department with suspicion of infection * whose assessment includes a cbc with differential * meets emr sepsis definition exclusion criteria: * pregnancy * prisoners * transfers from other ed * previously enrolled
occipital nerve stimulation (ons) for migraine: optimise

Conditions: Migraine Disorders

Summary: the primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ons) using the boston scientific corporation (bsc) precision™ system in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.

initial reports of managing migraine headache with ons described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. the leads were tunneled under the skin to an implantable pulse generator (ipg) implanted in the chest wall or abdomen. the optimise trial is designed to be a pivotal study of the boston scientific precision neurostimulation system, when the system is used for ons. the precision system has been previously been approved for spinal cord stimulation (scs).

Eligibility criteria:
key inclusion criteria: * onset of chronic migraine at least 6 months prior to start of screening determined by a well-documented history * evidence of intractability * posterior-dominant head pain * stable pattern of headache symptoms for at least 6 months prior to the beginning of screening * onset of migraine before the age of 50 * if female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test key exclusion criteria: * diagnosed with any major psychiatric disorder not specifically listed in key exclusion criteria 2-4 (e.g. multiple personality disorder, schizophrenia) * untreated panic disorder * untreated major depression evidenced by a phq-9 score \>20 * untreated generalized anxiety disorder evidenced by a gad-7 score ≥15 * currently diagnosed with severe personality disorder * a female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception * participating in another drug, device, or biologics trial within 3 months prior to screening * a terminal illness associated with survival \<24 months

Keywords: headache pain chronic
response to noninvasive mechanical ventilation according to the breathing pattern

Conditions: Neuromuscular Disorders; Chest Wall Disorders; Obesity Hypoventilation Syndrome (OHS)

Summary: the purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

breathing pattern will be analyzed along the adaptation to 3 different noninvasive-mechanical-ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).

Eligibility criteria:
inclusion criteria: * hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home noninvasive mechanical ventilation). * transcutaneous carbon dioxide (co2) basal pressure ≥ 50 mmhg when conscious. * clinically stable (within the previous month). * patients without previous noninvasive mechanical ventilation treatment. exclusion criteria: * clinical exacerbation. * chronic airflow limitation forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) ratio \< 70% or sleep apnea-hypopnea syndrome
promoting exclusive breastfeeding among hiv infected women in a pmtct program

Conditions: HIV-infection/Aids; Breast Feeding

Summary: this study evaluates strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among hiv infected women in a resource limited setting.

this is a single center, operational research study with two components. a formative component and randomized intervention trial. the study aims are to inform, promote and evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among hiv infected women in a resource limited settings. the primary objective of the qualitative formative research which includes focus group discussions (fgd) and key informant interviews (kii) is to explore factors affecting decisions on ebf and continued breastfeeding among hiv infected women. the primary objective for the intervention phase is to compare either of two intervention strategies against the standard arm using ministry of health (moh) messages aimed at promoting ebf for 6 month.

Eligibility criteria:
inclusion criteria: * hiv-positive pregnant women in their late second or third trimester * on antiretroviral therapy (arvs) for pmtct or meets moh guidelines for arv therapy * intention to breast feed * willingness to deliver at mulago hospital * living within kampala and planning to stay within kampala district for months after delivery * willingness to participate during post partum period * willingness to be home visited * willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on ebf exclusion criteria: * none

Keywords: hiv breast feeding
effects of thoracic screw manipulation in patients with cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. the compression can occur as a result of disc herniation, spondylosis, instability, trauma, or rarely, tumors. thoracic spine manipulation (tsm) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. recent research has shown that thoracic joint manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. disc herniation accounts for 20-25% of the cases of cervical radiculopathy. most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. if peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root manual techniques include positional release technique, muscle energy technique, myofascial release technique, cyriax technique, natural apophyseal glides and sustained natural apophyseal glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression. thoracic spine manipulation (tsm) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. recent research has shown that thoracic joint manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Eligibility criteria:
inclusion criteria: * patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand * cervical lateral flexion and rotation \<60 degree * positive scores on 3 of 4 clinical tests: spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60° * hypomobility at t1- t5 thoracic vertebrae on springing test. exclusion criteria: * participants with a history of vertebro-basilary artery insufficiency. * patient with history of cervical surgery or arthroplasty * patients with a positive history of trauma, fracture or surgery of the cervical * spine * diagnosed cases of torticollis, and scoliosis * history of osteoporosis, any heart disease

Keywords: pain thoracic manipulation sustained natural epiphyseal glides neck disability index
resolution of allergic inflammation

Conditions: Grass Pollen Allergic Rhinitis

Summary: after an allergen challenge, the allergic inflammatory response disappears spontaneously. the initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.


Eligibility criteria:
eligibility criteria: inclusion criteria * allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing * grass pollen sensitization determined by a positive skin prick test and / or presence of specific iges to a grass pollen allergen extract exclusion criteria: * smoker * specific immunotherapy with grass allergens or other respiratory allergen for inclusion. * current exhibition to another clinically relevant respiratory allergen
pharmacokinetics of peginterferon alfa-2b in participants with moderate and severe renal impairment (p05655)

Conditions: Renal Insufficiency

Summary: this study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 19 to 40 kg/m\^2, inclusive * moderate renal impairment and severe renal impairment and/or end-stage renal disease (esrd) who may require hemodialysis and normal renal function * free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study * females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study * males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study exclusion criteria: * pregnant, intend to become pregnant, or breastfeeding * surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug * history of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study * positive for hepatitis b surface antigen, and/or for human immunodeficiency virus (hiv) antibodies. healthy participants positive for hepatitis c antibodies * previously received pegintron®, sylatron®, and/or pegasys * more than 10 cigarettes or equivalent tobacco use per day * history of malignancy * hypothyroidism or hyperthyroidism * history of depression requiring treatment with psychotherapy or medication * history of suicidality or at risk of self-harm or harm to others * history of autoimmune disorder requiring medical therapy * immune mediated renal insufficiency * removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)
performance of diuretic stress test in predicting short term renal recovery in oliguric critically-ill patients recovery in the short term

Conditions: Critical Illness; Oliguria

Summary: acute kidney injury (aki) is a common disorder and associated with high morbidity and mortality. however, distinguishing transient aki from persistent aki may help in individualizing treatment and limit short and long term consequences of aki. previous studies suggested usual urinary indices to perform poorly for separating transient from persistent aki in an unselected population of critically ill patients. the recent kdigo (kidney disease improving global outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis. recently, a furosemide stress test (fst) was validated in a cohort of unselected critically ill patients. this stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage aki. additionally, fst performance was higher than those of usual renal biomarker. the limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria. the primary objective of this study is to assess diagnostic performance of fst in differentiating transient and persistent aki. secondary objectives are to assess diagnostic performance of fst in predicting need for renal replacement therapy, and to confirm fst results after adjustment for confounders.


Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 y.o) * aki stage 1 or more according to kdigo * oliguria as defined by an oliguria lower than 0.5 ml/kg * affiliation to the national medical insurance exclusion criteria: * pregnancy * chronic kidney disease stage 4 or more * need for fluid bolus (\>1000 ml crystalloids or equivalent) or need for vasopressors increases or introduction in the 2 hours preceding inclusion * evidence of obstructive renal failure
validation of bracs to european portuguese

Conditions: Deglutition Disorders; Swallowing Disorder; Dysphagia, Oropharyngeal

Summary: the goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "the boston residue and clearance scale - bracs" to european portuguese

the boston residue and clearance scale (bracs) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (fees). it differs from other fees residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability. the purpose of this study was to translate and cross-culturally adapt the english version of the bracs into european portuguese and to investigate the reliability and validity of the translated version of the scale.

Eligibility criteria:
inclusion criteria: * fees recording that allowed good visualisation of the pharynx and larynx. * fees recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues. * fees recording of patients with a tracheostomy or under tube feeding. exclusion criteria: * fees recording of patients under 18 years of age.

Keywords: swallowing disorders dysphagia fiberoptic endoscopic evaluation of swallowing
bandage contact lens and oral analgesics versus patching and oral analgesics for pain following pterygium surgery

Conditions: Pterygium

Summary: the purpose of this study is to determine if patching the eye or a bandage contact lens along with tylenol #3 is more effective for pain control following pterygium surgery.


Eligibility criteria:
inclusion criteria: * primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision * size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain) * ability to understand the nature of the procedure and to complete all measurement requirements * adults (age greater than 18) exclusion criteria: * ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma) * patients who have had previous ocular surface surgery * contraindications to local anesthetics (such as known allergy) * pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known) * patients already on systemic analgesics for any other reason (such as rheumatoid arthritis) * allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)