Kornimate/medical-research-clean huggingface dataset:
biomarkers to predict and monitor response to infliximab

Conditions: Crohn Disease

Summary: the aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with crohn's disease (cd) that correlate with and can predict and monitor patients who will have a prolonged response to infliximab so that personalized medicine can be applied to patients with cd.

prospective, observational study will enroll 120 unique pediatric crohn's disease patients between the ages of 3-20 years among multiple sites. patients will be naïve to tnf inhibitor. if patient is going to start infliximab or infliximab biosimilar, patient may be enrolled in study. study length will be from commencement of infliximab until the infusion visit given at least 1 year after initiation. during the study, if the patient fails infliximab or biosimilar, they will be complete study once failure is indicated and discontinued on infliximab or biosimilar. patients may be on concurrent ibd therapy such as antibiotics, mesalamines, immunomodulators and may continue in study if non-standard induction schedule or changes made during induction or maintenance to dose or frequency. excluded patients will be those receiving infliximab or biosimilar infusions at home due to need for blood collection at time of infusion, on systemic corticosteroids (topical preparations such as budesonide are allowed), and those who have already undergone significant bowel surgery relating to their crohn's. study visits will take place in conjunction with previously scheduled routine clinic visits or infusion visits. at initial study visit, demographics, medical and surgical history, paris classification, pcdai, weight and height, fecal calprotectin, labs, egd and colonoscopy report and pathology report, cross-sectional imaging reports and concurrent medications will be obtained and entered. parameters measured at each study visit will include any obtained labs, weight and height, paris classification, pcdai, infliximab dose (mg/kg) and dose interval. there will be four study visits throughout the course of 1 year after initiating infliximab. at these four visits, blood will be obtained in paxgene tubes for rna analysis and serum for banking for somascan analysis.

Eligibility criteria:
inclusion criteria: * patients between the ages of 3-20 years old * patient starting infliximab or infliximab biosimilar, * patients naïve to tnf inhibitor exclusion criteria: * patients receiving infliximab or biosimilar infusions at home * patients already undergone significant bowel surgery relating to their crohn's.
the effect of different masks used by pregnant women on vital signs and non stress test during the covid-19

Conditions: Covid-19; Pregnant; Fetus; Mask

Summary: this study was conducted to examine the effects of different masks used by pregnant women on vital signs and non stress test (nst) during the covid-19. this study was conducted as a single-blind randomized controlled trial. healthy pregnant women aged 19 years and older, who were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were included in the study. the study consisted of a single surgical mask group (n=30), double surgical mask group (n=30), and n95 mask group (n=31). masks were given to the resting pregnant women 30 minutes before the nst, and they were provided to wear masks. after 30 minutes, the vital signs of the pregnant women were measured just before and after the nst, and the images of the nst traces were taken.


Eligibility criteria:
inclusion criteria: 1. being 19 years or older 2. being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy 3. being followed on an outpatient basis exclusion criteria: 1. having a multiple pregnancy 2. having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.) 3. being in the category of risky pregnancies (preeclampsia, gestational diabetes, etc.) 4. smoking 5. having alcohol and substance use 6. never done nst before 7. having an identified risk factor in the fetus 8. having barriers to communication 9. being a foreign national 10. being in contact with, or having, or suspected of having covid-19 and previously had covid-19.
full automaticity and remote follow-up

Conditions: Tachyarrhythmia

Summary: with the expansion of sudden cardiac death (scd) primary prevention indications, the number of implantable cardioverter defibrillators (icd) implants has increased significantly in the recent years. this has resulted in an increase of the number of follow-up (fu) to be performed and a growing workload for centers. remote fu system such as the medtronic carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events. the objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote fu can be an alternative to onsite visit.


Eligibility criteria:
inclusion criteria: * patient older than 18, * patient implanted with a fully automatic icd and remotely followed-up, * patient geographically stable and able to attend fu at investigative site * patient who signed a data release authorization form, exclusion criteria: * patient whose mental or physical capacity impedes to give an informed data release authorization, * patient already enrolled in a clinical study whose procedures may interfere with the results of the present study, * patients in new york heart association (nyha) class iv

Keywords: icd remote follow-up
a dose-ranging, cross-over study of the safety and efficacy of abt-089 in adults with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the objective of this study is to compare the safety and efficacy of five doses of abt-089 (2 mg qd, 5 mg qd, 15 mg qd, 40 mg qd and 40 mg bid) to placebo in adults with adhd.


Eligibility criteria:
inclusion criteria: * meet criteria for attention deficit hyperactivity disorder * have voluntarily signed an informed consent form * are between 18 and 60 years of age * will use contraceptive methods during the study * women must not be pregnant or breast-feeding * must be in generally good health * are fluent in english exclusion criteria: * they have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation * they have a current diagnosis of major depressive episode, generalized anxiety disorder (gad), or post-traumatic stress disorder (ptsd) or have a clinically significant sleep disorder requiring treatment * they require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers * they failed to respond to two or more adequate trials of fda-approved adhd medication * they have violent, homicidal or suicidal ideation * they have a significant history of medical diagnoses, seizure disorder, tourette's syndrome or a central nervous system (cns) disease, excluding adhd * they have a urine drug screen that is positive for alcohol or drugs of abuse * they have a history of substance or alcohol disorder (abuse/dependence) during the last 3 months

Keywords: adhd
viral kinetics study of telbivudine and entecavir in adults with chronic hepatitis b

Conditions: Hepatitis B; Chronic Hepatitis B

Summary: this exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.


Eligibility criteria:
inclusion criteria: * male or female, 18-70 years of age with documented compensated hepatitis b "e" antigen (hbeag)-positive chronic hepatitis b * able to comply with study regimen and provide written informed consent exclusion criteria: * pregnant or breastfeeding * unwilling to use double barrier method of contraception * co-infected with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv) * received hepatitis b therapy in the past * use of immunomodulatory therapy in past 12 months * history of or symptoms of hepatic decompensation or pancreatitis * frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs * concurrent medication likely to preclude compliance with schedule of evaluations * use of other investigational drugs within 30 days of enrollment * abnormal laboratory values during screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: hbeag-positive, chronic hepatitis b telbivudine entecavir viral kinetics
randomized study of testosterone and progressive resistance exercise in men with burn injury

Conditions: Burns

Summary: objectives: i. determine whether testosterone normalization ameliorates muscle protein hypercatabolism by increasing net protein synthesis in men with burn injury. ii. determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men. iii. determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men. iv. determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis. v. determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass and muscle strength in these patients.

protocol outline: this is a randomized study. patients are stratified according to percent of total body surface area (tbsa) burned (no more than 40% vs more than 40%). patients receive standard inpatient burn care. during hospitalization, patients are randomized to one of two treatment arms: arm i: patients receive testosterone intramuscularly (im) weekly for 2-3 weeks during hospitalization. arm ii: patients receive standard care only during hospitalization. after hospital discharge, patients with burns covering no more than 40% of tbsa are randomized to arm iii, iv, or v, whereas patients with burns covering more than 40% of tbsa are randomized to arm iii or v. arm iii: patients receive testosterone im every 2 weeks for 2 months. arm iv: patients receive testosterone as in arm iii. patients perform progressive resistance (weight lifting) exercises 3 times a week for 2 months concurrently with testosterone therapy. arm v.: patients receive standard convalescence care only.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- second degree or worse burn injury percent of total body surface area burned and degree of burn(s) must be carefully quantified --patient characteristics-- cardiovascular: no limiting or unstable angina no myocardial infarction within the past 6 months no horizontal or downsloping st segment depression greater than 0.2 mv and/or frequent or repetitive arrhythmias (defined as more than 10 premature ventricular contractions per minute) no hypertension that is uncontrolled by one blood pressure medication no prior arrhythmia or valvular disease requiring treatment other: no history of prostate cancer or indication of an occult carcinoma, defined by psa greater than 4.0 micrograms/l

Keywords: burns dermatologic disorders rare disease
branched chain aminoacid supplementation in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: malnutrition is a frequent complication in patients with liver cirrhosis. most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines. we hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy


Eligibility criteria:
inclusion criteria: ambulatory patients patients with confirmed diagnose of liver cirrhosis patients classified as child-pugh a or child pugh b exclusion criteria: acute or chronic renal failure pregnancy overt hepatic encephalopathy

Keywords: branched chain aminoacids nutritional status hepatic encephalopathy
effect of time shift of transcranial direct current stimulation (tdcs) for treatment of acute tinnitus

Conditions: Tinnitus

Summary: the treatment for patients with acute tinnitus consists of methylprednisolone and hyperbaric oxygen therapy. for this study transcranial direct current stimulation (tdcs) was added to the protocol. the purpose is to determine the effect of the time shift of tdcs. two conditions will be compared: tdcs simultaneously with the hyperbaric oxygen therapy or tdcs 3 weeks after the start of the tinnitus. an audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and 12 weeks.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * presence of acute tinnitus or worsening of tinnitus caused by otogenic disease * registration in uza within 48 hours after start tinnitus * vas-score ≥ 4 * ability to understand and sign informed consent exclusion criteria: * history of epileptic seizures * severe organic comorbidity * psychiatric disorders or a history of psychiatric disorders with psychotic symptoms * pace maker * pregnancy

Keywords: transcranial direct current stimulation time shift
relationship of nutritional support for critically ill children with clinical outcomes in a pediatric hospital in bolivia (nutpebol)

Conditions: Critically Ill Children; Nutritional Support

Summary: the aim of this observational study is to learn about the characteristics of nutritional support in critically ill children. the primary question to be answered is is there an association between nutritional support of the critically ill child and clinical and hospital outcomes in children admitted to a pediatric referral center? patients will be followed throughout their hospitalization, with a step-by-step evaluation of the nutritional support received through standard care and a review of the results obtained in the patients.

the study aims to know the type and characteristics of nutritional support received by critically ill children hospitalized in bolivian hospitals; to follow them during their hospitalization to verify their weight, nutritional status and the nutritional support they receive; to understand which types of nutritional support offer better clinical and hospital outcomes; finally, to be able to propose some guidelines to physicians, through guidelines or other tools for the dissemination of scientific information, in order to benefit more children.

Eligibility criteria:
inclusion criteria: * admitted to intensive care or intermediate care in hospital wards * complete clinical and anthropometric data. exclusion criteria: * congenital or acquired chronic disease affecting growth (secondary malnutrition) * on medication (corticosteroids, immunoglobulins, albumin) * burn patients, with prosthetic implants, postoperative of large tumor resections. * unknown history of pre-referral hospital management or hospitalized in other health facilities.

Keywords: critically ill children nutritional support
a study of jab-21822 in adult patients with advanced solid tumors harboring kras p.g12c mutation in china

Conditions: NSCLC; Solid Tumor

Summary: to assess safety, tolerability, pk, efficacy and determine recommended phase 2 dose (rp2d) of jab-21822 (glecirasib) administered in adult participants with kras p.g12c-mutant advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. advanced (metastatic or unresectable) kras p.g12c mutant solid tumors, with failure or absence of standard treatment 3. subject must be ≥18 years 4. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 5. subjects with life expectancy ≥3 months. 6. subjects must have at least one measurable lesion as defined by recist v1.1. 7. there was no serious organ dysfunction in the screening stage 8. male or female subjects of reproductive age agree to use adequate contraception exclusion criteria: 1. history of intestinal disease or major gastric surgery or inability to swallow oral medications 2. other active cancer 3. previously treated with kras g12c inhibitor 4. active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv) 5. impaired heart function or clinically significant heart disease 6. pregnant or breast-feeding 7. previous allogeneic bone marrow transplant or organ transplant 8. intended study subjects who were unable to abstain from alcohol during medication 9. other unqualified conditions judged by the investigators

Keywords: kras p.g12c mutant advanced solid tumor; nsclc
acute low back pain. topical diclofenac and oral ibuprofen.

Conditions: Low Back Pain

Summary: this is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. participants will be randomized to one of three study arms: 1) oral ibuprofen + topical diclofenac; 2) oral ibuprofen + topical placebo; 3) oral placebo + topical diclofenac. outcomes will be determined at 48 hours (2 days) and 7 days later.


Eligibility criteria:
inclusion criteria: * present to emergency department (ed) primary for management of low back pain (lbp), defined as pain originating between the lower border of the scapulae and the upper gluteal folds. flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. * musculoskeletal etiology of low back. patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. the primary clinical diagnosis, at the conclusion of the ed visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal lbp. * patient is to be discharged home. * age 18-69. enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly. * non-radicular pain. patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. * pain duration \<2 weeks (336 hours). * prior to the acute attack of lbp, back pain must occur less frequently than once per month. * non-traumatic lbp: no substantial and direct trauma to the back within the previous month * functionally impairing back pain: a baseline score of \> 5 on the roland-morris disability questionnaire exclusion criteria: * not available for follow-up * pregnant * any analgesic medication use on a daily or near-daily basis * allergic to or intolerant of investigational medications * open wounds or skin breakdown of the lower back * contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) severe heart failure (nyha 2 or worse) 3) chronic kidney disease (gfr \<60ml/min) 4) current use of anti-coagulants 5) cirrhosis (child pugh a or worse) or hepatitis (transaminases 2x the upper limit of normal)
prospective analysis of eosinophilic esophagitis in patients presenting with dysphagia

Conditions: Esophagitis

Summary: this is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (eoe) and to establish which presenting factors warrant esophageal biopsies. we hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with ee.

all patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. if patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. informed consent will take place prior to enrollment. after patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. an egd with biopsies will then be performed. biopsies will be taken from 4 quadrants in the proximal and distal esophagus. the distal esophagus biopsies will be taken 5 cm proximal to the z-line. proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.

Eligibility criteria:
inclusion criteria: * patients aged 18-90 presenting with dysphagia or food impaction * ability to undergo esophagogastroduodenoscopy and biopsies * no significant cardiopulmonary disease, or other contraindication to egd exclusion criteria: * contradiction to egd and/or biopsies such as boerhaave's syndrome, or history or bleeding disorder or elevated inr * inability to provide informed consent * esophageal varices

Keywords: dysphagia eosinophilic esophagitis
role of neutrophil activation

Conditions: Patients Requiring Endotracheal Intubation

Summary: patients will undergo placement of an endotracheal tube (ett) as standard of care. tracheal lavage will be conducted using 5 ml of sterile saline solution by a push/suction technique. specimen samples obtained by wall suction will be collected at 2 time points following intubation. blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.


Eligibility criteria:
inclusion criteria 1. ages 18 to 65 2. american society of anesthesiologists physical status classification (asa) i and ii 3. required to have endotracheal intubation 4. scheduled for short admission (\<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures. 5. estimated duration of surgery 3 to 4 hours. 6. provide informed consent exclusion criteria 1. active pulmonary disease within 5 days prior to enrollment 2. on immunosuppressive medications 3. previous tracheal surgery 4. on azithromycin 5. diabetes 6. pregnancy 7. smoking history of less than 6 weeks prior to surgery 8. surgery or intubation within 5 days of surgery 9. planned surgical procedure involving neck or thoracic regions 10. active pulmonary disease 11. autoimmune disease (hiv, aids, rheumatoid arthritis 12. hepatitis 13. cancer

Keywords: endotracheal intubation
treatment of breakpoint cluster region-abelson (bcr-abl) negative all in adults

Conditions: Acute Lymphoblastic Leukemia

Summary: after consolidation therapy adult patients (≥18 yr) with ph-negative all will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (allohsct) according to both measurable residual disease (mrd) and results of genetic study performed at baseline.

patients will be uniformly treated with four drug-induction: vincristine (vcr), prednisone (pdn), pegylated asparaginase (pegasp), daunorubicin (dnr). resistant patients will receive a second induction with fludarabine, ara-c, g-colony-stimulating factor (g-csf) and idarubicin (flag-ida). patients with adequate mrd clearance after induction will receive 3 blocks of early consolidation. if adequate mrd clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. the remaining patients will receive early or delayed allohsct.

Eligibility criteria:
inclusion criteria: * patients 18-60 yr with de novo ph-neg all * eastern cooperative oncology group (ecog) 0-2 (or \>2 if due to all) * informed consent exclusion criteria: * mature b-all, ph+ all or blast crisis of chronic myeloid leukemia (cml), all of ambiguous lineage * ecog \>2 not due to all * impaired cardiac, respiratory, hepatic or renal function not due to all * pregnancy * hiv positivity * severe psychiatric disease * negative to sign informed consent.

Keywords: all adult ph-negative minimal residual disease transplantation