Kornimate/medical-research-clean huggingface dataset:
thrive use in pediatric populations- multi site

Conditions: Oxygen Deficiency; Desaturation of Blood; Hypoventilation; Anesthesia; Adverse Effect

Summary: thrive (transnasal humidified rapid-insufflation ventilatory exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. the use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. this study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.


Eligibility criteria:
inclusion criteria: * pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries exclusion criteria: * pregnancy * absence of parent or legal guardian able to provide written consent for study participation * anatomical or surgical contraindications (epistaxis, basilar skull fractures or abnormalities, nasal surgery or obstruction, nasal fractures, nasal vascular abnormalities), tracheostomy tube * emergent surgery for which application of hfnc might delay surgery or might result in increased aspiration risk.
north carolina newborn exome sequencing for universal screening

Conditions: Metabolism, Inborn Errors; Hearing Loss; Hereditary Disease

Summary: the nc nexus research study is exploring the utility of next generation sequencing in newborn screening and parental decision making. the national institutes of health (nichd and nhgri) are co-funding this study under a single u-19.

the investigators will enroll and perform whole exome sequencing on two cohorts of patients. one cohort will consist of two hundred newborns with no known conditions whose parents will be recruited during the mother's pregnancy. the second cohort will include two hundred infants and children up to the age of five years with diagnosed conditions including conditions detected through standard newborn screening such as phenylketonuria and other inborn errors of metabolism, hearing loss and other rare conditions that may fit criteria for newborn screening in the future. parents will be introduced to the study by their clinician or a study recruiter. those who agree to enroll in phase i will review an online decision guide and be offered a study visit conducted by a genetic counselor to obtain informed consent for genomic sequencing of their child. parents consenting to have their child's genome sequenced will be seen after the child's birth or at a convenient pre-arranged time and duplicate saliva samples will be collected from the children and one sample will be sent to the biospecimen processing (bsp) facility and to dr. jonathan berg's laboratory for sequencing and the other sent to the molecular genetics laboratory (mgl) for dna extraction and storage until needed for clinical confirmation. results will be returned for diagnostic (in the diagnosed cohort) and medically actionable disorders of childhood (both cohorts). two-thirds of parents who consent to sequencing will be randomly assigned to be eligible to request additional findings and use a supplement of the online decision aid. all results will be reported to parents by trained genetic professionals (genetic counselors and clinical geneticists)

Eligibility criteria:
inclusion criteria: * uncomplicated pregnancy and healthy newborn exclusion criteria: * abnormalities such as major malformation or chromosomal disorder detected prenatally or significant complications during pregnancy or at the time of delivery.
sil as maintenance therapy in multiple myeloma

Conditions: Multiple Myeloma

Summary: the goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

the investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. event-free survival (efs), progression-free survival (pfs), overall survival (os), adverse events (aes) will be assessed.

Eligibility criteria:
inclusion criteria: * pathologically confirmed multiple myeloma according world health organization (who) classification; * patient is ≥ 18 years of age at the time of signing the informed consent form (icf). * patient must understand and voluntarily sign an icf prior to any study-specific assessments/procedures being conducted; * patient is willing and able to adhere to the study visit schedule and other protocol requirements; * documented response to asct (pr, vgpr, cr/stringent complete response \[scr\]) according to imwg criteria. exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * pregnant or lactating women
effect of reck in posterior spinal fusion

Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Disease

Summary: "reck" is a combination of local anesthesia medications, used for the purpose of pain control. reck is an acronym which stands for ropivacaine, epinephrine, clonidine, and ketorolac. the purpose of this study is to investigate the effect of reck local injectable anesthetic in the setting of posterior spinal fusion. our specific aims are the following. primary aim: to investigate the effect of reck local injectable anesthetic on postoperative vas pain scores. secondary aims: to investigate of effect of reck injection on postoperative opioid consumption and hospital length of stay. hypothesis: reck injection will significantly decrease postoperative vas pain score, opioid consumption, and hospital length of stay compared to placebo controls.

patients will be randomized into two groups. intraoperatively, they will be given either 1) a 50 ml reck (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 ml injection of saline (control group). reck is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. all patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.

Eligibility criteria:
inclusion criteria: * age 18-88 years old * undergoing spinal fusion at 1-3 lumbar levels via a posterior approach. exclusion criteria: * revision surgeries * surgeries indicated for trauma, tumor, or infection * preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness * known hypersensitivity to any of the reck components

Keywords: spine surgery lumbar fusion pain control opioid utilization local anesthesia reck r.e.c.k. ropivacaine epinephrine clonidine ketorolac randomized controlled trial
clinical trial to assess the safety and pharmacokinetics of da-2802 319mg and viread 300mg in healthy male volunteers

Conditions: Healthy

Summary: this phase i clinical study is to evaluate the safety and pharmacokinetics of da-2802 319mg and viread 300mg after a single oral dose in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * age between 20 to 50, healthy male subjects(at screening) * body weight over 55kg, bmi between 18.0 - 27.0 * volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. exclusion criteria: * volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder) * volunteer who had gi tract disease(crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) * genetic disorders such as glucose-galactose malabsorption, lapp lactose deficiency, galactose intolerance which is contraindication to viread * volunteer who had hypersensitivity reaction to medicines including tenofovir, aspirin, or antibiotics * exceed 1.5 times the normal range of ast, alt at screening test before randomization * history of drug abuse, or a positive urine drug screen * having etc drug or herbal medicines within 2 weeks before first administration or otc drug or vitamin preparations within a week before first administration * participation in any other clinical trial involving investigational drugs within 3 months * volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months * regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study * volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge) * volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods * volunteers who are not using adequate contraception methods or have a pregnancy plan * volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study * any condition that, in the view of the investigator, would interfere with study participation

Keywords: hepatitis b
plyometric exercise with obese children

Conditions: Flat Feet

Summary: obesity is one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. the purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children with flexible flatfoot.

a sample of 47 male children participated in the current study. the participants were selected from different elementary schools in taif, saudi arabia. their age ranged from 7 to 11 years. the sample was randomly divided into 3 groups: the experimental group i, (egi), the experimental group ii, (egii), and the control group (cg). the egi received a plyometric exercise program. the egii received the corrective exercises 2 sessions per week for 10 weeks. the control group did not perform any planned physical activities during the intervention period but continued in their routine physical activities. the prokin system was used to assess the static balance, timed up and go test was used to assess functional mobility, and navicular drop test was used to assess the degree of flatfoot deformity, prior to and after the intervention for all groups.

Eligibility criteria:
inclusion criteria: * body mass index percentile equal to or greater than the 95th percentile * all had no previous history of strength or balance training or involvement in competitive sports emphasizing muscular strength or balance. * all participants had balance deficiency and mobile flat foot. exclusion criteria: * previous injury to the lower limb required medical care. * confounding conditions, such as a deformity of or surgery in the lower limb. * visual impairment, or neuromuscular disorders. * engagement in obesity treatment programs, three months prior to the study.
a study of jnj-64281802 for the prevention of dengue infection

Conditions: Dengue

Summary: the purpose of this study is to evaluate the prophylactic effect of jnj-64281802 with respect to the prevention of laboratory-confirmed dengue virus (denv) infection up to the last day of dosing among participants who have no evidence of current denv infection at baseline.


Eligibility criteria:
inclusion criteria: * healthy on the basis of physical examination, medical history, and vital signs performed at screening. if there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. this determination must be recorded in the participant's source documents * must have a body mass index (bmi, weight in kilogram \[kg\] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive, and a body weight of greater than or equal to (\>=) 40.0 kg at screening * a woman must have a negative highly sensitive urine pregnancy test at screening * a male participant must agree not to donate sperm for the purpose of reproduction during the study and for \>= 90 days after receiving the last dose of study intervention * must sign an informed consent form (icf) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: * having any dengue virus (denv)-associated clinical signs and symptoms * known allergies, hypersensitivity, or intolerance to jnj-64281802 or its excipients * any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria * reduced immune function to be: (a) known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy) * received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 \[covid-19\] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study
necessity assessment of me-nbi targeted biopsy compared with efb

Conditions: Early Gastric Cancer

Summary: the aim of the present study was to assess whether it was necessary to conduct magnifying endoscopy with narrow band imaging (me-nbi) targeted biopsy compared with endoscopic forceps biopsy (efb) from white light endoscopy in diagnosing early gastric cancer (egc). meanwhile, the investigators proposed the most cost-effective way to diagnose egc.

me-nbi has been widely used for the diagnosis of stomach diseases, especially in the early diagnosis of gastric cancer. the aim of the present study was to evaluate diagnostic efficacy of me-nbi targeted biopsy and me-nbi combined with targeted biopsy compared with efb from white light endoscopy and me-nbi combined with efb. a prospective study was conducted encompassing suspected egc. all patients were performed white light endoscopic examination with efb and then me-nbi with me-nbi targeted biopsy. outcome measures were assessed and compared, including diagnostic efficacy of efb from white light endoscopy,me-nbi combined with efb, me-nbi targeted biopsy and me-nbi combined with targeted biopsy.

Eligibility criteria:
inclusion criteria: * consecutive patients with gastric lesions detected by white light endoscopy and suspected of egc exclusion criteria: * they had advanced gastric cancer * lesions were histopathologically confirmed to be submucosal tumors * they had a history of gastrectomy * tissue biopsy wasn't obtained during last white light endoscopy * they couldn't tolerate another endoscopic examination
evaluation of intravenous fluid therapy within dallas acute pancreatitis protocol

Conditions: Acute Pancreatitis

Summary: acute pancreatitis (ap) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.

in the last 20 years, the incidence of ap and rate of hospitalization have steadily increased. approximately, two-thirds of ap patients will have a mild and self-limiting course of the disease, leaving the remaining one-third experiencing moderately severe to severe disease that is associated with worse outcomes. overall, the estimated mortality of pancreatitis is 1% however, mortality can be as high as 30% to 40% among patients with ap and organ failure or pancreatic necrosis. despite numerous randomized clinical trials, there is no medication shown to be successful at treating ap. ap is associated with fluid deficit secondary to low intake and vomiting. early intravenous fluid (ivf) resuscitation has been long-established as the initial cornerstone treatment to prevent hypovolemia and subsequent organ failure within the first 48 to 72 hours. the rationale for such intervention is to provide adequate intravascular volume support to counteract fluid shift into the third space. however, available evidence for an effective fluid regimen is lacking with regard to the type of fluid, the optimal rate of administration, and how to assess appropriate goals/targets for adequate resuscitation. furthermore, the literature has presented conflicting results on whether aggressive versus goal-directed fluid resuscitation will lead to a reduction in mortality and improve outcomes. although early supportive care with ivf therapy is recommended by the major guidelines, there are potential, serious complications associated with aggressive resuscitation, including volume overload, respiratory failures, intra-abdominal compartments.

Eligibility criteria:
inclusion criteria: * ● age \> 18 years * diagnosis of ap based on international statistical classification of diseases( icd)-10 code exclusion criteria: * ● diagnosis of chronic pancreatitis * patients who did not follow the ivf infusion protocol * received \< 24 hours of ivf therapy * transferred from another institution
optimized diagnostics for improved therapy stratification in invasive fungal infections

Conditions: Systemic Mycosis

Summary: invasive fungal infections (ifi) in immunocompromised patients pose a major challenge for diagnostics designed to permit timely onset of appropriate treatment. the aim of the current clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of ifi, is to test newly developed diagnostic approaches to invasive fungal infections in relation to established procedures. the studies will be performed in a prospective, blinded fashion, and represent a work package within the fungitect grant supported by the european commission. the studies will focus on analyses of blood-samples from patients with febrile neutropenia during treatment of acute leukaemia and other tumour entities, and patients undergoing allogeneic stem cell transplantation treated with intensive chemotherapy.

samples from immunosuppressed patients with febrile neutropenia (np - defined as fever ≥ 38.5ºc and \<500 anc) will be taken: * at the start of neutropenic fever * after 24 hours * after 48 hours * before the start of antimycotic therapy, if pertinent * at the end of antimycotic therapy, if pertinent the results ot analyses by a panfungal pcr screening assay developed at our institution (european patent no 1960536) and methods newly developed during the fungitect project will be compared with conventional methods for fungal diagnostics such as hr (high resolution)-ct, serological testing, histology and fungal culture. additionally, genomic approaches will be employed to investigate host- and pathogen-related factors of susceptibility, pathogenicity and antimycotic resistance.

Eligibility criteria:
inclusion criteria adult study: * patients between 18-90 years of age with high risk of invasive fungal infections * signed informed consent pediatric study: * patients between 0-18 years of age with high risk of invasive fungal infections * signed informed consent exclusion criteria adult study: * pregnancy * no consent pediatric study: - no consent
efficacy and safety of roflumilast in japanese patients older than 40 years with chronic obstructive pulmonary disease (apta-2217-06)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the study is to investigate the effect of roflumilast (apta-2217) on lung function in patients with chronic obstructive pulmonary disease (copd). roflumilast will be administered orally once daily. the study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). the study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria:
main inclusion criteria: * patients with chronic obstructive pulmonary disease * current smoker or ex-smoker * 30 to 80% of predicted fev1 after inhalation of short acting beta stimulant main exclusion criteria: * patients with poorly controlled copd * patients who need for long-term oxygen therapy * patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation

Keywords: copd phosphodiesterase 4 inhibitor roflumilast
the effect of lt to rt shunt using veno-veno-arterial extracorporeal membrane oxygenation (ecmo) on coronary oxygenation in lung transplantation patients

Conditions: Interstitial Pulmonary Fibrosis ARDS; COPD (Chronic Obstructive Pulmonary Disease); Bronchiectasis; Lymphangioleiomyomatosis; Primary Pulmonary Hypertension; ARDS (Acute Respiratory Distress Syndrome)

Summary: ecmo(extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure patients. there are two types of ecmo, which is veno-veno (v-v) that can be used in respiratory failure patients and veno-arterial (v-a) that can be used in cardiac failure patients. v-a ecmo can also be used during lung transplantation, substitution of cardiopulmonary bypass, which can show sufficient performance during operation and better postoperative outcome. however, regarding v-a ecmo circulating from femoral vein to femoral artery, there is a pro blem of differential hypoxia which might influence coronary artery and head vessels. in this prospective study, the investigators are planning to put another ecmo catheter into internal jugular vein which takes a role of left to right shunt, to mitigate the hypoxia of coronary artery.


Eligibility criteria:
inclusion criteria: 1. scheduled for double lung transplantation exclusion criteria: 1. patients who have history of coronary artery occlusive disease 2. patients with arrhythmia