Kornimate/medical-research-clean huggingface dataset:
determinants of early functional outcome after reconstructive surgery

Conditions: Osteoarthritis

Summary: this exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.

despite the positive outcomes of total knee arthroplasty (tka) surgery on symptoms such as pain, perceived function and health-related quality of life (qol) current research highlights the persistent deleterious effects of retained aberrant neuromuscular alterations on physical function, which may also directly impact falls risk. importantly, observed increases in neuromuscular deficits that occur prior to surgery track through into the post-operative stage with functional limitations that are sustained and which can persist at least one year after surgery. clearly, it is crucial to strive to identify modifiable factors that might successfully ameliorate this pathophysiological process prior to surgery, reduce post surgical impairments and which also accelerate recovery. among other determinants that might contribute towards understanding of optimal functional recovery following reconstructive knee surgery is the influence of genes. the evaluation of specific genotypes and subsequent protein expression might provide further insight into the extent of genetic influence. for example, it is not yet known whether patients with specific genotypes experience an accelerated recovery. currently, there is a paucity of research on the influence of gene-environment interactions on an individual's response to physical conditioning. the proposed research will be an exploratory study, involving four repeated-measures assessments from 10 weeks prior to surgery to 12 weeks after surgery. this study offers a novel evaluation of the overall patterning of changes and will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological performance capabilities, genotypes and levels of habitual physical activity.

Eligibility criteria:
inclusion criteria: * males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary tka. exclusion criteria: * individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis * rheumatic disorder * other orthopaedic conditions affecting lower body function * neurological disorders

Keywords: arthroplasty replacement knee osteoarthritis
cd-19 car-t cell for pediatric all or lymphoma

Conditions: Lymphoma, B-Cell; Acute Lymphoblastic Leukemia, Pediatric

Summary: this study seeks to examine the efficacy and safety of the administration of autologous t cells that have been modified through the introduction of a chimeric antigen receptor (car) targeting the b cell surface antigen cd19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (all) or lymphoma. the overall goal of this study is to validate the safety profile of administration cd19-car t cells and describe the response rate in children with relapsed/refractory all or lymphoma.


Eligibility criteria:
inclusion criteria: * subjects must have relapsed or refractory all or lymphoma treated with at least two lines of therapy. disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen. * the patient's disease must be cd19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available. * age 1-17 years. * performance status: subjects \> 10 years of age: karnofsky ≥ 50%; subjects ≤ 10 years of age: lansky scale ≥ 50%. * normal organ function. * total bilirubin ≤ 3 times upper limit of normal * ast (sgot) ≤ 5 times upper limit of normal * alt (sgpt) ≤ 5 times upper limit of normal * serum creatinine ≤ 2 times upper limit of normal * subjects must have the following hematologic function parameters: hemoglobin (hb) level \> 8 g/dl; absolute lymphocyte count \> 0.1x10\^9/l; platelet \> 50x10\^9/l * prior therapy wash-out. at least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis. * subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * autologous transplant within 6 weeks of planned car t cell infusion. * recipient of car-t cell therapy outside of this protocol. * active central nervous system (cns) or meningeal involvement by tumor. * history of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast). * active human immunodeficiency virus (hiv) infection. * subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or breastfeeding women. * evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy. * serologic status reflecting active hepatitis b or c infection.

Keywords: car-t cell pediatric
methadone in pediatric anesthesiology ii

Conditions: Pain

Summary: three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. our secondary goal is to determine the pharmacokinetics of iv methadone in children (0.3 and 0.4 mg/kg).

randomized, controlled, modified dose-escalation design. patients receive standard monitoring for anesthesia and postoperative care. surgical and anesthesia (except for opioid use) care are not altered for study purposes. all patients are induced by propofol and muscle relaxants. in the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone hcl (0.4 mg/kg ideal body weight, ibw). in the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone hcl (0.3 mg/kg ideal body weight, ibw). subjects in the study groups will receive methadone (iv bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. in the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

Eligibility criteria:
inclusion criteria. * age 11-18 years * undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of \> 3 days * signed, written, informed consent from legal guardians and assent from patient exclusion criteria. * history of or known liver or kidney disease. * females who are pregnant or nursing. * children with developmental delay * children undergoing surgery for scoliosis of musculoskeletal origin

Keywords: spinal surgery methadone
carotid plaque stabilization and regression with evolocumab.

Conditions: Carotid Artery Disease

Summary: the caruso trial aims at investigating the efficacy of evolocumab in promoting carotid plaque morphological stabilization and regression as compared to traditional lipid lowering therapy (llt). primary end-point of the study is the superiority of evolocumab on top of ongoing llt versus ongoing llt in carotid plaque morphological stabilization and regression at 6 and 12 months, respectively. secondary end-points are: ldl-cholesterol (ldl-c) absolute and percentage changes in the two groups at 12 month follow-up, and adverse cerebrovascular and cardiac events at 12 and 24 months

optimal lipid-lowering therapy (llt) is a mainstay for the therapeutic management of atherosclerotic vascular disease. cardiac and cerebrovascular adverse events and progression of atherosclerosis are, indeed, reduced in proportion to the achieved ldl cholesterol (ldl-c) levels.in addition, regression of atherosclerotic plaques with optimal llt has been observed. however, optimal llt with statin and ezetimibe, might be limited by the onset of adverse effects (i.e. disabling myalgias, diarrhea) with are usually dose -dependent, and the maximum tolerated statin dose might be insufficient to reach the recommended ldl-c goals. the advent of proprotein convertase subtilisin kexin type 9 inhibitors (pcsk9i) has allowed the achievement of very low ldl-c levels, and the fulfillment of the recommended ldl-c targets. however, while the experience with pcsk9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding carotid plaque regression following therapy with pcsk9i. only a few case reports have been published, and no observational study has been carried out so far. furthermore, morphological carotid plaque stabilization has a prognostic role, and the possibility of its early achievement with pcsk9i may be relevant, especially in the context of percutaneous or surgical carotid interventions.

Eligibility criteria:
inclusion criteria: asymptomatic patients with uni- or bilateral carotid artery stenosis ≥50% and ldl-c values ≥100 mg/dl despite ongoing lipid lowering therapy exclusion criteria: * age \<18 or ≥81 years old * known intolerance to evolocumab * ongoing or previous treatment with pcsk9i * prior stroke or transient ischemic attack * total carotid occlusion * major active infection or major hematologic, renal, hepatic, or endocrine dysfunction * malignancy with life expectancy below 24 months * failure to sign informed consent
'combine-2': real-world evidence for effectiveness of two drug regimen, antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor

Conditions: HIV Infections

Summary: dolutegravir (dtg) is a well-tolerated 2nd generation integrase strand transfer inhibitor (insti); rilpivirine (rpv) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (nnrti) and lamivudine (3tc) is a nucleoside reverse transcriptase inhibitors (nrtis). this study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2dr). this is a multi-site observational study in subjects who have started and/or who plan to initiate 2dr with an integrase inhibitor plus a reverse transcriptase inhibitor. the study does not require any changes to the routine standard of care that subjects receive. approximately 500 eligible subjects will be included from potential investigational sites across europe and data from them will be collected either retrospectively or prospectively.


Eligibility criteria:
inclusion criteria: * hiv positive male or female subjects aged 18 years or over and who have started 2dr with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with hiv rna suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment. exclusion criteria: * no specific exclusion criteria

Keywords: 2dr hiv lamivudine combine-2 dolutegravir
roliver - prospective cohort for the identification of liver microbiota

Conditions: To Generate Microbial Hypotheses Putatively Responsible for the Onset of Liver Fibrosis

Summary: the existence of an adipose tissue microbiota causally involved in the triggering of a low grade inflammation could resemble what observed in liver fibrosis. to generate microbial hypotheses putatively responsible for the onset of liver fibrosis we sequenced the 16srdna gene from liver biopsies from 36 obese patients (roliver cohort) and describe an original mathematical approach to decipher signatures of early stage of liver fibrosis f0, f1, f2.

liver diseases and notably fibrosis are featured by a gut microbiota dysbiosis with a large diversity. classical statistical analyses does not allow to discriminate between the different low score of liver fibrosis f0,f1,f2. the existence of an adipose tissue microbiota causally involved in the triggering of a low grade inflammation could resemble what observed in liver fibrosis. to generate microbial hypotheses putatively responsible for the onset of liver fibrosis we sequenced the 16srdna gene from liver biopsies from 36 obese patients (roliver cohort) and describe an original mathematical approach to decipher signatures of early stage of liver fibrosis f0, f1, f2. we identified that protebacteria as the main phyla in liver with pseudomonadaceae and proteobacteriaceae families representing \~60% of the 16srdna gene diversity. while primary component analyses were unable to discriminate between the three groups the partial least square discriminant analysis appears as a powerful tool to identify signatures predictive for each group. we further constructed a matrix of interacting otu clusters surrounding early scores of liver fibrosis. eventually, we applied the tfidf approach to exemplify the rare variables which could be carrying some information suitable to refine the diagnosis. altogether, we here propose a mathematical approach suitable for precise identification of bacteria putatively involve in the progressive development of liver fibrosis that represent hence a new therapeutic opportunity.

Eligibility criteria:
inclusion criteria: * bariatric patients * morbid obesity patients exclusion criteria: * serious chronic associated illness (heart failure, cirrhosis, panhypopituitarism or autoimmune diseases), consumption of alcohol (\> 20 g ethanol intake per day), related use of medication (use of laxatives, fiber supplements or probiotics in the previous 6 weeks), inflammatory disorders and use of immunomodulatory drugs. other exclusion criteria were: history of bariatric surgery, use of anti-obesity drugs in the previous 3 months, recent (last 2 months) or on-going antibiotic use, excessive use of vitamin d supplementation; active or recent (last 3 months), participation in a weight loss program or weight change of 3 kg during the past 3 months, pregnant or planning pregnancy within 6 months or breastfeeding women, drug abuse, and other reasons identified by the investigator.
evaluation of lung metastases based on ultrashort echo time mri

Conditions: Hepatoblastoma; Radiology

Summary: analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of ute-mri in lung metastases of hepatoblastoma with chest ct as gold standard


Eligibility criteria:
inclusion criteria: * children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery) * recent chest ct scan (within 14 days) * no mri contraindications * the guardian of the children are willing to undergo the examination after full communication and informed consent exclusion criteria: * mri contraindications (including but not limited to: contrast medium allergy; claustrophobia;metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate \< 60 ml min-1 (1.73 m2)-1)) * patients with hepatoblastoma aged 14 years and above * children after surgery for hepatoblastoma * application of any contrast medium within 24 h before the mri and/or ct examinations * there is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.
measurement of the prevalence of sensory integration disorders in babies having heart disease surgery for transposition of the great vessels before 6 months of age

Conditions: Great Vessels Transposition Surgery

Summary: the purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

baby's development takes its roots in sensorimotricity. baby coordinates different senses (visual, auditory, tactile, taste, vestibular) to understand the space around him and to implement voluntary motor strategies. these sensory links also allow him to invest hisoral zone and consolidate his oral feeding. another good sensory integration is necessary for a child to develop harmoniously on motor and psychic levels. in 2018 the study of l. dagenais revealed a gap in posturomotor development on babies operated on for isolated congenital heart disease. however nobody assess sensory disorders in these babies. with this study the investigators wish to clarify the sensory impact in this situation.

Eligibility criteria:
inclusion criteria: * infant born at term (over 37 weeks) * with heart disease, of the transposition of the great vessels type, whether or not associated with an interventricular communication * having a cranial perimeter in the norm at birth: between 32 and 37 cm. * surgery scheduled before the age of 6 months * no opposition from parents exclusion criteria: * other disease or malformation * parents who do not speak french

Keywords: sensory integration disorders great vessels transposition surgery
pulmonary recruitment maneuver with 15 and 30 cmh2o pressure to reduce the postoperative shoulder pain

Conditions: Surgery

Summary: pulmonary recruitment maneuver (prm) has been shown to reduce postoperative shoulder pain by removing excessive intraabdominal gas following laparoscopic surgery(ls). a recent study demonstrated that compared to prm in the supine position, prm at semi-fowler position provides better evacuation of the remaining intraabdominal gas following gynecologic ls. this study aimed to compare the impact of prm with 15 cm h2o and prm with 30 cm h2o on postoperative shoulder pain in patients undergoing gynecologic ls.

pulmonary recruitment maneuver (prm) consists of five manual pulmonary inflations where each positive pressure inflation was done for 5 s at a maximum pressure of 30-40 cm h2o in the neutral position. when used after laparoscopic surgery and just before the extubation, prm has been shown to facilitate the removal of intraabdominal gas and thus reduce the postoperative shoulder pain which is associated with the volume of the gas accumulating under the diaphragm. a recent study demonstrated that compared to prm in the supine position, prm at semi-fowler position provides better evacuation of the remaining intraabdominal gas and less postoperative shoulder pain following gynecologic ls. however, whether a prm with lower pressure is also effective in reducing postoperative intraabdominal gas and postoperative shoulder pain is of question. this study aimed to compare the impact of prm with two pressures (15 cm h2o or 30 cm h2o) in addition to the semi-fowler position on postoperative shoulder pain in patients undergoing gynecologic ls.

Eligibility criteria:
inclusion criteria: * must be scheduled for ls for benign causes * must be american society of anesthesiologists (asa) class i or ii. exclusion criteria: * previous lung surgery * preexisting emphysema * previous pneumothorax

Keywords: gynecologic laparoscopic surgery post-laparoscopic shoulder pain pulmonary recruitment manoeuvre
nirs monitoring to detect aki in preterm infants

Conditions: Acute Kidney Injury; Premature Infant

Summary: this study will examine the relationship of oxygen levels, using near-infrared spectroscopy (nirs) monitoring, and kidney injury in infants born prematurely. nirs is a skin sensor which detects the amount of oxygen going to different organs, most often used to monitor the brain and kidney.

this prospective, single-center study was conducted at unitypoint health-meriter hospital (madison, wi, usa) in preterm neonates admitted to a level iii nicu from april 2018 to august 2019. the primary study aim was to assess changes in rrso2 with continuous renal nirs monitoring to detect aki during the first 7 days of age. the invos 5100 c (somanetics, troy, mi, usa) four channel nirs monitors were used to measure rrso2 (measured at the right or left flank) and cerebral regional somatic tissue oxygenation (crso2; measured at the forehead) for all neonates. at each measurement site, for skin protection, subjects had a transparent mepitel (with safetac technology, norcross, ga) adhesive dressing placed with the adhesive neonatal nirs sensor (invos oxyalert nirsensor, covidien) adhered over the mepitel dressing. neither cerebral or kidney sensors were placed with ultrasound guidance. tissue oxygenation was recorded every 3 seconds until 7 days of age, and the sensor was changed one time when the patient reached three to four days of age per the company's recommendation. there were no restrictions on positioning or handling of neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin pressure injuries. researchers, staff, and parents were blinded to rrso2 values.

Eligibility criteria:
inclusion criteria: * preterm infants \< 32 weeks * admitted to unity point health(uph) meriter newborn intensive care unit (nicu) * application of nirs by 48 hours of age exclusion criteria: * congenital anomaly of the kidney or urinary tract (cakut)

Keywords: near infrared spectroscopy creatinine urine output
intrauterine hyaluronic acid gel for prevention of intrauterine adhesions

Conditions: Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel

Summary: women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups. 1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity 2. control group - no injection 4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in israel. during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.


Eligibility criteria:
inclusion criteria: * women undergoing hysteroscopic removal of retained placenta after delivery exclusion criteria: * known adverse reaction or allergy to hyaluronic acid history of intrauterine adhesions acute pelvic inflammatory disease

Keywords: retained placenta operative hysteroscopy intrauterine adhesions hyaluronic acid