Kornimate/medical-research-clean huggingface dataset:
micafungin lock therapy

Conditions: Catheter-Related Fungal Infections

Summary: the study proposes to investigate, in children admitted at children's medical center at dallas, the effectiveness of antimicrobial lock therapy (alt) with micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (cvc) and at the same time to investigate the effectiveness of micafungin alone as systemic therapy in the treatment of candidemia in a pediatric population.

the antimicrobial lock therapy (alt) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. advantages of the alt are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. the infectious diseases society of america, the society for healthcare epidemiology of america and others recommend the alt for the treatment of uncomplicated bacteremias. this technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. this study plans to enroll approximately 20 children admitted to the children's medical center at dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of alt with micafungin against fungal infections.

Eligibility criteria:
inclusion criteria: * children, 6 months-18 yrs, with a central line fungal infection, presumed candida, admitted at children's medical center. * signed informed consent by parents and assent by minor if applicable. * subjects with likely survival beyond 1 week. exclusion criteria: * pocket, tunnel or exit-site infection * known allergic reactions to the micafungin or echinocandins. * severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis) * mixed infections * inability to lock the catheter lumen for minimum 8h because of other medications administration * subjects requiring ecmo or cvvh. * patients with hiv, congenital immunodeficiencies. * positive pregnancy test or breastfeeding.

Keywords: catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter
change of treatment landscape and survival in metastatic pancreatic cancer after nal-iri in republic of korea

Conditions: Pancreatic Neoplasms

Summary: pancreatic cancer is a very aggressive disease and its prognosis is poor. large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer. there is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. the randomized phase iii study, napoli-1 trial has revealed that liposomal irinotecan (nal-iri) plus fluorouracil/leucovorin (fl) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy. in this study, the investigators will evaluate how the treatment landscape has been changed since the appearance of nal-iri in korea. by retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-iri/fl) and after the launch of nal-iri (cohort 2; with nal-iri/fl), investigators will identify the degree of improvement in treatment outcome brought about by nal-iri and will confirm whether the nal-iri could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.


Eligibility criteria:
inclusion criteria: 1. patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021 2. histologically or cytologically confirmed adenocarcinoma of exocrine pancreas 3. documented metastatic disease; disease status may be measurable or non-measurable as defined by recist v1.1 guidelines 4. locally advanced pancreatic cancer; disease status was defined by nccn guidelines. 5. recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy 6. at least 18 years of age exclusion criteria: 1. other histology (ex. neuroendocrine tumor, etc.) 2. cohort 2 (other regimens); patients who received nal-iri at least once after diagnosis
multifunctional nutrition tube on social condition and experience in cerebralvascular accident

Conditions: Stroke

Summary: the aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either intermittent oro-esophageal tube or nasogastric tube. patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. the observation group will receive enteral nutrition support through intermittent oro-esophageal tube, while the control group will receive it through nasogastric tube. researchers will then compare the psychological condition and experience of the two groups.

the study will last 15 days for each participant. the goal of this clinical trial is to compare the differences on psychological condition and experience in ischemic stroke patients using intermittent oro-esophageal tube and nasogastric tube. patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. on this basis, the observation group will use intermittent oro esophageal tube for enteral nutrition support, while the control group will use nasogastric tube. researchers will compare psychological condition and experience of two groups.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for ischemic stroke . * dysphagia confirmed by video fluoroscopic swallowing study. * clear consciousness. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.
dupilumab versus topical corticosteroid effectiveness - comparison in the treatment of stenotic eoe

Conditions: Eosinophilic Esophagitis

Summary: the goal of this clinical trial is to \[primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.\] in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. the main question\[s\] it aims to answer \[is/are\]: does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? are comparative effective clinical trials feasible in this patient population? researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response. participants will be asked to: * be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily. * participate in 8 study visits over 52 weeks * complete questionnaires * have an endoscopy with biopsies and endoflip measurements. * swallow an esophageal string test


Eligibility criteria:
inclusion criteria: * seen at chco for clinical care. * age 12 - 25 years old inclusive * weight ≥40 kg at the time of screening visit * confirmed eoe as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy * report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening. * evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm) exclusion criteria: * esophageal dilation performed at index endoscopy * patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria. * patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria. * eligible patients on current stcs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment. * patients who have received dupilumab in the past 12 months for any indication are excluded. * diet restrictions and ppi use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period. * patients with a fasting morning cortisol \<5 within 2 months of screening will not be enrolled. if repeat cortisol levels are normal, patients can be reconsented. * known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder. * patients with a known gelatin allergy will be excluded from est collection.

Keywords: dupilumab fluticasone
risk stratification directed conditioning regimen for haploidentical hsct in saa

Conditions: Aplastic Anemia; Stem Cell Transplant Complications; Engraft Failure

Summary: the haplotype hsct system including bu(0.8mg/kg q6hx2d)ctx(50mg/kgx4d)ratg(2.5mg/kgx4d) , established in institute of hematology of peking university ,has been evaluated to be effective for acquired saa.but some patients with high risk factors may not tolerate ctx 200mg/kg,alternative conditioning regimen including bu/fludarabine/dercreased ctx was studied in this trial.

patients enrolled in this study would receive bu (iv)0.8mg/kg q6hx2d,fludarabine 30mg/m2x5d ,ctx(cyclophosphamide) 25mg/kg/dx4d,ratg (thymoglobulin,sang stat,france) 2.5mg/kg/dx4d. bm or blood samples from patients were obtained to assess engraftment and chimerism after hsct. the time point that investigators monitor bm or blood samples at 1 month,2 months, 3 months,6 months, 9 months and 1year,2years,3years 5 years after hsct.

Eligibility criteria:
a：inclusion criteria 1. patients diagnosed as acquired severe aplastic anemia(saa) /very vsaa 2. patients with age 3-55 years 3. patients have no matched sibling donor 4. patients have no matched unrelated donor 5. patients have no severe infection 6. patients have no severe organ dysfunction 7. patients have risk factors of potential intolerance to previous condition regimen including bucy(200mg/kg)and atg 8. consent form signed b. exclusion criteria ： 1. patients with congenital saa/vsaa 2. patients with age\ 55 years 3. patients with matched sibling donor 4. patients with matched urd 5. patients with severe infection 6. patients with severe organ dysfunction 7. pregnancy women 8. no consent form signed

Keywords: haploidentical transplantation aplastic anemia
efficacy comparison of polyethylene glycol loxenatide and gliclazide on the brain function in t2dm patients

Conditions: Type 2 Diabetes Mellitus; Cognitive Function Abnormal

Summary: this is a prospective, randomized, open label, parallel,4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in t2dm patients with normal cognitive status or mci.

this is a prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in t2dm patients with normal cognitive status or mci inadequately controlled with metformin monotherapy. the control group was treated with gliclazide. there are 1 principal investigator, 6 sub-investigators and 1 nurse in research centre. the sub-investigators will screen in the outpatient and inpatient departments to enroll 58 patients (29 patients for each arm) totally with the inclusion and exclusion criteria in 9 months. the patients will be randomized at a 1:1 ratio into loxenatide and gliclazide treatment group with a computer-generated random order. all patients will also continue on their existing dose and regimen of metformin throughout the study. at the baseline, clinical information collection, 100g-steamed bread meal test, biochemical measurement, body composition analysis, cognitive assessment, olfactory test and functional magnetic resonance imaging(fmri) scan will be conducted for all patients. during the treatment period, visits at 4-week intervals will be performed to evaluate the safety of drugs and adjust the dose of metformin if hypoglycaemia occurs; meanwhile, fasting and 2-hour postprandial plasma glucose assayed by fingerstick, physical examination, and olfactory test will be conducted. at the end of the study, all of the assessments will be performed again for all recruited subjects, including early withdrawal patients.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus ; * aged:40 -75 years ; * cognitive function assessment suggests normal status or mild cognitive impairment; * a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days, * hba1c 7 - 10%; * ≥6 years of education; * right-handed. exclusion criteria: * patients unable to complete brain mri scanning; * nasal disease that affected olfactory function; * hepatic dysfunction with liver transaminases \> 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate \< 60ml/min/1.73m2 ; * acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use; * a history of related drug allergy; * alcohol or drug misuse; * pregnant, breast-feeding or intending to become pregnant.

Keywords: functional mri cognition olfactory function loxenatide
a 6-week study to evaluate the efficacy and safety of lurasidone hcl in acutely psychotic patients with schizophrenia

Conditions: Schizophrenia

Summary: this is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine xr.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent and aged between 19 and 75 years of age. 2. meets dsm-5 criteria for a primary diagnosis of schizophrenia. 3. cgi-s ≥ 4 at screening and baseline. 4. subject is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study. 5. subject is able and agrees to remain off prior antipsychotic medication for the duration of the study. 6. subject is in good physical health on the basis of medical history, physical examination, and laboratory screening. exclusion criteria: 1. the subject has evidence of any chronic organic disease of the cns (other than schizophrenia) 2. subject has participated in a prior trial of lurasidone. 3. clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. 4. in the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 5. considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Keywords: schizophrenia acutely psychotic patients with schizophrenia latuda lurasidone
remote prescribed and monitored exercise program after pulmonary rehabilitation in individuals with chronic lung disease

Conditions: Pulmonary Disease, Chronic Obstructive; Rehabilitation

Summary: remote prescribed and monitored exercise program after pulmonary rehabilitation in individuals with chronic lung disease

the benefits of exercise during post pr (pulmonary rehabilitation) programs in copd (chronic obstructive pulmonary disease) patients is well established. however, there are numerous patient's and program factors that influence the benefits gained (e.g. exercise intensity and frequency, goal setting, non-exercise modalities, compliance, social support and supervision). the investigators aim to explore the possibility of a real-life program that will allow the patient the freedom to perform exercise in their own environment. the biogradient system allows both goal oriented, supervised exercise prescription, and the ability to adapt to the patient's schedule and preferences. the system also provides as needed human involvement for encouragement and supervision. the investigators hypothesize that the primary outcome (the six-minute walk test, see outcomes section) will not change significantly in active participants and measures of quality of life and adherence will be higher than reported in the literature in similar publications. moreover, data collected may provide opportunity to explore the factors that might influence the primary and secondary outcomes, and in particular hospitalizations and exacerbations. the current study is a patient blinded, randomized control trial, comparing usual care to goal oriented supervised post pr program. after recruitment the patient will be randomized to usual care arm or supervised exercise arm. the study duration will be 1 year (per participant), and the minimal time for each participant to be included in the final analysis will be 3 months (with at least two outcome measurements). at the end of the study each patient will be scheduled a short interview with the research coordinator for assessment of outcome measurements and spirometry testing.

Eligibility criteria:
inclusion criteria: to be eligible for enrollment, participants must have the following inclusion criteria: 1. age\>18 years old 2. diagnosis of copd, based of fev1/fvc\<0.7 3. fev1 % predicted \>30% 4. participated in pr for at least 18 sessions in the preceding year. 5. capable of providing signed written informed consent exclusion criteria: * participants are excluded if they have at least one of the following criteria: 1. currently attend (more than 5 future sessions) or eligible for a pr program 2. on long term oxygen therapy (ltot) 3. participation in another clinical study that may have an impact on the primary outcome of the current study 4. deemed by the healthcare team to be physically incapable of participating in the study 5. presence of comorbidities which, in the opinion of the healthcare team, might prevent patients from safely undertaking an exercise programme at home (for example severe orthopaedic or neurological impairments, severe cognitive impairment)
insomnia prevention in children with acute lymphoblastic leukemia

Conditions: Pediatric Acute Lymphoblastic Leukemia; Leukemia; Acute Lymphoblastic Leukemia

Summary: the goal of this research study is to understand the acceptability and feasibility of the sleep all night intervention among children with acute lymphoblastic leukemia (all) in hopes of improving the discussion of sleep disorders with clinical providers. the name of the intervention used in this research study is: sleep all night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.

this research study is to conduct a single-arm pilot study to determine the acceptability and feasibility of sleep all night for children with acute lymphoblastic leukemia (all). participation in this research study is expected to last 1 month. it is expected about 30 children will take part in this research study. the national cancer institute (nci) is providing funding for this research study through a grant.

Eligibility criteria:
inclusion criteria: * patient in the maintenance phase of therapy on or as per dfci 16-001 and has completed at least two cycles of maintenance therapy to allow adequate recovery from the more intensive consolidation phase. * english or spanish speaking child and primary caregiver (parent/guardian). * child aged 4-12 years. exclusion criteria: * primary team declines permission to approach. * children with critical illness (defined as icu admission)

Keywords: pediatric acute lymphoblastic leukemia leukemia acute lymphoblastic leukemia
dsm-5 personality disorders in adults with autism

Conditions: Autism Spectrum Disorder

Summary: rationale: self-report measures are frequently used for research and clinical assessments of adults with autism spectrum disorder (asd). however, there has been little research examining agreement between self-report and informant-report in this population. reliable self-report measures are essential for conducting research with and providing high quality clinical services for adults with autism spectrum disorder. objective: this study aims to examine the usefulness of self-report of dsm-5-tr pd traits in adults with asd compared to informant-reports by administering the self-report screening measure of the structured clinical interview for dsm-5 screening personality questionnaire (scid-5-spq).


Eligibility criteria:
inclusion criteria inclusion criteria for asd participants: (1) primary diagnosis of asd according to the dsm-5-tr, (2) age 18+ years, (3) no intellectual disability, and (4) at least having completed a primary and secondary education. inclusion criteria for informants: participants were asked to identify individuals who knew them well and were capable of providing accurate descriptions of their personality traits, preferably informants that cohabited with the participants. when cohabitants were unavailable, participants were asked to identify "the person who knows you best." additionally, eligibility of informants for inclusion required that, historically, the informant and the participant talked at least monthly and interacted face-to-face at least yearly. exclusion criteria exclusion criteria for asd participants: (1) no asd diagnosis, (2) current substance abuse, (3) psychotic disorders, (4) schizophrenia, (5) eating disorder, (6), mental retardation (iq\<80), (7) suicidal ideations and (8) age \<18 years. exclusion criteria for informants: (1) age \<18 years, (2) intellectual disability, and (3) not being able to state and/or recognize psychological and problematic functioning of their participating relative with asd.

Keywords: autism personality disorder
long term effect of bariatric surgery on pelvic floor disorders

Conditions: Bariatric Surgery Candidate; Weight Loss

Summary: bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. more than eighty percent of the operated patients are women. nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (pfd). this work aims at studying the evolution of pfd in women following a bariatric surgery more than 18 months ago in a french university center hospital.


Eligibility criteria:
inclusion criteria: * women, * aged from 18 to 50 years old the day of their surgery, * had a bariatric surgery in poitiers university hospital center (france), * are under french social security system. exclusion criteria: * to be under guardianship or tutelage measures * to express opposition to participate to this study.