Kornimate/medical-research-clean huggingface dataset:
combination of basiliximab and pegaspargase in the treatment of enktcl

Conditions: Extranodal NK/T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of basiliximab in combination with pegaspargase in the treatment of relapsed/refractory nk/t-cell lymphoma.

the investigators previously found that cd25 was elevated in patients who were resistant to chemotherapy, and cd25 can mediate resistance, which can be reversed by targeting cd25 therapy. thus, the purpose of this study is to evaluate the efficacy and safety of basiliximab in combination with pegaspargase in the treatment of relapsed/refractory nk/t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * pathology confirmed diagnosis of nk/t-cell lymphoma. * previously treated with pegaspargase-based regimens. * pet-ct or mri scan with at least one measurable lesion. * ecog score of 0-3 points. * the lab tests within 1 week before enrollment meets the following: * blood routine: hb≥80g/l, plt≥50×10e9/l. * liver function: alt, ast, tbil≤2 times the upper limit of normal. * renal function: cr is normal. * coagulation: plasma fibrinogen≥1.0g/l. * cardiac function: lvef≥50%, ecg is normal * sign the informed consent form. * voluntary compliance with research protocols. exclusion criteria: * patients with a history of pancreatitis. * active infection requires icu treatment. * concomitant hiv infection or active infection with hbv, hcv. * serious complications such as fulminant dic. * significant organ dysfunction: * respiratory failure * nyha classification≥2 chronic congestive heart failure * decompensation hepatic or renal insufficiency * high blood pressure and diabetes that cannot be controlled * cerebral vascular events within the past 6 months. * pregnant and lactating women. * had a history of autoimmune diseases, and disease was active now. those who were known to be allergic to drugs in the study regimen. * patients with other tumors who require treatments within 6 months. * other experimental drugs are being used.

Keywords: extranodal nk/t-cell lymphoma basiliximab pegaspargase cd25
safety and pharmacokinetics of at-007 in healthy subjects and in adult subjects with classic galactosemia

Conditions: Classic Galactosemia

Summary: this study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose (sad) and multiple ascending dose (mad) study in healthy adult subjects and adult subjects with classic galactosemia.

the study is designed to assess the safety and pk of at-007 in healthy subjects and subjects with classic galactosemia as well as the effect of at-007 on biomarkers of galactose metabolism (galactose, galactitol, and other galactose metabolites) in subjects with classic galactosemia. this study consists of 4 parts: * part a (sad) in 32 healthy subjects. once daily oral escalating dose (6 active, 2 placebo). * part b and c (mad for 7 days) in 36 healthy subjects. once daily multiple daily dosing (8 active, 2 placebo per each dose cohort). * part d (sad followed by mad for 27 days) in 18 subjects with classic galactosemia. once daily followed by multiple daily oral dosing (6 active, 2 placebo for each dose cohort).

Eligibility criteria:
inclusion criteria: * diagnosis of classic galactosemia confirmed by evidence of absent or significantly decreased (\<1%) galt activity in red blood cells and by galt gene analysis * urine galactitol \>100 mmol/mol creatinine * galactose-restricted diet exclusion criteria: * complications of cg resulting in disability that, in the opinion of the investigator, may prevent the subject from completing all study requirements (e.g., severe neurological deficits, severe cognitive impairment, or severe language difficulty). * renal disease (egfr \< 90 ml/min/1.73 m2 or albuminuria).

Keywords: classic galactosemia aldose reductase inhibition galactose, galactitol
prevalence of iem among upper git symptoms

Conditions: Esophageal Motility Disorders

Summary: * detect the prevalence of iem among upper git symptom . * clarify the role of hrm in diagnosis of refractory upper git symptoms.

ineffective esophageal motility (iem) is characterized by both failed peristalsis and frequent swallows with breaks in the middle/distal peristaltic wave and it may result in symptoms reflecting poor esophageal emptying. as such, iem may play a role in gastroesophageal reflux disease (gerd) and nonobstructive dysphagia.1 the definition of iem has evolved after the introduction of high-resolution manometry (hrm), esophageal pressur topography (ept), and the chicago classification of esophageal motility, that-in its second version-defined iem as weak peristalsis, small (2-5 cm) and large (over 5 cm) peristaltic defects, or frequent (\>30%) failed peristalsis. 2 more recently however, the updated third version of the chicago classification eliminated small and large breaks from the list of criteria and defined ineffective swallows by a dci \< 45 mmhg.s.cm with ≥50% ineffective swallows constituting iem, thus eliminating the distinction between failed swallows and weak swallows.3 iem, as well as fragmented peristalsis, is considered as minor disorders of peristalsis and their clinical significance remains debatable. iem is the most common abnormality observed in routine esophageal manometry, with an estimated prevalence of 20%-30% reported a prevalence of 51% in patients with esophageal dysphagia. before 2008 a threshold of 30% was used, but a threshold of 50% correlates better with dysphagia and heartburn. high-resolution manometry (hrm) provides an improved and more detailed information on esophageal motility when compared to conventional manometry, and today is considered the best test for diagnosis of motility disorders.

Eligibility criteria:
inclusion criteria: 1. patient bove the age of 18 years old 2. all patient presented with upper git symptoms exclusion criteria: 1 - patients \<18 years old 2- patient with known obstructive esophageal disease by endoscopy (i.e. cancer, stricture) 3- systemic illnesses, scleroderma 4- esophagogastric junction (egj) outflow obstruction (mean integrated relaxation pressure ≥15 mmhg). 5- achalasia, 6-patient who had previouslyundergone esophageal surgery (i.e. antireflux surgery or myotomy) or endoscopic intervention (i.e. transoral fundoplication) were excluded. 7- patient with atypical (ent or respiratory) symptoms only . 8-patient with oropharyngeal dysphagia without associated esophageal symptoms . 9-patient receiving chemotherapy or radiotherapy 10-patient with thyroid disfunction 11- patient with pulber palsy
one-year outcomes in survivors of the severe covid-19 pneumonia (co-qo-icu)

Conditions: COVID; ARDS; Quality of Life

Summary: many of the patients hospitalized for a severe form of sarscov-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, in the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life. to date, there is little data on the fate of patients treated in resuscitation for a severe form of covid-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. the objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in resuscitation for a severe form of covid-19 in the short (3 and 6 months), medium (1 year) and long (5 years) end of their stay in icu. to do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the nice chu. all patients admitted to resuscitation for a severe form of covid-19 who have accepted the longitudinal medical follow-up proposed by the nice chu will be included in the study and data from the computerized medical record will be analyzed.


Eligibility criteria:
inclusion criteria: * patients hospitalized in icu for an ards table * pcr sarscov-2 nasopharyngeal or positive pulmonary samples

Keywords: long term prognosis six-minute walk test restrictive syndrom
propylene glycol/glycerol intake and cardiorespiratory function

Conditions: Lung Injury

Summary: propylene glycol/glycerol intake is increasingly popular. the propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

background. propylene glycol/glycerol intake is increasingly popular. the propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function. specific aim of the research. this research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake: * propylene glycol/glycerol cessation restores cardiorespiratory function. * chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation. * chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.

Eligibility criteria:
inclusion criteria: * subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year * subject must be former smokers exclusion criteria: * chronic or acute illness * substance abuse * chronic medication intake
clomiphene citrate for treatment of acromegaly

Conditions: Acromegaly

Summary: to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)

acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. selective estrogen receptor modulators (serms) resulted in similar effects in both genders. clomiphene citrate, a serm that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes. the aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment. in this prospective, open label, single center trial, sixteen male patients were studied. clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.

Eligibility criteria:
inclusion criteria: * patients with active acromegaly on regular use of a stable dose of octreotide-lar and/or cabergoline for at least one year, * insulin like growth factor 1 above the reference range during the last year of follow-up and * testosterone levels within or below the third inferior tertile of normality. exclusion criteria: * radiotherapy in the last 10 years, previous venous embolism (including family members), * previous prostatic cancer or symptomatic benign hypertrophy, * triglyceride levels above 400 mg/dl, * renal failure defined by estimative of renal filtration below 30 ml/min, * liver disease defined by hepatic enzymes 3 times above normal limit, * active oncologic disease in the last 10 years and previous cardiac or cerebrovascular disease.

Keywords: acromegaly serm clomiphene
fitmi ad home therapy for individuals with mci or mild dementia due to alzheimer's disease

Conditions: Cognitive Dysfunction; Dementia, Mild

Summary: this study will investigate the efficacy of a newly developed exercise device (fitmi ad) for individuals with mild cognitive impairment (mci) or mild dementia due to alzheimer's disease. fitmi ad uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.


Eligibility criteria:
inclusion criteria: * have mci or mild dementia due to ad (i.e. clinical dementia rating (cdr) score 1 for mild dementia or 0.5 for mci) * ability to clearly see the screen and hear the audio instructions from the tablet * have a family member or friend who can answer questions about the participant's daily living skills * willing to participate in a research study. exclusion criteria: * age \< 50 years old * use of a wheelchair as a primary mobility device (use of a cane or walker is permitted) * presence of other neurologic conditions such as movement disorders or history of stroke * other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
safety and efficacy of dexamethasone as adjunctive therapy to ranibizumab in subjects with choroidal neovascularization and age-related macular degeneration

Conditions: Subfoveal Choroidal Neovascularization; Age-Related Maculopathy

Summary: this study will evaluate the safety and efficacy of dexamethasone (ozurdex®) as adjunctive therapy to ranibizumab (lucentis®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration


Eligibility criteria:
inclusion criteria: * received at least 2 and no more than 3 monthly lucentis or avastin injections * last lucentis or avastin was injected approximately 4 weeks prior to screening * visual acuity between 20/320 and 20/40 exclusion criteria: * active ocular infection * contraindication to pupil dilation in either eye * eye surgery including cataract surgery and/or laser of any type within 3 months
assessment of marginal bone loss and anterior implant stability in immediate versus early implant placement

Conditions: Marginal Bone Loss

Summary: this study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw.


Eligibility criteria:
inclusion criteria: * presence of unrestorable bilateral anterior teeth. * harmonious gingival contour and thick gingival phenotype * minimum 4 mm of apical bone and 2 mm of intact labial plate * absence of periapical pathology exclusion criteria: * systemic conditions affecting osseointegration or healing * active oral infections or periodontal disease * dehiscence or fenestration defects * poor oral hygiene or heavy smoking
moyamoya disease biomarkers in patients with intracranial atherosclerotic stroke

Conditions: Moyamoya Disease; Intracranial Atherosclerotic Stroke; Intracranial Steno-occlusive Disease

Summary: the aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. to do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients).

1. purpose both moyamoya disease (mmd) and intracranial atherosclerotic stenosis (icas) are more prevalent in asians than in westerners, although the reason for the race-ethnic differences is unsettled. it is possible that patients with adult-onset mmd were misclassified as having icas, which may in part explain the high prevalence of intracranial atherosclerosis in asians. it is important to differentiation between these two diseases because mmd and icas have differential therapeutic strategies (surgical revascularization in mmd vs. the use of antithrombotics/statins and stenting in icas). the ring finger 213 (rnf213) was recently identified as a susceptibility gene for mmd in east asians. characteristic high-resolution (hr) mri findings of mmd and icas have recently been reported. the aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. to do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients). 2. conditions: stroke, intracranial occlusive lesion 3. intervention: none 4. study period: jan 22, 2014 \~ dec 31, 2016 5. study design: observational model time perspective: retrospective-prospective

Eligibility criteria:
inclusion criteria: 1. intracranial atherosclerotic stroke * patients with age over 20 years * patients with focal neurological deficits presented within 7 days of symptom onset * patients with acute ischemic lesions on diffusion-weighted image (dwi) * patients with stenosis on the relevant intracranial vessels (distal ica and/ or m1) 2. moyamoya disease * patients with age over 20 years * patients who performed conventional angiography * patients who are diagnosed as having either definite or probable moyamoya disease 3. healthy subjects * subjects with age over 20 years * subjects with no history of cerebrovascular disease exclusion criteria: * patients with extracranial stenosis more than 50% * patients with potential sources of cardio-aortic embolism * patients with moderate to severe renal disease * pregnancy or lactation * patients with short life expectancy

Keywords: moyamoya disease intracranial atherosclerotic stroke intracranial steno-occlusive disease ring finger 213 (rnf213) gene mutation high-resolution mri
the efficacy of aerobic exercise in the rehabilitation of patients with covid-19-related myocardial injury

Conditions: Long COVID; Myocardial Injury

Summary: a study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with covid-19-related myocardial injury


Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 65 years; 2. a history of new coronavirus infection; 3. patients with a clinical diagnosis of covid-19-related myocardial injury; 4. in the late stages of recovery from covid-19-related myocardial injury, at least 3 months after diagnosis; 5. negative cardiopulmonary exercise test; 6. after completing respiratory rehabilitation at our hospital in the previous period; 7. normal blood biomarker tests and essentially normal 2d-ste, normal left ventricular systolic function, no spontaneous or inducible arrhythmias on electrocardiographic monitoring, and the patient's clinical status is stable, with most of the symptoms in significant remission, and the daily still activities are intolerant or do not reach the pre-disease exercise level; 8. classification of nyha heart function of class i or ii; 9. voluntarily sign the informed consent form; 10. not participating in other clinical trials. exclusion criteria: 1. a previous history of coronary atherosclerotic heart disease and heart failure; 2. a combination of severe arrhythmia or cardiogenic shock; 3. a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis; 4. a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency 5. a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc; 6. those who have serious mental illness and are unable to cooperate 7. those with incomplete clinical data; 8. those who have dropped out or terminated the trial by themselves.
in vivo computer-aided prediction of polyp histology on white light colonoscopy

Conditions: Colonoscopy; Histology; Computer-aided Diagnosis; Artificial Intelligence; Colorectal Polyp; Adenoma Colon Polyp; Hyperplastic Polyp

Summary: our group, prior to the present study, developed a handcrafted predictive model based on the extraction of surface patterns (textons) with a diagnostic accuracy of over 90%24. this method was validated in a small dataset containing only high-quality images. artificial intelligence is expected to improve the accuracy of colorectal polyp optical diagnosis. we propose a hybrid approach combining a deep learning (dl) system with polyp features indicated by clinicians (hybridai). a pilot in vivo experiment will carried out.

optical diagnosis aims to predict the histology of a polyp based on its endoscopic features. this practice could avoid histopathological analysis and reduce the derived costs. under this premise, the american society of gastrointestinal endoscopy (asge), in its preservation and incorporation of valuable endoscopic innovations (pivi) statement, established a diagnostic threshold for real-time endoscopic assessment of diminutive polyps. the rationale for its implementation is that the prevalence of advanced histology in polyps \< 5mm is very low (0.5%). several studies have demonstrated that optical diagnosis of small polyps is safe and feasible in clinical practice and comparable to the current gold standard, histopathology. however, the accuracy of optical diagnosis has been shown to be insufficient in community-based practices or in non-expert hands and the diagnosis is even more difficult in diminutive polyps \< 3 mm in which the discrepancy between the endoscopic and pathological diagnosis is about 15%. artificial intelligence (ai) has emerged as a help tool for polyp characterization. aiming to improve optical diagnosis using ai methods, we propose a hybrid approach that combines dl with characteristics of polyps manually indicated by endoscopists (hybridai).

Eligibility criteria:
inclusion criteria: * age \> 18 years * approval of participation in the study. signature of informed consent * patients with at least one polyp of any size/morphology diagnosed in a routine or screening colonoscopy * endoscopies performed with high definition endoscopes exclusion criteria: * age \<18 years * refusal to participate in the study * polyps partially resected in a previous endoscopy * patients with inflammatory disease * impossibility to wash remains of stool or mucus on the surface of the polyp
tr-701 fa vs linezolid for the treatment of acute bacterial skin and skin structure infections

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Summary: this is a randomized, double-blind, double-dummy, multicenter, global phase 3 study of iv to oral tr-701 fa 200 mg once daily for 6 days versus iv to oral zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of absssi in adults. patients are to start treatment with at least 2 iv doses and may receive iv therapy for the entire treatment duration. approximately 100 to 140 sites globally will participate in this study. patients with an absssi caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.

the primary objective is to determine the noninferiority (ni) in the early clinical response rate of intravenous (iv) to oral 6 day tr-701 free acid (fa) compared with that of iv to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (itt) analysis set in patients with acute bacterial skin and skin structure infections (absssi).

Eligibility criteria:
inclusion criteria: * patients requiring iv antibiotic therapy and with systemic signs of infection diagnosed with absssi. * diagnosed with cellulitis/ erysipelas, major cutaneous abscess, or wound infections exclusion criteria: * uncomplicated skin infections * severe sepsis or septic shock * absssi solely due to gram-negative pathogens

Keywords: absssi tedizolid phosphate tr-701 acute bacterial skin and skin structure infections