Kornimate/medical-research-clean huggingface dataset:
efficacy/safety study of glimepiride to type 2 diabetes patients based on metformin and basal insulin treatment

Conditions: Diabetes Mellitus, Type 2

Summary: all the guidelines suggest that metformin as the basis of type 2 diabetes medication, and evidence is sufficient.at the same time the basal insulin injection once a day are more and more widely used in diabetes patients in china. this study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes patients with inadequate glycemic control with combined therapy of metformin and basal insulin.


Eligibility criteria:
inclusion criteria: * understand the whole test process, voluntary and signed informed consent form * men and women aged 35 to 70 years old * 20≤bmi\<35 kg/m2 * diagnosed with type 2 diabetes * undergoing metformin(dose not less than 1000 mg/day)in combination with basal insulin injection once a day * hba1c7.0-11% * patients should be able to self blood glucose monitoring exclusion criteria: * sulfonylureas,glinides,tzds use within 3 months before the study * pregnant or lactating women * a history of ketoacidosis * allergy to sulfonylureas or sulfa drug patients * apparent dysfunction of liver and kidney patients(alt\>2 times upper normal limit,serum creatinine\>1.2 times upper normal limit) * poor blood pressure control(systolic pressure\>180mmhg or diastolic blood pressure\>110mmhg) * heart disease,cardiac insufficiency,unstable angina pectoris,ecg indicates left ventricle hypertrophy,severe anemia(hb\<9.0g/d1) * severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder) * bmi\<20 orbmi≥35kg/m2 * alcohol or drug abuse ,or can't collaborate due to mental disorder * digestion and absorption function obstacle or other endocrine disorders * other chronic diseases required long-term glucocorticoid treatment

Keywords: glimepiride metformin basal insulin hemoglobin a, glycosylated glucose fluctuation hypoglycemia
inspiratory muscle training in patients receiving allogenic stem cell transplantation

Conditions: Inspiratory Muscle Training; Stem Cell Transplantation; Respiratory Muscle Training

Summary: the study is a monocentric, controlled randomized trial. its an interventional method study. there is a control and an interventional group. the interventional group is receiving a specific inspiratory muscle training with "respifit" (special device for inspiratory muscle training) during the first 30 days after allogenic stem cell transplantation. the investigators want to show that the training group gets stronger inspiratory muscles. the investigators measure the change of pimax values and mvv values.


Eligibility criteria:
inclusion criteria: * patients receiving allogenic stem cell transplantation * age 17 - 80 years old * informed consent exclusion criteria: * actual pneumonia at the beginning of the trial * impaired vision * patient is not able to handle "respifit"

Keywords: respiratory muscles hematopoetic stem cell transplantation inspiratory muscle training
the long-term prognosis of moderate to severe bronchial hyperresponsiveness (bhr) in asthmatic preschool children

Conditions: Intrinsic Asthma; Allergic Asthma; Allergy; Bronchial Hyperresponsiveness

Summary: the aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. the investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.

a positive family history with prevalence of atopy, eczema, wheezing are well-known factors predicting asthma. caudri et al. found more important predictors like perinatal transmission, parental use of inhalative medications and wheezing/dyspnea out of viral infections(5). measurement of bhr in children was in most studies a second outcome parameter. four visits will be performed, baseline and after 1, 3, and 5 years. at visit 1 the investigators will characterize all patients by a isaac survey. at each visit in children a methacholine challenge, a skin prick test, eno, rast and total ige will be performed. at visit 3 and 4 sputum will be induced. in parents only at the first visit a methacholine challenge will be performed. a genetic identification of adam33 gene from edta blood shall be provided. adams are multidomain proteins with a metalloprotease domain, associated with airway remodelling. visits should be kept in a time interval without asthma therapy and respiratory infection. to examine the feasibility of methacholine challenges in preschool children data measured in 2006 will be analysed.

Eligibility criteria:
inclusion criteria: * informed consent * age 3 to 6 years * diagnosis asthma * pulmonary function: fev1 (% pred.)≥ 70% * ability to carry out 2 reproducible flow volume loops * moderate to severe bhr (pd20 fev1 ≤ 0,3 mg methacholine) * more than 4 weeks interval since last infection * 8 hours washout period of short acting beta agonist * 1 week washout period of ipratropium bromide * 1 week washout period of long acting beta agonist * 4 weeks washout period of systemic corticosteroids * 4 weeks washout period of leukotriene antagonists exclusion criteria: * age \ 6 years * pulmonary function test: fev1 (% pred.) \< 70% * others chronic diseases or infections (e.g., hiv, tuberculosis, malignancy) * incapability to perform spirometry * current participation in another clinical trial

Keywords: asthma preschool child bronchial hyperresponsiveness methacholine challenge test atopy
corticosteroids in severe covid-19(asap-c study)

Conditions: Severe COVID-19

Summary: administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome(sars-co-2) infection are recommended by several guidelines. in the very beginning of sars-co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (covid-19) acute respiratory distress syndrome (ards), despite previous data and clinical practice for patients with refractory or severe form of ards.

administration of systemic corticosteroids for patients with severe forms of sars-co-2 infection are recommended by several guidelines. in the very beginning of sars-co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (covid-19) ards, despite previous data and clinical practice for patients with refractory or severe form of ards. but at the latest after publication of recovery trial (randomized evaluation of covid-19 therapy, july 2020) and ensued metaanalysis of world health organization (who) working group, the routine administration of systemic corticosteroids was revisited. however, there are ongoing critical debate of the evidence regarding the dose, administration, timing and type of corticosteroids and ongoing randomized controlled trial (rct) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of covid-19. the dynamic of covid-19 surges, flip-flop of official recommendations within very short period of time and ongoing critical debate could be with possible variations of daily clinical practice regarding using systemic corticosteroids. in an electronic evaluation form that will be send to european society of intensive care (esicm) members. the electronic survey will contain 10 question. in the questionnaire the participants will have to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with covid-19 ards.

Eligibility criteria:
inclusion criteria: * members of european society of intensive care exclusion criteria: * not members of european society of intensive care
neuro strengths-based approach to autism

Conditions: Autism Spectrum Disorder

Summary: the neuro-strength-based approach to autism (nsbaa) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. it is not intended to be a new approach to intervention but hopefully a unifying approach to understanding autism that all therapists, educators, clinicians, and parents can use when working with autistic individuals. it was developed by an autistic occupational therapist, based on her lifetime obsession of learning everything she could about how typical brains work, and, following her diagnosis, how the autistic brain works. being on the autism spectrum herself and having worked with, and interacted with, autistic individuals of all ages and abilities in school, clinical, and personal settings, the author attempts to explain the autistic brain from both the scientific as well as autistic perspectives.


Eligibility criteria:
inclusion criteria: * 5-20 slps / otr/ls, regardless of nationality * working in a clinical, home or school setting with less than 25 years of experience * at least 2 years of experience working with autistic clients exclusion criteria: * minors * adults unable to consent * undocumented individuals * prisoners, * uncertified therapists * therapists from baio enterprises.
a study to evaluate the efficacy and safety of mabthera alone and in combination with either cyclophosphamide or methotrexate in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: wa16291 is a phase iia "proof-of-concept" study. the primary objective of this study is to determine the safety and efficacy of rituximab (a b cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior disease modifying anti-rheumatic drug (dmard) therapy and currently have an inadequate clinical response to methotrexate.


Eligibility criteria:
inclusion criteria: * participants with moderate to severe rheumatoid arthritis (ra) who have previously failed 1-5 dmards who currently have partial clinical response to treatment with methotrexate * using methotrexate as a single dmard for at least 16 weeks, of which the last 4 weeks prior to baseline on a stable oral dose greater than or equal to (\>=) 10 milligrams per week (mg/week) * \>=21 years of age * swollen joint count (sjc) and tender joint count (tjc) \>= 8 (out of 66 and 68 joints respectively) * at least 2 of the following parameters at baseline: c- reactive protein \>= 15 mg/dl; erythrocyte sedimentation rate \>= 30 millimeters per hour (mm/hr); morning stiffness \>45 minutes * rheumatoid factor titer \>=20 international units per milliliter (iu/ml) * corticosteroid (less than or equal to \[=\<\] 12.5 milligrams per deciliter \[mg/d\] prednisone or equivalent) or non-steroidal anti-inflammatory drugs (nsaids) are permitted if stable for at least 4 weeks prior to baseline exclusion criteria: * american rheumatism association (ara) class iv ra disease * concurrent treatment with any dmard (apart from randomized treatment) or anti-tnf-alpha therapy * active infection or history of recurrent significant infection * prior history of cancer including solid tumors and hematologic malignancies (except basal carcinoma of the skin that have been excised and cured) * evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders * bone/joint surgery within 6 weeks prior to screening * rheumatic autoimmune disease other than ra * active rheumatoid vasculitis * prior history of gout * chronic fatigue syndrome
lentiviral gene therapy (zamtocabtagene autoleucel) ltfu

Conditions: Non Hodgkin Lymphoma

Summary: this is an observational long-term follow-up (ltfu) study for subjects who previously received zamtocabtagene autoleucel, known as mb-cart2019.1.

this is a non-therapeutic study design. after successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post mb-cart2019.1 infusion. subjects will be assessed yearly for the occurrence of delayed adverse events (aes), monitored for replication competent lentivirus (rcl) and assessed for long term efficacy as well as car-t persistence.

Eligibility criteria:
inclusion criteria: * received zamtocabtagene autoleucel in a miltenyi biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study. * provided written informed consent to participate in this study. exclusion criteria: * none

Keywords: chimeric antigen receptor car t cd19 cd20
a multi-center cohort study of risk factors and outcomes of encephalopathy of prematurity in china

Conditions: Encephalopathy

Summary: the purpose of this study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age \<32 weeks in china.

recent years have witnessed an increase in survival of very or extremely low birth weight infants, with a corresponding increase of attention to encephalopathy of prematurity (eop) and the following neurological disorders. studies suggested that hypoxic-ischemic injury and perinatal infection might be the two main risk factors of eop, including white matter injury, neuronal-axonal diseases and cerebellar hemorrhage, which have a strong impact on neurological outcomes. sequelae like cerebral palsy or mental retardation become a burden to both the family and society. therefore, the risk factors of brain injury become the critical issue of both obstetrics and neonatology. more importantly, little is known about the morbidity of neurodevelopmental impairment and its risk factors in china. thus, the aim of our study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age \<32 weeks in china.

Eligibility criteria:
inclusion criteria: * preterm infants with gestational age less than 32 weeks exclusion criteria: * major congenital malformations * chromosomal disorders * metabolic diseases

Keywords: prematurity
hemodynamic measurements during liver transplantation

Conditions: Liver Transplantation

Summary: the purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.

pulmonary artery catheter (pac)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (olt). placement of pac is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. this study compares two newer fda approved much less invasive devices to the pac. the two new devices assess the heart function based either on the peripheral arterial waveform alone (vigileo, edwards lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (lidco, cambridge, uk).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * scheduled for liver transplantation * patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects) exclusion criteria: * we will exclude patients taking lithium based medication * patients who weigh less than 40 kg; and * patients who are pregnant

Keywords: end-stage liver disease hemodynamic measurements hyperdynamic circulation pulmonary artery catheter cardiac output
the relation between dedicated extremity mri synovitis and structural deterioration radiographic in patients with rheumatoid arthritis in clinical remission. preliminary study

Conditions: Rheumatoid Arthritis

Summary: the major aim of treatment for rheumatoid arthritis is remission. nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. numerous definitions of the remission proposed by literature remain imperfect. recently ultrasonography and mri seem to be helpful in diagnosis and follow-up of rheumatoid arthritis. studies in patients with clinical remission are reporting 75 to 90% of persistent mri and ultrasonography synovitis, 45% of cases with synovial activity. to our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression. on the other hand, no studies with extremity dedicated rmi in patients with remission are reported. in this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated mri synovitis the structural radiographic progression at one year.


Eligibility criteria:
inclusion criteria: * earlier rheumatoid arthritis (\<1 year) * clinical remission (das 28 \<2,6 ou sdai \<5) since 6 months before the inclusion * unchanged dmards and /or biologic therapy since 6 months before the inclusion * unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy * no contre-indication to the mri exclusion criteria: * contra-indication to mri * pregnant or breast-feeding women

Keywords: rheumatoid arthritis clinical remission synovitis dedicated extremity mri
a prospective study to assess the utility of ca-4f in a canadian cardiology setting

Conditions: Transthyretin Amyloid Cardiomyopathy ("ATTR-CM")

Summary: this study will assess whether ca-4f can improve diagnosis of attr-cm in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investigations.

this is a prospective multicentre observational study to assess whether ca-4f can improve diagnosis of attr-cm in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investigations. the algorithm will be used to screen electronic health records of participating cardiologists for patients suitable for pyp scans to investigate potential attr-cm and determine its positive predictive value. input parameters to the algorithm will be extracted from the pseudonymized electronic health records of patients who visited participating cardiologists in the 12 months preceding their enrolment. the records of patients with elevated pre-test likelihood of attr-cm will be queried for canadian heart failure society red flag symptoms to facilitate clinical review. participating cardiologists will review the red flag symptoms and electronic health records of patients with elevated pre-test likelihoods and document whether further investigation with pyp is clinically justified with supporting rationale. patients for which further investigation is clinically justified will be referred for confirmatory testing and the results of additional investigations will be documented. the positive predictive values of "moderate", "high" and "very high" ca-4f risk scores will be calculated by determining the percentage of those patients for which further investigations were performed and resulted in diagnosis of attr-cm.

Eligibility criteria:
inclusion criteria: * licensed cardiologist in the canadian provinces of ontario, saskatchewan or british columbia * outpatient cardiology practice with ≥1,200 unique patients annually * have used an electronic medical record system for ≥36 months from enrollment * currently subscribed to the advanced computing platform by ensho health or using a cloud-hosted electronic medical record system compatible with the apollo electronic data capture system * experience with the clinical management of attr-cm * access to pyp scanning for follow-up investigations * previous participation in clinical studies exclusion criteria: * predominantly hospital-based cardiology practice * have used an electronic medical record system for \<36 months from enrollment * electronic medical record system incompatible with the apollo electronic data capture system * no prior experience with the clinical management of attr-cm * no access to pyp scanning for follow-on investigations * no prior participation in clinical studies
automatic evaluation of the extent of intestinal metaplasia with artificial intelligence

Conditions: Intestinal Metaplasia of Gastric Mucosa; Artificial Intelligence; Endoscopy

Summary: gastric intestinal metaplasia(gim) is an important stage in the gastric cancer(gc). with technical advance of image-enhanced endoscopy (iee), studies have demonstrated iee has high accuracy for diagnosis of gim. the endoscopic grading system (eggim), a new endoscopic risk scoring system for gc, have been shown to accurately identify a wide range of patients with gim. however, the high diagnostic accuracy of gim using iee and eggim assessments performed all require much experience, which limits the application of eggim. the investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of im and calculate the eggim scores.

globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. gastric intestinal metaplasia (gim) is an intermediate precancerous gastric lesion in the gastric cancer cascade. studies have shown that the 5-year cumulative incidence of gastric cancer in im patients ranges from 5.3% to 9.8% . with technical advance of image-enhanced endoscopy (iee), studies have demonstrated iee has high accuracy for diagnosis of gim. the endoscopic grading system (eggim), a new endoscopic risk scoring system for gc, have been shown to accurately identify a wide range of patients with gim. however, the high diagnostic accuracy of gim using iee and eggim assessments performed all require much experience, which limits the application of eggim. the investigators aim to design a computer-aided diagnosis program using deep neural network to automatically evaluate the extent of im and calculate the eggim scores.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 years who undergo the iee examination exclusion criteria: * patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy * patients with previous surgical procedures on the stomach * patients who refuse to sign the informed consent form