Kornimate/medical-research-clean huggingface dataset:
effect of acid suppression medication on pediatric microbiome

Conditions: Clostridium Difficile Infection

Summary: the colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. proton pump inhibitors (ppis) and histamine-2 receptor antagonists (h2ras) are widely used in children, but the effects of ppis and h2ras on the pediatric colonic microbiome are unknown. this study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (gerd), and determine the duration and magnitude of microbiome changes.

otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for gerd will be eligible for this study. subjects donate samples before and after being treated with ppis or h2ras (must donate at least 2 baseline pre-ppi samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive ppis or h2ras). all children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. the primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of ppis or h2ras (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.

Eligibility criteria:
inclusion criteria: * zero to 4 years old * being considered for ppi or h2ra treatment for refractory gerd * parent is able to give informed consent exclusion criteria: * prevalent c. difficile infection (excluded via stool pcr at week 0) * use of systemic antibiotics within the past 90 days * use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days) * increased risk for fracture due to vitamin d deficiency or other causes * chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome) * congenital deficiency in immunity (e.g., such as iga deficiency) * cystic fibrosis * significant dynamic or uncontrolled comorbidity such as hiv or malignancy * use of medications with potential interaction with ppis

Keywords: clostridium difficile infection proton pump inhibitors histamine-2 receptor antagonists gastroesophageal reflux disease
study evaluating venlafaxine er in recurrent depression

Conditions: Depressive Disorder, Major; Recurrence

Summary: the purpose of this study is to review the long-term comparative efficacy of venlafaxine er in achieving and sustaining remission (wellness) in patients with recurrent major depression


Eligibility criteria:
inclusion criteria * clinical diagnosis for recurrent major depression exclusion criteria * the patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine er during the current episode of major depression or the patient is treatment-resistant * known hypersensitivity to venlafaxine or fluoxetine * history or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder

Keywords: depression
evaluation of the severity of hepatic fibrosis by magnetic resonance elastography in the diagnosis of endogenous hypercorticism

Conditions: Cushing Syndrome; Metabolic Syndrome

Summary: the main hypothesis of the hepacort study is that upon diagnosis of endogenous cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of cushing's syndrome. the hepacort study is the first exploratory study to assess the severity of liver fibrosis in patients with cushing's syndrome or suspected of presenting by magnetic resonance elastography (mre).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old; * person affiliated to a social security scheme or beneficiary of such a scheme; * person having received complete information on the organization of the research and having signed informed consent; * person having carried out a preliminary clinical examination adapted to the research. * patients with cushing's syndrome (for the cushing's syndrome group) * patients with possible cushing's syndrome (for the suspected cushing's syndrome group) defined as response to the dexamethasone supression test with 1 mg of dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/l carried out in the 3 months preceding ; * patients with metabolic syndrome (for the metabolic syndrome group) exclusion criteria: * person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion; * person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion; * person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion; * person with chronic liver disease; * person with alcohol misuse, defined by a weekly consumption of more than 10 standard units; * person with a morphotype that does not allow an mri examination to be performed; * woman of childbearing age who does not have an effective means of contraception; * contraindication to performing an mri examination. * person referred to in articles l. 1121-5, l. 1121-7 and l1121-8 of the french public health code.
relationship training for children with autism and their peers

Conditions: Autism; Autistic Disorder

Summary: this study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism.

children with autism often have poor relationships with other children during their childhood and through their adult lives. a number of peer-related intervention models have been developed, but these models have not been thoroughly reviewed or implemented within the school setting. this study will examine the social inclusion of children with autism, following different peer-related interventions training children with autism and their peers. children will be randomly assigned to one of four interventions that comprise all autistic children, all nonautistic children, or a mixed group of both. the first intervention focuses on improving the social skills of autistic children. the second intervention involves educating the peers of autistic children to increase their acceptance of their autistic peers. the third intervention is a combination of the first two interventions. children assigned to the fourth intervention will receive the usual training offered in their local school districts. training for each group will be conducted twice a week for 6 weeks. characteristics of the autistic child will be assessed through an interview that evaluates intelligence quotient (iq), language skills, and social interaction. teachers will be asked to complete a questionnaire describing the autistic child and his or her interaction with peers. the autistic children will complete a friendship survey, clinical global impressions scales, and a battery of neuropsychiatric tests. all assessments will be conducted at study start and again at study completion.

Eligibility criteria:
inclusion criteria for autistic and nonautistic participants: * autistic or nonautistic peer of autistic child * full inclusion in a classroom with nonautistic children * currently in kindergarten or grades 1 through 5 * intelligence quotient higher than 70 * expectation to stay in the same school and classroom for the duration of the study * able to provide parent consent and child assent exclusion criteria: * mental age-equivalent less than 4 years * conditions other than autism, or sensory or motor impairments

Keywords: interpersonal relationships child
leukocyte dysfunction in diabetic patients.

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to study impairment of white blood cell function in patients with type ii diabetes.

leucocytes from poorly controlled diabetes exhibit aberrant chemotaxis, increased susceptibility to bacterial infection, leukotriene production, lysosomal enzyme release, proinflammatory cytokine expression and production of reactive oxygen species. aberrant glucose concentration in diabetics affects functions of peripheral blood system as well as the immune system leading to impaired host defense. impaired wound healing is a serious complication associated with diabetes. we hypothesized that impairment in leukocyte function results in dysfunctional inflammatory response in diabetic wounds. the proposed studies focus on characterizing mechanisms that will improve our understanding of the dysfunctional inflammatory response resulting in non-healing chronic wounds in diabetics.

Eligibility criteria:
inclusion criteria: * adults ages 40-60 yrs old clinically diagnosed with type ii diabetes * adults ages 40-60 yrs old without diabetes exclusion criteria: * unable to provide informed consent * pregnant females * therapeutically immuno-compromised
the effect on fluid balance after cardiac surgery after use of two different priming protocols

Conditions: Coronary Heart Disease

Summary: "the impact on fluid loading after cardiac surgery by use of two different priming solution" fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. myocardial oedema has been reported to impair both systolic and diastolic function. an association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients. the investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). in one animal study the investigators used colloides as an additive to the cpb-prime. the investigators observed reduced fluid leakage and less total tissue water in several organs. the planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. the patients will be randomized to receive either tetraspan® (hes) or acetated ringer's solution in the cpb-prime. accurate accounts of fluid additions, blood loss and diuresis will be kept. determination of cardiac output (c.o.), intrathoracic blood volume (itbv), extravascular lung water (evlw) and global end diastolic volume (gedv) will be monitored by use of the transpulmonary thermodilution technique picco®plus system.


Eligibility criteria:
inclusion criteria: * patients undergoing cabg, * ef(ejection fraction) more than 40% exclusion criteria: * reduced ef (less than 40%) evf less than 30%, * estimated gfr less than 60%, * bmi less than 18 or more than 32
role of gray scale and color doppler ultrasound in diagnosis of pediatric neck masses

Conditions: Pediatric Tumor

Summary: our aim is to assess the role of the gray scale and color doppler ultrasound in diagnosis of the different pediatric neck masses .

neck masses are a common occurrence in the pediatric population and often represent a diagnostic challenge for the clinician involved . fortunately , the vast majority of these lesions are ultimately proven to be benign in nature (1). even though clinical examination and patient's history are the first and indispensable steps in the initial diagnosis, the role of imaging is crucial, not only to determine whether a mass represents a true tumour or not , but also to achieve a more correct diagnosis and determine the extension of the lesion and its relation with the nearby anatomic structures (2). ultrasound (us) should serve as the primary initial imaging modality in children for palpable masses and assessment of superficial glandular structures. because of the smaller neck size and less subcutaneous fat, sonographic penetration and resolution is generally improved as compared with adults (3 ). doppler imaging can also elucidate how flow is distributed within a mass may have diagnostic significance and help us in determining the nature of the lesion as well as it is of great importance in assessment of vascular lesions (4) though ultrasound is most common method used for evaluation of pediatric neck masses , and ct as well as mri are used as an additional tool when necessary ( 3 ) , few studies have looked at the sensitivity and specificity of the different imaging modalities of the pediatric neck masses and most studies have investigated the epidemiology of the pediatric neck masses (5) which make histopathological diagnosis still the gold standard in distinguishing the etiology of pediatric neck masses and ruling out malignant disease (6)

Eligibility criteria:
inclusion criteria: - clinical cases who are suspected for and provisionally diagnosed for "neck swelling" in children (below age of 18 years). exclusion criteria: 1. patients with conditions that may hinder ultrasound examination like subcutaneous emphysema and thick skin scarring. 2. patients who are unwilling/uncooperative or have not given consent for participation.
clinical research of robo1 specific bicar-nk/t cells on patients with malignant tumor

Conditions: Malignant Tumor

Summary: immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. robo1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. this study is for evaluation of the safety and efficacy of robo1 car-nk/t cell immunotherapy for malignant tumors.


Eligibility criteria:
inclusion criteria: 1. age 18\~75 years old, male or female 2. life expectancy ≥ 6 months 3. ecog score: 0-3 4. robo1 expression in malignancy tissues detected by immuno-histochemistry (ihc) 5. advanced solid tumor was diagnosed by pathological or clinical physicians 6. laboratory examination: white blood cell≥3 x 10\*9/l, blood platelet count≥70 x 10\*9/l, hemoglobin≥80g/l, lymphocyte count≥15%, total bilirubin≤100 mol/l, alt and ast less than five times of the normal level, serum creatinine less than 1.5 times of the normal level 7. signed informed consent 8. women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion exclusion criteria: 1. expected overall survival \< 6 months 2. patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> class ii, nyha), or myocardial infarction within 6 months 3. abnormal lung function: fev (forced expiratory volume) \< 30% prediction, dlco (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90% 4. other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 5. unable or unwilling to provide informed consent, or fail to comply with the test requirements
a study of ro4917838 in patients with sub-optimally controlled symptoms of schizophrenia (nn25307)

Conditions: Schizophrenia

Summary: this randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of ro4917838 in patients with sub-optimally controlled symptoms of schizophrenia. patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of ro4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * diagnosis of schizophrenia * clinical stability for 16 weeks (4 months) prior to randomization * antipsychotic treatment stability for the past 12 weeks prior to randomization * with the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics) exclusion criteria: * has treatment resistant schizophrenia as judged by the treating physician or have failed two trials * evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease) * patient has a body mass index (bmi) of \ 40 kg/m2, respectively * diagnosis of mental retardation or severe organic brain syndromes * in the investigator's judgment, a significant risk of suicide or violent behavior
electromyography for diaphragm effort

Conditions: Diaphragm Injury; Muscle Weakness; Weaning Failure; Physiological Stress

Summary: mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. the ventilator then temporarily takes over the function of the respiratory muscles. during treatment in the intensive care, the amount of support provided by the ventilator is usually lowered gradually, until the point that the patient can breathe unassisted once again. however, in a large fraction of patients (up to 40%) it takes days to weeks before the patient is able to breathe unassisted, even after the initial disease has been treated. this is called prolonged weaning. a possible cause of prolonged weaning is weakness of the respiratory muscles. the diaphragm, the largest respiratory muscle, can become weakened if it is used too little, much like all other muscles in the body. additionally, damage and weakness of the diaphragm can occur when the diaphragm has to work excessively. therefore, it is important that the diaphragm works enough; not so little that it becomes weakened, but not too much either. measurements of pressure generated by the diaphragm are needed to determine the current level of diaphragm activity in a patient on mechanical ventilation. however, these measurements are rarely performed, because they are time-consuming and require placement of two additional nasogastric catheters. this is a shame, as adequate loading of the diaphragm might prevent development of weakness, leading to shorter duration of mechanical ventilation. finding alternative measurements of diaphragm effort might be a solution to this problem. it has been hypothesized that the electrical activity of the diaphragm provides a reliable indication of diaphragm effort. this study aims to determine whether there is a correlation between pressure generation by the diaphragm and electrical activity of the diaphragm over a wide range of respiratory activity, from low effort to extreme effort, in healthy volunteers.


Eligibility criteria:
inclusion criteria: * informed consent * age \>18 years exclusion criteria: * history of cardiac and/or pulmonary disease or current medication use * history of pneumothorax * contra-indications for nasogastric tube placement (recent epistaxis, severe coagulopathy, current upper airway pathology) * contra-indication for magnetic stimulation (cardiac pacemakers or metal in cervical area)

Keywords: monitoring breathing effort intensive care diaphragm weakness
combination treatment for enterococcus faecalis bacteriemia multicenter, observational study"

Conditions: Enterococcal Bacteraemia; Enterococcus Faecalis Infection; Enterococcal Endocarditis; Bloodstream Infection

Summary: prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated enterococcus faecalis bloodstream infection (ef-bsi). the aims of our study are: primary: to compare the efficacy of appropriate monotherapy vs combination treatment for ef-bsi, according to standard of care. secondary: 1. to compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. in this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy. 2. to compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients: a. patients with low versus high risk of endocarditis according with the "number of positive blood cultures, origin of the bacteremia, previous valve disease, auscultation of heart murmur (nova) score". b. patients with metastatic septic localizations. c. patients with catheter-related bsi. d. patients with indwelling cardiovascular device or prosthetic valve. 3. to validate the nova score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with ef-bsi. 4. to estimate optimal duration of treatment of ef-bsi in patients without endocarditis. 5. to evaluate the rate of 90-day development of clostridium difficile infection. the promoting center is s. orsola-malpighi hospital is a 1,420-bed tertiary care university hospital in bologna with an average of 72,000 admissions per year. a dedicate team of infectious diseases (id) specialists is active in the promoting center. investigators of this team have already coordinated multicenter studies on infections topics. centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form. all consecutive, unselected patients with monomicrobial ef-bsi will be screened for study inclusion. we expect to enroll about 500 patients. period of data collection will be from september 2019 to 31th december 2020.


Eligibility criteria:
inclusion criteria: * adult (\>18 years) * first monomicrobial ef-bsi * receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for ef-bsi in empirical or definitive therapy * written informed consent exclusion criteria: * short term (within 3 days from bsi) mortality * other concomitant infection

Keywords: combination therapy bloodstream infection enterococcus faecalis infection endocarditis