Kornimate/medical-research-clean huggingface dataset:
trial of center-based vs. in-home pivotal response treatment (prt) in autism

Conditions: Autism; Autism Spectrum Disorder; ASD

Summary: the aim of this clinical trial is to compare the efficacy of a 16-week center-based pivotal response treatment (prt-c) versus home-based pivotal response treatment (prt-h) in targeting social communication deficits in young children with autism spectrum disorder (asd) with significant language delay. the two groups will also be compared to a control group that consists of children who are receiving treatment as usual (tau).


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder (asd) based on autism diagnostic interview revised (adi-r), autism diagnostic observation schedule, second edition (ados-2) or childhood autism rating scale, second edition (cars-2), diagnostic and statistical manual 5th edition (dsm-5), and expert clinical opinion; * boys and girls between 2.0 and 5.11 years; * ability to participate in the testing procedures to the extent that valid standard scores can be obtained; * language delay as measured by the preschool language scale, 5th edition (pls-5): standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds; * stable treatment (e.g., applied behavior analysis - aba), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements; * no anticipated changes on treatment during study participation for center-based pivotal response treatment (prt-c) and in-home pivotal response treatment (prt-h); * no more than 60 minutes of individual 1:1 speech therapy per week; * availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures. exclusion criteria: * current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.); * receiving aba of 15 hours or more; * presence of active medical problem (e.g., unstable seizure disorder or heart disease); * previous adequate pivotal response treatment (prt) trial; * participants living more than 30 miles from stanford university; * child's primary language other than english.

Keywords: pivotal response treatment prt center based social and communication
impact of sars-cov-2 pandemic on psychological state of health care workers

Conditions: SARS-CoV-2

Summary: in covid-19 pandemic, many health-care workers (hcws) have worked in high-pressure environments. they have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders.

throughout the sars-cov-2 pandemic, many hcws have worked in high-pressure environments. moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to challenges in the delivery of high-quality care, possibly due to a lack of experience or equipment, or as a result of low staffing levels. these unfavorable circumstances and exposure risk to infection are likely to increase the risk of mental health disorders such as post-traumatic stress disorder (ptsd) or depression, other anxiety disorders, substance misuse and suicide in the present study, this study aimed to assess the psychological state of hcws who were facing challenges of sars-cov-2pandemic comparing them to non medical staff group based on use of the hamilton anxiety and depression rating scale.

Eligibility criteria:
inclusion criteria: * all health workers team exclusion criteria: * no exclusion criteria

Keywords: sars-cov-2 anxiety depression
neurophysiological effects of whole coffee cherry extract in older adults

Conditions: Memory Deficits

Summary: this study was designed to characterize the changes in the brain and body associated with whole coffee cherry extract (wcce). wcce is a patented extract of whole coffee fruit (coffee berries) from coffea arabica. whole coffee cherries are a source of naturally occurring nutrients. there are no known side effects or allergens associated with wcce other than that which would be associated with a consuming typical cup of coffee. previous studies suggest that increases in serum concentrations of both serum total and exosomal brain-derived neurotrophic factors (bdnf) may represent one of the mechanisms responsible for improved cognitive function after acute wcce administration. mild cognitive impairment (mci) is an intermediate stage between the expected cognitive decline of normal aging and the more serious decline of dementia. it can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. furthermore, mci is associated with reduced circulating bdnf. due to earlier studies reporting the ability of wcce to stimulate increases in circulating and exosomal bdnf, it has been postulated that wcce may also acutely improve cognitive function (as measured using behavioral tasks and fmri). the purpose of this study is to extend and elucidate the findings of previous investigations by examining the acute neurophysiological effects of wcce using blood-oxygen level dependent (bold) functional magnetic resonance imaging (fmri) and magnetic resonance spectroscopy (mrs) employing a double-blind, randomized crossover design to investigate the acute effects of a single dose of wcce or placebo (silica oxide) on neuronal activity in older participants.


Eligibility criteria:
inclusion criteria: * complaints of memory, verified by an informant * 55 years of age or older exclusion criteria: * mri contraindications * diagnosis of alzheimer's disease or suspected diagnosis at the time of visit by study personnel * significant cerebrovascular disease * history of cardiovascular disease * current or recently prescribed medication known to interfere with peripheral and/or cerebral blood flow or vascular function
safety of lactobacillus fermentum in newborn infants

Conditions: Tolerance

Summary: in the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. however, there are few studies studying the effects of probiotics in newborns. the objective of the present study is to analyze safety and tolerance of the probiotic lactobacillus fermentum cect5716 isolated from human milk.


Eligibility criteria:
inclusion criteria: * healthy 1 month infants exclusively formula-fed exclusion criteria: * gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux) * gastrointestinal surgery * cow's milk protein allergy * metabolic disorders (diabetes, lactose intolerance) * immune deficiency * antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Keywords: probiotic infant nutrition safety infections
ofatumumab in japanese patients with cd20 positive follicular lymphoma or chronic lymphocytic leukemia

Conditions: Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Summary: this is an open-label study to evaluate safety, tolerability, efficacy and pk profile of ofatumumab monotherapy in japanese follicular lymphoma (fl) or chronic lymphocytic leukemia (cll) patients. subject will receive ofatumumab 8 weekly infusions.


Eligibility criteria:
inclusion criteria: * signed informed consent. * histologically confirmed relapsed or refractory cd20 positive fl grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or cd5, cd19, cd20 and cd23 positive relapse or refractory cll. * subjects must have adequate blood, liver, and kidney function. * subjects who passed the provided periods from the last anti-cancer treatments at screening * ecog performance status of 0-2 * life expectancy more than 24 weeks at screening exclusion criteria: * current and past malignancy other than fl and cll within 5 years prior to screening. * known richter's transformation * previous autologous stem cell transplantation within 24 weeks prior to screening * previous allogeneic stem cell transplantation * known cns involvement * history of significant cerebrovascular disease * current cardiac disease requiring medical treatment * chronic or ongoing active infectious disease requiring systemic treatment * patients with pleural effusion or ascites detectable by physical examination * positive serology test for any of hbsag, anti-hbc or anti-hcv * known hiv positive * pregnant or lactating women * women of childbearing potential and male patients not willing to use adequate contraception

Keywords: cd20 positive chronic lymphocytic leukemia follicular lymphoma gsk1841157 japanese patient ofatumumab
effect of varied outreach methods on appointment scheduling, appointment completion, and receipt of covid-19 vaccination

Conditions: Health Care Utilization; Vaccine Preventable Disease

Summary: our objective is to determine the effectiveness of varied outreach methods to children age 12-17 years old who are due for a well child check visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the covid-19 vaccination.


Eligibility criteria:
inclusion criteria: * age 12-17 years * has not had a well child check in past 365 days * no future well child check visit scheduled * parent preferred language = english or spanish exclusion criteria: * phone number not available in electronic health record
safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: a randomized controlled trial

Conditions: Bronchiolitis; Lower Respiratory Tract Infection; Bronchial Hyperreactivity

Summary: the goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. we hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. after admission, (parents of) participating children will fill out questionnaires. we will compare the two groups on their hospitalization duration and recovery. in other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?


Eligibility criteria:
inclusion criteria: * 6 weeks to 12 years of age (corrected age for children with gestational age \< 37 weeks) * hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, as diagnosed by the treating physician. viral wheeze can only be diagnosed below the age of 6 years. * requiring supplemental oxygen as per usual care (spo2 \<92% or for treating symptoms of respiratory distress as determined by the treating physician as respiratory distress in children with an asthma attack is mainly driven by hypoxia, they are at risk of undertreatment in the acute phase of the attack. therefore, children aged 6-12 years of age with an asthma attack are excluded from this study. exclusion criteria: * children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency) * children born \<32 weeks gestational age * children already included in other studies, which potentially interfere with this study * children (of parents) without a stable internet connection needed for answering questionnaires * children previously included in the current study * considering questionnaires are only available in dutch and english, children (of parents) with different languages will be excluded.

Keywords: oxygen saturation target spo2 children
the effects of tranexamic acid on blood loss during orthognathic surgery

Conditions: Tranexamic Acid; Orthognathic Surgery

Summary: this study seeks to answer the question: does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery? if it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.


Eligibility criteria:
inclusion criteria: * patients undergoing either * bilateral saggital split osteotomy (lower jaw surgery) * lefort 1 osteotomy (upper jaw surgery) * combination of bsso and lefort * patients between with ages of 16-65 * no cardiac comorbidities (hypertension, congenital heart malformation) * no known coagulopathy * no regular prescription medication altering normal blood coagulation (nsaids, other anticoagulants) * asa i and ii patients exclusion criteria: * patients younger than 16 and older than 40 * patients with known coagulopathy * patients with cardiac comorbidities * patients with a family history of bleeding disorders * patients who have undergone previous orthognathic surgery * asa iii patients or higher
evaluation of etomidate on adrenal function in trauma patients

Conditions: Adrenal Insufficiency

Summary: trauma patients are at increased risk for adrenal function insufficiency. a commonly used agent for rapid sequence intubation (rsi) is known to decrease adrenal function. we want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following rsi in trauma patients.

the study will have two arms. patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for rsi. patients on the other arm will receive standard therapy at this institution which consists of versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for rsi. both drug regimens have a rapid onset, short duration and short half-life. patients will be randomly assigned to one arm of the study. the trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. the numbers will correspond to a log, delineating which medication is given. the nurse will document the medication as rsi study drug - etomidate or rsi study drug - standard and the randomization packet number (ie, rsi study drug, etomidate, #1, rsi study drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the er resuscitation bay. baseline cortisol level will be drawn prior to rsi. an additional cortisol level will be drawn 4-6 hours later. following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn iv and rechecking a cortisol level in 60 minutes. adrenal insufficiency will be defined as a baseline cortisol level of \<15 or an increase in cortisol of \<9 after cortrosyn administration. patients will be monitored for 24 hours for hemodynamics, iv fluid administration , and use of vasopressors. patient will be resuscitated to adequate mean arterial blood pressure and urine output. any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg iv every 6 hours.

Eligibility criteria:
inclusion criteria: * trauma mechanism of injury * patient requires rapid sequence induction for ventilatory support exclusion criteria: * \<18 years old * prisoners * pregnant women * patients with a history of adrenal insufficiency * patients with adrenal trauma documented by ct scan * patients receiving corticosteroids in the previous year

Keywords: adrenal insufficiency etomidate rapid sequence induction
to evaluate the efficacy and safety of vitamin b12 contains extract of lamb's stomach in treatment of chronic atrophic gastritis (cag)

Conditions: Chronic Atrophic Gastritis (CAG)

Summary: the purpose of this study is to determine whether gastropyloric complex capsules are safe and effective in the treatment of chronic atrophic gastritis (cag).

till now, there is no ideal treatment to chronic atrophic gastritis(cag). this study is try to find a possible treatment to cag with gastropyloric complex capsules.

Eligibility criteria:
inclusion criteria: * age 18-70 years, male or female * histologically diagnosed cag * hp negative confirmed by gastric mucosal staining * signed an written informed consent exclusion criteria: * cag with high-grade intraepithelial neoplasia * severe gastric mucosal erosion or bleeding needing treatment * active peptic ulcer, gerd, or esophageal stricture * history of upper gi tract surgery * history of malignant diseases * with depression, anxiety neuroses, or hysteria * heart failure (nyha class lll or lv), liver disease (alt ≥ 80 iu/l, ast ≥ 80 iu/l) or renal disease(cr ≥ 150 ummol/l) * uncontrolled hypertension * uncontrolled diabetes * alcohol abuse * drug allergy * participated in another investigational study within 4 weeks prior to visit 0 * pregnancy, be a nursing mother or without conception control * there is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study
efficacy study of pristinamycin versus amoxicillin to treat tonsillitis induced by streptococcus in children

Conditions: Tonsillitis

Summary: the primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (v3 (d10/d14)), in terms of bacteriological efficacy of pristinamycin (pri) administered for 4 days versus amoxicillin (amx) administered for 6 days in the treatment of tonsillitis caused by gas, in subjects aged between 6 and 25 in the per protocol (pp) group.


Eligibility criteria:
inclusion criteria: * subjects of both sexes * aged between 6 and 25 years, * weight : ≥ 20kg * with suspected gas-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°c, appreciable satellite adenopathy) * confirmation by positive rdt * provision of throat swabs for culture * ability to swallow tablets exclusion criteria: * related to the study disease: * suspected viral infection (concomitant dysphonia, cough, conjunctivitis, rhinitis) * adenophlegmon, peritonsillar abscesses. * related to the study treatment: * known or suspected allergy to beta-lactamines (penicillin, cephalosporin) * suspected infectious mononucleosis (increased risk of skin disorders) * phenylketonuria (due to the presence of aspartame) * congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase deficiency (due to the presence of lactose, in powder or suspension form) * allergy to pristinamycin and/or virginiamycin * history of pustular rash with pristinamycin * hypersensitivity or gluten intolerant (due to the presence of wheat starch) * ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol, tacrolimus or oral anticoagulants. * related to previous treatment: * subjects receiving antibiotic therapy in the month prior to inclusion, except for azithromycin, for which the exclusion period is 3 months. * subjects on short-term corticosteroids. subjects on long-term corticosteroids initiated before the start of the study and taken at a controlled dosage may be included. * related to subjects: * breast-feeding women * women either pregnant or attempting to conceive * subjects likely, during the course of the study to receive treatments prohibited by the protocol * treatment with other investigational drugs in the 4 weeks prior to inclusion in the study * immunodepression, clinically significant endocrine disease, cardiovascular disease, neurological disease, or any other marked diseases resulting in complications in performance of the study or interpretation of the study data * known hepatic impairment * known renal impairment (creatinine clearance \< 30 ml/minute) * cancer, blood dyscrasias * previous history of drug or alcohol abuse. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluation of a simple clinical test to detect the risk of falling in patients with bpco and research for predictive factors of fall risk.

Conditions: COPD Diagnosed

Summary: the risk of falling in increased in patients with chronic obstructive pulmonary disease. to date, a screening test (the berg balance scale, bbs) is used to evaluate this risk but it spends 20 to 30 minutes to complete. the aim of our study is to evaluate the sensitivity of a more straightforward test (timed up and go, tug)) to assess the fall risk. the tug is routinely used in elderly to screen for frailty.

we will recruit copd patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. the patients will be proposed to perform the following tests and to fill in questionnaires: - questionnaires: elderly falls screening test to quantify the falls in the last year, hospital anxiety and depression scale, activities-specific balance confidence scale. tests: * berg balance scale measuring balance in 14 different functional tasks (abnormal cut-off value \<56) * timed up and go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value \>12 seconds). * 6 minute walk test evaluating endurance to submaximal exercise. * isokinetic maximal force of the quadriceps at 60°/s * balance control: posturography consisting in measuring variations when standing on a force platform. * body composition assessment through dual xray absorptiometry (dxa), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density. * blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin d, albumin transthyretin, cell count, c reactive protein. analysis of the results: we will calculate the sensitivity of the tug test (abnormal test) to detect fall risk as assessed by an abnormal bbs score. moreover, in fallers, we will search for predictive factors. more specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease). perspectives: when validated as a screening test for the risk of falling in copd patients, the tug test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.

Eligibility criteria:
inclusion criteria: * copd confirmed by pulmonary function tests * long term oxygen therapy since at least 3 months in the lot+ subgroup exclusion criteria: * exacerbation of copd necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks * pulmonary rehabilitation in the last 3 months * any neurological disease affecting balance control. * inability to perform a walk test

Keywords: fall balance control screening test oxygen skeletal muscle mass