Kornimate/medical-research-clean huggingface dataset:
comparison of breathing events detected by the sleepstyle 200 auto continuous positive airway pressure (cpap) device to attended polysomnography

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnoea (osa) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing. the standard treatment for osa is nasal continuous positive airway pressure (cpap), which consists of pressurized air applied to the nose via a mask. generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (sdb) events are abolished. despite therapy efficacy, compliance to cpap therapy is sub-optimal. due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current cpap devices. healthcare providers can use this reported data to make appropriate treatment decisions. for this reason the data needs to be accurate. the sleepstyle™ 200 auto series cpap humidifier is an auto adjusting cpap which stores comprehensive compliance data. the aim of this study is to compare the reliability of the sleepstyle™ 200 auto series cpap data to laboratory-based psg in detecting sleep disordered breathing. hypothesis: the sleepstyle™ 200 auto series reporting features accurately detects indices of sleep disordered breathing.


Eligibility criteria:
inclusion criteria: * apnea hypopnea index (ahi) \>15 from diagnostic night * ≥18 years of age exclusion criteria: * contraindicated for cpap use
treatment efforts addressing child weight management by unifying patients, parents & providers

Conditions: Obesity, Childhood; Pediatric Obesity; Childhood Obesity; Adolescent Obesity; Overweight; Overweight and Obesity; Overweight or Obesity; Overweight Adolescents; Weight Gain; Overnutrition; Body Weight; Body Weight Changes; Nutrition Disorders

Summary: the us preventive services task force (uspstf) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. family-based behavioral treatment (fbt) is an effective treatment that targets both child and parents and meets the uspstf recommendations. by contrast, the american medical association (ama) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (pcp) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. our study compares a staged approach enhanced standard of care (esoc) vs. esoc + fbt, to provide families and pcps with information on the best intervention approach for the behavioral treatment of childhood obesity. our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on black children, families insured by medicaid, and sex differences.

note: our enrollment number includes two participants (one child and one parent) from each enrolled family.

Eligibility criteria:
inclusion criteria for children include: * have a bmi percentile ≥95th for age and sex; * comfortable speaking english language; * able to provide written or verbal (based on age) informed assent; * willing to change diet, physical activity, and/or weight; * patient of a participating clinic/practice; and * able to participate in scheduled sessions. inclusion criteria for parents include: • comfortable speaking and reading english language. exclusion criteria include: * families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period; * children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation; * families for whom the primary care provider (pcp) or site pi thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the pi/pcp believes these factors will interfere with study/intervention participation); and * families in whom the parent or child exhibits eating disorder symptomatology.

Keywords: weight management child intervention weight loss behavior therapy nutrition
molecular basis of food allergy

Conditions: Food Allergy; Eosinophilic Esophagitis

Summary: the study examines the molecular basis of food allergy. it explores the interaction between t cells, inkt cells, basophils and cytokines in the development of food allergy. the study also explores these factors in development of tolerance "outgrowing" food allergy. it will also explore the genetic factors that lead to the development of food allergy. the study examines all type of food allergy including ige mediated reactions, eosinophilic esophagitis and food protein induced enterocolitis

food allergy (fa) is a common pediatric atopic disease. characteristically children affected by fa become sensitized to food in the first few months of life and spontaneously outgrow the disease by 5-6 years of age in about 80% of cases. at the present time, diagnosis of fa is made by a combination of history, skin testing and food challenge. the pathogenic mechanisms leading to food sensitization and subsequent spontaneous tolerance development are not understood.

Eligibility criteria:
inclusion criteria for study group: 1. males or females age 1 month to 65 years. 2. diagnosis of food allergy. food allergy can be either ige or non-ige mediated food allergy including eosinophilic esophagitis and food protein induced enterocolitis. inclusion criteria for control group: 1. age and sex matched patients without food allergies 2. sibling and parents of patients with food allergies inclusion criteria for control group with atopy: 1. age and sex matched patients without food allergies 2. sibling and parents of patients with food allergies 3. patients with atopy exclusion criteria 1. underlying disease or medical problem that is judged to serious or risky to allow 3 ml/kg of blood to be drawn from a vein (such as serious anemia, cancer, poor vein abscess, serious infections). 2. subjects that do not meet the enrollment criteria may not be enrolled. any violations of these criteria will be reported in accordance with institutional review board (irb) policies and procedures study procedures.

Keywords: food allergy eosinophilic esophagitis food protein induced enterocolitis inkt cells t cells
piloting ivr (interactive voice response) for chronic pain treatment

Conditions: Chronic Pain

Summary: this study is designed to develop and test the use of interactive voice response (ivr) technology to deliver pain management treatment. ivr allows individuals to receive and provide information by using their touchtone telephone. this will allow more people with chronic pain to receive treatment even if they are not able to drive to an appointment regularly. in the first part of the study, the investigators will develop new materials like patient handbooks and pre-recorded explanations about common pain control techniques. in the second part of the study, a small number of persons with chronic pain will receive treatment using the new materials. we will ask for their feedback about how well they liked using the new materials and if the materials are understandable. this will allow us to revise the materials if we need to prior to studying them with a larger group of people with chronic pain.

background: cognitive behavioral therapy (cbt) has been shown in two meta-analyses to be effective in reducing pain intensity, disability, and affective distress in persons with chronic pain. although effective, traditional cbt is time-intensive and requires patients to make frequent office visits. an alternative is to improve treatment accessibility and efficiency of treatment provision through the use of electronic methods such as interactive voice response (ivr) technology. objectives: this pilot project was designed to test the feasibility and perceived value of ivr-based cbt intervention materials for the treatment of chronic pain. the project involved adapting traditional cbt materials for use in a ivr-based chronic pain treatment. methods: the project occurred in two phases. phase 1 included the revision of materials to support the ivr-based intervention including 1) a patient handbook, 2) a library of ivr-compatible scripts for the presentation of pain treatment topics, and 3) guidelines for providing personalized feedback. phase 2 included the evaluation of the developed materials by a small group of patients with chronic pain. after the treatment materials were revised, their usability, feasibility and perceived value were tested with a small sample of veterans with chronic pain. status: this study is complete.

Eligibility criteria:
inclusion criteria: * pain for at least 6 months; * average pain level of \>3 on a scale of 0 (no pain) to 10 (worst imaginable); * access to touchtone phone exclusion criteria: * current alcohol or substance abuse; * current psychosis; * current suicidal ideation; * current life threatening or acute physical illness

Keywords: chronic pain ivr cognitive-behavior therapy
interleukin 33 in juvenile idiopathic arthritis patients

Conditions: Juvenile Idiopathic Arthritis

Summary: the aim of this study is to measure serum and synovial fluid levels of il 33 and its relative mrna expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (jia) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound findings.

subjects and methods subjects:this study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of benha university hospital and benha children hospital and thirty apparently healthy children as controls. they will be classified into: * group (i) study group:60 cases of children with juvenile idiopathic arthritis. * group (ii) control group:60 of apparently healthy children matched for age and sex a)full history taking b) full clinical examination c) clinical assessment of disease activity d) laboratory investigations: all subjects will be investigated by 1. complete blood count. 2. erythrocyte sedmentation rate. 3. c-reactive protein . 4. liver enzymes: alt and ast. 5. rheumatoid factor. 6. antinuclear antibody (ana). 7. serum ferritin 8. serum and synovial fluid interleukin 33 by elisa and its relative expression in peripheral blood mononuclear cells by pcr e) musculoskeletal ultrasound examination

Eligibility criteria:
inclusion criteria: * children less than 16 years old diagnosed according to ilar classification criteria of juvenile idiopathic arthritis exclusion criteria: * 1-exclusion other causes of arthritis in children as: 1. other autoimmune diseases vasculitis- sle- rheumatic fever- dermatomyositis- polymyositis- enteropathic arthritis- behcet disease- sjogren-scleroderma- mixed connective diseases 2. infectious disease or septic arthritis. 3. metabolic diseases. 4. endocrine diseases. 5. neuropathic diseases. 6. heritable bone disease. 7. neoplastic diseases including leukemia. 8. sarcoidosis. 9. familial mediterranean fever. 2-exclusion of children with diseases that affect serum level of il 33 as: 1. inflammatory diseases of airway e.g asthma 2. inflammatory bowel disease 3. systemic lupus erythmatosus 4. inflammatory skin disease e.g :atopic dermatitis 5. cancer

Keywords: juvenile idiopathic arthritis interleukin 33
diabetes management program for hispanic/latino

Conditions: Type 2 Diabetes Mellitus; Type 2 Diabetes

Summary: to compare diabetes telemonitoring to comprehensive outpatient management (com) on critical patient-centered outcomes, including hba1c.

the investigators propose a multiphase mixed method, comparative effectiveness research randomized control trial (cer rct) to: specific aim 1: assess usability of an evidence-based dtm intervention utilizing a community based participatory research (cbpr) approach and adapt it to facilitate acceptability and feasibility in a population of h/l patients with t2d, and their caregivers and providers. specific aim 2: assess whether h/l patients receiving dtm attain significantly improved patient-centered outcomes compared to com, through a cer rct. expected outcomes include improved diabetes quality of life (qol), glucose management (gm), blood pressure (bp), cholesterol, medication adherence, and diabetes self-efficacy (se), and reduced diabetes distress, problem areas in diabetes (paid), inpatient utilization, unscheduled t2d physician visits and sick days.

Eligibility criteria:
inclusion criteria: * hispanic patients with a diagnosis of diabetes * speaks english or spanish exclusion criteria: * patient is not hispanic * patient does not have a diagnosis of diabetes
intensity-modulated radiation therapy (imrt) in the treatment of non-anaplastic non-medullary thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease. * age ≥18 years * karnofsky performance status ≥70% * men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment. * patients must have ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * women who are pregnant or lactating * inability to comply with study and/or follow-up procedures

Keywords: non-anaplastic non-medullary radiation imrt doxorubicin 13-070
the safety and efficacy of tolvaptan for patients with tricuspid regurgitation and right heart failure after left heart valves replacement

Conditions: Tricuspid Regurgitation; Right Heart Failure

Summary: the investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.


Eligibility criteria:
inclusion criteria: 1. patient with tricuspid regurgitation and right heart failure after left heart valves replacement 2. patients who takes existing diuretic 3. the patient is willing to participate in the study exclusion criteria: 1. patients with hypersensitivity to study drug 2. anuric patients 3. patients with hypernatremia 4. female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant 5. malignant tumor 6. patients with serious hepatic disorder or serious renal failure 7. patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Keywords: tolvaptan safety and efficacy left heart valves replacement
plant stanols and liver inflammation in overweight and obese children

Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NAFLD; NASH; NASH - Nonalcoholic Steatohepatitis; Childhood Obesity; Childhood Overweight; Pediatric Obesity

Summary: obesity is associated with a variety of co-morbidities. children with obesity are more likely to have risk factors associated with cardiovascular diseases (cvd) and cvd risk markers (e.g. hypertension, elevated serum cholesterol, and type 2 diabetes mellitus), but also with organ specific pathologies such as a non-alcoholic fatty liver disease (nafld). a recent meta-analysis has shown that the prevalence of nafld in obese pediatric populations is approximately 35%, compared to approximately 8% in general pediatric population, making it a very important health threat in these populations. successful pharmacological interventions to treat or prevent nash are not yet available and so far only weight loss has clear benefits. however, it is well known that sustained weight-loss is difficult to achieve on the longer-term. the investigators recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. moreover, javanmardi et al. recently demonstrated in a population of adult nafld patients, that plasma concentrations of alanine transaminase (alt) were reduced after daily plant sterol consumption (1.6 g/d) for 6 weeks. in this study, the investigators propose to evaluate the effect of consuming soft chews enriched with plant stanol esters (3 grams/day) on alt concentrations in children with overweight or (morbid) obesity who are at risk of developing nafld, in a randomized, placebo-controlled, double blinded study with an intervention period and follow-up period of 6 months. 52 overweight and obese children with elevated alt concentrations (\>39 u/l for boys and \>33 u/l for girls) will be included. all children will be randomly allocated to consume control or plant stanol ester enriched soft chews on a daily basis for a period of 6 months. after 12 months there will be an additional blood sample to evaluate whether the 6 months intervention is still effective.


Eligibility criteria:
inclusion criteria: * participation in lifestyle intervention, provided by the centre for overweight adolescent and children healthcare (coach), at the department of pediatrics at the maastricht university medical center (mumc+). * age between 4-18 years old * plasma alt concentrations above 39 u/l for boys and above 33 u/l for girls. * willingness to consume 6 soft chews on a daily basis, for a period of 6 months. exclusion criteria: * presence of a severe medical condition, which contraindicates, in the investigators judgement, entry to the study. * no signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older).

Keywords: non-alcoholic fatty liver disease nafld nash non-alcoholic steatohepatitis liver inflammation overweight obesity adolescents children lifestyle combined lifestyle intervention
insulin pump-rt advisor (ipra©): a decision support software for diabetic patients treated by insulin pump and using continuous glucose monitoring. experimental study. evaluation by an expert patient panel.

Conditions: Type 1 Diabetes

Summary: the purpose of the study is to assess the relevance of the advices provided by the ipra© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

patients will be asked to evaluate the ipra advices by connecting to ipra© application by using their smartphone, 30 times a week for two weeks. at the end of this two week period, a satisfaction questionnaire will be completed.

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age, * patients with type 1 diabetes for more than 2 years, * patients treated by insulin pump for more than 6 months, * patients using of real-time continuous glucose monitoring for more than 3 months, * patients able to evaluate the ipra advices by connecting to ipra© application 30 times a week, * patient able to provide written informed consent, * patient able to provide written non-disclosure agreement exclusion criteria: * pregnancy or breastfeeding, * current infectious disease, * patients with no smartphone® or internet access, * adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Keywords: real time continuous glucose monitoring, decision support software, smartphone application.
geriatric emergency department fall injury prevention project

Conditions: Fall; Fall Injury; Emergencies

Summary: this prospective randomized study will assess an emergency department (ed) based prevention strategy in geriatric patients at high risk for recurrent falls and injury. falling is a major health hazard in older adults with a number of proposed but unproven protocols to prevent fall-related injuries. this study proposes to study one of these strategies, the cdc's stopping elderly accidents, deaths and injuries program (the steadi program).

the purpose of this study is to assess whether certain emergency department patients at high risk of recurrent falls and injuries related to falls will benefit from the recommendations of the center for disease control and prevention's (cdc) stopping elderly accidents, deaths and injuries program (steadi program). study subjects will be randomized to one of 3 arms: 1) current care; 2) a phone-based fall-prevention strategy; or 3) a home-visit fall prevention strategy 1. current emergency department care 2. steadi recommendations administered via phone at 14 days 3. steadi recommendations administered via a home visit at 14 days the steadi recommendations include the following: * follow-up with a primary care physician * an assessment of your risk of falling. this includes looking at your ability to walk, your strength and balance. * assessment medications looking for potential medication interactions * measuring your vital signs (blood pressure and heart rate) * assessment of your vision * assessment of your footwear * recommendations to improve home safety (such as ensuring proper lighting, ensuring adequate hand-rails, and others) initial data collection will occur at the time of the ed visit. intervention will occur 14 days after ed visit. telephonic follow-up will occur at 3 months and 6 months after study enrollment. data will be collected from the patients/patient representatives and medical records. all data will be collected by trained research assistants (ras)

Eligibility criteria:
inclusion criteria: * patients over the age of 65 with a ground level fall who live at home will be eligible for study inclusion exclusion criteria: * being transferred from another facility, trauma activation, hospice or palliative care participant, end-stage heart failure (two or more congestive heart failure hospitalizations in past 6 months), end stage emphysema (two or more chronic obstructive pulmonary disease hospitalizations in past 6 months), metastatic cancer, severe leukemia or multiple myeloma or lymphoma on treatment or requiring transfusion and end stage renal disease requiring dialysis. an additional exclusion criterion is patients with dementia, if the subject is unable to state name or unable to point to an object (for those with aphasia)

Keywords: geriatric