Kornimate/medical-research-clean huggingface dataset:
type 1 diabetes education and support study

Conditions: Type1diabetes

Summary: diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens black patients ages 18-30 years with type 1 diabetes (t1d). in order to combat this issue, this study assesses the feasibility of the culturally tailored intervention t1des and evaluates the effect of the t1des intervention on diabetes outcomes in a pilot randomized clinical trial among black young adults with t1d.

this research focuses on the unique needs of black young adults aged 18-30 years to address a critical gap in the research and clinical care. the goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among black young adults with t1d, addressing the pervasive racial disparity in health outcomes for this population. the specific aims for this study are to: aim 1: assess feasibility of the culturally tailored intervention t1des by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team. aim 2: evaluate the effect of the t1des intervention on diabetes outcomes in a pilot randomized clinical trial among n=40 black young adults age 18-30 years with t1d and elevated hba1c (\>7.5%) by comparing changes in hba1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to t1des compared to the diabetes education-only control condition. the goal of this study is to provide diabetes education and emotion regulation support tailored for black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.

Eligibility criteria:
inclusion criteria: * kaiser permanente georgia member * aged 18 - 30 years * confirmed diagnosis of type 1 diabetes * hemoglobin a1c \> 7.5 at time of enrollment * a cell phone able to send/receive text messages * self-reported race of black or african american * ability to read in english and provide informed consent exclusion criteria: * developmental delay or other cognitive impairment that would render the participant unable to provide informed consent * subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions * diabetes complications that would preclude participation in the study

Keywords: diabetes type 1
effects of myofascial release in cerebral palsy children

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is a common disorder which leads to physical disability in children throughout life and begins in early childhood. in cerebral palsy spasticity is considered as a primary factor leads to much impairment which is inversely related to functional development that means greater the spasticity lowers the level of function. there are many ways to treat spasticity which involve stretching, strengthening, postural education, neuromuscular electrical stimulation, cryotherapy and myofascial release technique.

this study will be a randomized controlled trial. study will be approved by ethical committee. after that informed consent will be taken and patients will be included in the study on the basis of inclusion criteria. non probability convenience sampling technique will be used and study will be conducted on 28 patients with spastic hemiplegic cerebral palsy, 6 to 12 years of age. patient will be randomly categorize into two groups by using flip coin. experimental group will receive myofascial release on ankle planterflexors and quick icing treatment protocol on ankle dorsiflexors. control group will receive only myofascial release treatment protocol on ankle planterflexors. pre and post intervention assessment will be made for both groups. tone of planterflexors will be assessed by modified ashworth scale, ankle passive range of motion will be assessed by goniometer and static balance will be assessed by romberg test(open eyes).

Eligibility criteria:
inclusion criteria: * subjects with hemiplegic cerebral palsy * both genders * age between 6 to 12 years * gmfcs level i and ii * modified ashworth scale (grade1 - grade 3 exclusion criteria: * hypersensitive to cold * underwent any corrective surgery * specific perceptual and cognitive impairments * subjects who has received botulinium toxin injection in the past 6 months

Keywords: cerebral palsy myofascial release range of motion quick icing
bariatric surgery, hormones, and quality of life

Conditions: Obesity; Hormone Disturbance; Quality of Life; Hyperandrogenism

Summary: the purpose of this study is to characterize the hormonal status in fertile women undergoing laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation between health-related quality of life and proposed hormone changes post-operatively.

sex hormone levels in women with obesity are altered in comparison to normal weight subjects. most previous studies have focused on questionnaire surveys, and on the emotional/psychological aspect of health-related quality of life (hrqol). it has been shown that bariatric surgery can affect reproductive ability, but the relationship between hormonal changes and hrqol has been sparsely studied. hormone balance is affected by fat allocation, insulin levels and liver function, and these factors are all influenced postoperatively. also body image and altered body mass composition can influence sexuality in diverse ways. this leads us to theorize that liver production of shbg will change after surgery and impact serum concentrations of sex hormones. normalized levels of testosterone and estrogen may lead to reduced symptoms of hyperandrogenism, restitution of normal menstrual cycles and changes in sexual functioning. the focus of this study is to analyze sexual and health-related quality of life through questionnaire analyses, and to investigate levels of sex hormones pre- and postoperatively in women undergoing bariatric surgery. results from questionnaire analyses and hormone data will be tested for possible correlations.

Eligibility criteria:
inclusion criteria: * premenpausal women * bmi \>30 * undergoing laparoscopic gastric bypass surgery exclusion criteria: * smoking * liver disease * concomitant hormone treatment including all forms of hormone-based contraception

Keywords: bariatric surgery sex hormones women quality of life
neurology measures in fa children

Conditions: Friedreich Ataxia

Summary: the purpose of this study is to identify ways to follow progression of friedreich's ataxia (fa) and be able to measure changes over time in children with fa. participants will have biannual visits to observe how the disease progresses over time and determine the rate of progression. funding source- food and drug administration office of orphan products development (fda oopd).

investigators seek to identify biological and clinical tests to be used in future clinical trials. the purpose of this research study is to learn more about friedreich's ataxia (fa) progression in children. there will be biannual visits which will include a core set of tests and procedures. these include: a collection of medical history, detailed neurological exam, ataxia scales, and health questionnaires. at each visit, blood and cheek swab samples will be obtained to monitor frataxin levels. a select number of children's hospital of philadelphia (chop) participants will have the opportunity to participate in further procedures to better understand how fa affects different tissues. these include a magnetic resonance imaging (mri) scan and a motor evoked potentials (mep) procedure. the mri scan analyzes how muscle activity is affected in fa. the magnet will be used to capture images of the calf muscle before and after exercising on an ergonomic foot pedal. the mep procedure measures how strong the connection is between the brain's motor cortex and a selected body part, specifically the participant's dominant hand.

Eligibility criteria:
inclusion criteria: 1. males or females age 2 to 18 years. 2. genetically confirmed diagnosis of friedreich's ataxia (fa) or clinically confirmed diagnosis of fa, pending confirmatory genetic testing through a commercial or research laboratory 3. parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: 1) inability to complete study evaluations

Keywords: friedreich ataxia frda fa friedrich ataxia (frda)
retrospective study on the incidence and management of anemia in oncology

Conditions: Anemia; Cancer

Summary: the incidence of anemia ranges from 20 to 75% depending on the type of cancer. it is often present at diagnosis and increases with specific treatments. it has an impact on overall survival and quality of life. its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies). transfusion is the most common treatment offered in the management of anemia. the incidence of anemia and its consequences are often underestimated during cancer management. recommendations were published in 2012. an inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * follow-up for cancer justifying hospitalization, * presenting anemia defined by a hemoglobin level \<11 g / dl, * patient not having objected to the collection of his data after oral and written information. exclusion criteria: * patients with a hemoglobin level ≥ 11 g / dl, * adult patients under guardianship, curatorship or deprived of liberty, * pregnancy or breast-feeding in progress at the time of hospitalization.
exacos eg population

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a common, progressive disease characterized by airflow obstruction which is not fully reversible. acute exacerbations of copd (aecopd) are described as worsening of copd symptoms (breathlessness, cough, and sputum volume and purulence) beyond normal day to day variation. between 30-50% of patients with copd experience at least one aecopd per year (1). even a single moderate aecopd increases risk of future multiple aecopd events, starting a spiral of excessive disease progression and leading to an increased risk of death (2). aecopds have also been associated with other clinical outcomes such as accelerated lung function decline. studies have shown that aecopds are related to future aecopds, however, little is known about clinical burden and health care utilization in the copd population. to date, most of published literature reports a combined category of moderate-severe exacerbations, typically stratifying patients as experiencing frequent (i.e., two or more events per patient-year) vs. infrequent (none or one) exacerbations. in egypt, copd is considered one of the most burdensome chronic diseases, with acute exacerbations being directly associated with its burden on patients 'lives. although no official epidemiological data is available for copd, its prevalence in egypt was estimated to be 3.5% in the international epidemiological survey study breathe in 2012, while its prevalence in high-risk egyptian population -defined as population engaged in construction, exposed to biomass fuel, or with smoking history - is estimated to be 9.6%. moreover, a study reporting on the burden of copd indicated that the age standardized prevalence of copd increased by 62% over 3 decades. regarding aecopd, studies have explored its reported etiologies and clinical outcomes in egypt; however, data specifying its incidence and frequency in egypt is still limited.


Eligibility criteria:
inclusion criteria: 1. are over the age of 40 years old; 2. have had an investigator-confirmed diagnosis of copd of at least 3 years prior to the index date; 3. have copd-related data recorded in medical records for at least 3 years prior to the index date, including spirometry (at least one fev1 measurement) and medication data; 4. have signed a written informed consent form exclusion criteria: 1. have a diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis. this is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to copd is impossible.
cpap reduces hypoxemia after cardiac surgery

Conditions: Acute Respiratory Failure Requiring Reintubation

Summary: the aim of study is to evaluate whether the application of a continuous positive airway pressure (cpap) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

we want to test the hypothesis that the application of a continuous positive airway pressure (cpap) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate. primary end point: to reduce the rate of re-intubation. secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (icu) and hospital length of stay.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery on cardiopulmonary bypass * pao2 /fio2 \< 200 after extubation * extubation time \< 24 h. exclusion criteria: * patients \< 18 years old * extracorporeal membrane oxygenation * severe cardiac dysfunction (fe\<25%) * mechanical ventilation before the intervention * severe copd (patients on oxygen therapy, with a fev1\< 50%) * heart or lung transplantation * lack of consent.

Keywords: intubation respiratory failure cardiac surgery
master i - microvolt t wave alternans testing for risk stratification of post mi patients

Conditions: Myocardial Infarction; Arrhythmia, Ventricular; Ischemic Cardiomyopathy

Summary: the purpose of the study is to determine the usefulness of microvolt t wave alternans (mtwa) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. mtwa testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. the objective of the study is to prove that if a patient has a negative mtwa test, they will be less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. the results of the study will help doctors to determine which patients would benefit the most from having an implantable cardioverter defibrillator (icd) implanted.


Eligibility criteria:
inclusion criteria: * patients indicated for an icd with a history of heart attacks * lvef \<= 0.30 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment exclusion criteria: * patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (class i indications) * patients who have undergone an electrophysiologic study with ventricular stimulation or a mtwa test within 1 year prior to enrollment * patients with medical conditions that preclude the testing required by the investigational plan or limit study participation * patients unable to complete mtwa testing requirements due to current atrial fibrillation or flutter * patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for mtwa testing are not available * patients who have experienced an mi within 1 month prior to enrollment * patients with advanced cerebrovascular disease per physician's assessment * patients classified as nyha class iv at time of enrollment * patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment * patients with a life expectancy of less than 1 year * patients with prior icd * patients unable to complete follow-up visits at the study center * patients who are enrolled or intend to participate in another clinical study that would compete with the study objectives (assessment will be the responsibility of the clinical trial leader with guidance from the executive committee)

Keywords: myocardial infarction microvolt t wave alternans test implantable cardioverter defibrillator (icd) ventricular arrythmias
impact of levagen+® palmitoylethanolamide (pea) in a cross-over trial examining stress and cognition in university students

Conditions: Wellness, Psychological; Well-Being, Psychological

Summary: the goal of this randomised cross-over trial is to learn about the effects of levagen+® palmitoylethanolamide (pea) supplementation on cognition, wellness and well-being in young and healthy university students. the main question it aims to answer is: • does the pea supplementation affect parameters of stress, mood, cognition and well-being in university students? participants will complete 2 baseline on-site visits during which they will be assigned to levagen+® palmitoylethanolamide (pea) treatment or placebo arm each time and: * complete anthropometric measurements, questionnaires and surveys, * undergo blood and saliva sampling * complete a cognitive assessment (cantab) * a randomly chosen cohort will also measure heart rate variability (hrv) over 3 days. researchers will compare the pea treatment group to the placebo to see if there is a significant difference.

the study will investigate the effect of levagen+® palmitoylethanolamide (pea) supplementation on parameters of stress, well-being and cognition at defined time points. assessments will be made using a combination of a range of stress measures, which will include physiological and psychometric parameters. physiological measures will include assessments of known biomarkers of the principal stress-sensitive physiological systems, the hypothalamic-pituitary-adrenal axis, and the autonomic nervous system, while psychometric measures will include established instruments to assess general health, somatic stress symptoms, academic stress, response to stress, cognition, and mood.

Eligibility criteria:
inclusion criteria: * males \& females * 18 to 40 years of age * fully enrolled full-time university students from london exclusion criteria: * consumption of \>14 servings of alcohol/week * any learning disability (e.g. dysphasia) * any neurobiological disorders (e.g. autism) * smokers any allergies/health issues related to items being ingested * any serious illnesses or those on chronic medication * any pregnant or lactating women * any woman who is trying to conceive * any chronic gastrointestinal disorders * any chronic menstrual disorders (e.g. pcos) * any subjects who have undergone menopause or undergoing the perimenopause transition * any eating disorders * any depression/mental disorders * any obese sedentary (not physically active) individual, according to bmi values * any abnormal blood pressure levels * shift work

Keywords: nutraceutical palmitoylethanolamide pea cognition stress inflammation wellness well-being bdnf supplement
a bioavailability study on dronabinol

Conditions: THC

Summary: this study is a two part study

this study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions

Eligibility criteria:
inclusion criteria: * healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a bmi ≥18.0 kg/m2 and ≤ 30.0 kg/m2. exclusion criteria: * smokers
examination of the lipid metabolism of the liver after choline substitution in cystic fibrosis

Conditions: Cystic Fibrosis Liver Disease

Summary: pilot study to investigate the effect of choline chloride in cystic fibrosis patients with liver steatosis by comparing their status before and after the intervention

within this single arm pilot study patients with cystic fibrosis and liver steatosis receive choline chloride (2x0.5 gram three times a day) as a food supply for 88 days. d9-choline metabolism is measured before and after the intervention phase. hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (vldl) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

Eligibility criteria:
inclusion criteria: * age \> 18 years * male * cystic fibrosis is verified * pancreatic insufficiency * decline of plasma phosphatidylcholine and steatosis of the liver * informed consent is given exclusion criteria: * cirrhosis of the liver * hyperreactivity to choline containing food * allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections * fev1 \< 40% * smoker * chronic alcohol consume * clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver * implants or other reasons which make magnetic resonance examinations impossible
a dose-ranging study to evaluate efficacy and safety of vx-150 in subjects with acute pain following bunionectomy

Conditions: Acute Pain

Summary: this study will evaluate the dose-response relationship and safety of vx-150 in treating acute pain following bunionectomy.


Eligibility criteria:
key inclusion criteria: before surgery: * body mass index (bmi) of 18.0 to 38.0 kilogram per meter square (kg/m\^2) * be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (mayo and popliteal sciatic block) not to include base wedge procedure after surgery: * subject reported pain of greater than or equal to (\>=) 4 on numeric pain rating scale (nprs) and moderate or severe pain on the verbal categorical rating scale (vrs) within 9 hours after removal of the popliteal sciatic block on day 1 * subject is lucid and able to follow commands * all analgesic guidelines were followed during and after the bunionectomy key exclusion criteria: before surgery: * history in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and stage 0 cervical carcinoma in situ * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * history of abnormal laboratory results \>=2.5\*upper limit of normal (uln) * history of peripheral neuropathy * a known or clinically suspected infection with human immunodeficiency virus or hepatitis b or c viruses * prior medical history of bunionectomy or other foot surgery on the index foot * history of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen after surgery: * subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery other protocol defined inclusion/exclusion criteria may apply