Kornimate/medical-research-clean huggingface dataset:
atherosclerosis and omega-3 fatty acids in alaskan natives

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Arteriosclerosis

Summary: to determine whether there were differences in the prevalence and extent of atherosclerotic lesions in the coronaries and aortas between alaskan natives and non-natives, and whether the extent of the lesions was related to omega-3 fatty acids in blood and tissues.

background: purported low mortality from coronary heart disease in eskimos from greenland, canada, or alaska has been interpreted by many investigators as synonymous with the absence of or reduced amount of atherosclerotic lesions in the coronary arteries compared to populations with a high rate of coronary heart disease. it was thought that this study would help to clarify the role of omega-3 fatty acids in atherosclerosis but also would help in making a decision whether to recommend to the general public the inclusion of fish oils, which contain large amounts of these fatty acids in the diet, for prevention and/or reduction of atherosclerotic heart disease. design narrative: coronary arteries, aortas, blood, adipose tissue, and liver were collected at autopsy from deceased alaskan natives, aged 5 years and above, dying of all causes and from a similar number of age- and sex-matched non-native alaskans. tested standardized methods of gross evaluation, histomorphometry, and chemistry were used to characterize, measure, and evaluate the prevalence and extent of atherosclerosis in arteries. chemical methods for determination of blood and tissue lipids and gas liquid chromatographic methods for determination of fatty acids in various lipid fractions in plasma and tissues were used. risk factors for coronary artery disease were evaluated from tissues taken at autopsy. hypertension was evaluated by an examination of kidney arterioles. cigarette smoking was evaluated by measurement of thiocyanate in the blood and the presence or absence of diabetes was evaluated by measuring glycosylation of hemoglobin from red blood cells. findings were compared with those studied in other populations such as blacks and whites in new orleans, and japanese, norwegians and nineteen other ethnic groups in the international atherosclerosis project. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cultivando la salud: a breast and cervical cancer screening promotion program for low-income puerto rican women

Conditions: Breast Cancer; Cervical Cancer

Summary: the overall goal of this education program is to increase breast and cervical cancer screening in low-income women in puerto rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in canóvanas, puerto rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. to evaluate promotoras' delivery of the cls screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the cls intervention program compared with usual practice (no intervention).

the proposed promotora and community based breast and cervical screening education program includes the following specific aims: aim 1. to train community health workers (promotoras) from taller salud to implement the cls breast and cervical cancer screening program. taller salud staff train and build capacity of promotoras to implement the cls community-based education and navigation program. aim 2. to deliver the cls intervention program to at least 600 women in canóvanas municipality, puerto rico. aim 3. to evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in canóvanas, puerto rico. aim 4. to adapt and update intervention materials

Eligibility criteria:
inclusion criteria: * women aged 21 and older for pap cohort * women aged 40 and older for mammography cohort exclusion criteria: * having completed a papanicolau test in the past 3 years if participant is between the ages of 21-65. * having completed a mammography screening in the past year if participant is aged 40 or older * have a hysterectomy * currently pregnant * history of any type of cancer

Keywords: hispanic women behavioral intervention lay health workers
reducing lung congestion symptoms in advanced heart failure

Conditions: Heart Failure

Summary: the objective of the relieve-hf study is to provide reasonable assurance of safety and effectiveness of the v-wave interatrial shunt system by improving meaningful clinical outcomes in patients with new york heart association (nyha) functional class ii, class iii, or ambulatory class iv heart failure (hf), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

this is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a shunt treatment arm and a non-implant control arm. a total of approximately 500 patients will be randomized. patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. all implanted patients will be followed for a total of 5 years from the time of the study device implantation.

Eligibility criteria:
main inclusion criteria: * both heart failure with reduced ejection fraction (hfref) and heart failure with preserved ejection fraction (hfpef) patients * nyha class ii, class iii, or ambulatory class iv hf * receiving guideline directed medical and device therapy (gdmt) for heart failure * for nyha class iii and ambulatory class iv, at least one prior hospitalization for heart failure within the last year or elevated bnp level of at least 300 pg/ml or nt-probnp level of at least 1,500 pg/ml. bnp/nt-probnp levels corrected for bmi * for nyha class ii, must have both hospitalization and elevated bnp levels as above specifications main exclusion criteria: * systolic blood pressure \ 160 mmhg * presence of intracardiac thrombus * pulmonary hypertension with pasp of ≥70 mm/hg or pvr \> 4 wu * significant rv dysfunction - tapse \<12mm or rvfac ≤25% * left ventricular end-diastolic diameter (lvedd) \>8cm * moderate to severe aortic or mitral stenosis * stroke or tia or dvt within the last 6 months * egfr \<25 ml/min/1.73 m\^2 * anatomical anomaly on tee or ice that precludes implantation of shunt across fossa ovalis (fo) of the interatrial septum * inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (ivc) is not patent * hemodynamic heart rhythm, or respiratory instability at time of final exclusion criteria
interventions to improve asthma management/prevention at school

Conditions: Asthma; Lung Diseases

Summary: to design, develop, implement, and test the effectiveness of a three component health services and health education intervention for primarily hispanic inner-city elementary school students at high risk for asthma morbidity and mortality.

background: the study was part of an initiative "interventions to improve asthma management and prevention at school". the broad agency announcement was released in june, 1994. design narrative: the study used a randomized intervention trial to test the effectiveness of a comprehensive school-based asthma program to increase linkages with primary care physicians, to increase self-management activities, and to reduce morbidity associated with asthma. the study used a nested design in which the schools were the unit of design, allocation, and analysis. effects were measured from aggregate data about students and data from school measures to control asthma. there were three components to the intervention. first, case finding for asthma through screening in both intervention and control schools. second, a linkage management system that connected the child with a source of primary care and enhanced communication among the school nurse, the primary care physician, and parents. third, the development and implementation of interactive multimedia and decision support system techniques to tailor individualized learning opportunities for children with asthma. the interventions occurred in the school setting and included tailored feedback for children, teachers, nurses, primary care providers, and the family. assessments were made of the potential for diffusion of the components to target audiences.

Eligibility criteria:
inclusion: school-aged children enrolled at participating schools
glyceryl-trinitrate-induced headache in patients with familial hemiplegic migraine

Conditions: Familial Hemiplegic Migraine

Summary: the aim of the present study is to explore the importance of migraine genes on the headache/migraine responses after gtn in fhm-patients and healthy volunteers.

glyceryl trinitrate (gtn) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. after systemic administration gtn is transformed to nitric oxide (no). treatment of spontaneous migraine attacks with an inhibitor of no is effective in 60% of patients. these data show that no is involved in both initiation and maintenance of migraine attack. the importance of migraine genes is disputed. evidence from fhm patients with known mutations indicates that migraine pathways in fhm may be different from normal migraine. the aim of the present study is to examine whether this difference also exists in fhm patients without known mutations. the project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria:
inclusion criteria: * diagnosis of familial hemiplegic migraine (ihs-classification criteria) exclusion criteria: patients and controls: * a history of cerebrovascular disease and other cns- disease * a history of serious somatic and mental disease * a history suggesting ischaemic heart disease * a history of hypo- or hypertension * daily intake of medication apart from oral contraceptives * abuse of alcohol or medicine (opioid analgesics). * pregnant or breastfeeding women. on the study day: * no intake of a simple analgesic in the previous 48 hours * no headache in the previous 48 hours

Keywords: familial hemiplegic migraine
the safety and effectiveness of three anti-hiv drug combinations in hiv-infected patients who have taken azt

Conditions: HIV Infections

Summary: to evaluate the safety and efficacy of low and high doses of lamivudine ( 3tc ) in combination with zidovudine ( azt ) and zalcitabine ( dideoxycytidine; ddc ) in combination with azt. per 02/27/95 amendment: to evaluate the efficacy and safety of both blinded and open-label combination therapy.

patients are randomized to one of three treatment arms: low-dose 3tc plus azt, high-dose 3tc plus azt, or ddc plus azt. treatment continues for 32 weeks, with possible extension to 52 weeks. per 02/27/95 amendment: patients may continue therapy on azt and low-dose 3tc on an open-label basis. open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Eligibility criteria:
inclusion criteria patients must have: * hiv positivity. * cd4 count 100-300 cells/mm3. * prior azt therapy for 24 or more weeks and currently on azt. exclusion criteria patients with the following prior conditions are excluded: * history of intolerance to azt. * history of grade 2 or worse peripheral neuropathy. prior medication: excluded: * any prior antiretroviral therapy other than azt. required: * concomitant azt therapy. required: * at least 24 weeks of prior azt.

Keywords: zalcitabine drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents zidovudine
epigenetics modifications in morbid obesity and obstructive sleep apnea patients: the epimoosa study

Conditions: Obstructive Sleep Apnea; Morbid Obesity; Epigenetic Disorder

Summary: this study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. a home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. the principal investigator make the decision of starting cpap among patients with obstructive sleep apnea according to current clinical guidelines. one year follow up after bariatric surgery will be performed. a total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months). at every visit, all patients had: sleep questionaries, blood samples, ekg-holter and spirometry are collected.


Eligibility criteria:
inclusion criteria: * bmi consistently \> 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment * bmi 35-40 kg/m2 with comorbidities associated with morbid obesity (mo) susceptible to improvement with weight loss (high bp, diabetes, dyslipidemia, osa, etc.), following more than 1 year of unsuccessful controlled medical treatment. * a signed informed consent form exclusion criteria: * obesity hypoventilation syndrome or treatment with positive pressure devices. * diagnosis of systemic inflammatory disease. * neoplastic diseases in the last 5 years. * a cardiovascular event in the last 6 months. * pregnancy

Keywords: obstructive sleep apnea morbid obesity epigenetics bariatric surgery
comparing clinical efficacy of one-week dual delayed-release dexlansoprazole and esomeprazole for gerd grade a and b

Conditions: Gastroesophageal Reflux Disease

Summary: rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (gerd) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. this pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating gerd patients.

a comparative study to different ppis in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with ph \> 4 and average of mean ph were greater for dexlansoprazole than esomeprazole . however, the study did not report the clinical effect after tablets used. there was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (gerd) between dexlansoprazole 60 mg and esomeprazole 40 mg. therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for gerd.

Eligibility criteria:
inclusion criteria: * patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have los angeles grade a and b erosive esophagitis proven by endoscopy were recruited exclusion criteria: * taking antisecretory agents, such as ppis and histamine-2 receptor antagonists within 2 week prior to the endoscopy * coexistence of peptic ulcer or gastrointestinal malignancies * pregnancy * coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), * previous gastric surgery * allergy to dexlansoprazole or esomeprazole * symptom score of a validated questionnaire (chinese gerdq) less than 12
secondary and tertiary digital prevention of non-alcoholic and dysmetabolic liver disease

Conditions: NASH; NAFLD

Summary: the prevalence of metabolic dysfunction-associated steatotic liver disease (masld) and its severe form, metabolic dysfunction-associated steatohepatitis (mash), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (hcc), and the need for liver transplantation. due to the lack of noticeable symptoms during the early stages, the detection of masld is often delayed until the disease has advanced. currently, the treatment options masld are limited to lifestyle interventions such as dietary changes and physical activity. despite the increasing prevalence of masld, there are no drugs available on the market specifically for this condition. the goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (hcps), integrated with simple clinical data (anthropometric, laboratory and imaging data). this study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced masld at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease. to achieve this goal the study will leverage on a mobile app named opentele in order to test the adherence to lifestyle changes in patient with masld and on the connected clinical dashboard. the app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims: * to implement a strategy for delay progression of liver disease; * to reduce the effect of cirrhosis (tertiary prevention).


Eligibility criteria:
inclusion criteria: * diagnosed with masld and lsm\>= 10 kpa * age \>= 18 years old * sufficient digital literacy or supported from a caregiver with sufficient digital literacy * smartphone (android or ios) able to download and run the app * able to understand and communicate in italian * able to sign the informed consent exclusion criteria: * major psychiatric disorder * not able to use digital technologies
vitality acupunch exercise program for older adults with sarcopenia

Conditions: Muscle Mass; Muscle Strength; Sleep Quality

Summary: this project was aimed to test the effects of a six-month va program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia.

a cluster-randomized controlled trial was conducted to test the effects of a six-month va program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a va experimental or a control group. the experimental group received the va program led by certified instructors 3 times per week and 40 minutes per session for 6 months; the control group continued with their regular daily activities. one pre-test and two post-tests, 3 months apart, were conducted.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years old * have been living in the facility for at least 3 months * intact cognitive function with the short portable mental status questionnaire score ≥ 8 * hand-grip strength \< 28 kg for men and \< 18 kg for women * calf circumference \< 34 cm for men and \< 33 cm for women exclusion criteria: * have spinal cord injury * have severe cardiovascular or pulmonary diseases * have musculoskeletal diseases
myfembree®: a retrospective cohort study using an administrative healthcare database to assess pregnancy outcomes in women treated with relugolix combination therapy

Conditions: Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk

Summary: this is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (ehd) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (hcps). the study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

the study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a united states (us) administrative claims database. the primary outcome measure is major congenital malformations (mcms) among linked live births. secondary outcome measures include spontaneous abortion (sab), stillbirth, small size for gestational age (sga), and preterm birth. infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of mcms. anticipated enrollment is 530 live births.

Eligibility criteria:
inclusion criteria: * woman ≥ 18 and ≤ 50 years of age at time of conception * diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception) cohort 1 * exposure to relugolix combination therapy at any time during pregnancy cohort 2 * no exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy) exclusion criteria: * exposure to known teratogens during pregnancy * \< 6 months of continuous healthcare coverage immediately prior to date of conception

Keywords: relugolix uterine fibroids endometriosis pregnancy
trial assessing zactima against placebo in prostate cancer subjects undergoing intermittent androgen deprivation hormonal therapy

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether treatment with zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer * prostate specific antigen (psa) greater than or equal to 5 ng/ml * recent completion of first hormone treatment \[intermittent androgen deprivation with a luteinising hormone releasing hormone (lhrh) analogue\] * screening psa ≤1.0 ng/ml (within 6 weeks prior to study day1) exclusion criteria: * bone or soft tissue metastases * significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

Keywords: prostate cancer hormone treatment