Kornimate/medical-research-clean huggingface dataset:
effectiveness of user and expert driven internet-based lifestyle interventions on hypertension control

Conditions: Hypertension

Summary: hypertension is a leading risk factor for cardiovascular disease and mortality. lifestyle counseling is recommended as a first line therapy for reducing blood pressure (bp) and risk for cardiovascular events. recent studies suggest that e-based lifestyle interventions are effective in evoking therapeutic change in bp1. however, bp response and adherence to exercise and diet behavior varies significantly after e-based interventions due to variations in treatment methodologies. consensus is not yet established for a standardized e-counseling protocol for hypertension. as noted in our systematic review, the two dominant models of e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven (self-guided, collaborative). expert-driven programs prescribe specific changes for lifestyle behavior which are intended to facilitate compliance to behavioral change. in contrast, the user-driven method actively involves the subject in goal-setting and/or the selection of the intervention used to reach the behavioral goal. one conclusion from the systematic review is that these models are used indiscriminately in e-counseling programs. there is currently inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven in reducing bp while modifying lifestyle behaviour. it is possible that a combination of expert-driven and user-driven features for lifestyle e-counseling is most effective. however, before these two approaches can be combined, it is essential to establish the strengths and limitations of each model.

this study will use a 3-parallel group, randomized controlled design: 3 (groups: control, expert-driven, and user-driven e-counselling) by 2 (assessments: baseline, 4-month). controls will receive general e-information on bp management. the expert-driven e-counselling group will provide a prescribed exercise and a diet plan. the user-driven e-counselling group will a program that enables the patient to choose areas of focus. all subjects will be sent 16 e-messages on a weekly schedule.

Eligibility criteria:
inclusion criteria: * unchanged prescription for anti-hypertensive medication at least 2 months before enrollment. * participants prescribed antihypertensive medication were also required to have sbp ≥130 mmhg and/or dbp ≥85 mmhg, in order to prevent "floor effects". exclusion criteria included: * diagnosis of kidney disease, major psychiatric illness (e.g. psychosis), alcohol or drug dependence in the previous year, pregnancy and sleep apnea. there was no racial or gender bias in the selection of participants.
effectiveness and safety of inhaling hypertonic saline in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and copd as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. the objective of this study was to analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. in a double-blind randomised parallel placebo-controlled trial, conducted at the clínicas integradas of the evangelical faculty of paraná,sixty-eight patients (age 67 ± 6.5 years; fev1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks.

background: the use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and copd as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. objective: to analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. design and setting: this was a double-blind randomised parallel placebo-controlled trial, conducted at the clínicas integradas of the evangelical faculty of paraná. methods: sixty-eight patients (age 67 ± 6.5 years; fev1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks. results: after the 8-weeks the treatment period, both groups showed significant changes in functional exercise capacity (p\<0,001), dyspnoea (p\<0,001) and quality of life. when compared both groups, there was a significant improvement in placebo group in functional exercise capacity (p\<0,001). conclusion: the present study concluded that inhaling hs reduces the functional capacity, compared to placebo and being associated with the appearance of coughs and bronchial spasms.

Eligibility criteria:
inclusion criteria: * patients with copd diagnosis based on clinical findings and spirometry (fev1 \< 60% predict) according to american thoracic society20 clinically stable for at least the last month * aged between 40 and 75 years old * ex-smokers * without severe and/or unstable heart disease or any other pathologic conditions that could impair physical activities (e.g., cerebrovascular diseases and rheumatism), were included. * respiratory medication was permitted, prior and throughout the duration of the study, such as bronchodilators and corticosteroids. exclusion criteria: * patients with unstable lung disease (as evidenced by the administration of intravenous antibiotics for four weeks before screening) * evidence of reactive airways (fev1 ≥ 20 percent response to bronchodilatation or clinical diagnosis of asthma) were excluded

Keywords: copd hypertonic saline quality of life dyspnoea.
risk factors associated with calcification of the aortic valve

Conditions: Aortic Stenosis; Aortic Sclerosis

Summary: the purpose of this study is * to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(cad). * to determine whether there is relationship between calcium metabolism and calcific aortic valve disease associated with cad.

cardiovascular disease, mainly coronary artery disease, causes more than one half of deaths in the developed countries. only recently, calcific aortic valve disease, was proved to belong to the family of atherosclerosis. it is associated with higher cardiovascular morbidity and mortality, the cause of which is not entirely clear. the link to significant coronary artery disease, probably, is of highest importance. we compare groups of patients with coronary artery disease and calcific stenotic, sclerotic or intact aortic valve. the aim is to assess and compare their risk profile to verify our hypothesis that, within significant coronary artery disease, calcific aortic valve identifies a subgroup of patients with higher cardiovascular risk, assessed by endothelial dysfunction and the two year follow-up of cardiovascular events on optimally set treatment. further, we study the possible association of valvular calcification and calcium metabolism in patients with normal kidney function.

Eligibility criteria:
inclusion criteria: * significant stenosis (more than 50% diameter stenosis) of one or more coronary arteries * aortic sclerosis (group 1) or stenosis (ava \< 1cm2/m2, or mean gradient ≥ 30 mmhg) (group 2) or normal aortic valve (group 3) exclusion criteria: * rheumatic heart disease (defined as aortic stenosis with commissural fusion + rheumatic mitral valve disease) * status post aortic valve replacement * congenital complex heart disease (except bicuspid aortic valve) * moderate to severe aortic insufficiency (grade \> 2/4) * marfan syndrome * infective endocarditis * hypertrophic obstruction cardiomyopathy * acute coronary syndrome within less than three months * severe heart failure, nyha class iv * severe locomotion disability * renal failure requiring dialysis * significant systemic disease or other disease severely limiting the patient prognosis (e.g. known cancer, liver cirrhosis) * primary hyperparathyroidism * patient non-compliance

Keywords: aortic valve calcification endothelial dysfunction calcium metabolism coronary artery disease
study of amg531 (romiplostim) in patients with aplastic anemia

Conditions: Aplastic Anemia

Summary: to evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when amg531 is subcutaneously (sc)-administered with ciclosporin a (csa) therapy for 6 months in patients with aplastic anemia (aa) who were previously untreated with immunosuppressive therapy.


Eligibility criteria:
inclusion criteria: 1. voluntary signed informed consent to participate in the study; 2. a diagnosis of aa confirmed by blood and bone-marrow examinations, etc.; 3. considered to require new treatment with immunosuppressive therapy provided that nsaa must be platelet or erythrocyte transfusion-dependent. 4. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 to 1at screening; exclusion criteria: 1. previously treated with anti-human thymocyte immunoglobulin (atg), csa, or alemtuzumab; 2. diagnosed as having congenital aa (fanconi anemia, congenital dyskeratosis, etc.); 3. diagnosed as having acute myelocytic leukemia (aml) or chronic myelomonocytic leukemia; 4. concurrent thrombocytopenia of other etiologies (e.g., myelodysplastic syndrome (mds), idiopathic thrombocytopenic purpura (itp), cirrhosis); 5. concurrent active infection not adequately responding to appropriate therapy; 6. concurrent clinically significant illness(es) items which are deemed by the investigator to be likely to affect the study conduct and assessments. 7. having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent. 8. concurrent paroxysmal nocturnal hemoglobinuria (pnh) 9. having grade 2 or higher bone marrow reticulin based on bone marrow pathology (2nd edition) ; 10. history of chromosome aberrations discovered in bone marrow cells. 11. having blast cells \> 2% in bone marrow; 12. positive for anti-human immunodeficiency virus (hiv) antibody; 13. receiving prophylactic or therapeutic treatment for hepatitis type b 14. having hepatitis c virus (hcv) infection confirmed by hcv-rna or other tests at screening. 15. planned hematopoietic stem cell transplantation during the study; 16. systemic treatment with any of the following medication for the treatment of aa within 4 weeks before day 1: * anabolic steroids * corticosteroids; 17. pregnant or breastfeeding women, or women willing to become pregnant; 18. other conditions unsuitable for participation in the study in the opinion of the investigator.

Keywords: aplastic anemia romiplostim
neurodevelopmental impact of treatment in hypothyroxinaemia of prematurity.

Conditions: Transient Hypothyroxinemia of Prematurity

Summary: nowadays, taking care of preterm birth is associated with an important increase in survival. this increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. thyroid hormones are essentials for brain development, especially for neuronal differentiation. transient hypothyroxinaemia of prematurity (thop) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. various studies have showed various results regarding the consequences of thop on neurodevelopment in premature neonates. however, the biggest and most powerful studies agree to say that thop impair neurodevelopment. on the other hand, only a few studies evaluated the impact of treatment of thop, and only two focused on treating exclusively the neonates with a biological diagnosis of thop (suzumura and co. in 2010 and nomura and co. in 2014) and their results are inconsistent. in this study, we aim to show that a treatment with l-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with thop (defined as a level of l-t4 \< 12 pmol/l and a level of tsh \< 15 mui/l before 15 days of life or \< 85 mui/l after 15 days of birth) is associated with an increased neurodevelopmental prognosis.


Eligibility criteria:
inclusion criteria: * premature infants born before or at 3032 weeks of gestation * for whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit. exclusion criteria: * other type of thyroid dysfunction (including, but not exclusively: mother with basedow disease, congenital hypothyroidism, hyperthyroidism) * associated polymalformative sindrome

Keywords: transient hypothyroxinaemia of prematurity, thop, preterm, prematurity, neurodevelopment, l-thyroxine, asq score
study of the effect of the time of diagnosis (antenatal vs. postnatal) on the post-traumatic reactions of parents of children undergoing oesophageal atresia surgery "

Conditions: Atresia, Esophageal

Summary: this is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's ea diagnosis. an ancillary study will be carried out among the fathers present who agree to participate in the study.


Eligibility criteria:
inclusion criteria: * be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 ea; * not to have objected to participating in the study (information and non-objection form signed by the investigator); * to be socially insured. exclusion criteria: * woman or man whose child with ao has a chromosomal abnormality; * woman or man whose child with ao has a polymalformative syndrome; * female or male minor ; * pregnant woman; * woman or man who does not speak french; * woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship); * woman or man deprived of liberty.

Keywords: esophageal atresia post-traumatic reactions early accompaniment perinatal posttraumatic stress disorder questionnaire cross-sectional study in psychology
non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving me-chanical ventilation - effects on cognitive function

Conditions: Delirium; Cognition Disorders

Summary: through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. however, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. the nonseda trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six icus in denmark, norway and sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. this is a substudy of the nonseda trial, concerning 250 patients included at trialsite kolding, denmark. the aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from icu. our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.


Eligibility criteria:
inclusion criteria: * endotracheally intubated * expected time on ventilator \> 24 hours * age ≥ 18 years * informed consent exclusion criteria: * severe head trauma where therapeutic coma is indicated * therapeutic hypothermia where therapeutic coma is indicated * status epilepticus where therapeutic coma is indicated * patient has participated in the study before * patient is transferred from another icu with length of stay \> 48 hours * patient is comatose at admission * pao2/fio2 ≤ 9, if sedation is necessary for oxygenation * patient does not speak danish, swedish or norwegian at a reasonable level

Keywords: respiration, artificial critcal care
cortical reorganization models for motor areas and inter-hemispheric equilibrium post-stroke: a pilot study

Conditions: Stroke

Summary: the main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fnirs technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test fugl-meyer.

the secondary objectives of this study are: a. to evaluate changes in functional outcomes (box and blocks test and nineholepeg test from day 0 to day 60. b- to evaluate changes in autonomy (barthel index) from day 0 to day 60.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient presents with a severe cognitive disorder * the patient has severe aphasia with a boston diagnostic aphasia examination (bdae) scale score strictly less than 2 * the patient has heminegligence with a bells test \> 6 on the left. * the patient presents with limited amplitude in the paretic upper limb (shoulder abduction \ 30° or dorsal wrist flexion \<20°). * imbalanced/uncontrolled epilepsy
interdialytic resistance exercises in with chronic kidney diseases

Conditions: Chronic Kidney Diseases

Summary: fifty chronic kidney disease patients' ages will range from 40 to 55 years. they will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment.


Eligibility criteria:
inclusion criteria: 1. fifty patients with ckd, are on hemodialysis for longer than threemonths 3 sessions/ week. 2. theirageswillrangefrom40 to 55yearsold. 3. their body mass index is more than 18.5 and less than 29.9 %. 3-all patients have hemodynamic stability over the month before beginning the program. exclusion criteria: * 1. severe chest diseases(either obstructive or restrictive). 2. clinical signs of a severe cardiac event.(eg, severe atherosclerosis, congestive heart failure), 3. severepsychiatricorcognitiveimpairment,whounabletofollowcomment. 4. neurological disorders affecting respiratory muscles or any muscular dystrophies(cervical disc or bulge). 5. patients with severe self-limiting illness (e.g., cancer). 6. peripheral artery disease in lower extremities. 7. systolic blood pressure \< 180 mmhg, diastolic blood pressure more than 105 mmhg, or heart rate above 120 bpm during dialysis. 8. patient with uncontrolled- diabetes.
safety, tolerability, pharmacokinetics, and pharmacodynamics of isis 443139 in participants with early manifest huntington's disease

Conditions: Huntington's Disease

Summary: this study tested the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of isis 443139 administered intrathecally to adult participants with early manifest huntington's disease.


Eligibility criteria:
key inclusion criteria: * diagnosed with early manifest huntington's disease * male or female, aged 25 to 65 years, inclusive, at the time of informed consent * able and willing to meet all study requirements, including travel to study center and participation in all procedures and measurements at study visits * have a trial partner who is reliable, competent and at least 18 years of age, is willing to accompany the participant to select trial visits and to be available to the study center by phone if needed * able to tolerate mri scans, blood draws and lumbar punctures * reside within 4 hours travel of the study center key exclusion criteria: * clinically significant medical condition, such as severe chorea, active suicidal ideation or any other conditions which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study * recent treatment with another investigational drug, biological agent, or device * prior treatment with an antisense oligonucleotide \[including small interfering ribonucleic acid (sirna)\] * any history of gene therapy or cell transplantation or any other experimental brain surgery * presence of an implanted shunt for the drainage of cerebrospinal fluid (csf) or an implanted central nervous system (cns) catheter * history of post-lumbar-puncture headache of moderate or severe intensity and/or blood patch * malignancy within 5 years of screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated * hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks of screening or planned during the study

Keywords: huntington's disease httrx early manifest huntington's disease
effectiveness of pharmacotherapy follow-up care in outpatients with type 2 diabetes mellitus

Conditions: Pharmaceutical Services

Summary: hypothesis: pharmacotherapy follow-up can improve clinical outcomes of outpatients with type 2 diabetes mellitus. methods: in this single blind, placebo-controlled trial, the participants with type 2 diabetes mellitus are randomized into two groups: 1. pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and 2. control (n=30, attended by the usual procedure of dispensing). primary outcomes evaluated are: hospitalization (percentage of participants hospitalized), severe evolving complication - ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or absence). other parameter checked: a1c hemoglobin (hba1c), blood glucose (bg), blood pressure (bp), total cholesterol (tc), waist circumference (wc), body mass index (bmi) and mortality. the investigators follow up all patients for up to 12 months.

background. few brazilian randomized controlled trials have established the benefits of pharmacotherapy follow-up in care of outpatients with type 2 diabetes mellitus in low-middle income country. this study evaluate the effectiveness of pharmacotherapy follow-up care to get better outcomes in outpatients with type 2 diabetes mellitus attended in the public health service in brazil. method: in this single blind, placebo-controlled trial, the investigators random patients with type 2 diabetes mellitus into two groups: 1) pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and 2) control (n=30, attended by the usual procedure of dispensing). primary outcomes checked are: percentage of hospitalization, severe evolving complication (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia, coronaropathy and evolving foot lesion). the investigators also check: a1c hemoglobin (hba1c), blood glucose (bg), blood pressure (bp), total cholesterol (tc), hba1c/bp, hba1c/tc, waist circumference (wc), body mass index (bmi) and mortality. the participants are followed up to 12 months.

Eligibility criteria:
inclusion criteria: patients with previous diagnosis of type 2 diabetes, hba1c greater than 7% and age greater than 18 years exclusion criteria: types of diabetes other than type 2 diabetes; patients not responsible for administering their drugs and patients with mental deficits that could no understand the study.