Kornimate/medical-research-clean huggingface dataset:
effect of omega-3 fatty acids on sleep and behavior (pilot study)

Conditions: Disturbances in Initiating and Maintaining Sleep; Behavior Problem

Summary: the aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. the study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers.

previous studies show omega-3 fatty acid supplements improve adolescent's antisocial behavior. however it is less known whether the same effect could be achieved in younger children. furthermore it is not known whether omega-3 fatty acids could also improve parental behavior and parenting style which could further reduce behavioral problems in children. moreover, we recently found that children who consume fish more frequently have less sleep problems but it is not known whether omega-3 supplements could also potentially improve children's sleep. we aim to test several hypotheses in this random controlled trial of omega-3 fatty acids. the study design will consist of a double-blind, randomized placebo-controlled trial of children and their caregivers in a community sample in the city of philadelphia. it will utilize a random parallel design, in which child and mother pairs will be randomly assigned to either omega-3 supplementation (treatment condition) or a placebo (control condition). this results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent and child receiving the placebo. treatment will last 45 days. assessments will take place at 0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of treatment).

Eligibility criteria:
inclusion criteria: * child between ages 5-9 with mother available to participate in intervention study exclusion criteria: * intellectual disability * significant psychiatric and physical illness * extensive use of nutritional supplements within the past three months * seafood allergy * diabetes

Keywords: omega-3 fatty acids sleep behavior parenting
an observational study of patients with primary open angle glaucoma (poag) or ocular hypertension (oht) who switched iop-lowering treatments

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study is a prospective, observational study of changing from any iop-lowering treatment to a prostaglandin analogue-containing iop-lowering medication for patients with primary open angle glaucoma (poag) or ocular hypertension (oht). the decision to change medications lies with the physician according to their standard practice.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma (poag) or ocular hypertension (oht) * previously prescribed any iop-lowering therapy which has been stopped and a new prostaglandin analogue -containing iop-lowering therapy started exclusion criteria: * none
efficacy of high-intensity nppv and low-intensity nppv in patients with chronic hypercapnic copd

Conditions: COPD; Hypercapnic Respiratory Failure

Summary: high-intensity noninvasive positive pressure ventilation (nppv), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. however, no definitive conclusions have been drawn to decide whether high-intensity nppv is the best setting for treating patients with chronic hypercapnic copd. for now, no unified method for setting up high-pressure nppv has been established. most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. however, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.therefore, seeking a method to establish individualized high-intensity nppv is of vital importance.


Eligibility criteria:
inclusion criteria: clinically stable with chronic hypercapnic copd (baseline arterial carbon dioxide pressure (paco2) of 50 mmhg or higher, measured resting in a sitting position and breathing room air without having used nppv for at least 1 hour) exclusion criteria: * other lung/pleural diseases or thoracic deformity * severe heart failure (new york heart association class iv), severe dysrhythmia * unstable angina, or malignant comorbidity * obesity (bmi ≥ 35 kg/m²) * severe obstructive sleep apnea syndrome
imaging study of chronic low back pain in patients taking pain medication

Conditions: Low Back Pain

Summary: duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. we will use functional magnetic resonance imaging (fmri) to investigate the neural and functional correlates of pain.


Eligibility criteria:
inclusion criteria:- males aged 18-60 * back pain * must be able to comply with study visit schedule and other study requirements * capable of performing the experimental tasks exclusion criteria:- contraindications for mri examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body) * known hypersensitivity to duloxetine or any of the inactive ingredients * uncontrolled narrow-angle glaucoma
effects of oleuropein on blood parameters and inflammatory markers in adults with metabolic syndrome

Conditions: Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Obesity

Summary: the aim of this study is to determine the effect of 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. the baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

this study was conducted to investigate the effect of adding oleuropein to the medical nutrition therapy of individuals with metabolic syndrome on their anthropometric measurements and biochemical parameters. sub-objectives of the study; determining the presence of inflammation in patiens with metabolic syndrome determination of the effect of diet and diet combined with oleuropein on both fasting blood glucose, insulin and blood lipid profile. determination of both anti-inflammatory and antidiabetic effects of oleuropein. determination of the effect of diet and diet combined with oleuropein on anthropometric measurements. the aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic syndrome as a result of the medical nutrition therpy with consumption of olive leaf extract (2 times a day) that has been contain 100 mg oleuropein for 6 weeks.

Eligibility criteria:
inclusion criteria: * individuals who volunteer to participate in the study by signing the voluntary consent form * diagnosed with metabolic syndrome * individuals who did not have any infection at the time the study started * not consuming any medication * not pregnant or lactating * women aged 18-49 who have not entered menopause and men in the same age group * willing to consume the given extract * not allergic or intolerant to olive leaves * no history of drug use * people with a bmi below 40 kg/m2 exclusion criteria: * the patient included in the study leaves the study * any health issues that may affect the results of the research during the research. * occurrence of the problem and/or infection * becoming pregnant during the research * being in the experimental group and not consuming extract regularly * failure to comply with the regulated medical nutrition treatment * failure to participate in routine meetings and failure to complete necessary measurements * starting to use any medication or nutritional supplement during the study * leaving study voluntarily

Keywords: metabolic syndrome oleuropein medical nutrition therapy
stemi treatment optimization by ischemic postconditioning and ivus guidance

Conditions: ST Elevation Myocardial Infarction

Summary: the purpose of is study is to investigate whether ischemic postconditioning (ipost) and intravascular ultrasound-guided (ivus) percutaneous coronary intervention (pci) improve the clinical outcome of patients with st-segment elevation myocardial infarction treated with primary pci.


Eligibility criteria:
inclusion criteria: * age ≥18 years * acute onset of chest pain with \<12 hours duration * stemi as characterized by 2 mm st elevation in 2 or more v1 through v4 leads or presumed new left bundle branch block with minimum of 1 mm concordant st elevation or 1 mv st-segment elevation in the limb lead (ii, iii and avf, i, avl) and v4-v6 or st depression in 2 or more v1 through v4 leads indicating posterior ami. exclusion criteria (ipost2): pre-pci timi flow 0 or 1 potential pregnancy inability to provide informed consent unwillingness to consent unavoidable to use thrombectomy spontaneous coronary artery dissection time from symptoms onset to ppci \> 12 hours culprit in bypass graft other reason for not including the patient exclusion criteria (istemi): potential pregnancy inability to understand information in order to provide informed consent unwillingness to consent spontaneous coronary artery dissection time from symptoms inset to ppci \> 12 hours culprit in bypass graft other reason

Keywords: primary pci coronary angiography intravascular ultra sound (ivus)
corticosteroids as additive in temporomandibular joint (tmj) arthrocentesis

Conditions: Arthritis

Summary: the aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (tmj). twenty-eight participants with tmj arthralgia, mainly related to osteoarthritis ae randomly assigned to two arms of a parallel double blind rct. in both arms an arthrocentesis procedure is carried out, while a single dose intraarticular dexamethasone was delivered to participants in one arm. saline was delivered in the other arm to serve as a control. follow up visits were scheduled after 1, 3 and 24 weeks. during each visit tmj pain (on a 100mm vas) and joint stiffness (mouth opening in mm) are scored. generalized estimating equations (gee) are used for statistical analysis.

the arthrocentesis procedure was performed under local anaesthesia and took place in a closed operation room under controlled conditions. after marking the points for insertion of the needles, a first 18 gauge injection needle was inserted into the upper intra-articular space of the tmj. correct positioning of the needle was determined by injecting and aspirating saline. subsequently, a second 18 gauge needle was inserted into the upper joint space about 8-10 mm anterior of the first needle. correct positioning of the second needle was confirmed by allowing injected saline to leave the joint through the first needle. after positioning of the needles, one needle was connected to a medical infusion system to passively allow isotonic saline of 37 degrees celsius to enter the upper joint compartment. the other needle was connected to an outflow tube to allow the fluid to exit the joint. in about 15 minutes, approximately 300 ml saline passively flushed the joint. thereafter, the inflow was stopped and the prepared syringe (see randomisation procedure) that contained either dexamethasone or saline was connected to the inflow needle. in this way, either 1 cc of dexamethasone or an equal amount of saline was washed through the joint in a blinded way. at the end of the procedure, the needles were removed from the joint, and after hemostasis by compression (if necessary) the skin overlying the tmj was covered with a sterile band aid. all patients were then instructed to avoid tmj loading by following a soft diet for at least two weeks, then gradually advancing to more tough food. in addition, ibuprofen 600 mg 3dd was prescribed for the first 2-5 days to reduce any postoperative pain. all procedures were performed by one surgeon. follow up visits were scheduled after 1 (t1), 3 (t2) and 24 (t3) weeks.

Eligibility criteria:
inclusion criteria: pain localized in one of the tmjs (tmj arthralgia). exclusion criteria: * no significant relief of pain within 10 minutes after anaesthesia (injecting 0,1 ml articaine 40 mg/ml) of the tmj * past history of open surgery in the affected joint * known polyarthritis (mostly rheumatoid arthritis) * age under 18 yrs * ankylosis of the tmj * reported pregnancy

Keywords: tmj corticosteroids osteoarthritis arthrocentesis pain
assessment of a mobile intervention to increase adherence to asthma medication among adolescents

Conditions: Asthma

Summary: the purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. the intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. this study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the act \[asthma control test\], and lung function as measured by spirometry.


Eligibility criteria:
inclusion criteria: * age 11-19 * asthma diagnosis * currently prescribed a hydrofluoroalkane (hfa) asthma controller medication * english-speaking * has a smartphone or access to a smartphone or tablet exclusion criteria: * pregnant * foster care * emancipated minor

Keywords: patient compliance mobile applications
study of the impact of mother-of-pearl nutritional supplementation on the prevention of post-menopausal osteoporosis

Conditions: Post Menopausal Osteoporosis

Summary: post-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. they also increase the risk of morbidity and mortality. given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. the very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. there is a need for prevention of osteoporosis.

mother-of-pearl is a candidate for long-term use due to the combination of its effects: calcium supplementation, anti-resorptive activity and osteoanabolic activity. our hypothesis is that powdered mother-of-pearl supplementation limits bone loss in postmenopausal women with risk of becoming osteoporotic.

Eligibility criteria:
inclusion criteria: * post-menopausal women (50-65y) with risk of becoming osteoporotic * t-score between -1 and -3 * absence of fragility fractures history exclusion criteria: * absence of parathyroid glands (phospho-calcic regulation) * presence of kidney stones * patients who follow a treatment that could interfere with bone metabolism (corticotherapy, menopausal hormonal therapy, anti-oestrogen treatment, non-controlled hyperthyroiditis, hyper- and hypothyroiditis) * bone diseases (paget'disease, osteomalacia) * chronic alcoholism

Keywords: mother-of-pearl osteoporosis ageing nutrition health prevention
phase iv, 9 weeks comparison between micardis 80 mg and amlodipine 10 mg on biological ppar gamma activities

Conditions: Hypertension; Metabolic Syndrome X

Summary: the objective of the study is to compare ppar activities (increase of adiponectin level) between micardis and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment. an ancillary study performed in one center will assess adipocyte differentiation (ppar gamma stimulation) in 30 subjects (15 per arm).


Eligibility criteria:
inclusion criteria: patient written informed consent is signed prior to any trial specific procedures participation * male patients \> 18 years * mean seated sbp \> 130mmhg and/or dbp \> 85mmhg treated with antihypertensive drug(s) * with at least 2 more criteria of metabolic syndrome (ncept iii). biological data available within 6 months prior to enrollment visit. * abdominal obesity \> 102 cm at screening * tg \> 1.5 g/l * hdl \< 0.4 g/l * glycemia \> 6 mmol/l exclusion criteria: patients with any of the following conditions will be excluded from trial: * confirmed type 1 or 2 diabetic patients treated or not * secondary hypertension * mean seated sbp\>180 mmhg and/or dbp \>110 mmhg at screening * hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1: * sgpt (alt) or sgot (ast) ¿ twice the upper limit of the normal range * serum creatinine ¿ 2.3 mg/dl (or 203 ¿mol/l) * bilateral renal artery stenosis or renal artery stenosis in a solitary kidney * patients post-renal transplant or with only one functioning kidney * clinically relevant hypokalemia or hyperkalemia at visit 1 * uncorrected volume or sodium depletion at visit 1 * primary aldosteronism * hereditary or known fructose intolerance * biliary obstructive disorders * patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-ii receptor antagonists * history of drug or alcohol dependency within the previous six months * concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form * symptomatic congestive heart failure (new york heart academy (nyha) functional class chf ii-iv) * unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (ptca) or coronary artery bypass graft (cabg) surgery less than three months prior to informed consent * stroke less than six months prior to informed consent * sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator * hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve * known allergic hypersensitivity to any component of the formulations under investigation * concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
l-arginine effects on chronic hypertension in pregnancy

Conditions: Hypertension in Pregnancy

Summary: the purpose of this study is to evaluate the effects of oral l-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.


Eligibility criteria:
inclusion criteria: * pregnant women between 18-20 weeks of gestation with chronic hypertension exclusion criteria: * other maternal or fetal systemic disease

Keywords: chronic hypertension in pregnancy
evaluation of patients with systemic sclerosis without specific or associated autoantibodies

Conditions: Systemic Sclerosis

Summary: systemic sclerosis (ssc) is a complex systemic autoimmune disease with variable phenotype and prognosis. autoantibodies are important diagnostic biomarkers in ssc. more than 90% of patients with ssc had anti-nuclear antibodies. autoantibodies specific to ssc (anti-topoisomerase i antibodies, anti-centromeres, anti-rna polymerase iii, anti-th/to, anti-fibrillarin, anti-nor90) or associated with overlap syndromes (anti-rna polymerase iii antibodies -pm/scl, anti-ku, anti-u1rnp, anti-trim21) are detected in most patients. excluding anti-trim21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes. around 5 to 10% of patients with ssc have no autoantibodies detectable with routine biological tests. recently, new autoantibody specificities have been described in ssc (anti-eif2b, anti-ruvbl1/2, anti-bicd2, anti-u11/u12 rnp antibodies). "seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease. primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies. secondary objectives are: * to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies * to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status


Eligibility criteria:
inclusion criteria: * patient with systemic sclerosis defined according to acr/eular 2013 classification criteria * patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis * patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase i, anti-centromere, anti-rna polymerase iii (rp155 and rp11), anti-th/to antibodies , anti-fibrillarin, anti-nor90, anti-pm/scl, anti-ku, anti-u1rnp and anti-ssa antibodies (independently of antinuclear antibodies status) exclusion criteria: * patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies * patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up
middle east african registry women cardiovascular disease

Conditions: Heart Failure; Atrial Fibrillation; Valvular Heart Disease; Ischemic Heart Disease

Summary: the mea cardiology societies have joined forces to tackle the issue by establishing a tangible real-world data registry in every mea country. this endeavor has resulted in the development of a multicenter registry called mea-wcvd, which is being sponsored by each national cardiology society from participating countries. all data gathered will be consolidated into a singular registry for thorough analysis. country specific analysis will be performed.


Eligibility criteria:
inclusion criteria: * all incomers in cardiovascular (cv) diseases in hospital or out hospital facilities with one of the 4 diagnosis (heart failure (hf), atrial fibrillation (af), valvular heart disease (vhd), ischemic heart disease (ihd) * age over 18 years old * men and women * signature of consent form exclusion criteria: patients with diseases other than the 4 previously mentioned in inclusion criteria
multicenter study of the safety and efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: study of the safety and efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe chronic plaque psoriasis * active psoriasis, despite topical therapies exclusion criteria: * other active skin diseases or skin infections * prior exposure to any anti-tnf therapy * subject has other active skin diseases * multiple concomitant therapy restrictions and/or washouts (topicals, uv, other systemic ps therapies) * poorly controlled medical conditions * history of neurologic symptoms suggestive of central nervous system (cns) demyelinating disease. * history of cancer or lymphoproliferative disease * history of active tb or listeriosis, or persistent chronic or active infections * known to have immune deficiency or is immunocompromised * clinically significant abnormal laboratory test results * erythrodermic psoriasis or generalized pustular psoriasis