Kornimate/medical-research-clean huggingface dataset:
nebivolol in the supine hypertension of autonomic failure

Conditions: Hypertension; Pure Autonomic Failure; Multiple System Atrophy

Summary: the purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (bystolic), compared to metoprolol (lopressor) and sildenafil (viagra) on blood pressure in patients with autonomic failure and supine hypertension.

nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (no) bioactivity. the contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to no mechanisms. we propose to determine the effect of nebivolol on blood pressure in this patient population. a decrease in blood pressure will imply increased bioactivity of no. comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).

Eligibility criteria:
inclusion criteria: * male or female and aged 18 years or over. * clinical diagnosis of orthostatic hypotension associated with primary autonomic failure (parkinson disease, multiple system atrophy and pure autonomic failure). * a documented fall in systolic blood pressure of at least 20 mmhg, or in diastolic blood pressure of at least 10 mmhg, within 3 minutes after standing. * supine hypertension, defined as a systolic blood pressure \>150 mm hg or diastolic blood pressure \> 90 mm hg. * provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care. exclusion criteria: * have changed dose, frequency and or type of prescribed medication, within two weeks of study start. * women of childbearing potential who are not using a medically accepted contraception. * have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness. * diabetes mellitus or insipidus. * in the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing. * in the investigator's opinion, are unable to adequately co-operate because of individual or family situation. * in the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia. * are not able or willing to comply with the study requirements for the duration of the study. * persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).

Keywords: supine hypertension autonomic failure nitric oxide nebivolol
social skills in children with developmental coordination disorder (dcd)

Conditions: Developmental Coordination Disorder

Summary: in this study we will examine the social-communicative skills of children with developmental coordination disorder (dcd) by using online parental questionnaires in children aged 5 to 15y.

developmental coordination disorder (dcd) is a neurodevelopmental disorder described in the dsm-v characterized by motor coordination problems which significantly interfere with daily living activities and participation. the problems cannot be explained by another disorder and are already present in early life. although dcd is a 'motor' disorder, other domains may equally be affected. children with dcd show lower health-related quality of life, more socio-emotional problems, and experience more academic difficulties. it has been proposed that social skills may mediate the emergence of socio-emotional problems at a later age. previous research has suggested that socials skills of children with dcd may be altered. however, the process remains unclear. one possible hypothesis is that early motor coordination problems leads to avoiding or inhibits age-appropriate physical and social activities, which may reduce the opportunities to develop adequate socials skills and/or may impact negatively on a child's developing self-esteem and create a sense of isolation and exclusion. indeed, it has been reported that these children spend more time playing alone and are often onlookers instead of actively engaging in play. in general they exhibit a lower participation rate which may contribute to the reported poorer peer relations, less (deep) friendships, and a tendency for more bullying and loneliness. they also feel less competent in peer and social relations. poorer social interaction skills and more social communication problems have been recognized in these children even interfering in non-verbal skills such as poorer recognizing of facial expressions and emotions and a reduced tendency to follow gaze which may be similar to children with asd. it can be debated if these social problems are comorbid or rather a secondary consequence. with this study the investigators aim to map social responsiveness problems in children with developmental coordination disorder and clarify if and which domains are most affected. the investigators defined the following research question: "do children with developmental coordination disorder experience social responsiveness problems compared to typically developing children? if so, which domains are most affected?".

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dcd * comorbidities are allowed (f.e. asd, adhd, add,...) exclusion criteria: - any other neurodevelopmental disorder which might affect motor development (f.e. cp).

Keywords: children social communication
ocular manifestations in rheumatic diseases

Conditions: Uveitis; Conjunctivitis; Keratoconjunctivitis Sicca; Xerophthalmia; Eye Hemorrhage; Optic Neuritis; Papilledema; Orbital Diseases; Retinal Vein Occlusion; Retinal Artery Occlusion; Macular Edema; Retinitis; Chorioretinitis; Iridocyclitis; Scleritis; Choroid Hemorrhage; Blindness; Amaurosis Fugax

Summary: this is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis.

for the purposes of determining the prevalence of ocular complications in inflammatory rheumatic diseases, the following search terms were used: conjunctivitis, keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis, papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis, chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax. these terms were searched in the context of a corresponding inflammatory disease on medline, cochrane and web of science from their inception (1966, 1991 and 1990 respectively) until the point of study completion. studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in an inflammatory rheumatic disease. studies were excluded if they were review articles, case reports where all patients experienced the same ocular comorbidity, if different comorbidities were not grouped independently, and if the study reported on fewer than 20 patients. when the same study cohort was used in more than one analysis, the most recent or largest sample-size study was included. the strengthening the reporting of observational studies in epidemiology (strobe) checklist was used to assess the quality of cohort, case-control, and cross-sectional studies.

Eligibility criteria:
inclusion criteria: * studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in inflammatory rheumatic disease exclusion criteria: * review articles, * case reports where all patients experienced the same ocular comorbidity * if different comorbidities were not grouped independently * if the study reported on fewer than 20 patients
a study of the safety and tolerability of lpcn 1144 in subjects who completed the lpcn 1144-18-002 trial

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is an open-label extension to study lpcn 1144-18-002. the study is aimed at evaluating the safety and tolerability of lpcn 1144 in adult men with nash.

this is a multicenter, open-label extension protocol to provide lpcn 1144, an investigational drug, to subjects with nash who have completed the lpcn 1144-18-002 protocol. enrolled subjects will be given lpcn 1144 for up to 36 weeks. subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of lpcn 1144, adverse events, and overall subject health. subjects will be given the option of having a liver biopsy performed at week 36.

Eligibility criteria:
inclusion criteria: 1. subjects who have completed the 38 week study lpcn 1144-18-002 and wish to be treated with lpcn 1144 2. subject must sign the informed consent form to participate in the study exclusion criteria: 1. has participated or is participating in any other clinical (investigational) study after completion of lpcn 1144-18-002 study 2. subjects who are currently receiving any androgens or estrogens 3. subjects who are not willing to use adequate contraception for the duration of the study 4. use of drugs historically associated with nafld (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment 5. any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
a clinical trial to study the safety, tolerance and immunogenic response to gardasil and bivalent rlp2086 vaccine when given at the same time to children between the ages of 11 and 17

Conditions: Vaccines; Meningococcal Vaccines

Summary: this is a clinical study to assess the safety, tolerance and immunogenic response to gardasil (human papilloma virus (hpv)) and rlp2086 vaccine. healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either gardasil and rlp2086 concomitantly, rlp2086 and saline concomitantly, or gardasil and saline concomitantly. the subjects are adolescent children between the ages of 11 and 17 years old.


Eligibility criteria:
inclusion criteria: * male or female subjects from 11 to 17 years old at the time of they start the study. * subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator. exclusion criteria: * previous vaccination with any meningococcal serogroup b vaccine. * previous vaccination with any hpv vaccine. * contraindication to vaccination with gardasil or any hpv vaccine.

Keywords: vaccine rlp2086 gardasil hpv meningitis b n. meningitidis serogroup b adolescents single-blind meningococcal vaccines
platelet transfusion refractoriness

Conditions: Platelet Transfusion Refractoriness

Summary: platelet transfusion refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. platelet transfusion refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by hla-i molecules.

a preliminary study has shown different isotypes of anti-hla i in patients with platelet transfusion refractoriness. our hypothesis is that the type of anti-hla i antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for platelet transfusion refractoriness.

Eligibility criteria:
inclusion criteria: * adult patient with hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion. exclusion criteria: * patient under guardianship * minor patient
dapagliflozin versus glimepiride effect in patient with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: research objectives: the aim of the study to check the effect of dapagliflozin versus glimepiride on insulin regulated aminopeptidase (irape), nt-pro bnp and interleukin-34 (il-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.

method and proposal steps: 1. approval will be obtained from research ethics committee of faculty of pharmacy, damanhour university. 2. all participant agreed to take part in this clinical study and provide informed consent. 3. 60 patients with type 2 dm will be enrolled internal medicine department, tanta university hospital. 4. serum samples will be collected for measuring the biomarkers. 5. all enrolled 60 patients will be mentioned as two groups; group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. group 2 (n=30): are the patients who are prescribed glimepiride 6. all patients will be followed up during 3 months' period. 7. at the end of 3 months, step 4 will be repeated. 8. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. measuring outcomes: the primary outcome is the change from baseline to post-treatment insulin sensitivity reflected by change of serum level of measured marker after 3 months. 10. results, discussion, conclusion, and recommendations will be given. methodology: 1. fasting blood glucose (fbg) 2 hrs. post prandial blood glucose(2hppbg) will be measured by glucometer. 2. hba1c %, fasting plasma insulin (fpi), interleukin-34 (il-34), nt-pro bnp and extracellular domain of insulin regulated aminopeptidase (irape) will be assayed by enzyme-linked immunosorbent assay (elisa). 3. homeostatic model assessment of insulin resistance (homa-ir) will be calculated.

Eligibility criteria:
inclusion criteria: 1. 60 patients with type 2 dm diagnosed clinically. the age ranged from 18 to 70 years. there are no limits to the duration of dm and gender. 2. hba1c ≥ 7 exclusion criteria: 1. other types of dm 2. hypersensitivity to the drug 3. abnormal liver function 4. patients with renal impairment (egfr ≤ 60 ml/min) 5. previous history of bladder cancer
bile acids and gut microbiota as potent coronary atheroma risk factors: a prospective study in human

Conditions: Coronary Disease

Summary: the purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects. our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.

atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of death worldwide. the prevention of risk factors can reduce the development of cardiovascular diseases. the final goal of our study is to find new protective or new risk factors that can be modulated to reduce the incidence of cardiovascular events. gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic regulation. some bile acids, especially the secondary bile acids, transformed from the primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules. we want to compare the pool of bile acids and the composition of gut microbiota between the coronary patients and the healthy subjects to identify the potential protective or deleterious bacteria / bile acids. all patients admitted for a scheduled coronary angiogram will be included, then divided into two groups: coronary or healthy, based on the presence or the absence of atheroma during the coronary angiogram. feces and blood samples, and clinical and biological data, will be collected during the patient's hospitalisation. no additional exam will be performed. the blood sample will be collected during the coronary angiogram or during a routine blood test.

Eligibility criteria:
inclusion criteria: - all patients admitted for a coronary angiogram exclusion criteria: * statins, hypolipemic drugs, corticoids, anti hiv drugs * antibiotics adminisitration in the last 3 months * past of cholecystectomy * hepatic disorders * acute coronary syndrome * no agreement, insufficiency in comprehension * non fasting for at least 8 hours

Keywords: coronary disease bile acids gut microbiota risk factors atherosclerosis
association of ferritin levels with clinical parameters in patients with fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: the aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

this sectional study included 100 patients with non-anemic fms diagnosis and 100 patients with non anemic non fms diagnosis whose ferritin levels were measured within the last four weeks. the participants were evaluated using fibromyalgia impact questionnaire (fiq), beck anxiety inventory (bai), beck depression inventory (bdi) and pittsburg sleep quality index (psqi) as well as with a questionnaire form about descriptive characteristics. serum ferritin level of \<30 ng/ml was considered iron deficiency.

Eligibility criteria:
inclusion criteria: * fibromyalgi syndrome patients * ferritin levels were measured within the last four weeks exclusion criteria: * parenteral or enteral iron usage in last four weeks * hemoglobin level was less than 12 g/dl * infection * malignity * active inflammatory arthritis * serious skin variations * serious peripheral vascular disease * iron storing disorder * pregnant or lactating patients

Keywords: fibromyalgia syndrome, ferritin, sleep
efficacy and safety trial to evaluate the effect of sch 497079 on weight in obese and overweight participants (study p05483)(completed)

Conditions: Obesity; Overweight; Body Weight

Summary: the purpose of this study is to evaluate the effect of sch 497079 on weight in obese and overweight participants. the primary measure of effectiveness is the change in body weight during treatment. additional measures include waist circumference and body mass index (bmi). in addition, the safety of sch 497079 in obese and overweight participants will be evaluated. the primary hypothesis is that treatment with sch 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

following screening, eligible participants will enroll in a run-in period. participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (sch 497079 or placebo in a 2:1 ratio) with stratification according to gender. baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the randomization visit (visit 3). following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet. participants will have scheduled visits after the randomization visit at 2 to 4 week intervals. each participant will be encouraged to adhere to medication and dietary instructions.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age, of either sex, and of any race. * obese or overweight participants. exclusion criteria: * participants who have a history of major eating disorders, gastrointestinal (gi) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, gi, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
correlation of atrial fibrillation recurrence after bipolar radiofrequency ablation with microrna expression

Conditions: Atrial Fibrillation

Summary: the recurrence rate of atrial fibrillation (af) after bipolar radiofrequency ablation was about 30%. besides the factors, left atrium diameter, the duration of af, nt-probnp, and ejection fraction(ef), some studies demonstrated that the specific microrna expression (mirna1, mirna19,mirna23, mirna409 ) showed the significant change in af patients compared with normal sinus patients, who underwent catheter ablation. therefore, the correlation of atrial fibrillation recurrence and above-mentioned microrna after bipolar radiofrequency ablation remained unclear, although bipolar radiofrequency ablation had high rate of sinus.

numerous studies identify specific microrna (mirna) expression profiles associated with atrial fibrillation (af), changes in plasmamirna expression in pre-and post-operativeafpatients who have received catheterisation . the correlation of atrial fibrillation recurrence and above-mentioned microrna after bipolar radiofrequency ablation remain poorly characterized. this study aimed to reveal disease-related biomarkers by detecting plasmamirna expression in af patients, and examining the levels of af-specific mirnas in patients after bipolar radiofrequency ablation, in order to help gauge therapeutic effects and assess prognosis. a total of 50 han chinese patients with af who had received bipolar radiofrequency ablation recruited to the study. atrial fibrillation-specific plasma mirnas were detected by sequencing and quantitative reverse transcription polymerase chain reaction. according to af recurrence rate of about 30%, the expression levels of af-specific mirnas were investigated in15 post-operative af patients and 35 patients with normal sinus after ablation,to explore changes in mirna expression.

Eligibility criteria:
inclusion criteria: persistent atrial fibrillation, with alone mitral valve stenosis or regurgitation exclusion criteria: left atrium more than 60mm ejection fraction less than 30% complicated with other valve disease of aortic valve stenosis or regurgitation

Keywords: atrial fibrillation, ablation, microrna
use of gastrografin in the management of fecal impaction in patients with severe chronic constipation

Conditions: Fecal Impaction

Summary: fecal impaction (fi) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. it has been shown to confer a therapeutic beneﬁt in adhesive small bowel obstruction (sbo). the investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.


Eligibility criteria:
inclusion criteria: 1. a confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment. 2. rome iii criteria for chronic constipation present for ≥8 weeks. exclusion criteria: 1. patients with a history of colorectal surgery or an organic cause of constipation; pregnancy. 2. patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies). 3. patients with medical or psychiatric illness. 4. patients with abnormal laboratory data or thyroid function.

Keywords: chronic constipation fecal impaction gastrografin randomized controlled trial