Kornimate/medical-research-clean huggingface dataset:
the effect of stress on dna integrity and the effect of cognitive behavioral therapy on stress and infertility in women

Conditions: Infertility; Stress

Summary: the general hypothesis of the research is that stress decreases fertility and that cognitive behavioral therapy will reduce stress and increase fertility. secondarily, we hypothesize that stress has a detrimental effect on dna integrity and that stress reduction will reduce dna damage in the cell.


Eligibility criteria:
inclusion criteria: * women between the ages of 18-35 without children undergoing ivf treatment exclusion criteria: * undergoing treatment for a dsm-iv axis i psychiatric illness.
to demonstrate the relative bioavailability of metformin hcl 500 mg extended release (xr) tablets under fasting conditions

Conditions: Type II Diabetes

Summary: to demonstrate the relative bioavailability of metformin hcl 500 mg xr tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
safety, efficacy and pk/pd of qge031 vs. placebo in patients with active bullous pemphigoid despite oral steroid treatment

Conditions: Bullous Pemphigoid

Summary: to evaluate the safety and efficacy of qge031 versus placebo in patients with bullous pemphigoid. efficacy will be assessed as a reduction of disease activity. how qge031 is broken down by the body and the impact it has on different blood and tissue markers will also be explored.

this study was planned to be divided into 2 distinct parts. part 1 was a multicenter, randomized, placebo-controlled study evaluating the efficacy, safety, pk and pd of multiple, subcutaneous doses of qge031 in the treatment of patients with bp with disease refractory to oral steroid treatment. patients were treated with qge031 or placebo in a 2:1 ratio. part 2 of this study was planned to be a multi-center, open label, dose range finding study evaluating the efficacy, safety, pk and pd of multiple, subcutaneous doses of qge031 in the treatment of patients with bp with disease refractory to oral steroid treatment. this study was stopped after part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( \>50% better then placebo)

Eligibility criteria:
inclusion criteria: * patients diagnosed with bullous pemphigoid * stable dose of prednisone at or above 10mg per day but no greater than 1 mg/kg/day * weigh between 40-120kg * total ige level up to 5000 iu/ml exclusion criteria: * use of rituximab within 1 year other protocol-defined inclusion/exclusion criteria may apply

Keywords: bullous pemphigoid qge031
quantification of the visual benefits of soft toric contact lenses compared to soft spherical contact lenses

Conditions: Astigmatism

Summary: the aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.

this will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

Eligibility criteria:
inclusion criteria: - subjects will only be eligible for the study if: 1. they are of legal age between 18 and 40 years. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they are current wearers of any soft contact lens (i.e. have worn lenses in the last six months). 5. they have refractive ocular astigmatism between 0.00dc and -1.50dc in one or both eyes. 6. they have a spherical component to their ocular refractive error between 0.00 and - 6.00 ds. 7. they could attain at least 0.10 logmar distance high contrast visual acuity in one eye with the study lenses within the available power range. 8. they can be fitted satisfactorily with both lens types. 9. they own an acceptable pair of spectacles. 10. they agree not to participate in other clinical research for the duration of this study. exclusion criteria: - subjects will not be eligible to take part in the study if: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they have had corneal refractive surgery. 5. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 6. they are pregnant or breastfeeding. 7. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 8. they have an amblyopic eye, in which case only dominant eye will be assessed for that subject. 9. they have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. hiv) or diabetes. 10. they have a history of severe allergic reaction or anaphylaxis. 11. they have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
pharmacodynamics of product octreotide acetate lar 30 mg compared to product sandostatin lar ®

Conditions: Acromegaly

Summary: check the pharmacodynamics of the drug octreotide acetate lar 30 mg imported and distributed by chemical laboratory pharmaceutical bergamo ltda. compared to the drug sandostatin lar ® (octreotide acetate 30 mg) manufactured by novartis biociências s / a, using as activity analysis of growth hormone (gh) and growth factor insulin-like 1 (igf-1 ) after a single dose of the drug in patients with acromegaly

secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Eligibility criteria:
inclusion criteria: - accept the terms of consent; * be aged over 18, regardless of sex; * patients with acromegaly who presented gh levels ≥ 2.5 ng / ml or no suppression of gh levels to less than 1 ng / ml after tolerance test glucose and igf-i levels for age and sex; * patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased gh and igf-i; * patients waiting hypophysectomy with increased levels of gh and igf-i exclusion criteria: * have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study; * have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study; * have been treated with somastostatina analog or dopamine agonist in the last 2 months; * present history of myocardial infarction, angina and / or heart failure; * patients who present calculation of the gallbladder and have not undergone cholecystectomy; * pregnant women and nursing; * patients who have allergies to medicine; * patients with a history of acute pancreatitis; * patient with altered levels of amylase
oral sildenafil in persistent pulmonary hypertension secondary to meconium aspiration syndrome in newborns

Conditions: Meconium Aspiration Syndrome; Persistent Pulmonary Hypertension of Newborn

Summary: the purpose of this study is to to study the role of oral sildenafil in persistent pulmonary hypertension of newborn (pphn) secondary to meconium aspiration syndrome (mas) in newborns and to study risk factors of mas developing into pphn.

design: randomized control trial setting: neonatal intensive care unit in a tertiary care hospital patients: patients diagnosed with mas with pphn according to clinical criteria. 97 patients with mas were enrolled in the study over a period of 8 months, out of which 40 patients with pphn were randomized into two groups. intervention: group a received sildenafil through a feeding tube (1 mg/kg/dose q6h) for 8 doses. group b received a placebo. outcome measures: improvement in oxygen saturation (spo2), oxygenation index (oi), duration of hospitalization and mechanical ventilation and mortality.

Eligibility criteria:
inclusion criteria: * newborns were diagnosed with mas if any of the two of the following three criteria were present. (1) meconium staining of liquor or staining of umbilical cord or skin or nails. (2) respiratory distress, within one hour of birth. (3) radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation). newborns with mas diagnosed with clinical pphn were enrolled in the study for drug trial. pphn was determined either clinically by loud p2(second component of second heart sound), 10% or greater pre-/post ductal difference in arterial oxygenation (obtained by acid base gas analysis) or upper limb- lower limb spo2 difference (obtained by pulse oximetry). exclusion criteria: * (a) babies with congenital heart disease (b) congenital anomalies particularly those which were incompatible to life or which was the cause for respiratory distress e.g. diaphragmatic hernia (c) respiratory morbidities such as hyaline membrane disease, congenital pneumonia (d) babies with pphn secondary to mas admitted after 12 hours of delivery (e) non availability of consent of guardian for interventional procedures

Keywords: mas pphn sildenafil newborn pulmonary hypertension
circulating exosomes and endothelial dysfunction in patients with obstructive sleep apneas hypopneas syndrome

Conditions: Endothelial Dysfunction

Summary: evaluation of mirna contained in exosomes in obese and osa patients with endothelial dysfunction evaluated by digital plethysmography (endopat) compared to obese and osa patients without endothelial dysfunction.

the aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion. the endothelial function will be evaluated after polysomnography, on obese patients with osa (ahi \>15).

Eligibility criteria:
inclusion criteria: * adult subject * subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent * subject with osa (defined by ahi \>15/h) exclusion criteria: * cardiac or vascular desease
comparison of bcg rivm and russian strains for treating non-muscle-invasive bladder cancer (nmibc)

Conditions: Non Muscle Invasive Bladder Cancer

Summary: the goal of this clinical trial is to compare the efficacy and safety of two bacillus calmette-guérin (bcg) substrains (rivm and russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (nmibc) in adult patients. the main questions it aims to answer are: * is there a significant difference in recurrence-free survival (rfs) between the bcg rivm and bcg russian substrains? * is there a significant difference in progression-free survival (pfs) between the two substrains? * are there notable differences in the incidence of treatment-related adverse events between the strains? researchers will compare patients treated with bcg rivm to patients treated with bcg russian to determine whether one substrain offers superior clinical outcomes in terms of recurrence, progression, and adverse events. participants will: undergo transurethral resection of bladder tumor (turbt) prior to initiating therapy. be randomly assigned to receive either bcg rivm or bcg russian intravesical therapy. receive an induction course of six weekly instillations of the assigned bcg substrain. receive maintenance therapy at regular intervals (3, 6, 12, 18, 24, 30, and 36 months) based on risk classification. undergo regular follow-up with cystoscopy and urine cytology to assess recurrence, progression, and adverse events.


Eligibility criteria:
inclusion criteria: * age ≥18 years, * histopathologically confirmed nmibc (stages ta, t1, or cis), * classification as intermediate, high, or very high risk (who either refused or were not suitable candidates for radical cystectomy), * no prior bcg therapy, * no evidence of upper urinary tract carcinoma or distant metastases and * a minimum follow-up period of 12 months. exclusion criteria: * patients who did not receive adequate bcg therapy (defined as receiving fewer than 5 of the 6 induction doses or fewer than 2 of the 3 maintenance doses), * patients with a follow-up period of less than 12 months and * patients who received multiple bcg strains during the follow-up period.
study of fluconazole in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: antifungal therapy is widely used for individuals with autism spectrum disorders (asd). the current investigation will examine the effects of fluconazole on behavioral functioning among children with asd. this is a double-blind, randomized, placebo-controlled study of oral fluconazole in children who meet criteria for asd. pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of fluconazole therapy. in addition, children will undergo comprehensive medical history, physical examination, and laboratory analyses. our objective is to quantify differences in behavioral functioning between the fluconazole treatment and a placebo. our primary hypothesis is that, on average and relative to the placebo, children with asd who receive fluconazole will show greater improvements in symptoms of autism.


Eligibility criteria:
inclusion criteria: 1. male or female participants, three to ten years of age. 2. meets clinical criteria for an autism spectrum disorder. 3. no antifungal use in the preceding 3 months. 4. results of pyrosequencing analysis that have identified yeast 5. each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. each legal guardian must understand the nature of the study and must provide written consent to study protocol. exclusion criteria: 1. history of allergic reaction to fluconazole or other azole antifungal agents 2. current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus 3. history of uncontrolled epilepsy 4. weight less than 15 kg at screening 5. presence of a chronic medical condition that might interfere with study participation or where study participation would be contraindicated or clinically significant abnormal baseline laboratory results. 6. recent (less than two months prior to study entry) initiation of behavior therapy a child will be excluded at any point during the study if it is revealed that a major change (either addition or deletion) of treatment or service provision has occurred.
effectiveness of md on mets patients

Conditions: Obesity

Summary: the metabolic syndrome (mets), is a complicated condition linked to coronary artery disease.this group includes visceral obesity (abdominal or android type obesity), insulin resistance (ir), hypertension, and dyslipidaemia.the global prevalence of mets is estimated to be about one-quarter of the world population or over a billion global citizens .a high mets prevalence of 55% was found in egyptians, 85.6% among diabetics, and 76.6% among hypertensive patients .people can modify their diet, physical activity, decrease smoking habits to lower their chance of developing mets. frequent exercise can lower blood pressure while increasing insulin sensitivity, lipolysis, and energy expenditure. it has the ability to improve blood lipid parameters .diet is one of the most important tools available to improve mets. however, the diet for the prevention and treatment of mets remains unspecified beyond weight control and reduction in total calories. several evidences show that it should generally be low in saturated fats, trans fats, cholesterol, sodium and simple sugars .the adherence to the mediterranean diet(md) brings up two positive features, firstly the activity levels are increased and secondly the environmental impact becomes self-rewarding. the more the md is favoured, the more the self-productivity is achieved resulting in a stronger life style adaptation .md causes reduction of cvd incidence and outcomes decreases bp (systolic and diastolic) , inverses association with mortality,improvements in dyslexia, decreases incidence of t2dm.


Eligibility criteria:
1. inclusion criteria: all people diagnosed as metabolic syndrome * (hypertension(systolic bp≥130 or diastolic bp ≥85) * prediabetes fasting plasma glucose(100-125),oral glucose tolerance test(140-199)hba1c(5.7-6.4)ada * diabetes, fasting\>125, oral glucose tolerance test\>200, hba1c≥6.5 ada . * hyperlipidaemia(tg≥150 mg\\dl-hdl\<40 in male and \<50 in female) \[12\] * obesity(waist circumference ≥102cm in male and ≥88cm in female) \[12\] 2. exclusion criteria: * type 1 diabetes * patients with renal or advanced liver disease(failure) * oral contraceptives, psychiatric, neurologic medications and steroid therapy * patients with heart failure and presence of stent * endocrine disease (thyroid disease especially hypothyroidism-cushing disease)
characterization of exosomes platelets-released

Conditions: Platelet Thrombus

Summary: extracellular vesicles (evs) play a key role in cell-to-cell communication. they are small vesicles that contain rich molecular cargo. recently, they have been proposed as biomarkers for clinical diagnostics. evs include three classes: small evs (exosomes), large evs (microparticles), and apoptotic bodies. platelet-derived evs (pevs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. the information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.

this study is a multicentre, observational. we plan to enrol 54 subjects from centro cardiologico monzino irccs, and 121 buffy coat related to 121 subjects from centro trasfusionale fondazione irccs ca' granda ospedale maggiore policlinico. biographical and anthropomorphic data will be recorded, a fasting blood venous sample (from ante-cubital vein) will be collected for the haematochemical analyses and for research samples.

Eligibility criteria:
inclusion criteria: * subjects without known pathologies exclusion criteria: * individuals with gastrointestinal diseases, * individuals with history of hepatic diseases, * individuals with history of urogenital diseases, * individuals with history of hematological diseases, * individuals with history of immunological diseases, * individuals with history of renal diseases, * individuals with history of metabolic diseases * individuals with history of respiratory diseases * individuals with history of cancer * individuals with history of cardiovascular disease * individuals having permanent organ damage * individuals with major trauma in the last 6 months prior to enrollment * individuals with surgery in the last 6 months prior to enrollment * individuals taking medication in the 15 days prior to enrolment.

Keywords: exosomes, platelet activation, platelet inhibitors
epic (evaluating perioperative ischemia reduction by clonidine)

Conditions: Heart Disease

Summary: in canada 1 patient in 200 dies within 30 days of an operation. more than half of these deaths are the direct result of a heart related complication. this cause of death happens 4 times more often than in the same people who do not have an operation. we do not have an effective way to stop these heart attacks. stress causes the heart rate and the blood pressure to go up which causes the heart to work harder and may be the reason for some heart attacks. one group of drugs that stops the heart from working harder and decrease the number of heart related complications are beta-blockers. we wish to add another drug, which has been shown to reduce heart rate and blood pressure, will reduce the number of heart attacks after an operation. clonidine has been shown to reduce heart attacks after operations. since we know it is not a good idea to stop beta-blockers we want to see if giving clonidine as well as a beta-blocker is safe and has the desired effect of decreasing the number of heart attacks. we want to find out how good the combination of these two drugs are at decreasing the number of heart attacks. hypothesis: the addition of clonidine to chronic b-blockade will reduce mortality and cardiac morbidity among intermediate-to-high risk patients undergoing non-cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥ 45 years 2. current use of b-blocker therapy\>=30 days prior to surgery 3. undergoing non-cardiac surgery with an expected length of stay ≥ 48 hours for medical reasons 4. informed consent 5. undergoing major vascular surgery (excluding carotid endarterectomy, dialysis shunt, and vein stripping) or meet \>= 2of the following criteria: 1. coronary artery disease 2. congestive heart failure 3. stroke or transient ischemic attack 4. diabetes mellitus requiring oral hypoglycemic or insulin therapy 5. preoperative renal insufficiency (creatinine clearance below 60 ml/min) 6. peripheral vascular disease, as defined by any of the following: history of ischemic intermittent claudication or rest pain, history of revascularization procedure to legs, peripheral arterial obstruction of \>= 50% luminal diameter 7. age \>=70 years 8. intermediate-risk surgical procedure: intra-peritoneal, intra-thoracic, carotid endarterectomy, major orthopedic (hip, knee, spine) surgery, radical prostatectomy, or head-and-neck surgery exclusion criteria: - if meets any of the following 1. prior adverse reaction to clonidine or a-2 agonists 2. current use of clonidine or a-2 agonists 3. current congestive heart failure 4. only b-blocker taken by patient is sotalol 5. left ventricular ejection fraction \<=40% 6. systolic blood pressure \< = 90 mmhg 7. concomitant life-threatening disease likely to limit life expectancy to \<=30 days. 8. clinically significant aortic stenosis, defined as an aortic valve area \ = 25 mmhg

Keywords: alpha 2 agonists cardiac events non cardiac surgery
visual perception difficulties after stroke

Conditions: Stroke; Visual Perception

Summary: the goal of this observational study is to learn how well the oxford visual perception screening (oxvps) tool can identify stroke survivors with visual perception difficulties. the main aim is to determine the accuracy and utility of the oxvps compared to the current gold standard assessment in stroke survivors. in other words, how well can the oxford visual perception screening tool (oxvps) identify stroke patients with visual perception problems? participants will completed the oxvps and the current gold standards visual perception screening tool.

this is a non-experimental cross-sectional study. it aims to compare the new screening test oxvps to the gold standard tests for visual perception difficulties. patients will be recruited at stroke rehabilitation units at hospitals in the north east of england and in oxfordshire. following consent: * participants will complete the paper version of the oxford visual perception screen oxvps (\~15 min). * participants will complete screening for visual perception problems with a validated screening tool (\~30-120 min). * participants will complete screening for cognition alterations and sensory vision with validated screening tools. (\~30 min) * stroke details (time since stroke, severity) and demographic data (age, socio-economic status) will be collected to evaluated representativeness of the sample.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage). * within 6 weeks of confirmed stroke. exclusion criteria: * insufficient understanding of english * clinical concerns that patient is unable follow simple instructions. * clinical concerns that patient is unable to concentrate for 15 minutes. * no capacity to provide informed consent.