Kornimate/medical-research-clean huggingface dataset:
effect not imposing covid-19 testing prior to elective cataract surgery

Conditions: Cataract Surgery; COVID-19

Summary: the world health organization declared corona virus disease (covid19) a pandemic since march 2020. since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. covid 19 testing has already standardized within the medical field as doctors wearing scrubs or fitness examination before operation. we are now more than 2 years into covid-19 pandemic with more than 6 effective vaccines available in the market for public to boost and build up their immunity against the virus. every 3 to 4 months we hear about a new strain and another wave of the virus attacking the world, therefore healthcare institutions face enormous challenges in balancing patients' needs and simultaneous safety to health care workers. the indian council of medical research in june 2020 proposed that testing for covid-19 for asymptomatic patients coming for elective surgeries should be performed for neurosurgery, ear nose, and throat (ent) surgery, dental procedures, etc. and for non-surgical interventions like bronchoscopy, upper gastrointestinal endoscopy and dialysis. a role of preoperative testing of covid-19 for every patient is still controversial especially in asymptomatic healthy patients with not known exposure to a covid positive patient. most patients attending eye out patient department (eopd) are aged 65y and older are considered at a higher risk for worse outcome in case of covid-19 infection. therefore a rethink of a cataract surgery pathway should include preoperative perioperative and postoperative care in order to maintain safety conditions for patients and for healthcare staff. covid-19 can infect anyone and result in transmission of infection before the patient become symptomatic or even without ever developing symptoms. therefore preoperative screening of patients undergoing ophthalmic surgery should be considered.


Eligibility criteria:
inclusion criteria: * asymptomatic adult undergoing cataract surgery exclusion criteria: * symptomatic patients (fever, cough lethargy malaise , headache, and aches, sore throat and diarrhoea
platelet administration to patients with traumatic brain injury who were treated with aspirin

Conditions: Aspirin Treatment; Traumatic Intracranial Bleed; Hemorrhage Growth; Neurological Outcome

Summary: traumatic brain injury (tbi) is a devastating disease with high morbidity and mortality. although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones). aspirin is a commonly used antiaggregate drug that interferes with the clotting system. the antiaggregate effect may be neutralized by administration of platelets. thus, potentially, patients receiving aspirin and undergoing tbi, are at a higher risk for increasing an intracranial bleed. in this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets. the primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.

traumatic brain injury (tbi) is a devastating disease with high morbidity and mortality. although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones). aspirin is a commonly used antiaggregate drug that interferes with the clotting system. the antiaggregate effect may be neutralized by administration of platelets. thus, potentially, patients receiving aspirin and undergoing tbi, are at a higher risk for increasing an intracranial bleed. in this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets. the primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.

Eligibility criteria:
inclusion criteria: * age \>18 years old * chronic aspirin treatment * first ct scan less than 12 hours following the trauma * gcs \>3 * no immediate surgical cranial lesion * isolated head injury * consent * contusions \>1.5cc or acute subdural hemorrhage in any size exclusion criteria: * anticoagulation treatment * more than one antiaggregate * coagulopathy * thrombocytopenia (less than 100000) * intracranial tumor * active hematological disease * more than 8 hours between first and second ct scan * more than 2 hours between first ct and platelet admission
a study to evaluate the relative bioavailability and food effect of a new tablet formulation of vx-993

Conditions: Pain

Summary: the purpose of the study is to evaluate the pharmacokinetics (pk), safety, and tolerability of vx-993 in healthy adult participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * a total body weight of more than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before first dose of the study drug key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption, distribution, metabolism, or excretion other protocol defined inclusion/exclusion criteria may apply.
prevalence of polycystic ovary syndrome (pcos) in obese premenopausal women

Conditions: Polycystic Ovary Syndrome

Summary: between 40% and 85% of women with polycystic ovary syndrome (pcos) are overweight or obese and obesity is closely linked to the development of pcos. although it is well established that obesity increases the severity of the clinical features of pcos, data regarding the prevalence of pcos in obese women and the change in body weight in women with pcos over time are scares. in a prevalence study it was investigated whether obesity increases the risk of pcos in the general population and they demonstrated that the prevalence rate of pcos in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. these results suggest that the risk of pcos is only minimally increased with obesity. on the other hand, in a spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of pcos, which is markedly higher compared with the 5.5% prevalence of pcos in lean women in spain. first the investigators aim to estimate the prevalence/probability of pcos among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in sweden. secondly, to elucidate whether women diagnosed with pcos respond to standard weight reduction regime to the same extent as women without pcos.


Eligibility criteria:
inclusion criteria: pcos diagnostic criteria should be the presence of both clinical and/or biochemical hyperandrogenism and/or oligo-/amenorrhea and/or polycystic ovaries (pco). exclusion criteria: 1. exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin \< 27µg/l), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/l), and androgen secreting tumors. 2. pregnancy or breastfeeding the last 6 months. 3. any sign of climacteric symptoms. 4. language barrier or disabled person with reduced ability to understand information. 5. oral contraceptives and insulin sensitizing agents is commonly used among women with pcos since it may interfere with hormone profile. as the prevalence of pcos can be assumed to be increased among women using oral contraceptives and insulin sensitizing agents, they are included but analyzed separately.

Keywords: pcos
ras blockade at bedtime versus on awakening for aldosterone breakthrough

Conditions: Chronic Kidney Disease

Summary: objective: to show that the frequency of aldosterone breakthrough is lower when ras blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough. duration of the study: inclusion 2 years, follow-up one year, total 3 years design: prospective, multicenter, randomized, controlled, open label, two parallel groups. main selection criteria: inclusion criteria * chronic kidney disease stage 3 to 4, * acei (captopril, enalapril, or ramipril), and/or arb (losartan, valsartan, or irbesartan) on awaking for at least three months, * history of hypertension or proteinuria \> 0,5 g/24h or g/g créatininurie. exclusion criteria * office blood pressure ≥ 160/100 mmhg, * anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor. evaluation criteria: primary: serum aldosterone levels at one year. secondary: * serum aldosterone/renin ratio, * 24h urine aldosterone, * significant aldosterone breakthrough defined by a \>10% increase of serum aldosterone levels over baseline values, * aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values, * hba1c, * urinary albumin/creatinine ratio (uacr) on spot morning urine samples, * systolic home blood pressure (sbp), * estimated glomerular filtration rate (egfr) using the mdrd equation.

rational: serum aldosterone levels may increase despite blockade of the renin angiotensin system (ras) with angiotensin converting enzyme inhibitors (acei) or angiotensin receptor blockers (arb). this aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. antihypertensive drugs are given either on awaking or at bedtime. ras is stimulated during nighttime. ras blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough. objective: to show that the frequency of aldosterone breakthrough is lower when ras blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough. duration of the study: inclusion 2 years, follow-up one year, total 3 years design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 3 to 4, * acei (captopril, enalapril, or ramipril), and/or arb (losartan, valsartan, or irbesartan) on awaking for at least three months, * history of hypertension or proteinuria \> 0,5 g/24h or g/g creatininuria, * adult with social security insurance, * informed consent signed. exclusion criteria: * office blood pressure ≥ 160/100 mmhg, * pathology with life expectancy \< 1 year, * anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
effects of dietary pork and egg on appetite, meal-patterning, and weight loss in men

Conditions: Weight Loss

Summary: the purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. this is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).


Eligibility criteria:
inclusion criteria: * age range: 21 years and older * body mass index between 25.0-39.9 kg/m2 * weight stable (\< 4.5 kg (\~10 lbs) weight gain or loss within last 6 months) * body fat \>25% (assessed by skinfold and plethysmography (if needed)) * non-smoking (within the last 6 months) * constant habitual activity patterns (within last 3 months) * clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose \<110 mg/dl) * not taking medications known to influence appetite or metabolism * non-diabetic exclusion criteria: * age: \<21 years * body mass index: outside of the 25.0-39.9 kg/m2 range * gained or lost \> 4.5 kg (10 lbs) within the last 6 months * body fat \<25% as assessed by plethysmography * smoker (currently or within the last 6 months) * intermittently been involved in a diet and/or exercise program within the last 3 months * clinically abnormal blood profiles as identified by our study physician, arthur rosen, md * taking medications (currently or within the last 3 months) known to influence appetite or metabolism * clinically diagnosed as diabetic * allergies to eggs * lactose intolerance * clinically diagnosed with diverticulosis * clinically diagnosed with diverticulitis
prospective registry of patients with isolated severe tricuspid regurgitation

Conditions: Tricuspid Regurgitation

Summary: prospective registry for patients with severe isolated tricuspid regurgitation (tr) without significant left-sided valvular or myocardial diseases. aim: to evaluate clinical course and prognostic factors of patients with severe isolated tr.

inclusion criteria severe isolated tr for more than 6 months exclusion criteria 1. severe mitral and aortic valvular heart disease 2. age equals to or more than 75 years 3. malignancy or serious comorbidity with life expectancy \< 5years 4. acute or subacute infective endocarditis requiring antibiotics therapy 5. untreated hyperthyroidism 6. constrictive pericarditis 7. unclosed significant atrial septal defect 8. previous tricuspid valve surgery 9. significant coronary artery disease 10. cardiomyopathy 11. pregnancy 12. severe resting pulmonary hypertension(tr vmax \>4.0 m/s)

Eligibility criteria:
inclusion criteria * severe isolated tr for more than 6 months exclusion criteria 1. severe mitral and aortic valvular heart disease 2. age equals to or more than 75 years 3. malignancy or serious comorbidity with life expectancy \< 5years 4. acute or subacute infective endocarditis requiring antibiotics therapy 5. untreated hyperthyroidism 6. constrictive pericarditis 7. unclosed significant atrial septal defect 8. previous tricuspid valve surgery 9. significant coronary artery disease 10. cardiomyopathy 11. pregnancy 12. severe resting pulmonary hypertension(tr vmax \>4.0 m/s)

Keywords: clinical course and prognostic factors in patients with severe isolated tr
the bipolar illness onset study (the bio study)

Conditions: Bipolar Disorder

Summary: this longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite electronic smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder

the study will include 300 patients with newly diagnosed/first episode bipolar disorder, 200 healthy siblings or child family members and 100 healthy individuals without a family history of affective disorder. all individuals will be investigated with repeated blood tests, smartphone recordings, neuropsychological tests and brain imaging during a five to ten year study period.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed/first episode bipolar patients, 2. first-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients. 3. age- and gender matched sample of healthy individuals without a first-generation family history of effective disorders exclusion criteria: 1. significant physical disorders 2. schizophrenia or related disorders

Keywords: bipolar disorder blood smartphone brain imaging cognition neuropsychology
effect of nigella sativa on lipid profiles in elderly

Conditions: Dyslipidemia

Summary: the purpose of this study is to determine whether nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.

cardiovascular diseases are still common health problems worldwide. they are major causes of morbidity and mortality in many countries. dyslipidemia is the main risk factor of cardiovascular events. despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. however, evidence of the effectiveness of many herbs or other traditional drugs is lacking. nigella sativa or black seeds are traditional herbs used for years in middle east and india. they are believed to cure many diseases, including dyslipidemia. therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.

Eligibility criteria:
inclusion criteria: * age of 60 years or more * having dyslipidemia (total cholesterol \>200 mg/dl or ldl \>100 mg/dl or triglyceride \> 150 mg/dl or hdl \< 40 mg/dl (male) or hdl \< 50 mg/dl (female) exclusion criteria: * alt or ast are two times of upper normal limit * creatinine clearance test is below 30

Keywords: nigella sativa dyslipidemia elderly
pars plana vitrecromy in patients aged 85 years and above

Conditions: Vitreous Injury; Retinal Detachment; Age Related Macular Degeneration

Summary: we reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the tel aviv medical center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until december 2015.

we reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the tel aviv medical center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until december 2015. we will be measuring visual acuity, intra-ocular pressure, demographics (age, gender), indication for surgery, ocular co-morbidities, surgical parameters (time of surgery, type of anesthesia - general or local, type of suture), and intraoperative and postoperative complications. primary outcome - visual acuity will be measured at base line, after 1 week, 1 month, 3 months, 6 months / last follow up (until december 2015). visual acuity will be determined by a standardized chart test (snellen chart). for statistical analysis, all va values were converted to logmar scale. according to holladay and the university of freiburg study group results, blindness was set at 0.00125/2.9 (decimal/logmar), light perception at 0.0025/2.6, hand movements at 0.005/2.3 and counting fingers at 0.014/1.85. data will be analyzed using spss software. a p-value of 0.05 will be considered statistically significant and t-tests analysis will be used to compare between means. secondary outcomes - demographics, indication for surgery, ocular co morbidities will be measured at baseline. surgical parameters and intraoperative complications will be measured at 1 week. postoperative complications will be measured during follow up after 1 week, 1 month, 3 months, 6 months / last follow up (until december 2015). complications will be measured by examination of intraocular pressure, slit-lamp and fundus (ophthalmoscopic exam).

Eligibility criteria:
inclusion criteria: patients aged 85 years and above, who underwent pars plana vitrecromy in the tel aviv medical center during the years 01/01/2006 - 31/12/2013 exclusion criteria: any other

Keywords: retinal detachment trauma age related macular degeneration
search for genetic basis of vulvodynia

Conditions: Vulvodynia

Summary: the purpose of this study is to investigate the possibility of an association between localized provoked vulvodynia (lpv) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (snps) in and around the genes encoding heparanase (hspe-1), vanilloid receptor vr1 (trpv1), and nerve growth factor (ngf).

the short-term goal proposed for the current study was to investigate the possibility of an association between localized provoked vulvodynia (lpv) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (snps) in and around the genes encoding heparanase (hspe-1), vanilloid receptor vr1 (trpv1), and nerve growth factor (ngf). eight polymorphic snps in the three different genes suspected to be involved in lpv has been examined as follow: 1. hspe gene: four polymorphic snps: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the ashkenazi jewish population 2. trpv1 gene: two polymorphic snps: rs222747 and rs8065080. 3. ngf gene: a novel t to c snp in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of ngf.

Eligibility criteria:
inclusion criteria:o meeting friedrich's criteria \[50\] for vulva vestibulitis syndrome * diagnosed by a gynecological examination with lpv * diagnosed with a severe degree of the syndrome according to marinoff \[48\] * classified with the primary type of the syndrome according to an interview * with both parents of ashkenazi origin.
endomaster ease system for treatment of colorectal lesions

Conditions: Colonic Neoplasms

Summary: this is a prospective, single arm study to assess the safety and performance of the endomaster ease (endoluminal access surgical efficacy) system for the treatment of patients with colorectal neoplasms.

prospective, single arm study to assess the safety and performance of robotically assisted esd of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 85; 2. suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas. exclusion criteria: 1. informed consent not available; 2. carcinoma of colon or rectum with known involvement beyond the submucosa; 3. evidence of distant spread of colon cancer; 4. presence of another active malignancy; 5. pregnancy; 6. patients considered unfit for general anaesthesia; 7. the endoscopic platform cannot reach the target site; 8. current participation in another clinical research study.

Keywords: colonic esd robotic endoscope