Kornimate/medical-research-clean huggingface dataset:
comparing efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after ramadan

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa and asia. the aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after ramadan.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing informed consent. algeria: male or female, age at least 19 years at the time of signing informed consent * subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (visit 1) * treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (visit 1) * subjects not on any oad(s) (oral anti-diabetic drug) prior to trial participation or subjects on fixed daily dose(s) of oad(s) for at least 90 days prior to screening (visit 1). the oad(s) include any of the following anti-diabetic drug(s)/regimen: biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject medical record) insulin secretagogues (sulfonylureas (su) and glinides), dipeptidyl peptidase-4 inhibitors (dpp-4 inhibitors), a-glucosidase inhibitors, sodium-glucose co-transporter 2- inhibitors (sglt2 inhibitors ) (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) * hba1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis) * intention to fast (daytime, i.e., between dawn and sunset) during ramadan after receiving medical counselling regarding the risk of fasting * willing to give blood during ramadan exclusion criteria: * any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (visit 1), subjects performing intense physical labour)
oral nano vitamin d supplementation efficacy in inflammatory bowel disease

Conditions: Vitamin D Substitution

Summary: the purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.

conventional oral vit d formulas have variable availability esp. in ibd patients. oral nano vitamin d is absorbed in the mouth. the aim of this study is to compare the efficacy of both formulations by matching vitd levels after supplementation and to determine the equivalent dose.

Eligibility criteria:
inclusion criteria: * the inflammatory bowel disease patients exclusion criteria: * liver and renal disease * hypercalcemia * hyperparathyreoidism * chronic pancreatitis * concomitant vitamin d medication * pregnancy * sarcoidosis * malignancy * inability to obtain valid data from subject
are axioscapular muscles activity and cervical curvature associated with disability in neck pain

Conditions: Neck Pain; Electromyohgraph

Summary: despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. the quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. this study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue.


Eligibility criteria:
inclusion criteria: * chronic nonspecific neck pain * age between 20 and 40 years, * either sex * symptoms lasting longer than three months exclusion criteria: * pregnancy * spinal surgeries * spinal deformities * visual or auditory issues * ongoing physical or medical treatment for cervical or low back pain
analysis of genetic and environmental parameters influencing growth rate of precocious puberty children

Conditions: Central Precocious Puberty

Summary: the goal of cpp-edg 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. in this view, we are collecting clinical data and biological samples of children attended as outpatients at the pediatric endocrine center of pisa from 1998 to present (the study is still open). from biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different gnrh agonists.


Eligibility criteria:
inclusion criteria: * clinica diagnosis of central precocious puberty * diagnosis is based on growth spurt, bone age advancement, positive gnrh agonist stimulating test, pubertal sex steroid levels before 8 years of age for female and 9 years for male, respectively exclusion criteria: * thyroid disorders * peripheric diagnosis of precocious puberty * genetic disorders

Keywords: precocious puberty, genetics, environmental factors
levamisole and isoprinosine in the treatment of covid19: a proposed therapeutic trial

Conditions: Respiratory Tract Infections

Summary: the use of both levamisole \& isoprinosine has both synergistic and complementary effect in the treatment of covid 19 infection

study design: randomized controlled trial, randomization by closed envelope technique informed consent will be written for each patient of either group at the beginning of the study all patients will have the following investigations done: cbc with differential, esr, pcr for covid 19, d dimer and ct chest and confirmed cases will included in the study pregnant and lactating women together with children with other comorbidities will be excluded from the study study groups: duration of the study is 4 weeks both groups with persistent covid 19 symptoms that require hospitalization group 1: 30 patients with confirmed covid19 infection and sharing clinical features like fever, malaise, sore throat, runny nose, persistent cough \&dyspnea, requiring hospitalization group 2: control group: 30 patients treatment endpoint • cure of patients: improvement of symptoms laboratory findings esr and total leucocytic count returning to normal pcr negative radiological improvement • worsening of symptoms or fatalities

Eligibility criteria:
inclusion criteria: * confirmed covid 19 infection (positive pcr, elevated esr, leucopenia) * clinical picture of covid 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose exclusion criteria: * mild cases of covid 19 that do not require hospitalization * pregnant \& lactating women * children with other comorbidities * people who received previous treatment for covid 19 in the last 2 weeks n.b. diabetes and hypertension not excluded

Keywords: levamisole isoprinosine covid19
exploration of neural bases in social cognition

Conditions: Interpersonal Relations; Schizophrenia; Magnetic Resonance Imaging, Functional

Summary: an impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. social cognition is the way the social world is understood, perceived and interpreted. it includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (tom), social perception, social knowledge and attributional style. since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fmri) bold signal is the main objective of this study. the secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects. forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. the social cognition paradigm will be developed and the fmri activations will be compared to those of a visual cartoon based task, known to turn on the neural network of tom. bold signal variations at a high statistical correction ratio (p\<0.05) will be explored and compared to the signal of a second fmri, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fmri, p\<0.05). twenty matched patients with schizophrenia (dsm-iv-r), aged from 18 to 60 will be included to test the secondary objective. we make the hypothesis of a fmri functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.

social cognition neural basis. impairment of the "social brain" in schizophrenia

Eligibility criteria:
inclusion criteria: * subjects aged from 18 to 60 years old * who have signed a consent and, if there is one, whose legal representant has signed a consent 1)for healthy subjects: * without any psychiatric affection (mini international neuropsychiatric interview) 2)for patients * meeting the dsm-iv-r criteria for schizophrenia or schizoaffective disorder exclusion criteria: * pregnant woman * neurological affection * medical objection to magnetic resonance imagery (mri)

Keywords: ecological task fmri schizophrenia social cognition
biomarkers of dyspnea in emergency room

Conditions: Severe Dyspnea; CAPD; AE COPD; Acute Heart Failure; Pulmonary Embolism

Summary: the purpose of this study is to evaluate the capacity of some novels biomarkers procalcitonin (pct), midregional proadrenomedullin (mr pro adm), midregional pro-atrial natriuretic peptide (mr pro anp), copeptin (ct pro arginine vasopressin), pro endothelin to stratify the risk in severe dyspnea.

in emergency department shortness of breath (sob)is a common symptom and its cause is not easy to be identified. the risk stratifying remains a challenge, prognostic value of biomarkers might be helpful.

Eligibility criteria:
inclusion criteria: * tachypnea \> 25 /min or pa02 \< 70 mmhg or spo2 \< 93% * diagnosis suspected: cap, pe,eacopd, ahf exclusion criteria: * other cause of dyspnea, * unreachable on day 30

Keywords: dyspnea mortality
resveratrol in type2 diabetes and obesity

Conditions: Type 2 Diabetes; Obesity; Insulin Resistance

Summary: the main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.

the main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. this research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ros) generation and the pro-inflammatory transcription factor nuclear factor-kb (nf-kb) and the inflammatory mediators regulated by it. the hypothesis that resveratrol suppresses the high fat, high carbohydrate (hfhc) meal induced inflammatory and oxidative response, will also be investigated. this research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the homeostasis model assessment of insulin resistance (homa-ir), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.

Eligibility criteria:
inclusion criteria: 1. 20 years of age and older 2. healthy obese subjects with bmi \> 30 3. type 2 diabetics with bmi \> 30 4. subjects with good peripheral vein. 5. subjects on statins, ace inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study. exclusion criteria: 1. subjects on any antioxidant medication 2. patient on non-steroidal anti-inflammatory drug 3. on any agent with significant antioxidant properties. 4. history of drug or alcohol abuse 5. any life threatening disease 6. allergy to peanuts, grapes, wine, mulberries. 7. pregnant women. 8. coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. 9. subjects on anticoagulants.

Keywords: type 2 diabetes obesity insulin resistance resveratrol inflammation
efficacy and safety of tolvaptan in japanese patients with acute heart failure

Conditions: Heart Failure

Summary: the aims of the present study are to investigate prospectively the clinical course and outcome of the hospitalized heart failure patients treated with tolvaptan for management of fluid retention and serum sodium levels of less than 140 meq/l and also to analyze the factors related with the efficacy including outcome of tolvaptan therapy.

vasopressin mediates fluid retention in heart failure. tolvaptan, an oral, nonpeptide, selective vasopressin v2-receptor antagonist, shows promise for management of heart failure.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients for decompensated heart failure with signs of fluid retention despite using diuretics other than tolvaptan and planned tolvaptan use 2. serum na \< 140 meq/l 3. age: \> or = 20 years at the time of informed consent 4. provided written informed consent. exclusion criteria: 1. hemodynamic instability 2. patients with hypersensitivity to tolvaptan or similar compounds 3. anuric patients 4. patients who cannot feel thirst and are difficult to intake the fluid 5. patients who are pregnant, potentially pregnant or willing to be pregnant 6. patients have taken tolvaptan before enrollment after hospitalization 7. acute coronary syndrome 8. adrenal insufficiency 9. patients scheduled to undergo coronary angioplasty within the study period 10. ineligible patients according to the investigator's judgment

Keywords: diuretics vasopressins sodium
observational study to assess the incidence rate of the major adverse cardiovascular events (mace) and safety of fenofibrate (lipilfen capsule)

Conditions: Metabolic Syndrome

Summary: the purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (mace) and safety of fenofibrate (lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * patients \>20 years of age. * history of acute myocardial infarction * metabolic syndrome diagnosis exclusion criteria: * current liver disease or ast or alt greater than 3 times the upper limit of reference range * pre-existing gallbladder disease * moderate to severe renal disorder (serum creatinine \>2.5mg/dl) * pancreatitis diagnosis
controlled evaluation of angiotensin receptor blockers for covid-19 respiratory disease

Conditions: Coronavirus Disease 2019; COVID-19

Summary: the controlled evaluation of angiotensin receptor blockers for covid-19 respiratory disease (clarity) study is a pragmatic prospective, open-label, randomised controlled trial. clarity aims to examine the effectiveness of angiotensin ii receptor blockers (arbs) on improving the outcomes of people who tested positive for covid-19 disease.


Eligibility criteria:
inclusion criteria: potential participants must satisfy all of the following: 1. laboratory-confirmed\* diagnosis of severe acute respiratory syndrome-coronavirus-2 infection within 10 days prior to randomisation 2. age ≥ 18 years 3. a) systolic blood pressure (sbp) ≥ 120 mmhg or b) sbp ≥ 115 mmhg and currently treated with a non-renin angiotensin aldosterone system inhibitor blood pressure (bp) lowering agent that can be ceased 4. participant and treating clinician are willing and able to perform trial procedures. 5. either intended for hospital admission for management of covid-19, or (in australia only) intended for management at home with one or more of the following criteria: 1. age≥60 years 2. body mass index ≥30kg/m2 (derived from the patient's self-report of their height and weight where these are not measured directly) 3. diagnosis of diabetes defined as hba1c ≥7% and/or the consumption of glucose lowering medication 4. history of cardiovascular disease 5. history of chronic respiratory illness 6. currently treated with immunosuppression exclusion criteria: 1. currently treated with an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker or aldosterone antagonist, aliskiren, or angiotensin receptor-neprilysin inhibitors (arni) 2. serum potassium \> 5.2 mmol/l or no potassium testing within the last 3 months 3. for those intended for hospital admission, an estimated glomerular filtration rate (egfr) \<30ml/min/1.73m2 or no egfr testing within the last 3 months, or for those intended for management at home (australia only), an egfr \<45ml/min/1.73m2 or no egfr testing within the last 3 months 4. known symptomatic postural hypotension 5. known biliary obstruction, known severe hepatic impairment (child-pugh-turcotte score 10-15) - see table below 6. intolerance of arb 7. pregnancy or risk of pregnancy, defined as; 1. (in australia only) women younger than 51 years who have not had a negative pregnancy test during the past 3 days and/or who do not agree to use adequate contraception 2. (in india only) women who are pregnant 8. women who are currently breastfeeding 9. individuals who are not able to take medications by mouth at enrolment, or who are not expected to be able to take medications by mouth during the first 48 hours after randomisation

Keywords: angiotensin receptor blocker (arb) angiotensin converting enzyme 2 (ace2) coronavirus disease 2019 (covid-19) severe acute respiratory syndrome-coronavirus-2 (sars-cov-2)
a dose-ranging study to evaluate efficacy and safety of pf-06700841 in systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: assessment of pf-06700841 in participants with moderate to severe active, generalized systemic lupus erythematosus (sle) that have inadequate response to standard of care.


Eligibility criteria:
inclusion criteria: * male and/or female subjects between ≥18 and ≤75 years of age inclusive. * diagnosis of moderate to severe active lupus. * receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. exclusion criteria: * active renal lupus * severe active central nervous system (cns) lupus * have cancer or a history of cancer within 5 years of screening. * have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. * active bacterial, viral, fungal, mycobacterial or other infections * psychiatric condition including recent or active suicidal ideation or behavior * have active fibromyalgia/myofascial/chronic pain. * pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and wocbp who are unwilling or unable to use a highly effective method of contraception.
neoadjuvant chemoradiation in patients with borderline resectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. this study is a multicenter prospective randomized phase ii/iii study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. the study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. this study is a multicenter prospective randomized phase ii/iii study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. the study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy. this phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with brpc who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in korea. the primary endpoint was the 2-year survival rate (2-ysr). interim analysis was planned at the time of 50% case enrollment.

Eligibility criteria:
inclusion criteria: * \>18 years old or \<75 years old * ecog 0-2 * biopsy proven adenocarcinoma of the pancreas * no history of previous chemotherapy * borderline resectable pancreas cancer * no distant metastasis * wbc at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, platelet count at least 125,000/mm3 * bilirubin less than 2.5 mg/dl ast less than 5 times upper limit of normal * creatinine no greater than 1.5 times upper limit of normal * informed consent exclusion criteria: * history of previous chemotherapy * history of radiation at \>25% area of bone marrow * stage unspecified, with distant metastasis, recurrent pancreas cancer * history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). patients who are ned after 5 years after treatment of malignant neoplasm can be candidate of this study * pregnant, breast-feeding patient * uncontrolled or active infection * uncontrolled cardiopulmonary disease

Keywords: pancreas cancer borderline resectable locally advanced resectability chemotherapy radiation chemoradiation neoadjuvant survival prognosis recurrence response rate