Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of linagliptin (bi 1356) plus metformin in type 2 diabetes, factorial design

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the randomised part of the study is to investigate the efficacy and safety of bi 1356 plus metformin compared to bi 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. for the open-label part of the study the objective is to estimate the efficacy and safety of bi 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks


Eligibility criteria:
inclusion criteria: patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (hba1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (hba1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm exclusion criteria: myocardial infarction, stroke or transient ischemic attack (tia), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a glp1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass
effect of vitamin d on metabolic profile in overweight or obese women

Conditions: Overweight; Obesity

Summary: the investigators investigated the effect of vitamin d3 supplementation on metabolic profile (anthropometric measures, blood pressure lipids, lipoproteins and glycemic indices) in overweight or obese women.

vitamin d deficiency is a worldwide health problem and is determined as a risk factor in cardiometabolic disorders including cardiovascular disease, metabolic syndrome, and type 2 diabetes mellitus. the investigators investigated the effect of vitamin d3 supplementation on metabolic profile in overweight or obese women. a double blind randomized clinical trial was conducted in 77 premenopause overweight or obese women. participants were classified into two groups : vitamin d supplementation \[1000 iu/day as cholecalciferol tablets (n=39)\] or placebo (n=38). vein blood samples were taken after at least 12 hours overnight fasting. selected anthropometric measures, blood pressure lipids, lipoproteins and glycemic indices were measured at baseline and after 12 weeks. body fat mass was determined using bia. also the investigators assessed dietary intake using 24 hours food recall and semi-quantitative food frequency and physical activity using ipaq questionnaires. the investigators conducted the study between october 2009 and march 2010 at the medical school, tehran, iran. recruitment began in october 2009 via advertisements and was terminated in october 2009. the investigators excluded patients with a history of cardiovascular disease, liver disease, gastrointestinal disease, kidney disease, diabetes mellitus, and osteoporosis. moreover, pregnancy, lactation, vegetarianism, and intake of dietary supplements were the exclusion criteria.

Eligibility criteria:
inclusion criteria: * female * 18-50 years old * premenopause * bmi ≥25 exclusion criteria: * cardiovascular disease * liver disease * gastrointestinal disease * kidney disease * diabetes mellitus * osteoporosis * pregnancy * lactation

Keywords: vitamin d metabolic profile overweight obesity
selective serotonin reuptake inhibitors, fluoxetine versus the standard oral desmopressin for management of mono-symptomatic nocturnal enuresis.

Conditions: Nocturnal Enuresis; Enuresis; Enuresis, Nocturnal

Summary: to determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.


Eligibility criteria:
inclusion criteria: 1. age ≥ 7 years 2. severe enuresis with at least (50%) seven wet nights out of 14 3. failed treatment 4. the enuresis alarm was either ineffective or considered impractical due to the family circumstances. exclusion criteria: 1. underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions 2. patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder. 3. untreated constipation 4. contraindications to fluoxetine or desmopressin treatment
tislelizumab in combination with chemotherapy for conversion therapy of locally nonresectable escc

Conditions: Esophageal Squamous Cell Carcinoma; Locally Advanced Carcinoma

Summary: this is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable escc.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 75 years; 2. understand the research procedure and content, and voluntarily sign written informed consent; 3. patients with clinical stage iia-iiib esophageal cancer were assessed by endoscopic ultrasonography, ct/mri and other imaging. 4. esophageal surgery experts believe that patients with potentially resectable esophageal cancer 5. no blood transfusion was received 3 months before enrollment; 6. ecog ps score: 0-1. exclusion criteria: * patients meeting any of the following criteria are not eligible for inclusion: 1. women who are pregnant or breastfeeding; 2. previous or concurrent malignancy; 3. participated in clinical trials of other drugs within four weeks; 4. have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc. 5. patients with hypersensitivity to human or mouse monoclonal antibodies; 6. those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 7. according to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.

Keywords: drug: tislelizumab chemotherapy
safety and efficacy of bmmnc in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the aim of this study is to prove the bmmnc therapy in multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

multiple sclerosis (ms) is considered to be an autoimmune disease that is caused by the immune system attacking the central nervous system (cns) leading to myelin loss and axonal damage, resulting in long-term disability. the pathophysiology of ms is complex with involvement of genetic and environmental factors that define the susceptibility to generate the autoimmune attack. ms is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. when this nerve covering is damaged, nerve signals slow down or stop.the nerve damage is caused by inflammation. inflammation occurs when the body's own immune cells attack the nervous system. currently, treatment of ms relays mainly on immunosuppression combined with monoclonal antibodies and steroid therapies.the most advanced application for mscs in the neurological clinical arena is in multiple sclerosis.this clinical study time period is for 1 year. this study is carried out to see the role of bmmnc cell therapy in multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

Eligibility criteria:
inclusion criteria: confirmed diagnosis of ms, aged 18 - 65 years. duration of disease: \>5 years signed, written informed consent willing and able to comply with study visits according to protocol for the full study period exclusion criteria: * patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results * patient with any active or chronic infection * no life-threatening organ dysfunction. * pregnancy or risk of pregnancy. * patients who are seropositive for hiv1, hiv2, hepatitis b surface antigen, and hepatitis c * patients unable to give written informed consent in accordance with research ethics board guidelines * treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization * treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization * treatment with corticosteroids within the 30 days prior to randomization * current treatment with an investigational therapy

Keywords: stem cell multiple sclerosis bmmnc
restart ticrh alpha pilot protocol, restarting doacs after traumatic intracranial hemorrhage

Conditions: Anticoagulants; Increased

Summary: randomized pilot trial of restarting doacs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

restart ticrh two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. entry into the trial is primarily driven pragmatically by clinician intent to restart any direct oral anticoagulant (doac, i.e. apixaban, rivaroxaban, edoxaban, dabigatran. there is no head to head evidence of superiority of any drug) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. doac will be at label dose with label adjustments for creatinine clearance. doac will be at continuation dose, i.e. not initial therapy high doses in the setting of vte.

Eligibility criteria:
inclusion criteria: 1. acute traumatic intracranial hemorrhage on anticoagulation for atrial fibrillation (af) or venous thromboembolism (vte) 2. patient is higher risk for stroke or other thrombotic events as witnessed by having a cha2ds2-vasc score of \> 3 (at least 3 of the following risk factors: age greater than 65, (age \> 75 counts for 2 points), history of stroke or tia (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension) 3. doac prescribed at label dose with creatinine clearance adjustments. doac at continuation dose, i.e., not initial therapy high doses in the setting of vte exclusion criteria: 1. mechanical valve or ventricular assist device (vad) 2. sdh \>8 mm maximum width or any midline shift at any time point or more than one sdh 3. physician plan to start/restart antiplatelet therapy during trial period 4. abbreviated injury scale other than head \>3 5. pregnancy 6. inability to understand need for adherence to study protocol 7. renal function below doac label exclusions 8. any active pathological bleeding (e.g. no acute blood on most recent ct) 9. hypersensitivity to drug or other label contraindication 10. any bleeding that the investigator deems unsafe to restart doac at 1 week post injury, or conversely unsafe to hold doac to 4 weeks 11. completion of doac therapy expected prior to 60 day primary endpoint, e.g. 3-6 month vte treatment 12. concomitant need for strong inducers/inhibitors of p-gp and cyp3a4 13. low body weight (\<45kg) 14. inability to swallow

Keywords: restart anticoagulant doac
study to assess the efficacy and safety of ublituximab in participants with relapsing forms of multiple sclerosis (rms) ( ultimate 1 )

Conditions: Relapsing Multiple Sclerosis (RMS)

Summary: this study determines the annualized relapse rate (arr) in participants with rms after 96 weeks (approximately 2 years) treatment with intravenous (iv) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/iv placebo.


Eligibility criteria:
inclusion criteria: * 18-55 age * diagnosis of rms (mcdonald criteria 2010) * active disease * expanded disability status scale (edss) 0-5.5 (inclusive) at screening exclusion criteria: * treatment with prior anti-cluster of differentiate 20 (cd20) or other b cell directed treatment * treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation * diagnosed with primary progressive ms (ppms) * pregnant or nursing
use of ketamine prior to cardiopulmonary bypass in children

Conditions: Ventricular Septal Defect

Summary: to assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.


Eligibility criteria:
inclusion criteria: * less than one year of age * undergoing cardiac surgery for repair of ventricular septal defect * requiring cardiopulmonary bypass * not requiring retrogrades cerebral perfusion exclusion criteria: * downs syndrome
reproducibility and method comparison studies of the quo-test™ a1c system and the quo-lab a1c test and clia waiver study of the quo-test™ a1c system

Conditions: Diabetes

Summary: the quo-test a1c analyzer and reagent test system (quo-test a1c system) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. the quo-test a1c system is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. it is for multiple patient use. only auto-disabling, single use lancing devices should be used with this system.


Eligibility criteria:
inclusion criteria: * aged 18 years or over * able to read english * read, understood and signed the informed consent form * agrees to participate and does not withdraw\\ * either healthy (without diabetes) or has type 1 or type 2 diabetes exlcusion criteria: • declines participation or withdraws before study completion

Keywords: type i diabetes type ii diabetes hba1c
ultrasonographic evaluation of osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: assessment of the effectiveness of ultrasonography in correlation to conventional imaging for the detection of the definite grading of knee osteoarthritis.

assessment the effectiveness of ultrasonography in correlation to conventional imaging for the detection of the definite grading and the complication of knee osteoarthritis for patient complaining from knee pain coming to our radiology department for imaging with a clinical signs of knee osteoarthritis.

Eligibility criteria:
inclusion criteria: age: above 30 years. unilateral or bilateral knee joint affection. symptomatic patient. exclusion criteria: * any female patient in the child bearing period presented with chronic inflammatory joint disease as rheumatoid arthritis, sle. systemic diseases: renal failure. significant joint trauma or surgery.
comparison of the efficacy and safety of two intensification strategies in subjects with type 2 diabetes inadequately controlled on basal insulin and metformin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and north america. the aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. eligible subjects with an hba1c equal to or above 7% at end of treatment in nn1250-3643 (nct01193309) trial will be randomised to receive treatment intensification while subjects with an hba1c below 7% at end of treatment in nn1250-3643 (nct01193309) may continue to receive insulin degludec treatment. subjects are to continue their pre-trial metformin treatment.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject). * the subject must have completed the end of treatment visit of nn1250-3643 with insulin degludec once daily + metformin. * ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol exclusion criteria: * participated in nn1250-3643 and treated with insulin glargine * previous treatment with glucacon like peptide (glp-1) receptor agonists (e.g. exenatide, liraglutide) * impaired liver function, defined as alanine aminotransferase (alat) 2.5 times the upper limit of normal at end of treatment in nn1250-3643 * impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/l (= 1.3 mg/dl) for females or according to local label for metformin \[for france: glomerular filtration rate below 60 ml/min, calculated by the cockroft \& gault formula\] at end of treatment in nn1250-3643.
clınıcal effects of high-flow nasal oxygen use ın gerıatrıc patıents

Conditions: Biliary Obstruction; Oddi's Sphincter Constriction; Biliary Stones

Summary: it is designed to monitor the efficacy of nasal cannula or hıgh-flow nasal oxygen in geriatric patients for endoscopıc retrograde cholangıopancreatography procedures. the aim of the study is to evaluate the efficacy and safety of oxygen support obtained with low-flow nasal cannula and hıgh-flow nasal oxygen during endoscopıc retrograde cholangıopancreatography in the patient group at risk for adverse respiratory events. we hypothesized that high-flow nasal oxygen administration can prevent adverse respiratory events such as deep sedation and patient position that may endanger the airway safety of patients, and reduce the problems in cardiac and hemodynamic parameters that may develop.

in this retroprospective study, it was aimed to compare the effects of high flow nasal oxygen and standard nasal cannula use on hypoxia and oxygenation in geriatric endoscopic retrograde cholangiopancreatography cases performed under sedation in the prone position. data belonging to the nasal cannula group will be obtained by scanning the forms and files retrospectively. data in the high flow nasal oxygen group will be prospectively recorded during the procedure. after the general anesthesia approval of the patients who will be applied ercp, they are taken to the application room in the endoscopy unit. here, standard monitoring (pulse oximetry, electrocardiography (ecg), non-invasive blood pressure measurement) is performed according to the criteria of the american society of anesthesiologists (asa). in sedated patients for endoscopic retrograde cholangiopancreatography intervention, starting 5 minutes before sedation at 5-minute intervals; during the application, blood pressure, pulse, spo2, presence of arrhythmia, interruptions due to airway interventions are monitored by the anesthesiologist and recorded in the case report form. after the standard monitoring is established, preoxygenation is performed for 3 minutes. then, 5 l/min of oxygen is given through the nasal cannula throughout the procedure. patients who will receive oxygen support with high flow nasal oxygen (inspired o2 flo high flow oxygen therapy) will be given 40 l/min oxygen with a high flow nasal oxygen system after preoxygenation. patients will be followed for at least 15 minutes after the procedure or until the patient recovers.

Eligibility criteria:
inclusion criteria: * patients with physical condition class ii-iii of the american society of anesthesiologists, ----aged 65-90, * with spo2 of 92% and/or below in room air, exclusion criteria: coagulation disorder, nasopharyngeal obstruction, * bleeding tendency, * mental status disorder, * dementia, * cognitive impairment, * intubation, * tracheostomy, * need for oxygen therapy due to pre-existing disease, * patients on home oxygen or ventilator, * pregnancy, * recent history of epistaxis or allergy to propofol patients will be excluded.

Keywords: nasal oxygen high flow nasal oxygen geriatric endoskopic retrograde cholangiopancreatography
11c-methionine pet as prognostic marker of gliomas

Conditions: Glioma

Summary: this is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.

this is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center. we will review 11c-methionine pet data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to idh1 mutation status, mgmt promoter methylation and 1p/19q co-deletion. these markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Eligibility criteria:
inclusion criteria: * diagnosis of glioma * 11c-methionine within 30 days before surgery exclusion criteria: * absence of tumor specimen * no clinical data * 11c-methionine can not be evaluated

Keywords: glioma; 11c-methionine pet
the effect of eswt for cubital tunnel syndrome

Conditions: Cubital Tunnel Syndrome

Summary: the shock wave is a new and potential intervention for the reinnervation of peripheral nerve. the purpose of this study was to assess the effect of extracorporeal shock wave therapy on cubital tunnel syndrome.

investigators perform a prospective randomized, single-blinded study to investigate the effect of eswt in patients with cubital tunnel syndrome. patients were randomized into intervention and control group. participants in intervention group received three-sessions of eswt and single one session of eswt was given in control group. the evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Eligibility criteria:
inclusion criteria: 1. age between 20-80 year-old. 2. typical symptoms and signs of cubital tunnel, such as positive tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study. exclusion criteria: 1. cancer 2. coagulopathy 3. pregnancy 4. inflammation status 5. patients who had conditions mimicking cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.