Kornimate/medical-research-clean huggingface dataset:
nephroprotective effect of nicorandil in type 2 diabetes mellitus

Conditions: Type2 Diabetes Mellitus

Summary: this study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .


Eligibility criteria:
inclusion criteria: * patients newly diagnosed with t2dm with diet control and good glycemic index ( hb a1c\< 7 ) * age range between 18 and 60 years old. * both sexes. * stage 1and stage 2 ckd according to kdigo . * controlled htn . exclusion criteria: * pregnant and lactating females. * patients with hypersensitivity to nicorandil. * other causes of ckd or nephropathy eg : uncontrolled htn , renal malignancy , collagen disease as amyloidosis and some autoimmune disease as ( sle and rh.fever ) . * uncontrolled htn and its antihypertensive medications ( acei , arb ) and other antihypertensive medications . * patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
low dose of diltiazem for rate control of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. we will compare the standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation with rapid ventricular response in ed.


Eligibility criteria:
inclusion criteria: * atrial fibrillation with rapid ventricular response in emergency room exclusion criteria: * age\<18 * systolic blood pressure\<90mmhg * no consent

Keywords: atrial fibrillation with rapid ventricular response
weight loss and appetite reduction after percutaneous electrical stimulation dermatome t6

Conditions: Weight Loss

Summary: the patients are randomized into 4 groups : patients undergoing pens of dermatome t6 in and a 1200 kcal diet (group 1), patients undergoing pens t6 and a 2000 kcal/day, patients undergoing transcutaneous electrical neurostimulation (tens) of dermatomes t11-t12 and following a 1200 kcal diet and those patients following only a 1200 kcal diet (group 4). weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

the patients were randomized into 4 groups using an internet randomization module: patients undergoing pens of dermatome t6 in conjunction with the implementation of a 1200 kcal diet (group 1), patients undergoing pens t6 and following a normocaloric diet (2000 kcal/day) (group 2), patients undergoing transcutaneous electrical neurostimulation (tens) of dermatomes in right iliac fossa (dermatomes t11-t12) and following a hypocaloric diet (1200 kcal/day) (group 3) and those patients following only a 1200 kcal diet (group 4). weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Eligibility criteria:
inclusion criteria: * patients with obesity (bmi\>30 kg/m2) or overweight (bmi 25-30 kg/m2) exclusion criteria: * untreated endocrine disease causing obesity * serious psychiatric illness.
a safety and effective study of ginkgolides diterpene lactone meglumine injection in the treatment of ischemic stroke.

Conditions: Ischemic Stroke

Summary: the aim of this study is to evaluate the safety and effectivity of ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

after randomized to 90 + 7 days mrs 0-1 points is the primary outcome measure,evaluate the safety and effectivity of ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Eligibility criteria:
inclusion criteria: 1. aged 18 to 80 years of age, and gender not limited。 2. within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the chinese medical association of the fourth national conference on cerebrovascular disease); 3. the first onset, or always not obvious legacy of stroke sequela (mrs acuities were before the onset of 1); 4. the degree of nerve function defect score (nihss) score 4 to 24 points, body movement component (nihss score paragraphs 5 and 6) total score 2 points or higher; 5. understand and voluntarily signed informed consent. exclusion criteria: 1. head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc. 2. the serious disturbance of consciousness (ia nihss score 2 points or higher); 3. with hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis; 4. serious abnormal liver and kidney function, liver function laboratory indexes of alt \> 3 uln, renal laboratory uln cr \> 1.5); 5. a history of mental illness or dementia patients; 6. severe organ or other systemic disease, accompanied by any organ or system of malignant tumor, or ongoing anti-tumor treatment, the estimated lifetime \< 3 months; 7. significant drug or alcohol abuse; 8. allergic constitution, as well as to two or more drugs or food allergies;this medicine ingredients allergy or known; 9. have pregnancy (check blood hcg positive screening tests, namely hcg \> 5 miu/ml), during the test preparation is pregnancy or lactation in women; 10. in the past three months in other clinical trials; 11. researchers do not determine poor adherence, or any other suitable for patients to participate in this study.

Keywords: acute ischemic stroke safety and effectiveness ginkgo diterpene lactone meglumine injection
closed-loop insulin delivery in children less than 7 years of age

Conditions: Type 1 Diabetes Mellitus

Summary: the investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have type 1 diabetes. in type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. the standard treatment is to give insulin either by shots or using an insulin pump. a new device, called closed-loop insulin therapy, uses a continuous glucose monitor (cgms) linked to an insulin pump by a computer. the cgm will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. it will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. this study will compare children's current insulin therapy with the closed-loop system. the knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better type 1 diabetes care.

we will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. subjects will be admitted to the inpatient clinical research center for 48 hours. they will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.

Eligibility criteria:
inclusion criteria: * age \< 7 years old * type 1 diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months * treated with insulin pump therapy for greater than 6 weeks exclusion criteria: * any other chronic medical condition * weight below 10 kg as this is the minimal required weight for the amount of blood being drawn

Keywords: closed loop insulin delivery diabetes type 1 diabetes artificial pancreas
a single-arm study of bempegaldesleukin (nktr-214) plus nivolumab in cisplatin ineligible patients who have locally advanced or metastatic urothelial cancer

Conditions: Urinary Bladder Neoplasm; Neoplasm Metastasis

Summary: the main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (nktr-214) in combination with nivolumab by assessing the objective response rate (orr) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.


Eligibility criteria:
key inclusion criteria: * provide written, informed consent to participate in the study and follow the study procedures * eastern cooperative oncology group (ecog) performance status of ≤ 2 * measurable disease per recist 1.1 criteria * histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed tcc) * fresh biopsy or archival tissue * no prior systemic chemotherapy or investigational agent for inoperable locally advanced or muc * ineligible for cisplatin key exclusion criteria: * patients who have an active, known or suspected autoimmune disease * patients must not have received prior il-2 therapy * prior treatment with an anti pd-1, anti pd-l1, or anti cytotoxic t lymphocyte associated protein 4 (anti ctla-4) antibody, agents that target il-2 pathway, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways * patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to cycle 1 day 1 additional protocol-defined inclusion/exclusion criteria applied

Keywords: bladder bladder cancer cd122 cisplatin ineligible immuno-oncology immunotherapy locally advanced urothelial cancer metastatic urothelial cancer muc natural killer cells nivolumab nktr-214 opdivo® pd-l1 urothelial cancer urothelial metastatic urothelial carcinoma urothelial carcinoma bempegaldesleukin bempeg cpi combination il-2
a study to evaluate the efficacy and safety of ak111 in subjects with moderate to severe plaque psoriasis

Conditions: Psoriasis; Skin Diseases

Summary: this is a randomized, double-blind, placebo-controlled, multicenter phase iii clinical study to evaluate the efficacy and safety of ak111 in the treatment of subjects with moderate to severe plaque psoriasis.

this is a randomized, double-blind, placebo-controlled, multicenter phase iii clinical study to evaluate the efficacy and safety of ak111 in the treatment of subjects with moderate to severe plaque psoriasis. subjects will be randomized to receive ak111 or placebo subcutaneously and followed up to week 56.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥18 years old. 2. subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis. 3. at screening and baseline, pasi score ≥ 12 , body surface area(bsa) ≥ 10%, spga ≥ 3. 4. suitable for systematic therapy assessed by investigators. 5. subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration. exclusion criteria: 1. types of psoriasis other than chronic plaque-type psoriasis. 2. drug-induced psoriasis. 3. evidence of active tb. patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. 4. positive results of confirmatory test for hepatitis b, hepatitis c, human immunodeficiency virus (hiv) or syphilis. 5. history of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. 6. progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization. 7. history of malignant tumour within 5 years before screening. 8. previous or current autoimmune diseases. 9. allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
palliation of dyspnea with mouth piece ventilation in aecopd

Conditions: COPD Exacerbation; Dyspnea

Summary: an uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of copd without acute hypercapnic respiratory failure. subjects are recruited from the local respiratory ward. the main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.


Eligibility criteria:
inclusion criteria: * a previous diagnosis of copd * hospitalized due to acute exacerbation of copd * at least moderate dyspnea (nrs = numeric rating scale ≥ 4) * no acute hypoventilation (ph ≥ 7.35 and pco2 ≤ 6.0 kpa) * able to understand the study and to give informed consent exclusion criteria: * unable to participate and use mpv due to e.g. delirium or lack of co-operation * acute hypoventilation (ph \ 6.0 kpa) * acute need for ventilatory support * the cause of the dyspnea can be successfully treated * unable to give informed consent * a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home
assessment of dw-mri measures : reproducibility and repeatability in pelvic imaging on mr-linac with healthy volunteers

Conditions: Rectum Cancer; Pelvic Cancer

Summary: this study evaluates the reliability of functional mri measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. the aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional mri in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.

volunteers will be required to complete a questionnaire to ensure their eligibility and safety for undergoing an mri. this questionnaire, along with safety information, will be reviewed before each mr session. subsequently, volunteers will undergo three mri sessions, ideally two on the same day, with the last session scheduled 10 to 17 days apart from the previous ones. each session is expected to last approximately 60 minutes (several sequences), and no contrast agent will be injected at any point. on the first day, volunteers will have an mri on the 1.5 tesla mr-linac unity (elekta device) and an mri on a standard 1.5 tesla mri (siemens). between days 10 to 17, they will exclusively undergo an mr-linac session.

Eligibility criteria:
inclusion criteria: * ≥ 18 yo * healthy * volunteer * ability to undergo an mri exclusion criteria: * \< 18yo * contraindication to undergoing an mri (see safety questionnaire) * previous pelvic irradiation * pelvic pathology

Keywords: repeatability reproducibility mr-linac radiotherapy functional mri
revaccination with influenza vaccine gsk1247446a

Conditions: Influenza; Influenza, Human

Summary: the protocol is designed to demonstrate the safety of influenza vaccine gsk1247446a after revaccination.

the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * a male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial. * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * if the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period. * planned administration of an influenza vaccine other than the study vaccines during the entire study period * previous vaccination against influenza since january 2007. * acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period. * history of hypersensitivity to a previous dose of influenza vaccine. * history of confirmed influenza infection within the last 12 months. * pregnancy. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute disease at the time of enrolment.

Keywords: influenza influenza vaccine
cricopharyngeal dysfunction and esophageal diverticulum

Conditions: Zenker Diverticulum; Progressive Dysphagia; Pharyngoesophageal Diverticulum

Summary: patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

a prospective, multi-institutional study comparing the effectiveness of the above procedures will provide a large cohort using standardized diagnostic studies, diverticulum size measurements, treatment approaches, pre-operative and post-operative assessment of symptoms in order to both compare the effectiveness of the procedures and to stratify the patients in order to determine whether demographics such as age, pre-operative size, and/or peri-operative co-morbidities influence outcomes.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cervical esophageal diverticulum, with zenker's as most common, or cp bar (with diagnosis of early zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments. patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up. exclusion criteria: * patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.
sequential left prefrontal repetitive transcranial magnetic stimulation, with high frequency, for treatment-resistant depression

Conditions: Treatment-Resistant Depression Disease

Summary: sequential left prefrontal repetitive transcranial magnetic stimulation (rtms), with high frequency, for treatment-resistant depression have been shown to have antidepressant effects. but doubts remain about the magnitude of previously demonstrated treatment effects.the aim of this study is to test whether daily weekday left prefrontal rtms safely and effectively treats resistant depression disorder compared to sham controls.

design: prospective, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers. setting: university psychiatric hospitals in tehran including roozbeh hospital, rasool hospital and imam hossein general hospital will refer clients to iranian national center for addiction studies, tehran university of medical sciences. patients: about 60 patients with unipolar nonpsychotic major depressive disorder, according to dsm-iv, resistant to treatment. intervention: we delivered rtms to the left prefrontal cortex at 120% motor threshold (10 hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. sham rtms used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of major depression * resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials exclusion criteria: * other current axis i disorders (except simple phobia and nicotine addiction) * personal or close family history of seizure disorder * ferromagnetic material in body or close to head * neurologic disorder * pregnancy * taking medications known to lower seizure threshold (eg, theophylline)

Keywords: repetitive transcranial magnetic stimulation depression left prefrontal
non invasive assessment of heart failure

Conditions: Heart Failure

Summary: 1. to identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction. 2. portray the health profile of heart failure patients admitted in internal medicine department either heart failure with reduced ejection fraction or heart failure with preserved ejection fraction. 3. to compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy 4. vitamin d and its relation to cardiovascular disease and heart failure.

heart failure (hf) is a growing epidemic related to significant morbidity and mortality. the prevalence of the disease continuously increases due to the ageing population and success in treating cardiovascular diseases that often precede hf. lifetime risk of hf is still high with 20-45% and strongly age-dependent . structural or functional alterations in the heart lead to reduced cardiac output and rising intracardiac pressures. the resulting hf syndrome comprises typical symptoms such as dyspnoea, ankle swelling and fatigue . heart failure is classified into right sided heart failure and left sided heart failure,the later one is classified to hf with reduced ef (hfref) involving patients with an ef\< 40% and heart failure with preserved ejection fraction (hfpef) the proportion of hfpef seems to be slightly lower than that of hfref . for patients presenting with breathlessness, there is a need for a reliable biomarker for the early diagnosis of heart failure. similarly, there is also a need for better monitoring of patients receiving treatment for heart failure. non-invasive means such as a biomarker have therefore become useful. there are many potential biomarkers for heart failure, the investigators will discuss the biomarkers that are available for clinical use in patients with heart failure to further assess prognosis and possibly direct hf therapy. there is evidence that aldosterone antagonists can oppose the effect of aldosterone in promoting cardiac fibrosis.furthermore, elevated levels of cardiac aldosterone have been demonstrated in a rat model of hypertensive diastolic hf, and use of the aldosterone antagonist, eplerenone, was associated with attenuation of left ventricular diastolic dysfunction and reduction in left ventricular mass and fibrosis in this model.thus, aldosterone antagonism has the potential to be a beneficial therapeutic strategy in patients with hfpef. vitamin d has the potential to improve the symptoms ofheart failure (hf) and to modulate the disease,vitamin d supplementation can reduce blood pressure and improve skeletal muscle function and strength. animal studies suggest that active vitamin d down-regulates the renin-angiotensin-aldosterone system (raas), reduces retention of salt and water, and reduces myocardial hypertrophy.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosed heart failure dyspnea grade iii or iv 2. heart failure with ejecton fraction ≤40 exclusion criteria: 1. acute coronary syndrome. 2. active infection 3. chronic kidney diseased patients 4. conn's disease

Keywords: heart failure echocardiography