Kornimate/medical-research-clean huggingface dataset:
evaluation of cerebral parenchymal changes in patients undergoing proximal aortic surgery with deep hypothermic circulatory arrest using diffusion mri

Conditions: Cerebral Infarct; Neurological Morbidity; Neurological Complication

Summary: deep hypothermic circulatory arrest (dhca) (18 degree) without cerebral perfusion is a safe technique. resarchers use this technique in patients with proximal aortic pathologies. during the dhca period, cerebral silent ischemic events may occur. but the silent ischemic events don't neurological problems with patients.

it is important to evaluate neurological functions in patients with ascending aortic and aortic root aneurysms who underwent deep hypothermic circulatory arrest (18 degrees) and did not undergo cerebral perfusion. however, neurological changes that are reflected in the clinic are not always encountered. using preoperative and postoperative diffusion magnetic resonance imaging, silent ischemic lesions that are not reflected in the clinic can be detected. although there are studies using dw-mri in patients undergoing different cerebral protection methods in the literature, there are no studies conducted on patients who underwent deep hypothermic circulatory arrest without cerebral perfusion. to detect silent ischemic lesions with preoperative and postoperative diffusion magnetic resonance method in patients with ascending aortic and aortic root aneurysms undergoing deep hypothermic circulatory arrest (18 degrees) and without cerebral perfusion, and to investigate the correlation between preoperative and postoperative neuron-specific enolase levels and serbral findings. cerebral ischemic lesions that may occur in patients undergoing deep hypothermic circulatory arrest (18 degrees) and undergoing ascending aortic and aortic root aneurysm surgery without cerebral perfusion will be detected, and the clinical follow-up and treatment of the patients will be better managed. we base the imaging of diffusion mr among the examinations to be performed on literature studies that show that withdrawal of patients in the early postoperative period (3rd-7th days) due to the surgical method to be performed without cerebral perfusion under deep hypothermic circulatory arrest, increases the specificity and sensitivity of the test. therefore, the application of diffusion mr imaging in the early postoperative period (3rd-7th days) after a surgical technique performed under deep hypothermic circulatory arrest (18 degrees) without cerebral perfusion constitutes an indication for diffusion mr in order to detect cerebral ischemic lesions in the early period. therefore, diffusion mr imaging to be taken in the early period (3rd-7th days) will provide us with the opportunity to create an effective algorithm in terms of patient treatment and follow-up.

Eligibility criteria:
inclusion criteria: * patients with ascending aorta and aortic root aneurysm. * 18-85 years old exclusion criteria: * patients without ascending aortic and aortic root aneurysms * outside the age range of 18-85, emergency surgery, * exceeding the magnetic resonance imaging extraction time limit.
effect of oxygen-supply on 6-minute-walking-distance of copd iii/iv-patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to investigate the six-minute-walking-distance of copd-patients with breathing oxygen in comparison to breathing normal air. patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called "oxygen responders." the study is aimed to find attributes of oxygen responder and to investigate, if a patient can change the "respond" with higher performance and endurance.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease iii/iv exclusion criteria: * severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics)) * severe exacerbation during rehabilitation * cardiac insufficiency

Keywords: copd iii/iv oxygen supply six-minute-walking-test oxygen responder
single centre study to determine the antibody response to g17dt in patients with advanced pancreatic cancer.

Conditions: Jaundice; Pancreatic Cancer

Summary: the study was designed to assess the effect of jaundice on the ability of g17dt to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with g17dt either immediately (group a), or following biliary stenting when jaundice had resolved (group b). patients not jaundiced at time of presentation were to enter group b. patients received 3 intramuscular injections of g17dt at weeks 0, 1, and 3. a booster injection was offered to patients who had measurable anit-g17dt antibodies but had anti-g17dt antibodies that fell below a pre-specified threshold after week 23. patients were evaluated until study closure ort until patient death.

Eligibility criteria:
inclusion criteria: * patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection. * if patients were jaundiced, bilirubin had to be \>80 μmol/l. * male or female patients over 18 years of age. * world health organization (who) performance status of 0 to 2. * patients with a life expectancy of at least 8 weeks. * patients must have given written informed consent. exclusion criteria: * patients undergoing a potentially curative resection. * jaundiced patients with a bilirubin value \<80 μmol/l. * patients not considered fit for endoscopic or percutaneous biliary stenting. * patients receiving any other anti-cancer therapy. * history of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix. * females who were pregnant, planning to become pregnant, or who were lactating. * patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study. * previous g17dt treatment. * haematological indicators: haemoglobin (hb) \<10.0 g/dl. white cell count (wcc) \<4.0×109/l. platelets \<100×109/l.
alfuzosin for medical expulsion therapy of ureteral stones

Conditions: Kidney Stones

Summary: the goal of this study is to conduct a prospective controlled trail of four currently approved department of defense (dod) - formulary medications for use as medical expulsion therapy (met) for kidney stones. between 8% and 15% of americans will develop symptomatic urolithiasis in there life. several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (met) of distal ureteral calculi. none of these studies have been widely publicized outside the specialty of urology. recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (flomax) was used for met. met has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. the investigators will evaluate the effectiveness of met as initial management for kidney stones using dod-approved formulary medications.

patients presenting to naval medical center san diego with symptomatic ureteral stones visible on ct and kub, and who are medically stable will be offered enrollment. upon consent, patients will be randomly assigned to one of four outpatient treatment arms, randomized 1:1:1:1 and include; group 1 - alfuzosin 10 mg daily, group 2 - nifedipine 30 mg daily, group 3 - doxazosin 4 mg daily, or group 4 - prazosin 1 mg twice daily. the primary endpoint is stone expulsion rate and secondary endpoints are time to expulsion, need for additional intervention, degree of pain control, amount of narcotic use, and evaluation of study drug side effects. the treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. patients will also receive oral pain medication as needed.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * single ureteral stone \< 1 cm in greatest dimension exclusion criteria: * age \< 18 years * active unstable angina * history of or active postural hypotension (\>20 mmhg drop in orthostatic sbp) * allergy to alpha-blockers * acute or chronic renal failure as demonstrated by a serum creatinine of \> 1.4 mg/dl * urinary tract infection * multiple ureteral stones * current uncontrolled diabetes * alpha-blocker therapy within 30 days for any reason * current pregnancy or lactation * patient desire for immediate stone removal

Keywords: kidney stones ureteral stones medical expulsion therapy
loteprednol ophthalmic gel for the treatment of ocular inflammation and pain following cataract surgery

Conditions: Inflammation; Pain; Cataract

Summary: the objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

the objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (bid and tid) for the treatment of postoperative inflammation and pain following cataract surgery.

Eligibility criteria:
inclusion criteria: visit 1 (screening visit) * be willing and able to comply with all treatment and follow-up/study procedures. * be a candidate for routine, uncomplicated cataract surgery visit 3 (postoperative day 1) * have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber iol implantation, not combined with any other surgery) in the study eye. * have ≥ grade 2 anterior chamber (ac) cells (6-15 cells) in the study eye. exclusion criteria: * have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or confound the result(s) of the study. * have known hypersensitivity or contraindication to the study drug(s) or their components.
primary aldosteronism in hypertensive patients in china

Conditions: Hyperaldosteronism; Primary; Hypertension Secondary

Summary: to investigate the prevalence of primary aldosteronism (pa) in chinese patients with newly diagnosed hypertension.

this is a nationwide sampling study. to investigate the prevalence of primary aldosteronism (pa) in chinese patients with hypertension, we will conduct a case detection of pa in chinese hypertensive patients from 10 centers of china (including beijing, chongqing, shanghai, guangzhou, et al.); furthermore, a case confirmation of pa (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. this study will be completed in two years.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed hypertension(with a course less than six months); 2. drug negative, or voluntary to discontinue/change the anti-hypertensive medications; 3. aged between 18-80 year, gender is not limited; 4. voluntary to sign on the informed consent. exclusion criteria: 1. patients with severe cardiac, hepatic or renal dysfunction; 2. suspicious or confirmed other types of secondary hypertension, including cushing's syndrome, pheochromocytoma and renal artery stenosis.

Keywords: prevalence primary aldosteronism hypertension nationwide
confocal laser endomicroscopy guided medical thoracoscopy for the diagnosis of pleural disease

Conditions: Pleural Diseases; Pleural Effusion

Summary: a prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (ncle) in the diagnosis of fibrinal pleurisy of unknown etiology. patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. subjects were randomized to either the ncle guided biopsy group (group a) or the visual biopsy group (group b) according to the randomization table (1:1 ratio). ncle was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or ncle guided biopsy with histopathological results, compare whether ncle guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.


Eligibility criteria:
inclusion criteria: * patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis; * patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion; * sign informed consent. exclusion criteria: * there is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery; * hemodynamic instability; * refractory hypoxemia; * patients with pregnant and lactating patients * any illness or condition that interferes with the completion of the initial or subsequent assessment.
uvb-induced treg cells exert antigen-specific suppression through lag-3

Conditions: Psoriasis; Atopic Dermatitis

Summary: the goal of this clinical trial is to compare the immune cell population in blood of the participants with psoriasis/atopic dermatitis before and after uvb treatment. the main questions it aims to answer are: 1. how immune cells in the pbmcs from blood of participants are affected by uvb treatment 2. will uvb treatment expand the antigen-specific treg cell population 3. will uvb treatment enhance the suppressive function of treg cells participants giving written informed consent will donate their blood (20 ml) before uvb treatment begins. after 8 to 10-week treatment course, the participants will donate their blood (20 ml) again. researchers will compare immune cell population changes in the pbmcs of participants before and after uvb treatment. in addition, researchers will purify treg cells from participant blood before and after uvb treatment to test their suppressive activity by ex vivo suppression assay.

uvb irradiation suppresses immune responses partly via the induction of treg cells. however, it is still not clear whether the therapeutic effect of uvb to treat skin inflammatory diseases (such as psoriasis and atopic dermatitis) results from the increase of treg cell population. in addition, how uvb induces antigen-specific treg cells needs to be elucidated. in this study, researchers will examine the treg cell population in the blood of participants with psoriasis or atopic dermatitis under uvb treatment. we will analyse changes of immune cell populations in the blood of participants using mess cytometry. we will also investigate the suppressive function of treg cells sorted from peripheral blood mononuclear cells (pbmcs) to see whether uvb treatment will affect the function of treg cells. enrolled participants will donate 20 ml of blood before uvb treatment begins. they will receive uvb irradiation 2 to 3 times per week, and the treatment course will last 8 to 10 weeks, which is defined as a complete treatment. after a complete treatment, the participants will donate 20 ml of blood again, and the trial ends.

Eligibility criteria:
inclusion criteria: 1. at least 20 years of age 2. able and willing to provide written informed consent exclusion criteria: 1. uv exposure in the last 8 weeks before study entry 2. patients with contraindications for uv-treatment 3. history of cancer and primary immunodeficiency 4. pregnant or nursing mother 5. participating in another clinical trial

Keywords: uvb treatment antigen specificity regulatory t cell mass cytometry
effect of probiotics containing yogurts on the composition of biofilms in patients under orthodontic treatment

Conditions: Dental Caries; Oral Health

Summary: aim: to assess in vivo if the intake of yogurt containing bifidobacterium animalis ssp. lactis dn- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. methods: a crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. during periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. mutans streptococci, lactobacilli, total aciduric microorganisms, candida spp. and total cultivable microorganisms will be counted. the values before and after the treatment will be compared with wilcoxon's test (p\<0.05).


Eligibility criteria:
inclusion criteria: * excellent oral health * patients under bimaxillary orthodontic treatment exclusion criteria: * any chronic disease * antibiotics and/or antimicrobial use in the previous 3 weeks * topic fluoride or chlorhexidine use in the previous 3 weeks * presence of cavitated or active carious lesions * patients with intolerance to lactose.
a clinical trial to investigate safety/tolerability and pharmacokinetics of da-1229_01(evogliptin/metformin xr 2.5/500 mg x 2 tablets) compared to co-administration of evogliptin 5 mg and metformin xr 1000 mg in healthy male volunteers

Conditions: Type 2 Diabetes Mellitus

Summary: this phase i clinical study is to evaluate the safety/tolerability and pharmacokinetics of da-1229_01(evogliptin/metformin xr 2.5/500 mg x 2 tablets).


Eligibility criteria:
inclusion criteria: * age between 19 to 45, healthy male subjects(at screening) * body weight between 55kg - 90kg, bmi between 18.0 - 27.0 * fpg 60-125mg/dl glucose level(at screening) * volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. exclusion criteria: * volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) * volunteer who had gi tract disease(crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) * volunteer who had drug(aspirin, antibiotics) hypersensitivity reaction * subject who already participated in other trials in 2 months * subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
comparison of educational services and outcomes for patients treated for childhood cancer

Conditions: Cancer; Brain Tumor

Summary: the purpose of the study is to evaluate some educational outcomes of children treated for childhood cancer.

the aim of this telephone survey was to test the efficacy of systemic educational program services in improving school outcomes as compared to hospitals who provide educational liaison services in an ad hoc manner.data from this study will be used to help secure funding to surther investigate the broader use of educational liaison services.

Eligibility criteria:
inclusion criteria: * must have had childhood cancer or brain tumor and been diagnosed between 1994-2001 and at least 6 years of age at diagnosis. * must have been treated at golisano children's hospital or children's hospital of pittsburgh exclusion criteria: * less than 6 years of age

Keywords: cancer education learning brain tumor school
a safety and efficacy trial of the combination of aliskiren / hydrochlorothiazide (hctz)(300/12.5 mg and 300/25 mg) compared to aliskiren 300 mg in hypertensive patients

Conditions: Hypertension

Summary: evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and hctz (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years old or older. * patients with a diagnosis of hypertension. * patients who are eligible and consent to participate in the study exclusion criteria: * severe hypertension * previous or current diagnosis of heart failure. * history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci). * other protocol-defined inclusion/exclusion criteria may apply

Keywords: diastolic systolic hypertension aliskiren blood pressure hydrochlorothiazide, hctz
ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases

Conditions: Guillain-Barre Syndrome

Summary: the aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.

failed extubations are not uncommon in most icus, the failure rate ranging from 2 to 20%. since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations. many studies have been done on the effect of imt by threshold imt and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on abgs.

Eligibility criteria:
inclusion criteria: 1. difficult to wean guillain barre patients who have been on mv for at least 48 hours. difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (sbt)and may require up to 3 sbts or up to 7 d from the first attempt to achieve successful weaning (b´eduneau g. et al.,2017) and (annia f. et al.,2019). 2. age: \>18 years. 3. both sexes will be included. 4. ventilator mode: pressure support mode with fio2≤ 0.5, positive end expiratory pressure (peep) will be\<8-10cm/h2oand respiratory rate \< 25. 5. conscious oriented patient with glasgow coma score ≥13. 6. alertness will be titrated to a riker sedation agitation score of 4. 7. ph\>7.25, arterial oxygen saturation \>90%. 8. cardiovascular stability. 9. maximal inspiratory pressure from 15 to 30 cm h2o and able to trigger spontaneous breaths on ventilator. exclusion criteria: 1. persistent hemodynamic instability as life threatening arrhythmias, acute heart failure. 2. severe breathlessness, when spontaneously breathing. 3. any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course). 4. spinal cord injury. 5. skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs. 6. patients on heavy sedation and respiratory muscle paralysis. 7. high peak airway pressure (barotraumas). 8. bmi ≥ 40.