Kornimate/medical-research-clean huggingface dataset:
can insulin glargine improve myocardial function in patients with t2d and coronary artery disease (cad)

Conditions: Coronary Artery Disease; Type 2 Diabetes

Summary: the field of secondary prevention remains an extremely important goal for diagnostic and therapeutic approaches keeping in mind that 40% of all patients with acute myocardial infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known and treated and for which there are no guidelines for treatment. in this context, accumulating evidence shows beneficial effects for treating diabetes mellitus early in the course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be associated with undesired risks. accordingly, the present randomized and controlled pilot study is designed as hypothesis creating study to create first data about potential medication in early type 2 diabetes including impaired glucose tolerance of patients with known coronary artery disease as means of secondary prevention by comparing oral antidiabetic therapy with metformin with insulin glargine o.d. and by studying the respective effects on cardiovascular function and metabolism both in the fasting state and after a standardized meal. as diastolic myocardial function has emerged as important prognosticator, the hypothesis was tested that treatment with insulin glargine improves myocardial function in patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired glucose tolerance.

this is a single centre, short term (24 weeks), therapy controlled and randomized prospective study with blinded analysis of the ultrasound data in 28 patients with known coronary artery disease, normal systolic cardiac function and with newly diagnosed type 2 diabetes including impaired glucose tolerance who are treated by ≤1 oral antidiabetic medication. after recruitment and informed consent, patients are randomized to two treatment arms which takes into account age and presence or absence of therapy with statins. in one treatment arm, therapy is based on insulin glargine sc o.d., while in the other treatment arm, therapy is based on oral metformin, up to 2000 mg daily. both treatment arms will be titrated to the target of fasting glucose ≤110 mg/dl during the first 12 weeks. the patients in the insulin treatment arm will be instructed in the skills of self-medication by the departmental diabetic teaching programme prior to starting study medication and are encouraged to keep records of any episode of hypoglycemia throughout the study.outpatients visits for metabolic control and ultrasound assessment are at weeks 4, 12 and 24 after baseline and are associated with life style instructions for all patients.

Eligibility criteria:
inclusion criteria: * coronary artery disease * type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose * treatment by ≤1 oad exclusion criteria: * contraindications for metformin or insulin glargine * on insulin therapy * pregnancy and breastfeeding

Keywords: diastolic function, postmeal glucose, insulin glargine
improvement of colonoscopy preparation by new media (app)

Conditions: Gastrointestinal Neoplasms

Summary: feasibility of an newly programmed offline application for smartphones (spa, app) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

first feasibility testing of a newly programmed app/spa for android system named colopr-app. it is an strictly offline working, autonomous system downloaded to the smartphone. it creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

Eligibility criteria:
inclusion criteria: * outpatient colonoscopy * smartphone owner with android system exclusion criteria: * chronic renal failure * anticoagulants * pregnancy * diabetes mellitus (iddm)

Keywords: colonoscopy new media app colonoscopy preparation spa smartphone application
a safety and efficacy of pomalyst® capsules under the actual use in all patients who are treated with pomalyst at a dose of 1 mg, 2 mg, 3 mg, or 4 mg

Conditions: Multiple Myeloma

Summary: 1. planned enrollment period one year (the planned number of patients to be enrolled is set to 400 patients.) since all patients who are prescribed with pomalyst are registered in revmate®, enrollment using the registration form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. during a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from revmate® will be, as necessary, maintained. 2. planned duration of the surveillance anticipated to be 2 years and 6 months from the start date of release of pomalyst


Eligibility criteria:
inclusion criteria: * among relapsed or refractory multiple myeloma patients, all patients who received pomalyst will be targeted in this surveillance. exclusion criteria: * n/a

Keywords: pomalyst teratogenicity bone marrow suppression thromboembolism peripheral neuropathy infection tumour lysis syndrome somnolence depressed level of consciousness confusion fatigue dizziness acute renal failure heart failure arrhythmia interstitial pneumonia hypersensitivity hepatic function disorder jaundice
effect of malnutrition on primary and permanent dentation

Conditions: Study Focus on the Effect of Malnutrition and Dental Problem

Summary: the caries index delayed eruption and enamel malformation will recorded for a 2 group of participants

the participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and dmf score modified dde index for measurement of developmental defects in enamel

Eligibility criteria:
inclusion criteria: * parent accept to sign the informed consent participants not suffering from any other systematic disease exclusion criteria: * non coopreative patient suffering from systematic disease
a clinical trial to study the safety and efficacy of bone marrow derived autologous cell for the treatment of stroke.

Conditions: Stroke,

Summary: this study is single, centre trial to study the safety and efficacy of bone marrow derived autologous mncs(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of body and face

this study is single centre trial to study the safety and efficacy of bone marrow derived autologous mncs(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of body and face

Eligibility criteria:
inclusion criteria: * patient should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hypertension. * willingness to undergo bone marrow derived autologous cell therapy. * patient those provide fully informed consent form for the study. * ability and willingness to regular visit to hospital and follow up during the protocol procedure. exclusion criteria: * patients with pre - existing or current systemic disease such as lung , liver ( exception; history of uncomplicated hepatitis a),gastrointestinal, cardiac , immunodeficiency,(including hiv) or laboratory investigation that could cause a neurological defect.history of life threating allergic or immune- mediated reaction. * alcohol and drug abuse / dependence. * severe skin infection. * haemodynamically unstable. * subject with primary and secondary diabetes , insulin depenence,
rhodiola crenulata as an adjunctive therapy in copd

Conditions: COPD

Summary: we hypothesize that add-on rhodiola l extract capsule to the regimen of patients with moderate-to-severe copd (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.

this is a single center, randomized, double-blind, placebo controlled clinical trial. eligibility criteria: 1. moderate-to-severe copd patients 2. aged 40-80 years, 3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption, 4. no acute exacerbation of copd, 5. clinically being stable for one month and longer, 6. not undergoing exercise training program. primary endpoint: six-minute walk distance in meters at week 12.

Eligibility criteria:
inclusion criteria: 1. moderate-to-severe copd patients 2. aged 40-80 years, 3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption, 4. no acute exacerbation of copd, 5. clinically being stable for one month and longer, 6. not undergoing exercise training program. exclusion criteria: 1. uncontrolled diabetes mellitus by plasma fasting sugar \>200 mg/dl, 2. uremia or ckd stage 5, 3. chronic heart failureby nyfc iii, 4. cerebrovascular disease, 5. uncontrolled anemia by hb \< 10 mg/dl, 6. active malignant diseases, 7. other hospitalized acute illness, 8. systemic prednisolone \> 10 mg per day.

Keywords: copd, rhodiola l., clinical trial, biomarkers, spirometry
the importance of sleep quality and the blood-brain barrier in cognitive disorders and alzheimer's disease

Conditions: Blood Brain Barrier Defect; Sleep Deprivation; Sleep Apnea; Alzheimer Disease

Summary: the aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. to assess whether sleep quality is associated with the blood-brain barrier and alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of alzheimer's disease.

the aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. to assess whether sleep quality is associated with the blood-brain barrier and alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of alzheimer's disease. sleep quality impairment is a known risk factor for memory impairment. there is increasing evidence of a link between measurable sleep parameters, in particular a reduction of slow waves of deep sleep in cognitive deficits. also, breathing pauses during sleep are associated with increased daytime sleepiness and cognitive impairment. this observational study is intended to establish a possible link between subjective memory disturbances and altered sleep quality or respiratory breaks during sleep. in the run-up to this study, they performed a special mri scan of the head and a lumbar puncture (removal of nerve water) in a different context. the aim of this imaging study and the new biomarker in brain water was to investigate the function of the blood-brain barrier that occurs in alzheimer's disease. the results of the studies on the quality of sleep should be evaluated in the context of this study in connection with the findings of the mri examination and lumbar puncture.

Eligibility criteria:
the eligibility criteria are defined by the study protocol from the observational study dzne - longitudinal cognitive impairment and dementia study (delcode).
a study of cisplatin (or carboplatin) and etoposide with or without figitumumab (cp-751,871) in patients with extensive-stage small cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: this study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease small cell lung cancer.

the study prematurely discontinued on january 26, 2011 due to slow enrollment. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of extensive stage disease small cell lung cancer (sclc), with tumor biopsy sample required. * eastern cooperative oncology group (ecog) performance status 0 or 1. total igf-1 \> or = 120 ng/ml exclusion criteria: * any prior systemic therapy for small cell lung cancer (sclc) * hba1c \> or = 5.7%

Keywords: small cell lung cancer extensive stage disease sclc igf-1r inhibitor
fastthread interference screws

Conditions: ACL Injury

Summary: surgery using the arthrex peek or biocomposite fastthread interference screw for acl or pcl (pcl at us sites only, biocomposite screw pcl only) repair or reconstruction.

the objective of the study is to evaluate the continued safety and effectiveness of the peek and biocomposite fastthread interference screws used for anterior cruciate ligament (acl) and posterior cruciate ligament (pcl) repair or reconstruction (pcl at us sites only, biocomposite screw pcl only). to assess safety, device-related adverse events will be reported and evaluated over the course of the study. to evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the visual analogue scale (vas) for measuring pain in the affected knee and the knee injury and osteoarthritis outcome score (koos) as well as range of motion (rom, optional) for measuring knee functionality.

Eligibility criteria:
inclusion criteria: * subject requires surgery using the arthrex peek interference screw for acl or pcl (pcl at us sites only) repair or reconstruction or the arthrex biocomposite interference screw for pcl (pcl at us sites only) repair or reconstruction. * subject is 18 years of age or over. * subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state). * subject signed informed consent and is willing and able to comply with all study requirements. exclusion criteria: * current bilateral injury of the acl or pcl. * injury of the acl and pcl in the same knee. * insufficient quantity or quality of bone. * blood supply limitations and previous infections which may retard healing. * foreign-body sensitivity. * any active infection or blood supply limitations. * conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. * subjects that are skeletally immature.
the effect of local anesthetic and clonidine on the cutaneous silent period during spinal anesthesia

Conditions: Inguinal Hernia; Spinal Anesthesia

Summary: the cutaneous silent period is a non-invasive technique that gives insight into the function of thin a delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. it is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of a-delta and c fibers. the aim of the study is to examine functional changes of aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.


Eligibility criteria:
inclusion criteria: asa one and two status bmi 18,5 to 24 exclusion criteria: coagulation disorders polyneuropathy diabetes mellitus alcoholism systemic inflammatory and malignant diseases stroke

Keywords: levobupivacaine nerve fibers clonidine
validation of coronary calcium subtraction to improve diagnostic accuracy of coronary ct angiography

Conditions: Coronary Artery Disease

Summary: coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (ccta). a novel approach to potentially overcome this limitation is coronary calcium subtraction. the primary hypothesis of the study is: - coronary calcium subtraction ccta will improve diagnostic accuracy as compared to conventional ccta on a per-patient basis

ccta is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. however coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of ccta. a novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation. * study objective: to assess diagnostic accuracy using coronary calcium subtraction coronary ct angiography (ccta) as compared to conventional ccta. * material and methods: a total of 200 patients with suspected or known coronary artery disease (cad) who have been referred for invasive coronary angiography (ica) will prior to ica undergo additional research ccta with the newly developed coronary calcium subtraction protocol. based on the coronary calcium scan (cs), coronary calcium score will be calculated according to the agatston score. conventional contrast enhanced ccta studies will be analyzed for image quality and the presence and extent of coronary stenosis. using a dedicated algorithm, subtraction will be performed on all datasets to obtain ccta subtraction images. subtracted images will be analyzed similar to the conventional ccta images. ica will serve as the gold standard. image quality will be compared between conventional and subtracted ccta. in addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ica will be compared. finally, factors influencing the performance of coronary calcium subtraction will be evaluated.

Eligibility criteria:
inclusion criteria: * age \> 55 years * scheduled for invasive coronary angiography * logistically possible to perform ccta before invasive evaluation exclusion criteria: * known iodine-contrast allergy * estimated gfr below 50 ml/min * atrial fibrillation or other persistence cardiac arrythmia * contraindication to betablockers (bronchospasm, lvef less than 40%) * implanted pm or icd * previous mechanical heart valve surgery * inability to maintain breath-hold for at least 5 sec * patient-related condition resulting the inability of the patient to understand the informed consent form of the study

Keywords: multidetector computed tomography coronary stenosis coronary artery disease angina pectoris
composed abdominal wall analysis. collecting tissue and blood from patients undergoing elective laparosopic cholecystectomy. objective to describe the normal abdominal wall

Conditions: Hernia; Abdominal Wall

Summary: people who will be eligible to be asked about participation in the research project are individuals who seek planned care for surgery on their gallbladder due to gallstone disease. the group of patients is chosen as they can represent a normal material that enables comparison with hernia-specific disease in the abdominal wall. basic data such as height, weight, sex, age, medication and asa class will be collected in the form of a study form and stored in a database in a pseudonymised form. during the sampling of biological material, the test subjects will be under general anesthesia, which is why the sampling will not mean increased pain or discomfort other than what is standard after a gallbladder operation with the minimally invasive technique. no additional wound area will be added to the test subjects as the sample pieces are taken from the area at the umbilicus where one operates by default. the sampling is not planned to be repeated, but is performed at the time when the patients perform their cholecystectomy. during the sampling, centimeter-sized pieces of skin, fatty tissue, connective tissue and muscle are taken. furthermore, serum and plasma will be collected. two tubes of blood samples (10 ml total) are taken, centrifuged and pipetted before being frozen for later analysis. pieces of tissue are placed in formalin before transport to the laboratory. the study form regarding the patient\&#39;s basic state of health will be filled in by the operator on the day of surgery and will be stored pseudonymized when the research subject is assigned a study number. patients who are troubled by gallstone disease and are referred for minimally invasive surgery of the gallbladder at the surgical center västerbotten in skellefteå will receive oral and written information and will be asked to participate in the study. approximately 200 cholecystectomies are performed annually at skellefteå hospital. we understand that within a reasonable period of time it will be possible to include 40 patients, which is the goal, also taking into account the exclusion criteria that exist. the inclusion of patients is expected to take approximately one year


Eligibility criteria:
inclusion criteria: - individuals seeking planned care for surgery on their gallbladder due to gallstone disease exclusion criteria: * disseminated cancer, * ongoing acute inflammation of the gallbladder, * known connective tissue disease, * cortisone medication, * bmi \&gt;35, * clinically measured rectus diastasis of \&gt;4 cm and/or concurrent abdominal wall hernia * patients operated for abdominal wall hernia

Keywords: hernia
prospective population study on candidemia in spain

Conditions: Fungemia

Summary: the aim of this study is to describe the epidemiology of fungal blood infections in spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). the study is to be performed in five big cities which represent different geographic areas: barcelona, bilbao, madrid, sevilla and valencia.


Eligibility criteria:
inclusion criteria: * fungal isolate obtained from blood sample exclusion criteria: * none

Keywords: fungemia, fungal infection, susceptibility, antifungal
nebulised 3% hypertonic saline in infants with acute bronchiolitis

Conditions: Acute Bronchiolitis

Summary: this study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.

bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. clinical manifestations vary from mild to severe, even life-threatening respiratory failure. airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.

Eligibility criteria:
inclusion criteria: * pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at can tho children's hospital. exclusion criteria: * family members do not agree to let the child participate in the study. * severe respiratory failure required mechanical ventilation. * the patient left on his own during treatment.

Keywords: bronchiolitis 3% hypertonic saline