Kornimate/medical-research-clean huggingface dataset:
effect of nesiritide infusion on insulin sensitivity in healthy obese insulin resistant subjects

Conditions: Diabetes

Summary: the purpose of the study is to compare the effects of nesiritide to placebo administered by a continuous iv infusion over 48 hours for the treatment of insulin resistance in healthy, obese, insulin resistant individuals.


Eligibility criteria:
inclusion criteria: 1. age 40-65 years inclusive 2. men and women 3. able to provide written, informed consent 4. weight stable (± 3 kg) during the 3 months prior to enrollment 5. bmi ≥ 30 kg/m2; body weight ≤ 106 kg 6. resting blood pressure ≥ 110/60 mmhg and ≤ 150/100 mmhg exclusion criteria: 1. known coronary artery disease, angina or heart failure 2. type 1 or type 2 diabetes (a1c ≥ 6.5% and/or fasting plasma glucose \>125mg/dl) 3. bleeding disorders 4. hemoglobin level \< 12.5 g/dl for women; \< 13.0 g/dl for men 5. acute or chronic infections 6. hepatitis and/or cirrhosis (ast or alanine aminotransferase 2.5 times upper limit of normal) 7. severe asthma or chronic obstructive pulmonary disease 8. renal insufficiency (creatinine \> 1.6 mg/dl) 9. prior bariatric surgery 10. inflammatory bowel disease or malabsorption 11. cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ) 12. psychiatric or eating disorders 13. untreated or inadequately controlled thyroid (abnormal tsh) or other endocrine disorders 14. active rheumatoid arthritis or other inflammatory rheumatic disorder 15. pregnant or nursing women 16. presence of clinically significant abnormalities on electrocardiogram 17. smoking (within the last 3 months) 18. known hypersensitivity to nesiritide or any of its excipients 19. poor intravenous access 20. use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phenteramine or other weight loss or anorectic agents.

Keywords: human b-type natriuretic peptide
a clinical trial to evaluate the safety and efficacy of allo-asc-dfu for second deep degree burn injury subjects

Conditions: Burn Injury

Summary: this clinical trial is a phase ii controlled, parallel, open-label trial, designed to test the efficacy and safety of allo-asc-dfu and conventional therapy in deep second-degree burn wound subjects.

allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating deep second-degree burn wounds.

Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age and older. 2. subjects who have deep second-degree burn wound ≥100cm\^2. 3. tbsa(total burn surface area) ≤ 30% 4. negative for urine beta-hcg for women of childbearing age. 5. subject is able to give written informed consent prior to study start and comply with the study requirements. exclusion criteria: 1. subject who have been enrolled in another clinical study within 30 days of screening. 2. subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue. 3. subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term 4. subjects with active infection. 5. subjects with hemorrhagic and hemocoagulative disease. 6. subjects who are unwilling to use an "effective" method of contraception during the study. 7. subjects who have a history of malignant tumor within the last five years, or is currently undergoing. 8. subjects who are pregnant or breast-feeding. 9. subjects who are considered to have a significant disease which can impact the wound healing by the investigator 10. burn wound is present on any part of the face. 11. subjects who are considered not suitable for the study by the investigator. 12. subjects who are not able to understand the objective of this study or to comply with the study requirements
determination of functional exercise capacity, respiratory muscle endurance in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Healthy

Summary: there are not enough studies in the literature comparing functional capacity, respiratory functions and muscle strength of ipf patients with healthy individuals. this study aims to compare functional capacity, respiratory functions and muscle strength of ipf patients with healthy individuals.


Eligibility criteria:
inclusion criteria: * being over 18 years old * having a clinical, radiological and/or pathological diagnosis of ipf * volunteering to participate in the study * not having had a respiratory tract infection in the last month * not having an accompanying airway disease such as copd * being in the stable phase of the disease exclusion criteria: * patients who have had an ipf attack within the last three months and/or are in the acute exacerbation of the disease; who use a walking aid; who have unstable angina or class iii-iv heart failure according to the new york heart association congestive heart failure classification; who have orthopedic, neuromuscular, neurological and cardiac diseases that may affect walking and balance; who have serious comorbid conditions such as cancer or neoplasm; who have a history of sarcoidosis, tuberculosis, emphysema and/or lung surgery; who have communication problems, mental and cognitive problems, and who cannot adapt to the applied assessment methods will be excluded from the study.

Keywords: quality of life muscle strength respiratory function tests pulmonary fibrosis
cognitive biases modification treatment for social anxiety

Conditions: Social Phobia

Summary: adults with social phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns. outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on dsm-iv criteria. the investigators expect to find significant reduction in social anxiety symptoms in the treatment groups relative to the placebo control group. the investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.


Eligibility criteria:
inclusion criteria: people suffering from social anxiety exclusion criteria: pharmacological or psychological treatment

Keywords: attention bias modification treatment interpretive bias modification cognitive bias modification attention training social anxiety
topical application of gtn 0.4% in the treatment of anismus following stapled haemorrhoidopexy

Conditions: Pain After Stapled Haemorrhoidopexy

Summary: this study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.


Eligibility criteria:
inclusion criteria: * patients with symptomatic ii-iii grade haemorrhoids and rectal mucosal prolapse * adults aged ≤ 75, male or female exclusion criteria: * concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)
intra-procedural transthoracic echocardiogram to facilitate left bundle branch area pacing (lbbap)

Conditions: Heart Failure

Summary: the goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. the main questions this aims to answer are: 1. does this help the doctors with figuring out the wire location during implantation? 2. does this reduce the wire placement procedure time? 3. does this reduce the x-ray imaging time during the procedure? participants will be asked to: 1. have a physical exam and echocardiogram (ecg) at initial visit, 2 weeks post implant, and 3 months post implant. 2. have a urine pregnancy test (if applicable) 3. have a heart ultrasound during implant procedure 4. answer questions related to heart failure symptoms to see what stage of heart failure is present 5. have device interrogation (a wand placed over the chest to see that the device is working properly) at a visit 2 weeks post implant and at 3 months post implant.

the ec-lbbap study is a prospective, single-enter, observational research study. the study team will identify all patients who satisfy the inclusion and exclusion criteria. the study team will evaluate the feasibility and success rates of echocardiogram guided lbbap lead implantation. eligible patients will undergo lbbap using medtronic 3830 lead and c315his sheath. lbbap will be confirmed at implant using left bundle potentials recorded from the lead, ecg morphology during unipolar and bipolar pacing, peak left ventricular pacing (lv) activation time and lead depth in the 2d transthoracic echo at implant. during implant procedure, transthoracic echo windows will be identified and documented: parasternal short and long axis, apical 2 and 4 chamber views and subcostal views to visualize the proximal interventricular septum. following venous access using cephalic vein cut-down or ultrasound guided axillary vein access, the lead implantation in the left bundle branch region will be guided by echocardiography. retrospectively, the study team will identify 20 consecutive previous patients who satisfy inclusion and exclusion criteria (control patients). the study team will compare the difference in procedural success between case and control patients.

Eligibility criteria:
inclusion criteria: * patient with indication for permanent pacemaker or implantable cardioverter defibrillator (icd) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy * patient is willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * inability to provide informed consent * pregnant * enrolled in a concurrent study that may confound the results of this study
multicenter study to evaluate the efficacy and safety of metoclopramide nasal spray in men with diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: the purpose of this study is evaluate the safety and efficacy of metoclopramide nasal spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to metoclopramide nasal spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Eligibility criteria:
inclusion criteria: * male subjects between the ages of 18 and 75 years * willingness and ability to give written informed consent * the ability to read, understand and speak english * prior diagnosis of type 1 or type 2 diabetes * diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying * a mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization * willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study exclusion criteria: * gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility * a history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product * a history of, or physical findings suggestive of, tardive dyskinesia * a history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening * malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening * renal dysfunction calculated as creatinine clearance (crcl) \<40 ml/min at screening * hemoglobin a1c \>11.5% at screening

Keywords: diabetes gastroparesis delayed gastric emptying nausea vomiting bloating abdominal pain early satiety gastric stasis gastropathy
outcomes data of bone marrow stem cells to treat hip and knee osteoarthritis

Conditions: Hip and Knee Osteoarthritis

Summary: the purpose of this study is to determine if bone marrow concentrate may be successful in the treatment of osteoarthritis. bone marrow concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. this study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis. inclusion criteria: * subjects must be scheduled for an autologous bone marrow hip or knee injection * subjects must have a diagnosis of hip or knee osteoarthritis * subjects must be between the ages of 18 and 85 * subjects must be willing and able to sign informed consent * subjects must be willing and able to return for scheduled follow-up evaluations exclusion criteria: * subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment * subjects for whom baseline data is not available


Eligibility criteria:
inclusion criteria: * subjects must be scheduled for an autologous bone marrow hip or knee injection * subjects must have a diagnosis of hip or knee osteoarthritis * subjects must be between the ages of 18 and 85 * subjects must be willing and able to sign informed consent * subjects must be willing and able to return for scheduled follow-up evaluations exclusion criteria: * subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment * subjects for whom baseline data is not available

Keywords: osteoarthritis stem cell injections bone marrow autologous
sport as therapy: a 6-months lifestyle-intervention for patients with coronary artery disease and/or diabetes

Conditions: Exercise Training; Coronary Artery Disease; Diabetes Mellitus, Type 2

Summary: regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. the feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. the objective of this study is to translate regular exercise training into a community based setting. a 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. the aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.

from 2011, patients insured at "techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. the last phase of 12 weeks, supervised training is only once/week. patients are asked to perform exercise training 3-5 times weekly. at the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. resistance training starts after 6 weeks and is performed within the supervised training. all patients were offered an individual nutritional counseling.

Eligibility criteria:
inclusion criteria: * coronary artery disease and/or diabetes mellitus * heart failure exclusion criteria: * all conditions which are not compatible with exercise training: * severe orthopedic disorders * severe psychiatric disease * severe valve insufficiency * presence of myocardial ischemia (decision made by cardiologist)
biomarker database registry for photodynamic therapy

Conditions: Actinic Keratosis

Summary: the purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine photodynamic therapy, in order to measure biomarkers that are relevant to vitd and 5fu metabolism and might be predictive of pdt outcome. the biomarkers to be examined include serum vitd levels at the time of pdt, and the presence/absence of gene alleles that correlate with expression of several proteins involved in vitd and 5fu metabolism. the presence of these biomarkers will be correlated to the improvement in ak lesion counts at the patient's routine follow-up visit 3 months after pdt treatment.

patients who have been scheduled to receive pdt in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the informed consent (ic) that describes the purpose of the study. if the patient indicates that he/she is interested, the physician or study nurse will review the ic with the patient on the day of pdt and answer all questions. after the patient signs the ic, the patient will have their blood drawn by a caregiver who has completed pts phlebotomy training. dna samples will be stored in a locked minus 80 degree ultrafreezer, in dr. maytin's laboratory (room nd4-25a in the lerner research institute). the samples will be maintained for up to 10 years. blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit mrn along with the date that the phlebotomy was performed (i.e. the date of the blood draw). this should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the oracle database and thereby enter the subject's laboratory results into the proper data field. the informed consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the principal investigator (pi) in writing. information will not be disclosed to third party outside of cleveland clinic for research purposes.

Eligibility criteria:
inclusion criteria: * males or females, at least 18 years of age * patient has nonhypertrophic actinic keratosis, at least 10 ak lesions present on the face, scalp, forearms, chest, or legs at the time of pdt treatment exclusion criteria: * taking doxycline, a photosensitizer * using topical retinoids, since these can exacerbate the post-pdt erythema reaction * pregnant
epigenetic changes in hepatocellular carcinoma developed after direct acting antiviral therapy for chronic hepatitis c

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is the most common type of liver cancer, its survival rate ranks only second to lung cancer and it is a severe threat to human health. in egypt, hcc constitutes a significant public health problem. where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively. it has a poor prognosis after discovery, which is usually at a late stage of disease. this had been strongly linked to the hepatitis c virus epidemic that affected around 10-15% of the egyptian population during the last 3 decades, and was reported as the highest prevalence of hcv in the world. however, the pathophysiological mechanisms involved remain unclear. the occurrence of hcc is a complicated process involving multiple genes and steps. imbalances in cellular signal transduction pathways, deficiencies in dna repair regulating genes, activation of protooncogenes, inactivation of tumor suppressor genes and epigenetic modifications all promote the occurrence of liver cancer.

hcc is the fourth leading cause of cancer mortality in 2018. the alarming incidence of hcc is explained by genetic and epigenetic alterations, as well as by the presence of risk factors: hepatitis c virus (hcv), hepatitis b virus (hbv) infection, alcohol consumption, smoking, diabetes, dietary exposure to aflatoxins, and obesity. the development of direct-acting antivirals (daas) with cure rates of higher than 90% has been a major breakthrough in the management of patients with chronic hcv infection. however, although viral cure decreases the overall hcc risk in hcv-infected patients, it does not eliminate virus-induced hcc risk, especially in patients with advanced fibrosis. furthermore, convenient biomarkers to robustly predict hcc risk after viral cure and strategies for hcc prevention are absent. these unexpected findings pose new challenges for patient management. meanwhile, recent studies in patients treated with interferone-free therapy have also identified several risk factors for developing hcc after achieving sustained virological response (svr), namely advanced hepatic fibrosis and higher levels of alpha feto protein and agglutinin-positive mac-2 binding protein. epigenetics refers to inherited altered gene expression without an alteration of the dna sequence itself. epigenetic alterations, such as dna hypomethylation or hypermethylation and aberrant expression of micro-rnas have been studied and associated with hcc. epigenetic changes may represent diagnostic and prognostic biomarkers of hcc.

Eligibility criteria:
inclusion criteria: * hcc treated with daas drugs for chronic hepatitis c in assiut university hospital. exclusion criteria: * cases who started treatment for hcc like alcohol ablation or chemoembolization * hepatitis b infection * non-responder patients to daas

Keywords: hepatocellular carcinoma epigenetics dna methylation direct-acting antivirals
assessment of the effect of clonidine for cataract surgery

Conditions: Pain; Arrythmia

Summary: clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular and blood pressure and arrhythmias.the objective of this study is evaluating the analgesic effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias for cataract surgery.

after approved by the ethical committee and signed informed consent, 40 patients aged from 40 until 80 years undergoing cataract extraction will be randomized in two groups. exclusion criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency, chronic use of beta-blockage channel drugs. group 2, patients will receive a single dose of 4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will receive a sterile saline solution dose. pain intensity will be assessed with the numeric rating scale. the antiarrythmic effect will be assessed with the continuous measure by holter. the number of patients was calculated by instat graph® program. to detect difference in pain intensity of 3 between the groups by nrs, with 95% of power (estimated sd= 2.0), when the alpha level is set at 0.05, the sample should be of 20. statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. the statistical program that will be utilized is instat graph®.

Eligibility criteria:
inclusion criteria: * cataract surgery * topical anesthesia exclusion criteria: * myocardial ischemia * psychiatric disease * chronic pain * drugs dependency * use of beta-blockage channel drugs

Keywords: clonidine cataract surgery arrythmia anesthesic medication