Kornimate/medical-research-clean huggingface dataset:
efficacy and safety comparison between smoflipid and lipovenoes mct

Conditions: Gastrectomy; Malnutrition

Summary: comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.

the comparison of two lipid emulsion product will be performed. patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. if the patient needs total parenteral nutrition (tpn) treatment after surgery for at least 5 days and meets all criteria, then he/she will be enrolled and randomized to ether of the groups, smoflipid or lipovenoes mct. during the treatment period, efficacy variables and safety variables will be measured. life quality evaluation will also be performed through questionnaires collection.

Eligibility criteria:
inclusion criteria: 1. age between 25 \~ 75 years old 2. postoperative (gastrectomy) patients required parental nutrition for at least 5 days 3. signed informed consent form exclusion criteria: 1. known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients 2. known type iv hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. if the fasting s-triglyceride value at the time of inclusion is \>2.26 mmol/l (\>200 mg/dl) the subject must not be included 3. severe liver insufficiency (total serum bilirubin ≧ 3 mg/dl or parental nutrition as a contraindication.) 4. severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as s-creatinine value of \>3mg/dl (250 µmol/l), or dialysis/hemofiltration therapy 5. over weight (bmi\> 30kg/m2) 6. severe blood coagulation disorders 7. inborn abnormality in amino acid metabolism 8. unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) 9. known diabetic ketoacidosis 7 days prior to randomization. 10. acute shock 11. general contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency 12. pregnancy or lactation 13. chemotherapy within 7 days before start of the trial 14. participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study 15. already accept parental nutrition therapy.
a study to assess the impact of a non-sls toothpaste upon oral mucosal desquamation

Conditions: Sloughing Skin; Mucosal Inflammation

Summary: this study is to compare the effect on oral mucosal desquamation of a non-sls toothpaste and an sls-containing toothpaste..

subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth. for visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale. the following outcomes will be generated from the sloughing data: 1. whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12; 2. subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.

Eligibility criteria:
inclusion criteria: 1. internal (university of birmingham dental school) panellists only 2. willing to sign an informed consent form and complete a medical history questionnaire. 3. must be available for the duration of the study. 4. must be a current non-smoker and not chew tobacco. 5. have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease exclusion criteria: 1. show unwillingness, inability or lack of motivation to carry out the study procedures 2. are pregnant or breastfeeding females. 3. are diabetic. 4. have severe oral mucosal problems. 5. orthodontic banding or removable partial dentures 6. have an active cold sore. 7. have any oral piercings. 8. have a mouth ulcer or who experience mouth ulcers on a regular basis, lichen planus vesiculo-bullous disorders 9. obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will effect either the scientific validity of the study or if the volunteer's participation would affect their well being 10. volunteers who are at risk from transient bacteraemias. 11. regular use of medication, which could interfere with study objectives or affect the validity of the study. 12. have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion. 13. have problem of bleeding after brushing. 14. must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks. 15. has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste. 16. the subject is participating in other studies testing oral care products. 17. the subject is an employee of unilever.
evaluation of antibody detection tests for visceral leishmaniasis diagnosis in eastern africa

Conditions: Leishmaniasis, Visceral

Summary: according to recent estimates by the world health organization (who) on eastern africa, not all visceral leishmaniasis (vl) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. the main approach for vl diagnosis involves antibody detection using the rk39 rapid diagnostic test (rdt) and alternatively the direct agglutination test (dat) to confirm clinically suspected cases. suspected cases with negative rk39 rdt and/or dat results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. unfortunately, the diagnostic performance of rk39 in eastern africa is suboptimal, particularly in settings with a high vl/hiv co-infection rate. a recently developed rdt, based on the recombinant antigen rk28, may overcome this problem, with studies reporting better performance than the rk39. however, data are not definitive, as studies comparing rk28 rdts with rk39 rdt are limited. another recently developed rdt detects immunoglobulin g1 (igg1) specific to leishmania and has shown promising results in the indian subcontinent. this study aims to undertake a multi-country assessment of the performance of rk28 and igg1 rdts, as compared to the currently used rk39 rdt.

primary objective and endpoint: to evaluate the performance of different diagnostic tests in detecting anti-leishmania antibodies to improve early diagnosis of vl in eastern africa, in particular ethiopia, and kenya. evaluation of the diagnostic performance of the rdts for primary vl diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests. design: prospective single arm diagnostic accuracy study. multicountry. with participants being suspected cases of vl

Eligibility criteria:
inclusion criteria: * patient with clinical signs compatible with vl. * is a first vl episode suspected. * patient ≥ 5 years old (≥ 4 years old in kenya). * patient from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. in the case of minors, assent from the children (12-17 years old in ethiopia, uganda and sudan, and 13-17 years old in kenya) will be obtained, as per country legal requirements. * clinical samples required vl diagnosis (peripheral blood, lymph node or bone marrow or spleen aspirate) can be obtained from the patient and patient shows willingness. exclusion criteria: * patient already on treatment for vl. * patient is a suspected vl relapse case. * patient has had previous vl episodes. * patients \< 5 years old (\< 4 years old in kenya). * pregnant woman. * patient has post/para-kala-azar dermal leishmaniasis (pkdl).

Keywords: visceral leishmaniasis diagnostics rdt eastern africa
intravenous tranexamic acid reducing intraoperative blood loss in huge meningiomas resection

Conditions: Tranexamic Acid; Intraoperative Blood Loss; Meningioma

Summary: intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. however, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. the purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.


Eligibility criteria:
inclusion criteria: * patients undergoing elective supratentorial meningioma resection with estimated tumor diameter \>5cm on brain image. * age between 18-65 years. * american society of anaesthesiologist (asa) physical status ⅰ to ⅲ * obtain written informed consent. exclusion criteria: * allergic to tranexamic acid. * history of thrombotic disease. * history of chronic kidney disease * receiving other anticoagulation or antiplatelet treatment. * refuse to provide written informed consent
satisfaction with pediatric intravenous catheter placement in the emergency department

Conditions: Intravenous Placement Procedure

Summary: the purpose of this study is to determine the satisfaction among parents and nurses of pediatric patients with iv catheter placement in the emergency department.

the objectives of this study are to evaluate whether the proportion of parents satisfied with their child's iv placement procedure is higher after the introduction of zingo compared to standard of care and to evaluate changes in nursing staff satisfaction with performing iv placement procedures after using zingo prior to iv placement compared to standard of care.

Eligibility criteria:
inclusion criteria: * phase a: parent of a pediatric patient from the age of 3 to 18 years of age who requires a peripheral iv placement in the emergency department * parent must be able to read and understand english and provide written informed consent * parent must be present during the iv placement * phase b: parent did not participate in phase a * nurse has completed zingo tm in-service training prior to participation * zingo is used prior to performing the iv placement procedure exclusion criteria: - parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study

Keywords: iv placement; parent satisfaction level
sorafenib in hepatocellular carcinoma clinical practice in italy

Conditions: Hepatocellular Carcinoma

Summary: prospective, non-interventional, multi-center study. patients affected by hepatocellular carcinoma (hcc) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with hcc under daily-life treatment conditions.


Eligibility criteria:
inclusion criteria: * patients with histologically/cytologically confirmed hcc or radiographically diagnosed as per aasld criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made * patients must have signed the informed consent form * patients must have a life expectancy of at least 8 weeks inclusion criteria must follow the approved local product information. exclusion criteria: * prior treatment with sorafenib * concomitant participation in other clinical studies exclusion criteria must follow the approved local product information.

Keywords: hepatocellular carcinoma cancer, liver sorafenib nexavar
supervised exercises compared with radial extracorporal shock wave therapy (reswt) in patients with sis

Conditions: Shoulder Pain

Summary: the purpose of this study is to compare supervised exercises with another non-operative frequently used treatment, radial extracorporeal shockwave therapy (reswt), for patients with subacromial impingement syndrome.

shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. a majority of shoulder complaints lasts for more than three months and become chronic. few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living. supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). the purpose of this study was to compare supervised exercises with another non-operative common used treatment method for these patients, radial extracorporeal shockwave therapy (reswt). the study is designed as a randomised, single blind clinical controlled study.

Eligibility criteria:
inclusion criteria: * subacromial shoulder pain lasting for at least three months and age between 18 and 70 years. * dysfunction or pain on abduction * had a normal passive glenohumeral range of movement * pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º) * positive hawkins-kennedys test. exclusion criteria: * shoulder pain bilateral (both shoulders required treatment) * earlier operated in affected shoulder * had multidirectional instability * had the cervical syndrome * rheumatoid arthritis * clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology * not able to understand spoken or written norwegian * considerable emotional distress * needed anticoagulant medicine * being pregnant * had had shock wave therapy or supervised exercises before.

Keywords: shoulder pain supervised exercises radial shock wave therapy
ligation of the intersphincteric fistula tract (lift) + biodesign for anal fistula

Conditions: Anal Fistula

Summary: the lift+biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the biodesign® tissue graft as part of their lift procedure.


Eligibility criteria:
inclusion criteria: * persistent primary or recurrent trans-sphincteric anal fistula exclusion criteria: * patients with prior fistulotomy, fistulectomy, lift, cutting seton or advancement flap procedure * fistula with multiple tracts * recto-vaginal fistula * active infection in the anal fistula * physical allergies or cultural objections to porcine products * patient is not medically fit to undergo the lift procedure as judged by the treating physician * previous diagnosis of collagen disorder * history of crohn's disease, irritable bowel syndrome, radiation therapy in the rectoanal region

Keywords: anal fistula ligation of the intersphincteric fistula tract lift tissue graft
a prospective observational trial to determine cardiovascular diseases in hiv-infected patients

Conditions: HIV-infection; Coronary Heart Disease; Myocardial Infarction; HIV-encephalopathy; Heart Failure; Aging

Summary: the hiv/heart study (hivh) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (cvd) in hiv-infected patients. the study population includes outpatients from specialized hiv-care units of the german ruhr region, who were at least 18 years of age, were known to have a hiv-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. from march 2004 (pilot phase) to may 2014 (7,5 year follow-up) 1481 hiv+ patients were recruited in a consecutive manner. the standardised examinations included a targeted assessment of medical history and physical examination. blood was drawn for comprehensive laboratory tests including hiv specific parameters (cd4 cell count, hiv-1 rna levels) and cardiovascular items (lipid concentrations, bnp values and renal parameters). furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ecgs) and transthoracic echocardiography (tte). examinations were completed in accordance with previously defined standard operating procedures. cvd were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

a comprehensive detailed description of the study procedures had been previously published (european journal of medical research 2007;12:243-248). comprehensive non invasive cardiovascular examination * anamnesis * file recherche,physical examination * documentation of the cardiovascular and antiretroviral medical therapy * electrocardiogram * transthoracic echocardiography * exercise electrocardiogram * exercise montreal cognitive assessment test * exercise the grooved pegboard test * blood collection * questionnaire to quality of life and health economics

Eligibility criteria:
inclusion criteria: * age \> 18 years * known hiv-infection * written informed consent exclusion criteria: * acute cardiovascular disease * unstable hemodynamic status in the three weeks before inclusion * pregnancy

Keywords: hiv, aids antiretroviral therapy aging heart failure coronary heart disease myocardial infarction hiv-associated neurocognitive disorders
a safety study of khk4951 in healthy volunteers and patients with wet age-related macular degeneration

Conditions: Healthy Volunteers; Wet Age-related Macular Degeneration

Summary: the purpose of this study is to evaluate safety and tolerability after administration of khk4951 in healthy volunteers and patients with wet age-related macular degeneration.


Eligibility criteria:
inclusion criteria: healthy volunteers * voluntary written informed consent to participate in the study * japanese or white men 20 to \< 50 years at the time of informed consent * bmi 18.5 to \< 30.0 at screening * intraocular pressure (study eye) 10.0 mm hg to 21.0 mm hg * monocular or binocular visual acuity (corrected visual acuity if correction is required) ≥ 1.0 at screening inclusion criteria: patients * voluntary written informed consent to participate in the study * age ≥ 50 years at the time of informed consent * amd-associated by active subfoveal cnv lesions in the study eye or juxtafoveal cnv lesions with cnv-associated findings in the fovea in the study eye * cst ≥ 300 μm in the study eye at screening, as measured by oct * bcva score ≥ 23 letters in the study eye at screening and enrollment, as measured by the etdrs visual acuity chart * bcva score ≥ 58 letters in the non-study eye at screening, as measured by the etdrs visual acuity chart * in subjects with prior treatment of the study eye with anti-vascular endothelial growth factor (anti-vegf) drugs such as beovu, eylea, lucentis, avastin, or macugen, presence of response to the anti-vegf drug(s) as judged by the investigator or subinvestigator based oct, fa, visual acuity, or other assessment results exclusion criteria: healthy volunteers * current illness requiring treatment * history of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct * history of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease) * history of or current dry eye * abnormal findings on oct at screening or enrollment examination exclusion criteria: patients * clinical findings or a history of conditions other than wamd affecting the retina and choroid (e.g., diabetic retinopathy, diabetic macular edema, myopic cnv, retinal vein occlusion, or premacular membrane) in either of the eyes * any of the following diseases in the study eye: * glaucoma * ischemic optic neuropathy * retinitis pigmentosa * current or history of vitreous hemorrhage or macular hole in the study eye * any abnormality in the anterior segment of the eye or vitreous body that may affect fundus observation by oct, color fundus photography, or fluorescein angiography
a single-dose, dose-escalation study of a long-acting mod-6031 in healthy overweight or obese subjects

Conditions: Obesity

Summary: mod-6031 is a long-acting reversibly pegylated oxyntomodulin (oxm) therapeutic. the active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human oxm and is an agonist for both glucagon-like peptide-1 (glp1) and glucagon (gcg) receptors. the peptide is a natural appetite suppressant, secreted by l-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. thus, mod-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.

this will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of mod-6031 or matching placebo (6 mod-6031 to 2 placebo subjects). the initial mod-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. each subject will receive a single study drug injection in the morning (dosing day designated as day 0) and will be monitored for 30 days.

Eligibility criteria:
inclusion criteria: * healthy male, between 18 to 55 years of age. * bmi 27-35 kg/m2 (inclusive). * generally good health. * triglyceride ≤ 400mg/ml * ecg with no clinically significant abnormalities. * negative hiv, hepatitis b or hepatitis c serology tests at screening * no significant abnormalities in clinical laboratory parameters * no history of alcohol or drug abuse. exclusion criteria: * history of clinically significant medical condition. * any cardiac conduction defect. * any acute or unstable disease. * history of malignancy diagnosed within the past 5 years. * known or suspected diabetes and/or hba1c \>6.4% on screening. * known allergy to any drug. * treatment with weight loss drugs (within 3 months prior to dosing). * liposuction or other surgery for weight loss within the last year. * evidence of eating disorders (bulimia, binge eating). * history of regular alcohol consumption exceeding. * use of tobacco or nicotine-containing products. * subjects that have difficulty fasting or consuming the standard meals that will be provided.

Keywords: obesity