Kornimate/medical-research-clean huggingface dataset:
initial temperature of high flow nasal cannula

Conditions: Oxygen Therapy

Summary: in the literature there are no indication on which is the best setting of the humidification temperature at the start of treatment with high flow nasal cannula (hfnc) in intensive care unit (icu). the primary objective of this study is to understand whether there is a difference between the approaches to the humidification temperature for initiating hfnc treatment based on the perceived comfort of icu patients. we hypothesize that a gradual increase in temperature (31-34-37°c or 34-37°c) could lead to a different comfort as compared to 37°c as initial starting setting. the secondary aim is to assess the patient's dryness and humidity level of the nose.

this is a single-center, parallel arm (1:1:1) interventional, non-pharmacological, pragmatic randomized trial. adult patients who need hfnc treatment for clinical indication will be enrolled and receive a different initial temperature of humidification. the treatment with hfnc will be carried out as it normally happens for clinical practice, that is the doctor will decide the oxygen concentration, from 21 to 100%, and the flow, from 30 to 60 liters / minute (usually 40-60 liters / minute), according to the patient's level of hypoxia. for the specific purpose of this study, the humidification temperature will be set by the nurse based on the enrollment arm (37°c vs 34-37°c vs 31-34-37°c) rather than by clinical decision. the 37°c arm implies the setting of the temperature immediately at 37°c. the 34-37°c arm implies the setting of the temperature at 34°c and after 15 minutes at 37°c. the 31-34-37°c arm implies setting the temperature initially at 31°c, after 15 minutes at 34°c and after another 15 minutes at 37°c. after 30 minutes at 37°c (target temperature), the patient will be asked to indicate his comfort level, using 5 score visual numerical scale (vns) ranging from 1 (extreme discomfort) to 5 (best comfort) and the dyspnea level, using borg scale ranging from 1 (no dyspnea) to 10 (extreme dyspnea). the level of dryness of the nose, hfnc settings and vital signs will also be recorded for each step. the treatment with hfnc will be provided with the airvo 2 (trade mark) system (fisher \& paykel healthcare, new zealand). all study procedures will be performed at the icu of the fondazione irccs (scientific institute for research, hospitalization and healthcare) ca' granda ospedale maggiore policlinico.

Eligibility criteria:
inclusion criteria: * patients need hfnc as per clinical indication * patients without icu delirium (cam icu negative) exclusion criteria: * patients unable to express informed consent

Keywords: hfnc, patient comfort, temperature
eliminating learning curve related morbidity in fast track laparoscopic roux-en-y gastric bypass

Conditions: Postoperative Complications; Operative Time; Surgical Volume

Summary: background: laparoscopic roux en y gastric bypass (lrygb) is associated with a significant learning curve. we report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track lrygb. method: using a stepwise training programme the ry gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. a laparoscopic surgeon without experience in upper gi surgery was mentored by an experienced bariatric surgeon. during 6 months full time fellowship 300 operations were performed. results: the trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. in 110 patients the trainee performed both procedures. two percent had peri-operative complications compared to 1% of 1000 patients. all were repaired and had an uneventful recovery. two percent had postoperative complications \< 30 days compared to 2.8% in the clinic. in the trainees series there were no leaks compared to 1% in 1000 patients. operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic. conclusion: using a systematic training program in laparoscopic ry gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.


Eligibility criteria:
inclusion criteria: patients undergoing laparoscopic gastric bypass exclusion criteria: * super obesity * male patients

Keywords: laparoscopic gastric bypass learning curve complications operative time
efficacy evaluation of dotarem compared to gadovist in the diagnosis of peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: this study is an efficacy evaluation of dotarem®-enhanced magnetic resonance angiography (mra) compared to gadovist®-enhanced mra in the diagnosis of clinically significant abdominal or lower limb arterial diseases.


Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years. * patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages ii-iv according to the classification of leriche and fontaine) or/and doppler ultrasonography indicating abdominal or lower limb arteriopathy. * patient scheduled for a conventional x-ray angiography (intra-arterial digital substraction angiography = dsa) within 30 days of mra with a minimum time interval of at least 24 hours between the 2 examinations. exclusion criteria: * patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of mra and x-ray angiography will be performed. * patient who had a major cardiovascular event within 30 days prior to the inclusion. * patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

Keywords: mra-contrast agent comparison in peripheral disease
effectiveness of sacral foam pad in preventing pressure injury in surgical patients with supine position

Conditions: Pressure Ulcer

Summary: in surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility. the objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

the incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. sacral foam pad (mepilex(®) border sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. in this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. the patients will randomized to control and intervention groups, both groups recruited 105 patients. in control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (mepilex(®) border sacrum) in intervention group. after surgery, the occurrence and severity of sacral pressure injury was evaluated. the results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.

Eligibility criteria:
inclusion criteria: 1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.patients have no any skin lesion. exclusion criteria: 1. under 20 years 2. patients have any skin lesion.
study of rimonabant/metformin combinations to investigate diabetes (blood sugar) control in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in glycosylated hemoglobin 1c (a1c) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. the secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising high density lipoprotein cholesterol (hdl-c) in comparison with metformin at 9 months. another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

the duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. this study will end for all patients when the last patient has been treated for at least 9 months.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ada criteria) * patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline a1c assessment in all patients * a1c ≥7.0 % and ≤10.0 % * fasted plasma glucose at screening visit ≤260 mg/dl (14.44 mmol/l) exclusion criteria: * treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit * in the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days * presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders * presence or history of cancer within the past five years * pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: rimonabant/metformin combination
predictive model for postoperative mortality

Conditions: Postoperative Complications

Summary: surgery has risk of morbidity and mortality. risk factors include: patient factors; surgical factors; and anesthetic factors. the risk is much higher in emergency cases. the study of relevant risk factors can lead to improvement in patient management and reduction in mortality.

objective: to identify risk factors for postoperative mortality within 3 days in adult patients undergoing emergency surgery and construct a predictive model. methods: this will be a retrospective, exploratory and analytical study. all medical records of adult patients undergoing emergency surgery between january 2013 to december 2014 will be used to analyze for relevant risk factors using binary logistic regression analysis. a predictive model to predict postoperative morbidity within 3 days will be constructed.

Eligibility criteria:
inclusion criteria: * emergency surgery * age =\> 18 years exclusion criteria: * caesarean section * incomplete medical record
the psychological effects of different sedation protocol on mechanically ventilated critically ill adults.

Conditions: Sedative Withdrawal Delirium

Summary: the study was designed to explore the effects of different sedation protocol on incidence rates of delirium and ptsd in severe patients with mechanically ventilation.


Eligibility criteria:
inclusion criteria: * written informed consent * critically ill adults whose expected time of mechanical ventilation is longer than 24 hours * aged between 18 years old to 85 years old. exclusion criteria: * subjects with brain injury; * history of cardiopulmonary resuscitation; * mental disability; * taken neuromuscular blocking drugs; * inability to exchange; * contraindicated to midazolam or morphine; * inconvenience to daily interruption
platelet transfusion in hbv-related acute-on chronic liver failure

Conditions: Acute-On-Chronic Liver Failure

Summary: acute-on-chronic liver failure (aclf) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. it is associated with multi-organ failure and a high risk of short-term mortality. thrombocytopenia is common in aclf. in addition, the function of platelet is also compromised according to our previous data. the aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of hbv-related aclf. this is a single center, open labeled randomized controlled study. there are two arms. subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. while those in standard medical treatment group will receive standard medical treatment only. the major endpoint is 28-day transplant-free mortality rate.


Eligibility criteria:
inclusion criteria: * age 18-60 years old * diagnosed with acute-on-chronic liver failure (grade-2) according to easl-clif criteria and grading system. * chronic hepatitis b infection. * adp inhibition rate ≥70%. exclusion criteria: * combined with chronic liver disease other than chronic hbv infection. * previous decompensation. * intracranial hemorrhage proved by radiological methods, symptoms and physical signs. * under anti-platelet or anticoagulants therapy within 4 weeks. * esophageal variceal bleeding within 1 week. * platelets transfusion within 1 week. * hepatocellular carcinoma or other types of malignancies. * pregnancy or breastfeeding. * severe chronic extra-hepatic disease. * comined with situations that researchers considered not suitable for inclusion * refusal to sign the informed consent form.

Keywords: acute-on-chronic liver failure platelet hepatitis b
development and validation of an adl-score based on fim and ebi

Conditions: Neurologic Disorder; ICF; Medical Rehabilitation; Assessment; Functional Independence; Observational Study

Summary: the aim of this mixed-methods-study is to develop and validate an algorithm to transform fim (functional independence measure) and ebi (extended barthel index) into an adl score (activities of daily life) that can be used to compare outcome quality of rehabilitation clinics. the following steps are performed: 1. development of an adl-algorithms by experts 2. validation of the adl-algorithms in a quantitative approach 3. finalization of the adl-algorithms by experts based on study results


Eligibility criteria:
inclusion criteria: * admission to in-patient neurologic rehabilitation clinic exclusion criteria: * no sufficient language skills (german, french or italian)
exercise therapy in patients with peripheral artery disease: evaluating the clinical effectiveness of exercise therapy and exploring determinants of improvement

Conditions: Peripheral Arterial Disease

Summary: i. to investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (wp i) ii. to assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (wp ii)


Eligibility criteria:
the study population will comprise patients diagnosed with lower-extremity artery disease (abi ≤0.9 and/or 20% decrease after a maximal treadmill test) suffering from intermittent claudication (rutherford 1-3) presenting with new complaints (at least 6 months after previous revascularization) at the vascular center of university hospitals leuven will be included if according to current guidelines their initial treatment should be conservative inclusion criteria: * age \> 17 yrs * abi ≤0.9 and/or 20% decrease after a maximal treadmill test * intermittent claudication (rutherford 1-3) * ability to undertake an exercise test and read and understand dutch questionnaires exclusion criteria * exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing * other comorbidity limiting participation in the exercise group
cell-wave study: combined extracorporal shock wave therapy and intracoronary cell therapy in chronic ischemic myocardium

Conditions: Congestive Heart Failure

Summary: extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction. shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy

single center, phase i-ii study (safety, feasibility and efficacy) double-blind, randomised trial (cell therapy), single blind (shockwave)

Eligibility criteria:
inclusion criteria: * patients with chronic ischemic heart disease * patients with anterior myocardial infarction \> 3months * ef \< 50% or nyha ii-iv * age 18-80 * informed consent exclusion criteria: * ventricular thrombus * infarct \< 3 months. * active infection or fever * chronic inflammatory disease (e.g m. crohn, rheumatoid arthritis) * hiv infection oder active hepatitis * neoplastic disease w/o complete remission within 5 years * stroke \< 3months * creatinine \> 2 mg/dl * relevant liver disease (got \> twice the upper limit). * anemia (hemoglobin \<10 mg/dl) * thrombocytopenia \< 100.000/µl * allergies to aspirin, clopidogrel, heparin * history of bleeding disorder * history of coagulopathy * gastrointestinal bleeding \< 3 months * surgery or trauma \< 2 months * pregnancy * mental retardation * participation in other clinical study \< 1 month

Keywords: extracorporal shock wave therapy cell therapy
study of growth hormone and bone in obesity

Conditions: Obesity; Osteopenia

Summary: obesity is an important risk factor for osteoporosis and fractures. with the growing prevalence of obesity in the u.s., understanding the pathophysiology of bone loss in this population is of importance to public health. growth hormone (gh) is a critical mediator of bone homeostasis and is markedly reduced in obesity. our preliminary data suggest an important role for the gh/insulin-like growth factor 1 (igf-1) system in the pathogenesis of bone loss in obesity. the development of novel imaging techniques provides an opportunity to investigate the effects of gh on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. the investigator hypothesizes that low-dose gh administration for 18 months will improve skeletal health.


Eligibility criteria:
inclusion criteria: * ages 18-65 and generally healthy * bmi ≥ 25 kg/m2 * bone mineral density (bmd) t score ≤ -1.0 and \> -2.5 (as measured by dxa) exclusion criteria: * for women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome * history of diabetes mellitus, cancer or other serious chronic disease * use of osteoporosis medications * anemia
muscle energy technique versus myofacial release in adolescents with spinal deformity

Conditions: Idiopathic Spinal Deformities

Summary: spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important. this study will investigate the effect of muscle energy technique compared to myofacial release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).


Eligibility criteria:
inclusion criteria: * children in this group will be healthy category according to cdc (centers for disease control and prevention) growth chart which ranged from bmi-for-age 5th to 85th percentiles . all children are normal \&perform all activities of daily living * they were able to understand and follow verbal commands and instructions included in the testing procedures. exclusion criteria: * all of them could be part of recreational activities in their public schools but no competitive sports. children who participated in any regular sport activities involving the lower extremities will be excluded. * none of them had any surgical intervention . * none of them had any history of other musculoskeletal deformities or neuromuscular disorders. * hey had neither visual, auditory defect.
pulsehaler drug deposition study in chronic obstructive pulmonary disease patients

Conditions: COPD

Summary: this study is aimed at finding the effect of pulsehaler™ with albuterol on lung deposition of aerosol and on pulmonary functions in copd patients


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd), established for at least 1 year * post-bronchodilator fev1/fvc \< 0.7 * post-bronchodilator fev1 in the range 30% - 70% predicted * age: 40 years or older * patient signed the informed consent form exclusion criteria: * pneumothorax in the past, per anamnesis. * women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive. * severe cardiac disease, e.g., congestive heart failure (chf) grade 3 or higher * coronary artery bypass graft (cabg) or acute myocardial infarction (mi) within last 3 months * other severe systemic disease * non-cooperative or non-compliant patient
paravertebral block, an adjunct to general anaesthesia for breast surgery?

Conditions: Breast Cancer

Summary: aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

usually breast tumour surgery in the academic hospital maastricht is performed under general anaesthesia. perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc bupivacaine 0.25%. postoperative pain management consists of paracetamol, occasionally combined with naproxen, and if necessary piritramide 0.2 mg/kg i.m. alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (pvb) with or without general anesthesia. a pvb according to eason and wyatt (1) can be performed preoperatively with insertion of an end-hole catheter t3-t4. with this technique we expect a better pain relief postoperatively.

Eligibility criteria:
inclusion criteria: * extended mamma surgery one-sided * asa class i and ii exclusion criteria: * all contra indications for local anaesthesia * coagulation disorders * infection * allergic reactions

Keywords: asa class i and ii