Kornimate/medical-research-clean huggingface dataset:
early versus late initiation of ecmo (extracorporal membrane oxygenation) trial (elieo-trial)

Conditions: Acute Respiratory Distress Syndrome

Summary: this trial is a prospective randomized multicenter trial that assigns patients to either a treatment for acute respiratory distress syndrome (ards) with an extracorporal membrane oxygenation (ecmo) immediately after admission to the intensive care unit or conservative treatment. the later can undergo ecmo following failure of conservative therapy as a rescue therapy. patients will be included within 24 hours of the onset of symptoms of ards and will be randomized according to standard procedure. follow-up will be performed until day 90 after study inclusion.

patients suffering acute ards defined according to the berlin definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (pao2/ fio2) ≤ 200 (ii) bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a pulmonary arterial wedge pressure (paop) less than or equal to 18 mm hg (v) less than 96 hours from onset of ards (vi) less than 7 days from the initiation of mechanical ventilation will be treated by ecmo either within 24 hours to referral to an ards ecmo center or as rescue therapy after failure of conventional therapy. outcome measures have been chosen according to robustness and sensitivity to change. they are of high clinical impact and reflect the treatment effect desired by clinicians. primary efficacy endpoint: all cause mortality by 90-days. key secondary endpoints are: 2. 28 day all cause mortality 3. sofa organ failure scores at day at day 1-7, 14, 28 and 90 days 4. duration of mechanical ventilation support 5. icu length of stay

Eligibility criteria:
inclusion criteria: * ards as defined according to the berlin definition1 * the term "acute onset" is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization. * patients must be enrolled within 96 hours of onset of ards and no later than 7 days from the initiation of mechanical ventilation. exclusion criteria: * age less than 18 years * more than 7 days since initiation of mechanical ventilation * more than 96 hours since meeting inclusion criteria * patient, surrogate or physician not committed to full intensive care support * pregnancy

Keywords: acute respiratory distress syndrome extracorporal membrane oxygenation outcome ventilation therapy qol
potassium citrate to prevent age related bone loss

Conditions: Osteoporosis

Summary: osteoporosis, a disease in which the bones become weak and are more likely to break, is a major health problem in the united states. too much acid in the body appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. the purpose of this study is to determine the effect of various doses of potassium citrate, a supplement that can neutralize acid, on bone density and muscle mass in older, healthy adults.

over 10 million adults in the united states have osteoporosis, and another 18 million have low bone mass, a risk factor for developing this disease. each year, approximately 1.5 million fractures are associated with osteoporosis. adequate intake of calcium and vitamin d is the current nutritional approach to preventing age-related bone loss. however, even with sufficient levels of these nutrients, bone loss can still occur. too much acid in the body, caused by diet, aging, and protein metabolism, appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. potassium citrate can neutralize acids. the purpose of this study is to determine the effect of various doses of potassium citrate on bone density and muscle mass in older, healthy adults. this study will last 6 months. baseline measurements will take place from weeks 1 through 4. during this time, participants will first receive a placebo over a 2-week period. participants will then undergo a calcium balance study, involving consumption of certain study foods for 12 days and an overnight stay at the research unit for a calcium absorption test. the calcium balance study will be followed by blood collection. at week 5, participants will be randomly assigned to receive either potassium citrate or placebo daily. for the first 9 weeks of treatment, there will be weekly blood collection and periodic urine collection for all participants. at month 6, blood and urine will again be collected, and participants will complete questionnaires on diet and physical activity, and a second calcium balance study.

Eligibility criteria:
inclusion criteria: * good general health exclusion criteria: * abnormal kidney, liver, or bone function * currently taking medications that might affect potassium or bone

Keywords: calcium balance
opinion of patients under treatment that meets the criteria of new treatment strategy according to gina 2006

Conditions: New Strategies; GINA 2006; Patient Opinion

Summary: cross-sectional, one visit study. all the data will be collected through questionnaires. descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians.


Eligibility criteria:
inclusion criteria: * patients diagnosed with persistent asthma (gina 2005) for at least 6 months before entering the study * patients who are under treatment according to the new strategies described in gina 2006 for at least 3 months before entering the study exclusion criteria: * patients who are not willing to sign the informed consent form * copd patients

Keywords: asthma treatment gina 2006 patient perception
clinical efficacy of a virtual reality tool for the treatment of obesity

Conditions: Obesity, Morbid

Summary: the objective of the study, which is framed within european union's h2020 project titled socrates, is to assess the clinical efficacy of a virtual reality (vr) embodiment tool for treating obesity and to compare it to usual care, through a randomized controlled trial


Eligibility criteria:
inclusion criteria: * bmi ≥ 30 kg/m2 and ≤ 55 kg/m2. * receiving ambulatory treatment at the vall d´hebron university hospital. * no concurrent involvement in other treatment related to the obesity condition. * minimal digital skills and able to use a proper digital device (smartphone, tablet, computer). * oral and written understanding of the spanish language to complete the questionnaires and use the system. * acceptance to sign the informed consent to participate. exclusion criteria: * body mass index \> 45. * presence of an eating disorder during the last 2 years. * non-stabilised severe mental disorder that could interfere with the successful implementation of the research protocol (i.e. psychosis, depression with suicidal risk, alcohol or drug abuse, psychotic or manic symptoms). * auditory or visual complications that might affect the participant during exposure to the vr platform. * intellectual disability or any major illness seriously affecting cognitive performance (i.e. neurological disorders). * personal history of epilepsy.

Keywords: virtual reality obesity motivational interviewing embodiment psychological treatment
epidural pulsed radiofrequency treatment in failed back surgery syndrome

Conditions: Back Pain; Failed Back Surgery Syndrome; Neuropathic Pain

Summary: low back pain can persist in some patients with history of back surgery. in some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. a component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology). there are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. however, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. in this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-80 * history of at least one operation due to lumbar disc herniation * having radicular pain radiating to the lower extremities exclusion criteria: * having undergone surgery for an etiology other than lumbar disc herniation * accompanying spinal stenosis and spondylolisthesis * presence of fracture, infection, coagulopathy and pregnancy * mental disorders that may negatively affect cooperation during assessments.
nt-814: evaluation of its ability to alter the abuse liability of oxycodone in an exploratory clinical study

Conditions: Opioid Use Disorder

Summary: healthy adult men who abuse opioids and are physically dependent on them will be invited to participate in a study to examine the ability of nt-814, a neurokinin (nk) antagonist at the 1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.

after completing the screening process, participants will be scheduled for admission onto the general clinical research unit on 5-south for a 13-week study. during week 1, participants will be detoxified from opioids. during week 2 after the detoxification period, participants will be randomized to receive one of four maintenance doses of nt-814. during weeks 3-4 participants may receive oxycodone during laboratory sessions and will complete a cue exposure session involving presentation of neutral and drug cues. participants then will have the opportunity to self-administer drug by making clicks on a computer mouse. weeks 2, 5, 8, and 11 will be medication stabilization weeks following by testing during weeks 3-4, 6-7, 9-10, and 12-13. at the conclusion of the study, participants will be given an exit interview during which the study will be described. those who are interested in treatment for their drug use at the end of the study will be offered referrals to studies at our substance treatment and research service or other treatment providers.

Eligibility criteria:
inclusion criteria: * dsm v criteria for opioid use disorder moderate-severe (304.00) * physically healthy * able to perform study procedures * normal body weight (bmi \ 17.5), and total body weight \>50 kg (110 lbs) * total testosterone in the laboratory normal range (250-1100 ng/dl) * current or history of intranasal opioid use. * must be willing to use adequate forms of contraception (e.g. condoms in combination with spermicide) for the duration of the study and a specified amount of time after participation. exclusion criteria: * on parole or probation * elevated liver function (i.e. ast and alt \>2 times the upper limit of normal) or impaired renal function (creatinine within normal limits) * 12-lead ecg-based repeated demonstration of qtcf \> 450 msec at screening * hiv positive * any physical disorders that might make participation hazardous
study of the clinical scoring system and cytokines for prediction of inflammatory response in major surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome

Summary: cardiac surgery with cardiopulmonary bypass (cpb) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. the aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. this correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.

systemic inflammatory response syndrome (sirs) is commonly found in most major surgery. early detection of sirs will lead to early treatment. serum cytokines levels are reliable markers for sirs detection but with high cost and inconvenience. clinical scoring systems are commonly used for assessment of patients with sirs. if they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.

Eligibility criteria:
inclusion criteria: * adult patients who had undergone elective cardiac surgery with cpb exclusion criteria: * under 18 years of age * needing emergency surgery * needing intra-aortic balloon pump

Keywords: cytokine cardiac surgery clinical scoring system
prevalence of chronic obstructive pulmonary disease in the portuguese population

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the epicopdpt study (prevalence of chronic obstructive pulmonary disease in the portuguese population) primary objective is to estimate the prevalence of chronic obstructive pulmonary disease (copd) in the portuguese population aged 20 and over. it is a cross-sectional study of a representative sample of the portuguese population aged 20 and over, using standardised post-bronchodilator spirometry. questionnaires will be applied to collect sociodemographic, economic, clinical, and therapeutic data.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 years and over, with permanent or temporary residence for at least one year in the national territory; * written informed consent for study participation. exclusion criteria: * any condition that makes it impossible to perform spirometry, in accordance with standards of the joint american thoracic society/european respiratory society, and as described in the "contraindications for spirometry testing" section of the study procedures manual; * any condition that makes it impossible to perform the bronchodilation, as described in the "contraindications for bronchodilation" section of the study procedures manual; * severe cognitive disability that may interfere with the person's capability to participate in the study.
registry of patients referred for heart transplantation

Conditions: Advanced Heart Failure; Heart Transplantation

Summary: main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (oht) according to hfss score, other risk factors and biological markers and verification of their prognostic value in polish population.

part i 23.10.2008- 31.12.2005 creation of the polish national registry of patients referred for cardiac transplantation and after heart transplantation - including urgency of qualification and prognosis. main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (oht) according to hfss score, other risk factors and biological markers and verification of their prognostic value in polish population. all patients with advanced heart failure referred as potential candidates for oht in all active transplantation centers were included in the registry. part ii 1.01.2006 -30.11.2007 since 2006 only patients which were definitely enlisted on the waiting list for heart transplantation were included in the registry clinical and laboratory data were recorded in the internet based form. clinical data included the etiology of the disease, nyha class, duration of symptoms pharmacological therapy, left ventricular ejection fraction, ergospirometric maximal oxygen uptake (v02 max) results and right heart catheterization results , ecg data of leading heart rhythm and qrs duration \>=0,12 s and other were stored sodium ,ntprobnp levels and hs crp plasma levels were recorded during first 48 hours of hospitalization. all patients were followed in a prospective cohort study until the end point : death or oht , observations were censored at the end of the study. the urgency of oht and death data was recorded by information from participating centers and national death registry quarries. primary end point : death for all causes or urgent (unos 1) heart transplantation secondary end point: death without transplantation death or heart transplantation substudy polkard hf registry - genetic polymorphism substudy study start date 01.04.2004 end 30.10.2007 study population: all consecutive patients included into polkard hf registry, who agreed to participate and signed icf related to the substudy. estimated size 350 - 450 patients. aims: to describe the potential impact of selected candidate genes polymorphisms on the heart failure prognosis and the survival of patients after orthotropic heart transplantation

Eligibility criteria:
inclusion criteria: * men and women aged \>10 years with advanced heart failure * referred as potential candidates for orthotropic heart transplantation exclusion criteria: * refusal to participate in the registry * not enlisted for heart transplantation (since 2006)

Keywords: heart failure, prognosis, markers,heart transplantation
repetition improves precision and trueness of digital intraoral scans

Conditions: Tooth Diseases

Summary: the objectives of this study were to compare the precision of two digital intraoral scanners from a series of repeat scan images, and to investigate the effect of the learning curve on changes in trueness when scanning the full arch of the oral cavity in actual patients.

study participants: this study was approved by the institutional review board of ehwa womans university medical center mokdong hospital, and dental hygienists who were suitable for the purpose of the study were selected (ect14-02a-27). participants were assigned one of four patients, and subsequently scanned the oral cavity of a single patient 10 times repeatedly over 4 days. study design: the participants visited the dental clinic and performed scanning for 4 days. in order to investigate the difference in the precision and trueness of two types of intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner. on the first day, either of the two types of scanners (itero and trios), and a patient were assigned. then, the participants were trained in theory and practices of the assigned scanner, and subsequently, using it, scanned the dental arch of the assigned patient twice. on the second and third days, the dental arch of the same patient was scanned 3 times respectively, and on the fourth day, the experiment was finished after scanning the same patient twice. statistical analyses: collected data were analyzed using the spss ver. 20.0 statistical package. for the determination of differences in the deviations according to the scanner, the independent two-sample t-test was conducted to examine the significance of the precision data. for comparisons of trueness according to repeated learning, the repeated measure anova was used to test for differences between the scanners, clinical experience of the participants, and the scanning region within the same scanner group. the significance of time-dependent changes, and the interaction between the scanner group and time variables, were examined by within-subject tests. differences between the scanner groups were examined by between-subject tests. the significance of the 10 consecutive scans and four visits within the scanner group, and the difference between the scanner groups at each time point, were examined by the post-hoc test, which was performed using the bonferroni method as a multiple comparison (α= 0.05).

Eligibility criteria:
inclusion criteria: * the selection criteria for the participants were as follows: they had the clinical experiences between 3 - 11 years, understood the purpose of the study well, gave their consent, and were able to carry out a 4-day learning course. those who were inadequate to carry out the study mentally or physically. exclusion criteria: * applicant who was considered inappropriate .for this study by the principal investigator was excluded from the selection

Keywords: cad digital imaging prosthetic dentistry
vitamin d supplementation of lactating mothers

Conditions: Vitamin D Deficiency

Summary: the investigators would like to test the hypothesis that maternal vitamin d supplementation during lactation in dose 1200iu/d (400iu from multivitamins + 800 iu cholecalciferol) is more effective than 400iu/d (400iu from multivitamins + placebo)to built appropriate maternal vitamin d status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both. the investigators also want to confirm that vitamin d supplementation of exclusively breastfed infants in dose 400iu/d is adequate to build appropriate vitamin d status independently of mother's vitamin d supplementation up to 1200 id/d. additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin d status of pregnant women at the delivery and their newborn infants.


Eligibility criteria:
inclusion criteria: * healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem exclusion criteria: * maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment. * infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.

Keywords: vitamin d vitamin d deficiency breastfeeding body composition bone mineral content
genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery

Conditions: Prostate Cancer

Summary: this trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer

primary objectives: i. to explore the performance of these models in predicting the likelihood of biochemical recurrence (bcr). secondary objectives: i. to explore the performance of these models in predicting upgrading and upstaging prior to surgery. ii. to explore the performance of these models in improving risk stratification among patients eligible for active surveillance. iii. to determine whether prostatic massage or surgery raises the count of circulating tumor cells (ctc) in post-digital rectal exam (dre) blood specimens. outline: patients receive prostatic massage and undergo a digital rectal exam (dre). laboratory assessments are performed and blood samples are collected for molecular biology testing. on the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.

Eligibility criteria:
inclusion criteria: - all men undergoing robotic prostatectomy or cystoprostatectomy at city of hope will be eligible for the study exclusion criteria: - men who undergo neoadjuvant treatment with androgen deprivation therapy (adt) or salvage prostatectomy including those who have had brachytherapy will be excluded

Keywords: stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer