Kornimate/medical-research-clean huggingface dataset:
hp129 xenon imaging and bos in lung transplantation

Conditions: Bronchiolitis Obliterans

Summary: the research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of bos, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. this research may improve patient outcomes through earlier diagnosis of changes leading to bos by obtaining image guided research biopsies of transplanted lung. biopsies may be used for future research of ex vivo biomarkers of bos and in the development of treatments through future clinical trials.

this protocol aims to * develop new imaging methods that are sufficiently sensitive to allow early diagnosis of bos. * improve patient treatment outcomes through earlier diagnosis of changes leading to bos by obtaining image guided biopsies of transplanted lung. * provide image guided biopsies for use in future research of ex vivo biomarkers of bos and in the development of treatments through future clinical trials. the study will achieve these aims through a prospective, non-randomized, longitudinal, observational study that will recruit about 5 subjects a year for 5 years. the study will follow these post lung transplant patients at 6 months and 1 year with 129xe mri (hyperpolarized 129xenon magnetic resonance imaging) and image guided bronchial biopsies to detect early bos and to better understand bo disease progression. the biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to bos and to facilitate identification and validation of translatable pharmaceutical targets.

Eligibility criteria:
inclusion criteria: * lung transplantation within the last 10 years or being assessed for possible lung transplantation. * participant must be able to hold their breath for up to 16 seconds. exclusion criteria: * standard mri exclusion criteria * bleeding disorders * participant is claustrophobic or otherwise unable to tolerate the imaging * pregnancy or positive pregnancy test * symptoms of respiratory infection within the past two weeks. * baseline oximetry at mri visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
intensive intervention to improve lifestyles in subjects with intermediate cardiovascular risk.

Conditions: Cardiovascular Risk Factor

Summary: this is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. subjects will be selected by consecutive sampling at urban primary care health centers from salamanca (spain) and they will be randomized to a control or an intervention group. both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. the effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.


Eligibility criteria:
inclusion criteria: * adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the framingham risk equation will be included. exclusion criteria: * personal history of atherosclerotic disease. * unable to do exercise or follow the mediterranean diet. * institutionalized. * terminal illness. * mental disorders that limited the intervention compliance.

Keywords: health education life style risk factors cardiovascular diseases cognitive performance quality of life
clinical outcomes of early kasai surgery with umbilical cord mscs in biliary atresia

Conditions: Biliary Atresia; Kasai Portoenterostomy; Mesenchymal Stem Cell Transplantation; Liver Function Disorders; Liver Fibrosis; Survival Rate

Summary: the goal of this clinical trial with historical control is to evaluate whether umbilical cord-derived mesenchymal stem cell (uc-msc) therapy can improve clinical outcomes in infants with biliary atresia undergoing kasai surgery before 90 days of age. the main questions it aims to answer are: does uc-msc therapy improve liver function parameters (bilirubin, albumin, liver enzymes, coagulation profile)? does uc-msc therapy reduce complications such as anemia, ascites, jaundice, and improve peld scores? does uc-msc therapy improve overall survival compared to standard kasai surgery alone? researchers will compare the group receiving uc-msc in 2025-2027 with a historical control group of patients who previously underwent kasai surgery without uc-msc therapy. participants will: undergo preoperative evaluation, including laboratory and imaging tests. receive kasai surgery combined with intraoperative trans-portal vein injection of 20 million uc-mscs. be monitored postoperatively through serial laboratory tests, imaging (fibroscan), and clinical assessments at scheduled intervals. be followed up for potential serious adverse events and survival outcomes.


Eligibility criteria:
inclusion criteria: * infants diagnosed with biliary atresia confirmed by intraoperative findings. * underwent kasai portoenterostomy at an age less than 90 days. * parents or legal guardians have provided informed consent to participate in the study and follow all study procedures. exclusion criteria: * infants with severe malnutrition. * infants with major congenital anomalies other than biliary atresia. * infants with positive tumor markers.
managed ventricular pacing ("mvp") trial

Conditions: Heart Disease

Summary: the purpose of the study is to compare two device settings (sets of instructions) used by the icd. the implantable cardiac defibrillator ("icd") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). the study will compare how much time either icd wire is used by the icd and the status of congestive heart failure.

recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure (chf) in some implantable cardioverter defibrillator (icd) patients. chf refers to symptoms (shortness of breath, fatigue, fluid overload) caused by decreased pumping action of the heart muscle. the icd can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). both settings allow the heart to beat more naturally using its own electrical signals. two device settings will be compared. managed ventricular pacing (mvp) will allow the icd to use both wires only as necessary. this setting allows the icd to send electrical signals to the top and bottom chambers of the heart if needed. the other setting, ventricular pacing (vvi) will allow the icd to operate the bottom chamber of the heart if it is needed.

Eligibility criteria:
inclusion criteria: * conventional indication for icd therapy according to current evidence-based guidelines and in accordance with the corresponding united states centers for medicare and medicaid services national coverage determination for the use of icds. * prior myocardial infarction ("mi") and an left ventricular ejection fraction ("lvef") of less than 30% * ischemic dilated cardiomyopathy (idcm), new york heart association ("nyha") class ii or ii heart failure, and lvef less than or equal to 35% * non-ischemic dilated cardiomyopathy (nidcm) greater than 3 months, nyha class ii or ii heart failure, and lvef less than or equal to 35% * first icd implant * successful implant with a study device with approved labeling exclusion criteria: * failure to meet any of the inclusion criteria * class i pacing indication * chronic atrial fibrillation ("af") without any documented sinus mechanism for at least 6 months * inability or unwillingness to give informed consent * life expectancy less than 12 months or a heart transplant anticipated within 6 months * inability to successfully comply with study participation and follow up requirements * patient involved in another clinical trial that may confound the results of the study

Keywords: icd pacing heart failure
electronic distraction for icu patients

Conditions: Adult ICU Patients

Summary: this is a feasibility study of electronic devices in order to reduce neuro-psychological disorders and suffering in intensive care unit (icu) patients. a first step study is necessary to define which device is effective and safe to reduce symptom intensities, among music therapy, virtual reality with real pictures, virtual reality with artificial pictures, and common devices (radio or television). if some devices are effective to reduce patients' symptoms, a second step will be to implement and assess the impact of these tools in a multicenter trial.

quality of life following intensive care unit discharge is more and more anticipated during the icu stay. psychological trauma during icu stay, related to medical management, can be very deleterious at short and long term, inducing psychological troubles as post-traumatic stress disorder and delaying the return to a normal social and professional life. for this reason, managing patients' distress is particularly important in the intensive care setting. there has been an increasing number of new technologies for the distraction of patients in different settings. a today, a large amount of electronic distraction is available. tv and radio are available in each icu, music therapy has already been studied and it is currently used in some icus. virtual reality (vr) is used to improve attention and memory in stroke patients. furthermore, vr seems to decrease stress post trauma disorders and phobia, as well as pain and anxiety during surgical procedures and physiotherapy. our first step study will help us to determine which electronic distraction has the most effect on the top five discomfort symptoms frequently observed in icu: pain, anxiety dyspnea, thirst and sleep privation.

Eligibility criteria:
inclusion criteria: * patient admitted in intensive care unit, * adult, * french speaking, * awake (rass ≥ -1), * not delirious (cam-icu negative), exclusion criteria: * patient refusal * psychosis or preexisting cognitive dysfunction * cerebral injury, * hygiene/microbiological harm, * pregnancy, * decision of withdrawal of care

Keywords: icu pain anxiety thirst dyspnea sleep discomfort distress virtual reality music therapy
anti-mers-cov convalescent plasma therapy

Conditions: Respiratory Distress Syndrome (& [Hyaline Membrane Disease])

Summary: since the first report of the middle east respiratory syndrome corona virus (mers- cov) in september 2012, more than 800 cases have been reported to the world health organization (who) with substantial mortality.

world knowledge about this virus is accumulating but data about the clinical presentations of infected patients and common treatments, including ribavirin, interferon and methylprednisolone, lack evidence. although drugs with anti- coronavirus (cov) activities have been identified, as yet no anti- mers- cov drug has been approved and a vaccine has yet to be developed. previous reports on other viral infections including sars have suggested that convalescent plasma or serum is effective where no other treatment is available or in an emergency. a recently completed systematic review and meta-analysis by the university of nottingham - world health organization collaborating center indicates that convalescent plasma therapy may be the most promising near-term therapy patients with for mers- cov infection. in this study, investigators will study the pharmacokinetics of immunoglobulin in response to convalescent plasma administration in order to inform a much larger study which will investigate the efficacy of convalescent plasma. plasma will be collected from patients who recently recovered from mers-cov, health care workers who had potential exposure and are tested for anti mers-cov serology and rt-pcr after obtaining their consent. this convalescent plasma will be stored in the blood bank as per their policies and procedures. patients with mers-cov positive after meeting the eligibility criteria will receive 2 units of convalescent plasma . clinical data as well as the standard laboratory studies will be collected at baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 14 years of age * inpatients who are mers-cov positive (by pcr) * willingness to have blood, respiratory and urine samples obtained and stored for subsequent analysis. exclusion criteria: * clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily not mers-cov in origin. * history of allergic reaction to blood or plasma products (as judged by the investigator) * known iga deficiency * medical conditions in which receipt of 500ml volume may be detrimental to the patient (e.g., decompensated congestive heart failure) * females who are pregnant or breast feeding.

Keywords: corona virus convalescent plasma serology
preoperative diet before sleeve gastrectomy

Conditions: Pain

Summary: patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and immunonutrition formula.postoperative pain and acute phase reactants at 24hours after surgery are investigated.

patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 kcal/day (group 1), those receiving preoperative balanced energy high protein formula (group 2) and those receiving preoperative immunonutrition formula (group 3). postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Eligibility criteria:
inclusion criteria: * bmi \>40 kg/m2 * bmi \> 35 kg/m2 with the presence of comorbidities associated to obesity exclusion criteria: * gastroesophageal reflux * patients with uncontrolled psychiatric disorders * active infections or malignancies * other concomitant pathology considered as a contraindication for bariatric surgery
an 18-month trial of a low glycemic load diet

Conditions: Obesity

Summary: the primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial.

the prevalence of obesity has risen dramatically among children in the u.s. since the 1960s. effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to combat type 2 diabetes and heart disease. evidence from animal studies, short-term human studies and epidemiology suggests that diets designed to minimize the rise in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of obesity and related complications. this project proposes an month rct comparing a low glycemic load diet to a conventional low fat diet. both diet groups will receive identical treatment intensity, behavioral modification and physical activity recommendations. the primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes include insulin resistance and cvd risk factors. compliance will be assessed by interviewer-administered, 24-hour dietary recalls.

Eligibility criteria:
inclusion criteria: * age 18 to 35 years * body mass index (bmi) ≥ 30 kg/m2 * access to a working telephone * conversant in english * written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition exclusion criteria: * body weight \>300 lbs * major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem * an obesity-associated genetic syndrome (e.g., prader-willi) * an abnormal screening laboratory test (alt, creatinine, bun, hematocrit) * fasting blood glucose ≥ 126 mg/dl) * taking any prescription medication that affects body weight (glucocorticoids, neuropsychiatric agents), blood pressure, or serum cholesterol concentrations * currently smoking (1 cigarette during any of the last 7 days) * previous diagnosis of an eating disorder (anorexia nervosa, bulimia, binge-eating disorder) * if female, not pregnant or planning to become pregnant in the next 18 months and not lactating * failure to complete the pre-enrollment visits
vitamin d and endometrial receptivity in infertile women

Conditions: Infertility

Summary: this is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking vitamin d for 8 weeks.

the aim of this study is to assess the effect of vitamin d supplementation on vaginal / endometrial biomarkers and endometrial receptivity in women with fertility problems. women will have vaginal swab and endometrial biopsy twice. the first endometrial biopsy is performed using a pipelle sampler 7 days after luteinizing hormone surge (lh+7) at baseline and the attachment rate of the trophoblast spheroid onto the isolated endometrial epithelial cells will be assessed to assess endometrial receptivity at baseline. implantation biomarkers will be checked. they will take vitamin d 50,000 iu once per week for 4 weeks, followed by 50,000 iu once every 2 weeks for 4 weeks. after 8 weeks of vitamin d, a second vaginal swab and endometrial biopsy using a pipelle sampler by standard technique will be collected from the patients 7 days after luteinizing hormone surge (lh+7) and the endometrial receptivity will be compared. the laboratory staff will not know whether the patient is taking any vitamin d when performing the trophoblast spheroid attachment assay/ biomarkers.

Eligibility criteria:
inclusion criteria: * age of women \< 40years old * normal uterine cavity as demonstrated by pelvic scanning with or without saline infusion sonogram or hysteroscopy * regular ovulatory cycles they will be divided into three groups: * rif patients (n=35)- those who have failed to get pregnant after replacing four or more cleavage stage embryos or two or more blastocysts in two consecutive transfers. * rpl patients (n=35)- those who have failed in three pregnancies before 24 weeks of gestation and includes embryonic and fetal losses. * 'infertile group'(n=35)- infertility except rif and rpl, e.g. those seeking for preimplantation genetic testing, male factor infertility, unexplained infertility. exclusion criteria: * history of any medical condition or medications that may predispose to vitamin d sensitivity, altered vitamin d metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants * taking vitamin d supplement * endometrial polyp or fibroid distorting the uterine cavity * presence of hydrosalpinx not corrected surgically * refusal to join the study • discontinuation criteria- * if the woman becomes pregnant during the study * pelvic inflammatory disease/ uterine perforation after endometrial biopsy * vitamin d toxicity (hypercalcemia) * withdrawal by patient

Keywords: vitamin d endometrial receptivity infertility recurrent pregnancy loss recurrent implantation failure
dexmedetomidine versus nalbuphine in prevention of emergence agitation following adenotonsillectomy in pediatrics

Conditions: Emergence Delirium

Summary: the aim of the present study is to compare the effect of iv infusion 0.5 µg/kg dexmedetomidine and iv 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.

consent will be obtained from legal guardian of children,patients will be randomized according to computer randomization to one of two groups, dexmedetomidine group (dex)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by iv infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline iv ,nalbuphine group (nal)group will receive iv infusion of 50 ml of 0,9%normal saline by iv infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline iv after induction of anesthesia.

Eligibility criteria:
inclusion criteria: * children of (american society of anesthesiologist)asa physical status grade i or ii. * aged 2-5 years * undergoing elective adenotonsillectomy. exclusion criteria: * history of hypersensitivity to the studied drug. * refusal of the legal guardian to participate in the study. * severely agitated child at induction of anesthesia * occurrence of postoperative bleeding at(post anesthesia care unit) pacu

Keywords: dexmedetomidine emergence agitation adenotonsillectomy
a long-term safety study of alks 5461

Conditions: Major Depressive Disorder

Summary: this is a 52-week open-label study to evaluate the safety and tolerability of alks 5461.


Eligibility criteria:
inclusion criteria: * agree to use an approved method of contraception for the duration of the study * have the potential to safely benefit from the administration of alks 5461 * have a diagnosis of major depressive disorder (mdd) * additional criteria may apply exclusion criteria: * have a positive test for drugs of abuse * currently pregnant or breastfeeding * have a current primary axis-i disorder other than mdd * have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime * have attempted suicide within the past 2 years * have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * have had a significant blood loss or blood donation within the past 60 days * additional criteria may apply