Kornimate/medical-research-clean huggingface dataset:
combined immunosuppression for pediatric crohn's disease

Conditions: Crohn Disease; Infliximab; Immunosuppression; Children, Only

Summary: this is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric crohn's disease.


Eligibility criteria:
inclusion criteria: 1. 6-18 years old 2. diagnosis of crohn's disease 3. pediatric crohn's disease activity index (pcdai)\>30 or the simple endoscopic score for crohn disease (ses-cd) \>10 before treatment 4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, pediatric crohn's disease activity index (pcdai)\>10 or the simple endoscopic score for crohn disease (ses-cd)≥3 after exclusive enteral nutrition or corticosteroids 5. the patient or legal guardian sign the informed consent documents exclusion criteria: 1. history of biological agents targeting at tumor necrosis factor (tnf) 2. crohn's disease-related surgery 3. infections 4. tumors
retinal oxygen function after radiation therapy

Conditions: A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)

Summary: the investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). since different regions of retina receive different radiation doses, the investigators will assess for a dose response as well.

radiation therapy (rt) is a common treatment for patients with cancers of the sinonasal area, orbit, skull base, nasopharynx, and brain. because of the close proximity of these targets to the eyes, the retina is often incidentally and unavoidably irradiated. as a result, some patients develop radiation retinopathy and possibly vision loss. clinicopathologic studies suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small vessel occlusion and ischemia that can lead to neovascularization, increased capillary permeability, and visual loss in the regions of retina perfused by damaged vasculature. unc has a novel, non-invasive retinal imaging technology called a retinal oximeter which measures hemoglobin oxygen saturation of retinal vessels. the difference in oxygen saturation between a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region supplied by that vessel pair.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the time of radiation therapy (no upper age limit) 2. history of radiation therapy delivered at unc-ch or rex hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment 3. estimated average dose to at least one quadrant of one retina ≥ 30 gy exclusion criteria: 1. history of diabetes, retinal vascular occlusions, glaucoma, retinitis pigmentosa, occipital stroke or any other ophthalmologic or systemic problem that may confound visual field results. 2. residual tumor within the visual pathway: retina, optic nerves, optic chiasm, optic radiations and brain.

Keywords: sinus/nasal cancer
effects of a land and aquatic exercise-based program on pain, mobility and quality of life in patients with chronic low back pain

Conditions: Chronic Low-back Pain (cLBP)

Summary: the goal of this randomized clinical trial\] is to study the effect of a combined aquatic and land-based exercise program compared to an aquatic program on pain, functional disability, and quality of life in adults with chronic low back pain. the main question it aims to answer is: "does a combined aquatic and land-based exercise program improve functional disability and quality of life and reduce pain in adults with chronic low back pain?". participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group). researchers will compare groups to find any differences in pain, funcional disability and quality of life.


Eligibility criteria:
inclusion criteria: * both gender; * portuguese nationality; * aged over 18 years; * chronic low back pain lasting three months or longer and with an intensity of 3 or higher on the visual analogue scale at rest. exclusion criteria: * individuals who refuse to participate or do not provide informed consent; * pain radiating to the lower limb; * recent pregnancy or childbirth (less than 8 weeks ago); * ongoing physical therapy treatments; * severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention; * history of spinal surgery; * inflammatory, infectious, or malignant spinal diseases; * psychiatric disorders that may affect adherence and symptom assessment.

Keywords: pain exercise hydrotherapy aquatic therapy disability
cardiac output measurement by tee

Conditions: Cardiac Disease

Summary: transesophageal echocardiography (tee) has become a standard monitoring tool during cardiac surgery. it allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. the imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. cardiac output (co) is the result of stroke volume (sv) multiplied by the heart rate. measurement of cardiac output (co) is used to quantify the performance of the left ventricle. it is commonly achieved using a pulmonary artery catheter (pac) (also known ad swann-ganz catheter). a known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. cardiac output is measured based on the duration and degree of temperature change. this method remains an accepted gold standard. tee allows measurement of cardiac output using a number of different 2d and 3d imaging modalities. although current guidelines identify the method of the disks(mod) as the gold standard other technique could potentially be more precise. in this study, the investigators want to assess the accuracy of four different tee methods to measure cardiac output compared with thermodilution as a standard of care.

the measurement of the lv performance, as reflected by measuring cardiac output (co), is an important component of hemodynamic assessment during cardiac (and non-cardiac) surgery. it has become standard of care in guiding fluid management and inotropic therapy in both the operating room (or) and the intensive care unit (icu) in most centres, and is considered by far the most understood and commonly communicated parameter of cardiac performance, in addition to being consistently shown as a predictor of patients' outcome. several methods have been used to measure co. the most commonly used is via thermodilution (pac), but its invasive nature and potential for serious complications led to the utilization of the non-invasive methods, such as those based on tee. since the establishment of the role of tee in the setting of hemodynamic monitoring during cardiac surgery, various ways of quantifying lv function have been utilized. the method recommended by current guidelines is a volumetric calculation via the method of disks (modified simpson's method, mod). recent advances in ultrasound technology and software development allow the utilization three-dimensional (3d) volumetric assessment and speckle tracking for cardiac deformation.

Eligibility criteria:
inclusion criteria: * age \>18 * undergoing elective cabg, av or aortic surgery (aortic root and ascending aortic arch surgery), with cpb. exclusion criteria: * emergency surgery * moderate or severe valve pathology * atrial fibrillation * patients with known contraindications to either the insertion of a pac or the use of tee.
midodrine in hepatopulmonary syndrome

Conditions: Hepatopulmonary Syndrome (HPS)

Summary: this proof-of-concept clinical trial will determine the safety and tolerability of midodrine in patients with hepatopulmonary syndrome (hps). exploratory endpoints will assess the effect of midodrine on oxygenation, intrapulmonary shunting and symptoms.


Eligibility criteria:
inclusion criteria: * moderate to very severe hepatopulmonary syndrome, defined as the presence of all of the following: 1. liver disease or portal hypertension 2. intrapulmonary shunting on contrast-enhanced echocardiogram 3. hypoxemia \[a-a gradient ≥15mmhg (or ≥20mmhg if age \>64) and pao2\<80mmhg on arterial blood gas testing\] * ability to provide informed consent * ability to comply with study medication use and testing, in the opinion of the principal investigator or co-investigator exclusion criteria: * vulnerable study population, including imprisoned individuals, non-english speaking patients * participation in other investigational drug studies * any of the following conditions: * systolic blood pressure\>160mmhg or diastolic blood pressure \>100mmhg * heart rate \<50bpm * urinary retention at baseline * left ventricular ejection fraction \<50% * women who are pregnant, nursing, or who plan to become pregnant while in the trial * women of child-bearing potential not willing or able to use highly effective methods of birth control
detection of cerebral ischemia with artificial intelligence.

Conditions: Ischemia, Cerebral; Ischemic Stroke; Artery Occlusion; Artery Carotid Stenosi; Anesthesia; Surgery

Summary: in patients undergoing planned surgery for carotid tromendarterendectomy, a non-invasive device that registers heart rate variability is attached. furthermore a non-invasive device that monitors cerebral oxygenation- near infrared spectroscopy as well as electroencephalography is also attached. at times when surgeons clamps the carotid artery, there will be a moment with controlled cerebral ischemia. this will be registered by the devices. the information obtained will be used to teach artificial intelligence what patterns are related to cerebral ischemia. the same procedure will be performed in patients undergoing ocklusive cerebral trombectomy, so the artificial intelligence will learn to recognize cerebral reperfusion.blood samples will be drawn before and after cerebral ischemia may occur and will be analyzed for neurobiomarkers and cardiac biomarkers. to teach the algorithm patterns from anaesthesia and surgery in patients without pre existing neuronal injury, the same method will be applied to patients undergoing mixed abdominal surgery. this group will provide a better knowledge of neuro biomarker patterns during anesthesia and surgery.

the neurobiomarkers that will be analyzed for detection of cerebral ischemia is glial fibrillary acidic protein, neurofilament light chains, s-100b, neuron specific endolas, total-tau. cardiac biomarkers are troponin-t and nt-pro brain natriuretic peptide. blood sampling will occur before anesthesia induction and 2 and 24 hours after surgery or plausible ischemia for patients undergoing surgery for carotid endarterectomy. for patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after the patient has arrived to the hospital as well as 2 hours and 24 hours later. for patients undergoing mixed abdominal surgery, sampling will be done before anesthesia induction and 2 hours and 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * patients planned for carotid surgery or trombectomy * giving informed consent to participate exclusion criteria: * patients that do not consent patients with arrythmia or pacemaker
enterobacteriaceae producing extended-spectrum β-lactamases (esbl) decolonization study

Conditions: Enterobacteriaceae Infections

Summary: multidrug-resistant enterobacteriaceae producing extended-spectrum β-lactamases (hereafter called esbls) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. as is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of esbls mostly intestinal and urinary carriage. to the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic esbl eradication strategy. eradication of esbl carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. even if eradication turns out to be impossible, transient suppression of esbl might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective. the purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against esbls can lead to decolonization of esbl carriage in hospitalized patients.


Eligibility criteria:
inclusion criteria: patients can be enrolled into the study provided that all of the following criteria are met: 1. microbiologically documented rectal carriage of esbl-producing enterobacteriaceae, without signs and symptoms of active infection with esbl-producing enterobacteriaceae at any body site 2. patient must give written informed consent to participate in the study. the informed consent can be given by the legal representative if necessary. exclusion criteria: 1. women who are pregnant or nursing 2. active infection 3. treatment with antimicrobial agents with activity against esbl-producing enterobacteriaceae 4. contraindication to the use of one of the study drugs (e.g. renal insufficiency with creatinine clearance \< 30 ml/min) 5. patient already enrolled in another study, or in the present study for a previous episode 6. psychiatric disorder or unable to understand or to follow the protocol directions 7. permanent indwelling urinary catheter that can not be changed 8. resistance of the esbl-producing enterobacteriaceae to one of the study drugs 9. known hypersensitivity to one of the study drugs

Keywords: antibiotic resistance esbl carriage
reducing eating disorder risk factors

Conditions: Eating Disorders

Summary: the purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.

female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance. participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. the 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. the program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. changes in body mass index (bmi) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. one-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.

Eligibility criteria:
inclusion criteria: * college students at risk for developing an eating disorder exclusion criteria: * suicidal or other severe psychopathology * alcohol or drug abuse * body mass index (bmi) \ 32 * current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months
efficacy of psychotherapy treatment of children with tics

Conditions: Tic-Disorder

Summary: the main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme compared to an alternative treatment which aims at the activation of resources in children and adolescents aged 8 to 18 years with tic disorders.

the main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme (thics, woitecki \& döpfner, 2014) compared to an intervention aimed at the activation of resources (stark, perri et al., 2014) for children and adolescents with tic disorders. this habit reversal treatment programme was developed at the department of child and adolescent psychiatry and psychotherapy at the university of cologne and has already been evaluated in a pilot-study (woitecki \& döpfner, 2011, 2012). the activation of resources treatment programme was also developed at this department and is currently evaluated in different studies. effects are expected in both interventions, but a larger effect is expected in the thics treatment

Eligibility criteria:
inclusion criteria: * 8-18 years * diagnosis of chronic motor or vocal tic (f95.1) or tourette-syndrome (f95.2) * ygtss total score f95.2\>13, f95.1\>9 * tics are the main problems * intelligence iq\>80 * if medication, then has been stable for at least one months in medicated patients * no change in medication treatment is planned * ability to participate in weekly outpatient treatment * acceptance of randomization exclusion criteria: diagnosis of autism spectrum disorder or psychosis parallel continuous psychotherapy of tics or comorbid -

Keywords: tic-disorder, tourette-disorder, habit reversal training, resources activation
melatonin to prevent brain injury in unborn growth restricted babies

Conditions: Fetal Growth Retardation

Summary: intrauterine growth restriction is the term used to describe a condition where an unborn baby does not reach its optimum size. in the short and long term, intrauterine growth restricted babies have a higher risk of serious disease and even death. it is well established that very low levels of oxygen in the baby's blood can harm the baby's health through a state known as oxidative stress. currently, there is no established treatment available to treat intrauterine growth restriction or its complications. in experimental animal studies however, the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative stress and improve health of the unborn babies that have suffered from intrauterine growth restriction. this study aims to find out if the use melatonin twice per day throughout pregnancies affected by intrauterine growth restriction will lower the level of oxidative stress experienced by the unborn baby. if this is the case melatonin may help protect the unborn baby from damage caused by oxidative stress, this will be studied in a separate future study.


Eligibility criteria:
inclusion criteria: * estimated fetal weight \<10th percentile in combination with abnormal fetoplacental doppler studies. * singleton pregnancy. * live fetus. * gestational age: from 23+0 weeks until 34+0 weeks. * normal fetal anatomy on ultrasound. * confirmed gestational age. * no indication for immediate delivery. * basic understanding of the english language. * 18 years or older. * consent obtained. exclusion criteria: * fetal demise. * multiple pregnancy. * known abnormal karyotype. * presence of any congenital abnormality. * unknown duration of pregnancy. * iugr attributable to non-placental factors.
the circadian rhythm in cushing syndrome in active phase and during remission (thehours)

Conditions: Cushing Syndrome

Summary: this is an observational, open, prospective multi-centre study designed to evaluate melatonin and cortisol circadian rhythm, immunological profile and anthropometric parameters in cushing syndrome patients during active remission state.

cushing syndrome is a severe condition caused by prolonged exposure to high levels of glucocorticoids. this is a disease with high morbidity and mortality due to metabolic, cardiovascular, coagulative, psychiatric complications of hypercortisolism. the loss of circadian secretion of cortisol is one of the most sensitive and specific diagnostic features of cushing's syndrome that normalizes during remission. the evaluation of the circadian rhythm of cortisol is one of the diagnostic tests recommended by the guidelines to evaluate the state of the disease's activity. studies in literature have shown several correlations between states of hypercortisolism and circadian secretion of melatonin, displaying reduced melatonin secretion throughout the day and the suppression of circadian rhythm of cortisol. however, the dynamics of the normalization of melatonin circadian rhythm during remission from cushing syndrome are unclear. therefore, the aim of our study is to evaluate the changes in circadian secretion of melatonin in cushing's syndrome during active disease and during remission (3 and 6 months), according to the rational scientific influence of endogenous hypercortisolism on the function of the pineal gland. in addition, the changes in circadian secretion of cortisol, of mononuclear cells of the blood (pbmc) and of anthropometric-metabolic parameters, will be analyzed.

Eligibility criteria:
inclusion criteria: * cushing syndrome during active phase exclusion criteria: * malignancy * alcoholism or drug addiction * psychiatric disorders * clinical or laboratory signs of significant cardiovascular, hepatobiliary disease * clinically significant renal dysfunction * pregnancy * any medication with agents which could interfere with glucocorticoid kinetics and melatonin secretion

Keywords: cushing syndrome adrenal insufficiency peripheral blood mononuclear cells melatonin cortisol immunological profile cushing disease
randomized trial for pharmacogenomics-based tuberculosis therapy (rt-pgtt)

Conditions: Pulmonary Tuberculosis

Summary: the purpose of this study is to elucidate whether the individualized medicine based on nat2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.


Eligibility criteria:
inclusion criteria: * newly diagnosed pulmonary tuberculosis patients * informed consent including pharmacogenomic analysis exclusion criteria: * abnormal liver and kidney function test before treatment * long-term use of steroids and/or immunodepressants * inadequate clinical conditions

Keywords: pulmonary tuberculosis isoniazid arylamine n-acetyltransferase 2 pharmacogenomics genetic polymorphisms individualized medicine drug-induced hepatotoxity