Kornimate/medical-research-clean huggingface dataset:
anti-thrombin iii (atiii) vs placebo in children (<7mo) undergoing open congenital cardiac surgery

Conditions: ATIII Deficiency

Summary: the purpose of this study is to test whether the administration of atiii during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (cpb) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. the investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the icu period.

if preoperative atiii functional assay level is less than 70% patients would be enrolled and randomized to either placebo (normal saline) or atiii.

Eligibility criteria:
inclusion criteria: * all patients less than 7 months of age going for cardiac surgery that will require cardiopulmonary bypass (cpb) with a documented atiii level below 70% exclusion criteria: * less than 2.5kg * known or suspected hereditary atiii deficiency (family history of venous thrombosis with decreased plasma levels of atiii and no other potential causes of acquired decreased atiii) * on ecmo (extracorporeal membrane oxygenation ) at time of surgery * known history of thrombosis * renal failure as described by the pediatric rifle criteria * h/o intracranial hemorrhage * prematurity less than 37 weeks estimated gestational age * previously diagnosed pro-thrombotic or hemorrhagic disorder * prior atiii supplementation * prior therapeutic anticoagulant use
efficacy and safety of intravitreal triamcinolone acetonide in eyes with post vitrectomy diabetic vitreous hemorrhage

Conditions: Post Vitrectomy State; Recurrent Diabetic Vitreous Hemorrhage

Summary: the purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. in contrast, ivt injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position. we believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

Eligibility criteria:
inclusion criteria: * previous vitrectomy due to proliferative diabetic retinopathy * recurrent diabetic vitreous hemorrhage exclusion criteria: * monocular vision * uncontrollable intraocular pressure

Keywords: post vitrectomy recurrent diabetic vitreous hemorrhage intravitreal triamcinolone injection
a clinical trial via telepsychiatry of treatments for the management of emotional dysregulation in youth

Conditions: Mood Disturbance; Mood Disorders; Natural Supplements; Alternative Treatment

Summary: this study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and n-acetylcysteine (nac) in the treatment of mood dysregulation in children and adolescents (ages 5-17). subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) nac.


Eligibility criteria:
inclusion criteria: * male or female subjects, 5-17 years of age. * current symptoms of emotional dysregulation as indicated by combined t-scores on the child behavior checklist \> 180 on the anxiety/depression + aggression + attention subscales. * subjects and their caregivers must be english-speaking, and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * subjects and their caregivers must be willing and able to comply with all study procedures. * each subject and his/her parent/guardian must understand the nature of the study. the subject's parent/guardian must sign an informed consent document and the subject must sign an informed assent document. * subject must be able to swallow pills. * subject must have access to a computer with a camera, speaker, microphone, and internet connection. exclusion criteria: * investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. * serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. * history of bleeding diathesis, including those with von willebrand disease. * uncorrected hypothyroidism or hyperthyroidism. * history of sensitivity to omega-3 fatty acids, inositol or nac. a non-responder or history of intolerance to omega-3 fatty acid, inositol or nac after 2 months of treatment at adequate doses as determined by the clinician. * severe allergies or multiple adverse drug reactions. * unstable or untreated seizure disorder. * dsm-iv substance use, abuse or dependence. * judged clinically to be at serious suicidal risk or c-ssrs score ≥ 4. * current diagnosis of schizophrenia. * current diagnosis or symptoms of psychosis. * iq \< 70. * pregnant or nursing.
understanding gastrointestinal conditions in children with autism spectrum disorder (asd)

Conditions: Gastrointestinal Disorders; Autism Spectrum Disorders

Summary: the purpose of this research study is to help us learn if children with autism spectrum disorder (asd) have gastrointestinal (stomach and intestine) problems more frequently than children without asd do. the investigators hope to learn if children with asd and gastrointestinal (gi) disorders have certain problem behaviors (pb), such as self-injury and aggression, more than children with asd but no gi disorders do. the investigators want to learn if the gastrointestinal symptoms questionnaire (giq) can help us tell which children with asd also have gastrointestinal disorders. hypothesis 1: children with asd exhibit high rates of symptomatic gi dysfunction that are not identified by current diagnostic evaluation. hypothesis 2: painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of pb in an identifiable subpopulation of pb-expressing children. the investigators anticipate that the proposed study will raise the standard of medical care for children with asd by improving current methods of identifying gi dysfunction and determining whether there is a significant relationship between gi dysfunction and pb in this population.


Eligibility criteria:
inclusion criteria: * children who are atn registry subjects between 2 and 17 years old (inclusive) * meet criteria for an asd according to the diagnostic measures autism diagnostic observation schedule (ados) and dsm-iv symptom checklist, which were conducted at an established atn center within the last 18 months exclusion criteria: * diagnoses of rett syndrome, childhood disintegrative disorder, or other genetic disorders (e.g. fragile x, down syndrome, etc.).

Keywords: asd autism gastrointestinal gastrointestinal conditions in children with asd
umbilical cord milking in neonates who are depressed at birth-developmental follow up (midab-fu)

Conditions: Hypoxic-Ischemic Encephalopathy; Birth Asphyxia

Summary: an extension of the midab trial, the midab-follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (ucm) or immediate cord clamping (icc).

the midab-follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in midab trial. the difference in survival and neurodevelopmental impairment in infants who received ucm and icc will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Eligibility criteria:
inclusion criteria: * enrolled in midab trial exclusion criteria: * none
effects of physical activity on quality of life among female undergraduate students

Conditions: Quality of Life

Summary: the main objective of the study is to determine the effects of physical activity on quality of life among female undergraduate students


Eligibility criteria:
inclusion criteria: -moderate level of academic stress measured on academic stress scale exclusion criteria: * students with diagnosed psychological disorders * systematic diseases
heat wrap for renal colic

Conditions: Renal Colic

Summary: non-steroidal anti-inflammatory drugs (nsaids) (diclofenac, kotorolac, piroxicam) opioids (petidine, tramadol, fentanyl), paracetamol and topical agents (emla, diclofenal gel), have been shown to be effective in the treatment of renal colic . nsaids are commonly used to treat renal colic, but they can reduce renal blood flow and cause kidney damage. in addition, there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency and chronic obstructive pulmonary disease. gastrointestinal complications (ulcers, reflux, etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. on the other hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even respiratory depression. in addition to these pharmacological agents, stair-stroke, turkish bath, blanket or hot water bag and local warming are now used in the treatment of renal colic in traditional methods. heat wrap is an effective, natural solution designed to remove muscle pain with the help of heat and used regularly by physical therapists. the heat wrap is activated by air contact within a few minutes after its removal from its sheet and does not contain any drugs. it contains heat from the active iron particles in contact with air. after a few minutes of application, it begins to spread the natural, long-term (8 hours) heat by targeting the source of the pain. the patient satisfaction is high because it is odorless and thin. in the literature, considering the success of heat therapy in patients with renal colic (bath entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of alternative treatment with pain-relieving alternative treatments with little potential for side effects and to see its applicability in daily treatment plans.


Eligibility criteria:
inclusion criteria: - patients with renal colic exclusion criteria: * pregnants * known allergies to heat tapes

Keywords: heat wrap
noninvasive positive pressure ventilation in overlap syndrome

Conditions: COPD; Sleep Apnea Syndromes; Non-invasive Positive Pressure Ventilation

Summary: chronic obstructive pulmonary diseases (copd) coexisting with obstructive sleep apnea is called overlap syndrome (os). patients with os seem to have worse prognosis than patients with only one disorder. noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of os patients is still not fully investigated. the aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in os patients.


Eligibility criteria:
inclusion criteria: * patients with copd and sleep apnea dyspnea syndrome exclusion criteria: * patients with non-stable hemodynamics; * patients with limited life expectancy; * patients with other severe respiratory diseases; * patients with motor neuron diseases; * patients with contraindications for nippv
study of tj011133 in participants with relapsed/refractory advanced solid tumors and lymphoma

Conditions: Solid Tumor; Lymphoma

Summary: the purpose of this study is to assess the safety and tolerability of tj011133 in participants with solid tumors and lymphoma.

this is an open-label, multi-center, multiple dose, phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (mtd) or maximum administered dose (mad), pharmacokinetic (pk), pharmacodynamic, and recommended phase 2 dose (rp2d) of tj011133, an anti-cd47 antibody, in participants with advanced relapsed or refractory solid tumors and lymphoma. the study will be conducted in 2 parts. part 1 comprises a single agent dose escalation (part 1a) and 2 separate combination therapy dose escalations (part 1b with pembrolizumab and part 1c with rituximab) and part 2 includes a dose expansion study.

Eligibility criteria:
inclusion criteria: * part 1: participants with advanced relapsed/refractory solid tumors and lymphoma. * part 2 with rituximab: participants with diffuse large b-cell lymphoma (dlbcl) or indolent b-cell lymphoma, with at least one measurable lesion by lugano and available fresh metastatic biopsy sample prior to study entry. * part 2 with pembrolizumab: participants with locally advanced non-small-cell lung carcinoma (nsclc) with disease progression or immune-oncology treatment naive epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by response elevation criteria in solid tumors (recist) 1.1, and available fresh metastatic biopsy prior to study entry. * all parts: eastern cooperative oncology group (ecog) performance status 0 to 1 and adequate bone marrow, renal, and liver functions. exclusion criteria: * participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study. * participants with burkitt's lymphoma, lymphoblastic lymphoma, richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma. * participants with mantle cell lymphoma. * impaired cardiac function or clinically significant cardiac diseases. * prior treatment with cd47 or sirpα inhibitors. * prior autologous stem cell transplant \<=3 months prior to starting study. * prior allogeneic stem cell transplant with either standard or reduced intensity conditioning. * prior chimeric antigen receptor or chimeric antigen receptor t-cell therapy. * history of autoimmune anemia or autoimmune thrombocytopenia. * positive direct antiglobulin test. * active graft versus host disease (gvhd) or ongoing immunosuppression for gvhd.

Keywords: solid tumor lymphoma
mobile app for eating disorders in adolescents

Conditions: Eating Disorders in Adolescence

Summary: this study aims to evaluate the effectiveness of ggtca-ad to decrease the maladaptive beliefs associated with eating disorders (ed) in non-clinical adolescent population. specifically, a randomized controlled trial with parallel design and two groups (experimental and control) will be carried out in adolescents aged 13-15 years to assess the changes pre and post use of the app. it is expected that after the use of the ggtca-ad app for 14 days, at the primary level, a: decrease in the degree of ascription to dysfunctional beliefs associated with ed; and at the secondary level: increase in body satisfaction and self-esteem; decrease in eating symptomatology; and no changes in emotional symptomatology. these results are also expected to be maintained in subsequent follow-up at 1 month.

there is a digital platform called ggtude, which is composed of different modules, each of them aimed at working with different mental health problems. the goal is to provide an easy-to-use tool as a cbt complement to work on the self-dialogue that relates to the core beliefs associated with the psychological problem in particular. to achieve this target, a cognitive training exercise is performed: different sentences appear in the form of beliefs, and the person must identify and accept those beliefs that are functional, adaptive and positive, dragging them to the lower part of the screen; and reject those that are dysfunctional, maladaptive and negative dragging them to the upper part of the screen. the ggtca app is a module of ggtude that was developed to work on dysfunctional beliefs associated with eating disorders. previous research showed that the app produced a statistically significant decrease of mean scores in maladaptive beliefs associated with ed and a statistically significant increase in self-esteem in adult population. furthermore, adolescence is a developmental stage vulnerable to the development of these disorders, so it's relevant to adapt the ggtca application to the adolescent population (ggtca-ad) and to evaluate its effectiveness.

Eligibility criteria:
inclusion criteria: (1) ages between 13 and 16; (2) that the parents or guardians of the adolescents and the participants have signed the informed consent form; (3) have a dispositive with internet access. exclusion criteria: (1) have inadequately answered control questions, for example "please check the option every day in this sentence".

Keywords: maladaptive beliefs cognitive therapy eating disorders mobile app adolescents e-health
fimasartan optimal reduction targeting elevated blood pressure: the forte study

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan

a multi-center, cluster-randomized, prospective, observational study

Eligibility criteria:
inclusion criteria: * subjects who voluntarily signed informed consent for participating in this clinical study * male and female over the age of 19 * hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan exclusion criteria: * renal dialysis patients. * diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor. * severe renal disorder * subjects with hereditary disorders of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * medical history with hypersensitivity to fimasartan * pregnant women or lactating female. * participate in another clinical trial.

Keywords: home blood pressure fimasartan
study visceral adipose tissue and liver stifness in a retrospective cohort of diabetes mellitus patients

Conditions: NAFLD; Type 2 Diabetes

Summary: non alcoholic fatty liver disease (nafld) is an emergent disease worldwide, and soon the leading cause of hepatic transplant in the usa. among this high number of patients, the current challenge is to detect or even predict patients at risk of inflammation (non alcoholic or steatohepatitis or nash) and end-stage fibrosis, which are the best predictors of liver-related mortality. visceral obesity is intimately associated with metabolic disease and adverse health outcomes, such as diabetes, and nafld. it has been demonstrated that visceral adipose tissue-linked inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related complications. the aim of this study was to evaluate the association of the quantity and percentage of visceral adipose tissue by dual x-ray absorptiometry and liver stiffness by fibroscan in patients with type 2 diabetes, and other predictors of fibrosis such as fib-4 and fibrotest. we retrospectively collected the data of all the diabetic patients who had undergone a dexa and a fibroscan between january 1st, 2014 and decembre 31th, 2019, in the universitary hospital of nancy, france.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * patients who had undergone a vcte examen at universitary hospital of nancy between january 1st, 2014 and december 31th, 2019 * - patients who had undergone a dexa at universitary hospital of nancy with less than one year of difference with vcte exclusion criteria: * viral, ethylic, drug-linked, genetic, self-immune hepatitis, liver cancer or metatasis ; other causes who could interact with fibroscan or biological markers (thrombocytopenia, undernutrition) * type 1 diabetes mellitus * weight variation (\>5% of body weight) between dexa mesure and fibroscan mesure * fail of vcte examination * high alcohol consumption (\>30g/day for men and \>20g.day for women) * pregnant women * other causes of secondary hepatic steatosis (drug-linked, parenteral nutrition, rare diseases...) * any other pathology that the investigator would consider not compatible with the research * patients in any other research protocol three months before inclusion * person referred as in the public health code (articles l.1121-5, l.1121-7 and l.1121-8) : pregnant or nursing woman, minor adult, major adult under legal protection, adult unable of giving consent * person deprived of their liberty by judicial or administrative decision, person under psychiatric care as described in articles l. 3212-1 and l.3213-1.

Keywords: nafld nash insulin resistance type 2 diabetes visceral adipose tissue dxa fibroscan vibration-controlled transient elastography liver cirrhosis