Kornimate/medical-research-clean huggingface dataset:
intravenous l-citrulline to treat children undergoing heart bypass surgery

Conditions: Heart Defects, Congenital; Hypertension, Pulmonary

Summary: this clinical trial will determine the safety and effectiveness of intravenous l-citrulline in children undergoing cardiopulmonary bypass during heart surgery. participants will be randomly assigned to either l-citrulline or a placebo (a substance that has no medicine in it). citrulline is a protein building block in the body that can convert into another substance, nitric oxide (no), which controls blood pressure in the lungs. increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (icu). the hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and no metabolites and prevent elevations in the postoperative pvt leading to a decrease in the duration of postoperative invasive mechanical ventilation.

increased pulmonary vascular tone (pvt) can complicate the postoperative course of the following five surgical procedures for congenital heart defects: 1) unrestrictive ventricular septal defect (vsd) repair; 2) atrioventricular septal (avsd) repair; 3) arterial switch procedure for transposition of the great arteries (tga); 4) bidirectional glenn shunt procedure; and 5) fontan procedure for single ventricle lesions. pvt is partially controlled by no. arginine, the precursor to no, is a product of the urea cycle. preliminary data have been presented regarding 169 infants and children who have undergone one of six previous surgical procedures. it was found that urea cycle function and plasma arginine levels were significantly decreased in all participants. furthermore, participants with increased pvt had significantly lower arginine levels compared to participants with normal pvt. finally, a genetic single nucleotide polymorphism (snp) in the rate limiting urea cycle enzyme (carbamyl phosphate synthetase i \[cpsl t1405n\]) appeared to affect postoperative plasma arginine levels and pvt. the hypothesis is that genetic polymorphisms in the rate limiting urea cycle enzyme cpsl, and other important enzymes in the urea cycle, influence the availability of no precursors. it is further hypothesized that perioperative enhancement of urea cycle function with the key urea cycle intermediate (citrulline) will increase plasma arginine and no metabolites and prevent elevations in pvt.

Eligibility criteria:
inclusion criteria: * undergoing cardiopulmonary bypass surgery with 1 of the following 5 procedures: 1. avsd repair 2. vsd repair 3. bidirectional glenn 4. modified fontan 5. arterial switch exclusion criteria: * pulmonary artery or vein abnormalities not being addressed surgically * preoperative requirement for mechanical ventilation or intravenous inotrope support * any condition that might interfere with study objectives, as determined by the investigator * pregnant
non randomized controlled intervention study comparing two interventions of nutritional supplement on malnutrition, health and mortality

Conditions: Malnutrition

Summary: the hypothesis for the study is that 12 months of a ready-to-use supplementary food (rusf) distributions have a greater impact on children's health than the standard rusf distributions during the hunger gap period (june to september). we estimated that the 12 month rusf will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).


Eligibility criteria:
inclusion criteria: * children between 6 months and 24 months of age exclusion criteria: * children who can 't swallow * children from parents who does not want to be in the study

Keywords: malnutrition children's health prevention ready-to-use supplementary food lipid based nutrient supplement chad children
magnetic resonance elastography in glioma: exploring tumor stiffness and adhesion

Conditions: Glioma

Summary: this study will investigate the relationship between tumor stiffness and adhesion in gliomas using mre. by utilizing preoperative mre and intraoperative neuronavigation, followed by comprehensive molecular pathology analysis, we aim to explore the correlation of tumor stiffness and adhesion with molecular and genetic characteristics of gliomas. additionally, the predictive value of mre in terms of pathological staging and prognosis will be determined. this research may pave the way for improved clinical decision-making, personalized treatment approaches, and more accurate clinical trials for glioma patients.

magnetic resonance elastography (mre) is an advanced imaging technique that measures the mechanical properties of tissues, providing valuable information about tissue stiffness, elasticity, and adhesion. in the case of gliomas, a type of brain tumor arising from glial cells, mre has shown promising potential in the diagnosis, classification, and prediction of pathological and molecular features. this clinical trial aims to investigate the relationship between tumor stiffness, adhesion, glioma grading, and genetic alterations by combining magnetic resonance elastography (mre) imaging findings with molecular pathological analysis. moreover, the study aims to predict patient survival based on the physical properties of the tumor. preoperatively, we will use mre to enhance the accuracy of navigation and determine tumor stiffness and adhesion properties. intraoperatively, under the guidance of neuronavigation, tissue samples will be obtained, and the operating surgeon will assess the tumor's stiffness, elasticity, and degree of adhesion. postoperatively, all tissue specimens will undergo molecular pathological analysis. the integration of mre findings with molecular pathology data will enable precise classification and subtyping of gliomas. furthermore, all patients will receive systematic treatment after surgery, and long-term follow-ups will be conducted. this comprehensive approach combining mre, molecular pathology analysis, and clinical follow-up aims to investigate the predictive value of mre in terms of molecular pathological features and prognosis in gliomas.

Eligibility criteria:
inclusion criteria: * all patients undergoing glioma resection surgery are eligible for inclusion in the study cohort. exclusion criteria: * patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings) * pregnant women in the first trimester (within three months) * patients with severe claustrophobia or anxiety * patients with severe fever * patients who can not tolerate mre * patients with vascular malformations and aneurysms. * patients who do not sign an informed consent

Keywords: magnetic resonance elastography brain tumor glioblastoma mr elastography tumor molecular pathology
risperidone vs. bupropion er augmentation of ssris in treatment-resistant depression

Conditions: Unipolar Depression

Summary: the purpose of this study is to evaluate the comparative effectiveness of risperdal (risperidone) or bupropion er (extended release) combined with a ssri medication and to test the relative safety of the combinations.

major depression is a severe disorder with serious consequences. effective treatments are available; however, in clinical trials 30-40% of patients do not experience even a 50% reduction in depression severity scores, while 50-70% fail to achieve a full therapeutic response. futhermore, impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit. if anything, the situation is at least as bad or not worse in clinical practice. clearly, alternatives are needed to manage this common clinical condition. the addition of bupropion er (extended release) to an ssri has empirical support, and has become the most common augmentation strategy in the us. a comparative trial of the combination of risperidone or bupropion er added to an ssri in treatment resistant deperssion could help support risperidone for this condition; such a trial seems warranted at this time. patients who are currently on a ssri at an adequate dosage for at least 3 weeks with no response, will be randomly assigned (open-label) to either risperidone or bupropion er augmentation for a period of 6 weeks. patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group.

Eligibility criteria:
inclusion criteria: * male or female 18 years or older * dsm-iv diagnosis of major depressive disorder of at least moderate severity, but without psychotic features * ham-d 17 score of 18 or above * have a documentable history of 2 prior adequate trials of antidepressants including an ssri without sufficient response. a clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms. * must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks. * ability and willingness to provide consent for participation in the study. exclusion criteria: * any medical condition that would preclude treatment with an ssri, risperidone, or bupropion er * any clinically significant unstable medical condition * diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder * current psychotic symptoms (hallucination or delusions) * alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month * documented non-response to the combination of a novel antipsychotic or bupropion er and a ssri * concomitant use of any psychotropic other than an ssri or zolpidem (prn for sleep) * score of 4 on the suicide item of the ham-d scale and determination by the investigator of significant suicide risk * known sensitivity to risperidone or bupropion er

Keywords: treatment resistant depression
train your brain and exercise your heart? advancing the treatment for attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: attention deficit hyperactivity disorder (adhd) is a developmental disorder that has a severe impact on a child's life and society. the core symptoms are attention problems, hyperactivity and impulsivity. these symptoms are related to disruptions in neurocognitive functions (such as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as 'cortical underarousal' as measured with the electroencephalogram). to date, the only evidence-based treatment is pharmacological. medication is not effective in 20-30% of the children with adhd and it can have side effects. the lack of alternatives for medication is a severe problem for these children and society. neurofeedback is becoming increasingly popular for treating adhd. neurofeedback is a training in which a person learns to alter its cortical regulation. neurofeedback has been classified as 'probably effective' but its treatment effects need further empirical evidence. non specific training effects, such as individual attention, may also contribute to treatment success. in this research project the investigators compare the efficacy of neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable with neurofeedback in terms of non-specific effects. exercise is also a promising treatment because of its positive effects on behavior, neurocognition in several patient groups. for these reasons, exercise deserves systematic research in adhd. furthermore, the investigators compare the efficacy of these two treatments with an optimal pharmacological treatment with methylphenidate (mph). the main question is if neurofeedback and exercise are comparable in efficacy with mph for treating adhd. the primary outcome measure is behaviour (symptoms of adhd). secondary outcome measures include neurocognition and cortical regulation. this research project will give answer to the question if neurofeedback and exercise are as effective as mph. furthermore, it will give insight in how these interventions will give rise to improvements in behavior.


Eligibility criteria:
inclusion criteria: * adhd diagnosis * iq above 80 exclusion criteria: * neurological disorder * severe physical or cognitive disability

Keywords: adhd neurofeedback exercise neurophysiology
heated high flow oxygen use in infants with bronchiolitis and hypoxia

Conditions: Bronchiolitis; Hypoxia

Summary: bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and children. multiple supportive therapies have been tried in infants with bronchiolitis including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in infants with bronchiolitis, with hypertonic saline showing a borderline statistically significant improvement. this prospective, randomized study will compare css and pews scores on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen via humidified high-flow nasal cannula (hhfnc). the results will help determine if infants with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have improved clinical severity score (css) and pediatric early warning system (pews) scores and ultimately decreased lengths of admissions when compared to patients treated with nasal cannula oxygen therapy with/without bronchodilator therapy. hypothesis heated humidified high-flow nasal cannula delivery of oxygen decreases respiratory distress as measured by pediatric css and pews when compared with routine nasal cannula oxygen delivery in infants with bronchiolitis.


Eligibility criteria:
inclusion criteria: 1. are previously healthy infants ages 3 months to 18 months of age 2. have o2 saturations of \< 92% on room air while awake 3. have a clinical diagnosis of bronchiolitis 4. have a css score showing moderate distress \>4 5. have a planned admission to the hospital for either inpatient or observation status 6. have parental consent to enroll in study exclusion criteria: 1. have significant apnea or bradycardia events reported by parent or witnessed in emergency department 2. have prior airway disease diagnosis other than uri within the previous two months 3. were previously intubated; previously having had airway bronchoscopy or surgery 4. they are ex-preemies, i.e. had an estimated gestational age of \<37 weeks at time of birth 5. have a diagnosis of lobar consolidation or round pneumonia by chest x-ray 6. have pleural disease by chest x-ray 7. have history of cardiac disease, renal disease, hematologic disease such as sickle cell disease or leukemia, congenital hemoglobinopathies or congenital adrenal hyperplasia 8. have undergone prior radiation or chemotherapy 9. have functional or anatomical bowel obstruction as demonstrated by persistent vomiting or tensely distended abdomen 10. have history of choanal atresia or cleft palate 11. have history of neuromuscular disorder, e.g., spinal muscular atrophy, muscular dystrophies, cerebral palsy or hypotonia 12. have impending respiratory failure as demonstrated by blood gas with pco2 of greater than 60 or apnea spells lasting greater than 30 seconds

Keywords: infants bronchiolitis hypoxia emergency department length of stay pediatrics
obesity among young adult males born with cesarean section.

Conditions: Caesarean Section; Obesity; Cesarean Section Complications

Summary: previous research has suggested that cesarean section may be associated with an increased risk of developing obesity in childhood, adolescence and adulthood. yet, previous studies have been small or unable to differentiate between elective and non-elective cesarean section. therefore, using a population-based cohort the purpose is to examine the associations between vaginal delivery, elective and non-elective cesarean section on the risk of developing obesity in young adulthood among swedish young singleton males. using the swedish medical birth registry, the recorded mode of delivery and indication of delivery which will be matched to those males who perform military conscription, where their body mass index is recorded. the investigators hypothesize that there will be an elevated risk of obesity in those born with non-elective cesarean section, as a function of confounding, while those born with elective cesarean section will not have a higher risk of obesity than those born with vaginal delivery.


Eligibility criteria:
inclusion criteria: * singleton birth. * retrievable from medical birth registry. exclusion criteria: * no available information on mode of delivery. * not conscripted. * extreme values at conscription.

Keywords: obesity cesarean section vaginal delivery elective cesarean section non-elective cesarean section
an hiv status-neutral microeconomic intervention

Conditions: Feasibility Studies

Summary: the aim is the current study is to establish feasibility and acceptability of the secure intervention to improve hiv prevention and care continua outcomes. to meet this aim, the study has the following objectives: 1. to deliver a two-armed pilot rct of the secure intervention with 40 transgender women of color. 2. the determine acceptability of the intervention with transgender women of color.

this is a two-arm randomized waitlist controlled trial in which transgender women of color will be randomly allocated to either the enhanced microeconomic intervention that builds on the trans sistas of color project's existing microeconomic interventions, which includes: (1) $250 in emergency assistance; and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents). the existing intervention will be enhanced to include (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and hiv prevention and care; (2) employment-focused mentoring; and (3) an unconditional grant ($1,200) for use towards acquiring self-led or formal employment. each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. participants will also complete qualitative exit interviews within one month of completion of intervention completion for both conditions.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old; 2. assigned male at birth; 3. self identifies as female, transgender woman, or another feminine gender identity; 4. self identifies as a person of color (i.e., any racial/ethnic identity except non-hispanic white); 5. reports earning less than $32,800 gross annual income (current living wage in michigan); 6. reports condomless sex in the past 6 months; 7. lives in detroit, mi greater metropolitan area (\~50 mile radius); 8. speaks english.

Keywords: transgender hiv microeconomic
comparison of two formulations of bio-k

Conditions: Antibiotic-Associated Diarrhea

Summary: main research question: the investigators would like to find out if both the bio-k (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use. why is this research project important? about 25% of patients who use antibiotics may develop diarrhea as a side effect. symptoms are mild and consist of watery diarrhea and abdominal pain. some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. there are some studies that suggest bio-k drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. as a result, st. joseph's healthcare has recently to use bio-k routinely to try to reduce risk of patients developing diarrhea. no other hamilton hospitals use bio-k routinely as there is not strong evidence about the effectiveness of bio-k for the prevention of diarrhea. this study will provide more information about bio-k's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.


Eligibility criteria:
inclusion criteria: * speak english * capable of providing consent * reachable by telephone within the next three months * willing to comply with study protocols * age over 65 years * prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose exclusion criteria: * icu patients * transplant patients * patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-tnf agents, interleukin-2 chemotherapy) * hiv patients with cd4+ count less than 250 cells/mm3 * neutropenic patients with total neutrophil count less than 500 * patients with prosthetic heart valves
russian disc degeneration study

Conditions: Intervertebral Disc Degeneration; Genetic Predisposition to Disease

Summary: the main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. diverse biological samples (whole blood, plasma, disc tissue) along with mri imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. it will lay the groundwork for the development of early diagnostics of ddd and its personalized treatment. the study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. it is planned to recruit patients within 36 months.


Eligibility criteria:
inclusion criteria: 1. age over 18; 2. presence of lumbar mri scans; 3. signed informed consent for voluntary participation is provided. exclusion criteria: 1. any contraindication or inability to undergo baseline procedures; 2. prior surgeries at any level of the lumbar spine; 3. other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study; 4. history or presence of hiv, hepatitis b, hepatitis c.

Keywords: biobank functional genomics transcriptomics glycomics