Kornimate/medical-research-clean huggingface dataset:
brexpiprazole in treatment of children and adolescents with irritability associated with autism spectrum disorder

Conditions: Irritability Associated With Autism Spectrum Disorder (ASD)

Summary: the purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.


Eligibility criteria:
key inclusion criteria: * primary diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnosis of asd * aberrant behavior checklist - irritability (abc-i) subscale score of ≥ 18 * clinical global impressions - severity (cgi-s) scale score pertaining to irritability ≥ 4 * mental age of ≥ 2 years as determined by investigator based upon school participation, social history or medical records * ability for parent/caregiver to follow all protocol procedures * able to swallow tablets * able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period key exclusion criteria: * primary diagnosis of bipolar i disorder, including any dsm-5 current diagnosis of bipolar ii disorder, schizophrenia, schizoaffective disorder, major depressive episode, and post-traumatic stress disorder (ptsd). attention-deficit/hyperactivity disorder (adhd) maybe exclusionary if it is the primary disorder, or is not stable or adequately treated. * current or historical diagnosis of fragile-x syndrome or rett's disorder * history of neuroleptic malignant syndrome * a significant risk of committing violent acts, serious self-harm, or suicide * epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions * current hypothyroidism or hyperthyroidism * uncontrolled type i or type ii diabetes * uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension * weight \< 15 kg * previous exposure to brexpiprazole * sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study

Keywords: autism irritability autism spectrum disorder asd
effect of erythropoietin on preterm brain injury

Conditions: Premature Birth

Summary: epo has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. our hypothesis is that epo could prevent preterm brain injury. the aims of this study include: to investigate the safety and efficacy of epo by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of epo on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of epo.

periventricular leukomalacia (pvl) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. the current therapy is only supportive to maintain the live sign stable. there is no effective therapeutic strategy for preterm brain injury. erythropoietin (epo) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. furthermore, recombinant human epo (rhepo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. it has been considered to be safe and well tolerated in preterm infants. however, there is no conclusion yet if the epo has the effect to prevent preterm brain injury. the purpose of the study was whether the rhepo (500 u/kg) given to very preterm infants (gestation age \< 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. very preterm infants with gestational age of \< 32 weeks and admit to our nicu are eligible for enrollment. after informed consent is obtained, infants will be randomly assigned to either epo group or vehicle group. the primary short-term outcome measures are brain injury (intraventricular hemorrhage (ivh) and periventricular leukomalacia (pvl)) and rop. the long term outcomes are whether rhepo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.

Eligibility criteria:
inclusion criteria: * preterm infants admitted to the nicu with gestational age \<32 weeks * birth weight \<1500g and less than 72hours of age exclusion criteria: * 1. infants with genetic metabolic diseases 2. congenital abnormalities 3. pneumothorax 4. grade iii-iv intracranial hemorrhage

Keywords: erythropoietin preterm brain injury cerebral palsy pvl
results of different location of ahmed glaucoma valve implantation in refractory glaucoma, superior versus inferior

Conditions: Glaucoma

Summary: purpose:to compare the efficacy and safety of ahmed glaucoma valve (agv) implantation in the superior versus inferior quadrants. methods: in a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent agv implantation in the superior or inferior quadrants. main outcome measures included best corrected visual acuity (bcva), intraocular pressure (iop), number of glaucoma medications, complications and success rate (defined as at least 30% iop reduction below preoperative values and 5\<iop\<22 mmhg with or without glaucoma medications). other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.


Eligibility criteria:
inclusion criteria: * patients with refractory glaucoma who need agv implantation exclusion criteria: * eyes with less than 3 months follow-up * severe conjunctival adhesions and scarring for the site of surgery * presence of thin sclera and staphyloma for the site of surgery * the presence or anticipated need for silicone oil for superior implantation * active neovascular glaucoma for inferior implantation
rebif compliance support program - assessing needs in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this 1-arm, open-label, multicentric, observational study aims to collect subject centric information in line with routine care. subjects' expectations of therapy, side effect management and lifestyle may influence adherence to therapy. this survey aims to determine whether such factors and/or others affect the successful initiation and maintenance of rebif therapy. the data collected during this study will include information on the subject's treatment including expectations, experience, training and support. the results of the study will be used to understand the impact on subjects' compliance and tailor training and support services to subject's need. it will also be made available to other healthcare organisations involved in the subjects treatment.

multiple sclerosis (ms) is a chronic, inflammatory, demyelinating disease of the central nervous system and is one of the most common causes of neurological disability in young adults. it is characterised by multifocal, recurrent attacks of neurological symptoms and signs with variable recovery. eventually the majority of subjects develop a progressive clinical course. it is important to carefully initiate and maintain subjects with ms on therapy. information will be gathered in a structured way which will enable easier identification of any subgroups of subjects who may be at risk of poor compliance. these risk groups could possibly include groups with particular attributes such as poor information at the start of treatment, unrealistic expectations or a particular life style. this study will be conducted during the contact with the subject necessary to deliver the homecare service. participants will be contacted by bupa home healthcare multiple sclerosis subject coordinators by telephone to conduct specific questionnaires during the 4 stages of the subject's treatment i.e. pre-installation of treatment, post installation of treatment, monthly pre delivery of drug and at a subject's end treatment. objectives * to collect subject centric information in line with routine care including subject's expectations of therapy, side effect management and lifestyle may influence adherence to therapy * to determine whether such factors and/or others affect the successful initiation and maintenance of rebif therapy

Eligibility criteria:
inclusion criteria: * subjects who have been prescribed rebif and referred to bupa home healthcare service by one of the participating referring centres exclusion criteria: * subject unwilling to give informed consent * subjects visiting private clinics

Keywords: multiple sclerosis rebif interferon beta-1a
comparison of breathing pattern during neurally adjusted ventilatory assist ventilation and pressure support ventilation

Conditions: Respiratory System Abnormalities

Summary: comparison of breathing pattern during mechanical ventilation. two modes of mechanical ventilation are compared (pressure support ventilation and neurally adjusted ventilatory assist)

eligibility : healthy subject without respiratory complications in the past subjects will breath spontaneously without mechanical ventilation, with pressure support ventilation and with neurally adjusted ventilatory assist during. three levels of pressurisation will be tested : 5 cmh2o, 8 cmh2o and 12 cmh2o duration of each condition will be about 15 minutes. measurements will include:flow, airway pressure, sao2, ptco2, diaphragmatic electromyography, chest wall motion by optoelectronic plethysmography

Eligibility criteria:
inclusion criteria: * age \> 18 years * healthy subject without any chronic disease exclusion criteria: * absence of consent * pregnant

Keywords: breathing pattern mechanical ventilation pressure support ventilation neurally adjusted ventilatory assist
pilot chart review study of sitaxentan sodium (thelin) in patients with pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: the objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (thelin) in "real-world" settings; to pilot test these methods at three study centers in europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (thelin) in "real-world" settings.

at each centre, approximately 12-15 pulmonary arterial hypertension (pah) consecutive patients who have received thelin and who meet all other study entry criteria.

Eligibility criteria:
inclusion criteria: * idiopathic pah, or pah secondary to connective tissue disease * receipt of thelin for treatment of pah * 6 months of follow-up (except in the event of death) subsequent to initial receipt of thelin * minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of thelin exclusion criteria: * participation in any investigational study of thelin or any other medication for the treatment of pah during the period beginning 6 months prior to initial receipt of thelin and ending 6 months subsequent to such receipt * receipt of thelin prior to january 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in stride-1, stride-2, and/or stride-6); or * known contraindications to thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment \[child-pugh class a-c\]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase \[ast\] and/or alanine aminotransferase \[alt\] \>3 times upper limit of normal \[uln\]; concomitant use of cyclosporin a; lactation)

Keywords: pulmonary arterial hypertension sitaxentan sodium thelin
glucose response of g-pen (glucagon injection) in pediatric t1d patients

Conditions: Diabetes Mellitus, Type 1

Summary: this is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of g-pen (glucagon injection) in a clinical research center (crc) or comparable setting.

this is an open-label, phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase. the procedure to evaluate the efficacy of g-pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. subjects ages 2-11 will then be given a 0.5 mg dose of g-pen, while subjects ages 12-17 will receive a 1 mg dose of g-pen. subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of g-pen when in a low normal glycemic stare. plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits. a follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.

Eligibility criteria:
inclusion criteria: * diagnosed with t1d for at least 6 months at screening. * current usage of daily insulin treatment. exclusion criteria: * pregnant or nursing * renal insufficiency * hepatic synthetic insufficiency * aspartate or alanine aminotransferase \> 3 times the upper limit of normal * hematocrit less than or equal to 30% * use of \> 2.0 u/kg total insulin dose per day * inadequate venous access * current seizure disorder * history of pheochromocytoma or disorder with increased risk of pheochromocytoma * history of insulinoma * history of glycogen storage disease. * active use of alcohol or drugs of abuse * administration of glucagon within 14 days of the first treatment visit * participation in other studies involving an investigational drug or device within 30 days
muscle protein metabolism in obesity

Conditions: Obesity

Summary: obesity is associated with reduced adenosine triphosphate (atp) turnover in skeletal muscle, a condition that can impair muscle metabolism. the proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-f1-atpase, which is directly responsible for atp assembly, in the muscle of obese individuals. this research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-f1-atpase in the muscle of obese individuals. the findings will help to develop appropriate interventions to improve muscle atp turnover and metabolism in obese people.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi): lean, 19-26 kg/m2; obese, 30-40 kg/m2 2. availability of transportation 3. ability to sign informed consent form exclusion criteria: 1. medication or supplements (i.e. amino acids, protein) known to affect protein metabolism 2. presence of acute illness 3. history of liver disease 4. uncontrolled metabolic disease 5. ecg documented abnormalities, atrial fibrillation, history of syncope, limiting or unstable angina, or congestive heart failure 6. chronically elevated blood pressure (systolic, \>140 mmhg; diastolic, \>100 mmhg) 7. cardiac pacemaker or other medical device implanted in the body 8. low hemoglobin or hematocrit 9. current participation in a weight-loss regimen, including extreme dietary practices 10. smoking 11. use of anabolic steroids or corticosteroids (within 3 months)

Keywords: muscle mitochondria amino acids exercise
the feasibility of a prehabilitation program in the liver transplant population at barnes-jewish hospital

Conditions: End Stage Liver Disease; Physical Activity

Summary: the primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at barnes jewish hospital for liver transplant candidates. those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. the intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. the secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.


Eligibility criteria:
inclusion criteria: * being evaluated for liver transplantation by barnes jewish hospital medical team exclusion criteria: * non-english speaking * medical contraindications to exercise as determined by the medical team

Keywords: liver diseases liver transplantation preoperative care physical therapy
gastrointestinal stromal tumors (gist) registry

Conditions: Gastrointestinal Stromal Tumors

Summary: the goal of this observational research study is to establish a registry of information regarding how different physicians treat and manage patients with gastrointestinal stromal tumors (gists). objectives: 1. to describe variation in management of patients with gist, overall and by patient and provider characteristics. 2. to provide participating physicians with information regarding management of their patients with gist compared to the aggregate experience of all physicians participating in the registry.

the registry, which is internet based, is intended to collect information about current practices in the management of gist without making any specific change to the standard of care as decided by each patient's treating physician. if you agree to participate in this study, your doctor will provide information to a data registry about your physical and clinical traits, the past and current medical care you have received to treat your gist, and clinically-related, economically-related, and health-related quality of life information. about 200 doctors will provide information on their patients for the registry. your doctor will collect this information when you first join the registry and at each regularly scheduled visit you make to your doctor's office. the information collection will continue for as long as you and your doctor feel it is appropriate. the information that is entered into the registry will remain there indefinitely. it is hoped that this sharing of information will lead to a better understanding of how to best treat patients with gist. you and your doctor will decide what treatment you will receive. because this registry is only to observe actual medical practice, it does not require you to receive any particular treatment. only your doctor and people who will help your doctor collect the information for this registry will know which information submitted to the registry belongs to you. data will be tracked in the registry using only id numbers and patient initials. the information submitted on the registry data collection forms will not be associated with a specific patient's identity. separately, you will be asked to provide your name, place of birth, and social security number. this information will not be entered into the registry databases and will only be used if it is necessary to perform a search should you become lost to follow up. if you do not want to provide your social security number you may still be enrolled in the registry. this is an investigational study. about 100 patients from m. d. anderson will be entered into the registry. in all, about 1800 patients will be registered. the registry will be active for at least 7 years.

Eligibility criteria:
inclusion criteria: 1. all patients who have been diagnosed with gist are eligible for enrollment. exclusion criteria: 1. patients with a histologic diagnosis other than gastrointestinal stromal tumor (gist).

Keywords: gastrointestinal stromal tumors gastrointestinal cancer gists gist registry registry
differential effects of protein quality on postprandial lipemia in response to a fat-rich meal in type 2 diabetes: comparison of whey, casein, gluten, and cod protein

Conditions: Type 2 Diabetes; Postprandial Lipemia

Summary: enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. it has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins. the purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diabetes exclusion criteria: * liver, kidney- and/or heart disease * serious hypertension (160/110 mmhg)

Keywords: whey protein gluten casein cod protein glp-1 postprandial triglyceride free fatty acids chylomicrons retinyl palmitate type 2 diabetes gip postprandial incretins
effect of nephrostomy on relative function of obstructed kidney

Conditions: Obstructive Uropathy

Summary: urinary tract obstruction is a serious health problem due to kidney damage. relative renal function has an important role in the treatment of obstructed kidneys. nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. recently, however, nephron sparing approaches have come to the fore. this indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. the aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (dmsa) before and 2 weeks after nephrostomy tube.

obstructive uropathy is one of the most important causes of acute renal injury and end-stage renal failure. obstruction of urine flow increases the intratubular pressure. this pressure increase causes decrease in renal blood flow and starts the inflammatory process. in the first few hours after total ureter obstruction, due to the increase in intratubular pressure glomerular filtration ceases and tubular transport is markedly decreased. long lasting obstruction results in renal fibrosis and end stage renal damage. basically obstructive uropathy leading to irreversible renal damage and loss of renal function is the main indication for simple nephrectomy. serious renal parenchymal damage is defined as non-functioning kidney having relative renal function (rrf) 10% or less in the literature. but recently in some studies it was suggested that by applying the nephrostomy catheter, ability of kidney to regain function can be evaluated before nephrectomy. so, possibility of gaining function should be kept in mind. in this study effect of percutaneous nephrostomy tube on serum creatinine, blood urea nitrogen (bun) and rrf in obstructed kidney with rrf 10% or less. before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and rrf in dmsa was recorded and compared.

Eligibility criteria:
inclusion criteria: * unilateral obstructed kidney with rrf 10% or less * unilateral obstructed kidney with grade 2 or more hydroureteronephrosis * defined etiology for unilateral obstructed kidney * estimated glomerular filtration rate (gfr) ≥ 30ml/min * approving the nephrostomy procedure exclusion criteria: * unilateral obstructed kidney with rrf above 10% * estimated gfr \<30 ml/min * diagnosis of bilateral obstructed kidneys * not approving nephrostomy

Keywords: obstructive uropathy relative renal function dmsa