Kornimate/medical-research-clean huggingface dataset:
growth hormone and brain functioning after traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the current protocol aims to compare the brain-functioning (fmri \& eeg) and white matter structural integrity (dti) of persons with mild to severe tbi with and without growth hormone deficiency during cognitive tasks; and to examine changes in cognitive and motor performance, eeg/fmri and white matter integrity associated with growth hormone treatment for twelve months using an open-label design in persons with gh deficiency/insufficiency following mild to severe tbi. to meet this aim, we are in the process of screening 40 persons with mild to severe tbi, ages 18-55, who are at least six months post injury. after screening, 10 persons with tbi and ghd (growth hormone deficiency) will receive daily rhgh injections titrated to bring their gh levels into the normal range over the course of twelve months. treatment will be initiated using rhgh (genotropin). subjects with tbi and ghd will be assessed at baseline, 6 months, and 12 months with eeg, fmri and dti, and neuropsychological measures. 5 persons with tbi who do not have ghd will be assessed at baseline and at 12 months with eeg, fmri and dti, and neuropsychological measures.


Eligibility criteria:
inclusion criteria: * mild to severe tbi * at least 6 months post injury * ages 18-55 exclusion criteria: * patients taking anticoagulants, anticonvulsants, cyclosporine, corticosteroids, and sex steroids * history of hepatitis b or c * history of symptomatic coronary disease or congestive heart failure * pre-existing neurologic disease such as epilepsy, alzheimer's disease, multiple sclerosis, brain tumors, etc. * obesity (bmi \> 30) * pregnant or lactating females * penetrating traumatic brain injury * having a pacemaker * diabetes and diabetic retinopathy * serious psychiatric conditions (e.g., schizophrenia, bipolar disorder, major depressive disorder, etc.) * patients with language problems such as aphasia * any sign of neoplastic activity * active malignancies * three-fold elevation of liver function tests (alp, alt, ast) * partially deficient in both cortisol and thyroid * fully deficient in either cortisol and thyroid * patients with claustrophobia * metal in the body that cannot be removed (especially in the head) * amputations on upper body limbs

Keywords: traumatic brain injury growth hormone neuroimaging
statin for immunomudulation in sepsis

Conditions: Sepsis

Summary: the purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients


Eligibility criteria:
inclusion criteria: * clinical diagnosis of several sepsis or shock septic * no more than twenty four hours than diagnosis exclusion criteria: * use of statins in the last thirty days * unequivocal indication for statin treatment * active treatment with imunosuppressors drugs * high risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase \> three times upper limit of normal * diagnosis of aids * unable to receive enteral medications * pregnancy * expected survival of less than 48 hours
exploring advanced imaging techniques to characterize botulinum toxin diffusion in human muscle

Conditions: Stroke; Muscle Spasticity

Summary: since the use of botulinum toxin in treating spasticity has already been proven effective, we are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post injection) in order to determine the specific toxin dose required for an optimal treatment response.

over the past decade, botulinum toxins (bt) have been extensively used to treat any number of diverse disorders, including functionally significant, focal spasticity in the arm and leg of persons with injury/disease of the central nervous system. spasticity is an involuntary muscle stiffness that limits movement of an extremity and often leads to pain, hygiene problems, difficulty in bed or wheelchair positioning, and functional deficits in self-care and mobility. there are three bt products on the market: myobloc®, botox®, and dysport®. fda approval for use of botox® in spasticity is anticipated sometime during 2010. in the weill cornell division of rehabilitation medicine alone, nearly 50,000 units of botox® were injected for the treatment of spasticity during the 2008-2009 academic year. (note: the vast majority of the bt market share in the us rests with botox®.) there is excellent evidence supporting the effectiveness of bt in decreasing tone and modest clinical evidence supporting functional improvement. despite the frequent use, however, there is astonishingly little evidence delineating the impact on diffusion of dosing, dilution, approach to muscle localization, or serotype of bt. to better study these relationships we will be using advanced imaging to develop a model to characterize the physical characteristics of bt diffusion in human skeletal muscle.

Eligibility criteria:
inclusion criteria: * diagnosis of umn disease * clinically significant spasticity in the gastrocnemius muscle to warrant botox® injection (made at the discretion of dr. o'dell) * naïve to all botulinum toxins in the lower extremity exclusion criteria: * mr incompatibility with implanted ferromagnetic devices.\[specifically, they may not participate in this study if they have a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices. they will be screened by the mri staff for past surgical procedures to determine the possibility of having an implanted medical or metallic device, shrapnel, or other metal, such as metal in the eye.\] * pregnancy or breast feeding

Keywords: mri magnetic resonance imaging botox botulinum toxin neurological stroke spasticity muscle stiffness diffusion weill cornell new york presbyterian hospital o'dell
megestrol acetate for the improvement of quality of life in esophageal cancer with chemoradiotherapy

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Summary: megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. can improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance put, chemotherapy, improve the quality of life, is widely used in tumor radiation and chemotherapy of terminally ill patients. but because of its vascular embolization, vaginal bleeding, arrhythmia and other serious complications, there is no unified standard. the purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical chemoradiation curative effect and side effects, for rational use in the process of radiation and chemotherapy megestrol provide guidelines. a total of 210 patients will be accrued from china.the primary end point is quality of life (will be evaluated by eortc qlq-c30); the secondary end point is the pathological response after treatment and adverse events.

the investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma and performed chemoradiotherapy from the oct 2014. the patients will be divided into two groups.experimental group：esophageal cancer patients with oral megestrol chemoradiation. megestrol（yining）：160mg/d，po,5 weeks in total，oen week before chemoradiotherapy and one week after chemoradiotherapy. chemoradiotherapy：chemotherapy and radiotherapy： 50gy in total，2 gy/d，5d/w.control group: esophageal cancer patients with chemoradiation without oral megestrol.chemoradiotherapy：chemotherapy and radiotherapy： 50gy in total，2 gy/d，5d/w.the primary end point is quality of life (will be evaluated by eortc qlq-c30); the secondary end point is the pathological response after treatment and adverse events.

Eligibility criteria:
inclusion criteria: * age 45-75years old * histologically proven squamous cell carcinoma of the esophagus the tumor was in t2-4n0-2m0 * the patients have not received the surgery or chemo-radiotherapy. * hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l, * alt、ast≤2.5\*n,cr≤1.5\*n. * performance status score 0-2 exclusion criteria: * pregnant, lactating women * oxaliplatin or fluorouracil allergy or metabolic disorders * radiotherapy contraindications * history of organ transplantation * brain metastasis * the peripheral nervous system disorders * severe infection * oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding * severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * other malignant tumor in recent 5 years.

Keywords: chemoradiotherapy esophageal squamous cancer megestrol
us and neurodevelopmental outcomes in the neonatal intensive care unit (nicu)

Conditions: Premature Birth

Summary: the objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. the investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.

the specific aims are as follows: 1. to identify clinical factors that are associated with muscle and adipose tissue measurements. the investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, c-reactive protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. the investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing adp) data at 35 weeks postmenstrual age (pma)/discharge from the neonatal intensive care unit. all other clinical data will be collected throughout the hospital stay. 2. to determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. the investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks pma/discharge and 4 months corrected age. the investigators will utilize event related potentials (erp) to measure speed of processing and recognition memory as early markers of brain development. 3. to determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. the investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks pma/discharge and 4 months corrected age.

Eligibility criteria:
inclusion criteria: * preterm infants born between 25 and 34+6 weeks gestation admitted to university of minnesota masonic children's hospital neonatal intensive care unit * medically stable at time of air displacement measurements exclusion criteria: * infants that require medical support preventing adp measurements from being taken
open-label single ascending dose of adeno-associated virus serotype 8 factor ix gene therapy in adults with hemophilia b

Conditions: Hemophilia B

Summary: the purpose of this study is to evaluate the safety of single ascending iv doses of a factor ix (fix) gene therapy in up to 16 adults with hemophilia b.

hemophilia b is a genetic x-linked bleeding disorder caused by a deficiency in blood-clotting factor ix (fix) activity. fix is synthesized in the liver and circulates in the blood as a proenzyme. current treatment for hemophilia b is based on replacement of the deficient fix with iv injections of recombinant fix protein prophylactically or as needed to treat bleeding episodes. this clinical program will test a gene transfer approach involving the use of a gene delivery vector carrying a fix gene. this first-in-humans study is intended to evaluate the safety, kinetics, and if possible, the dose of askbio009 required to achieve stable plasma fix activity between 10% and 40% of normal activity.

Eligibility criteria:
inclusion criteria: * males age 18-75 years, inclusive * established hemophilia b with ≥3 hemorrhages per year requiring treatment with exogenous fix or use of fix prophylaxis because of history of frequent bleeding episodes * plasma fix activity ≤2% (\<1% for first cohort; then per protocol) * negative for active hepatitis c virus (hcv), defined as hepatitis c virus antibody negative and negative (undetectable) pcr test for plasma hepatitis c virus ribonucleic acid (rna) or if hepatitis c virus antibody positive must have ≥2 consecutive negative (undetectable) pcr tests for plasma hcv rna at least 3 months apart, and negative at screening exclusion criteria: * family history of inhibitor to fix protein or personal laboratory evidence of having developed inhibitors to fix protein at any time (\>0.6 bethesda units on any single test) * documented prior allergic reaction to any fix product * detectable aav8 neutralizing antibodies * markers of hepatic inflammation or overt or occult cirrhosis as evidenced by one or more of the following: * platelet count \<175,000/μl * albumin ≤3.5 g/dl * total bilirubin \>1.5 x uln and direct bilirubin ≥0.5 mg/dl * alkaline phosphatase \>2.0 x uln * alt or ast \>2.0 x uln (except for subjects who are hiv infected) * liver biopsy in the past indicating moderate or severe fibrosis (metavir staging of 2 or greater) * history of ascites, varices, variceal hemorrhage or hepatic encephalopathy

Keywords: hemophilia b factor ix deficiency gene therapy
high frequency stimulation of the gpi or thalamus in tourette's syndrome

Conditions: Tourette's Syndrome

Summary: tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. the pathophysiology is still unknown. some data suggest an dysfunction of limbic circuits in basal ganglia. the aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe tourette's syndrome.


Eligibility criteria:
inclusion criteria: * tourette's syndrome (dsm iv) * inducing a disability in the social and personal life * no improvement with medical treatment * severe self suffering exclusion criteria: * cognitive impairment (mms \< 24) * depression

Keywords: tourette's syndrome high frequency stimulation globus pallidus thalamus
community health worker assisted task specific and cognitive therapy at home with exposure after stroke

Conditions: Stroke, Acute Ischemic

Summary: catches is a novel intervention for preliminary testing, integrating task specific therapy at home guided by community health workers (chw) under supervision of a licensed physical therapist (pt) guided by telehealth based cognitive behavioral therapy (cbt) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity. 1. to integrate and establish feasibility of catches intervention. hypothesis: a multidisciplinary team providing home based tst with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (fof) among post-acute stroke patients returning home. feasibility outcomes will include recruitment, retention, and fidelity of implementation. 2. test effects of the intervention on hypothesized treatment mechanism of fear of falling. hypothesis: therapy will reduce task specific fear of falling primary outcome will be change in activities-specific balance confidence scale. 3. explore physical activity measures subjectively and objectively. exploratory outcomes include pre and post timed up and go test, patient reported outcome surveys and activity as measured by wearable devices.

stroke is a leading cause of disability in the country, and ethno-racial inequities are persistent. almost two thirds of stroke patients are discharged home without effective rehabilitation or community-based support. falls can occur at home, and associated fear of falling leads to avoidance behaviors that limit physical activity and community reintegration. here the investigators propose a novel intervention in a feasibility study for preliminary testing, integrating task specific therapy at home guided by community health workers (chw) under supervision of a licensed physical therapist (pt) in conjunction with telehealth based cognitive behavioral therapy (cbt) with reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies to facilitate engagement in physical activity. the main objective is to assess the feasibility of this intervention. the secondary objective is to explore the underlying behavioral mechanism for behavior change and explore physical activity.

Eligibility criteria:
inclusion criteria: * aged over 18 years * plan for discharge home after stroke and ability to provide consent * low balance confidence (activities-specific balance confidence \< 80) exclusion criteria: * modified rankin scale \> 2 at time of enrollment * severe stroke (nih stroke scale \> 14 and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer) * legal blindness precluding ability to view infographic or education materials * terminal non-cardiovascular illness (life expectancy \< 1 year) * co-morbid mental illness requiring hospitalization * unavailable for follow-up * non-english and non-spanish speaking
studying biomarkers in urine samples from younger patients with wilms tumor

Conditions: Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage III Wilms Tumor

Summary: this research study is looking at biomarkers in urine samples from patients with wilms tumor. studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment

primary objectives: i. to characterize the urinary metabolite signature of 10 stage iii, favorable-histology, wilms tumor patients from the cooperative human tissue network (chtn) databank, as distinct from 10 normal controls. ii. to characterize and compare the urinary metabolite profile in 50 randomly selected, stage iii, favorable-histology, wilms tumor patients enriched with an additional 30 stage iii wilms tumor patients who have relapsed. iii. to establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature. iv. to characterize the urinary metabolite signature of wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology. outline: archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (nmr) spectroscopy and principal component analysis (pca). tumor tissue may also be examined by nmr and pca.

Eligibility criteria:
inclusion criteria: * patients diagnosed with stage iii, favorable-histology wilms tumors and patients diagnosed with stage iii, favorable-histology wilms tumors who have relapsed * tumor samples available from both groups * urine samples from the chtn bank * control urine samples * urine samples from patients with unfavorable histology * not specified * not specified
infraorbital nerve involvement on magnetic resonance imaging in igg4-related ophthalmic disease

Conditions: IgG4-related Disease; Orbital Infections, Inflammations and Irritations

Summary: infraorbital nerve enlargement (ione) on magnetic resonance imaging is known to be a possible consequence of igg4-related ophthalmic disease. however this imaging sign can also be found in other conditions causing orbital inflammation. this study aims at comparing the frequency of ione in patients suffering from igg4-related ophthalmic disease (igg4-rod) versus patients suffering from non-igg4-related ophthalmic disease (non-igg4-rod)


Eligibility criteria:
inclusion criteria : * patient aged 18 and older treated in fondation rothschild (tertiary ophthalmology facility, paris, france) from january 2006 through april 2015 * presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia. * the presence of at least one pretherapeutic mri confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. the mandatory minimal mri protocol include the following sequences: t1- and t2-weighted mri image, in the transverse and coronal plane, and a fat-suppressed t1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate. * completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for igg4. exclusion criteria : * clinical and biological signs of thyroid-associated orbitopathy * histologically proven lymphoma * pretherapeutic mri that is insufficient for an adequate interpretation * absence of igg4 testing in the pathology examination
paternal involvement in psychiatric care of adolescents managed for depression or suicide attempt

Conditions: Psychiatric Disorder; Depression; Suicide, Attempted; Child Mental Disorder

Summary: parental involvement, both quantitative and qualitative, is fundamental for a good psycho-emotional development of the child. the lack of parental involvement and especially paternal involvement significantly promotes the occurrence of behavioral disorders in children and later, in adolescence, the onset of depressive symptomatology. on the other hand, parental involvement has a protective role in the occurrence of behavioral disorders and decreases the risk of suicide attempts in adolescence. the authors of these cohort studies agree on the need for research on the identification of factors determining paternal involvement in order to organize specific prevention actions and targeted interventions to promote the involvement of fathers in psychiatric care of their adolescents. the prevention of adolescent suicide attempts appears to be a real public health issue in reunion island with a suicide rate among under-35s twice as high as in reunion than in metropolitan france. this work is a continuation of the guidelines of good practice of the high authority of health (has) which insist on the importance of "supporting the parental function by health and public action".


Eligibility criteria:
inclusion criteria: teenagers aged 13 to 17 * managed for a depressive episode (adrs score\> 3) or for a suicide attempt * speaking and understanding french and / or creole language exclusion criteria: * fathers without legal responsibility for the child * absence of consent of the adolescent or those responsible for parental authority