Kornimate/medical-research-clean huggingface dataset:
novel cross-species neurophysiological assays of reward and cognitive domains

Conditions: Translational Electrophysiology

Summary: the overarching goal of this multi-disciplinary research program is to develop and optimize new cross-species translational assessments of reward and cognition that will not only be assessed in parallel in humans and rats, but also produce neurophysiological and behavioral metrics that can be objectively compared across species. the research will build on prior studies by further developing and optimizing (in phase 1), then validating via pharmacological challenge (in phase 2), the following assays in both humans and rats: 1. advanced neurophysiological and computational modeling techniques to record and analyze eeg activity within and across species; and 2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility will be analyzed within and across species. the second phase of the study will test the translational validity of these assays, by assessing the impact of a targeted drug on task performance and eeg activity in both species.

the overarching goal of this multi-disciplinary research program is to develop and optimize new translational assessments of reward and cognition that will produce neurophysiological and behavioral metrics that enable objective comparison of drug effects. phase 1 (2016-2018) will seek to develop and optimize computer-based tasks to measure of reward learning and cognition, to be administered during an eeg examination. each participant will be asked to come for a single visit to complete a brief psychological assessment (interview and surveys), then perform two of the computer-based tasks while eeg data are collected. the three tasks are the flanker task, the reversal learning task, and the probabilistic reward task (prt). in phase 2 (2018-2021), a new set of participants will be enrolled for four visits. at the first visit they will have a brief psychological assessment (interview and surveys). they will then be assigned to one of the tasks developed during phase i, and they will also be assigned to one of the study drugs: modafinil (a cognitive enhancer) or methylphenidate (a dopamine enhancer). at the second, third, and fourth visit, the subject will be given their drug in one of the three doses: a low dose, a higher dose, and a placebo. they will then perform the assigned task during an eeg exam.

Eligibility criteria:
inclusion criteria: * healthy adults * right-handed exclusion criteria: * acute or chronic medical, neurological, or psychiatric illness * any past/current diagnosis of mental health disorder as defined by the diagnostic and statistical manual of mental disorders (dsm-5), including alcohol or substance abuse; * use of any psychotropic medications in the past 6 months * current depressed mood (beck depression inventory (bdi-ii) score \< 6) * current use of aspirin, nonsteroidal anti-inflammatory drugs (nsaids), warfarin, and other anticoagulants * history of cocaine, stimulant, and other dopaminergic drug use (e.g., amphetamine, methylphenidate) * positive toxicology screen at any session

Keywords: translational electrophysiology
hearing for learning initiative - a health facilitator model for otitis media

Conditions: Otitis Media; Conductive Hearing Loss

Summary: the hearing for learning initiative is a stepped-wedge cluster randomised controlled trial. the hfli will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services. this initiative will address the following research question: in urban, rural and remote aboriginal communities in the northern territory, does employment, training and integration of local ear and hearing clinical and education support officers into health and education services (the hearing for learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of aboriginal and torres strait islander children, during a four year trial period?

background: australian indigenous children achieve lower scores in school readiness and education outcomes than their non-indigenous peers. chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. local problem: failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children. this hearing for learning initiative aims to improve health care and education services. interventions: the intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention). trial design: a stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the hfli (intervention) periods with no hfli (control) periods. participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates. outcomes: the primary outcome is the change in the proportion of aboriginal and torres strait islander children who receive an ear assessment, between intervention and control periods.

Eligibility criteria:
inclusion criteria: aboriginal or torres strait islander, resident in participating community (cluster) exclusion criteria: none

Keywords: primary health care workforce aboriginal or torres strait islander facilitator education
effects of intensive training on reocvery of fingers dexterity following stroke

Conditions: Stroke

Summary: the investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.


Eligibility criteria:
inclusion criteria: * first symptomatic ischemic or hemorrhagic stroke * clinically evident upper-limb motor deficit * understand the study aim, is able to cooperate with the task for the specified time * clinically stable exclusion criteria: * other neurological or psychiatric illness which affects upper-limb motor function * an orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy. * sensory problems that prevent the patient from reporting pain during the robotic hand therapy * skin breakdown or wounds located in places where the hand contacts the robot. * patients with c/i to tms (history of seizures, the existence of cardiac pacer, vp shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo tms but may participate in the study * participation in another interventional study for upper limb rehabilitation
a dose-ranging study of fluticasone furoate (ff)

Conditions: Asthma

Summary: this is a phase iib, multi-centre, stratified, randomised, double-blind, double-dummy, parallel-group, placebo and active controlled study in children aged 5-11 years with persistent uncontrolled asthma. subjects meeting all of the inclusion criteria and none of the exclusion criteria at the screening visit (visit 1) will enter a four week run-in period during which time they will continue their current medications. visit 2 will occur two weeks into the run-in period to allow a review of compliance with daily diary and run-in medication. at visit 3 (end of run-in/randomization visit), subjects meeting the eligibility criteria who remain uncontrolled despite baseline therapy will be stratified based on pre screening inhaled corticosteroid (ics) use. once stratified, subjects will be randomised to the treatment phase of the study where they will receive one of five treatments for 12 weeks. approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of 115 randomized/evaluable subjects per treatment arm. subjects will attend on-treatment visits at 2, 4, 8 and 12 weeks (visits 4, 5, 6 and 7 respectively). a follow-up contact will be performed one week after completing study medication. all subjects must attempt spirometry measurements at visits 1 and 3. for all subjects, a timed 24-hour urine collection for urinary cortisol and creatinine excretion will be performed prior to randomization at visit 2 and within 7 days prior to visit 7. all subjects must perform pef daily between visits 1 and 7. the primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) pm pef from patient hand held electronic daily diary at endpoint (endpoint is defined as the mean over the last 7 days of treatment). safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol, and vital signs.


Eligibility criteria:
inclusion criteria: * written informed consent from at least one parent/ legal guardian to take part in the study.: * diagnosis of asthma * pre-bronchodilator pef between ≥50% to ≤90% of their best post-bronchodilator value * receiving therapy of short acting beta-agonist (saba) alone, ltm, or ics (total daily dose \<fp 200mcg or equivalent)exclusion : exclusion criteria: * history of life-threatening asthma * history of asthma exacerbation for asthma within 6 months prior to screening. * culture-documented or suspected bacterial or viral infection * significant abnormality or medical condition * present use of any tobacco products
chemotherapy in treating patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i/ii trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

objectives: i. determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer. ii. determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. iii. determine the clinical pharmacology of this regimen in these patients. iv. determine the rationale for the dose and chosen schedule of this regimen in these patients. outline: patients receive annamycin liposomal iv over 60 minutes on day 1. treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 14-30 patients will be accrued for this study within 7-30 months.

Eligibility criteria:
disease characteristics: diagnosis of locally advanced or metastatic breast cancer high likelihood of anthracycline resistance due to prior anthracycline exposure in the adjuvant or metastatic setting prior anthraquinone (e.g., mitoxantrone) insufficient prior cumulative anthracycline dose limited to doxorubicin-equivalent 350 mg/m2 by iv bolus or 450 mg/m2 by prolonged (at least 48 hours) infusion measurable or evaluable disease brain metastases treated by prior surgery and/or radiotherapy allowed if neurologic status stable 2 weeks after discontinuation of dexamethasone hormone receptor status: not specified patient characteristics: age: 18 and over sex: male or female menopausal status: not specified performance status: zubrod 0-2 life expectancy: at least 12 weeks hematopoietic: absolute granulocyte count greater than 1,500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 1.5 mg/dl cardiovascular: no history of heart failure ejection fraction at least 55% by 2-dimensional echocardiogram other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception other prior malignancy allowed if curatively treated and there is clear diagnosis of metastatic breast cancer requiring treatment prior concurrent therapy: biologic therapy: no concurrent prophylactic filgrastim (g-csf) chemotherapy: see disease characteristics at least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered endocrine therapy: see disease characteristics radiotherapy: see disease characteristics at least 3 weeks since prior radiotherapy and recovered surgery: see disease characteristics

Keywords: stage iv breast cancer stage iiia breast cancer recurrent breast cancer stage iiib breast cancer male breast cancer
relapse after allograft: link between locus of control and quality of life

Conditions: Allograft; Post-allograft Relapse

Summary: allogeneic hematopoietic transplantation (allohct) is a robust therapeutic that is used as a consolidation strategy in a number of haematological cancers. it provides durable responses as compared to chemotherapy alone. despite the potential of the graft-versus-tumor effect that is driven by allohct, relapse after allohct remains common. yet, the psychological impact of relapse after allograft is poorly appreciated.

for patients with hematological cancers of poor prognosis (acute myeloid leukemia, myelodysplastic syndromes...), proceeding to allogeneic hematopoietic transplantation (allohct) is the definitive curative approach. while allohct is an invasive procedure, patients experience social isolation and distressing symptoms when hospitalized. indeed, patients often report high levels of anxiety and/or depression during hospitalization and upon discharge. a number of risk factors have been linked to psychological morbidity and their impact on post-allohct relapse have been less investigated. of note, the health locus of control may play a significant role in determining patients' health-related behaviors. the health locus of control is defined as the set of beliefs a person has about his or her personal influence on health, including an internal locus of control (i.e. personal actions or thoughts can affect outcomes) and an external locus of control (i.e. outcome is believed to be determined by powerful others: god, health professionals, chance...). in this context, the aim of the study react is to identify the types of locus of control in relapsed patients after allohct and the possible association with current disease perception as well as further therapeutic strategies.

Eligibility criteria:
inclusion criteria: * major patient who has been informed about the study; * allografted patient with molecular or clinical relapse. exclusion criteria: * legal incapacity or limited capacity ; medical or psychological incapacity or limited capacity; * not able to understand and complete surveys.

Keywords: hematology allograft relapse psychological impact locus of control
study to evaluate the qtc interval in healthy volunteers dosed with dexpramipexole (qtc = electrocardiogram (ecg) interval measured from the onset of the qrs complex to the end of the t wave corrected for heart rate)

Conditions: Amyotrophic Lateral Sclerosis

Summary: to evaluate whether dexpramipexole prolongs the qtc interval when orally administered to healthy volunteers.

this is a phase i, single-center, blinded (with respect to dexpramipexole administration), randomized, placebo- and active-controlled, 4-period crossover study in approximately 68 healthy volunteers. this thorough qt/qtc study will be conducted to formally evaluate the effect of dexpramipexole on qt prolongation.

Eligibility criteria:
inclusion criteria: * aged 18 to 60 years old inclusive on day 1. * subjects who, in the opinion of the investigator, are healthy as determined by pre study medical history, physical examination, and 12 lead ecg. * male subjects and female subjects of childbearing potential must practice effective contraception (per protocol specifications). * normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmhg and a diastolic blood pressure of 50 to 90 mmhg. exclusion criteria: * history of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, long qt syndrome, or other conditions/diseases causing prolongation of the qt/qtc interval), in the opinion of the investigator. * a prolongation of qt/qtc interval (e.g., repeated demonstration of a qt/qtc interval \>450 ms before study treatment administration. * clinically important abnormalities in resting ecg that may interfere with the interpretation of qtc interval changes at screening, check-in, or pre-dose on day -1 of the first treatment period. * other medically significant illness. * clinically significant abnormal laboratory values. * pregnant women or women breastfeeding.
topotecan in treating patients with recurrent ovarian epithelial or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

objectives: i. determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer. ii. determine the nature and degree of toxicity of this treatment regimen in these patients. outline: patients receive topotecan iv over 30 minutes on days 1-3. treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 22-60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent ovarian epithelial or primary peritoneal carcinoma bidimensionally measurable disease (ascites and pleural effusions not considered measurable) platinum sensitive (defined as treatment free interval following response to platinum of greater than 6 months) one prior platinum based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound required patient characteristics: age: not specified performance status: gog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least lower limit of normal hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot and alkaline phosphatase no greater that 2.5 times uln renal: creatinine no greater than 1.5 times uln other: no active infection requiring antibiotics no neuropathy greater than grade 1 not pregnant negative pregnancy test fertile patients must use effective contraception no prior malignancy within past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: at least 3 weeks since prior biologic or immunologic agents chemotherapy: see disease characteristics recovered from prior chemotherapy patients with no prior paclitaxel therapy may receive second regimen that includes paclitaxel no other prior or concurrent cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens no prior topotecan endocrine therapy: at least one week since prior hormonal therapy for malignant tumor prior and concurrent hormone replacement therapy allowed radiotherapy: no prior or concurrent radiotherapy to target sites no prior radiotherapy to greater than 25% of bone marrow recovered from prior radiotherapy surgery: recovered from prior surgery other: no prior cancer treatment that contraindicates study

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer
testosterone, metformin, or both, for hypogonadism in obese males

Conditions: Hypogonadism; Obesity

Summary: the purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. this study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo


Eligibility criteria:
inclusion criteria: * men aged 18 to 50 years. * bmi \> or = 30 kg/m2. * total testosterone levels \<2.3 ng/ml (\<8 nmol/l) or testosterone levels 2.3-3.49 ng/ml (8-12 nmol/l) and free testosterone levels \<70 pg/ml. * lh levels \<7.7 miu / ml. * no evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of tsh, ft4, prolactin, acth, cortisol and igf-1 * being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol. exclusion criteria: * intolerance/allergy to metformin or testosterone undecanoate. * previous diagnosis of diabetes mellitus (hba1c\> 6.5% or fasting glucose\> 126 mg/dl or glucose\> 200 mg/dl after an oral glucose tolerance test) * treatment with oral hypoglycemic agents, insulin or glp-1 analogs. * poor kidney function: serum creatinine\> 2.0 mg / dl. * previous history of prostate cancer or breast cancer. * active cancer of any kind. * history of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin\> 2.0 mg / dl or got levels three times the upper limit of normal. * central hypogonadism of organic cause * use in the past 12 months of any drug that affects the pituitary-gonadal axis. * use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry. * uncontrolled hypertension (sbp\> 160 mmhg or dbp\> 100 mmhg) despite adequate antihypertensive therapy. * hiv infection or known active infection with hbv or hcv. * thrombotic or embolic disease. * heart disease, kidney or liver disease. * epilepsy or migraine not adequately controlled with treatment. * hematocrit\> 50% in the screening. * psa\> 4 ng / ml. * severe benign prostatic hypertrophy with an ipss scale score over 19. * evidence of drug or alcohol abuse (\> 50 g alcohol / day) * hematological diseases that produce increased risk of bleeding after intramuscular injection. * serious underlying disease that might affect the patient's ability to participate in the study (eg ongoing infection, gastric ulcers, active autoimmune disease). * reduced life expectancy (\<12 months) by the presence of comorbidities or advanced terminals. * participation in another clinical trial within 30 days before study entry. * previous diagnosis of hemochromatosis * treatment with phosphodiesterase-5 inhibitors: sildenafil, tadalafil or vardenafil

Keywords: hypogonadism obesity erectile dysfunction testosterone metformin weight loss insulin resistance