Kornimate/medical-research-clean huggingface dataset:
a phase ii trial of 18f-av-45 positron emission tomography (pet) imaging in healthy volunteers, patients with mild cognitive impairment (mci) and patients with alzheimer's disease (ad)

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: evaluate 18f-av-45 positron emission tomography (pet) imaging for distinguishing healthy control subjects, from subjects with alzheimer's disease (ad) or mild cognitive impairment (mci).


Eligibility criteria:
inclusion criteria ad: * male or female \>=50 years of age * meet national institute of neurological and communicative diseases and stroke/alzheimer's disease and related disorders association (nincds) criteria for probable ad with mmse score of 10-24 inclusion criteria mci: * male or female \>=50 years of age * have a clinical dementia rating (cdr) of 0.5 * mmse \>24 normal subjects: * male or female \>=50 years of age * mmse \>=29 * normal on psychometric test battery at screening * provide informed consent exclusion criteria: * have a history or current diagnosis of other neurologic disease * have had or currently have a diagnosis of other neurodegenerative disease * have participated in experimental therapy targeted to amyloid plaque
telepsychiatry to improve the management of adolescent depression in primary care

Conditions: Depression

Summary: background: depression is common in adolescents and it is associated with serious consequences. in chile, primary care team has a leading role in the management of depression in adolescents. nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. this situation is particularity complex in regions far away from the central zone. telepsychiatry is a potential solution to an equitable access to specialized clinical expertise. purpose: the purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the araucanía region, chile. study design: a cluster-randomized clinical trial will be carried out with 237 adolescents. the efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.

general aim to carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the araucanía region, chile. specific aims 1. to compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics. 2. to compare the level of health-related quality of life (hrqol) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics. 3. to compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics. 4. to evaluate adolescents' satisfaction with a telepsychiatry program. 5. to evaluate health staff's satisfaction with a telepsychiatry program.

Eligibility criteria:
inclusion criteria: * meets diagnostic criteria of a depressive disorder according a structured interview (mini-kid) exclusion criteria: * psychotic symptoms * bipolar disorder * current substance and/or alcohol dependence * suicide risk that requires specialized treatment * current treatment with antidepressant and/or psychotherapy * low intellectual abilities

Keywords: depression adolescents
neural mechanism of aldosterone-induced insulin resistance

Conditions: Hypertension

Summary: patients with high aldosterone hormone have higher blood glucose than normal people. this study is being done to understand how aldosterone hormone affects the nerve activity that controls blood flow in the muscles and blood glucose. the information may be helpful in selecting blood pressure medications which can improve not only blood pressure but also improve blood sugar.

patients with primary aldosteronism are known to have impaired insulin sensitivity, which is improved after removal of aldosterone-producing adenoma. in patients with essential hypertension, plasma aldosterone levels have been also shown to positively correlate with indices of insulin resistance. mechanism underlying aldosterone-induced insulin resistance is unknown. aldosterone has been shown to interfere with insulin signaling the vascular cells by increasing production of reactive oxygen species via activation of nadph oxidase, resulting in decreased availability of nitric oxide (no), the key mediator for insulin-mediated vasodilation. treatment with mineralocorticoid receptor antagonists has been shown to improve insulin sensitivity in mice with obesity and metabolic syndrome. aldosterone has also been shown to increase resting sympathetic vasoconstrictor activity to the peripheral circulation. however, effects of aldosterone and mineralocorticoid receptor antagonists on insulin-mediated skeletal muscle vasodilation, sympathetic activation, and vascular oxidative stress have not been assessed in humans. the investigators will collect venous endothelial cells, and measure skeletal muscle microvascular perfusion using octafluoropropane microbubble contrast agents, and measure sympathetic nerve activity in normotensive controls (nt), stage 1 essential hypertensive subjects (et), and patients with primary aldosteronism (pa) during hyperinsulinemic euglycemic clamp.

Eligibility criteria:
inclusion criteria: 1. normotensive controls 2. stage i (140-159/90-99 mmhg) untreated subjects with essential hypertension 3. patients with pa and stage i (140-159/90-99 mmhg) hypertension exclusion criteria: 1. congestive heart failure or coronary artery disease 2. blood pressure averaging \> 159/99 mmhg 3. serum creatinine \> 1.5 mg/dl 4. diabetes mellitus or other systemic illness 5. left ventricular hypertrophy by echocardiography or ecg 6. pregnancy 7. hypersensitivity to spironolactone, chlorthalidone, amlodipine, human recombinant insulin or definity 8. any history of substance abuse (other than tobacco) 9. history of gouty arthritis 10. patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts 11. hypersensitivity to perflutren, blood, blood products or albumin

Keywords: hypertension blood pressure sympathetic nerve activity vascular oxidative stress nitric oxide nitric oxide synthase (enos) endothelium endothelial dysfunction endothelial cell protein expression microvascular blood flow flow mediated dilation endothelial cell collection microbubbles definity
noninvasive brain stimulation for pain relief

Conditions: Pain, Acute; Pain, Chronic; Pain, Experimental

Summary: non-invasive brain stimulation techniques, transcranial magnetic stimulation (tms) and transcranial focused ultrasound (fus), is be applied to healthy human subjects, acute pain patients, and chronic pain patients to investigate their uses for pain relief.

the research team will be using non-invasive brain stimulation techniques, transcranial magnetic stimulation (tms) and transcranial focused ultrasound (fus) to investigate their uses for pain relief in humans: healthy human subjects, acute pain patients, and chronic pain patients. magnetic resonance imaging (mri) and electroencephalogram (eeg) recordings will be collected to achieve the following objectives: objective 1 aims to determine the effects of noninvasive brain stimulation on the pain-related brain activities during pain processing. we hypothesize that noninvasive brain stimulation approaches will increase or decrease cortical activity upon processing painful input. objective 2 aims to determine the effects of noninvasive brain stimulation on pain intensity and/or pain-related behavioral assessments. we hypothesize that noninvasive brain stimulation will influence pain-intensity and/or pain-related behavioral assessments. objective 3 aims to investigate the correlation between brain activity and pain relief after noninvasive brain stimulation. we hypothesize that noninvasive brain stimulation will suppress cortical activity in pain-related brain areas, reduce pain intensity, and/or improve pain-related behavioral assessments.

Eligibility criteria:
inclusion criteria: * healthy adults between 18 and 80 years of age. * chronic and acute pain patients: must have an mri (for ultrasound targeting) exclusion criteria: * direct report to the study team member * history of brain surgery * history of seizure * pregnant * have alcohol consumption exceeding 50 drinks/month * have history of opioid abuse (all subjects), or any recent opioid use (healthy controls) * have implant like pacemaker and aneurysm clip * current of psychiatric disease such as anxiety or depression, which is not optimally treated * current infection * current wound on the skin of upper and lower extremities * chronic pain patients: current chronic pain is not optimal controlled by pain medications (i.e. pain vas \>5)

Keywords: transcranial magnetic stimulation focused ultrasound noninvasive neuromodulation
ondansetron treatment for alcoholism

Conditions: Alcoholism

Summary: the purpose of this study is to: a) evaluate the effectiveness of ondansetron (zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. individuals will be "typed" into early onset and late onset alcoholism groups. individuals will be randomly assigned to a 12-week outpatient treatment program.


Eligibility criteria:
inclusion criteria: * meet criteria for alcohol dependence. * subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. * understand the requirements of the study and be able to complete the questionnaires and rating scales. exclusion criteria: * current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. * positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. * receiving current psychotropic medications. * current history of other psychiatric disorders excluding nicotine dependence. * hepatocellular disease. * pregnant females.
evaluation of alt-2074 in subjects with type-2 diabetes, haptoglobin type 2-2 genotype and coronary artery disease

Conditions: Diabetes; Coronary Artery Disease

Summary: alt-2074 (bxt-51072) belongs to a class of drugs called "glutathione peroxidase mimics." alt-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes. the purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of alt 2074. subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype

subjects will be male and female, 18 to 75 years old, with type 2 diabetes mellitus, a documented or suspected history of coronary artery disease, and a haptoglobin type 2-2 (hp 2-2) genotype. subjects on prescribed anti-diabetic and coronary artery disease medications may continue to take their medications throughout the study. subjects who qualify will receive active drug (alt-2074 20 mg, 40 mg or 80 mg) or placebo every 8 hours for 28 days. there will be three sequential cohorts of increasing doses of active drug. there will be 2 follow-up visits (days 35 and 42). blood and urine tests for safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure inflammation and oxidative stress will be performed throughout the study. electrocardiograms and 24-hour holter monitoring will also be performed at various time points during the study.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 75 years of age. 2. diagnosis of type 2 diabetes mellitus 3. stable coronary artery disease (cad) documented or suspected, not requiring adjustment for ≥2 months, as determined by: a. a history of myocardial infarction verified by q-wave electrocardiogram and/or medical records, occurring greater than 6 months before the screening visit; or b. a coronary angiogram and/or stress test; or c. a ankle brachial pressure index less than 0.9; or d. age greater than 60 years of age 4. hp 2-2 genotype. 5. ability to communicate and comply with all study requirements. -
pretreatment anti-therapeutic antibodies (pata) in patients treated with hu14.18k322a antibody

Conditions: Ewing Family of Tumors; Melanoma; Neuroblastoma; Osteosarcoma

Summary: hu14.18k322a is a monoclonal antibody developed at st. jude children's research hospital (sjcrh) that is made to bind to cancer cells that have a molecule called gd2 on their surface. sometimes the human body will make an antibody to the therapeutic antibody (like hu14.18k322a) that is being given for treatment. these are called human anti-human antibodies (haha). when testing for haha in a previous cohort of patients who received hu14.18k322a, it was found that some patients tested positive for high levels of an antibody before receiving hu14.18k322a or any other anti-gd2 antibody. in this study, investigators would like to know more about the nature of this pretreatment antibody, how often is it present, and if in the laboratory it increases the killing of tumor cells. objectives: * to determine whether pretreatment anti-therapeutic antibodies (pata) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-gd2 antibody hu14.18k322a * to determine if pata increases the anti-tumor efficacy of anti-gd2 antibodies in vitro

in the proposed study, investigators will seek to determine the nature of this antibody that is being detected in the haha test for this group of patients, and if, in the laboratory, it increases the killing of tumor cells, accounting for the observation that some the patients who tested positive may have an improved outcome. the study will analyze dna from blood samples of sjcrh patients treated with hu14.18k322a anti-gd2 antibody. serological studies and confirmatory genotyping studies will be performed in a laboratory at the university of wisconsin.

Eligibility criteria:
inclusion criteria: * all participants who have or will receive treatment at sjcrh with hu14.18k322a. exclusion criteria: * those not receiving treatment at sjcrh with hu14.18k322a.

Keywords: hu14.18k322a human anti-human antibodies (haha) pretreatment anti-therapeutic antibodies (pata)
evaluating additive effects of including canines in regulating together

Conditions: Autism Spectrum Disorder; Emotion Regulation

Summary: the primary objective is to evaluate the potential additive effect of animal-assisted intervention (aai) on a manualized behavioral treatment targeting emotion dysregulation (ed) in children with autism spectrum disorder (asd). aim 1: evaluate whether regulating together-canine demonstrates earlier and greater improvement in emotion dysregulation than regulating together-standard. aim 2: evaluate if regulating together-canine increases child engagement and learning compared to regulating together-standard. exploratory aim: explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

children between the ages of 8 years 0 months and 15 years 11 months with autism spectrum disorder (asd) and emotion dysregulation (ed) and their caregivers will participate in 5 research visits and 10 group intervention sessions. they are randomly assigned to either regulating together-standard group (no dog), or regulating together-canine group (with dog). characterization measures will be completed at screen (t1). all outcome measures will be completed at baseline (t2), post-treatment (1-2 weeks following treatment completion, t3), 10 week post treatment completion follow up (t4), and 6 month post treatment completion follow up (t5).

Eligibility criteria:
inclusion criteria: * concern of emotion dysregulation (ed) as measured by a score of 6 or greater on the emotion dysregulation inventory-reactivity (edi-r) * diagnosis of autism spectrum disorder (asd) * diagnosis confirmed by an experienced asd clinician and further supported by scoring in the range for asd on the autism diagnostic observation schedule (ados-2) * a full scale intelligence quotient score of 65 or greater on the weschler abbreviated scale intelligence (wasi-ii) * english is the primary language * family willing to keep prescribed medication stable over the course of the study period exclusion criteria: * participant has a phobia toward or is allergic to canines * participant has a history of aggression toward animals * participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury * presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others * presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss * a legal guardian is not available to provide informed consent
determining clinical study experiences of chronic lymphocytic leukemia patients

Conditions: Chronic Lymphocytic Leukemia

Summary: this research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials. this trial will scrutinize the experiences of patients diagnosed with chronic lymphocytic leukemia as they take part in a separate medical intervention clinical trial. the focus will be on tracking the rates of completion and withdrawal among these individuals. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chronic lymphocytic leukemia patients.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with chronic lymphocytic leukemia * patient is a minimum of 18 years or older * able to comprehend the investigational nature of the protocol and provide informed consent exclusion criteria: * pregnant or lactating women * patients who are currently receiving any other investigational drug * any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

Keywords: chronic lymphocytic leukemia
a study of real life treatment for multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: the main aim of this study is to learn how long it takes for people with mm to have a relapse after their first treatment. not all participants will have a relapse during the study. participants will visit their clinic every 3 months and be treated according to their clinic's standard practice. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

this is a non-interventional, prospective study of participants with mm relapses. this study will assess the low detection rate of biochemical relapses which will improve routine clinical practices and management of participants with mm in real world practice. the study will enroll approximately 350 participants. the data will be collected both prospectively and/or retrospectively at the specialized care (hematology) and will be recorded into electronic case report forms (e-crfs) of the electronic data capture (edc) system. all the participants will be assigned to a single observational cohort: • participants with mm this multi-center study will be conducted in the russian federation. the overall duration of the study will be approximately 4 years. the overall time for treatment and follow-up period will be approximately 2.5 years for each participant.

Eligibility criteria:
inclusion criteria: 1. with newly diagnosed multiple myeloma (ndmm) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (hdt-asct) who have had a response (defined as cr, vgpr, or pr) to the ongoing soc induction (1st line) therapy that has been started within 3 months before the inclusion. 2. eastern cooperative oncology group (ecog) performance status of 0 to 2 at the time of inclusion. exclusion criteria: 1. with ndmm eligible and non-eligible for a hdt-asct who have had sd or pd to the ongoing standard of care (soc) induction (1st line) therapy that has been started within 3 months before the inclusion. 2. current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.

Keywords: drug therapy
comparison of predictive factors related to coronary artery disease

Conditions: Coronary Artery Disease

Summary: in taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (cad). postmenopausal status is an independent risk factor for cad. early assessment and proper management of risk factors may reduce the prevalence rate of cad. in the past decade, despite increased attention to cad in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. because the prevalence of risk factors related to cad is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of cad among middle-aged women in three menopausal statuses. at the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.


Eligibility criteria:
inclusion criteria: * diagnosis of cad by coroangiography * lvef \>30% exclusion criteria: * impairment of physical activity * history of psychiatric disorder, vital arrhythmia

Keywords: women middle age risk factor