Kornimate/medical-research-clean huggingface dataset:
quantifying abnormalities in cortical activation associated with auditory hallucinations using functional magnetic resonance imaging

Conditions: Schizophrenia; Schizoaffective Disorder; Hallucinations

Summary: the goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. the investigators will use advanced magnetic resonance imaging (mri) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.

the goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. we will use advanced magnetic resonance imaging (mri) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. we will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. in order to address these aims, we will study four groups of subjects: 1. patients who have frequent auditory hallucinations, 2. patients who are beginning a regimen of anti-psychotic medication, 3. patients who do not have frequent hallucinations and are not changing medication strategies, and 4. age-matched normal controls. each group will contain 15 subjects for a total of 60.

Eligibility criteria:
inclusion criteria: investigators will study subjects who: * are between the ages of 18 and 65. * meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder or schizophrenia/schizoaffective disorder without auditory hallucinations. * have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated * are willing to change their current antipsychotic medication if indicated * are able to provide written consent normal controls must : * be between the ages of 18 and 65 * not meet the diagnostic criteria for schizophrenia or schizoaffective disorder or other psychiatric disorder involving hallucinations * not currently be treated with an antipsychotic drug * be able to provide written consent exclusion criteria: subjects and normal controls will be excluded from participation if there is: * evidence of non-psychiatric, chronic central nervous system (cns) disease (such as brain injury or neurological disease) * contraindication to mri, including prior claustrophobic reaction and severe movement disorder * a recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females) * a positive pregnancy result (for females)

Keywords: psychotic disorders auditory hallucinations brain structure psychiatric disorder with auditory hallucinations (at least one every 20 minutes) schizophrenia/schizoaffective disorder without auditory hallucinations
the use of artificial intelligence to predict cancerous lymph nodes for lung cancer staging during ultrasound imaging

Conditions: Lung Diseases; Lung Neoplasm

Summary: this study aims to determine if a deep neural artificial intelligence (ai) network (neuralseg) can learn how to assign the canada lymph node score to lymph nodes examined by endobronchial ultrasound transbronchial needle aspiration(ebus-tbna), using the technique of segmentation. images will be created from 300 lymph nodes videos from a prospective library and will be used as a derivation set to develop the algorithm. an additional100 lymph node images will be prospectively collected to validate if neuralseg can correctly apply the score.


Eligibility criteria:
inclusion criteria: * must be diagnosed with confirmed or suspected lung cancer and be undergoing ebus diagnosis/staging exclusion criteria: * none

Keywords: endobronchial ultrasound ultrasonographic features artificial intelligence deep neural network segmentation
a study of cc-90010 in combination with temozolomide with or without radiation therapy in participants with newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: the purpose of this study is to determine the safety and tolerability of cc-90010 when combined with standard of care treatment, temozolomide (tmz) with or without radiotherapy (rt) in the newly diagnosed who grade iv glioblastoma (ndgbm).


Eligibility criteria:
inclusion criteria: * primary isocitrate dehydrogenase (idh)-wild type newly diagnosed world health organization (who) grade iv glioblastoma * o6-methylguanine-dna methyltransferase (mgmt) promoter methylation status must be available prior to randomization * karnofsky performance status of ≥70 exclusion criteria: * indeterminate mgmt promoter methylation status * biopsy only of glioblastoma (gbm) at surgery, defined as \< 20% resection of enhancing tumor * any known metastatic extracranial or leptomeningeal disease other protocol-defined inclusion/exclusion criteria apply

Keywords: cc-90010 temozolomide glioblastoma newly diagnosed radiation therapy safety tolerability mtd and rp2d
efficacy, safety and tolerability study of avp-923 (dextromethorphan/quinidine) for treatment of symptoms of agitation in participants with alzheimer's disease

Conditions: Agitation; Alzheimer's Disease

Summary: the objectives of the study are to evaluate the safety, tolerability and efficacy of avp-923 compared to placebo, for the treatment of symptoms of agitation in participants with alzheimer's disease (ad).

eligible participants for this study must have a diagnosis of probable ad and must have clinically meaningful agitation secondary to ad. this is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment. up to 200 participants will be enrolled at approximately 30-40 centers in the us. study medication will be administered orally twice-daily from day 1 through day 70. screening must occur within within approximately 4 weeks prior to randomization. following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Eligibility criteria:
key inclusion criteria: diagnosis of probable alzheimer's disease (ad). the participant has clinically significant symptoms of agitation secondary to ad, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator. either out-patients or residents of an assisted-living facility or a skilled nursing home. cgi-s score is ≥ 4 (moderately ill) at screening and baseline. mini mental state examination (mmse) score at screening between 8 and 28 (inclusive). caregiver who is able and willing to comply with all required study procedures, ensuring that the participant attends all study visits and takes the study medication as instructed. in order to qualify as a caregiver for this study, the individual should spend time with the participant for a minimum of 4 hours on 4 separate days per week. key exclusion criteria: participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia). participant with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including qtc prolongation, or unstable valvular heart disease). participant with myasthenia gravis.

Keywords: avp-923-20 avp-923-30 avp-923 dextromethorphan quinidine neuropsychiatric inventory aggression efficacy safety
per-oral pyloromyotomy for treating infantile hypertrophic pyloric stenosis

Conditions: Infantile Hypertrophic Pyloric Stenosis; Pyloromyotomy

Summary: infantile hypertrophic pyloric stenosis (ihps) is the most common condition for surgical treatment in infant. traditionally, laparoscopic or open pyloromyotomy are the standard treatments. however, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. we are going to study the per-oral pyloromyotomy (pop), also named as gastric per-oral endoscopic myotomy (g-poem), which showed promising results for adult gastroparesis, for a novel application of treating ihps.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pyloric stenosis with or without sonographic confirmation. exclusion criteria: * comorbid conditions that could affect postoperative recovery. * needed an additional procedure during the same anaesthetic.
response of preterm infants to multisensory stimuli

Conditions: Mother-Infant Interaction

Summary: the aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.

the aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of neonates with gestational age ranging from 32 to 34 completed weeks and in the saliva of their mothers. the measurements are taken before and after sensorial stimuli including mother voice exposure +/- tactile distraction for 10 minutes. the two interventions are performed between day 5 and day 12 after birth and 24 to 48 hours apart. each child is randomised in a group depending on order of the two interventions. investigators hypothesize that an increase in the oxytocin/cortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect. concomitantly, the neonate's vital signs and his facial expressions are recorded during interventions. the mothers anxiety level is assessed pss-nicu questionnaire given before the first and after the second intervention.

Eligibility criteria:
inclusion criteria: * newborn gestational age 32 0/7 weeks to 34 6/7 weeks * born at university hospital geneva * french speaking parents * out of incubator * signed consent exclusion criteria: * newborn with one of the above conditions: * congenital malformation * intraventricular hemorrhage grade iii or iv * white matter abnormality * anti-epileptic or sedative drugs * altered consciousness level * infant requiring respiratory support * psychiatric disorders in the mother or antenatal use of psychoactive drugs * bilateral absent otoacoustic emissions and/or auditory evoked potential * parents refusal to participate

Keywords: neonates oxytocin late preterm stress family-centered intervention
a study to assess maternal and fetal outcomes after taking prucalopride during pregnancy

Conditions: Constipation; Pregnancy

Summary: this study will collect information on pregnant women diagnosed with constipation from their health care insurance claims records. it will include the following groups: * those who took prucalopride. * those who took other medicines for constipation. * those who did not take any prescription medicines for constipation. the main aim of the study is to assess the risk of major birth defects with the mother's use of prucalopride during the first 3 months of pregnancy. the study uses existing health care insurance information; participants are not enrolled, treated, or required to visit the doctor during this study.


Eligibility criteria:
inclusion criteria: * pregnant women with constipation. * maternal coverage by health care and prescriptions insurance during eligibility period: * live births: 90 days prior to the last menstrual period until 30 days post-delivery; * abortions (spontaneous abortions): from 180 days prior to the first code for abortion to 30 days after this diagnosis; * stillbirths: from 180 days prior to the first code for stillbirth to 30 days after this diagnosis. * for infant outcomes, the cohort will be restricted to pregnancies with linked offspring. * for major malformations, only pregnancies with livebirths will be included, since information regarding the pathology results from a pregnancy loss or the indication for termination is rarely recorded. in addition, infants are required to have full insurance coverage from delivery to at least 90 days after the delivery, unless the infant died prior to the end of the 90 days, in which case a shorter eligibility period until death is permitted. * for the analyses of pregnancy losses, the cohort also includes pregnancies ending in spontaneous abortion, stillbirth and any livebirth (linked or unlinked to a delivery). exclusion criteria: * termination of pregnancy will be identified but excluded from analyses (since malformations are rarely coded and these pregnancies will not be at risk for other outcomes). * pregnancies in which prucalopride is dispensed in the 3 months prior to the lmp but not during the first trimester (to ensure that there is not misclassification of the non-exposed) * women with opioids dispensed in the 3 months prior to lmp or during the first trimester (to exclude potential opioid-induced constipation) and women with inflammatory bowel diseases (because they are a contraindication) * for major malformations, the cohort excludes pregnancies with a chromosomal abnormality based on at least one inpatient or outpatient icd-9 code for 758.xx,759.81-759.83, or 655.1x within 90 days after delivery in the infant and/or maternal claims. * for major malformations, pregnancies with outpatient exposure to definite teratogens including warfarin, antineoplastic agents, isotretinoin, misoprostol, and thalidomide from lmp through lmp plus 90 days (that is, days of exposure overlap with 1st trimester).

Keywords: fetal and infant outcomes prucalopride
real world registry for use of the ion endoluminal system

Conditions: Lung Cancer; Multiple Pulmonary Nodules; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Summary: the primary objective of this study is to evaluate the performance of the ion endoluminal system with real-world use for pulmonary lesion localization or biopsy.

this study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the ion endoluminal system. the primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield. clinical trial registration is submitted voluntarily under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60.

Eligibility criteria:
inclusion criteria: * subject is 18 years or older at the time of the index procedure. * subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the ion endoluminal system. * subject able to understand and adhere to study requirements and provide informed consent. exclusion criteria: * subject is under the care of a legally authorized representative (lar) and is unable to provide informed consent on their own accord. * subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study. * female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices. * subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

Keywords: pulmonary biopsy pulmonary lesion localization shape sensing robotic assisted bronchoscopy ion intuitive
postprandial blood glucose control and gastric emptying in type 1 diabetes: pathogenetic factors and therapeutic options

Conditions: Diabetes Mellitus, Type 1

Summary: this study evaluates the prevalence of gastric emptying (ge) in type 1 diabetic patients (dm1) free of chronic complications in comparison with a group of healthy control subjects. the investigators will also assess the relationship between ge and glucose control (hba1c, postprandial glucose variability), gut peptide hormones (glp-1, gip, and ghrelin), and gastrointestinal symptoms. in addition, in patients with delayed ge the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.

diabetic patients with a delayed ge will be studied in 2 separate occasions in euglycemic condition and under cgm. on both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g). on the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load. on the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. the "tailored" insulin bolus will be defined according to the individual pattern of ge, as follows: * ge t1/2 121-180 min= 60% as bolus + 40% during following 2 h * ge t1/2 \>180 min= 40% as bolus + 60% during following 4 h glycemic variability will be assessed by the means of continuous glucose monitoring system and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, m value, mean amplitude of glycemic excursions (mage), low blood glucose index (lbgi), high blood glucose index (hbgi).

Eligibility criteria:
inclusion criteria: * dm1; * use of insulin pump; * disease duration ≥ 3 years. exclusion criteria: * presence of chronic complications of dm (including cardiovascular autonomic neuropathy); * bmi ≥ 30 kg/m2; * presence of chronic diseases other than dm1; * diseases that interfere with ge; * medications that interfere with blood glucose homeostasis (except insulin) and ge.

Keywords: type 1 diabetes mellitus gastric emptying insulin infusion pump
life style modifications prevents type 2 diabetes in asian indians

Conditions: Diabetes

Summary: three year prospective randomised controlled trial in igt subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes

lifestyle modification helps in primary prevention of diabetes in multiethnic americans, finnish and chinese populations. in a prospective community based study, we tested if the conversion to diabetes could be influenced by interventions in native asian indians with impaired glucose tolerance (igt) who were younger, leaner and more insulin resistant than the above populations. we randomized 531 (men : women, 421 : 110) subjects with igt \[mean age of 45.9 + 5.7 years and body mass index (bmi) of 25.8 + 3.5 kg/m2 into four groups. group 1 was the control (con), group 2 was advised lifestyle modification (lsm), group 3 was treated with metformin (met) and group 4 with lsm plus met. primary outcome measure was type 2 diabetes diagnosed by the who criteria. in a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in group 1 to 4 respectively. the relative risk reduction was 28.5% with lsm (95 % confidence interval (ci), (20.5 - 37.3), (p=0.018), 26.4% with met (95% ci, 19.1 - 35.1) (p = 0.029) and 28.2% with lsm plus met (95% ci, 20.3 - 37.0), (p=0.022) versus control group. the numbers needed to treat to prevent one incident case of diabetes were 6.4 for lsm, 6.9 for met and 6.5 for lsm+met. conversion of igt to diabetes is high in native asian indians. lsm and metformin significantly reduced the incidence of diabetes in asian indians with igt. there was no added benefit by combining both.

Eligibility criteria:
inclusion criteria: * both male and female. 35 - 55 years. no known history of diabetes. willing and available for a three years study. exclusion criteria: * pregnant women. subjects with major illness such as cancer, hepatic or cardiac diseases. tranferable jobs.

Keywords: impaired glucose tolerance intervention prevention
safety and efficacy study of ziprasidone in pediatric psychotic illness

Conditions: Schizophrenia; Affective Disorders; Psychotic Disorder; Psychotic Mood Disorder

Summary: the purpose of this research is to determine if ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of ziprasidone treatment leads to weight changes in children.

ziprasidone is a recently fda approved antipsychotic, and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects. this is important because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome. unfortunately, pediatric samples are often more sensitive to the side effects of psychotropic medications. because psychotropic medications are often used by clinicians long before they are studied in pediatric populations, it is important to further study these agents. twenty subjects with the diagnosis of a psychotic disorder, according to dsm-iv criteria, will be recruited for the study. if subjects have completed baseline evaluations, labs, ekg, and rating scales and are still eligible to participate, subjects will start on 20mg of ziprasidone at night. the second week this will increase to 20 mg twice a day. at visits that occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day increments. this allows for a maximum possible dose of 100mg. dosage may be decreased at any time secondary to side effects. the potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis. the potential benefits of this study outweigh the possible risks.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizophreniform do, schizoaffective do or psychotic disorder nos * male/female, ages 7.0-17 years old * normal intelligence, ability to provide assent and consent * not currently receiving adequate treatment exclusion criteria: * known hypersensitivity to ziprasidone (past failed trial) * history of qtc prolongation * recent myocardial infarction * uncompensated heart failure * currently treated with other qtc prolonging medications * unstable medical illness * if on diuretics, monitor regularly for hypokalemia

Keywords: schizophrenia pediatric psychotic disorders ziprasidone