Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial to evaluate the efficacy and safety of nv01-a02 in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder (ASD

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory phase 2 clinical trial designed to evaluate the efficacy and safety of nv01-a02 in pediatric participants diagnosed with autism spectrum disorder (asd).


Eligibility criteria:
inclusion criteria: - inclusion criteria: children aged 6 to 15 years (inclusive) as of the date of written consent individuals who meet all the diagnostic criteria for autism spectrum disorder (asd) as outlined in the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) dsm-5 diagnostic criteria for autism spectrum disorder (asd): * persistent deficits in social communication and social interaction across multiple contexts, as manifested by all of the following: a. deficits in social-emotional reciprocity b. deficits in nonverbal communicative behaviors used for social interaction c. deficits in developing, maintaining, and understanding relationships ② restricted, repetitive patterns of behavior, interests, or activities, as manifested by at least two of the following: a. stereotyped or repetitive motor movements, use of objects, or speech b. insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior c. highly restricted, fixated interests that are abnormal in intensity or focus d. hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment ③ symptoms must be present in the early developmental period (but may not become fully manifest until social demands exceed limited capacities, or may be masked by learned strategies later in life) exclusion criteria: * individuals weighing less than 16 kg or more than 70 kg individuals identified during screening with any of the following medical histories, comorbid conditions, or surgical histories: * severe psychiatric disorders (other than autism spectrum disorder) that may affect participation in the clinical trial * history of organic brain disease, neurological disorders, or epilepsy/seizures that are not fully controlled by medication or non-pharmacologic surgical treatment (note: participants with a history of simple febrile seizures may be included at the investigator's discretion) * severe peripheral arterial disease or coronary insufficiency * presence or history of psychotic symptoms such as delusions or hallucinations (e.g., worsening or recurrence of psychiatric illness) * gastrointestinal diseases (e.g., active peptic ulcers) or history of surgery that may affect absorption of the investigational medicinal product (note: participants with a history of simple appendectomy or hernia surgery may be included) * individuals displaying serious self-injurious or aggressive behavior requiring medical intervention during the screening period, as determined by the investigator * individuals with sensory abnormalities such as congenital hearing loss
vp3: vancouver primary prevention program (anxiety disorders prevention in school children)

Conditions: Anxiety

Summary: objective: 1. to evaluate the efficacy of a school-based cognitive behavior therapy (cbt) program in reducing anxiety disorder symptoms in at-risk public school children. 2. to determine whether parent education and involvement improves outcome in anxious children treated with cbt. 3. to determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and 4. to evaluate a new measure of teacher-rated anxiety disorder symptoms in children. hypothesis: 1. a cbt oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children. 2. children who have parental involvement will post stronger and more enduring treatment gains.


Eligibility criteria:
inclusion criteria: children enrolled in school between the ages of 7 and 13 who display anxiety symptoms. 1. anxiety disorder symptoms (identified by a score of 56 or higher on the masc; and teacher report, and /or parent recommendation) as the primary presenting problem. an enrolled child must have at least 2 of these criterions. 2. fluency in english. 3. parent willingness to sign consent form and to complete required assessments. 4. student willingness to participate (child assent) in 10-week affective education program and completion of required assessments. exclusion criteria:

Keywords: anxiety therapy behaviour
neurofunctional study of preterm infants' brain activity

Conditions: Brain Activity; Preterm

Summary: during hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. in preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (kmc), are actively promoted. studies carried out with electroencephalography showed that preterm infants who participated in kmc interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. it has also been observed that kmc carried out in preterm infant with gestational age \<33 weeks promotes adequate development of the primary motor cortex during adolescence. recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. after few days of life, the infant's brain picks up messages from the human context and interacts with them. for example, a study using near-infrared spectroscopy (nirs) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. the aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) kmc and 2) listening to their mother's voice, using optical topography, a multichannel nirs system.


Eligibility criteria:
inclusion criteria: * gestational age at birth ≤32 weeks * absence of brain injury and neurological problems * newborn-mother pairs in kmc * adherence to research by parents. exclusion criteria: * contraindications to kmc and nirs, according to internal protocol

Keywords: preterm infant kangaroo mother care family-centered interventions near-infrared spectroscopy
controlled trial of valproate versus risperidone in young children with bipolar disorder

Conditions: Bipolar Disorder

Summary: controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with bipolar i or ii disorder, mixed, manic or hypomanic episode.

the objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with bipolar i or ii disorder, mixed, manic or hypomanic episode.

Eligibility criteria:
inclusion criteria * subjects were male or female outpatient subjects, * 3.0 - 7 years 11 months of age * bipolar i or ii disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to dsm iv criteria (american psychiatric association 1994) * with a score \> 20 on the young mania rating scale (ymrs. exclusion criteria * clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions; * neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests: * cbc with differential, * electrolytes, * bun, * creatinine, * hepatic transaminases, * urinalysis, * thyroid indices (t3, total t4, free t4, tsh) and * ekg * mania due to a general medical condition or substance-induced mania * mental retardation (iq \<70), * evidence of fetal alcohol syndrome or an alcohol-related neurodevelopmental disorder, * schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the dsm-iv.
safety and intraocular pressure (iop) lowering effect of al-59412c

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to assess the safety and efficacy of al-59412c injected intravitreally relative to vehicle.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma or ocular hypertension. * retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye. * able to discontinue all intraocular-lowering (iop) medications according to the minimum washout period, based upon the class of medication. * mean washed out iop ≥ 24 millimeters mercury (mmhg) to ≤ 36 mmhg at 8 am in the study eye on two separate eligibility visits. * other protocol-defined inclusion criteria may apply. exclusion criteria: * lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye. * current or recent (within 30 days) use of any drug that may prolong the qt interval. * poor vision resulting from advanced glaucoma in the study eye. * intraocular surgery within the past 6 months in the study eye. * ocular laser surgery within the past 3 months in the study eye. * other protocol-defined exclusion criteria may apply.

Keywords: intravitreal injection intraocular pressure open-angle glaucoma ocular hypertension
examining whether project support works

Conditions: Parent-Child Relations; Parenting Self Efficacy; Child Mental Health

Summary: this study will involve a randomized, controlled trial with two parallel groups, project support and a treatment as usual control group. families with a child on the waitlist for trauma-focused services will be invited to participate. participation involves completing a baseline assessment of family functioning and trauma characteristics. participants will then be randomized to either project support or the treatment as usual control group. all participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.

the proposed research addresses the dearth of brief, empirically-supported programs designed for caregivers to mitigate the adverse effects of child trauma. this project will examine the telehealth delivery of project support, a program that addresses parenting skills and behavior problems among children exposed to violence or maltreatment. project support uses didactic, tailored instruction to teach caregivers how to listen to and comfort their child. this study builds on prior research which has found that project support is feasible and acceptable for both treatment providers and families on the waitlist for trauma-focused services. this phase of the research will examine the preliminary efficacy of project support in a randomized controlled trial, evaluating the impact of this intervention on caregiver emotional support, parenting self-efficacy, and family distress, compared to treatment as usual.

Eligibility criteria:
inclusion criteria: * family is seeking trauma-focused services for their child; * child is between 6 - 13 years old; * caregiver agreed to be contacted for volunteer research opportunities; * caregiver and child can communicate in english; * child has been living with caregiver for at the last 6 months or longer; * family is able to participate in services delivered via telehealth. exclusion criteria: * child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis); * child is in foster care or department of social services custody; * the caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.

Keywords: child trauma non-offending caregiver
en-bloc vs conventional resection of primary bladder tumor

Conditions: Bladder Cancer

Summary: based on current evidence, we hypothesize that eturb represents an improvement in the surgical management of nmibc. the resection is more precise and complete compared to cturb. moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy. to answer these questions, we designed a rct comparing eturb with cturb. primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.


Eligibility criteria:
inclusion criteria subjects must meet all the following inclusion criteria to participate in this study: * diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cta, ct1) * imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis; * diameter of tumor between 1cm and 3cm * number of lesions ≤3 (the position of small lesions relatively concentrated as one place) * patients who agree to eturb or cturb surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation exclusion criteria * pure carcinoma in situ * contraindications to surgery (i.e. bladder fibrosis) * diameter of tumor \>3cm * number of lesions \>3 * poor performance status making a surgical intervention too risky * life expectancy of less than one year * patient refused to participate * pregnancy * history of upper urinary tract malignancy
evaluation of ischemia and reperfusion interval with neuromonitorization in tourniquet application

Conditions: Quadriceps Muscle Atrophy; Tourniquet; EMG

Summary: the goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. the main questions it aims to answer are: * what are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet? * are the effects of two different tourniquet pressures on neuromonitoring significantly different? * can the ideal time of the reperfusion interval be evaluated by neuromonitoring? * are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. it will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period. the investigators will compare two different tourniquet pressure ( limb occlusion pressure +50 mmhg / + 100 mmhg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative mep decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.

as a result of the power analysis for this study, the number of samples was determined as 24. the study was started after the approval of the ethics committee. participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. it was planned to evaluate quadriceps tendon thickness by usg and mri, thigh circumference, vas scores, cbc, and ck in blood samples in the preoperative period of all patients. it was planned to obtain parameters related to mep by using intraoperative neuromonitorization during the surgery. in the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. finally, emg evaluation was planned for 1 month.

Eligibility criteria:
inclusion criteria: * operation planning in the foot and ankle area exclusion criteria: * having a history of previous foot and ankle surgery, * having a history of previous knee surgery or spinal surgery, * diagnosis of diabetes mellitus, * having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.), * having a diagnosis of a disease affecting the known peripheral vascular system (peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency), * having a disease that affects the ideal tourniquet application (chronic lymphedema, bmi\>35, stage 3 and above chronic renal failure, uncontrollable hypertension), * having been diagnosed with a known coagulation disorder, * history of pulmonary embolism or deep vein thrombosis. * asa score above 3 * surgery time to be less than 80 minutes
open-label phase iv clinical trial to evaluate the safety and tolerability of zoledronic acid in patients with prostate cancer and bone metastases

Conditions: Prostate Cancer

Summary: to assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histological confirmed diagnosis of carcinoma of the prostate * current or previous evidence of metastatic disease to the bone * receiving currently or not, hormonal therapy * ecog performance status of 0, 1, or 2 exclusion criteria: * patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less. * corrected serum calcium concentration, adjusted for serum albumin \< 8.0 mg/dl (2.00 mmol/l). * wbc\<3.0x10\^9, anc \< 1500/mm3, hb \< 8.0 g/dl, platelets \< 75 x 10\^9/l. * liver function tests \>2.5 uln, serum creatinine \>1.5 uln. * patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol. * known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula. other protocol-related inclusion / exclusion criteria may apply

Keywords: prostate cancer bone metastases zoledronic acid
computerized alcohol screening for children and adolescents

Conditions: Alcohol Related Disorders

Summary: the goal of this project is to develop a computerized screening program for primary care offices that is based on the niaaa's alcohol screening guide for children and adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. there have been few studies of alcohol screening and brief intervention conducted among adolescents receiving primary medical care. this project will develop and validate a new computerized alcohol screening for children and adolescents (casca) system based on the two age-specific screening questions of the niaaa guide and includes the crafft and audit as secondary risk and problem assessments. the system will yield a provider report with the screening results, level of risk, and recommended brief advice, counseling, or referral strategies. the specific aims of this project are to: 1)assess the sensitivity, specificity, positive and negative predictive values of the 'any drinking/number of drinking days' and 'friends' questions of the casca in identifying past-year use as determined by the timeline follow-back calendar (tlfb), and for identifying any problem use, abuse or dependence as determined by the audit, crafft and a structured psychiatric diagnostic interview (computerized disc-iv, youth version) at baseline (criterion validity); 2)assess the test-retest reliability of the casca in measuring drinking frequency categories and in classifying patients into low, medium and high risk categories; 3)assess the predictive validity of the 'any drinking/number of drinking days' and 'friends' questions in predicting drinking, "binge" drinking, and any problem use, abuse or dependence at 12-mos follow-up; 4)assess the degree to which the 'any drinking/number of drinking days' item of the casca predicts drug use risk as measured by the tlfb (any use and frequency), tobacco use as measured by the hooked on nicotine checklist (screen for potential nicotine dependence), drug use disorders as measured by the drug abuse screening test for adolescents, and the degree to which it predicts other mental health problems as measured by the youth disc predictive scales at baseline and 12-month follow-up; 5)compare the psychometric properties of the casca across subgroups, including: age, gender, race/ethnicity, practice type, provider type, and patient risks (e.g., those with/without friends who drink); and explore the possible effects of the casca system on drinking at 3-, 6-, 9-, and 12-month follow-ups.


Eligibility criteria:
inclusion criteria: * nine- to 18-years old * arriving for non-emergent care * have an email address and internet access * provide informed assent/consent. exclusion criteria: * unable to read or understand english * living away at college at the time of the recruitment visit * not available for computer/telephone follow-ups * judged by the provider to be medically or emotionally unstable at time of visit.

Keywords: alcohol related disorders
diabetic mellitus patients glucose range awareness after experiencing a new blood glucose meter feature

Conditions: Diabetes Mellitus

Summary: a single visit \& single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm) for ≥ 3 months * currently performing self monitoring of blood glucose (smbg) at home * aged ≥16 years exclusion criteria: * previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.