Kornimate/medical-research-clean huggingface dataset:
exploring theatrical expressive tasks for children with asd

Conditions: Autism; Autism Spectrum Disorder

Summary: autism spectrum disorder (asd), according to the diagnostic criteria of diagnostic and statistical manual of mental disorders- v edition (dsm-5), is a disorder involving (a) persistent deficits in social communication, social interaction and (b) patterns of restricted and stereotyped behavior and/or interests and/or activities. specifically, impairment in social interaction manifests itself in different areas of individual functioning and through various facets: social-emotional reciprocity, poor understanding of social rules, reduced sharing of interests, emotions or feelings, reduced or absent theory of mind, inability to initiate or respond to social interactions (turn-taking in conversation), and difficulties in the use of communication. facial expressions, vocal intonation, postures and gestures are crucial components of non-verbal communication that play a fundamental role in social-communicative functions. however, people with asd may show significant deficits in these forms of expression, negatively affecting the ability to generate an appropriate social response, which is essential for initiating and maintaining social interactions. children with asd tend to avoid eye contact with others and show little or no interest in people, often looking past them or away from them. this behavior contributes to presenting them as "markedly aloof and distant". the aim of the study is to explore the effect of specific expressive tasks, conducted by highly qualified personnel, in a group setting, by means of targeted theatrical activities. these activities include exercises focusing on the use of voice and posture, the variety of vocal intonations and the harmonization between verbal production and facial expressiveness. in the context of this study, 20 children will be involved, divided into an experimental group and a control group. the experimental group will include 10 children with asd who voluntarily participate in activities organized by the irib-cnr of messina. these children, aged between 6 and 11 years, present a medium-high level of cognitive functioning, as assessed by the wechsler intelligence scale for children- iv edition (wisc-iv) cognitive test. in parallel, the control group will consist of 10 normo-typical children, selected from the istituto comprensivo san francesco di paola of messina, having the same age group, who will not participate in the experimental activities.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder; * age between 6 and 11 years; * iq over 80 assessed by means of wisc-iv. exclusion criteria: * presence of other medical disorders

Keywords: autism children expressiveness theater technology
efficacy of mindfulness-cognitive oriented group intervention program on depressed university students

Conditions: Depression in Adolescence

Summary: the goal of this study is to reduce depressive symptoms as well as increase the positive coping strategy and quality of life in depressed university students. the main question it aims to answer is: • the efficacy of 4-week mindfulness-cognitive oriented group program the participants will be requested to participate in a 4-week program and do the mindfulness practice at home.

in this study, the investigators will recruit university students through a poster at chung shan medical university and the internet. for the screening, students will be requested to complete the assessments of the saint louis university mental status and beck depression inventory-ii. students who have suitable cognitive capacity and minor and above level of depressive symptoms will be included in the study. the participants will receive a mindfulness-cognitive oriented group program for 4 weeks. all the subjects will fill out the self-reported questionnaires at baseline, after the intervention, and one-month after the intervention. the assessments include beck depression inventory-ii, brief coping orientation to problems experienced inventory, world health organization quality-of-life scale-bref, occupational balance questionnaire, role checklist, and occupational questionnaire.

Eligibility criteria:
inclusion criteria: * currently enrolled as a student at chung shan medical university * between 18 and 30 years old * the saint louis university mental status (slums) total score is greater than 26 * the total score of beck depression inventory-ii (bdi-ii) chinese version is above 13 * fluency in spoken mandarin exclusion criteria: * the score of item 9 (suicidal ideation) of beck depression inventory-ii (bdi-ii) chinese version \> 0 * a current diagnosis of depressive disorder * a current diagnosis of a major physical illness (e.g., cancer, cerebrovascular disease (stroke), spinal cord injury, congenital or genetic disease, chronic renal failure, autoimmune disease, burns) or psychological disease (psychotic or other psychiatric disorders, bipolar disorder, substance-related or addiction disorder, neurodevelopmental disorder, neurocognitive disorder, substance- or drug-induced depression) * currently taking psychiatric medication or receiving psychotherapy

Keywords: mindfulness-based cognitive therapy depressive symptoms coping strategy quality of life university students
consultation in the emergency department

Conditions: Communication

Summary: this study intends to evaluate consultation in the emergency department. the purpose is to demonstrate that standardizing communication in the emergency department may lead to improved consultation.


Eligibility criteria:
inclusion criteria: * emergency medicine residents (pgy1-5) exclusion criteria: * did not want to partake in the study

Keywords: consultation
tissue kallikrein protect against ischemic stroke

Conditions: Stroke, Ischemic

Summary: the results of previous studies were used to assess the causal association between tk levels and stroke occurrence at 5 and 12 years of follow-up, respectively.

analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. we completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death). conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). we collaborated with the hospital platform's computer center to conduct follow-up through ai questionnaire surveys, followed by supplementing ai questionnaire data with telephone questionnaire surveys for those lost to follow-up. utilize r language r studio 4.11 for statistical analysis and plotting. evaluate the distribution of tk levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years. evaluate the distribution of tk levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years.

Eligibility criteria:
inclusion criteria: * 1) control population in the previous stroke case-control study; * 2) the chd case-control population in the previous study; * 3) the population in the community cross-sectional study of the previous study. exclusion criteria: * stroke patient

Keywords: stroke
to compare the safety and efficacy of perrigo's product to an fda approved product for the treatment of glaucoma or ocular hypertension in both eyes

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: to compare the safety and efficacy of perrigo's product to an fda approved product in the treatment of primary open angle glaucoma or ocular hypertension in both eyes.


Eligibility criteria:
inclusion criteria: 1. male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes 2. subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. 3. adequate wash-out period prior to baseline of any ocular hypotensive medication. 4. baseline (day 0/hour 0) pressure ≥ 22 mm hg and ≤ 34 mm hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm hg. 5. baseline best corrected visual acuity equivalent to 20/200 or better in each eye exclusion criteria: 1. females who are pregnant, breast feeding, or planning a pregnancy. 2. females of childbearing potential who do not agree to utilize an adequate form of contraception 3. current, or past history of, severe hepatic or renal impairment 4. current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye 5. current corneal abnormalities that would prevent accurate readings with the goldmann applanation tonometer 6. functionally significant visual field loss 7. contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy 8. use at any time prior to baseline of an intraocular corticosteroid implant 9. use within one week prior to baseline of contact lens 10. use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid 11. use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy 12. use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid 13. having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery) 14. having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction
pharmacokinetics and safety of transdermal megestrol acetate

Conditions: Cachexia

Summary: rationale: megestrol acetate (megace®) is a progestin analog that is fda approved for the palliative treatment of breast and endometrial carcinoma. it is also commonly used as an appetite stimulant, particularly in hiv and cancer patients with poor appetite from their primary disease and/or their therapy. megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. transdermal progestins are available and are fda approved. for example, ortho evratm is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin). key objectives: compare the pharmacokinetics of orally administered vs. transdermal megace and determine if there are any local side effects of the transdermal route.

study population: patients of any age who are already receiving oral megace as an appetite stimulant. patients must have an indwelling iv catheter in order to draw drug levels. major inclusion \& exclusion criteria: known hypersensitivity to the transdermal vehicle. taking any other medicine that would interfere with the megace assay. weight less than 10 kg. allocation to groups: patients will serve as their own controls. summary of procedures: patients will be on a stable dose of oral megace. to determine the steady state peak level and half-life for each patient, blood (2cc) will be drawn for a level in clinic 3 hours after an oral dose, then daily for 1-3 days. patients may then resume their oral megace, but must stop the medicine at least 5 half-lives prior to the transdermal dose. the transdermal dose will be applied as a gel under a transparent patch in clinic, and blood will be collected prior to, 10, 30, 60, 90, and 120 minutes, and 4 hours after the dose. the patch will be removed after the 4 hour blood level. the patient will return the following day for a 24 hour level, and the patient will be examined briefly for any local effects of the drug or vehicle, and then may resume the oral dose. major risks \& discomforts: patients will need to be in clinic for 3-5 separate days, one of which will last at least 4 hours, for drug levels to be drawn. there may be mild skin reaction to the transdermal vehicle or the megace.

Eligibility criteria:
inclusion criteria: * patients of any age who are already receiving oral megace as an appetite stimulant. * patients must have an indwelling iv catheter in order to draw drug levels. exclusion criteria: * known hypersensitivity to the transdermal vehicle. * taking any other medicine that would interfere with the megace assay. * weight less than 10 kg.

Keywords: transdermal megace pharmacokinetics
preservation of fat free mass during weight loss

Conditions: Muscle Loss

Summary: in this study, we aimed to examine the effect of whey protein supplementation given before night sleep on fat free mass (ffm) preservation during a 4 wk period on very low caloric diet (vlcd). half of the participants underwent a 4 week vlcd and walking program, while the other half underwent a 4 week vlcd, walking program and had an additional protein supplement before each night sleep.


Eligibility criteria:
inclusion criteria: * body mass index (kg/m\^2) \> 28 * age between 18 and 55 years exclusion criteria: * participation in regular resistance-, aerobic- or anaerobic training (\>1 h/wk within the last 3 month before intervention start) * diabetes physical disabilities that would hinder completion of the walking program.

Keywords: ffm vlcd exercise protein obesity
digital psychological intervention for pediatric functional abdominal pain disorders in primary care

Conditions: Functional Abdominal Pain Syndrome

Summary: the project involves researching two psychological treatments for functional abdominal pain in children. the treatments will be offered to children as an early intervention, at primary care level. the study will aim to find out if the treatments are effective and which children the different treatments are effective for.

the research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric fapd where specialist level community-based pediatric clinics (cpc, swedish barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (hc). as children with fapd benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. the model explores a collaboration whereby an initial diagnosis of fapd will be made by a general practitioner at a participating hc, following which digital interventions with two levels, managed by cpc, will be provided. the aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about fapd, and level 2 is a digitally delivered cognitive behavior therapy (cbt) based psychological intervention for fapd. the cbt intervention is a fully digital version of the aim to decrease anxiety and pain treatment (adapt), which has been developed into a swedish language version through a project funded by the innovation fund in region vastragotaland (vgr).

Eligibility criteria:
inclusion criteria: * eligible participants are children and young people aged 8-14. * diagnosed with functional abdominal pain disorders by their physician. * diagnosed at one of the participating primary care health centres. exclusion criteria: * children and young people with scores above the clinical cut-off on the revised child anxiety and depression scale (rcads). * children who do not follow the mainstream swedish national curriculum due to learning disabilities.
time schedules for sending invitations to colonoscopy screening

Conditions: Colorectal Cancer

Summary: the attendance rate to population based primary screening colonoscopy within nordicc trial (the nordic-european initiative on colorectal cancer, nct00883792) in poland is roughly 33%. the aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (six and three group) or 4 and 2 weeks (four and two group) prior to pre-specified screening colonoscopy appointment date. outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. the study is powered to detect 7% difference in participation in screening colonoscopy.


Eligibility criteria:
inclusion criteria: individuals aged 55-64 years living in warsaw area randomly drawn from population registry and randomized to the screening arm of the nordicc trial. exclusion criteria: * resident abroad * return of unopened letter of invitation and/or reminder (address unknown) * message from neighbour/family/post office on death of screenee (not updated in population registry). exclusion criteria for colonoscopy: * individuals with previous colorectal surgery (resections, enterostomies) * individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation). * on-going cytotoxic treatment or radiotherapy for malignant disease * severe chronic (longer than trial duration) cardiac (nyha iii-iv)or lung disease * lifelong anticoagulant therapy with warfarin * a coronary event requiring hospitalization during the last 3 months * a cerebrovascular event during the last 3 months

Keywords: screening colonoscopy attendance response colorectal cancer
arx788 in selected her2-mutated or her2-amplified/overexpressed solid tumors (ace-pan tumor-02)

Conditions: HER2 Mutation-Related Tumors; HER2 Amplified Solid Tumors

Summary: a global phase 2 study to evaluate the efficacy and safety of arx788 for selected her2-mutated or her2-amplified/overexpressed solid tumors (ace-pan tumor-02)

the study will enroll subjects with her2-mutated or her2-amplified/overexpressed locally advanced or metastatic solid tumor cancers whose prior standard of care therapies have failed. this basket trial will evaluate arx788 across multiple cancer populations, as defined by her2 genetic biomarkers

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and older * life expectancy \> 3 months * eastern cooperative oncology performance status ≤ 1 * her2 status must be determined from a local clinical laboratory improvement amendments (clia) or equivalent-certified laboratory. * cohort 1, cohort 2, and explanatory cohort a: her2 mutated subjects with pre-specified her2 activating mutation. subjects with her2 mutations in nsclc (cohort 1), breast cancer (cohort 2), and other solid tumors (cohort a) who have not received prior her2 antibody drug conjugate (adc) treatment are eligible. * cohort 3: subjects with her2 amplifications in biliary tract cancers (btc) who have not received prior her2 adc treatment are eligible. * cohort 4: subjects with her2 amplifications in colorectal cancer (crc), ovarian, endometrial, nsclc and other solid tumors who have not received prior her2 adc treatment are eligible. * cohort 5 her2 mutation or her2 amplification: subjects with her2 mutated or amplified tumors and have been previously treated with her2 adc are eligible. * subjects who are resistant or refractory to previous standard care of treatment. * subjects with stable brain metastases. * adequate organ functions. exclusion criteria: any subject who meets any of the following criteria is excluded from the study: * for cohort 4: breast and gastric/gej cancer are excluded. * prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months. * history of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by medical monitor. * exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of arx788. * clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of arx788. * radiotherapy administered less than 21 days prior to the first dose of arx788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of arx788, or radiotherapy-induced toxicity of grade 2 or greater based on nci-ctcae v 5.0. there are additional inclusion and exclusion criteria. the study center will determine if criteria for participation are met.

Keywords: her2 mutation her2 amplification non-small cell lung cancer (nsclc) colorectal (crc) biliary tract cancer (btc) breast cancer other solid tumors
phase i study of pazopanib alone and in combination with lapatinib in japanese patients with solid tumors

Conditions: Carcinoma, Renal Cell

Summary: this is a two part phase i study in japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.


Eligibility criteria:
inclusion criteria: * signed informed consent. * histologically or cytologically confirmed diagnosis of advanced solid tumor. * women and men with potential to have children must be willing to practice acceptable methods of birth control during the study. * ecog performance status of 0 or 1. * adequate bone marrow reserve and hepato-renal function. * able to swallow and retain oral medication. * for combo part, left ventricular ejection fraction within normal range or above 50%. exclusion criteria: * prior treatment with pazopanib, and with lapatinib for combo part. * clinically significant gastrointestinal abnormalities. * sevier diseases or conditions other than cancer. * poorly controlled hypertension. * use of warfarin for therapeutic anticoagulation. * use of other anti-angiogenesis agents, and other erbb inhibitors for combo part. * unresolved and/or unstable toxicities * pregnant or lactating females

Keywords: lapatinib, cancer pharmacokinetics, safety, pazopanib, japanese patients,
trigeminal neuralgia electrophysiology

Conditions: Trigeminal Neuralgia

Summary: the study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. the evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (eeg) and at the gasserian ganglion through an fda-approved recording electrode.


Eligibility criteria:
inclusion criteria (tgn): * adults of 18 years or older * scheduled to undergo percutaneous rhizotomy for facial pain exclusion criteria (tgn): * facial pain of unclear origin (i.e. not clearly tgn pain) * rhizotomy procedure canceled inclusion criteria (healthy controls) * adults of 18 years or older exclusion criteria (healthy controls) * diagnosis or history of facial pain such as tmd or tgn * history of migraine * history of any functional pain disorder: fibromyalgia, ibs, crps * recent chronic pain (within last month) * unwilling to participate for two hours in lab * current acute pain

Keywords: trigeminal neuralgia