Kornimate/medical-research-clean huggingface dataset:
a pilot trial examining digital parent training programs

Conditions: Child Behavior Problem; Parenting; Engagement, Patient

Summary: the purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of correspondence with the related deign mechanism.

the purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. the design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavior change. to achieve these goal two unguided digital parent training interventions, differentiated by their level of design (dpt-standard vs. dpt-enhanced), will be tested. this pilot aims to recruit 40-60 parents who report behavior problems in their children who will randomly receive one of the two interventions for 10 weeks. the impact of dpt-e on user engagement and reported child behavior problems will be assessed based on comparison with dpt-standard. parental behaviors and sense of competence will be collected to assess the impact of intervention design on these mechanisms of change. in addition, the role of parents' motivation, and their ability to invest effort in making changes during the intervention will be assessed, to examine whether these variables moderate the impact of intervention's design on the aforementioned relationships. the investigators also aim to explore whether the relationship between usage and clinical outcomes is stronger in those using dpt-e compared with dpt-standard.

Eligibility criteria:
inclusion criteria: 1. parents report they have a child between the ages of 3 and 7, who: 2. has externalized behavior problems based on a) parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) \& the average of all items ≥ 4, on a screening scale that consists of 9 items (on a likert scale between 1 and 7) that is based on dsm-v symptoms for odd. b) parents report ecbi problems to be above 14 or intensity to be above 130. 3. parents have access to computer at home with an internet connection and a smartphone with a mobile data plan. 4. parents can read and understand hebrew. exclusion criteria: 1. parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder. 2. parent and/or child are already receiving therapeutic intervention (for the child) in other setting. 3. the relevant child is treated with psychiatric medication.
postoperative controls of ventilation tubes in children - by general practitioner or otolaryngologist?

Conditions: Otitis

Summary: a large number of children with otitis media undergo surgery with ventilation tubes (vts) placed in the tympanic membrane. this is done to improve hearing and speech development and to reduce ear complaints. the long-term results of vts are unclear. follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made. the primary goal of this study is to investigate if follow-up care after surgery with vts of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient. in the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. user satisfaction and other aspects related to the quality of control will also be assessed. if the study shows that follow-ups after surgery with vts can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.

remark: the change in age range of included children from 4-10 to 3-10 was approved by rek (ethics committee) in november 2018.

Eligibility criteria:
inclusion criteria: * insertion of a ventilation tube in at least one ear * patient at trondheim university hospital, molde hospital, aalesund hospital, kristiansund hospital, stavanger hospital, hospital north norway, or innlandet hospital in gjøvik. exclusion criteria: * medical syndromes or other co-existing severe disease that possibly result in increased complication rate after insertion of ventilation tubes, i.e. downs syndrome, cystic fibrosis, primary ciliary dyskinesia * auditory processing disorder (apd) * severe neurogenic hearing loss (hl) at least one ear (\> 50db hl in frequencies 0.25 - 4.0 khz) * guardians or children who do not master the norwegian language

Keywords: child middle ear ventilation follow-up studies general practitioners
diagnostic utility of pleural fluid mage assay in patients with pleural effusion from primary lung cancer

Conditions: Unilatral Pleural Effusion

Summary: melanoma antigen (mage) gene is known to be expressed in tumor cells, testis and placenta. the purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid mage gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.


Eligibility criteria:
inclusion criteria: * unilateral pleural effusion on chest radiography exclusion criteria: * body temperature \> 38.3ºc and peripheral blood leukocytosis (\>12,000/μl)
the effectiveness of lymphatic bypass supermicrosurgery

Conditions: Breast Cancer Related Lymphedema; Lymphedema Arm

Summary: this study evaluate the effectiveness of lymphatic bypass supermicrosurgery (lbs) and axillary lymph node dissection (alnd) compare to alnd alone to prevent breast cancer treatment-related lymphedema (bcrl).

in the intervention group, lbs was performed after alnd with the intima-to-intima coaptation using the supermicrosurgery technique. the anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. the upper extremity lymphedema (uel) index and indocyanine green (icg) lymphography are utilized to evaluate the development of lymphedema.

Eligibility criteria:
inclusion criteria: * breast cancer patient aged \>18 years old * breast cancer patient with clinically alns metastases (cn1 or cn2). * breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel lymph node biopsy facility in the hospital. * any breast cancer patients that receive neoadjuvant systemic therapy. exclusion criteria: * stage iv breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy. * breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (slnb), and alnd. * breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy. * breast cancer patients with preoperative lymphatic system abnormality detected by icg lymphography. * breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation.

Keywords: lymphatic bypass supermicrosurgery primary lymphedema prevention axillary lymph node dissection
validation of apnea linktm for sleep apnea syndrome screening in a bariatric population

Conditions: Sleep Apnea Syndrome

Summary: sleep apnea syndrome (osa) frequently occurs in obese population undergoing bariatric surgery. there is a need for alternative screening tools for sleep apnea detection in the pre-operative period. the investigators would like to compare apnealink and complete polysomnography in this population.

osa can occur in up to 78% of patients undergoing bariatric surgery(1). moderate to severe case will benefit from cpap therapy, that can help avoiding post-operative complications(2). in this population, the investigators propose complete attended in-hospital polysomnography (psg)in patients with a clinical high probability of osa. according to obesity epidemics (3), waiting list for psg in sleep labs is every day longer. the investigators want to assess sensitivity and specificity of a new portable screening tool, apnealink, to detect osa in a bariatric population. design: monocentric and prospective study methods: patients: - osa suspicion based on : * symptoms and signs (snoring, apneas , neck circumference \>38 (women) or 43cm (men)) * bmi \> 50 * bmi \> 40, \> 40 y * bmi \> 35, men, hypertension * increased serum bicarbonate * polyglobulia measurements * polysomnography in sleep lab with concommitant recording performed with apnea linktm (nasal flow and oxymétry recording). * between 2 weeks : recording performed with apnea linktm (nasal flow and oxymétry recording)at home.

Eligibility criteria:
inclusion criteria: * obese patients * \> 18 years old * in whom a bariatric surgery is planified and who have to undergo a polysomnography for osa screening exclusion criteria: * pulmonary, neurologic, neuromuscular disease * \< 18 years old

Keywords: sleep apnea polysomnography obesity bariatric surgery
a post-marketing safety study of inactivated, split-virion influenza vaccine in subjects aged 3 years and older

Conditions: Influenza; Vaccination Adverse Event

Summary: to monitor the safety of shanghai institute of biological products company's influenza vaccine in subjects aged 3 years and older through adverse events following immunization surveillance system of china. the hypothesis is that there is no significant difference in the occurrence of adverse events among influenza vaccines manufactured by sibp and other companies.

inactivated split-virion vaccines from shanghai institute of biological products company have been used for more than 10 years in beijing population. some 160 thousands doses have been sold to subjects aged 3 years and older in this area. we review and summarize spontaneously reported adverse events from safety surveillance. adverse events were collected through the adverse events following immunization (aefi) surveillance system. beijing cdc and local prefectural cdc must organize an expert panel to investigate adverse events and assess causality, using criteria based on chinese standard procedures for vaccination. the panels consist of physicians, epidemiologists, pharmacists, and other relevant experts. in general, expert panels investigate deaths, life-threatening illnesses, and permanent disabilities, and immunization-program managers or vaccination providers investigate common, minor adverse events. adverse events are classified into one of five categories: vaccine reactions (common and minor to rare and more serious), program errors, coincidental illnesses, psychogenic reactions, and unclassifiable events. at the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. the following adverse events were required to be reported: adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) ; anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, \>37.5°c), angioedema, or a local injection-site reaction (diameter, \>2.5 cm) occurring within 5 days after vaccination; purpura, an arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination; and the guillain-barré syndrome occurring within 3 months after vaccination. other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.

Eligibility criteria:
inclusion criteria: * males and females aged 3 years and above on the day of immunization, who are eligible for seasonal influenza vaccination. * recipients of sibp's inactivated, split-virion influenza vaccine. exclusion criteria: * history of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein. * receipt of a live vaccine within 4 weeks prior to study day 1. * any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.

Keywords: safety influenza vaccine post-marketing
human phototoxicity test (823/2016)

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a hipaa authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
pmra and shapley-based machine learning for predicting lymph node metastasis in central subregions of clinically node-negative papillary thyroid microcarcinoma: a prospective multicenter validation and development of a web calculator

Conditions: Papillary Thyroid Microcarcinoma

Summary: background:management of clinically node-negative(cn0) papillary thyroid microcarcinoma (ptmc) is complicated by high occult lymph node metastasis (lnm) rates. we aimed to develop and validate a prediction model for central lnm using machine learning (ml) and traditional nomograms through probability-based ranking model approach (pmra). methods: we conducted a prospective multicenter study involving 4,882 patients across 3 hospitals (2016-2023). after applying inclusion criteria, 1,953 patients from the primary center were allocated to model train and test (7:3 ratio). external validation included prospective cohorts of 286 and 176 patients from two independent centers.13 ml algorithms and traditional nomogram models were systematically evaluated using pmra.we compared models using preoperative features alone versus those incorporating both preoperative and intraoperative frozen section pathology data. feature selection utilized six methods, with l1-based selection proving optimal for most predictions.model interpretability was enhanced through shapley additive explanations (shap) visualization.


Eligibility criteria:
inclusion criteria: * first-time thyroid cancer surgery patients * cn0-ptmc patients diagnosed through fine-needle aspiration and imaging. exclusion criteria: * secondary surgery * other pathological types of thyroid cancer * incomplete clinical data * distant metastasis or history of cervical radiation exposure.

Keywords: papillary thyroid microcarcinoma
a molecule basic study of early warning for new pathogenic risk of ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the investigators will recruit active ankylosing spondylitis patients for injection treatment of human mesenchymal stem cells (a prospective, open-label, masculine medicine controlled(nsaids), clinical trial), and collect their peripheral blood lymphocyte (pbmcs) and sera before and after the treatment of 24 weeks to test the gene expression profiles and study related pathogenesis of as


Eligibility criteria:
inclusion criteria: 1. aged from 16-65 years, sign the informed consent 2. fulfill 1984 modified newyork classification criteria for as 3. have an active refractory disease defined by a score ≥40 on the bath as disease activity index (basdai) (0-100) despite optimal non-steroidal anti-inflammatory drug (nsaid) treatment. 4. commitment to contraceptive for woman exclusion criteria: 1. completely stiff spine 2. received spinal or joint surgery within 2 months 3. received anti-tnf therapy within 3 months 4. history of the listed diseases: heart failure, multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis 5. female of pregnancy or breast feeding 6. hb≤ 9g/dl for male or hb ≤ 8.5 g/dl for male, alt/ast≥2folds of upper level normal range, creatine≥120mol/l(≤1.4mg/dl)
real-world study of chidamide combined with pd-(l)1 inhibitors and anti-angiogenic therapy for advanced mss-type colorectal cancer

Conditions: Colorectal Cancer

Summary: this is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in microsatellite stable advanced colorectal cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥18 years, male or female. histologically confirmed advanced colorectal cancer with microsatellite stable (mss)/proficient mismatch repair (pmmr) status confirmed by immunohistochemistry (ihc) or molecular testing. no restriction on prior immunotherapy or combined anti-angiogenic agents (e.g., bevacizumab or small-molecule tkis). ecog performance status of 0-2. at least one post-treatment efficacy evaluation. life expectancy ≥3 months. chidamide treatment duration \>3 weeks exclusion criteria: - 1. malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma. 2. severe comorbidities that may interfere with efficacy or safety analysis. 3. conditions deemed unsuitable for study inclusion by the investigator.
step-reduction in older men and women

Conditions: Older Adults; Reduced Physical Activity

Summary: this study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.

aging results in a progressive loss of muscle mass that is accelerated by periods of muscular disuse, common for older adults during hospitalization or convalescence from illness. transient physical inactivity has been shown to cause muscular atrophy and impairments in insulin sensitivity in both younger and older adults. however, the recovery capacity of older adults after such physical inactivity remains unknown. this study aims to determine the impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model mimicking short-term physical inactivity, on glycemic control in older adults and further investigate whether older adults are able to recover from the consequences of this inactivity simply by returning to their habitual activity for 14 days.

Eligibility criteria:
inclusion criteria: * non-smoker exclusion criteria: * use of assistive walking devices * chronic use of analgesic or anti-inflammatory drugs * history of neuromuscular problems or muscle and/or bone wasting disease * acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders * daily use of statins, particularly simvastatin and atorvastatin * use of medications known to affect protein metabolism * normally complete fewer than 3000 steps per day
verapamil vs steroid to prevent keloid recurrence

Conditions: Keloid Scars

Summary: keloid scarring is a severe cosmetic and painful disease of the skin. the gold standard treatment is yet to be clarified. this randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil. study hypothesis: intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.


Eligibility criteria:
inclusion criteria: * patient undergoing surgical removal of keloid * patient 18 years old or greater * length of excisional scar after surgical removal of keloid between 2 and 10 cm exclusion criteria: * keloid in face or hands * pregnancy or lactation * dementia * any heart or pulmonary condition * systemic treatment with beta-blockers, ace-inhibitors or calcium antagonists * systemic corticosteroidal therapy * intralesional steroid treatment within 2 months of surgery to remove keloid * flap surgery * lesions to face, hands and other cosmetically sensitive areas
eplerenone in hiv associated abdominal fat accumulation

Conditions: HIV

Summary: the purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in hiv-infected individuals. in non-hiv-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. in hiv-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. in this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. the investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.

the study is 12 months long, with two phases. in the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). in addition, all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to follow guidelines for a healthy level of physical activity. in the second 6-months of the study, all volunteers will continue to receive lifestyle modification and all will receive eplerenone.

Eligibility criteria:
inclusion criteria: 1. increased waist circumference based on ncep guidelines (\>102cm in men and \>88cm in women) and impaired glucose tolerance (either ifg \> 100 mg/dl but \ 140 mg/dl but \ 12 uiu/ml) 2. hiv positive for 5y and on a stable art regimen for at least 12 months 3. age ≥ 30 and ≤ 65 years of age exclusion criteria: 1. ace inhibitor, arb, verapamil, or spironolactone 2. potassium supplementation 3. estimated gfr\ 1.5 mg/dl 4. serum k \> 5.5 meq/l, alt \> 2.5 times the upper limit of normal, hgb \< 11g/dl 5. uncontrolled hypertension (sbp ≥ 160 or dbp ≥ 100) 6. current or prior steroid use within past 6 months 7. known history of diabetes mellitus or current use of anti-diabetic medications 8. concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of cyp34a 9. use of st. john's wart (cyp3a4 inducer) 10. pregnant or actively seeking pregnancy, breastfeeding 11. for women: pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal iud. 12. estrogen or progestational derivative use within 3 months 13. testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \< 3 months. 14. current growth hormone or growth hormone releasing hormone use 15. current viral, bacterial or other infections (excluding hiv) 16. current active substance abuse 17. patients with a significant history of cardiovascular disease, including prior mi or stroke

Keywords: hiv-infection eplerenone aldosterone visceral fat lipodystrophy