Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of netupitant and palonosetron hydrochloride capsules in preventing nausea and vomiting induced by radiochemotherapy in head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: the enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. on the first and third days, they took netopitam palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. the aim of this study is to evaluate the antiemetic effect of netopitam palonosetron capsules and to explore the effectiveness of using netopitam palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-75 years old; 2. head and neck tumors confirmed by histology or cytology (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer); 3. receive radical synchronous radiotherapy and chemotherapy; 4. the eastern oncology collaborative group (ecog) physical fitness score of the subjects was ≤ 2 points; 5. adequate organ and bone marrow function; 6. the expected life is at least 12 weeks; 7. pregnant or fertile patients (male or female) use reliable contraceptive measures; 8. when screening female patients with potential pregnancy, the pregnancy test must be negative; 9. the subjects voluntarily and strictly comply with the requirements of the research protocol and sign a written informed consent form. exclusion criteria: 1. recurrent and metastatic head and neck tumors; 2. previously underwent tumor resection surgery for treatment; 3. patients with platinum drug intolerance; 4. receiving any known or potential antiemetic medication within 24 hours prior to the first day, or experiencing symptoms of vomiting, retching, or mild nausea within 24 hours prior to the first day; 5. take nk1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment; 6. use cyp3a4 inducer within 4 weeks before chemotherapy, and use cyp3a4 substrate or strong or moderate cyp3a4 inhibitor within 1 week; 7. serious cardiovascular, pulmonary, diabetes, mental and other diseases; 8. pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 9. drug and/or alcohol abuse; 10. hypocalcemia or any other condition that may cause vomiting; 11. there are significant factors that affect the absorption of oral medication, such as chronic diarrhea and intestinal obstruction; 12. the subject has allergic reactions to netopitam palonosetron capsules or any of their excipients; 13. within 30 days prior to the baseline visit, the subject participated in another clinical study and used any exploratory drugs or devices; allow participation in observational research; 14. the researcher determines other situations that may affect the progress of clinical research and the determination of research results.
lifu for anxiety management

Conditions: Anxiety

Summary: this study is examining the effects of noninvasive brain stimulation on anxiety. low-intensity focused ultrasound (lifu) will be utilized to neuromodulate the brain prior to a task (npu). physiological recordings will be taken throughout (eeg, emg, hr, bp, rr, gsr).

this study is a research project examining the effects of noninvasive brain stimulation on anxiety. this study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. participants will undergo a functional magnetic resonance imaging (fmri) and a computed tomography (ct) scan, to image the bone and brain tissue. participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (lifu) sound waves, to temporarily change brain activity. participants will undergo a threat task involving brief (100ms) shocks (1-5ma) and startle noises. brain signals (eeg), muscle twitch (emg), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. participants will be asked to complete behavioral questionnaires.

Eligibility criteria:
inclusion criteria: * high or low trait anxiety exclusion criteria: * claustrophobia * contraindications to mri (implants) * contraindications to ct (pregnancy) * active medical disorder with cns effects (e.g. alzheimers) * history of neurologic disorder (e.g. parkinson's, epilepsy) * history of head injury w/ loc for \>10 min * history of alcohol or drug dependence * history of current cardiovascular disease
sucralose effects on glucose metabolism and gut microbiota

Conditions: Healthy

Summary: hypothesis: 1. long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults. 2. long-term consumption of sucralose may alter food behaviour in healthy adults.

artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. however, many emerging evidences showed artificial sweeteners may induce glucose intolerance. the objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy volunteers without underlying disease * normal oral glucose tolerance test * agree to participate by written informed consent exclusion criteria: * shift workers * history of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test) * malabsorption problem * regular consumption of nonnutritive sweeteners * liver impairment (aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 3-folds upper normal limit) * renal impairment (serum creatinine \>1.5 mg/dl) * use of medications affecting glucose level such as glucocorticoid, estrogen, androgen * pregnant and lactating woman * smoking within 6 months

Keywords: sucralose insulin secretion insulin sensitivity incretin gut microbiota food and eating behaviour healthy volunteers
abatacept and infliximab in combination with methotrexate in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this clinical research study is to learn if abatacept or infliximab in combination with methotrexate demonstrate a greater reduction in disease activity over placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * at least 3 months prior treatment with methotrexate (mtx) * at least 10 swollen joints and 12 tender joints and c-reactive protein of at least 1 mg/dl * washout required for other disease modifying anti-rheumatic drugs (dmards) exclusion criteria: * participants who have failed more than 3 dmards * participants previously treated with an approved biologic drug * history of cancer in the last 5 years * severe or recurrent bacterial infection * any previous or current medical conditions that are contraindications to the use of tnf blocking agents * women of child bearing potential
vaginal ovule with flavonoid tea extract for the correction of imbalance in the vaginal environment

Conditions: Vaginosis, Bacterial; Vaginal Flora Imbalance

Summary: randomized, blinded vehicle-controlled multicenter clinical trial (mat072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (ph, nugent score) of bacterial vaginosis. an ovule containing only the vehicle (polyethylene glycol 3000 s) was used as a control. the study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.

the objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis. composite primary endpoint designed as a drop in the nugent score, vaginal ph, or improvement of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm after 7 days of application and following 7 days after the application. secondary outcome measures were (1) correction of the vaginal environment (as previously defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in each parameter separately; (3) change in individual subjective symptoms, (4) exploratory analysis of the microbial environment at each subject visit. the study was approved and supervised by the national authority and ethics committee and prospectively registered in the czech national medical device trial registry rzpro and the european medical device trial registry eudamed.

Eligibility criteria:
inclusion criteria: * premenopausal participants * disturbed vaginal environment * not in need of antibiotic or antimycotic treatment * participants were citizens of the czech republic * age between 18 and 55 years * either a vaginal ph \> 4.5 or/and vaginal discomfort * able to follow the prescribed regimen * informed consents prior to any intervention, including diagnostic procedures. exclusion criteria: * no vaginal bleeding of unknown aetiology * hypersensitivity * pregnancy * lactation * period during enrollment * antibiotics in the previous 30 days * treated with any products with similar indication * acute urogenital infection * diabetes mellitus * advanced oncologic disease * participant to other trial * nugent score above 6

Keywords: tea polyphenols nugent score antioxidants vaginal ph complementary medicine
dapagliflozin (dapa) effects in hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the purpose of this study is to determine whether treatment with dapagliflozin (dapa) for 6 months will improve pulmonary capillary wedge pressure (pcwp) during exercise in heart failure/preserved ejection fraction (hfpef) and improve cardiac metabolism.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study specific procedures. * male or female. * symptoms of dyspnea (nyha ii-iii) with no non-cardiac or ischemia explanation. * ef ≥ 50% + bmi ≥ 30 kg/m\^2 * elevated pulmonary capillary wedge pressure (pcwp) during exercise (≥ 25 mmhg) ascertained at visit 1. patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized . exclusion criteria: * type i diabetes. * type ii diabetes with poor control (hgba1c ≥ 10%). * recent hospitalization (\< 30 days) or revascularization (\< 90 days). * primary cardiomyopathy (such as amyloid). * constrictive pericarditis. * dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator. * severe anemia (hemoglobin \< 9gm/dl. * significant left-sided valvular heart disease (\> mild stenosis, \> moderate regurgitation), * severe kidney disease (estimated glomerular filtration rate (gfr) \< 30) or liver disease,
using large language models such as gpt-4 to assess guideline adherence in patients with chronic obstructive pulmonary disease

Conditions: COPD

Summary: according to studies in the us and the netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. these findings have also been demonstrated in the management of copd. this leads to under- or over-treatment of patients and, in the case of copd, to exacerbations and hospitalisations. these exacerbations are a significant clinical problem, affecting patient's lung function, quality of life and mortality. they are also a burden on the healthcare system. technological advances in artificial intelligence offer the opportunity to address these issues in copd management. in the past year, there have been remarkable innovations in the field of natural language processing, especially through large language models such as gpt-4 from openai and bard or gemini from google. these models offer an opportunity to improve the implementation of evidence-based care in clinical practice. this study is a prospective, randomised trial that will compare therapy on discharge for patients with copd. one arm will receive no intervention, while the other arm will receive a treatment recommendation from an llm. the study will compare the percentage of patients treated according to the guideline.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * consent * discharge after hospitalization exclusion criteria: * lack of consent
promoting parental skills and enhancing attachment in early childhood

Conditions: Behavioral Disorders

Summary: child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. health promotion strategies (olds' paradigm) have proved their efficacy in vulnerable populations. capedp project sets out to evaluate a program of home visits in france

this program aims at reducing psychosocial disorders and promoting mental health, social support and attachment amongst at-risk young women and their family. 440 primigravida (pregnant women) will be randomised into two groups. the first group will receive routine follow-up as currently provided by national community health and social services. the second group will receive home visits by community workers. these visits will start during pregnancy and will continue up to the child's second birthday.

Eligibility criteria:
inclusion criteria: * being less than 26 years old * being pregnant for less than 27 weeks * being primiparous * living in the study area * being socially vulnerable: less than 12 years of education and/or socially isolated and/or eligible for a public health insurance for people with low resources. exclusion criteria: * refusal to participate * not able to speak french * having a medical follow-up which necessitates regular contact with health professional * not having health insurance * persons for whom follow up at 27 months is impossible (evaluation at baseline)

Keywords: child mental disorder home visit postnatal depression social support random selection
pharmacokinetics of twice or once daily dtg (50mg) in children with hiv and tb

Conditions: Tuberculosis; Hiv

Summary: stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg dtg in children (20-35kgs) co-treated with rif. note: an amendment has been added to include children from 3kgs and a dose of 10mg dispersible dtg

this is a single centre, open-label, non-randomised, prospective study evaluating the steady-state pharmacokinetics of twice-daily dose dtg administered during concurrent rif treatment and assessing safety and tolerance in hiv-tb co-infected children weighing 20 to 35 kg. dtg will be administered as a twice-daily dose 50mg tablet formulation both before starting and after completion of the standard six-month rif-based anti-tb treatment. the nrti background and anti-tb drugs will be prescribed following the national weight band dosing guidelines. those initially diagnosed with tb are likely to be sicker, and the recommendation is to start anti-tb treatment first and follow with art two weeks later.

Eligibility criteria:
inclusion criteria: * children \<18 years with confirmed hiv-1 infection weighing 20-35kg art-naive or experienced, with plans to use dtg for hiv treatment * diagnosis of tb disease with clinician initiating rifampicin-containing first-line therapy * parents/legal guardians/caregivers and children give informed written consent (or assent, where applicable) to be in the study * girls who have reached menses must have a negative pregnancy test at screening and be willing to adhere to two effective methods of contraception (barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment) if sexually active. the parents/caregivers will be counselled together with the child if the child tests positive in order to reduce any social harm which may arise. exclusion criteria: * history or presence of known allergy or contraindications to dtg * alanine aminotransferase (alt) ≥5 times the upper limit of normal (uln), or alt ≥3xuln and bilirubin ≥2xuln * severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (except for gilbert's syndrome or asymptomatic gallstones) * pregnancy or breastfeeding * a concurrent illness that could influence drug pk, i.e. severe diarrhoea, vomiting, renal or liver disease * treatment with concomitant medications known to have interactions with dtg * participants that are eligible for the study but refuse to give consent and/or assent

Keywords: dolutegravir (dtg) paediatrics hiv/tb co-infection
aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (jia) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (dmards), and methotrexate alone.

dmard-naive polyarticular jia patients with an early disease (onset less than 6 months) are randomized into one of three treatment strategies: (1) biological combination, i.e., anti-tnf therapy with infliximab plus methotrexate; (2) combination of dmards with methotrexate, sulfasalazine, plus hydroxychloroquine; and (3) methotrexate alone. the efficacy is evaluated by american college of rheumatology pediatric (acr pedi) criteria based on 6 core set variables (csvs): 1. no of active joints; 2. no. of joints with pain or tenderness and limitation of motion; 3. esr (mm/hr); 4. the childhood health assessment questionnaire (chaq); 5. physician's visual analogue scale (vas); 6. patient/parent vas. to fulfill acr pedi 75 criteria, 3/6 csvs have to improve 75% and not more than 1/6 csv worsen more than 30%. all direct and indirect costs are documented. the first phase of the study is open-label clinical trial lasting for 54 weeks. in the second phase of the study the patients are followed up to 5 years, and the long-term outcome of early aggressive therapy is analyzed. serum, urine, and saliva samples are collected at 3 and 5 years for translational research.

Eligibility criteria:
inclusion criteria: * juvenile idiopathic arthritis * arthritis lasting for at least 6 weeks but not more than 6 months * polyarticular disease with at least 5 active joints with at least 3 joints with pain or tenderness and limitation of motion * no previous treatment with dmards exclusion criteria: * systemic jia * any abnormality in the hematopoietic or lymphatic system * any major concurrent medical condition * inadequate psychosocial situation * pregnancy * a non-abstinent female with reproductive capacity without regular contraceptive use

Keywords: juvenile idiopathic arthritis polyarthritis combination therapy biologic agents tnf antagonists infliximab
functional changes in the brain after tibial nerve stimulation: a pilot study

Conditions: Spinal Cord Injuries; Bladder, Neurogenic

Summary: the lower urinary tract is innervated by the autonomous (sympathetic, parasympathetic) and the somatic nervous system. afferent information from the lower urinary tract (lut) (e.g. filling state and volume of the urinary bladder) is conducted via the dorsal roots to the sacral spinal cord and from there to the pontine micturition center (pmc) in the brain stem. the pmc has several connections to other cortical areas. these complex interactions with the cortex enable voluntary control of the lut and are crucial for urinary continence. the integrity of this neuronal circuit is crucial for an undisturbed function. deterioration of the nerve fibers due to a systemic neurological disease (e.g. spinal cord injury) can affect lut function. neurogenic lower urinary tract dysfunction can lead to urgency, urge incontinence, reduced bladder capacity and secondary deterioration of the upper urinary tract (i.e. kidneys). first-line therapy of neurogenic detrusor overactivity contains antimuscarinic treatment. in case of side effects or remaining detrusor overactivity, nerve stimulation (e.g. sacral neuromodulation and in effect nerve tibialis stimulation) is an accepted therapy option. the precise mechanism of action of these neuro-modulatory procedures is still unknown. utilizing state-of-the-art neuroimaging techniques, we intend to investigate the functional activation pattern after afferent tibialis nerve stimulation as well as the association with the architecture of the sacral roots. we aime to get a better insight into functional neuromodulation and central nervous processing. the study aim is to evaluate the feasibility in healthy subjects as a pilot study for the application of these method in patients with chronic, incomplete spinal cord injury.


Eligibility criteria:
inclusion criteria: * healthy volunteers * 18-50 years old * informed consent exclusion criteria: * history of neurological disease (eg. multiple sclerosis, epilepsy) * cardiac pacemaker, insulin or other pumps * claustrophobia * pathological findings in the uroflowmetry or post void residual assessment * medication with central nervous effects * pregnancy or lactating * unable to give informed consent
peer-led dissonance eating disorder prevention: virtual delivery

Conditions: Eating Disorders

Summary: this proposed pilot study will evaluate whether this body acceptance class produces greater reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month follow-up in this population.

dozens of eating disorder prevention programs have been evaluated, but only the 4-hr body project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year follow-up, produced larger reductions in outcomes than credible alternative interventions, been shown to engage the intervention target (valuation of the thin beauty ideal), and produced effects in trials from several independent teams. although undergraduate peer-educator-led body project groups have produced larger reductions in outcomes than an eating disorder education video, an unmoderated internet-based prevention program, and even clinician-led body project groups, it can be logistically difficult to schedule in-person body project groups with high school and college students. one solution to this key implementation barrier is to have peer educators deliver body project groups virtually over the internet. a pilot trial in sweden provided initial evidence that virtually-delivered peer-led body project groups produced greater reductions in eating disorder symptoms and future onset of eating disorders than an active expressive-writing intervention. the proposed pilot study will evaluate whether body project produces greater reductions in risk factor symptoms, eating disorder symptoms, and future onset of eating disorders in this population. participation in the intervention will last four weeks. participants will be randomly assigned to the intervention condition or waitlist-control condition. assessments will take place at pre-intervention, post-intervention, and 6 month follow up. waitlist control participants will receive the intervention after they complete their post-test assessment.

Eligibility criteria:
inclusion criteria: * body image concerns exclusion criteria: * n/a

Keywords: prevention peer leader feeding and eating disorders