Kornimate/medical-research-clean huggingface dataset:
pediatric study to evaluate the efficacy and safety of ezetimibe monotherapy in children with primary hypercholesterolemia (p05522)

Conditions: Primary Hypercholesterolemia

Summary: the purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (ldl-c) from baseline to 12 weeks of treatment in children \>=6 to \<=10 years old with primary hypercholesterolemia. the study will also evaluate the effect of ezetimibe on total cholesterol (tc), apolipoprotein b (apo b), high-density lipoprotein cholesterol (hdl-c), non-hdl-c, and triglycerides (tg). the safety of ezetimibe in this subject population will also be evaluated.


Eligibility criteria:
inclusion criteria: * each subject may be of either sex and of any race/ethnicity, and must be \>=6 and \ 159mg/dl * each subject's parent/guardian must be willing to give written informed consent on his/her behalf. exclusion criteria: each subject must not: * have known hypersensitivity or any contraindication to ezetimibe. * have use of any investigational drugs within 30 days of study entry. * be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial. * be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing * have known congenital cardiac disorder. * have documented or laboratory values consistent with homozygous familial hypercholesterolemia (hofh). * be known to be human immunodeficiency virus (hiv) positive.

Keywords: heterozygous familial hypercholesterolemia nonfamilial hypercholesterolemia
midazolam effect in children undergoing voiding cystourethrogram (vcug)

Conditions: Vesicoureteral Reflux

Summary: the purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (vcug) to see if this will significantly decrease children's anxiety and make the experience less traumatic.


Eligibility criteria:
inclusion criteria: * age 2-6 years * toilet trained * english speaking * already scheduled for vcug exclusion criteria: * allergic to midazolam * active uti * known urethral stricture * known urethral reconstruction * has history of abnormal sensation in pelvic area * has history of sexual abuse * has severe developmental delay * has diagnosis of anxiety disorders

Keywords: midazolam vcug anxiety
safety and efficacy of sph4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer

Conditions: Locally Advanced or Metastatic Breast Cancer

Summary: this study evaluated the safety and efficacy of sph4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on cdk4/6 inhibitor combined with endocrine therapy.


Eligibility criteria:
inclusion criteria: 1. patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (icf). 2. ecog (eastern cooperative oncology group) performance status score of 0 or 1. 3. life expectancy ≥ 3 months. 4. patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies. 5. at least one measurable lesion. 6. laboratory test results meet the relevant requirements for organ function. 7. subjects who agree to take effective contraceptive measures. exclusion criteria: 1. inflammatory breast cancer. 2. patients unsuitable for endocrine therapy at the investigator's discretion. 3. history of other malignancies prior to the start of study treatment. 4. patients with known metastases to central nervous system. 5. taking anti-tumor traditional chinese patent medicines at the time of signing the icf. 6. patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery. 7. patients who participated in a clinical trial and received other investigational drugs before the start of study treatment. 8. pregnant or lactating women. 9. history of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ nyha (new york heart association) class ii; mean qtc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment. 10. history of ischemic stroke or severe thromboembolic disease before the start of study treatment. 11. hepatitis b surface antigen positive and hbv (hepatitis b virus) dna \> 2,000 iu/ml or \> 104 copies/ml; hcv (hepatitis c virus) antibody positive and hcv rna positive; or known hiv infection. 12. history of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product. 13. presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment. 14. presence of uncontrolled infections before the start of study treatment. 15. known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders. 16. presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.
ultra processed foods consumption and impact in rheumatic diseases.

Conditions: Rheumatoid Arthritis; Spondyloarthritis; Osteoarthritis

Summary: ultra-processed foods (upf) represent one of the mainstays of today's diet. they are defined by the nova classification system. it was demonstrated that upf consumption was associated with activity of inflammatory bowel diseases with underlying mechanisms not fully identified yet. it is suspected that upf constituents could modify the gut microbiota, increase intestinal barrier permeability and directly engage immune surveillance systems, effects that could individually or synergistically increase the risk of immunomediated diseases. as some pathophysiological mechanisms are shared among ibd and rheumatic diseases, we have wondered if upf consumption could be associated with increased risk of rheumatic disease and/or with their activity. our primary aim will be to study the pattern of upf consumption in patients with rheumatic diseases. our secondary objectives will be to study the activity of diseases according to upf consumption.


Eligibility criteria:
inclusion criteria: * age \> 18 years * chronic rheumatic disease (rheumatoid arthritis, spondyloarthritis, osteoarthritis) * ability to perform questionnaires exclusion criteria: * judicial protection measure * refusal to participate in the study * suffering from 2 rheumatic disease simultaneously

Keywords: ultra-processed food osteoarthritis rheumatoid arthritis spondyloarthritis
a study of itacitinib for the prevention of cytokine release syndrome induced by immune effector cell therapy

Conditions: Cytokine Release Syndrome

Summary: "the purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (crs) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (iec) therapy for hematologic malignancies.


Eligibility criteria:
inclusion criteria: * part 1: eligible to receive any iec therapy for any approved indication. * part 2: eligible to receive yescarta for relapsed or refractory large b-cell lymphoma or follicular lymphoma. * eastern cooperative oncology group performance status 0 to 1. * willingness to avoid pregnancy or fathering children exclusion criteria: * evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin. * evidence of active hepatitis b virus or hepatitis c virus infection. * known human immunodeficiency virus. * active acute or chronic graft-versus-host disease requiring systemic therapy. * concurrent use of chronic systemic steroids or immunosuppressant medications. * any unresolved toxicity ≥ grade 2 (except stable grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy. * known history or prior diagnosis of immunologic or inflammatory/autoimmune disease affecting the central nervous system (cns) and unrelated to their disease under study or previous treatment. * clinically significant or uncontrolled cardiac disease. * acute lymphoblastic leukemia participants with protocol-defined cns status are eligible only in the absence of neurologic symptoms suggestive of cns leukemia. * diffuse large b-cell lymphoma participants must have no signs or symptoms of cns disease or detectable evidence of cns disease; participants who have been previously treated for cns disease but have no evidence of disease at screening are eligible. * laboratory values at screening outside the protocol-defined ranges.

Keywords: cytokine release syndrome immune effector cell-associated neurotoxicity syndrome janus kinase inhibitor immune effector cell therapy
observational study on efficacy, safety and convenience of using mixtard® 30 novolet® alone or combined with oha in treatment of type 2 diabetes in routine clinical practice

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to assess the efficacy, safety and convenience of the use of mixtard® 30 novolet® used alone or combined with oral hypoglycaemic agent (oha) in the management of type 2 diabetes mellitus in an out-patient setting.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * not adequately controlled on their current therapy
state dependent resonance in the bg-cortical loops

Conditions: Parkinson Disease

Summary: neuronal activity in circuits between the basal ganglia (bg) and motor cortical areas is abnormally synchronized and rhythmic. the oscillatory activity prevails at 8-30 hz in untreated parkinson's disease (pd) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. moreover, these different levels in bg-cortical loops are coherent in this frequency band. the 8-30 hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. an unanswered question is how do bg-cortical loops become so prominently engaged in this oscillatory activity? one possible explanation is that the resonance frequencies of the loops fall in the 8-30 hz band in the untreated state, so that oscillations in this band are transmitted particularly well. so we hypothesize loop resonances in the 8-30 hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.

stimulate stn (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using eeg over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator. experiments will be carried out both in the off medication and on medication condition.

Eligibility criteria:
inclusion criteria: * parkinson's disease idiopathic evolving for more than 5 years * electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the chu la timone for at least 6 months * doped sensibility superior to 50 % (estimated by the section iii of the score updrs) * efficiency of the stimulation superior to 30 % (estimated by the section iii of the score updrs) exclusion criteria: * patients not verifying the criteria of inclusion * absence of data concerning the location of electrodes

Keywords: parkinson
bifidobacterium animalis subsp. lactis for lowering the risk of common infections in hospitalized children

Conditions: Gastrointestinal Tract Infections; Respiratory Tract Infections

Summary: hypothesis: use of bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission this study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at children's hospital zagreb. the study will investigate the effect of supplementation with the probiotic strain bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections. the test product is a sachet containing 1 gram of powder. the test product will contain minimum 1 billion cfu (colony forming units) probiotic per serving. the placebo product is an identical product except for the absence of probiotics. the study includes an intervention period lasting the length of the hospital stay. the study product will be consumed daily in the morning together with breakfast. the consumption of the study products will be taken under the surveillance of the physician. data on infections will be diagnosed by a physician and recorded in a crf. the incidence of infections will be analyzed based on the information recorded in the crf.


Eligibility criteria:
inclusion criteria: * children hospitalized at the department of paediatrics, children's hospital zagreb * age from 1 year to 18 years * signed informed consent by the parents exclusion criteria: * immunodeficiency * infants from neonatal period until 1 year of age * re-hospitalisation (readmission in a hospital within one month) * receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization) * neoplasms * severe chronic diseases * hospitalization shorter than 3 days
a study to evaluate the safety and efficacy of multiple doses of lt3001 drug product in ais subjects

Conditions: Acute Ischemic Stroke

Summary: this is a phase ii, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of lt3001 drug product in subjects with acute ischemic stroke (ais)

this is a multicenter, double-blind, randomized, and placebo-controlled prospective phase ii clinical study, designed to evaluate lt3001 drug product versus placebo in subjects with ais. the study is planned to take place in multiple countries. subjects who participate in this trial should be treated with standard of care of ais therapies when appropriate.

Eligibility criteria:
inclusion criteria: 1. subject is aged 18 to 90 years. 2. subject has an nihss of 6 to 25. 3. subject is able to receive the first ip within 24 hours after stroke symptoms onset. neuroimaging inclusion criteria: 1. subject is able to undergo a contrast brain perfusion with either mri or computed tomography (ct). 2. subject has target mismatch profile on mri (perfusion is included) or ctp: ischemic core volume ≤70 ml, mismatch ratio ≥1.2 and mismatch volume ≥5 ml. exclusion criteria: 1. subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current ais. 2. subject has a pre-stroke disability (mrs ≥2). 3. subject has large ischemic core volume \>70 ml or aspects ≤5. 4. subject has symptoms of suspected subarachnoid hemorrhage. 5. subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment. 6. subject has significant mass effect with midline shift. 7. subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations. 8. subject has current uncontrolled hypertension despite treatment. 9. subject has inr \>1.7 or abnormal aptt or platelet count \<100,000/mm\^3. 10. subject has received conventional heparin or new oral anticoagulants within 48 hours before the first ip administration. 11. subject has blood glucose concentration \ 400 mg/dl. 12. subject has moderate or severe hepatic, renal, and/or active infectious disease. 13. subject is lactating, pregnant, or planning to become pregnant during the study. 14. subject has had history of sich, prior ais, myocardial infarction, or serious head trauma within 90 days before screening. 15. subject has had any major surgery within 90 days before screening. 16. subject has had a bleeding event within 21 days before screening. 17. subject has puncture of noncompressible vessels within 7 days before screening. 18. subject has participated in another investigational study and received ip within 30 days before screening or 5 half-lives (whichever is longer). 19. in the opinion of the investigator, the subject is not appropriate for the study.
symptoms and clinical signs of hypogonadism in testicular cancer survivors

Conditions: Metabolic Syndrome; Hypogonadism; Cardio-vascular Disease

Summary: the purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

recent studies have shown that metabolic syndrome is common among testicular cancer. patients with low levels of testosterone appear to be at higher risk of metabolic syndrome. a substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased lh-drive from the pituitary gland. whether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.

Eligibility criteria:
inclusion criteria: * earlier treatment of testicular germ cell cancer * no sign of relapse \> 1 year since latest treatment * testosterone \ 8 ie/l or * testosterone \> 12 nmol/l and lh \> 8 ie/l or * testosterone and lh within their normal ranges exclusion criteria: * testosterone substitution

Keywords: testicular neoplasms hypogonadism metabolic syndrome treatment related late effects
bioclean first care ex in combination with biofinity lens

Conditions: Myopia

Summary: to determine if patients are unreactive to the lens care solution / biofinity combination.

to determine if patients are unreactive to the lens care solution / biofinity combination in this cross-over study.

Eligibility criteria:
inclusion criteria: * is over 18 years of age (inclusive) * has had a self-reported visual exam in the last two years * is currently an adapted spherical soft cl wearer * has a cl spherical prescription between - 0.25 and - 12.00 (inclusive) * has less than 1.00d spectacle cylinder in each eye. * is correctable to a visual acuity of 20/20 or better in both eyes * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * is willing to comply with the wear schedule (at least 40 hrs per week) * is willing to comply with the visit schedule exclusion criteria: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has a cl prescription outside the range of - 0.25 to -12.00d * has a spectacle cylinder greater than -0.75d of cylinder in either eye. * has best corrected spectacle distance vision worse than 20/20 in either eye. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion * has persistent, clinically significant corneal or conjunctival staining * has active neovascularization or any central corneal scars. * is aphakic. * is pregnant or lactating. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
radiation therapy in treating patients with stage i, stage ii, or stage iii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. giving radiation therapy in different ways may kill more tumor cells. it is not yet known which type of radiation therapy is more effective in treating prostate cancer. purpose: this randomized phase iii trial is studying different types of radiation therapy to compare how well they work in treating patients with stage i, stage ii, or stage iii prostate cancer.

objectives: * compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage i-iii adenocarcinoma of the prostate. outline: this is a randomized, multicenter study. patients are stratified according to stage of disease (t1 vs t2 vs t3). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks. * arm ii: patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks. after completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter. projected accrual: a total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * stage i-iii disease (t1-t3, n0, m0) * no clinical or radiographic evidence of metastasis * if prostate-specific antigen (psa) ≥ 10.0 ng/ml and gleason score is 7, a radioisotope bone scan must show no evidence of metastasis * no evidence of lymphatic or visceral metastases of the abdomen or pelvis on ct scan or mri * psa ≤ 20 ng/ml * gleason score ≤ 7 (if stage t3 , score must be \< 7) patient characteristics: performance status * not specified life expectancy * more than 10 years hematopoietic * not specified hepatic * not specified renal * not specified other * no other malignancy within the past 5 years except basal cell or squamous cell skin cancer prior concurrent therapy: endocrine therapy * prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following: * luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide) * anti-androgens (e.g., flutamide, bicalutamide) radiotherapy * no prior pelvic irradiation surgery * no prior radical prostatectomy

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage ii prostate cancer stage iii prostate cancer