Kornimate/medical-research-clean huggingface dataset:
comparison of triflusal and clopidogrel in secondary prevention of stroke based on the genotyping

Conditions: Cerebral Infarction

Summary: the purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome p450 2c19 (cyp2c19) polymorphism.

clopidogrel has anti-platelet activity by irreversible inhibition of the p2y12 platelet receptor. clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. hepatic cyp2c19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. cyp2c19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group. this study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of cyp2c19 polymorphism. also we plan to prove that clopidogrel resistance is related to cyp2c19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different cyp2c19 polymorphism.

Eligibility criteria:
inclusion criteria: 1. patients who have non-cardiogenic ischemic stroke of toast classification within 30 days prior to screening 2. ≥ 20 years of age; adult, at the date of signing the informed consent 3. written informed consent exclusion criteria: 1. history for bleeding tendency or recent major bleeding within 2 weeks 2. chronic liver disease (alt \> 100 iu/l or ast \> 100 iu/l) or renal dysfunction (creatinine \> 4.0 mg/dl) 3. thrombocytopenia (platelet \< 100,000mm3) 4. any contraindication of antiplatelet agent 5. severe congestive heart failure 6. patients who need to take anticoagulants or two or more antiplatelet agents 7. severe concomitant disease with the expected survival less than 2 years 8. pregnant or nursing 9. any drug clinical trials within 30 days of signing the informed consent

Keywords: prospective randomized open label multi-center double-blind for cyp2c19 genotypes
adherence to topical hydrocortisone 17-butyrate 0.1% (locoid®) using different vehicles in adults with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this research study is to better understand adherence to locoid when people use it to treat atopic dermatitis.

an investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% body surface area and 2 or 3 on the investigator global assessment (iga) scale). the drug will be used within fda-approved labeling. subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a medication event monitoring system (mems) cap. this cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software. the study will consist of a 2-week treatment phase (visits at baseline and week 2). subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their ad lesions. adherence will be measured by mems cap.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age. * subjects must have diagnosis of mild to moderate atopic dermatitis using iga criteria. (2 or 3 on severity scale) * subjects must have \>5% tbsa and \<30% to be enrolled. * women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. exclusion criteria: * known allergy or sensitivity to topical locoid® cream, ointment or lipocream in the subject. * inability to complete all study-related visits. * introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. * requiring \>130 gm of cream in a 2 week period. * having facial or groin involvement of their disease. * pregnant women and women who are breast feeding are to be excluded. women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
estrogens effect on pain in postmenopausal women suffering of fibromyalgia

Conditions: Fibromyalgia

Summary: in order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.

fibromyalgia is a condition that preferentially affects women. sex hormones, and in particular estrogens, have been shown to affect pain processing and pain sensitivity, and estrogen deficit has been considered a potential promoting factor for fibromyalgia. however, the effects of estrogen treatment in patients suffering from fibromyalgia have not been studied. twenty-nine postmenopausal women were randomized to either eight weeks of treatment with transdermal 17β-estradiol (50 ug daily) or placebo according to a double-blind protocol. a self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed at three occasions: before treatment, after eight weeks of treatment, and twenty weeks after cessation of treatment.

Eligibility criteria:
inclusion criteria: * between 49-60 years * body mass index (bmi) of \< 30 * met the acr-90 criteria for the diagnosis of fibromyalgia * postmenopausal state since at least six months * not been using any hormonal treatments for the past three months * had normal mammography screenings exclusion criteria: * using psychotropic drugs or having a history of thromboembolism * diabetes mellitus, polyneuropathy, chronic liver disease, * alcohol or substance abuse, hemoglobinopathy, * endometrial adenomatous hyperplasia, or malignancy. * presence of untreated hypertension (\>160/95). * undiagnosed vaginal bleedings

Keywords: estrogen substitution pain hormonal levels quantitative sensory testing
neuropeptide y (npy) regulation of nociceptors

Conditions: Pain

Summary: neuropeptide y (npy) potently inhibits pain neurons in rats, but does this occur in human pain neurons? this hypothesis will be tested using microdialysis probes in patients who elect to have root canal treatment or extraction of thier tooth.

the ongoing studies in rats indicate that a sympathetically-derived neuropeptide, neuropeptide y (npy), potently inhibits the activity of the capsaicin-sensative class of nociceptors (i.e., "pain" neurons). it is not know whether these results, generated from rodent studies, occur in human tissues under normal or inflamed conditions. we plan to test the hypothesis that npy inhibits the initiation of neurogenic inflammation, as measured by reduced release of substance p, from capsaicin-sensitive class of petidergic neurons innervating normal and inflamed dental pulp. such actions would be physiologically and clinically significant, since inhibition of exocytosis from peripheral terminals of nociceptive primary afferent fibers would likely alter neurogenic inflammation, local vasodilation and , possibly pain. our research strategy takes advantage of a uniquely innervated tissue: dental pulp. application of any physiologic stimulus to human dental pulp, including thermal, osmotic, chemical or mechanical, produces only pain. thus, virtually all sensory neurons that innervate pulp appear to be nociceptors. accordingly, application of drugs to pulpal sensory neurons targets a population of sensory neurons consisting predominantly of nociceptors. the research questions are as follows: 1. determine the capsaicin concentration-response curve from evoking the release of immunioreactive substance p (isp) from normal and inflamed dental pulp. 2. determine the effect of npy on altering basal and capsaisin-evoked release of isp from normal and inflamed dental pulp. we will evaluate the hypothesis that npy inhibits capsaicin-sensitive neurons in humans using microdialysis probes implanted into anesthetized dental pulp, with release of immunoreactive substance p (isp) as our dependent measure. this study will include patients who have elected to have a root canal procedure performed or to have a tooth extracted.

Eligibility criteria:
inclusion criteria: * teeth with diagnosis of normal pulp or irreversible pulpitis * mandibular teeth * indication for either root canal or extraction of tooth * age between 18-50 exclusion criteria: * history of taking steroids within the last month * history of hyperthyroidism, hypertension, asthma, uncontrolled or complicated type-2 diabetes, drug abuse * age less than 18 or greater than 50 * maxillary teeth

Keywords: hyperalgesia nociceptors neurons
prospective randomized open label study of the treatment of therapy-associated diarrhea during percutaneous radiation therapy of the small pelvis. - comparison of loperamide and tincture of opium -

Conditions: Diarrhea; Enteritis; Cancer

Summary: therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. we investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. this includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma. * diarrhea grade 1 and grade 2 (classification nci-ctcae version 3.0) * ecog-grade 0-2 * enlightenment and written declaration of consent to the participation. exclusion criteria: * pregnant patients or patients in lactation period. * severe dysfunction of liver or kidneys * injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis * epilepsy * hypersensitivity to components of loperamide or tincture of opium * ileus * toxic megacolon * pseudomembranous colitis/ antibiotic-associated colitis * diarrhea associated with fever and bloody stools * acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes * severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis * dysfunctional draining of biliary area, biliary colics. * concomitant or earlier addiction of alcohol or opiates * severe heart disease * pheochromocytoma * acute hepatic porphyria * cor pulmonale * morbus addison * severe hypothyroidism * organisational problems or circumstances which prevent a complete collection of required data * artificial anus * participation in a clinical trial within the last 30 days before involvement * participation in an other clinical trial at the same time

Keywords: radiation therapy diarrhea enteritis supportive therapy therapy associated diarrhea therapy associated enteritis radiation therapy of the small pelvis
visual and refractive outcomes of a new diffractive trifocal toric intraocular lens

Conditions: Cataract

Summary: the purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric finevision pod ft iol. predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle independence will be investigated. the follow-up period is 3 months after which vision and refraction should have stabilized.

this prospective study was performed to investigate the visual performance and refractive predictability with the diffractive toric finevision pod ft iol (physlol, belgium). predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as rotational stability have been analyzed. the follow-up period was 6 months. all iol implantations were performed by the investigators dr. filomena ribeiro and dr. tiago b ferreira (hospital da luz, lisboa, portugal). the study population consists of patients undergoing routine cataract surgery. the study patients underwent binocular implantation of finevision iols depending on the preoperative amount of corneal astigmatism (either a toric pod ft iol in both eyes or a pod ft in the study eye and a non-toric pod f iol in the contralateral eye).

Eligibility criteria:
inclusion criteria: * age 21 and older * bilateral implantation of a finevision trifocal diffractive iol (either a pod ft in both eyes or a pod ft in the study eye and a pod f in the contralateral eye) * bilateral cataract surgery with grade 1-4 cataract * regular corneal astigmatism of 1.00 d or more before surgery in the study eye * previous written informed consent to surgery. written informed consent to participation in the study and data protection exclusion criteria: * relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. marfan syndrome) * irregular corneal astigmatism, any abnormality in corneal topography * systemic disease with impact on visual outcome * disability to understand and/or fill in patient questionnaires * history of other relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery) which might affect capsular stability or visual outcomes * expected residual cylinder ≥ 0.50 d

Keywords: trifocal toric hydrophilic
evaluation of the effectiveness and impact of nirsevimab administered as routine immunization

Conditions: RSV Infection

Summary: a longitudinal observational study based on routinely collected data on hospital and health care use for rsv infections will be undertaken. the galician public health registries will be used for data collection including baseline information and follow-up data. historical data will be retrieved for comparison purposes. the study aims to observe and analyze data from all the eligible children in galicia for nirsevimab treatment. the number of eligible children is expected to be approximately 14,000 per each rsv season.

the purpose of this study is to evaluate the impact of nirsevimab in preventing rsv in healthy infants and high-risk children less than 24 months of age at the start of rsv season in galicia. the target population to receive nirsevimab is around 14,000 subjects including all healthy newborns during the rsv season, those \ 80%). rsv testing is routinely performed in the hospital and emergency department settings. the galician regional surveillance information system will retrieve all the existing information of the different electronic databases for new rsv cases detected in galicia, including hospitalization, primary care, drug administration and immunization. rsv case ascertainment and classification will be per- formed by a specialized clinical team according to pre-established definitions.

Eligibility criteria:
inclusion criteria: * subjects born in galicia from april 1st, 2023 and march 1st, 2026 exclusion criteria: * no specific criteria has been reported
cognitive-behavioral therapy for mental disorder in covid-19 survivors

Conditions: Post Acute COVID-19 Syndrome

Summary: the consequences of the intensive care unit and the covid-19 disease are still uncertain. however, many studies are bringing out often psychological and dramatic consequences for many covid-survivor patients. among the ex-covid patients discharged from our intensive care unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of covid-19 of mindfulness-based stress reduction (mbsr) or usual care.

randomized controlled clinical study. all patients who survived covid-19 and discharged from the intensive care unit of the lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy a group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia. the second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy

Eligibility criteria:
inclusion criteria: * intensive care survivors * surviving covid-19 patients * patients with chronic pain anxiety depression and/or insomnia in drug therapy exclusion criteria: * patients with chronic pain anxiety depression and/or insomnia not in drug therapy * patients not hospitalized in intensive care for covid-19
feasibility and acceptability of powdered multinutrient formula

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the study aims to test the feasibility and acceptability of 1) consumption of empowerplus lightning sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.

the study aims to test the feasibility and acceptability of 1) consumption of empowerplus lightning sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. a limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the tasso device-collected plasma. parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. this study will inform us whether a larger efficacy study is possible in this population.

Eligibility criteria:
inclusion criteria: 1. age inclusive of and between 7 and 16 years at the time of enrollment 2. verbally willing to ingest one empowerplus lightning stick daily 3. attend all virtual study appointments and complete questionnaires 4. have been previously enrolled in a multinutrient study or complete a screening to match with participants from that study in terms of age and symptoms of adhd and emotional dysregulation 5. be medication and supplementation free (if supplement ingredient is contained in the lightning stick) prior to study initiation 6. willing to collect blood and urine samples, once, at home. exclusion criteria\*: 1. neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition 2. any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes type i or ii 3. known allergy to any ingredients of the intervention 4. any known abnormality of mineral metabolism (e.g., wilson's disease, hemochromatosis) 5. taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of adhd 6. any disability that would interfere with participant answering questions verbally 7. non-english speaking 8. pregnancy or sexually active at baseline. \*exclusion criteria will be based on parent/guardian report on child. if the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. potential participants may be reviewed virtually by study physician in the case of any concerns about participation.
expanded access to tak-881 for children and teenagers with primary immunodeficiency diseases in the usa

Conditions: Primary Immunodeficiency Diseases (PIDD)

Summary: the expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. this study will provide access to tak-881 for participants with pidd who have completed study tak-881-3002 \[nct06076642\], who continue to derive clinical benefit from maintenance treatment with tak-881 and wish to continue this treatment. all participants will receive tak-881 as subcutaneous (sc) injection using a qualified medical device (koru 24 g high flo subcutaneous safety needle set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum igg trough level and clinical response. participants will continue treatment until the benefit-risk no longer favors the participant or tak-881 becomes commercially available in the united states (u.s.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.


Eligibility criteria:
inclusion criteria: 1. participant has pidd and has completed the end-of-study visit of study tak-881-3002. 2. participant is demonstrating continued benefit from tak-881 for the treatment of pidd in the opinion of the treating physician. 3. participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of the expanded access program and can provide written informed consent/assent (if applicable), including providing consent/assent for use of the investigational medical device, before initiation of any program procedures. 4. participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety. 5. participant does not have a known hypersensitivity to tak-881 or its components. exclusion criteria: 1. participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program. 2. participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.

Keywords: drug therapy
effects of custom-designed 3d-printed and cad-cam insoles on individuals with flexible flatfoot

Conditions: Pes Planus

Summary: this study aims to investigate the effects of custom-designed insoles produced using computer numerical control (cnc) and 3d printers on plantar pressure distribution analysis, foot posture, plantar force distribution, foot pain, and satisfaction in patients diagnosed with pes planus.

this randomized controlled trial evaluates the impact of custom-designed insoles, created using computer numerical control (cnc) and 3d printing technologies, on plantar pressure distribution, foot posture, pain, and user satisfaction in individuals with flexible pes planus. the study targets adults aged 18-55, with specific clinical and postural inclusion criteria, and excludes individuals with biomechanical or neurological confounders. participants are randomly assigned to one of two intervention groups using a simple randomization method: one receiving cnc-produced insoles and the other 3d-printed insoles. assessments are conducted before and after 8 weeks of insole use, employing standardized tools such as the foot posture index, subtalar angle measurement, plantar pressure analysis, and satisfaction/function questionnaires. the primary aim is to explore comparative biomechanical and subjective outcomes to inform best practices in orthotic design and application.

Eligibility criteria:
inclusion criteria: * individuals aged between 18 and 55 years * diagnosed with flexible pes planus (flat feet) * no prior use of custom orthotic insoles within the past 6 months * able to walk independently without assistive devices * voluntarily agree to participate and provide informed consent exclusion criteria: * history of lower limb or foot surgery * presence of neurological, rheumatologic, or musculoskeletal disorders affecting gait * presence of severe foot deformities (e.g., rigid pes planus, cavus foot) * use of medications that affect muscle or joint function * pregnancy

Keywords: pes planus 3d insoles custom made insoles