Kornimate/medical-research-clean huggingface dataset:
the evaluation of the transcutaneous electrical stimulation medical device's safety and effectiveness in treating the patients with migraine

Conditions: Migraine

Summary: the purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. it is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.

* duration of study period (per participant): screening period (-6\~0weeks), intervention period (4weeks). * patient needs to visit site at least 3 times (screening, baseline, v4), v2 can be done with screening visit. v3 is tele-visit. * the clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. * during the study period, examination and treatment methods are carried out in the same way.

Eligibility criteria:
inclusion criteria: * men and women over 19 years old * patients with migraine with or without migraine aura who meet ichd-iii (2018) diagnostic criteria 1.1 1.2 * patients with history of migraine more than 1 year * patients who have headaches at least twice a month * those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs * a person who voluntarily agreed to participate in this clinical trial exclusion criteria: * those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches * those who are diagnosed with medication overuse headache in addition to migraine headaches * pregnant or lactating of women within 6months * among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. \*medically permitted contraception: condom, oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc * patients with mental illness who can interfere with their participation in the study. * in the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation. * patients with a history of drug or alcohol abuse * those who participated in other clinical trials within 30 days of screening.
neurodevelopmental outcomes of preterm infants treated for pain management with repeated doses of sucrose 24%

Conditions: Development

Summary: the purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants

preterm infants born at 27-33 weeks gestational age at sheba medical center will be recruited for this study. prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the american academy of pediatrics and canadian pediatric society. group 1.will be treated with sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure. group 2. similar to group 1 but breast milk or formula will replace sucrose. number of invasive procedures/day will be documented general movements by prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age griffiths developmental scales (gmds) will be used at 40 weeks, 14-16 weeks corrected age, and 3-6 month corrected age

Eligibility criteria:
inclusion criteria: * preterm infants born at smc exclusion criteria: * need for intubation * surgery * need for sedation * abnormal head ultrasound * genetic abnormalities * necrotizing enterocolitis * other painful conditions other than routine blood exams

Keywords: preterm infant pain neurodevelopment
exercise magnetic resonance imaging in patients with obesity associated heart failure

Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction

Summary: to aim of the exposure study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (cmr) imaging at rest and during exercise stress testing in patients with hfpef.

the exposure study investigates the effects of epicardial fat on ventricular interdependence at peak exercise. epicardial fat, the visceral fat situated directly adjacent to the heart, seems involved in the pathophysiology of heart failure with preserved ejection fraction (hfpef). it has been suggested that an abundance of epicardial fat surrounding the heart within a closed pericardial sac may constrain the heart leading to ventricular interdependence. the study is an investigator initiatied, cross-sectional, observational study, including 50 patients with hfpef. patients will be stratified according to high and low epicardial fat volume measured with cmr. the primary outcome parameter is the difference in lv eccentricity index at peak exercise between the two groups. pre-specified secondary outcome parameters between the subgroups are: 1) vo2-max, 2) lv and right ventricular (rv) diastolic strain rate, 3) slope of early lv/rv filling, 3) left and right atrial reservoir strain and emptying fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac output, all at peak exercise. the amount of epicardial fat will be correlated with change in lv eccentricity index from rest to peak exercise, change in lv/rv diastolic strain rate, change in slope of lv/rv filling, change in atrial reservoir strain and emptying fraction, change in pulmonary artery distensibility and pulsatility, and change in cardiac output. all results will be also compared between men and women.

Eligibility criteria:
inclusion criteria: 1. signs and symptoms of hf according to the europeans society of cardiology guideline. 2. lv ejection fraction ≥40%. 3. hfa-peff score ≥5 or hfa-peff score 2-4 in combination with positive stress test (figure 1). 4. \>18 years of age 5. in sinus rhythm 6. able to perform a bicycle exercise test 7. willing to sign informed consent exclusion criteria: 1. body weight \>140 kg 2. atrial fibrillation or other significant arrhythmia during the assessment 3. contraindications for cmr (e.g. claustrophobia, implanted cardiac devices) 4. myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \<3 months or untreated severe obstructive coronary artery stenosis 5. more than moderate left-sided valve disease. 6. complex congenital heart disease.

Keywords: epicardial fat hfpef exercise mri
clinical comparison between two surgical techniques for the treatment of gingival recessions

Conditions: Gingival Recession

Summary: the aim of this study is to test a surgical technique for the treatment of gingival recessions. the hypothesis of the study is to promote greater root coverage and better healing.


Eligibility criteria:
inclusion criteria: * recession defects are miller's class i or ii and do not vary more or equal than 3 mm * main complaint aesthetic issues or dentine hypersensitivity * the patient must be a candidate for bilateral root coverage procedure * patient shows sufficient plaque control (fmps \< 20%) * the patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures * the patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent exclusion criteria: * smokers * systemic diseases * pregnants or lactating * periodontal disease * general contraindications for dental and/or surgical treatment are present * the patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years * the patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Keywords: gingival recession acellular dermal matrix graft root coverage
distal radius fractures in patients over 70 years - volar plate or plaster

Conditions: Distal Radius Fracture

Summary: distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. an additional follow up at three years with x-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study. a health economy analysis will be preformed at 1, and 3 years for the participants with complete eq5d.


Eligibility criteria:
inclusion criteria: * dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture. * low energy injury * patient 70 years old or older * 72 hours or less since injury at time of diagnosis * patient registered in the stockholm region * patient understands spoken and written swedish exclusion criteria: * intraarticular displacement in radiocarpal joint of more than 1 mm * ulna fractured proximal to the base of the styloid process of ulna * earlier unilateral functional impairment of hand/wrist * injury to tendon, nerve or skin besides the fracture * rheumatoid arthritis or other severe systemic joint disease * severe psychiatric disorder, ongoing drug abuse or dementia (pfeiffer score 5 points or less) * besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle * medical illness that makes general anesthesia impossible

Keywords: distal radius fracture wrist fracture volar plate surgical treatment plaster immobilisation
a study to evaluate the safety, pharmacokinetics, and antitumor activity of ak127 in combination with ak104 in advanced and metastatic solid tumours

Conditions: Advanced or Metastatic Solid Tumours

Summary: a phase 1 study to evaluate the safety, tolerability, pk, immunogenicity, pharmacodynamics, and preliminary antitumor activity of ak127 in combination with ak104.

this is a , phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pk, immunogenicity, pharmacodynamics, and preliminary antitumor activity of ak127 in combination with ak104 in subjects with advanced and metastatic solid tumours. the study comprises of 2 phases: a dose escalation phase and a dose expansion phase. dose escalation for ak127 will occur using the 3+3+3 model given with a fixed regimen of ak104. dose expansion will open at the discretion of the sponsor.

Eligibility criteria:
inclusion criteria: 1. written and signed informed consent 2. in phase 1a, patients with relapsed or refractory advanced solid malignancies 3. in phase 1b, patients must have received no more than three prior lines of systemic therapy 4. subject must have at least one measurable lesion according to recist version1.1. 5. eastern cooperative oncology group (ecog) performance score of 0 or 1. 6. available archived or fresh tumor tissue 7. adequate organ function. 8. for dose-expansion cohorts (phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate. 9. females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product. exclusion criteria: 1. history of severe hypersensitivity reactions to other mabs. 2. subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration. 3. prior use of approved or investigational anti-tigit, anti-pvrig, or anti-cd96 therapy 4. receiving any other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment 5. any major surgery within 4 weeks prior to the first dose of treatment 6. receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment. 7. active or prior documented inflammatory bowel disease 8. history of organ transplant. 9. history of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies. 10. known active hepatitis b or c infections or history of hiv. 11. receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product. 12. patients with severe heart and lung dysfunction.
comparison of istent to laser in exfoliation glaucoma helsinki study group

Conditions: Exfoliation Glaucoma; Cataract

Summary: the purpose of the study is to investigate the efficacy of an istent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (exf)

exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with istent (65 patients), ii slt (65 patients) or iii cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with i istent (65 patients), ii slt (65 patients).

Eligibility criteria:
inclusion criteria: * signed consent of information * clinical significant cataract * able to attend 12 month period * mild to moderate exfoliation glaucoma according to european glaucoma society guidelines (egs) * group i stable glaucoma (iop within individual target iop), and group ii unstable glaucoma (iop above individual target iop) with baseline glaucoma medication * target iop ≥16 * able to understand finnish, swedish or english exclusion criteria: * clinical set target iop \< 16 mmhg in advanced glaucoma * baseline iop prior to enrolment ≥30 mmhg, and ≥3 glaucoma medications * closed angle * congenital angle anomaly * clinically significant corneal dystrophy or other hindering corneal condition * unable to use topical medical therapy * central corneal thickness of less than 480um or more than 620um * active uveitis, cystic macular edema (cme), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis. * previous intraocular surgery, refractive surgery or cycloablation * two or more prior slt or laser trabeculoplasty * unable to participate due to another medical disease or condition * participating in another clinical trial

Keywords: slt istent
intracerebral autologous stem cell therapy for chronic stroke patients

Conditions: Stroke; Stroke, Ischemic; Stroke; Sequelae

Summary: the goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (huns001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. the main questions it aims to answer are: can huns001-01 intracerebral transplantation demonstrate improvement in the mrs of disability for 1 year after intervention? can huns001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? participants will receive the below interventions. * screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * harvest of platelet concentrates (pc) * harvest of bone marrows (bm) * receive intracerebral transplantation surgery of huns001-01 * post-operative rehabilitation * follow-up studies (until 1 year or termination of the trial)


Eligibility criteria:
inclusion criteria 1. age between 20 and 70 years 2. clinical diagnosis of ischemic stroke between 6 months and 5 years ago 3. ischemic area in the territory of unilateral interanal cerebral artery 4. moderate to severe neurological symptoms; mrs 3 or 4, and brunnstrom stage ⅲ or iv 5. subjects with a dti-rainbow (r-dti) value of more than 70% at screening mr imaging 6. no significant neurological impairment before the stroke (pre-stroke mrs of 0 or 1) 7. subjects who can give informed consent by its self exclusion criteria 1. subject showing severe lower extremity contracture (maximum knee extension less than -15 degrees, maximum ankle flexion less than 0 degree)" 2. anaemia (hg \< 10·0 g/dl) 3. thrombocytopaenia (platelet count \< 100,000/mm3) 4. severe heart disease (ischaemic heart disease, heart failure) 5. severe systemic organ failure alt \<3·0× upper limit of normal total bilirubin \< 1·5× upper limit of normal serum creatinine \< 1·5× upper limit of normal 6. history of malignancy 7. carriers of infectious disease: syphilis, hbv, hcv, hiv-1/hiv-2, htlv-1, parvovirus b19 8. pregnant or lactating or expecting to become pregnant during the study 9. known serious allergy to any agents used in the study 10. contraindication for magnetic resonance imaging 11. history of seizure within 2 years 12. subject's body weight less than 45 kg for male and 40kg for female "13. participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future" 14. any condition that in the judgement of the investigator would place the patient at undue risk

Keywords: stem cell therapy mesenchymal stem cell ischemic stroke chronic
vonaprazan versus esomeprazole for healing of la grade b or higher esophagitis after poem

Conditions: GERD

Summary: peroral endoscopic myotomy (poem) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (gerd), with many patients developing la grade b or higher esophagitis. proton pump inhibitors (ppis) like esomeprazole are the standard treatment, but vonaprazan, a potassium-competitive acid blocker (p-cab), offers superior acid suppression and may provide enhanced healing in post-poem reflux esophagitis. primary objective: • to compare the healing rates of la grade b or higher reflux esophagitis at 8 weeks in patients receiving vonaprazan 20 mg versus esomeprazole 40 mg. secondary objectives * to assess improvement in reflux symptoms using the gerd-q score at 8 weeks. * to evaluate the incidence of adverse events in each treatment group.

study type: • randomized, open-label, two-arm, non-inferiority trial randomization and blinding: * randomization: 1:1 ratio between vonaprazan 20 mg and esomeprazole 40 mg. * stratification: based on la grade (b vs. c/d) at baseline. * blinding: open-label study, but outcome assessors will be blinded. study timeline: 1. all post-poem patients receive esomeprazole 40 mg for 2 months. 2. ppi is discontinued for 1 month (to allow reflux esophagitis to develop if persistent gerd exists). 3. at 3 months post-poem, patients with la grade b or higher esophagitis (on follow-up endoscopy) are randomized to either vonaprazan 20 mg or esomeprazole 40 mg for 8 weeks. 4. at 8 weeks post-randomization (5 months post-poem), healing of esophagitis is assessed. study arms: * arm a: vonaprazan 20 mg once daily for 8 weeks * arm b: esomeprazole 40 mg once daily for 8 weeks study procedures: baseline assessment (3 months post-poem, before randomization) * upper gi endoscopy: confirmation of la grade b or higher reflux esophagitis. * gerd-q score assessment. * randomization to vonaprazan 20 mg or esomeprazole 40 mg. follow-up (week 4 - interim visit) * gerd-q score assessment. end-of-treatment (week 8 - final visit, 5 months post-poem) * upper gi endoscopy to assess healing of reflux esophagitis. * gerd-q score reassessment. * final adverse event reporting.

Eligibility criteria:
inclusion criteria: * age ≥18 years * history of poem for achalasia * endoscopic confirmation of la grade b, c, or d reflux esophagitis at 3 months post-poem * gerd symptoms (heartburn, regurgitation) for ≥4 weeks * willingness to provide informed consent and comply with study procedures exclusion criteria: * history of prior anti-reflux surgery * presence of barrett's esophagus, esophageal stricture, or malignancy * severe gastroparesis or esophageal motility disorder unrelated to achalasia * pregnancy or breastfeeding * severe hepatic or renal impairment (alt/ast \>3× uln, egfr \<30 ml/min) * regular use of nsaids, steroids, or anticoagulants affecting esophageal healing
a comparison of acute psychobiological responses to laboratory stress tests

Conditions: Stress, Physiological; Stress, Psychological

Summary: the mannheim multicomponent stress test (mmst) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. however the utility of the mmst as a viable alternative to the more commonly used trier social stress test (tsst) to elicit hpa reactivity remains unclear as meaningful increases in saliva cortisol (\> 2.5 nmol/l) have been shown to occur in \ 70% of participants; likely as a consequence of the greater social evaluative component in the tsst. using a randomised between groups design, this study aims to compare psychobiological responses to the mmst and tsst.


Eligibility criteria:
inclusion criteria: participants who... * have read and signed the study informed consent * are healthy, recreationally active men and women aged 18-35 years * are willing to provide saliva samples throughout through the duration of the study * are using monophasic birth control (women only) exclusion criteria: participants who... * have a recent history or are a current smoker * are currently taking prescription/over-the-counter medication (excluding females taking oral combined contraception * consume ≥ 91 units of alcohol per month * have a clinically diagnosed history of cardiovascular and/or metabolic disease including diabetes and abnormal blood pressure * are pregnant * have a recent or ongoing viral or bacterial illness in past 4 weeks * have a clinically diagnosed psychiatric disorder * have a clinically diagnosed sleeping disorder * have a clinically diagnosed gambling addiction * bmi ≥ 30 kg/m2 - calculated in the online health screening questionnaire * endurance trained or engage in ≥3.5 hours of physical activity a week
impact of extremely early antiretroviral therapy to reduce viral reservoir and induce functional cure of hiv-1 infection

Conditions: HIV Infections

Summary: pilot study to evaluate the impact of extremely early art in the dynamics of viral reservoir, immune activation and inflammation in patients with hiv-1 infection of less than 20 days (fiebig stages i-ii) compared to patients with infection of 20-100 days (fiebig stages iii-v), to induce hiv functional cure.


Eligibility criteria:
inclusion criteria: * men who have sex with men * male's between18 and 65 years old * less than 100 days of infection * patient stage fiebig i to v * negative or incomplete western blot with negative p31 band exclusion criteria: * p31 positive band in western blot * positive delta32 ccr5 mutation, hla-b5701 or hla-b27 (´late' exclusion criteria) * active oncological disease * active hepatitis c virus infection

Keywords: hiv