Kornimate/medical-research-clean huggingface dataset:
drug eluting balloon for prevention of hemodialysis access restenosis

Conditions: Arteriovenous Fistulae; Arteriovenous Graft

Summary: the purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after pta (percutaneous transluminal angioplasty) of hemodialysis access (ha) in comparison with the uncoated pta balloon catheter.

in canada, there are over 20,000 patients with chronic end-stage renal disease (esrd)on long-term hemodialysis and the number is increasing rapidly.the creation of hemodialysis access (ha) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. these ha are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (\> 60% at one year). pta is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.although pta has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. there are currently no durable therapies for the prevention or treatment of ha dysfunction restenosis after pta. recently drug eluting balloon (deb) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. the investigators believe that the deb with paclitaxel will significantly decrease the ha restenosis rate at the treated site and therefore will improve the management of ha failures.

Eligibility criteria:
inclusion criteria: * clinical or hemodynamic evidence of ha dysfunction according to the clinician's judgment * patients with avf (arteriovenous fistulae)or avg (arteriovenous graft) located in the forearm or upper arm and is \> 3 months old * minimum age of 18 years and written informed consent * target lesion stenosis is \ 50% in luminal diameter reduction * maximum of two secondary lesions (stenoses) if the following criteria are satisfied: the secondary lesion is located in the graft or peripheral veins, the secondary lesion is \ 1.0 cm away from the target lesion, the secondary lesion is \>50% luminal reduction compared to the reference vessel diameter * reference vessel diameter between 4 to 7 mm * the ha must not be thrombosed and the lesion can be crossed with guide wire before angioplasty * lesion site: from 2 cm above the arterial anastomosis to the superior vena cava * restenotic lesion (previously treated by pta or stent) or de novo lesion exclusion criteria: * contraindication to angiography or pta * intervention of the ha circuit within the past 30 days * systemic infection or a local infection associated with the graft * the patient is pregnant * patient is enrolled in another investigational study. * life expectancy \< 12 months * history of severe allergic reaction to contrast media or to paclitaxel

Keywords: arteriovenous fistulae arteriovenous graft restenosis angioplasty drug eluting balloon
safety and efficacy of topically applied cta018 in plaque psoriasis

Conditions: Psoriasis

Summary: vitamin d and its analogs are currently widely used for the treatment of psoriasis. the study drug (cta018) is a novel analog of vitamin d, and this phase 2 study will investigate the efficacy and safety of cta018 in the treatment of psoriasis. patients with chronic plaque psoriasis will receive one of three doses of cta018 cream or vehicle (no study drug) daily for 12 weeks.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet * at least two evaluable plaques with cpss \>/= 6 * baseline psga \>/= 2 * women of childbearing potential msut agree to use an effective form of contraception exclusion criteria: * cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis * cannot have concomitant serious illness/condition that may interfere with participation in the study * cannot have used topical therapy within 2 weeks prior to baseline visit * cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit * cannot have had prolonged exposure to natural or artificial uv radiation within 4 weeks of baseline visit or intend to have exposure during the study * cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit * cannot have a history of hypercalcemia or kidney stones * cannot be unable or unwilling to discontinue calcium and/or vitamin d supplementation during the study * cannot be pregnant or a nursing mother * cannot be participating in or have participated in an interventional study within 30 days of study start

Keywords: psoriasis
study of exelon transdermal patch in amnestic mild cognitive impairment patients

Conditions: Mild Cognitive Disorder; Mild Cognitive Impairment

Summary: the goal of this project is to determine if task-activated fmri is sensitive to the central cholinergic deficit associated with mild cognitive impairment.

clinical studies suggest that cholinesterase inhibitors (cheis) exert a cognitive benefit with chronic use among mci and ad patients. some studies also demonstrate a slight treatment benefit for persons who are apoe 4 positive. we propose to conduct a 24-week, randomized, double-blind, placebo-controlled, parallel group study of the exelon® \[rivastigmine\] transdermal patch in 120 amci patients who have one or both apoe 4 alleles. our preliminary analyses indicate that amci patients, even those who convert to ad, exhibit increased fmri activation on our semantic memory activation task relative to not at-risk healthy participants and that increasing activation over time correlates with declines on neuropsychological testing. in addition, our preliminary data indicate that chei treated amci patients demonstrate normalization (i.e. reduction) in the magnitude of task-related neural activation over time relative to an untreated group. furthermore, changes in fmri magnitude demonstrated greater sensitivity to cholinergic modulation than changes on neuropsychological testing.

Eligibility criteria:
inclusion criteria: * diagnosis of amnestic mci * in good general health with no diseases expected to interfere with the study * ability to undergo mri * fluent in english * stable prescription dosages 1 month prior to testing * carrier of the apoe e4 allele (determined by blood draw at screening visit) exclusion criteria: * neurological illness/conditions * medical illnesses/conditions that may affect brain function * prior history of use of any cholinesterase inhibitor * instable or severe cardiovascular disease or asthmatic condition
a prospective blinded randomized study comparing laparoscopic sleeve gastrectomy and laparoscopic roux-en-y gastric bypass and their effect on gastro-esophageal reflux disease using 24 horus ph monitoring

Conditions: GERD

Summary: obesity has become a significant health problem in canada. it is known to be a risk factor for many diseases, including gastro-esophageal reflux disease (gerd). when medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. the two most common bariatric procedures performed are roux-en-y gastric bypass (lrygb) and laparoscopic sleeve gastrectomy (lsg). the gold standard for diagnosing gerd is esophageal ph monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. in the last few years lsg has gained in popularity due to its simplicity and short operative time. currently the comparison between bariatric surgery and gerd symptoms is very one sided. there are significant numbers of studies with conclusive results that state that lrygb has a positive effect on gerd symptoms, however there is little evidence that states the same about lsg. this means that the relationship between lsg and gerd is inconclusive. an objective evaluation of gerd using 24 hour ph monitoring and validated crfs at different follow up time points will contribute greatly to our understanding of what this relationship might be.


Eligibility criteria:
inclusion criteria: * fulfilled criteria for bariatric surgery as coined by national institutes of health conference. * their age is ≥18 years and ≤70 years * the group with symptoms of gerd needs to have diagnosis of gerd in their medical record and taking proton pump inhibitors on a daily basis. * able and willing to give written consent * the patient is willing to perform the pre-operative tests required for this study. * the patient fits for both surgeries - lsg or lrygb exclusion criteria: * previous bariatric surgery * previous anti reflux procedure * contra-indication to general anesthesia * any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure * pregnant or lactating female (women of child bearing potential must take a pregnancy test prior to surgery) * hiatal hernia above 4cm (measured in the pre-operative gastroscopy). * multiple surgeries in abdominal cavity or previous small bowel disease/resection * patient on cpap treatment for his osa disease

Keywords: gerd laparoscopic sleeve gastrectomy
npwti on closure of chronic pressure sores

Conditions: Pressure Sore

Summary: the primary objective of this study is to assess the effectiveness of the negative pressure wound therapy system with instillation therapy (npwti) on closure of chronic pressure sores. this intervention will be compared to wet-to-dry dressings, which is standard of care. in this post-market, on-label study, we hope to show that the npwti system more effectively closes pressure sores following debridement than traditional care.


Eligibility criteria:
inclusion criteria: 1. ischial and sacral wounds at stage 3 and 4. 2. any pressure sore that has the potential for a good seal. exclusion criteria: 1. any pressure sore that does not have potential for a good seal. 2. patients with fecal incontinence (due to potential for pressure sore to be near the anus). 3. patients who by the opinion of the principal investigator are not candidates for surgical closure (age, bmi, comorbidities, etc.). 4. patients who are pregnant. this is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. we therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.
understanding the natural history of rem sleep behavior disorder

Conditions: REM Sleep Behavior Disorder

Summary: the purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (ekg), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. researchers believe that early identification of these disorders could lead to treatments to prevent, delay, or slow the development of one of more of these diseases. some people with rem sleep behavior disorder (rbd) may go on to develop parkinson's disease or another related neurological disorder, but many do not.


Eligibility criteria:
inclusion criteria: * idiopathic rem sleep behavior exclusion criteria: * parkinson's disease * alzheimer's disease * multiple system atrophy * dementia * minors

Keywords: rem sleep behavior disorder rbd dream dreams
ologen (oculusgen)-glaucoma mmc control trial in india

Conditions: Glaucoma

Summary: the purpose of this study is to compare the safety and effectiveness of the ologen (oculusgen) biodegradable collagen matrix implant and the mmc group in filtration surgery.

1. study objective: to compare the safety and effectiveness of the ologen (oculusgen) biodegradable collagen matrix implant and the mmc group in filtration surgery. the primary endpoint is to prove the effectiveness via the reduction of iop, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. study design: the study is designed as an open-label, randomized, parallel, comparative study. patients who meet the inclusion/exclusion criteria and sign informed consent will be included. after enrollment, patients will be randomized into two groups: trabeculectomy with ologen (oculusgen) implant or trabeculectomy with mitomycin-c. 3. follow-up: there will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. a window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. further follow-up of subjects after the trial will be the responsibility of the investigator.

Eligibility criteria:
inclusion criteria: * age 18 years or over. * uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy. * subject able and willing to cooperate with investigation plan. * subject able and willing to complete postoperative follow-up requirements. * subject willing to sign informed consent form. exclusion criteria: * known allergic reaction to mitomycin-c or porcine collagen. * subject is on warfarin and discontinuation is not recommended. * normal tension glaucoma. * participation in an investigational study during the 30 days preceding trabeculectomy. * ocular infection within 14 days prior to trabeculectomy. * pregnant or breast-feeding women.

Keywords: glaucoma collagen matrix ologen oculusgen trabeculectomy anti scarring tissue engineering high risk patient for trabeculectomy aeon astron
exploring the association of imaging and tumor microenvironment in liver cancer using radiogenomic approach（radiogenomics-liver）

Conditions: Liver Cancer

Summary: this is the prospective, observational cohort study (radiogenomics-liver), which aims to explore the relationship between the imaging information of liver cancer patients, tumor microenvironment and the prognosis of liver cancer patients.


Eligibility criteria:
inclusion criteria: 1. patients treated for liver cancer in wuhan union hospital from august 2024 to august 2027; 2. aged \> 18 years old; 3. at least one ct scan or mri scan before treatment; 4. tissue biopsy pathological examination confirmed the diagnosis of the above tumors. exclusion criteria： 1. poor image quality; 2. incomplete clinical data or loss of follow-up; 3. presence of another primary malignancy other than liver cancer; 4. unclear pathological diagnosis.
seeq™ performance study

Conditions: Arrhythmia Type Unknown

Summary: the purpose of the medtronic seeq™ performance study is to build further evidence on the clinical and economic benefit of the medtronic market-released seeq™ mobile cardiac telemetry system/external cardiac monitor system (mct/ecm).


Eligibility criteria:
inclusion criteria: * patient is indicated for a seeq™ mct/ecm system for approved indications * patient is 18 years of age or older * patient is willing and able to provide consent and authorize the use and disclosure of health information * patient is willing and able to comply with the protocol exclusion criteria: * patient has known allergy and/or hypersensitivity to adhesives or hydrogel. * patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring. * patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the seeq™ * patient has an implanted cardiac device, (e.g., pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy)
postoperative analgesic efficacy of recto intercostal nerve block

Conditions: Laparoskopic Cholecystectomy; Recto Intercostal Nerve Block

Summary: laparoscopic cholecystectomy is a frequently performed surgery and the gold standard for the treatment of symptomatic gallstone disease. although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. poorly controlled early postoperative pain impairs recovery quality and increases the risk of postoperative pulmonary complications, serving as a risk factor for chronic pain development. multimodal analgesia, including opioids, is used to manage pain following laparoscopic cholecystectomy. however, opioid treatment may lead to side effects such as postoperative nausea and vomiting (ponv), respiratory depression, and constipation. the primary aim of this study is to evaluate the effect of recto-intercostal nerve block as part of multimodal analgesia on intraoperative opioid consumption and postoperative pain scores in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * american society of anesthesiologists (asa) physical status i-ii-iii * elective laparoscopic cholecystectomy surgery exclusion criteria: * under 18 and over 65 years old * asa score iv and above * advanced co-morbidity * history of bleeding diathesis * patient refusing the procedure * chronic opioid or analgesic use * patients who will operate under emergency conditions * block injection site infection * known allergy to local anesthetics * pregnancy

Keywords: remifantanile conception acute pain postoperatif pain
vitamin d supplementation in children

Conditions: Vitamin D Deficiency

Summary: prevalence of vitamin d deficiency in children in the northern country during winter season is very high (up to 90%). vitamin d supplementation at a dose 600 -1000 iu/d is recommended in polish children from september till april. however, there is shortage of studies in polish children. the aim of the study is to assess the effectiveness of vitamin d supplementation in the prevention of vitamin d deficiency in polish children (4-10 years of age).

prevalence of vitamin d deficiency in children in the northern country during winter season is very high (up to 90%). vitamin d supplementation at a dose 600 -1000 iu/d is recommended in polish children from september till april. however, there is shortage of studies in polish children. aims: 1. assessment of the impact of vitamin d intake at a dose of 1000 iu / day on vitamin d status in children aged 4-10 years. 2. evaluation of the effectiveness of supply of vitamin d at a dose of 1000 iu / day in preventing vitamin d deficiency and maintaining optimal vitamin d status ( 25ohd level \>30ng/ml) 3. evaluation of vitamin d status depending on age, bmi and body composition. 4. assessing the safety and tolerability of mel ● tiki vitamin d in children. material: children aged 4-10 years study desing: prospective intervention trial intervention: cholecalciferol at a dose 1000 iu/day for 3 months methods: 1. analysis of clinical characteristics (attendance at kindergarten / school, consumption of products rich in vitamin d, exposure to sun, use of sunblock's, the overall child's health (chronic diseases, medications, vitamins, micronutrients) 2. anthropometric measurements (body weight, height, bmi, assessment of body fat content - body composition by bioimpedance method- tanita) 3. assessment of vitamin d status (serum total 25ohd concentration in blood serum by immunochemiluminescence method) 4. collecting data on the tolerability and safety of meliki ● tiki vitamin d including possible symptoms of vitamin d overdose

Eligibility criteria:
inclusion criteria: * age 4-10 years; declaration of no use other preparations containing vitamin d; parental written informed consent exclusion criteria: * osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial

Keywords: cholecalciferol bmi winter
omega 3 fatty acids in colorectal cancer (crc) prevention in patients with lynch syndrome (colyne)

Conditions: Colorectal Cancer; Lynch Syndrome

Summary: this is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. the study will be a single arm, open label study.


Eligibility criteria:
inclusion criteria: * ability of participant or legally authorized representative (lar) to understand this study, and participant or lar willingness to sign a written informed consent * candidate for elective endoscopy procedure * participants with known lynch syndrome * eastern cooperative oncology group (ecog) performance status 0-1 * willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and biopsy at 12 months visit. * participants taking aspirin for chemoprevention must agree to stop it for at least 4 weeks prior to study entry and throughout the trial period * adequate organ and marrow function * women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal and barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. * men of child-bearing potential must not father a child or donate sperm while on this study and for 90 days after their last study treatment. exclusion criteria: * current or anticipated use of other investigational agents while participating in this study. * psychiatric illness/social situations that could limit compliance with study requirements. * pregnant or breast feeding. * familial adenomatous polyposis, putz-jeghers disease, ulcerative colitis, or crohn's disease. * previous or known active malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for more than 5 years * current use of anticoagulation therapy * current use of therapeutic doses of aspirin for reasons other than chemoprevention * use of omega 3 fatty acids or flaxseed supplements within 4 weeks before this study's screening/baseline colonoscopy * use of high dose omega 3 fatty acids within the past 3 months prior to study baseline/screening * current, regular use of non-steroidal anti-inflammatory drugs (nsaids) * allergy to fish and/or fish products * uncontrolled infectious disease * malabsorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel. * unable to swallow and retain oral medication

Keywords: omega 3