Kornimate/medical-research-clean huggingface dataset:
safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery

Conditions: Aortic Dissection Aneurysm

Summary: this trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.


Eligibility criteria:
inclusion criteria:(all of the following criteria were met for enrolment): 1. patients aged greater than 18 years old and less than 80 years old. 2. patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma. 3. patients needed endovascular repair (tever). 4. patients who needed complete coverage of the left subclavian artery (planned landing zone was in zone 2 of the aortic zone). 5. the proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (lsa) opening, but not the left common carotid artery (lcca). 6. suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment. 7. the patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives. 8. patients were willing to undergo follow-up evaluation as required by the study protocol. 9. the life expectancy of the patient is more than 12 months. exclusion criteria:(if any of the following criteria is met): 1. the lesion involved the proximal aorta of the lcca opening (zone 0 and zone 1). 2. the patient has a definite connective tissue disease (e.g., marfan syndrome). 3. the subjects had a history of previous thoracic endovascular aortic repair (tevar). 4. patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.). 5. patients with contraindications to antiplatelet and anticoagulant drugs. 6. the patient's compliance was poor and the follow-up could not be expected on time. 7. patients with acute systemic infection. 8. patients cannot tolerate general anesthesia. 9. patients judged by the investigator to be ineligible for endovascular treatment.
non culprit lesion study

Conditions: STEMI

Summary: the aim of the present study is to compare the evolution of non culprit lesions after treatment by bvs versus optimal medical therapy at 2-years follow- up

objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with bvs could facilitate the stabilization process into the atherosclerotic plaque with modifications of plaque morphology, especially the lipid content which is considered as one of the main factor leading to recurrent mace after an acs. the interaction between the polymer platform and the vessel wall, the effect of the everolimus on neointima growth and cellular response into the media could reduce the inflammatory process into the vulnerable plaque could be different under omt and bvs implantation.

Eligibility criteria:
inclusion criteria: * stemi and multivessel ascl * successful and uneventful primary pci * non culprit lesion \> /= 2.5mm rvd suitable for investigation by ffr * at least one segment of minimum 10 mm length containing a non culprit lesion exclusion criteria: * non compliant profile * patient not able to sign an ic * cardiogenic shock * left main disease * gfr\<30ml/min/m2 * previous cabg * lvef\<35%
diffusion tensor imaging of sural nerves in diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: this study aims to validate magnetic resonance imaging and diffusion tensor imaging (mri/ dti) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.


Eligibility criteria:
inclusion criteria: 1. presence of diabetes mellitus diagnosed for more than 6 months as defined by the world health organization classification. 2. presence of confirmed dpn as defined below. 3. age between 18-70 years. 4. have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations). 5. willingness to provide informed consent and cooperate with the medical procedures for the study. inclusion criteria for healthy controls: 1. age-matched non-obese (bmi \< 30) control subjects 2. normal glucose tolerance 3. normal blood pressure 4. normal lipid profile 5. free of any causes of neuropathy as described above. exclusion criteria: 1. nursing mothers or pregnant women (excluded by a positive pregnancy test). 2. patients with a history of previous kidney, pancreas or cardiac transplantation. 3. patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis c, systemic lupus erythematosus). 4. participation in an experimental medication trial within 3 months of starting the study. 5. subjects with implantable cardioverter defibrillators and other devices that would preclude mri scanning. 6. subjects who are unable or unwilling to comply with the experimental protocol.
study evaluating safety, tolerability, and immunogenicity of acc-001 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: to assess the safety, tolerability, and immunogenicity of acc-001, an investigational active immunization, in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease with mini-mental state examination (mmse) score of 16-26 (except germany: 21-26) * brain mri consistent with alzheimer disease * concurent use of chloniesterase inhibitor or memantine allowed if stable * other inclusion criteria apply exclusion criteria: * significant neurological disease other than alzheimer's disease * major psychiatric disorder * contraindication to undergo brain mri * clinically significant systemic illness * other exclusion criteria apply

Keywords: alzheimer's disease active immunization
measurement of hiv risk to create demand for safe male circumcision

Conditions: HIV

Summary: the study is aimed at testing whether use of a new index to measure risk for hiv in the context of hiv testing and counseling will increase demand for safe male circumcision (smc) services among hiv-negative non-muslim men in rakai. we will also study whether use of the index leads to positive sexual behavioral modifications among men. the study will also measure acceptability of the index among men.

three randomized trials, one of which was conducted in rakai, uganda, have shown that safe male circumcision (smc) reduces hiv acquisition in men by approximately 60%. recommendations from the world health organization (who) and the joint united nations programme (unaids) emphasize that smc should be considered an efficacious intervention for hiv prevention in countries and regions with heterosexual epidemics, high hiv and low male circumcision prevalence. in sub saharan africa, 14 countries including uganda have been selected to scale up smc, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. the scale up would avert more than 20 percent of new infections among men and women. however smc programs are faced with the challenge of low uptake of smc by older sexually active men who might be at higher risk of hiv. the need to increase smc coverage among men at high risk of hiv requires tools to measure individual hiv risk. rakai health sciences program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from rakai community cohort study (rccs) to assess whether hiv counseling and testing (hct), enhanced with measurement and communication of hiv risk (ehct), increases uptake of smc and leads to behavior modification among hiv-negative sexually active men aged 15-49 years in rakai district, uganda. the study is using a risk nomogram developed from the rakai community cohort study data to measure individual hiv risk in the intervention group and standard hct in the control arm. all men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.the study will also measure acceptability of the index among men.

Eligibility criteria:
inclusion criteria: * uncircumcised, non-muslim, hiv-negative, sexually active in the previous 12 months exclusion criteria: * refuses hiv testing, not willing to stay in rakai for at least 6 months following enrollment or unwilling to be traced
addressing school-related gender-based violence as part of the keeping girls in school initiative in zambia

Conditions: Gender-based Violence

Summary: the objective of this mixed-methods study is to evaluate the effectiveness of a school-based safe-space program delivered to secondary school students in zambia. the quantitative component of the study uses a randomized controlled trial to measure changes in students' experience of school-related gender-based violence (srgbv), attitudes towards gender and srgbv, socio-emotional well-being, and school climate, among other outcomes. meanwhile, the qualitative component of the study aims to understand the prevailing norms around srgbv in schools, the perception of the intervention and its impact, and the potential mechanisms through which the intervention generates its outcomes.

this study will evaluate the impact of the empowerment pilot, a school-based safe-space program delivered to secondary school students in zambia, implemented between may and november 2023. the main question it aims to answer is whether the empowerment pilot changes attitudes and norms around gender roles and school-related gender-based violence (srgbv), increases socio-emotional well-being, improves school climate, and reduces srgbv. we use a mixed-methods triangulation design and combined qualitative and quantitative approaches in data collection and analysis to enhance the validity, depth, and relevance of our findings. data will be collected from approximately 6,000 adolescent girls and boys and their teachers across three districts in zambia. the mixed-methods evaluation gives equal importance to the qualitative and quantitative components. however, this registration primarily describes the quantitative component of the study.

Eligibility criteria:
inclusion criteria for adolescent participants: * students enrolled in grades 8 - 11 of secondary schools in the 2023 school year at the start of the intervention
colligo-hcm: a multinational observational study of the real-world effectiveness of mavacamten among patients with symptomatic obstructive hypertrophic cardiomyopathy (ohcm)

Conditions: Hypertrophic Cardiomyopathy (HCM)

Summary: colligo-hcm is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (hcm) treatment in real-world clinical practice.

the mavacamten observational evidence global consortium in hypertrophic cardiomyopathy (colligo-hcm) is a global observational research initiative aiming to describe the real-world outcomes of treatments for obstructive hypertrophic cardiomyopathy (hcm), including mavacamten. this retrospective study uses data from existing medical records and electronic registries from hcm centers around the world.

Eligibility criteria:
inclusion criteria: * source cohort - have at least one recorded encounter with a hypertrophic cardiomyopathy (hcm) diagnosis during or after 2018 (the first is defined as the index) and aged ≥18 years on the index date. - disease-specific patient history documented in the medical record. * hcm sub-cohort - participants in the source cohort with a known hcm diagnosis * mavacamten sub-cohort - participants who have their first mavacamten prescription after the index date exclusion criteria: • hcm sub-cohort - hcm phenocopy (athlete's heart, hypertensive heart disease, fabry disease, pompe disease, danon disease, amyloidosis) observed after the first observed hcm-associated encounter in the medical record.

Keywords: mavacamten, ohcm, cardiac myosin inhibitor, nyha class, echocardiogram parameters, patient-reported outcomes
efficacy of zoledronic acid in osteoporosis

Conditions: Osteoporosis

Summary: there has been no comparative data between zoledronic acid and zoledronic acid combined with active vitamin d in primary and secondary osteoporosis.


Eligibility criteria:
inclusion criteria: * osteoporotic patients who want to take zoledronic acid exclusion criteria: * patients who are allergic to zoledronic acid or vitamin d * patients who are pregnant or breast-feeding * patients who have not taken zoledronic acid for the last 2 years
low-dose imaging technique (lite)

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the diagnostic accuracy of a breast mri when using a smaller dose of contrast compared to a full dose of contrast. each patient will be injected with a low-dose and standard dose of gadavist® acquired on two separate days. both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. to evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different mri pictures of their breasts. the scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.


Eligibility criteria:
inclusion criteria: * women between the ages of 18-80 * women with a suspected or biopsy proven enhancing lesion exclusion criteria: * women with a history of adverse reactions to contrast media * women with gfr below 30 ml/min/1.73m2 * women who are pregnant or breastfeeding
multiple dose healthy volunteer study of pf-03715455.

Conditions: Healthy Volunteers

Summary: evaluation of the multiple dose pharmacokinetics of pf-3715455 in healthy volunteers

healthy volunteer pk study

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * standard healthy volunteer criteria
randomized evaluation of atrial fibrillation treatment with focal impulse and rotor modulation guided procedures

Conditions: Persistent Atrial Fibrillation

Summary: the study is a prospective, multicenter, randomized study to assess the safety and effectiveness of firm procedures followed by conventional ablation including pvi versus a standard pvi procedure for the treatment of persistent atrial fibrillation (af).


Eligibility criteria:
key inclusion criteria: * at least two (2) documented episodes of persistent atrial fibrillation during prior 3 months * refractory, intolerant, or contraindicated to class i or iii anti-arrhythmic medications * left atrial diameter \< 6.0 cm key exclusion criteria: * previous af ablation * presence of structural heart disease * new york heart association (nyha) class iv. * ejection fraction \< 35%. * history of myocardial infarction (mi) within the past three months.

Keywords: focal impulse and rotor modulation mapping catheter (firmap) rotor firm-guided procedure reaffirm
denosumab effect on bone quality and function after lumbar fusion surgery

Conditions: Osteopenia; Spine Fusion; Denosumab Allergy

Summary: degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. it mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.

however, it was still unknown for denosumab effect on osteopenia patients after lumbar fusion. bone mineral density(bmd), bone turnover marker, lumbar functional status roland-morris disability functioning questionnaire (rmdq) and quality of life euroqol five-dimension (eq-5d), and quality of life questionnaire of the european foundation for osteoporosis-31 (qualeffo-31) score, rate of new fracture, re-operation, lumbar fusion, complications or adverse events were still unknown. our study will explore the effect of denosumab on lumbar, total hip, femoral neck bmd and bone turnover markers, functional status eq-5d, qualeffo-31 and rmdq score of participants after lumbar fusion at 12 months follow-up.

Eligibility criteria:
inclusion criteria: * participants aged 40 to 85 years * who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis * osteopenia with bmd t score between -1.0 and -2.5 via dual-energy x-ray * low back pain or leg numbness or weakness * mri demonstrated signs of nerve compression exclusion criteria: * cauda equina syndrome * progressive neurologic deficit * history of cancer * scoliosis greater than 15° * back open surgery history * have contraindications for surgery * who had anti-osteoporosis medication within 6 weeks
effect of rbt-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery

Conditions: Post-Operative Complications in Cardiac Surgery

Summary: the purpose of this study is to evaluate the effect of rbt-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (cpb). a sub-study will also be conducted to evaluate the pharmacokinetic (pk) profile of a single administration of rbt-1 by means of a poppk approach in subjects scheduled to undergo cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. male or female, ≥18 years of age at screening. 2. planned to undergo non-emergent cabg and/or cardiac valve surgery requiring cpb; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery. 3. if female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation. 4. if male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug. 5. willingness to comply with all study-related procedures and assessments. exclusion criteria: 1. surgery planned to occur \<24 hours from the start of study drug infusion. 2. presence of acute organ dysfunction (aki, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the investigator at the time of screening. 3. surgery to be performed without cpb. 4. chronic kidney disease (ckd) requiring dialysis. 5. hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low. 6. cardiogenic shock or immediate requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (iabp). 7. known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin. 8. known or suspected sepsis at time of screening. 9. asplenia (anatomic or functional). 10. history of hemochromatosis, iron overload, or porphyria. 11. known hypersensitivity or previous anaphylaxis to snpp or fes. 12. female subject who is pregnant or breastfeeding. 13. participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in ren-007. 14. in the opinion of the investigator, for any reason, the subject is an unsuitable candidate to receive rbt-1.

Keywords: cardiac surgery cabg valve cardiopulmonary bypass preconditioning
oligo-antigenic diet in the treatment of chronic anal fissures.

Conditions: Anal Fissures Treatment and Oligoantigenic Diet

Summary: patients with chronic constipation due to food hypersensitivity (fh) had an elevated anal sphincter resting pressure. no studies have investigated a possible role of fh in anal fissures (af). we aim to evaluate the effectiveness of a diet in curing af and the clinical effects of a double-blind placebo controlled (dbpc) challenge with cow's milk protein or wheat.

context: patients with chronic constipation due to food hypersensitivity (fh) had an elevated anal sphincter resting pressure. no studies have investigated a possible role of fh in anal fissures (af). objective: we aim to evaluate 1) the effectiveness of a diet in curing af; 2) the clinical effects of a double-blind placebo controlled (dbpc) challenge with cow's milk protein or wheat. design: the study will have two different parts: the first to verify the effectiveness of the oligo-antigenic diet in chronic af treatment; the second to search for a possible cause-effect relationship between the diet and the onset of the af. setting: we will enrol consecutive adult patients with chronic af who will refer to a surgical department of the university of palermo for a 3-years period. inclusion criteria are: evidence of caf evaluated by an experienced rectal surgeon; patient age \>16 years. exclusion criteria are: a diagnosis of inflammatory bowel disease, ongoing steroid treatment performed for any reason, an exclusion diet followed for any reason, and pregnancy. at the time of the first evaluation, routine laboratory tests, immunology tests, rectal biopsies and anal-rectal manometry will be performed. patients: patients, finally included in the study, will be randomized to one of the treatment groups. interventions: enrolled patients will be randomized to receive a "true elimination diet" or a "sham elimination diet"; both groups will also receive topical nifedipine and lidocaine. main outcome measures: the patients will be evaluated every two weeks for caf persistence or healing; anal pain will be scored on a visual analogue scale ranging from 0 (absence of pain) to 10 (intolerable pain). anal-rectal manometry will be repeated at the end of the study period, in all patients who will be treated.

Eligibility criteria:
inclusion criteria: * evidence of chronic anal fissures evaluated by an experienced rectal surgeon * patient age \>16 years. exclusion criteria: * a diagnosis of inflammatory bowel disease * ongoing steroid treatment performed for any reason * an exclusion diet followed for any reason * pregnancy.

Keywords: foof hypersensitivity anal fissures ano-rectal manometry