Kornimate/medical-research-clean huggingface dataset:
endurant stent graft natural selection global postmarket registry

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of engage is to prospectively collect global 'real world' data on the endurant stent graft system from aaa subjects.

the endurant stent graft natural selection global post-market registry, engage is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. this subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. engage aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. engage will not impose cip required study procedures affecting clinical practice.

Eligibility criteria:
inclusion criteria: * age ≥18 years or minimum age as required by local regulations * indication for elective surgical repair of aaa with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the instructions for use of the endurant stent graft system * signed consent form ("patient informed consent form" or "patient data release authorization form"). the subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information * intention to electively implant the endurant stent graft system * ability and willingness to comply with the cip. exclusion criteria: * high probability of non-adherence to physician's follow-up requirements * current participation in a concurrent trial which may confound study results

Keywords: endurant stent graft abdominal aortic aneurysm
be study of the fixed dose combination of 5 mg saxagliptin and 500 mg metformin hcl xr tablet relative to a 5 mg saxagliptin (onglyza™) tablet and a 500 mg metformin hcl xr (glifage® xr marketed in brazil by merck s.a.) tablet co-administered to healthy subjects in the fasted and fed states

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to demonstrate the bioequivalence (be) of saxagliptin and metformin from a 5 mg saxagliptin/500 mg metformin extended release (xr) fixed dose combination (fdc) tablet relative to 5 mg onglyza™ and 500 mg glifage® xr (marketed in brazil by merck s.a.) tablets administered together in both the fasted and fed states.

primary purpose: to demonstrate the bioequivalence of saxagliptin and metformin from a 5 mg saxagliptin/500 mg metformin xr fdc tablet relative to 5 mg onglyza™ and 500 mg glifage® xr (marketed in brazil by merck s.a.) tablets administered together in both the fasted and fed states.

Eligibility criteria:
inclusion criteria: * healthy men and women * women of childbearing potential (wocbp) who are using acceptable method of contraception * women who are not nursing exclusion criteria: * history of gastrointestinal (gi) disease * any gi surgery that could impact study drug absorption * history of allergy to drug class or related compounds * history of allergy to metformin or other similar acting agents. * history of any significant drug allergy. * estimated creatinine clearance (clcr) \< 80 ml/min using cockcroft-gault formula
comparison of a smartphone based self refraction tool with conventional refraction error estimation methods

Conditions: Refractive Errors; Self-Examination

Summary: self evaluating tools based on smartphone devices are public available on the market for each person. the tools are used to estimate the existing refractive error for each eye of a patient. hereafter, e.g. ordering glasses via internet could be the next step for this persons. the daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure. the study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.


Eligibility criteria:
inclusion criteria: * existing refractive error * using glasses or contac lenses exclusion criteria: * opacities (visus limitating) of cornea, lens or vitreous * known ocular pathologies except refractive error * epilepsia * irregular corneal topography
acceptability and tolerance study of new oral nutritional supplement

Conditions: Malnutrition

Summary: * to evaluate tolerance and acceptability of aymes rome in patients requiring supplementary oral nutritional support compared with currently available alternatives. * to obtain data to support a submission to advisory committee on borderline substances (acbs) for aymes rome (to allow for prescription in the community at national health service (nhs) expense).

to evaluate tolerance and acceptability of aymes rome in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of gi effects, compliance, product preference,convenience etc. to obtain data to support an acbs submissions for aymes rome (to allow for prescription in the community at nhs expense).

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) who are able to communicate their views regarding acceptability. * patients established on an oral nutritional supplement, being prescribed 1-2 ons providing approximately 300kcal/day * patients expected to require oral nutritional supplementation for at least 2 further weeks. * informed consent obtained. exclusion criteria: * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study * patients requiring a milk free diet * patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list) * patients with significant renal or hepatic impairment * patients with swallowing impairment requiring thickened fluids * patients with inflammatory bowel disease or previous bowel resection.
an algorithm for approaching temporomandibular disorders with osteopathic manual therapy in patients with fibromyalgia

Conditions: Fibromyalgia; Temporomandibular Disorder

Summary: nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. among the comorbidities it presents, one of the most frequent is temporomandibular disorders. a randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.


Eligibility criteria:
inclusion criteria: * be diagnosed as suffering from fibromyalgia, * present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint, * be over 18 years old, * understand spanish and/or catalan correctly, * and read and accept the informed consent form exclusion criteria: * history of trauma or recent surgery to the head, face or neck; * systemic, rheumatic or central nervous system diseases; * diagnosis of malignant tumors or cancer in the orofacial region; * participate in other studies at the same time.

Keywords: temporomandibular joint disorders fibromyalgia osteopathic medicine chronic pain musculoskeletal manipulations
assessment of the immunization levels against sars-cov2 virus in subjects who have received eu-approved covid-19 vaccines

Conditions: SARS-CoV2 Infection; Vaccine Reaction

Summary: patients who voluntarily visit vaccination centers in greece against covid-19 are recruited and their immunization levels against sars-cov2 are assesed by measurement of the levels of serum antibodies against sars-cov-2 before vaccination and in time intervals up to 6-9 months post-vaccination (indicatively 0-1-3-6-9 months post-vaccination).


Eligibility criteria:
inclusion criteria: * subjects who voluntarily receive covid-19 vaccination exclusion criteria: * patients who do not complete their vaccination * patients who do not provide info on their health status

Keywords: sars-cov2 vaccine age
real-life use of benart tm in patients with symptomatic knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: pmcf study to assess the effectiveness and safety of benart in the treatment of symptomatic knee oa in a real-life clinical setting when used according to the instructions for use.


Eligibility criteria:
inclusion criteria: * male or female aged between 18 and 99 years * diagnosis of symptomatic knee oa: kellgren \& lawrence grade ii/iii * physician's recommendation to use benart tm prior to recruitment * signed informed consent exclusion criteria: * known allergy or hypersensitivity to any of the benart tm components * infection or skin disease at or around the injection site * severe inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...) * history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...) * evidence of lymphatic or venous stasis or serious blood disorders * known pregnancy or breast feeding * significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture) * individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)
model 4296 left ventricular (lv) lead study

Conditions: Heart Failure

Summary: this study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. the shape and size of this new lead may make it a good choice for patients or physicians.

this study is a prospective, multi-center, non-randomized design trial. all consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. the study design has statistical power to show safety at one-month after implant.

Eligibility criteria:
inclusion criteria: * cardiac resynchronization therapy (crt)/cardiac resynchronization therapy-defibrillator (crt-d) indications according to the european society of cardiology/american college of cardiology/american heart association (esc/acc/aha) guidelines * on optimal medical treatment according to investigator opinion * indicated for implantable cardioverter defibrillator (icd) if crt-d is implanted * patient consent * geographically stable exclusion criteria: * left ventricular (lv) lead implant attempt in last 30 days * unstable angina or acute myocardial infarction (mi) in past 30 days * coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) in past 90 days * contraindicated for transvenous pacing * heart transplant * contraindicated for less than 1 milligram (mg) dexamethasone acetate * enrolled or intends to participate in concurrent drug and/or device study which would confound results * life expectancy shorter than duration of the study * exclusion criteria required by local law * unable to tolerate urgent thoracotomy

Keywords: heart failure cardiac pacing cardiac resynchronization therapy left ventricular lead
transcutaneous supraorbital nerve stimulator versus topiramate in prevention of recurrent migraine

Conditions: Migraine, Classic

Summary: migraine has been ranked as the second most disabling neurological disorder in the worldwide. medication or nonpharmacological treatments are all reasonable options for the prevention. oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (sns) was reported to be valuable for migraine acute treatment and even the prevention. as a new nonpharmacological therapeutic method, whether sns is equivalent to topiramate is still unknown. the aim of the present study was to compare their effects in a cohort of migraine patients. after diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either sns or topiramate, and were followed up prospectively. after a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. at least the following assessments will be performed: (1) change from baseline in the number of migraine days during the 3 observing months; (2) change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of sns versus topiramate.


Eligibility criteria:
inclusion criteria: * aged 18-60 years old; * diagnosed with definite migraine (ichd-3 code 1.1 or 1.2); * at least 2 migraine attacks per month during the past 3 months; * consent to participate in the study; * no contraindications to associated treatments. exclusion criteria: * received preventive treatments during the previous 3 months; * definite other kinds of headache, especially tension-type, medication overuse and secondary headache (ichd-3 code 8.2); * severe neurological or psychiatric disorders; * severe primary systemic disorders including heart, brain, liver, kidney, and hematopoietic system; * women with pregnancy or lactation.
comparison of transaxillary and transfemoral fully-percutaneous approaches for transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: retrospective, observational study to compare the outcomes of patient receiving tavi through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.

aortic stenosis (as) is the most frequently treated heart valve disease in our society. transcatheter aortic valve implantation (tavi) was originally described through an antegrade transeptal route by cribier and colleagues in 2002. because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less challenging alternatives, with transfemoral (tf) route as primary option. nevertheless, the tf approach is not feasible or of high risk in between 15 and 35% of the patients and vascular complications have been shown to be an independent predictor of death warranting alternative access techniques for tavi. in this regard, the transapical, direct aortic, transcarotid, transcaval, and transubclavian/transaxillary (tsc) implantation routes currently serve as alternative access options. the tsc approach was initially used in selected cases. however, recent series suggest that tsc may provide better outcomes than alternative routes when tf is inadequate. additionally, same studies suggest that, as compared to tf approach, tsc tavi may present lower rate of vascular complications with comparable rates of other major outcomes despite the worse baseline profile of patients who are considered inappropriate for tf procedures. moreover, fully-percutaneous tsc approach can be successfully performed with low rate of complications as was recently proposed by some authors. however, comparisons have been based in small series of cases, most of them with former iteration of tavi devices, and a formal prospective comparison has never been performed. therefore, our aim is to gather all cases of fully-percutaneous tsc and tf approaches for tavi in spain and portugal and compare the standardized safety and efficacy endpoints through a matched analysis.

Eligibility criteria:
inclusion criteria: * patients who underwent tavi through transfemoral of transaxillary fully-percutaneous approach between january 2017 and january 2019. exclusion criteria: -

Keywords: transcatheter aortic valve implantation (tavi) transaxillary approach
a randomized, double-blind, placebo-controlled, single ascending dose study of intravenously administered bms-986168 in healthy subjects

Conditions: Tauopathies

Summary: this is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, pk, pd and immunogenicity study of bms-986168 administered by an intravenous infusion in healthy subjects.

this study, previously posted by bristol-myers squibb, has transitioned to biogen under a licensing agreement.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ecgs and clinical laboratory determinations. * body mass index (bmi) of 18.5-30 kg/m\^2, inclusive. bmi=weight (kg)/\[height(m)\]\^2. * males and females, not of child-bearing potential, ages 21 to 65 years, inclusive. female subjects must have documented proof that they are not of childbearing potential. * male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed. exclusion criteria: * women who are of childbearing potential or breastfeeding. * any significant acute or chronic medical illness. * any history of cancer within 5 years of enrollment. * any major surgery within 4 weeks of study drug administration. * donation of blood or serum \> 500 ml to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration. * participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration. * inability to be venipunctured and/or tolerate venous access. * has smoked or used tobacco products within 6 months prior to study drug administration. * recent (within 6 months of study drug administration) drug or alcohol abuse as defined in dsm iv, diagnostic criteria for drug and alcohol abuse
personalized dendritic cell vaccine pilot for high risk tnbc after neoadjuvant therapy

Conditions: Breast Cancer; Triple Negative Breast Cancer

Summary: this is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * patient has stage ii-iii er/pr less than or equal to 10% her2 negative by fish and/or ihc breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to rcb ii or iii) disease. * patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to moffitt for whole exome sequencing. * patient is 18 years of age or older. * eastern cooperative oncology group (ecog) performance status of 0-1 * patients must have adequate organ and marrow function. * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment. * women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with known active locally advanced unresectable or metastatic cancer. * patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the principal investigator (pi). * patients who have a medical issue in the opinion of the treating physician and/or pi that would make them unsuitable for pheresis. * patients who are currently receiving any other investigational agents. * patients with psychiatric illness/social situations that would limit compliance with study requirements. * pregnant women are excluded from this study.
a feasibility study of psychological first aid versus dialectal behavioral intervention in undergraduate students with suicide risk: a comparative crossover randomized controlledtrial

Conditions: Suicidal Ideation

Summary: his feasibility study aims to compare the effectiveness of psychological first aid (pfa) and dialectical behavior therapy (dbt) interventions in reducing suicide risk among undergraduate students. the study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.

suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. psychological first aid (pfa) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. conversely, dialectical behavior therapy (dbt) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. this study explores the feasibility and effectiveness of these two interventions in a university setting.

Eligibility criteria:
inclusion criteria: participants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. they must be currently enrolled in a degree program, able to provide informed consent, and proficient in english. exclusion criteria: individuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with dbt or similar therapies within the last year, and physical health conditions that could complicate participation.
eligard observational registry for patients with prostate cancer

Conditions: Cancer of the Prostate

Summary: the objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using eligard. data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with eligard, provide a platform to better identify patient segments for the therapy with eligard®. furthermore registries are the only tools to accurately capture rare adverse events.

354 patients were enrolled in this study. only 88 patients completed the study. for those patients completing the three years of data collection, 10% were considered castrate resistant and remained on eligard®. for those patients not completing 3 years of follow-up, 8.8% were considered castrate resistant and did not continue in the study.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age. * histologically confirmed diagnosis of locally advanced or metastatic prostate cancer. * patient starting an androgen deprivation therapy with eligard at 3 or 4 month treatment frequency per standard of care. * signed written informed consent. exclusion criteria: * prior adt (within 6 months). * any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol. * life expectancy less than 2 years.

Keywords: prostate cancer