Kornimate/medical-research-clean huggingface dataset:
assessment of the uro-c cystoscope for use in diagnostic cystoscopy procedures

Conditions: Bladder Tumor

Summary: this is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. the primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.

a new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. the cystoscope, named the uro-c, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (lcd) monitor. cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used. this is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. the primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.

Eligibility criteria:
inclusion criteria: 1. otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and 2. ambulatory and able to undergo routine cystoscopy in the lithotomy position. exclusion criteria: 1. history of prior bladder/urethral surgery other than turbt; or 2. history of interstitial cystitis; or 3. presence of urinary tract infection (uti); or 4. gross hematuria; or 5. history of pelvic radiation therapy; or 6. procidentia; or 7. unable to read, understand, and/or provide a ranking of pain level during the procedure; or 8. unable or unwilling to provide consent to participation in the study.
68ga-dota-tate pet/ct imaging in nets

Conditions: Neuroendocrine Tumors

Summary: this clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the pet radiotracer 68ga-dota-tate, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. it is a single-center study, but with recruitment across all canada. the trial is prospective, non-randomized, open-label and with no control group. the superiority of this procedure over the former standard-of-care (octreoscan) was already established in previous and numerous studies across the world. as such, the current trial aims to gather data to further support the implementation of 68ga-dota-tate as the new standard-of-care for neuro-endocrine tumors (net).


Eligibility criteria:
inclusion criteria: 1. clinical requisition for a 68ga-dota-tate pet/ct signed by a referring doctor 2. patients with suspected or proven tumors expressing somatostatin receptors 3. informed consent by patient (or parents if patient is less than 18 years of age) exclusion criteria: 1. \*pregnancy (not an absolute exclusion). see below\*. 2. patient refusal to participate. 3. prior severe anaphylactic reaction to dota-tate or somatostatin analogs. * in the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. in this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. the conditions to decide whether to include the patient would be: * severe medical condition involving the life of the pregnant woman and/or the fetus; * existing treatments that are ineffective or may present toxicity to the woman and/or fetus; * high clinical suspicion of a somatostatin receptor overexpressing tumour; * negative, indeterminate or contraindicated first-line imaging tests; * therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery; * documented discussion with the treating team and the patient; * patient agrees.

Keywords: 68ga-dota-tate pet imaging pragmatic study neuroendocrine tumors (net)
improving blood lipid management in symptomatic intracranial atherosclerotic stenosis on clinical outcome

Conditions: Intracranial Artery Stenosis

Summary: sicasblm is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (ldl-c\>1.8mmol/l) without endovascular therapy.

sicasblm aims to determine the effectiveness of conventional lipid management combined with pcsk9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (ldl-c\>1.8mmol/l) without endovascular therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment 3. low density lipoprotein cholesterol \> 70mg/dl (1.8mmol/l) 4. receive 3t magnetic resonance angiography or multi-mode mr (high resolution is required), angiography can be included, and images for analysis can be obtained. 5. lipid-lowering indications of statins 6. signed an approved informed consents exclusion criteria: 1. contraindications to statins 2. there are contraindications to mri examination or cannot accept mri examination 3. stenosis caused by vasculitis, arterial dissection and moyamoya disease 4. patients with active bleeding or obvious bleeding tendency 5. severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating 6. uncontrolled severe diabetes and hypertension 7. other conditions inappropriate for inclusion judged by investigators

Keywords: symptomatic intracranial atherosclerotic stenosis stroke blood lipid management pcsk9 inhibitors
comparison of a new semi-invasive monitoring system with transpulmonary thermodilution in cardiac surgery patients

Conditions: Cardiac Output, High

Summary: the aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. the investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.

a recently introduced semi-invasive monitoring system consists of an algorithm that provides beat-to-beat measurement of ci by analysis of the arterial blood pressure tracing. by using the autocalibration mode this software calculates the individual aortic compliance and systemic vascular resistance by taking patient data like age, height, weight and gender into account. after estimation of beat-to-beat stroke volume, a subsequent multiplication by the heart rate delivers pulse contour cardiac index. furthermore, this device offers the opportunity for external calibration by a reference technique, e.g. pulmonary or transpulmonary thermodilution. the aim of the present study was to investigate the accuracy and trending ability of autocalibrated semi-invasive ci by a new arterial waveform analysis compared with transpulmonary thermodilution before and after cardiopulmonary bypass (cpb).

Eligibility criteria:
inclusion criteria: patients undergoing elective coronary artery bypass grafting personal declaration of consent to the study exclusion criteria: patients \<18 years of age a left ventricular ejection fraction ≤0.5 emergency procedures patients with haemodynamic instability requiring continuous pharmacologic support patients with intracardiac shunts severe aortic-, tricuspid- or mitral stenosis or insufficiency mechanical circulatory support.

Keywords: cardiac output monitoring semi-invasive pulse contour analysis transpulmonary thermodilution
muscle tenderness and hardness in migraine patients

Conditions: Migraine Disorders; Muscle Tenderness; Headache Disorders, Primary; Nervous System Diseases; Headache, Migraine

Summary: the aim of the study is to examine symptomatology, quantitative sensory test (qst) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

migraine patients exhibit different symptomatology and responses to treatment. for example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.furthermore the response to treatment differs between patients. differences in symptomatology, qst parameters and muscle stiffness can be used to subdivide and phenotype migraine patients. the investigators are examining migraine patients with: a semistructured interview, quantitative sensory testing (cold pain threshold, heat pain threshold and pin prick), muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. all tests are performed the same day

Eligibility criteria:
inclusion criteria: * migraine patients from the danish headache centre. migraine classified using the international classification of headache disorders (ichd3) criteria. exclusion criteria: * pregnant or lactating women * musculoskeletal injuries in the neck or shoulder * other primary headache disorders than migraine or tension type headache * on the time of examination: migraine free for at least 48 hours * on the time of examination: haven't trained the upper body for at least 48 hours * on the time of examination: haven't used painkillers for at least 48 hours healthy controls: exclusion criteria: * pregnant or lactating women * musculoskeletal injuries in the neck or shoulder * migraine disorders * 1. degree relatives with migraine disorders * over 1 day of tension type headache a month. * on the time of examination: haven't trained the upper body for at least 48 hours * on the time of examination: haven't used painkillers for at least 48 hours
enact: a study of enx-101 as adjunctive treatment in patients with focal seizures

Conditions: Focal Epilepsy

Summary: the enact trial is designed to evaluate the efficacy and safety of enx-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 75 years, inclusive, at screening 2. diagnosed with focal (partial onset) epilepsy according to the international league against epilepsy (ilae) 2017 classification of epilepsy, as confirmed by the epilepsy study consortium 3. able to provide an imaging study(ies) \[magnetic resonance imaging (mri) scan strongly preferred yet computed tomography (ct) acceptable\] obtained within the previous 10 years that can rule out a progressive cause of epilepsy 4. during the 3 months (84 days) immediately prior to screening: * ≥ 3 observable focal onset seizures per 28-day period * \<10 seizures per day * any seizure-free interval no more than 21 days in length, 5. during the 8-week baseline period prior to day 1: * ≥ 6 observable focal onset seizures * \< 10 seizures per day * no seizure-free interval of ≥ 21 days, 6. has been treated with antiseizure medications (asms) ≥ 2 years and currently being treated with: * one to 4 asms at stable doses for at least 28 days before screening (not including the rescue medication) * dose adjustments not expected during study exclusion criteria: 1. eeg shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave) 2. has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type 3. has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of lennox-gastaut syndrome 4. has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to screening 5. has history of psychogenic non-epileptic seizures 6. has history of status epilepticus within two years prior to screening 7. treatment of epilepsy with asm was initiated \< 2 years prior to screening 8. ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to screening 9. had epilepsy surgery for tissue resection \< 1 year prior to screening or radiosurgery \< 2 years prior to screening 10. had vagus nerve stimulation (vns), deep brain stimulation (dbs), responsive neurostimulator system (rns), or other neurostimulation for epilepsy device implanted or activated \< 1 year prior to screening, stimulation parameters have been stable for \< 3 months, or battery life of unit not anticipated to extend for duration of trial 11. initiated dietary therapy for epilepsy (e.g., ketogenic diet) \< 3 months prior to screening
cp-675,206 versus either dacarbazine or temozolomide in patients without prior therapy

Conditions: Melanoma

Summary: this is a phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. the primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive cp-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Eligibility criteria:
inclusion criteria: * surgically incurable melanoma, either stage iv or iiic with n3 status for regional lymph nodes and in-transit or satellite lesions. * serum lactic acid dehydrogenase (ldh) \<= 2 x uln * ecog performance status of 0 or 1 exclusion criteria: * received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or gm-csf) or with vaccines after complete resection of melanoma. * history of brain metastases
development and evaluation of a web-based diet quality screener for vegans - belgium

Conditions: Healthy

Summary: the primary objective of this study is to assess the construct validity and criterion validity for associations of the veganscreener with nutrient intakes from reference methods and associations with biomarkers of dietary intake. the investigators hypothesize that the screener is a valid tool to assess diet quality in the vegan population. the study will assess construct validity by testing whether the measure relates as it should to other measures (e.g., age, gender, education, socioeconomic status differences). the investigators will assess concurrent and predictive validity (types of criterion validity) by evaluating associations and agreement between 'gold standards', such as diet records, biomarkers, and multi-metabolite signatures of intake. the investigators will examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans is associated with a more favourable profile among vegans, for example, a lower blood pressure. this study is part of the european veganscreener consortium.


Eligibility criteria:
inclusion criteria: 1. self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming any dietary animal products more often than once/month, honey excluded) 2. self-reported omnivores. consuming on average daily (at least 5 times/week) meat/meat products. 3. age 18 to 65 years (1:1 ratio 18-35,99 and 36-65) 4. males and females (1:1 ratio) exclusion criteria: 1. self-identified pescatarians (excluding all meat, except for fish/seafood) and reductarians/flexitarians (intentionally reducing intake of animal-based products) 2. history of a disease known to affect intermediary metabolism (e.g., any diabetes on treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.) 3. bmi\>30 kg/m2 4. history of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic pancreatitis, other malabsorption, etc.). 5. pregnant or breastfeeding females.
assessment of the minimal residual disease in dlbcl from cell-free circulating dna by ngs

Conditions: Non Hodgkin Lymphoma

Summary: this is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfdna of a cohort of patients with diffuse large b-cell non-hodgkin lymphomas (dlbcl) before, during and after standard treatment

to determinate and to describe the clonal evolution, 30 dlbcl cases with available matched tumor dna and plasma will be collected and analyzed by routinely applicable next generation sequencing (ngs) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.

Eligibility criteria:
inclusion criteria: * age up to 18 years old * with a diagnosis formally established of dlbcl or transformed straightaway follicular lymphoma or 3b grade follicular lymphoma or burkitt-like lymphoma * eligible to a treatment by immunochemotherapy like r-chop, r-acvbp or r-chop like * first line of treatment * being able to benefit from standard extension assessment ( fluorine-18 fluorodeoxyglucose positron emission tomography (18f-fdg-pet) and bone marrow biopsy with a bone marrow aspiration) * written informed consent * tumor biopsy used for diagnosis available exclusion criteria: * patient who cannot receive polychemotherapy like r-chop, r-acvbp, or r-chop like * patient who cannot benefit from standard extension assessment and follow-up by with fluorine-18 fluorodeoxyglucose positron emission tomography (18f-fdg-pet) * pregnant or breast-feeding woman * guardianship, curatorship * patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons

Keywords: minimal residual disease, ngs, nhl, dna sequencing
adipose tissue & uremia

Conditions: Chronic Kidney Disease - Stage V

Summary: many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (ckd). however, to date, the underlying mechanisms of these disturbances remain elusive. many in vitro studies have demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic environment. in good agreement, several animal experiments have reported that chronic kidney disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid redistribution. the goal of this protocol is to collect and study structural and metabolic properties of white adipose tissue in ckd stage v patients to evidence adipose tissue dysfunction associated with ckd. the primary outcome measure will be the cellularity of the adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene expression profile using microarray and metabolic properties of adipose tissue (i.e. lipogenesis). to this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed ckd stage v patients, matched for age, gender and body mass index (bmi) will be recruited at the departments of nephrology or urology of lyon university hospital (lyon, france). the biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective urologic surgery (i.e. peritoneal dialysis catheter for ckd patients and radical prostatectomy for non ckd patients).


Eligibility criteria:
inclusion criteria: ckd (chronic kidney disease) and non-ckd patients: * at least 18 years of age * able and willing to provide informed consent * male gender * normal fasting glucose (less than 6 mmol/l ) * no evidence of significant concurrent illness * bmi \<30 kg/m2 * non acidotic (bicarbonate \>20 mmol/l) * normal coagulation profile ckd patients: • egfr (estimated glomerular filtration rate)\< 25 ml/min/m2 before the beginning of renal suppletion therapy non-ckd patients: • egfr \>50 ml/min/m2 exclusion criteria: * a known diagnosis of diabetes mellitus * enrolled in a other study that may confound results of this study. * have been treated with: corticosteroids or insulin or oral diabetic medications within 8 days prior to study entry * unwilling and/or not able to give written consent * patient with active systemic bacterial, viral or fungal infections

Keywords: white adipose tissue chronic kidney disease uremia adipocytes
short, animated storytelling (sas) for addiction stigma reduction

Conditions: Social Stigma Towards People With Addiction

Summary: stigma towards people with addiction is a well-documented problem that negatively impacts help-seeking, treatment and recovery. social contact with people recovering from addiction can promote empathy and reduce stigma, but social contact is difficult to scale. short, animated storytelling (sas) is a novel health communication approach that scales easily because it can leapfrog barriers associated with language, culture, literacy and education levels. this study will investigate if a sas video intervention can be used to reduce stigma, boost optimism and hope, and increasing empathy towards people with addiction. the study will also explore mechanisms of action of sas interventions, by measuring the contribution of sound design to the effect of the intervention.


Eligibility criteria:
inclusion criteria: * adults with basic english proficiency between the ages of 18-49 exclusion criteria: * none
d2-epg study: evaluation of new sensing circuitry and capture management

Conditions: Heart Diseases

Summary: this is an acute, prospective, multi-center, non-randomized, investigational device exemption (ide) clinical study.

the purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a ventricular capture management feature in subjects with implantable cardioverter defibrillator (icd) leads connected to an external pacemaker/defibrillator.

Eligibility criteria:
inclusion criteria: * patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt) device * patients must have or receive medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement. exclusion criteria: * patients who have 3rd degree heart block, as assessed by the investigator * patients who have a mechanical tricuspid heart valve * patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device

Keywords: sensing capture management heart failure icd indication