Kornimate/medical-research-clean huggingface dataset:
vaccine therapy in treating patients with advanced kidney cancer

Conditions: Kidney Cancer

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer.

objectives: i. evaluate the safety of multiantigen loaded dendritic cells (dc) vaccine in patients with advanced renal cell carcinoma. ii. evaluate the immunologic response to this regimen in this patient population. iii. evaluate the clinical response to this regimen in this patient population. outline: this is a sequential cohort study. all patients undergo total nephrectomy to harvest primary tumor for vaccine preparation. patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation. patients are assigned to 1 of 4 treatment arms. arm i: patients receive vaccination with irradiated autologous tumor lysate (tuly) intradermally (id) on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells (dc) id on days 7, 14, and 21. arm ii: patients receive vaccinations as in arm i, except dc are pulsed with tumor cells. arm iii: patients receive vaccination with irradiated autologous tumor lysate (tuly) iv on day 0 followed by vaccination with multiantigen liposome loaded dc iv on days 7, 14, and 21. arm iv: patients receive vaccinations as in arm iii, except dc are treated as in arm ii. patients are followed on days 28, 42, 70, and 112. projected accrual: a total of 24 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic renal cell carcinoma evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm * over 18 * ecog 0-1 * hematopoietic: * hemoglobin at least 10 g/dl (not transfusion dependent) * platelet count at least 75,000/mm3 * wbc greater than 3,000/mm3 * hepatic: sgot/sgpt no greater than 5 times upper limit of normal (uln) * alkaline phosphatase no greater than 5 times uln * pt/ptt no greater than 1.5 times uln * bilirubin no greater than 2.5 mg/dl * renal: creatinine no greater than 2.0 g/dl * hepatitis b surface antigen negative * negative pregnancy test * fertile patients must use effective contraception * at least 4 weeks since prior immunotherapy * at least 4 weeks since prior chemotherapy * at least 4 weeks since prior radiotherapy * at least 14 days since prior acute therapy for infection exclusion criteria: * uncontrolled cns metastasis * ischemic heart disease that precludes surgery * pulmonary condition that precludes surgery * other underlying condition or allergy that would preclude study * acute viral, bacterial, or fungal infection requiring therapy hiv negative * pregnant or nursing * other acute medical problems that would preclude study * concurrent corticosteroids (oral, topical, inhaled) * prior organ allografts

Keywords: stage iv renal cell cancer recurrent renal cell cancer
carotid web and stroke registry.

Conditions: Stroke; Carotid Web

Summary: introduction: carotid web (cw) is a common cause of stroke in young patients with a high recurrence rate. the factors associated with recurrences and the appropriate treatment to prevent them are currently unknown. main objective: to compare recurrences of ischemic stroke (cerebral infarction or transient ischemic attack) in patients with cw according to the preventive treatment. secondary objectives: * to describe the frequency of recurrences in patients with stroke and cw. * to compare the risk of complications, especially hemorrhagic complications, in patients with stroke and cw according to the type of preventive treatment given. * to describe the clinical and radiological characteristics of cw and identify which are associated with recurrences. * to detect genetic polymorphisms associated with the presence of cw in stroke patients. study design: multicenter, prospective registry of consecutive cases with ischemic stroke in which a carotid web is detected between 2022 and 2024. all patients with ischemic stroke or transient ischemic attack and age \> or = 18 years, in whom a carotid web is diagnosed, will be included. demographic and clinical variables, genetic study (not mandatory), diagnostic methods of cw, reperfusion treatment and secondary prevention will be collected. during a minimum follow-up of six months, vascular events (stroke, transient ischemic accidents, cerebral hemorrhages) and treatments (antiplatelet therapy, anticoagulation, endarterectomy, endovascular therapy) will be collected. once the registry has been completed, the frequency of recurrences and the factors associated with them will be analyzed. study population: patients with ischemic stroke or transient ischemic attack in whom a carotid web is detected. it is estimated to obtain data from approximately 100 patients. variables: demographic, clinical (past medical history, stroke characteristics), radiological (diagnostic method of cw, morphological characteristics of cw), therapeutic (preventive treatment initiated) and prognostic variables will be collected. recurrences in the form of stroke or transient ischemic attack (main variable) will be collected during a minimum follow-up of six months. cerebral hemorrhages, mortality and therapeutic changes during follow-up will also be collected. ethical considerations: this is an observational registry, with no changes in the management or treatment of the patients included, and with an anonymized data registry. written informed consent will be requested from the patient or his/her representative for participation in the registry and for obtaining a blood sample for the genetic study.


Eligibility criteria:
inclusion criteria: * patients with ischemic stroke or tia and * age \> or = 18 years. * carotid web diagnosed by angioct, angiomri or arteriography. * consent to participate from patient or representative exclusion criteria: * no informed consent obtained
benefit of singing in the care of premature children undergoing screening for retinopathy of prematurity in the neonatology and neonatal resuscitation unit of the dijon university hospital

Conditions: Prematurity; Eye Fundus

Summary: as part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. this examination seeks to establish whether the infant has retinopathy of prematurity. this disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time. the purpose of this study is to assess the discomfort caused by the screening in order to improve practices. to do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination. to do this, the participating children will be divided into 2 groups: * the "singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time * control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) the child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.


Eligibility criteria:
inclusion criteria: * infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth weight of less than 1250g * infant in whom a first screening examination (fundus) for retinopathy of prematurity (i.e. around 32 wa) must be carried out according to term by hospital protocol * infant hospitalized in the neonatal paediatrics and intensive care unit of the dijon university hospital * infant affiliated to the national medical insurance system * oral agreement of one of the two parents exclusion criteria: * infants with contraindications to the use of algopedol® 24% sugar solution, neosynephrine 2.5% mydriatic eye drops for pupillary dilatation, mydriaticum 0.5% mydriatic eye drops for pupillary dilatation and oxybuprocaine analgesic eye drops * infant with known deafness and no hearing aid * premature infant in critical condition * infant with hemodynamic and clinical instability making it impossible to perform the fundus examination because of the risk of decompensation * parent refuses the videotaping
ct portography in grading of liver cirrhosis

Conditions: CT Portography Grading of Liver Cirrhosis

Summary: esophageal variceal bleeding and hepatic encephalopathy are serious complications of hepatic cirrhosis, and they may lead to high mortality rate and severely threaten life quality of the patients

the occurrence and development of esophageal variceal bleeding and hepatic encephalopathy are closely related with portal vein system diseases, such as collateral circulation of portal hypertension and portal vein thrombosis. the prevention of esophageal variceal bleeding and hepatic encephalopathy in hepatic cirrhosis has become a hot spot in clinical practice. three-dimensional reconstruction of images obtained by multi-slice spiral computed tomography portography (msctp) is clear, realistic, and accurate. it can directly and quickly display all anatomical information of collateral portal vein system, and is recognized as a good method to display blood vessels

Eligibility criteria:
inclusion criteria: * patients with cirrhosis and\\or portal hypertension diagnosed by; laboratory or radiological parameters. exclusion criteria: * patients with ligation, disconnection or shunting of esophageal varices. patients with combined hepatic malignant tumor patients with splenectomy. patients with renal dysfunction or iodine allergy.
phase 3 study of sk-1403

Conditions: Secondary Hyperparathyroidism

Summary: to evaluate the efficacy and safety of treatment with sk-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility criteria:
inclusion criteria: * serum pth\>240 pg/ml at the screening * serum corrected ca≧8.4 mg/dl at the screening * stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration exclusion criteria: * primary hyperparathyroidism * severe liver disease * severe cardiac disease * history or family history of long qt syndrome * malignant tumor * uncontrolled diabetes mellitus * uncontrolled hypertension * history of severe drug allergy
chronic total occlusive lesions cmr study

Conditions: Chronic Total Occlusion; Image; Revascularization

Summary: this registry will include consecutive patients presenting with at least one chronic total occlusion on coronary angiogram who will be treated by percutaneous coronary intervention in our center. all patients will undergo a non-invasive assessment for myocardial ischemia/viability using cardiac magnetic resonance (cmr) prior to revascularization therapy. follow up cmr will be repeated in all participants after three months and one year. additionally, clinical outcomes and quality of life will be evaluated at baseline and at follow-up. primary objective of this study is to investigate the the reduction in ischemia (as evaluated by follow-up cmr) and the severity of angina according to clinical evaluation (including seattle angina questionnaires \[saq\], canadian class score\[ccs\] and 6-mins walking test).


Eligibility criteria:
inclusion criteria: * age \> 18 years * presence of at least one untreated cto at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists\], with timi 0 in the distal segment and at least 3 months old * patient has a clinical indication to perform cto pci * willing to participate and able to understand, read and sign the informed consent document. exclusion criteria: * cmr contraindications * contraindications to adenosine or dobutamine * severe chronic kidney disease (estimated glomerular filtration rate \[egfr\] \ 2.5 mg/dl)

Keywords: chronic total occlusion cardiac magnetic resonance revascularization
efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (psa) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic dmards).

the total maximum study duration, including the screening period was up to 76 weeks. at baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): group 1 (secukinumab 300 mg) or group 2 (adalimumab 40 mg). in order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. secukinumab (300 mg) was available in 2 x 1.0 ml pre-filled syringes (pfs) and adalimumab was available in 1 x 0.4 ml pfs. placebo (1.0 and 0.5 ml pfs) was also available. secukinumab 300 mg s.c injection (2 x 1 ml pfs) was administered at baseline, weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to week 48. adalimumab 40 mg (1 x 0.4 ml pfs) was administered at baseline followed by dosing every 2 weeks until week 50.

Eligibility criteria:
key inclusion criteria: * diagnosis of psa classified by caspar * rheumatoid factor and anti-ccp antibodies negative * diagnosis of active plaque psoriasis, with at least one psoriatic plaque of \>= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis * inadequate control of symptoms with nsaids * inadequate control of symptoms with a conventional dmard. key exclusion criteria: * pregnant or nursing women * evidence of ongoing infectious or malignant process * previous exposure to any biologic drug for psoriatic arthritis or psoriasis * subjects taking high potency opioid analgesics * ongoing use of prohibited psoriasis treatments/medications * previous treatment with any cell-depleting therapies including but not limited to anti-cd20 investigational agents.

Keywords: psoriatic arthritis secukinumab adalimumab monoclonal antibody caspar
tocilizumab for relapsing polychondritis

Conditions: Relapsing Polychondritis

Summary: this is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and tnf inhibitors. tolerability, and efficacy of the drug, tocilizumab will be monitored by clinical assessment and bloodwork.


Eligibility criteria:
inclusion criteria: * a single patient with unremitting inflammatory relapsing polychondritis exclusion criteria: * as this is a study in a single patient, there are no exclusions

Keywords: relapsing polychondritis unremitting inflammation il6
study to investigate the safety, tolerability and pharmacokinetics of azd1940

Conditions: Low Back Pain

Summary: a phase i, multi-centre, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of azd1940, including an interaction study, after administration of oral multiple ascending doses in adult subjects with chronic low back pain


Eligibility criteria:
inclusion criteria: * a diagnosis of chronic low back pain according to quebec task force class 1-3 and an average pain intensity score of 3-9 on nrs(0-10) during the past week. * clinical normal physical findings, including blood pressure, pulse rate \> 45bpm, ecg (with normal qtcf interval \<450msec and without any additional risk factors for torsades de pointes) and laboratory assessments, as judged by investigator * body mass index (bmi) ≥18 to ≤32 kg/m2 inclusive and body weight ≥50 to ≤100 kg exclusion criteria: * history of somatic disease/condition which may interfere with the objectives of the study, with the exception of chronic low back pain * history of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder * clinically significant illness with the exception of chronic low back pain

Keywords: pain safety chronic low back pain
study to evaluate the efficacy and safety of eg-009a compared to dex in patients with covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: to study signals of efficacy and safety of a currently available dosage form (im) of eg-009a in reducing the severity of respiratory disease in patients hospitalized with sars-cov-2 virus.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under international conference on harmonization (ich) e6(r2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to \<18, where locally and nationally approved) prior to performing study procedures 2. patient is aged at least 18 years, enrollment of patients \< 65 years old will be limited to 20% of the total with the first 50% of enrollment conducted solely among those patients ≥ 55 years old. 3. patient has sars-cov-2 pneumonia from covid-19 infection of moderate to serious severity (who ordinal scale for clinical improvement score of 4 or 5) 4. patient has covid-19 symptoms ≤ 10 days and at least 1 of the following: * radiographic infiltrates by imaging (chest x-ray, ct scan, etc.) * o2 saturation (spo2) ≤ 94% on room air * requiring supplemental o2 (patients on hfno ≤ 20 l/min with fio2 \< 0.5 are allowed), but not requiring mechanical ventilation. note: patients admitted with immediate need for mechanical ventilation are of a severity too critical for inclusion into this protocol. patients who are already in the hospital and have been removed from mechanical ventilation are not eligible. exclusion criteria: 1. patient has sars-cov-2 infection of severity ≥ 6 on covid-19 who ordinal scale for clinical improvement or for those subjects who have a who ordinal scale for clinical improvement score of 5, nasal intermittent positive pressure ventilation (nippv) or requiring hfno \> 20 l/min with fio2 ≥ 0.5 will be exclusionary. 2. patient is currently receiving extracorporeal membrane oxygenation, nitric oxide therapy, or high-frequency oscillatory ventilation 3. patient is unlikely to survive for \> 24 hours from randomization, in the opinion of the investigator 4. patient has a history of chronic oxygen use or any pre-existing respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 5. patient has a history of venous thromboembolism, dvt, or pulmonary embolus 6. has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's pk, pd, or biological activity (if known), whichever is longer, prior to the first dose of study drug in this study or is currently participating in another clinical study.

Keywords: covid 19
absorption, metabolism and excretion of 14c-olorofim in man

Conditions: Invasive Fungal Infections

Summary: single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. it is planned to enrol 6 healthy male subjects in cohort a (standard mass balance and metabolite profiling cohort) and up to 6 subjects in cohort b (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg \[14c\]-olorofim oral solution containing approximately 3.7 mbq (100 µci).

subjects will be screened up to 28 days prior to dosing and eligible subjects will be admitted to the clinical research unit (cru) on the day prior to dosing (day-1). each subject will be dosed on the morning of day 1 after an overnight fast. cohort a: subjects will remain resident in the cru up to 336 h post-dose (day 15), with whole blood, plasma, urine and faeces collected throughout this period. there may be up to two further 24 h residency periods (days 21 to 22 and days 28 to 29) for collection of plasma, urine and faeces if discharge criteria are not met. cohorts b1 and b2: subjects will remain resident in the cru up to 96 h post-dose (day 5) for collection of plasma, urine, faeces and bile. subjects will return for a short follow-up visit on day 10. cohort b1 subjects will have bile sampling up to 6 h postdose and cohort b2 subjects will have bile sampling up to 12 h postdose. cohort b divided into 2 sub-cohorts for logistical reasons only.

Eligibility criteria:
inclusion criteria: * healthy males age 18 to 55 years of age with body mass index of 18 to 30 kg/m2 (inclusive), and a body weight of 50 to 100 kg (inclusive). * subjects must be in good health as determined by a medical history, physical examination, vital signs, 12-lead ecg and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable). * must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day). exclusion criteria: * subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator * subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration * subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration * subjects who have received any medications, including st john's wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration * current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the 3 months prior to check-in. * radiation exposure, including that from the present study exceeding 1 msv in the last 12 months or 5 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study.