Kornimate/medical-research-clean huggingface dataset:
nivolumab and da-epoch-r in pediatric primary mediastinal (thymic) large b-cell lymphoma

Conditions: Primary Mediastinal (Thymic) Large B-cell Lymphoma; Children; Nivolumab

Summary: addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (da-epoch-r) may improve outcome in children with primary mediastinal large b-cell lymphoma

a total of 6 blocks of nivolumab+da-epoch-r are planned for all patients regardless of stage and other risk factors. nivolumab 40 mg (day 2), rituximab 375 mg/m2 (day 1) and prednisolone 60 mg/m2 (days 1-5) are administered at constant unchangeable doses. other drugs are administered at starting doses (etoposide 50 mg/m2 (days 1-4), doxorubicin 10 mg/m2 (days 1-4), vincristine 0,4 mg/m2 (days 1-4) and cyclophosphamide 750 mg/m2 (day 5). these starting doses are adjusted further according to standard principles of da-epoch-r.

Eligibility criteria:
inclusion criteria: * age from 0 years to 17 years 11 months * established on the basis of histological and immunohistochemical studies, the diagnosis of pmlbl (the presence of programmed death-ligand on tumor cells is not necessary) * lack of specific therapy for lymphoma * signed informed consent exclusion criteria: * age \>18 * history of specific therapy for lymphomas. * drug intolerance
the use of antibiotic sinonasal rinse after sinus surgery

Conditions: Chronic Rhinosinusitis

Summary: double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.


Eligibility criteria:
inclusion criteria: * chronic rhinosinusitis * undergoing endoscopic sinus surgery exclusion criteria: * age under 18 * documented adverse reaction to mupirocin
long-term efficacy and safety of aflibercept intravitreal injections for the treatment of diabetic macular edema

Conditions: Clinically Significant Diabetic Macular Edema

Summary: the endurance trial is a phase iv open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year vista dme (vgft-od-1009) endpoint. subjects will be treated with intravitreal aflibercept injections pro re nata (prn) based on the presence of cr-dme (clinically relevant-dme). in addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days

the endurance3 trial is a phase iv open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year vista dme (vgft-od-1009) endpoint. subjects will be treated with intravitreal aflibercept injections pro re nata (prn) upon the presence of cr-dme (clinically relevant dme) as noted by oct (optical coherence tomography) imaging and examination. in addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Eligibility criteria:
inclusion criteria: * enrolled and completed vista dme (vgft-od-1009) clinical trial * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent * enrollment in the trial within 12 weeks of trial activation exclusion criteria: * prior treatment with anti-vegf therapy in the study eye within 28 days of baseline * pregnant or breast-feeding women * sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study
impact of mobile phone texting service to support weight loss

Conditions: Obesity

Summary: this study evaluates the efficacy of a mobile telehealth short message service as a facilitator for weight management. half of the participants will receive a standard care weight management group intervention, while the other half will receive daily text messages via their mobile phone to help facilitate weight loss. it is hypothesized that the intervention group receiving text messages will be as successful as the control group at achieving weight loss over a 3-month period.

obesity, a chronic progressive disease, has become a major public health concern due to its increasing prevalence and association with many adverse health conditions including type 2 diabetes, many cancers and heart disease. the number of individuals requiring weight management intervention is increasing necessitating the need to explore other initiatives. developments in health technology are growing in popularity and there is increasing evidence that this type of intervention for obesity can significantly improve clinical outcomes. mobile phones are a popular means of communication that provide a convenient, inexpensive means to deliver a health technology intervention.short message service (sms) by mobile phone has the potential to serve as an intervention medium to promote weight loss that is accessible and easy to use.

Eligibility criteria:
inclusion criteria: * body mass index \> 35kg/m requiring to lose weight for an operation or having a co-morbidity including diabetes, osteoarthritis, high cholesterol, asthma, heart disease, high blood pressure or sleep apnoea or with a body mass \>40kg/m with no co-morbidities. * own a mobile phone * have the ability to use short message service * have access to weighing scales * mentally capable of informed consent * have the ability to read and speak english exclusion criteria: * uncontrolled hypothyroidism * poorly controlled psychiatric illness * current alcohol or drug abuse * learning disability * do not own a mobile phone * do not have access to weighing scales * does not have the ability to read or speak english
phage safety cohort study

Conditions: Prosthetic Joint Infection; Severe Infection

Summary: this cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.

all potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the hcl pharmacovigilance center. in addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.

Eligibility criteria:
inclusion criteria: * patient 18 years of age or older with a serious infection treated at crioac lyon by phage therapy * patient who did not object to participating in the study * patients ayant un poids minimum de 46kg exclusion criteria: * patients under guardianship/curatorship * patients deprived of liberty * pregnant or breastfeeding women

Keywords: phage adverse event severe infection compassionate treatment
a study to evaluate the pharmacokinetics, safety, and tolerability of upadacitinib in pediatric subjects with polyarticular course juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis (JIA)

Summary: this is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. this study consists of three parts: part 1 is multiple-cohort study that consists of two sequential multiple dose groups. participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in part 2. part 2 is open-label, long term extension study to evaluate safety and tolerability. part 3 is an additional safety cohort to evaluate long-term safety and tolerability.


Eligibility criteria:
inclusion criteria: * participant have total body weight of 10 kg or higher at the time of screening. * participant diagnosed with pcjia (rheumatoid factor-positive or rheumatoid factor-negative polyarticular jia, extended oligoarticular jia, or systemic jia with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular jia: \ 4 joints thereafter). * participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (lom) plus pain on motion and/or tenderness with palpitation, with lom present in at least three of the active joints. * if receiving methotrexate (mtx), have been taking mtx for at least 12 weeks immediately before and including study day 1 on a stable dose of \<=20 mg/m2 for at least 8 weeks before and including study day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care. * if on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including study day 1. exclusion criteria: * participant with diagnosis of enthesitis-related arthritis (era) or juvenile psoriatic arthritis (jpsa). * participant have prior exposure to jak inhibitor.

Keywords: upadacitinib abt-494 polyarticular course juvenile idiopathic arthritis (pcjia)
triple blockade of the renin angiotensin aldosterone system in diabetic (type 1&2) proteinuric patients

Conditions: Microalbuminuria; Macroalbuminuric Diabetic Nephropathy; Diabetes; Proteinuria; Albuminuria

Summary: study hypothesis: reduction in albuminuria has been shown to decrease progression of diabetic nephropathy. in diabetic nephropathy patients treated with maximal antihypertensive doses with dual raas blockade (total daily dose valsartan 320 mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent albuminuria reflects further additional raas activation. microvascular renal disease due to increased raas activation may be more effectively treated with triple blockade by the addition of a direct renin inhibitor (dri) aliskiren.


Eligibility criteria:
inclusion criteria: * macroalbuminuria \> 300mg/g * microalbuminuria 30-300mg/g * stable on max dose of an ace-i or arb (can also be titrated to max dosage of ace-i and arb and stable on those doses for at least 2 weeks) * blood pressure \<130/80 mm hg at time of enrollment * diabetic either type 1 or 2 exclusion criteria: * gfr \<60 m/min * potassium \> 5mg/dl at time of enrollment * pregnant * history of angioedema * ace-i cough * allergic to arb, ace-i, dri * a1c \> 9%
dose-finding safety study of biib014 in combination with levodopa in moderate to late stage parkinson's disease

Conditions: Parkinson's Disease

Summary: the main purpose of this study is to determine the safety of biib014 and how well biib014 is tolerated when given at different doses to patients with moderate to late-stage parkinson's disease who are also taking the parkinson's medication, levodopa (l-dopa). this study will also explore: 1. the pharmacokinetics of biib014 in parkinson's patients who are also taking l-dopa (this will be done by measuring the levels of biib014 in the blood at several different times during the study), and 2. the activity of biib014 when given to parkinson's patients who are also taking l-dopa (this will be done by performing different parkinson's disease assessments during the study to examine change in waking off time, change in time with troublesome dyskinesia, change in unified pd rating scale (updrs) scores, and clinical global improvement). patients who enter this study will be randomly assigned to receive either biib014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking. the study will be divided into 2 parts: * part a: a, rapid, sequential cohort, dose escalation to establish mtd, followed by * part b: a parallel-group exploration of the two highest tolerated doses versus placebo. note: as part a of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to part b.


Eligibility criteria:
inclusion criteria: * must carry a diagnosis of idiopathic pd according to uk parkinson's disease society brain bank clinical diagnostic criteria, and be hoehn \& yahr stage ii to iv (inclusive) when off. * must be on a stable dose of l-3,4-dihydroxyphenylalanine (l-dopa)/carbidopa or l-dopa/benserazide for at least 4 weeks prior to enrollment. * except for l-dopa and certain allowed dopamine agonists, must not be receiving any other pd medications. (current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment). * some subjects must demonstrate a definite end of l-dopa dose wearing off (at least 2 hours off time per waking day) and must be able to keep accurate patient diaries of pd activity. major exclusion criteria: * a mini mental state examination (mmse) score \<26. * history or clinical features consistent with an atypical parkinsonian syndrome. * any significant non-parkinson's central nervous system disorder. * any significant axis i psychiatric disease from the diagnostic and statistical manual of mental disorders (dsm). * any previous surgical intervention for parkinson's disease. * history of certain malignancies. * history of severe allergic anaphylactic reactions to any drug. * clinically significant baseline electrocardiogram (ecg). * orthostatic hypotension. * hba1c \>7.0%

Keywords: moderate to late stage parkinson's disease
the effect of high protein diets on weight loss and lean muscle mass in patients awaiting bariatric surgery

Conditions: Obesity, Morbid

Summary: all patients in cmdhb eligible for bariatric surgery are given a weight loss goal prior to surgery. it is unknown what the most effective diet is to lose weight, while still preserving muscle mass. the diet must also be acceptable and adhered to by patients. the aim of this study is to find out if a diet that is higher in protein and lower in carbohydrate than the standard ministry of health guidelines will have a greater effect on weight loss, preservation of lean muscle mass, surgical recovery score, adherence and acceptability.

this pilot project is a randomised control trial with 24 participants. diets will consist of 1200 and 1500kcals for females and males, respectively. the control arm is to receive the ministry of health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%). the intervention arm is to be lower in carbohydrate (40%), higher in protein (30%), moderate fat (30%). participants will be required to continue the diet for at least 8 weeks while waiting for surgery. at baseline and at eight weeks their weight, hip circumference, waist circumference, neck circumference and body composition measurements will be taken. during their prescribed diet they are required to fill out a 3-day diet record. at the end of eight weeks the participants will perform a twenty-four hour urine collect for urea and creatinine. this will help determine adherence. post-surgery (21-28 days) they will be required to complete a surgical recovery questionnaire and the above measurements will be recorded again. these data will be collected over a period beginning january 2015. it is expected that the intervention arm will have greater weight loss and better preservation of muscle mass leading to a better surgical recovery score. however because the intervention requires a higher intake of protein this may have an effect on adherence and acceptability in these participants. there are no known adverse effects of the intervention diet in the short term.

Eligibility criteria:
inclusion criteria: * participants in this study will be patients eligible for bariatric surgery under cmdhb. these participants must have a bmi greater than 35kg/m2 with co-morbidities or a bmi greater than 40kg/m2. exclusion criteria: * patients will be excluded from study if they do not attend surgeon or dietitian appointments. to be included in this study patients must be english speaking and weigh under 200kg.
benign acute pericarditis: brief versus longer treatment using aspirin

Conditions: Pericarditis

Summary: treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. aspirin or an nsaid at medium to high dosages is the mainstay of treatment. optimal length of treatment is not established. pericardite is a french multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. it is a non inferiority trial. exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease). primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities. secondary endpoint is: 6-month recurrence.


Eligibility criteria:
inclusion criteria: * age over 18 * first episode of acute pericarditis * chest pain lasting less than 24 hours exclusion criteria: * contraindication to aspirin * previous history of atypical chest pain * previous history of connective tissue disease, tuberculosis, recent mi, auto immune disease, neoplastic disease, thoracic trauma, previous thoracic surgery, antiplatelet routine treatment, anticoagulation

Keywords: acute pericarditis treatment recurrence
effects of vitamin c on hyperoxia-induced reduction of retinal blood flow

Conditions: Ocular Physiology; Regional Blood Flow

Summary: high arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly related to an interaction between reactive oxygen species and endothelium-derived vasoactive factors. vitamin c is a potent antioxidant capable of reversing endothelial dysfunction due to increased oxidant stress. vitamin c appears to have vasodilatory properties, but the underlying mechanisms are not well understood. in the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could be diminished by vitamin c. ocular blood flow will be determined by non-invasive methods, including laser doppler velocimetry and the zeiss retinal vessel analyser.


Eligibility criteria:
inclusion criteria: * men aged between 19 and 35 years, nonsmokers * body mass index between 15th and 85th percentile (must a 1991) * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 3 dpt. exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks

Keywords: vitamin c retinal blood flow intraocular pressure retinal vessel diameter
ropivacaine block alone or with perineural or systemic dexamethasone for pain in shoulder surgery

Conditions: Shoulder Injury

Summary: pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. no study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. this study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. patients will be recruited sequentially and assigned to the three groups at random in equal ratios. the hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. this result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.


Eligibility criteria:
inclusion criteria: 1. patients undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure. 2. patients are either: opioid naïve; or have not taken opiates for one month prior to surgery (tramadol is permissible). 3. patients have an american society of anesthesiology physical status i-iii. exclusion criteria: 1. females who are pregnant. 2. patients who are taking chronic daily opiates for one month prior to surgery except tramadol. 3. diabetic patients. 4. patients with creatinine above 1.1mg/dl for females and above 1.3mg/dl for males. 5. patients with contralateral pneumothorax or diaphragmatic paralysis. 6. patients with coagulopathy. 7. patients with clinically significant previous nerve injury in surgical extremity. 8. patients with an allergy to nsaids. 9. patients who are refusing a block. 10. patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (copd).

Keywords: pain blockade ropivacaine dexamethasone
effects of cerebral oxygen saturation on neuropsychological outcomes

Conditions: Cardiovascular Diseases; Postoperative Complications

Summary: the purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation (over 40%) on patients undergoing cardiac surgery. effects on neuropsychological outcome, length of icu stay, and length of hospital stay will be measured.

central nervous system dysfunction is a major cause of morbidity after cardiac surgery. this study seeks to evaluate the effects of cerebral oxygen saturation on the neuropsychological outcome of cardiac surgery patients. currently, monitoring of cerebral oxygen saturation levels is not part of routine and standard practice. subjects will be assigned to a control and intervention group. anesthesia and surgery will be performed as per usual standards of care. patients in both groups will be monitored with an oxygen sensor placed over the forehead. the data will be recorded continuously on a floppy disk. the control group will be treated according to current standard of care; the readings of brain oxygen saturation will not be visible to the clinician. in the intervention group, the reading of brain oxygen saturation will be monitored by the anesthesiologist throughout surgery. interventions will be performed to maintain cerebral oxygen saturations above 40%. neuropsychological tests will be completed pre-operatively and at two time points post-operatively. the tests used are the asem (antisaccadic eye movement) and the mmse (mini-mental state examination).

Eligibility criteria:
inclusion criteria: * adult patient * elective cardiac surgery with cardiopulmonary bypass * coronary artery disease or valvular heart disease or combination of both * ability and willingness to give informed consent exclusion criteria: * pediatric patients * emergency surgery * unable to understand english * allergic to tape used to attach oxygen sensor

Keywords: heart surgery cerebral oxygen saturation neuropsychological function