Kornimate/medical-research-clean huggingface dataset:
image guided rfa/mwa/cryo of rcc biomarker profile study

Conditions: Renal Cancer

Summary: often kidney cancer is diagnosed when the tumour is small and hasn't spread. rather than major surgery to remove the whole kidney, image-guided ablation involving heat (microwave or radiofrequency) or freezing (cryotherapy) is often used to destroy the tumour using minimal invasive technique with much less risk and discomfort. limited evidence suggests that ablation also activates the immune system which may help in fighting the cancer. we will investigate the immune and other changes by analysing blood samples from patients before and after ablation. understanding this will help in designing more effective new treatments combining ablation with biological therapies.

image-guided ablation therapies are increasingly being used in renal and other cancers as an alternative to major surgery, particularly in the context of small localised masses or when patients have significant co-morbidities. published analyses now also support the effectiveness of such treatments in terms of outcomes. tumour ablation has been reported to generate immune and inflammatory responses following tumour destruction, essentially through release of tumour antigens in effect acting as a tumour "vaccine", resulting in systemic anti-tumour responses. such studies are still limited but indicate possibilities in terms of combination therapies with immunotherapies and synergistic effects. in order to take this forward in renal cancer it is now critical that studies are undertaken to explore further the immunobiological and inflammatory changes associated with ablation therapies. we propose to do this using a relatively new multiplex and highly sensitive proteomic biomarker array technology which allows the profiling of circulating proteins using arrays targeted at specific disease areas or processes. we have used this platform to generate some pilot data on rcc patients undergoing ablation to show feasibility and now propose to extend this further. the main benefits to patients will be in terms of understanding how the immune and inflammatory responses are affected by ablation which ultimately may lead to the design of new more effective therapeutic strategies combining ablation with immunotherapies. ultimately more effective combination therapies would have health economic benefits and improved quality of life with potentially lower toxicity if the doses of the biological therapies could be reduced. some of the protein changes may also act as surrogate markers of response and guide optimal treatment administration.

Eligibility criteria:
inclusion criteria: 1. patients underwent image guided ablation for renal cell carcinoma (rcc) with heat-based energy (rfa/mwa) or ice-based energy (cryo) 2. no other prior treatment to rcc in either kidneys exclusion criteria: 1. patients with rcc that is not suitable for image guided ablation

Keywords: radiofrequency ablation (rfa) microwave ablation (mwa) cryoablation (cryo) biomarker
nutraceutical treatment for hypercholesterolemia in hiv-infected patients

Conditions: Hypercholesterolemia; Inflammation; Atherosclerosis

Summary: the effects of a nutraceutical combination (nc) containing low-dose monacolin k and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (pcsk9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (hiv)-infected patients receiving stable antiretroviral therapy (art).

this is a crossover interventional study of 26 hiv-infected patients on stable art with low density lipoprotein cholesterol (ldl-c) \>100 mg/dl, not receiving any lipid-lowering treatment. after a 3-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral nc containing red yeast rice-derived monacolin k 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme q10 2 mg vs no active treatment (nonc) was tested on plasma total cholesterol (tc), ldl-c, high density lipoprotein cholesterol (hdl-c), triglyceride, lipoprotein(a), pcsk9, high-sensitivity c-reactive protein (hscrp) levels and aortic pulse wave velocity (apwv).

Eligibility criteria:
inclusion criteria: * ldl-c \>100 mg/dl * no history of cardiovascular disease * stable art for at least 6 months exclusion criteria: * current or recent (≤6 months) treatment with lipid-lowering drugs * chronic kidney disease \[estimated glomerular filtration rate (gfr) \<60 ml/min\] * liver impairment (ast and/or alt \>3 times upper limit of normal) * current pregnancy * opportunistic infections within the past 3 months, * having received an organ transplant/immunosuppressive therapy

Keywords: cholesterol nutraceutical hiv pcsk9 hscrp stiffness
dexamethasone in cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. to evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension. in aids patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in aids patients with cryptococcal meningitis.

in aids patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in aids patients with cryptococcal meningitis. patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). additionally, standard antifungal therapy with amphotericin b and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * aerosolized pentamidine or systemic chemoprophylaxis for pcp. * preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin). patients must have: * documented initial episode or relapse of acute cryptococcal meningitis. (note: patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin b.) * acute cryptococcal meningitis with cerebrospinal fluid opening pressure \>= 250 mm h2o prior to receipt of antifungal therapy for this episode. * documented hiv infection or a diagnosis of aids based on a documented aids-defining opportunistic infection. * ability to begin therapy within 8 hours after the pre-entry lumbar puncture. * consent of parent or guardian if less than 18 years of age. note: * comatose patients eligible provided informed consent can be provided by guardian or next of kin. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * concurrent cns disease such as another infection or neoplasm that would interfere with assessment of response. * prison incarceration. concurrent medication: excluded: * acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study. * treatment or prophylaxis with other systemic antifungal agents at any time. * antiretroviral therapy during the first 72 hours of the study. prior medication: excluded within 7 days prior to study entry: * corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.

Keywords: aids-related opportunistic infections meningitis cryptococcosis dexamethasone drug therapy, combination fluconazole flucytosine acquired immunodeficiency syndrome amphotericin b brain diseases
effect of prebiotic and synbiotic supplementation in individuals undergoing roux-en-y gastric bypass.

Conditions: Obesity

Summary: the study will recruit patients submitted to bariatric surgery. individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass roux-y.

the study will recruit patients submitted to roux-en-y gastric bypass. individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) prebiotic group: oral supplementation with 6g/day of prebiotic for 15 days. 2) synbiotic group: oral supplementation with 6g/day of synbiotic for 15 days. 3) placebo group (control): oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.

Eligibility criteria:
inclusion criteria: * age greater than 18 years and less than 65 years * body mass index (bmi)\> 40kg/m2 or\> 35kg/m2 with at least one comorbidity * failure in the non-pharmacological and pharmacological treatment. exclusion criteria: * significant intellectual limitations without adequate family support. * uncontrolled psychiatric disorder. * alcohol dependence and / or illicit drugs dependence. * current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants * display intolerance prebiotics and / or probiotics and / or symbiotic * having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.

Keywords: roux-en-y gastric bypass inflammatory markers nutritional status fatty acids glucose prebiotic synbiotic
it's not just idiopathic pulmonary fibrosis study

Conditions: Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Summary: study of progression of fibrosis in ild

the overall aims of this study are * identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology * to prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including ra-uip, asbestosis, chronic hypersensitivity pneumonitis and unclassifiable fibrotic lung disease * investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression * prospectively evaluate longitudinal disease behaviour in patients with non ipf-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients

Eligibility criteria:
inclusion criteria * male or female aged ≥ 18 years old * able and willing to give written informed consent * recently diagnosed \[defined as diagnostic ct scan or surgical lung biopsy (if applicable) \>1st may 2017\] * an mdt diagnosis of fibrotic interstitial lung disease (reticulation, traction +/- honeycombing) sub groups * rheumatoid arthritis (rheumatologist diagnosed with anti-ccp antibodies and/or rheumatoid factor positive) * asbestosis (appropriate occupational history and radiological evidence of asbestos exposure) * chronic hp in accordance with consensus criteria (appropriate exposure history, radiological features +/- avian and fungal precipitins) * unclassifiable fibrotic lung disease (fibrotic lung disease otherwise unclassifiable despite extensive clinical and radiological examination) * ipf in accordance with consensus criteria (ats/ers/jrs/alat guidelines) as controls exclusion criteria: * participating in an interventional clinic trial * asymptomatic interstitial lung abnormalities (ila) and normal lung function. * change in clinical phenotype from initial radiological diagnosis to screening * acute hypersensitivity pneumonitis. * participants who do not possess a smartphone or have a valid email address (necessary for the home fvc readings)
retinal blood flow in response to an intravitreal injection of ranibizumab for central retinal vein occlusion (crvo)

Conditions: Central Retinal Vein Occlusion

Summary: ranibizumab (lucentis, genentech) is an off-label drug used for the clinical treatment of central retinal vein occlusion, which is one of the most common retinal vascular disorders. despite its clinical effectiveness, concerns remain regarding the systemic effects of the drug and previous studies have noted retinal arteriolar vasoconstriction following a ranibizumab injection. we aim to provide a physiological basis to these observations by assessing retinal blood flow before and after the ranibizumab injections. specifically, we will assess the blood flow parameters (i.e. retinal vessel diameter, velocity \& flow) immediately before the first injection and post-injection over a follow-up continued treatment period.

ranibizumab is an antibody fragment designed to inhibit the activity of vascular endothelial growth factor (vegf), which is responsible for the neovascularization and retinal edema responsible for interference of normal vision in central retinal vein occlusion. however, vegf has a role in the vasculature as a vasodilator where it alters the expression of tight junction proteins and upregulates the release of the vasodilator nitric oxide. consequently, intravitreal ranibizumab injections could result in systemic inhibition of vegf, leading to long-term retinal arteriolar vasoconstriction and potentially adverse cerebrovascular and myocardial accidents. therefore, evaluating retinal blood flow would provide a physiological foundation to this concern and provide physicians with valuable information regarding the risks of continued ranibizumab therapy. given the role of vegf as a vasodilator in the vasculature where it works to alter the expression of tight junction proteins and the production of vasoactive substances especially nitric oxide, inhibiting this molecule with ranibizumab could result in vasoconstriction in these vessels. we hypothesize that vasoconstriction and decreased retinal blood flow will be observed after an intravitreal injection of ranibizumab for treatment of central retinal vein occlusion.

Eligibility criteria:
inclusion criteria: * age \> 50 years * central retinal vein occlusion scheduled for first intravitreal injection of ranibizumab as part of their clinical care exclusion criteria: * previous history of intravitreal therapy, * history of thromboembolic events, * glaucoma or an intraocular pressure \>21 mmhg * diabetes mellitus or altered blood viscosity syndromes * blood donation in the previous 2 weeks * refractive error of +/- 6.00 ds and/or 2.00 dc

Keywords: retinal vein occlusion anti-vegf blood flow
hypothermia therapy in pediatric cardiac intensive care unit for suspected for brain injury

Conditions: Congenital Heart Defects; Brain Ischemia; Hypoxia Brain; Child; Hypothermia, Induced

Summary: cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. the most common cause of cardiac pathology is congenital heart defects (chd) about 4-8/1000 live births a year. the most common etiology of the brain insult is hypoxic ischemic injury (hii) as result of hemodynamic instability in the perioperative period. similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. although, hypothermia is most likely an effective treatment for hii in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. in this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (pcicu) following severe hii in the pcicu or operating room. the effect will be quantified by mri, serum biomarkers of brain injury, amplitude integrated eeg, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in pcicus.


Eligibility criteria:
inclusion criteria: 1. every child entering the pcicu, age \< 7 years 2. the child will enter arm 1 or 2 if he underwent the event described in section 3. 3. hypoxic ischemic event that would render hypothermia treatment is defined as * during the hospitalization in the pcicu before or after the surgery: resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl or resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood ph level of less than 7.1 * during the surgery near infra red spectroscopy lower than 40 for more than 5 minutes and serum lactate levels of more than 90 mg/dl during the event or the patient is re-connected to cardio-pulmonary bypass machine as a result of the event 4. initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3. exclusion criteria * suspected hypoxic ischemic event as described in the inclusion criteria in the 2 weeks prior to the pcicu admission * prolonged low cerebral perfusion before the pcicu admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and ph lower than 7.1 * rejection criteria * a second resuscitation after the hypoxic ischemic event and before a brain mri is done

Keywords: congenital heart defects hypoxic ischemic brain injury hypothermia therapy pediatrics
a study comparing the plasma drug exposure of an oral dose of palbociclib (pd-0332991) to an intravenous dose of palbociclib (pd-0332991)

Conditions: Healthy

Summary: the purpose of this study is to determine approximately what percentage of an orally administered dose of pd-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. this approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of pd-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of pd-0332991 administered as a 4-hour infusion.


Eligibility criteria:
inclusion criteria: 1. healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age. 2. a body mass index (bmi) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs) exclusion criteria: 1. any condition which could possibly affect drug absorption. 2. pregnancy or actively nursing females, or females of childbearing potential. 3. a positive urine drug screen.

Keywords: pd-0332991 absolute bioavailability study
precision of optical diagnosis in polyps between 5-15 mm and its implications on surveillance. a prospective, multicenter study.

Conditions: Colonic Polyps; Colon Neoplasms; Colon Cancer; Serrated Adenoma

Summary: this study evaluates the ability of endoscopists to perform a complete optical diagnosis of colorectal polyps between 5 and 15 mm, and the impact of the only endoscopic diagnosis on the follow-up program for those patients. this is a prospective study in which we compare the diagnosis regarding size and histology made by the endoscopist versus de pathologic diagnosis.

background: optical diagnosis of colonic polyps is an attractive possibility and a common practice. however, recommendations and the main decision concerning patients' management still rely on histological diagnosis, with controversial results in previous studies, usually designed to analyze the accuracy of this diagnosis in the setting of a 'resect and discard' or 'diagnose and leave' strategy. however, little has been studied on this diagnosis on polyps of about 10 mm, the threshold for the consideration as a high risk adenoma, that need a 3 year colonoscopy, or, in case of a smaller adenoma, with a recommended revision in 5 years. some studies have addressed the accuracy when estimating the polyp size, and others the histology by means of virtual or optical chromoendoscopy, but no one has studied both parameters, that are the two pillars in which a revision program for the patient is decided. hypothesis: our main purpose is to determine the accuracy of the complete optical diagnosis as made by the endoscopist in the endoscopy room, in order to give recommendations immediately after the colonoscopy, with no need of further histological analyses. aims: * to establish endoscopist accuracy, in different hospital settings, to predict size and histology of polyps between 5 and 15 mm and whether follow-up recommedations based on this diagnosis are accurate enough, when compared to the pathologic diagnosis. * to evaluate accuracy of the optical size estimation by the endoscopist, with respect to the measurement after resection and by the pathologist (after formaline fixation). * to analyze the rate of sessile serrated adenoma not diagnosed by the endoscopista on site. * to determine the proportion of incomplete resection and complications with different resection techniques. * to follow-up patients with high risk adenoma with the aim to establish the best follow-up schedule for those patients, and clarify this topic, still subjected to uncertainty.

Eligibility criteria:
inclusion criteria: * age between 18-80 years * colorectal polyps with an estimated size (endoscopist estimation) between 5 and 15 mm. * consent to be included in the protocol. exclusion criteria: * polyps sized \ 15 mm * polyps that cannot be resected. * polys that cannot be sent for pathologic study. * peacemeal resection. * polyposis syndromes with a previous histologic diagnosis. * patients do not consent to participate in the study.

Keywords: endoscopic optical diagnosis