Kornimate/medical-research-clean huggingface dataset:
uric acid reduction as a novel treatment for pediatric chronic kidney disease

Conditions: Hyperuricemia; Chronic Kidney Diseases

Summary: aim 1. to determine the effect of allopurinol treatment on renal function (glomerular filtration rate, gfr) in pediatric chronic kidney disease (ckd) patients with high uric acid levels (hyperuricemia). aim 2. establish whether allopurinol treatment reduces nlrp3 inflammasome and renal injury biomarkers.

uric acid levels often rise when kidney function declines. historically, high uric acid has not been treated unless the uric acid crystallizes in the joint space and causes clinical gout disease, more typically seen in adults. however, new research has shown that high uric acid levels are associated with the development of hypertension, inflammation, and both acute and chronic kidney injury. adult patients on renal dialysis who have hyperuricemia also have higher mortality rates. in several adult and in one pediatric clinical trial of uric acid lowering therapy (with allopurinol or febuxostat), treatment has demonstrated a slower rate of renal function decline and improved blood pressure compared to placebo. the pediatric trial was a 4-month placebo controlled trial of allopurinol, and showed positive improvement in renal function and blood pressure, but did not adequately control for potential confounders in the outcome. two known confounders that influence renal function (glomerular filitration rate, gfr) in pediatric ckd are race and glomerular or non-glomerular disease etiology. this study is designed to control for these confounders and establish whether allopurinol for 6 months of treatment to a goal range of 3-5 mg/dl will improve renal function compared to standard of care. the secondary outcome is to determine whether blood pressure is affected by the treatment and the magnitude of change of serum uric acid. this study will also explore whether allopurinol treatment alters activation of the nlrp3 inflammasome or renal injury biomarkers.

Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 1-5 * hyperuricemic (ua \>= 5.5 mg/dl) exclusion criteria: * contraindication to allopurinol * elevated baseline liver function tests * receiving acute or chronic dialysis * primary metabolic disorder * sickle cell disease * autosomal dominant polycystic kidney disease * cystinosis * bartter or gitelman disease * pregnant or nursing
a dose-range finding study of maa868 in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is a multicenter, randomized, subject and investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) effects of maa868 in patients with atrial fibrillation (af) or flutter at low risk of thromboembolic stroke or peripheral embolism.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 and \< 85 years old with paroxysmal atrial fibrillation (paf) or atrial flutter on 12 lead electrocardiography at screening or * patients with a history of paf or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory \[e.g. holter\] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have paf at screening. there is not time-limit for this. * patients with a congestive heart failure, hypertension, age ( \> 65 = 1 point, \> 75 = 2 points), diabetes, previous stroke/transient ischemic attack (2 points) (cha2ds2-vasc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (af); lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated exclusion criteria: * history of stroke, transient ischemic attack or systemic embolism * history of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.) * history of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding * known bleeding diathesis or any known active bleeding site at screening or baseline * family history of bleeding disorder * known active gi lesions predisposing to bleeding events * myocardial infarction, unstable angina pectoris or coronary artery bypass graft (cabg) surgery within 12 months prior to the screening period * known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area \<1.5 cm2) * patients with a prosthetic heart valve other protocol defined inclusion/exclusion criteria may apply

Keywords: atrial fibrillation flutter paroxysmal atrial fibrillation stroke cardiac arrhythmia
adapting the hitsystem to support prevention of mother-to-child hiv transmission

Conditions: HIV

Summary: the purpose of this study is to modify the hitsystem to engage and retain hiv+ pregnant women before, during and after delivery and evaluate the hitsystem impact on prevention of mother-to-child transmission (pmtct) related behaviors and outcomes. hitsystem 2.0 intervention will support a range of pmtct outcomes including retention in care, art adherence, and integration of maternal and pediatric hiv services in low-resource settings.

the study will be conducted in three phases: phases 1: the researchers will conduct formative research (focus groups and interviews) with hiv+ pregnant women and pmtct providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various pmtct-related services at the intervention site. phase 2: the researchers will design and refine the hitsystem 2.0 technical components to support pmtct outcomes guided by clinical content experts, technology analysts, and findings from phase 1. phase 3: the researchers will implement hitsystem 2.0 at one hospital over an 18 month period, and compare targeted pmtct outcomes to those at a matched control hospital. the study will be conducted at two government hospitals in kenya. hiv+ pregnant women will be enrolled in the hitsystem 2.0 at kapsabet hospital. hiv+ pregnant women receiving the current standard of pmtct care at nandi hills hospital will be the comparison group.

Eligibility criteria:
phase 3 inclusion criteria: * hiv+ pregnant women * present for first pmtct appointment at one of the study hospitals * own or have reliable access to mobile phone exclusion criteria: * n/a

Keywords: prevention of mother-to-child transmission (pmtct) kenya hitsystem 2.0 retention through pmtct cascade of care early infant diagnosis ehealth system-level intervention
hrim vs mucosal impedance in gerd participants

Conditions: Gastro-esophageal Reflux Disease (GERD)

Summary: does baseline impedance measured during the landmark phase of esophageal high resolution impedance manometry hrim correlates with direct mucosal impedance measurement and discriminates gerd from non gerd patients?

patients referred to the mayo clinic rochester for a clinically indicated high resolution impedance manometry (hrim), 24 hour impedance ph (mii-ph) study, and esophagogastroduodenoscopy (egd) will be recruited. gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant proton pump inhibitor (ppi) use. a negative 24 hour mii-ph study will be defined as an acid exposure time ≤2% off ppi therapy or ≤1% if on ppi therapy.

Eligibility criteria:
patients being seen at mayo clinic rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour ph impedance study. inclusion criteria: * adults ages 18-90 * patients scheduled for or have completed a hrim ( within 5 days) * patients scheduled for or recently have completed a mii-ph studies ( within 5 days) * patients scheduled for egd exclusion criteria: * technically limited esophageal hrim or mii-ph study * patients with hrim and mii-ph studies not performed within 5 days of each other * patients with egd not performed within 30 days of hrim and mii-ph studies * medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy
children severe traumatic skin lesions and functional outcome

Conditions: Burns

Summary: traumatic skin lesions require an adapted and early patient care management

traumatic skin lesions and in particular the burns which happen to growing children are complex and require an adapted and early patient care management. a child presents physical, psychological, and physiological characteristics which involve a specific functional prognosis. the aim of the study was to evaluate the functional outcome after a mid-term period from a severe skin traumatism occurring during childhood and which had required an initial graft.

Eligibility criteria:
inclusion criteria: * children who were hospitalized for an extensive and deep skin lesion on at least one joint, at chu amiens, from april 1999 to december 2014, in the physical and rehabilitation pediatric activity center. * and with a serious skin lesion: * what the total dermal area is estimated to be less than 25% * taking at least one articulation * dont a part is at least 2nd degree deep or third degree exclusion criteria: * first degree burns or superficial second degree burns resulting in death in the acute phase * a history of pre-burn disorders affecting growth * escarres

Keywords: burn child graft development complications autonomy
prevalence of pain in inpatient at the hospital italiano de buenos aires

Conditions: Pain

Summary: the purpose of this study is to determine the prevalence of patients with acute and chronic pain in the area of inpatient at the hospital italiano de buenos aires.

the diagnosis and treatment of pain during hospitalization are becoming increasingly important. in recent decades there have been articles that explain that pain is underdiagnosed, that there are patients who do not receive treatment or that it fails to decrease pain intensity. it has now been shown that pain is a common problem during hospitalization, showing a prevalence of 38 to 91% depending on the population studied. published studies show that there are three types of pain during hospitalization: acute or chronic pain that motivates the admission and continues during hospitalization, pain that appears during hospitalization but was not the cause of the admission or associated with health care, and,pain that appears during the hospitalization associated with health care. to complete the description of patients with pain during hospitalization it has been suggested the existence of a fourth group of patients presenting with chronic pain that does not motivate the admission but persists and does not interfere during hospitalization. in a study evaluating the italian population shows that the prevalence of pain is modified by marital status and age, and the intensity of pain increases with time evolution of pain and days of hospital stay. some studies, mainly in europe, show that the use of analgesics is high but the adherence to guideline recommendations for treatment of pain is low, or that the presence of pain is not recorded in the medical chart compared to the indication of analgesic treatment. these results demonstrate the need to determine the prevalence of pain in hospitalization at each institution, distinguishing the case of pain prior to admission or appearing during the same (or motivation), evaluating the indication of pain at each hospital, in order to learn about the current situation and design and implement actions to improve pain management in this institution.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years. * evaluated at 48 hours after hospital admission in areas general hospitalization, coronary care unit, adult intensive care, intermediate care and day hospital of the hospital italiano central exclusion criteria: * refusal to participate in the study or the informed consent process. * inability to understand or express pain (aphasia, dementia). * alteration ef the sensory. * language other than spanish. * inpatient at the emergency room. * presence of acute confusion or delirium.

Keywords: pain hospitalization
sarcopenia and multimodal rehabilitation on the prognosis of rectal cancer patients receiving ccrt

Conditions: Rectal Cancer

Summary: investigators use clinical trial to explore the role of sarcopenia and multimodal rehabilitation in prognosis of rectal cancer patients receiving concurrent chemoradiotherapy.

the impact of sarcopenia and the effect of multimodal rehabilitation will be evaluated in the rectal cancer patients receiving pre-operative concurrent chemoradiotherapy. this is a randomized trial.

Eligibility criteria:
inclusion criteria: * age\>20 * rectal cancer patients receiving concurrent chemoradiotherapy * agree to join the trial and sign the informed consent form exclusion criteria: * unstable vital sign * unable to excise * not suitable after evaluation by principal investigator

Keywords: rectal cancer concurrent chemoradiotherapy sarcopenia multimodal rehabilitation
a study to assess the long-term safety and tolerability of tmc114/rtv in hiv-1 infected participants after rolling-over from other tmc114 trials

Conditions: HIV

Summary: the purpose of this study was primarily to assess the long-term safety and tolerability of tmc114/rtv in addition to an individually optimized background antiretroviral therapy in hiv-1 infected participants. in addition, antiviral activity and immunological effect were also evaluated.

this was a phase ii, open label, multicenter trial of an investigational protease inhibitor tmc114 in the presence of ritonavir (rtv) in hiv-1 infected participants who were randomized in trials tmc114-c201, tmc114-c207 or in sponsor selected phase i trials and who might derive benefit from tmc114 therapy, as judged by the investigator. the trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. the maximal trial duration for each participant was104 weeks. during the treatment period, all participants were receiving tmc114 in combination with rtv, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (arv) therapy, selected by the investigator at a baseline of the study. sponsor provided a follow-up treatment with tmc114 for all participants who continued to benefit from treatment with tmc114/rtv until it became commercially available for the participant. participants, who completed the 96 weeks of treatment period with tmc114, had the opportunity to roll over to the extension of this trial, if tmc114 was not locally commercially available.

Eligibility criteria:
inclusion criteria * must be diagnosed with hiv * previously randomized in trials tmc114-c201, tmc114-c207 or in sponsor selected phase i trials * agreed to take at least 2 antiretroviral agents from baseline onwards * could comply with the protocol requirements * general medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial exclusion criteria: * a disallowed concomitant therapy * current or past history of active alcohol and/or drug use * pregnant or breast-feeding females * any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections) * clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis * clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication * laboratory abnormalities at screening (criteria variable according to the test)

Keywords: hiv aids tmc114 ritonavir norvir darunavir
a study to explore the association between blood pressure, hiv and antiretroviral therapy

Conditions: HIV Infections

Summary: the purpose of this study is to explore the association between blood pressure, hiv and/or its treatment in a cross sectional observational study.

deaths from aids have declined dramatically since the introduction of highly active antiretroviral therapy in hiv infected patients. however the incidence of heart disease has increased four-fold and is now one of the major causes of death in hiv infected patients. while hiv drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) hiv and/or its treatment is limited and conflicting. the researchers believe it of interest to study heart disease risk factors in patients with hiv infection to avoid one premature cause of death (aids) being replaced with another potentially preventable cause of death and disability (heart disease). in this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in hiv positive patients on and off antiretroviral therapy. these individuals will be matched for age, sex and ethnic group with hiv negative individuals.

Eligibility criteria:
inclusion criteria: * attending st. mary's sexual health outpatient department * patients willing to give written informed consent * ability to communicate in english exclusion criteria: * failure to give written informed consent in english

Keywords: blood pressure hiv antiretroviral therapy
hypoxia impairs endothelial function in hapes

Conditions: Healthy

Summary: aim of the study is to investigate the function of the systemic vascular endothelium in individuals susceptible to high-altitude pulmonary oedema during normoxia and normobaric hypoxia.

rationale: high-altitude pulmonary edema (hape) is characterized by excessive pulmonary vasoconstriction and is associated with decreased concentrations of nitric oxide (no) in the lung. objectives: we hypothesized that individuals susceptible to hape (hape-s) would also have dysfunction of the vascular no vasodilator pathway during hypoxia in the systemic vasculature. methods: during normoxia (fi(o(2)) = 0.21) and 4 hours of normobaric hypoxia (fi(o(2)) = 0.12, corresponding to an altitude of 4,500 m above sea level) endothelium-dependent and endothelium-independent vasodilator responses to intraarterial infusion of acetylcholine (ach) and sodium nitroprusside, respectively, were measured by forearm venous occlusion plethysmography in nine hape-s subjects and in nine hape-resistant control subjects. main results: pulmonary artery systolic pressure increased from 22 +/- 3 to 33 +/- 6 mm hg (p \< 0.001) during hypoxia in control subjects, and from 25 +/- 4 to 50 +/- 9 mm hg in hape-s subjects (p \< 0.001). despite similar responses during normoxia in both groups, ach-induced changes in forearm blood flow markedly decreased during hypoxia in hape-s subjects (p = 0.01) but not in control subjects. the attenuated vascular response to ach infusion during hypoxia inversely correlated with increased pulmonary artery systolic pressure (p = 0.04) and decreased plasma nitrite correlated with attenuated ach-induced vasodilation in hape-s subjects (p = 0.02). conclusions: hypoxia markedly impairs vascular endothelial function in the systemic circulation in hape-s subjects due to a decreased bioavailability of no. impairment of the no pathway could contribute to the enhanced hypoxic pulmonary vasoconstriction that is central to the pathogenesis of hape.

Eligibility criteria:
inclusion criteria: healthy, male volunteers, age: 18-55 - able and willing to give written informed consent exclusion criteria: * known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia) * regular medication and/or treatment with drugs within the last 4 weeks (exclusion has to be decided in each case) * acute or chronic illness * participation in clinical trial/blood donation within 2 month before the study * nicotine, drug and/or alcohol abuse.
correlation between ixip and final pathology specimen from radical prostatectomy: a multicenter prospective trial

Conditions: Prostate Cancer

Summary: the immune complex predictive index (ixip) is a predictive tool for prostate cancer (pca) diagnosis that integrates psa, psa-igm, prostate volume and age of the patient. an algorithm processes these parameters providing the probability of prostate cancer. several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. moreover, preliminary results from a prospective study showed that ixip could predict cancer aggressiveness, too.

since the 90s, serum psa has become the cornerstone of diagnosis of pca, however, due to its proven poor specificity, the actual role of psa testing has been largely debated, especially if used during opportunistic screening programs. leading to a significant risk of over-diagnosis and over treatment. in order to overcome drawbacks of psa-based diagnostic pathway several psa-derivates has been proposed. however, they were marginally used in clinical practice because not supplied by public health care systems. the immune complex predictive index (ixip) is a predictive tool for prostate cancer (pca) diagnosis that integrates psa, psa-igm, prostate volume and age of the patient. an algorithm processes these parameters providing the probability of prostate cancer. several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. moreover, preliminary results from a prospective study showed that ixip could predict cancer aggressiveness, too. all pathological specimens are analyzed by an expert uropathologist, following isup reccomandations. before radical prostectomy a blood sample from each patients is collected. serum psa-igm concentration is measured using prostate-ic kit in duplicate. the analysis with prostate-ic kit was performed on automated elisa analyzer.then the ixip index is calculated by using the online calculator (http://ixip.xeptagen.com/).

Eligibility criteria:
inclusion criteria are: * histologically proven prostate cancer, * patients scheduled for radical prostatectomy * paziente able to provide consent * age \> 18 years or \< 80 years exclusion criteria are: * neiadjuvant hormone therapy * salvage radical prostatectomy * concomitant solid or hematological tumors, * autoimmune disorders * or immunosuppressive therapies, * acute bacterial or viral infections.