Kornimate/medical-research-clean huggingface dataset:
safety sudy of atazanavir boosted with ritonavir in the treatment of hiv infection in pediatric patients

Conditions: HIV, Pediatric

Summary: the purpose of this study is to collect safety clinical data in hiv-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.


Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection diagnosed by protocol criteria * male or female children, ≥ 6 years to \<17 years 6 months of age at the time of first treatment * antiretroviral-naïve or treatment-experienced participants with a detectable viral load * antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (nrtis), which have been approved for pediatric use and dosed per local country label * antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and at least 2 nrtis, which have been approved for pediatric use and dosed per local country label. exclusion criteria: * experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment * antiretroviral-naive or -experienced hiv-1 infected patients with contraindication to study medications * documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope * family history of qtc interval syndrome, brugada syndrome, right ventricular dysplasia, or a corrected qtc interval of \>440 ms at screening * one of the following cardiac rhythm abnormalities documented on the screening electrocardiogram: 1. first degree atrioventricular (av) block, as defined by protocol 2. type i second degree av block while awake, type ii second degree av block at any time, complete av block at any time, or age-adjusted heart rate \<2nd percentile * coinfection with either hepatitis b or c virus
spine registry university hospital of cologne- department of orthopedics

Conditions: Outcome, Fatal; Spondylodiscitis; Vertebral Osteomyelitis

Summary: between january 2008 and december 2020 all patients with spine diseases were registered prospectively in the former european spine tango registry and later german dwg registry at the department of orthopedics and trauma at the university of cologne.

the following data were prospectively collected after enrollment: age, sex, body mass index (bmi), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and american society of anesthesiologists (asa) physical status classification system. in addition the following quality of life scores were collected: oswestry disability score (odi), core outcome measures index(comi), short form- 36 (sf- 36) and euroqol- 5d (eq- 5d).

Eligibility criteria:
inclusion criteria: * spine disease exclusion criteria: * younger than 18 years

Keywords: quality of life, treatment failure, relapse, spondylodiscitis, vertebral osteomyelitis
healthy weight for teens

Conditions: Obesity

Summary: power is uniquely positioned to evaluate characteristics of multi-component pwm programs that are associated with "favorable" health outcomes for treatment-seeking youth with obesity. the power data coordinating center developed ranking reports of the 33 participating sites based on weight status change at 6 months. an in-depth review of program design of 4 "top-performing" sites was conducted. a unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component pwm program. this orientation helped patient-families better understand the program's expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems. this information was used to tailor the intervention to better meet the needs of participating patient-families. when a survey of program characteristics was conducted of the 33 participating sites, this "top-performing site" was the only one to offer such a program orientation session prior to patient-families starting the pwm program. therefore this program feature was included as part of the "bundle of program enhancements" (bpe) for this proposed pragmatic pilot study.


Eligibility criteria:
inclusion criteria: * ≥ 12 years of age and \< 18 * scheduled for a new patient clinic visit at the multi-component pwm program at cchmc or hdvch * severe obesity (≥ 120% of the 95th percentile for bmi based on age and gender at time of screening visit) * able to understand and complete the consent process * have access to a smart phone, device, or computer with a web camera * have access to the internet exclusion criteria: * lacking capacity to provide informed consent * non-english speaking * participating in any other weight management program or research study related to weight management * have a sibling participating in any other weight management program or research study related to weight management * taking anti-obesity medication (phentermine, orlistat, qsymia, naltrxone-bupropion, lorcaserin, others at the discretion of the pi)
retrospective cohort study comparing a novel gel dressing vs soc in the treatment of radiation dermatitis

Conditions: Radiation Dermatitis

Summary: routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. data will be split into two cohorts: patients that received 1) strataxrt and 2) standard of care. the incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.


Eligibility criteria:
inclusion criteria: * diagnosed with head and neck cancer treated with radiation therapy with or without chemotherapy * fractionated courses including at least 30 fractions (treatments) * minimum of 18 completed radiation treatments * radiation dose: \> 50 gy * radiation technique: imrt * radiation equipment: truebeam or tomotherapy exclusion criteria: * prior radiation to the treatment area * patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis. * patients undergoing sbrt * patients with existing rashes or wounds in the target region or radiation therapy at rt start * patients receiving hypofractionation * patient receiving bolus
use of sucrose to relieve pain during eye exams in infants

Conditions: Apnea of Prematurity; Retinopathy of Prematurity; Pain

Summary: the purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. the investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. in addition this will lead to a decrease in events in the 12 hours following examination. events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.


Eligibility criteria:
inclusion criteria: * all premature infants admitted to the neonatal intensive care unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. this includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen. exclusion criteria: * any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. this includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus. * any infant being maintained on narcotics for any reason will not be eligible for the study. * all infants with major congenital anomalies will be excluded.

Keywords: pain control
resveratrol's effects in diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

diabetes mellitus (dm) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. one of the most important complications of dm is nephropathy. resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. the richest natural source of resveratrol is polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine. resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial no synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals. we hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. the aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (dm) * controlled blood sugar \[fasting blood sugar (fbs) \<130mg/dl and glycosylated hemoglobin (a1c)\<7% * urine albumin \>20mg/lit in two separate occasions during the last 3 months period * serum creatinin \< or = 2mg/dl exclusion criteria: * pregnancy * lactation * alcoholism * liver failure (acute or chronic) * renal failure: serum creatinin \>2mg/dl * glomerulonephritis * uncontrolled hypertension * congestive heart failure * prostate disease * malignancy * bilateral renal artery stenosis * any systemic disease other than dm * any infection or rheumatologic disorder * use of warfarin

Keywords: resveratrol diabetes mellitus diabetes complications diabetic nephropathies proteinuria albuminuria renal insufficiency
family-centered oral health promotion for new parents

Conditions: Dental Caries

Summary: early childhood caries (ecc) is a global health problem that causes pain and infection to the children affected. it is a common disease among preschool children in hong kong. there is a great need to improve at-home ecc preventive measures through oral health promotional activities as early as possible to parents. the investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of ms from the parents to their infants and then reducing the risk of ecc of the children at 3 years. the investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves. first-time expectant mothers and their husbands will be recruited. the recruited families will be randomly allocated to the test and control groups. in the test group, personal hygiene instruction (ohi) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. reinforcement of ohi and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. the consort statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results. it is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ecc. furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. this study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in hong kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. this will contribute significantly to the improvement of oral health in the population of hong kong.


Eligibility criteria:
inclusion criteria: * first-time pregnancy * of chinese ethnicity * ability to speak cantonese and read traditional chinese exclusion criteria: * pregnant women with any communication difficulties noted * informed consent not obtained

Keywords: early childhood caries (ecc) oral health promotion randomized controlled trial
sequential therapy of atorvastatin improve outcomes of st-elevated acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: statins have been approved to benefit patients underwent percutaneous coronary intervention (pci). the current study is designed to evaluate the effectiveness and safety of sequential therapy of atorvastatin in patients with st-elevated myocardial infarction and receive pci treatment.


Eligibility criteria:
inclusion criteria: * sighed informed consent * diagnosised as acute myocardial infarction * time frame less than 12 hours since the occurance of chest pain * aggred to receive sirolimus-eluted coronary stents * patients willing to accepte follow-up exclusion criteria: * allegy to statins or with a history against statin therapy * allegy to any products that will be used during ppci * disagreed to receive ppci and other related therapy * existing sever liver dysfuntion that statins can not be used according to the guildlines * sever kidney dysfunction (creatinine \>3mg/dl or egfr\<30ml/min) * sever left ventricular dysfunction (killip grade 3) * patients are currently taking medicine that may influence the use of statin * patients with a history of alcohol abuse or durg abuse * woman during pregnancy or lactation * patients who has attended other clinical trials * patients who has received pci or cabg previously * patients who can not agree to accept study protocol * other conditions that may not sutible for the current study

Keywords: sequential therapy atorvastatin acute myocardial infarction
addition of chidamide to the combination treatment of decitabine plus camrelizumab in combination treatment resistant/relapsed patients with classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this is a phase ii clinical trial for decitabine plus camrelizumab resistant/relapsed patients with hodgkin lymphoma. the purpose is to evaluate the efficacy and safety of the combination therapy of chidamide plus decitabine plus camrelizumab.


Eligibility criteria:
inclusion criteria: 1. subjects must have histological confirmation of relapsed or refractory hodgkin lymphoma (hl). 2. 12 to 75 years of age. 3. ecog performance of less than 2. 4. life expectancy of at least 3 months. 5. subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6. subjects must be relapsed or resistant for the treatment of decitabine plus camrelizumab. subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7. subjects must have adequate marrow, live, renal and heart functions. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month . 4. prior organ allograft. 5. women who are pregnant or breastfeeding. 6. women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
dkk3 for prognosis and monitoring of gfr decline in heart failure

Conditions: Heart Failure; Chronic Kidney Diseases

Summary: the individual course of chronic kidney disease (ckd) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (egfr) decline are needed. recently, urinary dickkopf-3 (dkk3) has been proposed to predict egfr decline in patients with ckd, independent of presence of albuminuria. the investigators sought to examine the association between changes in dkk3 levels and egfr decline in patients with heart failure (hf).

the individual course of chronic kidney disease (ckd) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (egfr) decline are needed. recently, urinary dickkopf-3 (dkk3) has been identified as an stress-induced, renal tubular epithelia-derived, secreted glycoprotein that induces tubulointerstitial fibrosis. urinary dkk3 has been found to predict egfr decline in patients with ckd, independent of presence of albuminuria, but its association with egfr decline in patients with heart failure (hf) is unknown. the investigators sought to examine the association between changes in dkk3 and egfr decline in patients with hf.

Eligibility criteria:
inclusion criteria: * outpatients ≥18 years of age with diagnosed hf or diabetes or hypertension exclusion criteria: * ckd with estimated gfr \<20 ml/min/1.73 m2 (2012 ckd-epi equation) * ckd with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload * active tumor disease * inflammatory or autoimmune disease requiring systemic immunosuppressive treatment * clinically apparent infections * recipients of solid-organ transplants * anticipated life expectancy of \<12 months * likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant) * pregnancy or possibility of pregnancy in the next 12 months
clinical and functional consequences of photodynamic diagnosis (pdd) and intravesical instillation therapy

Conditions: Non-muscle Invasive Bladder Cancer

Summary: the aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.


Eligibility criteria:
inclusion criteria: * non-muscle invasive bladder tumour exclusion criteria: * more than one previous bladder tumour recurrence * muscle invasive bladder cancer (at baseline or prior to inclusion) * utilization of urinary catheter * have had heart valve replacement performed * pregnant or lactating
local treatment of metastatic melanoma with autologous lymphocytes and the bispecific antibody rm28

Conditions: Malignant Melanoma

Summary: phase i/ii clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rm28 and autologous pbmcs in patients with metastatic melanoma stage iii/iv and unresectable metastasis.

phase i/ii clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rm28 and autologous pbmcs in patients with metastatic melanoma stage iii/iv and unresectable metastasis. the antibody is directed against epitops of human cd28 and the melanoma associated surface antigen hmv-maa. treatment over 5 days with dose escalation.

Eligibility criteria:
inclusion criteria: * malignant melanoma stage iii/iv * injectable soft tissue metastasis * informed consent given * karnofsky \>= 70% exclusion criteria: * additional chemotherapeutical treatment * systemic glucocorticoids * brain metestasis * other malignancies

Keywords: mrna vaccination melanoma
microrna biomarkers for neonatal opioid withdrawal syndrome

Conditions: Neonatal Opioid Withdrawal Syndrome; Neonatal Abstinence Syndrome

Summary: infants with neonatal abstinence syndrome (nas) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. the proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate micrornas (let-7a, mir-146a, mir-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with nas, and my human neural progenitor cell (npc) design of opioid withdrawal. by determining the mechanism through which micrornas impact npc differentiation in opioid withdrawal, and determining whether exosomal salivary microrna levels predict treatment dose and neurodevelopmental outcomes in infants with nas, this study will enhance our knowledge of nas-related biology and identify potential biomarkers that could improve medical care for this important medical condition.


Eligibility criteria:
inclusion criteria: * newborns ≥35weeks gestation with chronic in-utero opioid exposure (\>1month of gestation exposure). maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care * neonates born at penn state hershey medical center or transferred at \<48 hours after birth * mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation) exclusion criteria: * \<35 week gestation * infant required mechanical ventilation or non-invasive mechanical support * infant exposure to magnesium sulfate * opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\<48hours after birth). * infant with major congenital anomalies * parent or guardian unable to provide consent * mothers and neonates without history of opioid exposure/dependence

Keywords: microrna saliva neurodevelopmental exosomes infant