Kornimate/medical-research-clean huggingface dataset:
evaluation of aki by measuring the nephrocheck test after pediatric cardiac surgery

Conditions: Acute Kidney Injury; Cardiac Disease; Surgery

Summary: blood and urine samples of over 200 pediatric subjects (over 28 days to 3 years) undergoing complex cardiac surgery with cardiopulmonary bypass (cpb) will be collected at several time points to measure corresponding biomarkers such as serum creatinine, serum urea concentration, or nephrocheck test (\[timp-2\]\*\[igfbp7) to evaluate the diagnostic performance of aki by nephrocheck test .

at least 200 subjects having undergone pediatric cardiac surgery with cardiopulmonary bypass (cpb). enrollment will continue with a maximum of 350 subjects until 30 cases of aki (stage 2 and 3) are reached. blood and urines samples will be collected at several time points to measure biomarkers and set up a biobank. the samples used within the scope of this protocol will be fresh urine samples (1 to 2 ml) and blood samples. urine samples for \[timp-2\]\*\[igfbp7\] measurements will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule: * baseline before initiation of cardiopulmonary bypass (cpb, 0h). * - 2h, 4h, 6h, 8h, 12h, 24h, 48h after initiation of cpb blood samples for serum creatinine and urea concentration measurement will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule: * baseline before initiation of cardiopulmonary bypass (cpb, 0h). * 12h, 24h, 48h, 60h after initiation of cpb primary objective: to evaluate the proportion of subjects predicted to be at risk of aki (stage 2 and 3) using at least one measurement of nephrocheck in subjects having undergone pediatric cardiac surgery. secondary objectives: * to evaluate the incidence of aki (stage 2 and 3) according to the kdigo guideline * to study the kinetic profile of cell cycle arrest biomarkers (timp-2\*igfbp-7) during the first 48 hours in subjects having undergone pediatric cardiac surgery * to determine the baseline values of \[timp-2\]\*\[igfbp7\] in the targeted population before surgery * to determine profile differences of \[timp-2\]\*\[igfbp7\] between aki (stage 2 and 3) and non-aki groups * to evaluate the diagnostic performances of \[timp-2\]\*\[igfbp7\] to predict aki after pediatric cardiac surgery using a cut-off value of 0.3

Eligibility criteria:
inclusion criteria: * must sign the consent form * clinical diagnosis of complex congenital heart surgery (risk adjusted classification for congenital heart surgery \[rachs\] score \>=2) * must undergo elective cardiac surgery with cpb exclusion criteria: * clinical diagnosis of severe pre-existing renal insufficiency (scr \>2 times age-adjusted normal range) * significant abnormalities of the kidneys or genitourinary tract
boost: study of increased dosage of lopinavir/ritonavir (lpv/r)

Conditions: HIV Infections

Summary: this study will look to see if increasing the standard dose of kaletra is tolerated and if it will lower viral loads to undetectable levels. this study will also look at the pharmacokinetic data (amount of kaletra in blood at different times).

there are several reasons for low level viremia in patients on kaletra (lpv/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. little is known about the pharmacokinetics (pk), tolerability and safety of increased doses of lpv/r. the objectives of this 24-week single arm pilot study are to assess the pk parameters, safety, tolerability, change in viral load and cd4 counts on increased dose (600/150 and 800/200 mg) lpv/r in participants with low level viremia on standard dose lpv/r-based art. participants will undergo six pk samplings over 12 hours on standard dose lpv/r. the dose will be increased to 3 tabs (600/150) bid and blood will be sampled for pk after two weeks. if tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) bid and final pk sampling will be performed after two weeks. there will be a one time, optional, optimization of background regimen of nrtis two weeks after the first dose escalation. major eligibility criteria: * cd4 count: \> 50 * viral load: 200-75,000 on two most recent measures * current treatment: \> 16 weeks standard dose (400/100mg bid) lpv/r-based art (no other pi or nnrti allowed * prior treatment experience and resistance profile: up to 20-fold resistance to lpv/r

Eligibility criteria:
inclusion criteria: * cd4 count \>50 * viral load 200-75,000 on two most recent measures * more than 16 weeks on standard dose kaletra (lpv/r) * may be initial pi regimen or prior pi usage * up to 50-fold resistance to lpv/r exclusion criteria: * age \< 18 years old

Keywords: hiv/aids viremia kaletra pharmacokinetics viral load lpv/r treatment experienced
predelivery placental biomarkers- pregnancy and delivery outcome

Conditions: Pregnancy Complications; Placental Insufficiency

Summary: the prepped study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.

the main aim of the prepped study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.

Eligibility criteria:
inclusion criteria: * all pregnant women scheduled to deliver at the department of obstetrics at ouh who qualify for the study groups as specified in the "groups and intervention" section. exclusion criteria: * women who do not understand norwegian or english * communicable disease * younger than 18 years of age * legally incompetent * fetal malformations

Keywords: preeclampsia diabetes in pregnancy fetal growth restriction reduced fetal movements
vitamin d treatment for crohn´s disease

Conditions: Crohns Disease

Summary: the purpose of this study is to examine whether vitamin d treatment is effective in crohn's disease.

crohns disease is an inflammatory disease of primarily the small intestine and colon. in recent years scientists have hypothesized that low blood vitamin-d levels play a role in the development of autoimmune diseases, including crohns disease. the purpose of this study is to examine whether vitamin-d is effective in keeping remission in inactive crohns disease (double blind placebo controlled trial). the patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-d and the effect will be measured within 4 weeks.

Eligibility criteria:
inclusion criteria: * crohn's disease * inactive crohn's disease for at least 4 weeks * crohn's disease activity index (cdai) \< 150 * c-reactive protein within normal range * serum albumin within normal range exclusion criteria: * hypercalcemia * short bowel syndrome * pregnancy

Keywords: vitamin d crohns disease
identification of molecular defects in idiopathic cytopenia of undetermined significance

Conditions: Myelodysplastic Syndromes

Summary: the project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (icus) on the basis of molecular defects found in myelodysplastic syndrome (mds), in order to validate the hypothesis whereby icus may be a precursor of mds

the project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (icus) on the basis of molecular defects found in myelodysplastic syndrome (mds), in order to validate the hypothesis whereby icus may be a precursor of mds. to this end, high-throughput exon sequencing (using next-generation sequencing (ngs)) will be used to target the genes known to be mutated in mds. this study is important for two reasons. firstly, it will help to optimise the clinical monitoring of patients with molecular defects and considered to be at risk of progression. secondly, it will provide a better understanding of the fundamental molecular mechanisms underlying the progression of icus to mds.

Eligibility criteria:
inclusion criteria: * age 18 or over. * haemoglobin \<11 g/dl and/or a polynuclear neutrophil count \<1.5.109/l and/or a platelet count \<100.109/l * full clinical biochemistry/haematological profiling: complete blood count, blood smear, reticulocyte count, iron status, folates, b12, tsh, creatinine, liver enzymes, anas, rheumatoid factor, anticardiolipin antibodies, coombs test, epo assay, serological tests for hiv, hvb and hvc. * availability of a bone marrow differential cell count and an evaluation of myelopoiesis disorders (number of lineages, percentage of cells affected, etc.) plus perls staining. * availability of a cytogenetic analysis. * voluntary provision of written, informed consent * life expectancy \>6 months * social security coverage exclusion criteria: * an obvious cause of anaemia (if isolated): iron deficiency, chronic kidney failure (clearance \ 150g/l) * vitamin b12 or b9 deficiency * hepatomegaly, or clinical and/or ultrasound signs of portal hypertension * clinical and/or ultrasound signs of splenomegaly * abnormal liver enzyme levels: total bilirubin, alkaline phosphatases or transaminases \> 1.5n; gammagt \> 2n. a history of (or diagnostic criteria during screening) auto-immune diseases such as systemic erythematous lupus, antiphospholipid syndrome or evans syndrome. * an abnormal bone marrow differential cell count * a bone marrow karyotype revealing mds * medical, psychological or social conditions that prevent the participant from correctly understanding the study procedures. * legal guardianship and incarceration.

Keywords: idiopathic cytopenia of undetermined significance (icus) molecular defects
dietitian online - internet-based dietetic treatment within health care services

Conditions: Overweight and Obesity

Summary: the project aims to investigate the effect of internet-based dietetic treatment (idt) on patients, dietitians, and society. the project will show: * if idt is equivalent to traditional dietetic treatment with physical meetings * patients' attitudes to, and experiences of, meeting a dietician through video calls * how the dietician's work environment and working methods are affected by idt * if there are subgroups of patients where idt is more or less appropriate * health economic and environmental consequences of idt the major shortage of dietitians leaves patients with non-communicable diseases (ncd) without qualified dietary treatment. in a pilot study, the investigators have shown that idt has great potential to streamline healthcare and increase accessibility. in the project dietitian online, the investigators will conduct an rct with 400 ncd-patients allocated to either idt or standard dietetic treatment to see if idt affect treatment outcome and whether idt is appropriate for everyone. even though internet-based treatment (it) increases rapidly in society, there is little knowledge about the patients' experiences and how healthcare personnel incorporates it in their daily work. the investigators will conduct qualitative studies to meet this knowledge gap. general assumptions are that it is beneficial for society, both economically and environmentally, but very few studies have been done. the project will incorporate a full health-economic evaluation, including environmental impact.


Eligibility criteria:
inclusion criteria: * seeking/being referred to a dietitian for the treatment of obesity (bmi≥25) or obesity in combination with: * type 2 diabetes (hba1c\>48mmol/mol) and/or * elevated blood lipids (total cholesterol \>4,5 mmol/l and/or ldl \>2,5 mmol/l and/or triglycerides \>2,0 mmol/l) and/or * high blood pressure (\>140/90 hg) exclusion criteria: * other diagnoses requiring/might require nutritional treatment (eg cancer, copd) * dementia * severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult * pregnancy * need for interpreter

Keywords: dietetics telemedicine dietitian
interest of impedancemetry in monitoring hydration and hyponatremia during subarachnoid hemorrhages

Conditions: Subarachnoid Hemorrhage (SAH)

Summary: subarachnoid hemorrhage (sah) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces. the main late serious complication is delayed cerebral ischemia (dci), resulting in the appearance of new neurological deficits. prevention of icr involves in particular maintaining euvolemia, and early treatment of hyponatremia, itself dependent on the level of volume. evaluation of water status and sodium balance is therefore essential. this assessment is complicated and relies on indirect parameters, both clinical and biological. impedancemetry, making it possible to measure water volumes and sodium load, could be an aid in the management of blood volume and sodium intake.


Eligibility criteria:
inclusion criteria: * adult man, woman * hospitalized following subarachnoid hemorrhage within 72 hours of bleeding * admitted to the neurological intensive care unit for less than 48 hours * being able to understand the ins and outs of the study * having expressed his non-opposition exclusion criteria: * patients under legal protection * pregnancy

Keywords: subarachnoid hemorrhage impedancemetry hydration
open registry measuring impact of genomic testing on treatment decision after biopsy in newly diagnosed prostate cancer patients

Conditions: Prostate Cancer

Summary: this registry is intended to measure the impact of prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.


Eligibility criteria:
inclusion criteria: * newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics. * clinically localized (no evidence on clinical or imaging studies of advanced disease. * no hormonal therapy including lhrh agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable. * sufficient amount of tissue remains from biopsy to perform genomic testing. exclusion criteria: * patients with known history of hypogonadism will be excluded from the registry
clinical trial to evaluate the safety and efficacy of the addition of sitagliptin in participants with type 2 diabetes mellitus receiving acarbose monotherapy (mk-0431-130)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate whether the addition of sitagliptin reduces hemoglobin a1c (a1c) more than the addition of placebo for participants with type 2 diabetes mellitus (t2dm) on a steady dose of acarbose. the primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces a1c more than the addition of placebo in participants with t2dm with inadequate glycemic control on acarbose monotherapy.

the study includes an 8-week antihyperglycemic agent (aha) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. all participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods. \*: wash-off only applicable to patients who were on acarbose and another aha.

Eligibility criteria:
inclusion criteria: * has t2dm and is on acarbose alone at a stable dose of at least 50 mg t.i.d.(three times a day) for at least 10 weeks or on acarbose at a stable dose of at least 50 mg t.i.d. (three times a day) for at least 10 weeks in combination with another antihyperglycemic agent (aha) * is at least 18 years of age (for participants in india: between 18 and 65 years of age) * male or female who is unlikely to conceive (not of reproductive potential, or agrees to remain abstinent or use \[or have partner use\] acceptable birth control if of reproductive potential) exclusion criteria: * has a history of type 1 diabetes mellitus * use of thiazolidinedione (tzd), dipeptidyl peptidase-4 (dpp-4) inhibitors, glucagon-like peptide-1 (glp-1) receptor agonists, or insulin * has the following cardiovascular disorders: acute coronary syndrome; new or worsening symptoms of coronary heart disease; coronary artery intervention; stroke or transient ischemic neurological disorder * has liver or kidney disease * has cancer or any clinically significant disease or disorder as judged by the investigator

Keywords: type 2 diabetes mellitus t2dm
registry of acute coronary syndrome in the regional cardiovascular center

Conditions: Аcute Coronary Syndrome

Summary: the study is a prospective registry of patients consequently admitted to the regional cardiovascular center with a diagnosis of acute coronary syndrome, in order to study the behavior of patients from the first minutes of the onset of the anginal syndrome, and influence of the delay in calling of ambulance on short-term and long-term outcomes of the disease. other factors which may influence short-term and long-term outcomes will also be assessed.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18 and over, permanently residing in the moscow region and in moscow. 2. patients hospitalized in the regional vascular center of stupino clinical hospital (gbuz mo skb) with a diagnosis of acs with and without st-segment elevation. 3. signing an informed consent form to participate in the study and the processing of personal data, as well as conducting a telephone survey during the follow-up. exclusion criteria: 1. the patient's refusal to participate in the study and to allow the use of personal data during the study. 2. the presence of mental illness. 3. the patient plans to leave russia for permanent or long-term residence.

Keywords: acute coronary syndrome percutaneous coronary intervention unstable angina acute myocardial infarction
an exploratory study of the effects of a single dose of qax576 (an interleukin-13 monoclonal antibody) on simulated hayfever

Conditions: Allergic Rhinitis

Summary: this study will investigate whether a single dose qax576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever


Eligibility criteria:
inclusion criteria: * history of allergic rhinitis. exclusion criteria: * respiratory disease other than mild intermittent asthma. * received immunotherapy in past 3 years. * history of clinically significant drug allergy. * history of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis. * history of exposure to human therapeutic antibodies, immunoglobulins or other plasma products. other protocol-defined inclusion/exclusion criteria may apply

Keywords: allergic rhinitis, adults, monoclonal antibody, interleukin-13.
efficacy and safety of mp-424, peginterferon alfa-2b and ribavirin in non-responder genotype 2 hepatitis c infected patients

Conditions: Chronic Hepatitis C

Summary: this study will evaluate the efficacy and safety of mp-424 with peginterferon alfa-2b and ribavirin (rbv) in patients with genotype 2 hepatitis c, who did not respond to previous treatment.


Eligibility criteria:
inclusion criteria: * genotype 2, chronic hepatitis c * non-responders (patient who did not respond to previous treatment) * able and willing to follow contraception requirements exclusion criteria: * cirrhosis of the liver or hepatic failure * hepatitis b surface antigen-positive or hiv antibodies-positive * history of, or concurrent hepatocellular carcinoma * history of, or concurrent depression, schizophrenia,; or suicide attempt in the past * pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Keywords: genotype 2
oral health perception and difficulties encountered by parents in the implementation of oral hygiene of children under 6

Conditions: Carious Disease

Summary: a qualitative analysis was carried out on 15 participants, in 3 different places: the montpellier health center, a pediatric odontology practice in nîmes and a dentistry practice in marseille. two methods of analysis were chosen: thematic analysis and word counting.


Eligibility criteria:
inclusion criteria: parent or caregiver with at least one child under 6 years of age, with caod ≥ 1 and high rci exclusion criteria: * patient refusing to participate in the study. * patient who does not understand the french language or who has difficulty expressing himself.

Keywords: therapeutic patient education having one child who as less than 6 years old pediatric dentistry oral health chronic disease
cintec plus triage in hpv primary screening

Conditions: Cervical Cancer

Summary: prospective study which will recruit participants when they attend for a routine cervical screening. the study will evaluate the use of cintec plus for triage of human papillomavirus (hpv) positive participants in hpv primary screening.

the study will recruit participants (9800) prospectively by verbal invitation from the sample taker when they attend for their cervical screening test. recruitment will take up to one year to complete. participants in the study will undergo primary hpv testing. this will be followed by cervical cytology testing as per the normal national health service cervical screening programme (nhscsp) screening invitation pathway. participants testing hpv negative will have reached their end point and will exit the study. participants who test hpv positive will be triaged by cytology (the cytology screening result, available through the nhscsp screen will be used). participants with moderate or severe dyskaryosis (high-grade disease) will be immediately referred to colposcopy (as per nhscsp guidelines) without further testing. participants with borderline or mild dyskaryosis (low-grade findings) will undergo cintec plus cytology triage simulation; however, regardless of the cintec plus result, all participants will also be referred to colposcopy as per nhscsp guidelines. participants with negative cytology will undergo cintec plus cytology triage and those testing positive (an indication of increased risk of cin2+ \[high-grade disease\]) will be referred to colposcopy. participants with negative cytology who also test cintec plus negative will only be referred to colposcopy if they have tested positive for hpv16 or hpv18 as these 2 genotypes have been shown to confer an elevated risk for cin2+ compared with the other hpv types. participants with negative cytology who also test cintec plus negative and have tested positive for non hpv16 and hpv18 types will undergo repeat hpv testing at 12 months as the low risk of cin2+ associated with these participants does not justify immediate colposcopy referral and is unlikely to be granted ethical approval. clinical outcomes based on colposcopy and/or histology and/or cervical cytology will be recorded. all biopsies will have one slide stained with cintec histology (p16). the risk of cin2+ will be evaluated for all participants in the study. subsequently, clinical performance of cintec plus cytology will be evaluated. this work will also include a cost analysis.

Eligibility criteria:
inclusion criteria: * consenting women aged 25y-64y attending for cervical screening exclusion criteria: * women aged \ 64y