Kornimate/medical-research-clean huggingface dataset:
ketoanalogues for muscle mass loss in nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the goal of this non-commercial clinical trial is to assess efficacy and safety of ketoanalogues of essential amino acids in the prevention of protein-energy wasting in nephrotic syndrome.

adult patients with new diagnosis or relapse of nephrotic syndrome and glomerular filtration rate of ≥ 30 ml/min/1.73m2 will be included in the study. exclusion criteria will be a secondary cause of nephrotic syndrome, morbid obesity and severe diseases affecting nutritional status. participants will be randomly assigned to the intervention group (ka+mpd) or control group (mpd); randomization will be stratified by type of glomerular disease (podocytopathy or other type) and investigational site. the control group will follow the diet recommended in nephrotic syndrome - a medium protein diet (mpd) - under the care of a dietitian. intervention group will receive ketosteril (1 tablet for every 5 kg of ideal body weight) as an addition to the diet. all patients will also receive treatment for underlying glomerular disease in accordance with current guidelines and local practice. the main objective is to assess the efficacy of ketosteril as an add-on therapy in preventing the loss of lean tissue mass (ltm) over 6 months compared to a standard diet. the additional aims include the assessment of muscle function parameters, nephrotic syndrome severity and laboratory indicators of catabolism.

Eligibility criteria:
inclusion criteria: * nephrotic syndrome with serum albumin \ 3.5 g/day or \> 50 mg/kg; * new diagnosis or relapse of nephrotic syndrome (defined as: proteinuria of \< 2.0 g/day or upcr \< 2000 mg/g in the last 6 months prior to relapse and prednison dose equal to or less than 10 mg/day in the last 3 months prior relapse); * glomerular filtration rate qual to or higher than 30 ml/min/1.73m2 based on chronic kidney disease epidemiology collaboration (ckd-epi) equation. exclusion criteria: * diabetic kidney disease; * small vessels vasculitis; * systemic lupus erythematosus; * positive antinuclear antibodies, anti-dsdna or antineutrophil cytoplasmic antibodies (anca); * positive anti-hiv or anti-hepatitis c antibodies, hbsag; * hba1c \>7%; * monoclonal gammopathy; * pregnancy; * body mass index \>= 40 kg/m2; * severe acute or chronic disease affecting nutritional status; * neoplasm; * contraindication to ketosteril; * alcohol or drug abuse; * mental disorders; * failure to comply with medical recommendations, lack of cooperation; * participation in other clinical trial or the use of ketosteril in the last 1 year prior to screening.

Keywords: nephrotic syndrome protein-energy wasting neph-pew lean tissue mass ketosteril ketoanalogues
user experience of a telemedicine platform for the follow-up of post intensive care syndrome (pics)

Conditions: Critical Illness

Summary: survivors of critical illness may present with a set of physical, emotional and cognitive sequelae, known as post intensive care syndrome (pics). these alterations can become chronic over time and significantly affect patients' quality of life. therefore, follow-up and monitoring of critically ill patients after icu discharge, for example through telemedicine, could be essential for the prevention, early detection and management of pics. our main objective is to evaluate the suitability and user experience of a telemedicine platform from the perspective of critically ill patients. this study proposes the participation of icu survivors in the design and improvement of a telemedicine platform for pics follow-up through a qualitative approach. participants will test the platform in person three months after discharge from the icu and then undergo a semi-structured interview to assess their experience. the findings derived from this study may contribute to improve both the content and the format of the platform, optimizing resources and facilitating the management of post-icu sequelae, which will have a positive impact on the patient's recovery process.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * admitted to a medical/surgical icu * for respiratory failure, cardiogenic shock, or septic shock * with an expected icu stay of ≥48 hours * catalan and/or spanish speakers * who are able to give informed consent by themselves exclusion criteria: * history of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder * history of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, alzheimer's disease, parkinson's disease or multiple sclerosis * history of brain damage, such as traumatic brain injury or stroke * history of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder * suspected or confirmed substance use disorder * suspected or confirmed communicable disease in an isolated patient * uncorrected hearing or visual impairment * enrolled in another trial that does not allow co-enrollment

Keywords: qualitative research post-intensive care syndrome
dexrar: dexamethasone in revision arthroplasty

Conditions: Pain, Postoperative

Summary: trial name: dexrar: dexamethasone in revision arthroplasty: a randomised, blinded, 2-group clinical trial trial acronym: dexrar background: effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. no "gold standard" exists for pain treatment after revision total knee arthroplasty (tka) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy. objectives: the objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-tka in combination with paracetamol, ibuprofen and local infiltration analgesia intervention: the patients are randomised into to groups: a) 24 mg dexamethasone i.v. b) isotonic saline i.v. design and trial size: placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. blinding of assessor, investigator, caregivers and patients. sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.


Eligibility criteria:
inclusion criteria: * scheduled for unilateral, revision-tka: total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s). * age \> 18 * american society of anesthesiologists (asa) physical status classification system asa 1- 3. * body mass index (bmi) \> 18 and \< 45 * women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (hcg) pregnancy test * patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions. exclusion criteria: * patients who cannot cooperate with the trial. * concomitant participation in another trial involving medication * patients who cannot understand or speak danish. * patients with allergy to medicines used in the trial. * patients with daily use of methadone. * contraindications against nsaid, for example previous ulcer, heart failure, liver failure, or renal failure (egrf \< 60 ml/kg/1,73m2), known thrombocytopenia (\<100 mia/l) * patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.

Keywords: dexamethasone arthroplasty, replacement, knee revision
summary of infants weighing 500 grams or less

Conditions: Infant, Extremely Low Birth Weight; Microcephaly

Summary: this is a retrospective single-center cohort study. the comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.

this is a retrospective single-center cohort study. the study setting is a level iv neonatal intensive care unit (nicu) at nagano children's hospital in nagano, japan. we will retrospectively collect the data of those who were admitted to nagano children's hospital nicu between january 1, 2015, and december 31, 2019. eligible infants will be identified using our neonatal database and clinical records. the extracted data includes maternal background information and clinical course, infant's status at birth, the clinical course in nicu, and the follow-up data at 6 and 18 months of corrected age. among the eligible infants, those with a z score of birth head circumference \< -2 will be classified into the microcephaly group and others into the control group. the z score is calculated using the japanese growth standard.

Eligibility criteria:
inclusion criteria: * live-born infants weighing ≤ 500 g at birth * infants whose clinical course is available in the electronic medical record exclusion criteria: * stillbirths * infants who received only palliative care at birth * outborn infants * infants whose assessment at 3 years of age not completed at data analysis

Keywords: 500 grams or less prognosis
observatory: search for prognostic factors of pulmonary hypertension post-capillary in heart failure

Conditions: Heart Failure; Post-capillary Pulmonary Hypertension

Summary: this study will better understand the post-capillary pulmonary hypertension in heart failure, to determine its prognostic role and to consider specific treatment of different forms of pulmonary hypertension in post-capillary pulmonary heart failure.

patients with heart failure (hf) frequently have a post-capillary pulmonary hypertension (htpcap) which has two forms: passive and reactive. the prognosis, prevalence and pathophysiological mechanisms of cell and tissue involved in the onset and reversibility of these two forms of htpcap remain poorly understood. the latest recommendations of the european society of cardiology and the european respiratory society identify two forms of htpcap in the ic as a function of the extent of trans-pulmonary gradient (gtp) measured during right heart catheterization (gtp = mpap-pcap): passive (gtp £ 12mmhg) and reactive (gtp\> 12mmhg). in the latter form, the increase in pulmonary pressure would be disproportionate to the increase in left ventricular pressures. this study will permit to identify hemodynamic prognostic markers of the the ic, and clinical, biological and hemodynamic determinants of the htpcap in the ic. this will help to identify a population that could benefit from specific treatment to referred pulmonary artery.

Eligibility criteria:
inclusion criteria: * patient with heart failure (lvef preserved or altered or valvular heart disease) defined by a history of heart failure or lvef less than or equal to 50%. * patient with a right heart catheterization for medical reasons * medical treatment considered optimal: beta blockers, ace inhibitors or angiotensin ii receptor antagonists and/or aldosterone * stable patient: no significant cardiac decompensation or change the dose of diuretics for 28 days. * the patient has agreed and have signed consent. exclusion criteria: * patient is younger than 18 years. * patient with unstable heart failure (cardiogenic shock, acute cardiac decompensation). * coronary heart disease for which there is a maximum revascularization * organic valvular which is scheduled for surgical correction of valvular abnormality (plasty or replacement). * patient dialysis. * pah original pre-capillary catheterization, defined by a pcap ≤ 15 mmhg. * patient with triple installation of pm within 90 days. * patients who underwent revascularization within 90 days. * patients who underwent mechanical ventricular assistance. * patient with severe lung infection (cpt \< 60% of predicted, fev \< 60% predicted) or pulmonary embolism or respiratory failure with a pao2 in ambient air below 60mmhg or oxygen therapy. * patient with severe heart rhythm.

Keywords: observatory heart failure post-capillary pulmonary hypertension htpcap
electrophysiologic parameters and biomarkers predicting treatment response in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder to explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

case-control study repeated measures design

Eligibility criteria:
inclusion criteria: * dsm-iv-tr major depressive disorder * aged between 20 and 80 * durg-naive or drug-free exclusion criteria: * dsm-iv-tr substance-related disorders (except nicotine) * significant medical or neurological conditions * mental retardation or organic brain damage

Keywords: depression treatment electrophysiology biomarker
glycaemic control of biphasic insulin aspart 70 and 30 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * treatment with bhi (biphasic human insulin) 30 twice daily for at least three months * hba1c maximum 10.0% * bmi (body mass index) maximum 35.0 kg/m2 * able and willing to perform self-blood glucose monitoring (sbgm) exclusion criteria: * the receipt of any investigational drug within the last 30 days prior to this trial * total daily insulin dose minimum 2.0 u/(kg·day) * a history of drug abuse or alcohol dependence within the last 5 years * impaired hepatic function * impaired renal function * cardiac disease * severe, uncontrolled hypertension
dose escalation trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous aln-vsp02 in patients with advanced solid tumors with liver involvement

Conditions: Solid Tumors

Summary: the purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous aln-vsp02, an rnai therapeutic, in patients with advanced solid tumors with liver involvement.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy * patient has measurable tumor in the liver * at least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery * patient has an eastern cooperative oncology group (ecog) performance status score of 0-1 * patient has adequate hematologic, liver, and renal function * patient is seronegative for hepatitis b virus (hbv) and hepatitis c virus (hcv) * patient has a life expectancy \> 12 weeks exclusion criteria: * patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin \> 325 mg/day or other platelet inhibitory agents * patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrythmia * patient has known active brain or leptomeningeal metastases * patient has clinically significant cerebrovascular disease * patient has a seizure disorder not controlled on medication * patient has a known or suspected viral, parasitic or fungal infection * patient previously experienced a severe reaction to a liposomal product * patient has a known hypersensitivity to lipid products

Keywords: liver solid tumors advanced solid tumors with liver involvement
systemic lupus erythematosus within the framework of the multidisciplinary consultation

Conditions: Systemic Lupus Erythematosus

Summary: diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in brest ( france)

all patients coming to the lupus multidisciplinary consultation in brest ( france) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. in case of articular involvement, some xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .

Eligibility criteria:
inclusion criteria: * women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( france). * with written consentment exclusion criteria: * patients less than 18 years old * refusing to participate * under legal protection

Keywords: cutaneous lupus
dailies total1® lubricity post wear

Conditions: Refractive Error

Summary: the primary objective of the study is to demonstrate that the lubricity of dailies total1® (dt1) lenses after 16 hours of wear is equivalent to the lubricity of unworn dt1 lenses.

in this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. the ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Eligibility criteria:
inclusion criteria: * willing and able to sign informed consent document. * adapted, current soft contact lens wearer. * requires contact lens powers within the specified range of -0.50 diopters (d) to -10.00d. * cylinder between 0.00d and -1.00d (inclusive) in both eyes at visit 1 manifest refraction. * vision correctable to 20/25 or better in each eye at distance with study lenses. * willing to wear study lenses at least 16 waking hours in one day and attend all study visits. * able to be successfully fitted with study lenses. * other protocol-specified inclusion criteria may apply. exclusion criteria: * any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the investigator. * use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator. * use of artificial tears and rewetting drops during the study. * monocular (only one eye with functional vision) or fit with only one lens. * any abnormal ocular condition observed during the visit 1 slit lamp examination. * history of herpetic keratitis, ocular surgery, or irregular cornea. * pregnant. * participation in any clinical study within 30 days of visit 1. * other protocol-specified exclusion criteria may apply.

Keywords: dt1 dailies total1® lubricity
gut microbiota, mitochondrial function and metabolic health in obesity

Conditions: Obesity Adult Onset

Summary: it has been suggested that individuals with the condition known as metabolically healthy obesity (mho) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. in addition, to date, the identification of metabolic biomarkers and microbiota underlying the mho state is limited. in this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. to achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. in parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (bmi\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ros) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[mitofusin 1 (mfn1), mitofusin 2 (mfn2), mitochondrial fision protein 1 (fis1) and dynamin-related protein 1 (drp1) by rt-pcr and western blot\], markers of inflammation \[interleukin 6 (il6), tumoral necrosis factor alpha (tnfα), il1b, adiponectin, resistin, plasminogen activator inhibitor 1 (pai-1), monocyte chemoattractant protein-1 (mcp-1), caspase 1 and nlrp3 by western blot and technology xmap), metabolomic assay (nmr spectroscopy and pls-da), as well as gut microbiota content and diversity (16s rrna, miseq sequencing). finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers.


Eligibility criteria:
inclusion criteria: * patients with bmi≥30kg/m2, with at least 5 years of diagnosed obesity evolution. * patients have had stable body weight (±2 kg) during the 3 months prior to the study. exclusion criteria: * all patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, cushing's syndrome), and established liver and kidney failure (according to transaminase levels ±2 sd of the mean and estimated glomerular filtration rate using the ckd-epi formula \>60) will be excluded.

Keywords: metabolic syndrome very low-calorie diet microbiota oxidative stress inflammation
spanish validation of quality of life questionnaire (qolie-10) for epilepsy

Conditions: Epilepsy

Summary: validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. determination and assessment of the comparative safety of lamotrigine or valproic acid. assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy and normal neurological examination. * patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before. exclusion criteria: * pregnant or lactating women. * previous treatment with lamotrigine or valproic acid. * secondary epilepsy.

Keywords: quality of life qolie-10 epilepsy lamotrigine validation of questionnaire
treatment of refractory urinary retention secondary to benign prostatic hyperplasia (bph) with dual five alpha reductase inhibition combined with an alpha blocker

Conditions: Urinary Retention; Benign Prostatic Hyperplasia

Summary: to determine whether the addition of a dual five alpha reductase inhitor (dutasteride) will alleviate urinary retention secondary to bph in who have failed a voiding trial without a catheter. following treatment with an alpha blocker alone.


Eligibility criteria:
inclusion criteria: 1. males betewen the ages of 50 and 90 years of age.written informed consent. 2. men with acute urinary retention attributed to bladder outlet obstruction caused by bph, who have failed atleast 1 week trial of alpha blocker treatment. 3. psa level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml. exclusion criteria: 1. urinary retention attributed to a neurogenic or myogenic bladder dysfunction. 2. use of psychotrophic medications. 3. use of antichollinergic medications. 4. prostate cancer. 5. allery to five alpha reductase inhibitors. 6. prior prostate surgery. 7. urethral stricture. 8. bladder calculi. 9. invasive bladder cancer. 10. inability to understand or agree with the requirements of the study. 11. any investigational drug received within 30 days prior of study entry.

Keywords: urinary retention secondary to benign prostatic hyperplasia