Kornimate/medical-research-clean huggingface dataset:
nitrogen balance in infants after post cardiothoracic surgery

Conditions: Congenital Heart Disease

Summary: the objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. without appropriate nutritional consideration this process can lead to increased physiological instability. it has been extensively documented that critically ill patients are typically catabolic. this results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. the evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay. the results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.

Eligibility criteria:
inclusion criteria: * clinical decision to initiate parenteral nutrition based on determination by medical team * gestational age ≥ 35 weeks * birth weight ≥ 2000 grams * indwelling urinary catheters for urine collection * central venous access for parenteral nutrition exclusion criteria: * chromosomal abnormalities known to effect protein metabolism * hepatic failure defined as alt and ast \> 500 ul with an inr \> 2.5, not accounted for by therapeutic anticoagulation * renal failure defined as creatinine 2x the upper limit of normal for age. * sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics * excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the cccu; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study * requiring extra corporeal membrane oxygenation (ecmo) support

Keywords: infants nitrogen balance cardiothoracic surgery congenital heart disease malnutrition
descriptive study of the incidence of malignancy in severe asthma patients receiving benralizumab and other biologic therapy, a post authorization safety study

Conditions: Asthma; Neoplasms

Summary: this is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the international severe asthma registry (isar) and the us severe asthma registry (chronicle) and followed-up for occurrence of new malignancies. the primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. the secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.


Eligibility criteria:
inclusion criteria: * the study population includes patients with severe asthma recruited into isar and chronicle. severe asthma patients are defined as those receiving treatment consistent with global initiative for asthma (gina) step 5 or who are uncontrolled on gina step 4 treatment regimens. exclusion criteria: - patients who are not willing and able to sign written informed consent
a telemedicine mindfulness-based intervention for people with multiple sclerosis and their caregivers

Conditions: Multiple Sclerosis

Summary: the aim of the project is to investigate the impact of a multiple sclerosis specific telemedicine mindfulness-based intervention on the quality of life of people with multiple sclerosis and their caregivers.

the mindfulness protocol will be modified according to multiple sclerosis clinical peculiarities and implemented with a multimedia web-based software. the project will be divided in two parts. during the first phase of the project, a standard mindfulness-based stress reduction protocol will be modified according to clinical peculiarities and specific needs of people with multiple sclerosis. in the meanwhile, a multimedia software with these teaching will be developed, so that the training could be available online, from home. the protocol and the software will be tested for ergonomics in a pilot, qualitative, study. in the second phase, a randomized clinical trial will be performed. one-hundred and twenty multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental or to the control group. subjects in the experimental group will attend the telemedicine mindfulness intervention, while controls will join a psycho-educational telemedicine program. at baseline, post-treatment and at a 6-month follow-up, participants will be assessed for quality of life, anxiety, depression, quality of sleep and mindfulness level. a subgroup of subjects will be assessed with actigraphs, for an objective evaluation of their sleep and physical activity. experimental subjects will be assessed for participation and engagement to the treatment. data will be analyzed with a complex longitudinal design, considering both within and between groups comparisons. the dissemination process will involve scientific publication on neurological and psychological journals, a book, scientific meeting presentations and communication to general media. if there will be a positive effect of the mindfulness software, it will be diffused to multiple sclerosis clinics and associations.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting or secondary progressive multiple sclerosis. * ability to communicate and to understand tasks. * no change of disease-modifying treatment in the 3 months before the enrolment. * no clinical relapses or use of steroid treatment during the 4 weeks before the enrolment. * availability of a personal computer, smartphone or tablet (compatible with the software). * provided informed consent for study participation. exclusion criteria: * being a person who lives with the multiple sclerosis patient and provides him/her with most care and assistance * ability to communicate and to understand tasks * availability of a personal computer, smartphone or tablet (compatible with the software). * provided informed consent for study participation

Keywords: caregivers
efficacy and safety evaluation of prebiotics combined with quadruple probiotics in improving functional constipation.

Conditions: Functional Constipation

Summary: in this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open rct study. the experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. the patients took the combination of prebiotics and probiotics twice a day during the treatment period. the control group received only lifestyle instruction. at the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.

the purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. we will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. at the same time, we will use the bristol fecal traits scale (bsfs) and the constipation patient self-rating scale (pac-sym) and constipation patient quality of life scale (pac-qol) scores completed weekly. in addition, we will monitor indicators of inflammation (il-1β, il-6, tnf-alpha) and intestinal barrier function (lps), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation.

Eligibility criteria:
inclusion criteria: 1. age: between 18 and 60 years old 2. functional constipation was diagnosed using rome iv criteria. 3. no other relevant medications that may affect the gut microbiota before the start of the experiment 4. ability to participate 5. consent to participate in the study exclusion criteria: 1. organic constipation (such as intestinal obstruction, bowel cancer, etc.) 2. outlet obstructive constipation 3. previous abdominal, rectal, or perianal surgery except cholecystectomy, appendectomy, tubal ligation, and cesarean section 4. patients with constipation-oriented irritable bowel syndrome (ibs-c) or functional abdominal pain syndrome who meet rome iv criteria 5. a serious mental illness or any medical condition related to it 6. diseases of the small or large intestine, such as ulcerative colitis and crohn's disease 7. there are serious important organs such as respiratory, heart, liver, kidney and other functional insufficiency 8. use probiotics, prebiotics and/or biostime within 1 month

Keywords: prebiotics probiotics functional constipation randomized controlled trial
cardiovascular outcomes in the va's rheumatoid arthritis(vara) population

Conditions: Rheumatoid Arthritis; Cardiovascular Disease; Coronary Disease

Summary: rheumatoid arthritis (ra) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. however, the effects of ra are not confined simply to joint involvement. virtually every organ system can be affected by ra if left untreated. of particular note is ra's affect on the cardiovascular system. ra patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). recently, ra has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). women with ra have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). despite these studies showing the effects of ra on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large ra patient population to a risk factor and age matched control group. consequently it is the goal of this study to determine whether the cardiovascular event ratio in an ra patient cohort exceeds an age and risk factor matched cohort of non-ra patients. this study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with ra and if any standard cardiovascular medicines disproportionately contribute to patient outcome. hypothesis: given the increased cardiovascular disease burden associated with ra patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.


Eligibility criteria:
inclusion criteria: * patient included in the va rheumatoid arthritis database previously, who by definition will meet criteria for ra. * control subjects will not carry the diagnosis of ra.

Keywords: rheumatoid arthritis cardiovascular disease coronary disease
study of interferon-gamma in the complex treatment of patients infected with hiv and tuberculosis

Conditions: HIV Coinfection; Aids/Hiv Problem; Tuberculosis, Pulmonary; Human Immunodeficiency Virus; Lentivirus Infections; RNA Virus Infections

Summary: the primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of hiv and pulmonary tuberculosis and to determine the rational of its use.

study will evaluate safety and efficacy of the investigational medical product (imp) - interferon-gamma - in participants with hiv-infection and pulmonary tuberculosis. interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by nk-cells, cd4 th1 cells and cd8 cytotoxic supressor cells. interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. causes cytotoxic effects on the cells infected by intracellular pathogens. possess a bright immunomoduling action. thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and hiv. the aim of interferon-gamma use is to achieve a viral replication control, support cd4 level and help abacillation process. in this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 iu daily or every other day. the treatment regimen in this study will also include a basic antituberculosis therapy. the available clinical data do not suggest a risk for serious adverse events (saes) from the imp used in chosen doses. the study will screen hiv-infected participants 18-50 years old with pulmonary tuberculosis. participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. the study will last 30 days, during which participants will receive imp in various regimens according to the group.

Eligibility criteria:
inclusion criteria: * participants must sign the form of informed consent and agree to follow the protocol requirements * women willing to participate in the study must protect against possible pregnancy during all the study long * age 18-50 years * pulmonary tuberculosis * hiv/aids * indication for in-patient standard antituberculosis treatment exclusion criteria: * investigational research agents received within 30 days before the screening and participation in other clinical trials * immunosuppressive medications received within 6 months before the screening * current drug abuse for more than 3 years * contraindications to interferons of standard antimicrobial therapy

Keywords: interferon gamma, ifn-g, hiv infection, tuberculosis
pharmacokinetic and safety study of lower doses of ceritinib taken with a low-fat meal versus 750 mg of ceritinib in the fasted state in adult patients with (alk-positive) metastatic non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: a phase i study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with alk rearranged (alk-positive) metastatic non-small cell lung cancer (nsclc)

this was an open-label, randomized, multi-center, parallel design, phase i study in which the systemic exposure, efficacy and safety of ceritinib administered at 450 mg or 600 mg with a low-fat meal vs 750 mg in the fasted state was assessed in subjects with alk+ nsclc following multiple oral daily dosing of ceritinib. subjects were randomized in a 1:1:1 ratio to once daily doses of oral ceritinib (450 mg following a low-fat meal, 600 mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach). randomization was stratified by brain metastases at screening (presence or absence) and by prior treatment (prior crizotinib use with alk+ determined by fluorescent in situ hybridization (fish); crizotinib-naïve but could be previously treated with other systemic anti-cancer therapy with alk+ determined by fish, or treatment-naïve subjects with alk+ by ihc).

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of stage iiib (and is not a candidate for definitive multimodality therapy) or iv alk-positive nsclc. * patients may have received one prior treatment regimen with crizotinib (all other alk inhibitors are excluded). * patients may have received prior chemotherapy, biologic therapy, or other investigational agents. alk inhibitors other than crizotinib are excluded. * patient has a world health organization (who) performance status 0-2. exclusion criteria: * prior treatment with an alk inhibitor other than crizotinib. * history of carcinomatous meningitis. * presence or history of a malignant disease other than an alk-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years. * clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) * patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). * patient has other severe, acute, or chronic medical conditions * patient is currently receiving treatment with warfarin sodium (coumadin®) or any other coumarin-derivative anticoagulants.

Keywords: ldk378 ceritinib alk+ alk positive nsclc lung cancer
study of genetic anomalies of complement related proteins in patients with iga glomerulonephritis

Conditions: IGA Glomerulonephritis

Summary: objectives: i. determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and fc receptor fcgriii contribute to the pathogenesis of iga glomerulonephritis (iga-n). ii. compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset iga-n vs normal controls.

protocol outline: participants undergo qualitative genetic analysis of complement-related proteins. studies include: genomic re-arrangement of 4-gene unit, c4 dna sequence and rna expression, type-1 complement receptor dna sequence, fc-gamma receptor iiia isoform analysis, classical and alternative complement activation pathway assays, plasma c4 and c4d protein levels, and immunoglobulin patterns in glomerular deposits.

Eligibility criteria:
* iga glomerulonephritis

Keywords: iga glomerulonephritis rare disease renal and genitourinary disorders
study of safety and effects of garetosmab in healthy obese men and post-menopausal women

Conditions: Obesity

Summary: this study is researching an experimental drug called garetosmab, referred to as "study drug". the study is focused on otherwise healthy participants with obesity. the aim of the study is to see how safe and tolerable the study drug is. the study is looking at several other research questions, including: * how much study drug is in the blood at different times * what effect the study drug has on the blood clotting * what effect the study drug has on hormone levels * what effect the study drug has on some organs that produce hormones * what effect hormones have on the side effects produced by the study drug * whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. participants with obesity (defined as body mass index (bmi) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol 2. women must be postmenopausal, as defined in the protocol 3. serum testosterone within age-adjusted normal range for men at screening 4. the platelet count is within the normal lower and upper laboratory range key exclusion criteria: 1. patients diagnosed with type 1 or type 2 diabetes, as defined in the protocol 2. history of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol 3. history of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol 4. any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease 5. any chronic active infection or has received anti-hepatitis c virus (hcv) treatments within the previous 6 months, as defined in the protocol 6. antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer 7. use in the previous 90 days for \>7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed 8. for women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy note: other protocol-defined inclusion/exclusion criteria apply

Keywords: healthy postmenopausal
diagnosis of fabry disease: impact of an educational brochure intended for cardiologist

Conditions: Cardiomyopathies

Summary: the cardiac fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. they are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. fabry disease and heart attacks are still diagnosed late. this delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. the importance of early diagnosis of fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. with the blotter, we now have a simple and robust screening tool for fabry disease, achievable consultation. targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. we offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of fabry disease in normandy.


Eligibility criteria:
inclusion criteria: * patient with left ventricular hypertrophy of unknown etiology or of sarcomeric mhc pace, followed in normandy, has given its consent to the search of fabry disease criteria exclusion: * patients under 18 years patient refusal to participate in the study. lack of consent to the search of fabry disease