Kornimate/medical-research-clean huggingface dataset:
the intestinal dysbacteriosis in the pathogenesis of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis of Newborn

Summary: study description the goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. the main questions it aims to answer are: * 1. whether there is intestinal flora in the stool of premature infants. * 2. are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis. * 3. the detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. participants, premature infants diagnosed as necrotizing enterocolitis (nec group), will be asked to collect stool (usually 2 times) for intestinal flora analysis. if there is a comparison group: researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their nec counterparts.

when the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. after sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (nec group) and premature infants without necrotizing enterocolitis (control group). their stool and blood (usually 2 times ) are collected for intestinal flora and fabp (including l-fabp and i-fabp) analysis, respectively.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of necrotizing enterocolitis, * gestational age \<37 weeks, * body weight 1,000-2,500 g, * postnatal apgar score ≥7, * initial oral feeding tolerance. exclusion criteria: * serious hereditary or other serious diseases, such as heart, lung and abdominal malformations , * early or late onset septicemia, * early use of antibiotics in the newborn, * serious adverse reactions caused by probiotics.

Keywords: necrotizing enterocolitis intestinal flora
prevention of complications (sars-cov-2): clinical study

Conditions: Complication

Summary: viral diseases have always posed a threat to public health. recently, the sars-cov2 virus spread in an epidemic that began in china and soon spread globally, making its study extremely relevant, in order to seek mechanisms to combat it. therefore, this study seeks to evaluate the benefit of using hydroxychloroquine with or without apixaban in the early treatment of patients with suspected covid-19. prospective, randomized, double-blind, controlled study, performed at hospital das clínicas samuel libânio (universidade do vale do sapucaí) univás, pouso alegre, minas gerais, brasil. patients treated in the emergency department who are reported as suspected cases of covid-19 patients will be included, according to current guidelines. will be randomized into 4 groups: hydroxychloroquine, hydroxychloroquine + apixabana, only apixabana and control group, all receiving standard treatment recommended. included patients will be monitored during hospitalization or remotely assisted in home treatment. clinical, laboratory, electrocardiographic and image evaluation criteria will be considered to assess the evolution in 7 and 14 days after inclusion. results will be subjected to appropriate statistical analysis, with sample calculation. an early therapeutic approach is proposed in suspected and confirmed patients with covid-19, with the hope of reducing hospitalizations and severe forms of the disease.

the early administration of hcq or in association with apixaban, could prevent worsening of suspected covid-19, as well as preventing hospitalizations and the need for intensive treatment. in patients with mild to moderate disease, the use of hydroxychloroquine or hydroxychloroquine with apixaban or apixaban alone, could be able to reduce disease progression on an ordinal scale of outcome (including use of mechanical ventilation and death) and decrease the likelihood of hospitalization or worsening of clinical conditions.

Eligibility criteria:
inclusion criteria: * patients with suspected or confirmed covid-19, above 18 years old * patients with time between symptom onset and inclusion ≤ 14 days * patients with time between hospital stay and inclusion ≤ 48 hours exclusion criteria: * patients tested negative for covid-19 by rt-pcr, serological or rapid test method * patients unable to swallow for any reason * patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women * patients with liver toxicity, defined as ast / alt or increased bilirubin * patients with ventricular arrhythmias * patients with bleeding, major hematoma or blood dyscrasia; * patients who, at any time during the process, choose to give up participating in the study

Keywords: complications novel coronavirus 2019 sars-cov-2 chloroquine anticoagulants
gh21 combined with d-1553 in kras g12c mutant advanced solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

Summary: this s a multi-center, open-label phase ib/ii study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of gh21 combined with d-1553 in patients with advanced or metastatic solid tumors harboring kras g12c mutation.

this study includes 2 parts: dose escalation(phase ib) and dose expansion (phase ii). the objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of gh21 in combination with d-1553 in patients with advanced solid tumors harboring kras g12c mutation and to determine the rp2d for the combination therapy. in the dose expansion part, preliminary efficacy and safety of the combination therapy at the rp2d will be further explored in patients with specific cancer harboring kras g12c mutation.

Eligibility criteria:
inclusion criteria: * the patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure); * age ≥18 years old, male or female; * kras g12c mutant advanced solid tumor; * ecog performance status of 0 or 1 * at least one measurable lesion as defined by recist 1.1 exclusion criteria: * acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; grade iii-iv heart failure based on the new york heart association cardiac function scale at screening; during screening, echocardiography (echo) showed left ventricular ejection fraction (lvef) ≤50%; * patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs; * there is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° c within 28 days before the first dose; * any toxicity from previous antitumor therapy prior to initial administration has not returned to ctcae 5.0 rating ≤ class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk); * pregnant and lactating women; * the investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.
study of histological samples from patients with hereditary haemorrhagic telangiectasia

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: in this study the investigators will obtain histological samples from people with hereditary haemorrhagic telangiectasia (hht, also known as osler-weber-rendu syndrome).

hht is an inherited condition that leads to the development of dilated and fragile blood vessels. we propose to obtain small skin samples from patients with hht in order to analyze the samples using histological methods, and study the properties of vascular endothelial cells derived from patients. we hypothesize that these cells will show differences when compared to normal endothelial cells, which may be confirmed in single time point analyses in histological samples. we anticipate that that these findings may help to explain aspects of the hht disease phenotype.

Eligibility criteria:
inclusion criteria: * patients with hereditary haemorrhagic telangiectasia exclusion criteria: * unable to provide informed consent
effect of liraglutide on absorption of paracetamol 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 to investigate if there is a drug-drug interaction between liraglutide and paracetamol (benuron®) and to investigate the effect of liraglutide on post prandial glucose.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diet-treated subjects with type 2 diabetes with hba1c 7.5-9.5 % * subjects with type 2 diabetes in oral anti-diabetic drug (oad) monotherapy treated with metformin or alpha-glucosidase inhibitors with hba1c 7.0-9.5% * body mass index (bmi) 18.5-40 kg/m\^2 * subjects should have a stable body weight for at least 3 months prior to screening (as judged by the investigator) exclusion criteria: * impaired liver function * impaired renal function * clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure * any clinically significant abnormal ecg (electrocardiogram) * uncontrolled treated/untreated hypertension * recurrent severe hypoglycaemia as judged by the investigator * active hepatitis b and/or active hepatitis c * positive human immunodeficiency virus (hiv) antibodies * known or suspected allergy to trial product(s) or related products
prolongation of pregnancy in preeclampsia by therapeutic lipid apheresis

Conditions: Preeclampsia; Dyslipidemia; Proteinuria; Hypertension

Summary: preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. the cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. in severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. therefore, lipid apheresis is performed as lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and provide the fetus more time for maturation. in this individual treatment patients with early preeclampsia (\<= 32 weeks of gestation) will be offered a h.e.l.p.-apheresis to postpone caesarean section and therefore prolong pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant women * early preeclampsia (\< 32 week of pregnancy) * arterial hypertension during pregnancy * proteinuria (=\> 1 + dipstick or 0\> 300 mg/24h) * and/or intrauterine growth retardation (iugr) * informed consent exclusion criteria: * every acute indication for immediate delivery * no informed consent

Keywords: preeclampsia lipid apheresis apheresis
erythropoietin in hie neonate

Conditions: Neonatal Hypoxic Ischemic Encephalopathy

Summary: this study is aim to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy the study is conducted to answer the question : is erythropoietin will improve neonatal hypoxic ischemic encephalopathy?

hypoxic-ischemic encephalopathy (hie) remains a major cause of morbidity and mortality. hie causes 23% of neonatal deaths . erythropoietin is a 34kda glycoprotein that was originally identified because of its role in erythropoiesis. in the fetus, epo is produced in the liver, and, following the neonatal period, epo is produced in the kidney and the liver. epo is a cytokine with pleiotropic functions including erythropoiesis, modulation of inflammatory and immune responses. epo and the epo receptor (epo-r) are expressed by a variety of cell types in the brain including neuronal progenitor cells. epo transport across the blood-brain barrier is limited by its large size. only 1% to 2% of circulating epo crosses the blood-brain barrier under normal circumstances, most likely via passive diffusion . epo provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions (e.g., hypoxia) . epo's main role is to prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation . the use of epo reduces the need for blood transfusions in premature infants. to cross the blood-brain barrier, high doses at 2000 to 5000 iu/kg body weight are administered either early or late for prolonged periods of time. these high doses are well tolerated in preterm infants (i.e., epo is safe and devoid of untoward complications in this context . in previos studies , the first dose of r-hu-epo was administered at 1 to 48 h after birth, followed by doses every other day for 2 weeks. at 18 months-of-age neurodevelopmental outcomes were assessed. improved long-term outcomes in the r-hu-epo-treated infants were evident after moderate hie, but not in those with severe hie. there were no side-effects from r-huepo treatment .

Eligibility criteria:
inclusion criteria: - neonates who less than 1 month suffer from hypoxic ischemic encephalopathy exclusion criteria: * neonates who more than 1 month * neonates who suffer from brain insults other than hie
exploring adherence and knowledge among diabetic individuals in periodontal care

Conditions: Periodontitis

Summary: objective(s) the primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group a, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group b, test). secondary objectives include assessing the prevalence of periodontal disease (pd) in this diabetic sample population and evaluating the presence of specific biomarkers related to it. the final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. the aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes exclusion criteria: * last dental visit\<1 year * patient unable to give consent
clinical trial to evaluate safety and efficacy of ccx168 in anca-associated vasculitis

Conditions: ANCA-associated Vasculitis

Summary: the aim of this trial is to test the safety and efficacy of two dose regimens of the complement c5a receptor ccx168 in patients with anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis (aav). funding source - fda oopd

complement 5a and its receptor c5ar (cd88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis. this is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the safety and efficacy of the c5ar inhibitor ccx168 in subjects with anca-associated vasculitis. the aim of this trial is to test the safety and efficacy of two dose regimens of the complement c5a receptor ccx168 in patients with anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis (aav). study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of granulomatosis with polyangiitis (wegener's), microscopic polyangiitis or renal limited vasculitis * male and female subjects, aged at least 18 years, with new or relapsed aav where treatment with cyclophosphamide or rituximab would be required * use of adequate contraception during, and for at least the three months after, any administration of study medication is required * positive indirect immunofluorescence (iif) test for p-anca or c-anca, or positive elisa test for anti-proteinase-3 (pr3) or anti-myeloperoxidase (mpo) at screening * have at least one "major" item, or at least 3 other items, or at least 2 renal items on the birmingham vasculitis activity score (bvas) version 3 * estimated glomerular filtration rate (egfr) ≥ 20 ml per minute exclusion criteria: * severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement * any other multi-system autoimmune disease * medical history of coagulopathy or bleeding disorder * received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on day 1 * received intravenous corticosteroids, \>3000 mg methylprednisolone equivalent, within 12 weeks prior to screening * received an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit * received rituximab or other b-cell antibody within 52 weeks of screening or 26 weeks provided b cell reconstitution has occurred; received anti-tumor necrosis factor (tnf) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (ivig), belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening

Keywords: anca-associated vasculitis complement vasculitis c5ar
levetiracetam in the treatment of neuroleptic-induced tardive dyskinesia

Conditions: Dyskinesia, Medication-induced

Summary: an 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia


Eligibility criteria:
inclusion criteria: * subjects between ages 18 and 80 years * subjects must have a diagnosis of stable axis i psychiatric disorder at least 6 months prior to screening * subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria * subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening exclusion criteria: * presence of any axis ii condition within 6 months prior to screening * huntington´s disease, idiopathic dystonia, wilson´s disease, sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia * start of drugs-other than neuroleptics- that can cause dyskinesia * presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness

Keywords: neuroleptic-induced tardive dyskinesia keppra, levetiracetam
does a daily iron tablet improve anemia in cystic fibrosis

Conditions: Cystic Fibrosis; Anemia, Iron-Deficiency

Summary: this study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.


Eligibility criteria:
inclusion criteria: * history of pseudomonas aeruginosa colonization of the lung * transferrin saturation (tsat) less than or equal to 21% * hemoglobin concentration \<15.5 gm/dl (men) * hemoglobin concentration \<13.6 gm/dl (women) exclusion criteria: * use of iron-containing vitamin or supplement * pregnancy * lactation * cirrhosis * history of chronic visible (gross) hemoptysis * hereditary hemochromatosis * history of transfusion-related iron overload * use of iron chelator(s) * withdrawal of informed consent * contraindication to phlebotomy

Keywords: cystic fibrosis iron hepcidin anemia erythropoiesis
12-week study assessing change in psoriasis severity and level of stress using ten

Conditions: Psoriasis; Stress

Summary: this is a 12-week, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate to severe psoriasis treated with ten. psoriasis severity and stress levels will be measured at weeks 0, 4, 8 and 12.


Eligibility criteria:
inclusion criteria: * outpatient, male or female of any race, 18 years of age or older. * moderate (\>3 to \<10% bsa) with a pasi of at least 6 and less than 12 or severe (≥10% bsa) plaque psoriasis with a minimal pasi score of 12. * subject diagnosed with psoriasis at least 6 months prior to entering the study. * subjects who have received treatment in the past for psoriasis and are currently untreated or subjects who are on stable treatment for psoriasis that is expected to remain unchanged throughout the entire duration. * subjects who have not received psoriasis treatments in the past should be stable in their disease for the last 4 weeks. exclusion criteria: * guttate, erythrodermic, or pustular psoriasis subtypes. * evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis. * unstable psoriasis or unstable treatment of psoriasis over the entire duration of the study. * subjects with moderate psoriasis are not allowed to use concurrent systemic therapies for psoriasis (i.e., phototherapy, orals, biologics, etc.). topical medications are allowed; * subjects with severe psoriasis are allowed to use any concurrent therapy for psoriasis, provided that disease state is stable for ≥2 months and they meet minimum pasi requirements. * cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.
rotem in patients with placenta previa

Conditions: Placenta Previa; Placenta Accreta; Placenta Increta; Placenta Percreta

Summary: the rotational thromboelastogram (rotem) test can be performed on patients with placenta previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the predictors can be identified by comparing the patients who actually show massive bleeding with those who do not. applying these predictive factors to pregnant women undergoing cesarean section after diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the perioperative management because it is possible to select pregnant women with a factor of massive bleeding.


Eligibility criteria:
inclusion criteria: * cesarean section under spinal anesthesia * placenta previa * placenta accreta * placenta increta * placenta percreta exclusion criteria: * coagulopathy * medication with antiplatelets or anticoagulants
impact of cox2 on sera biomarkers from obese subjects

Conditions: Breast Cancer Survivors

Summary: obesity promotes worse outcome for post-menopausal breast cancer patients.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * post-menopausal as confirmed by medical history * ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's irb/ethics committee exclusion criteria: * evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease) * cachexia * active systemic illness (infection including viral illnesses such as hepatitis and hiv) * chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days) * known hypersensitivity to aspirin and/or omega-3 fatty acids * actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation * any aspirin or omega-3 free fatty acid supplementation within the last 14 days * subjects who are pregnant * history of medical noncompliance

Keywords: asprin omega-3 free fatty acids obesity cox-2 inhibitor