Kornimate/medical-research-clean huggingface dataset:
mabioncd20® compared to mabthera® in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate biosimilarity between test product mabioncd20® and the reference product - mabthera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of mabioncd20® and mabthera® in patients with moderate to severe active rheumatoid arthritis.

subjects who meet the criteria for participation in this study receive 2 intravenous infusions of mabioncd20® or mabthera® with two weeks interval in combination with methotrexate and folic acid. after the treatment period, patients are followed for 24 weeks, in order to continue checking safety. therefore, the total study lasts 48 weeks. there is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.

Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit * patients who are naive to tumor necrosis factor (tnf) antagonists or any other monoclonal antibody therapies * patients who have had an inadequate response to an adequate regimen of methotrexate exclusion criteria: * history of current rheumatic autoimmune disease other than ra and current inflammatory joint disease other than ra * contraindications according to the mabthera smpc and every serious coexisting diseases which, in the investigator's opinion, would preclude subject participation * positive tests for hiv, hepatitis b surface antigen (hbsag) anti-hbc antibody, hepatitis c antibody * prior treatment with rituximab, other anti-cd20 mab, anti-tnf-alpha drug or any other monoclonal antibodies * pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion * allergic reaction or intolerance to rituximab, mabioncd20 or any of their components * severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies

Keywords: rheumatoid arthritis autoimmune diseases rituximab immune system diseases joint diseases rheumatic diseases
inhaled furosemide for transient tachypnea of newborn

Conditions: Respiratory Morbidity

Summary: this is a randomized double blind clinical trial in which newborns with suspected transient tachypnea of the newborn (ttn) will receive either furosemide or normal saline by nebulizer every 6 hours for 24 hours.


Eligibility criteria:
inclusion criteria: * neonates with 34+0-39+0 gestational age * on the first day of life * with the clinical diagnosis of transient tachypnoea * need for cpap \>6 hours to obtain the oxygen saturation \>92% exclusion criteria: * systemic infection * intubation and mechanical ventilation before inclusion in the trail * malformation and any other disease with disturb of respiratory system
a study of adalimumab in adult japanese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult japanese subjects with ra


Eligibility criteria:
inclusion criteria: * meet acr criteria for diagnosis of active ra and have at both screening and baseline visits \>10 swollen joints, \>12 tender joints. * subjects must have failed prior treatment with one or more dmards. * a negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration. * body weight less than or equal to 100 kg exclusion criteria: * a history of, or current, acute inflammatory joint disease of different origin from ra. * prior treatment with any tnf antagonist, including adalimumab. * any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with iv antibiotics. * unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
effect of antioxidants on ocular blood flow, endothelial function, and cytokine levels in lps induced inflammatory model in humans.

Conditions: Retina; Regional Blood Flow; Endotoxin, Escherichia Coli

Summary: oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous. inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. in the present study, the infusion of lps, which is a cell wall component of gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. the assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. to investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. the measurement of forearm blood flow will be use to assess endothelial function. the main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after lps administration.


Eligibility criteria:
inclusion criteria: * men aged between 18 and 35 years, nonsmokers * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 3 dpt exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks
hemi artificial hipjoint versus total artificial hipjoint

Conditions: Optimized Treatment

Summary: this is a randomized controlled trial study comparing hemialloplastik versus total joint replacement.

seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a garden 3-4 femoral neck fracture or a fracture garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. the patients are followed for 24 mouths with x-ray stereo photogrammetric analysis (rsa) radiographs and clinical examinations.

Eligibility criteria:
inclusion criteria: * patients over 70 years, admitted two our hip-fracture department with a 3-4 garden femoral neck fracture or a fracture garden 1-2 with over 20-degree posterior tilt. * preoperative new mobility score ≥ 6th * patients must be able to speak and understand danish. * patients must be able to give informed consent and be cognitively intact (hindsøe score ≥ 6). * patients should be expected to be able to implement the postoperative controls. patients should not be medically ill: asa-score ≤ 3rd

Keywords: hip-fracture rsa
patient acuity rating: a tool to prevent in-hospital cardiac arrest

Conditions: Heart Arrest

Summary: the purpose of this study is to evaluate the accuracy of medical personnel in their ability to predict the likelihood of non-intensive care (icu), ward patients to clinically deteriorate (defined as a cardiac arrest, unplanned icu transfer, or unexpected death)via the use of a clinical judgement-based tool designed for this study, patient acuity rating (par), to predict short-term clinical deterioration. we will compare the ability of this tool to predict clinical deterioration compared to accepted physiology-based tools and tools combining judgment and physiology as well as other markers of deterioration such as physician order changes. we will compare the sensitivity, specificity and area under the curve of these combined models to the predictive models including only physiology or clinical judgment. we will assess the correlation between specific physician orders and patient deterioration to determine whether specific clinical activities, such as emergently obtained radiology exams, predict impending deterioration. we hypothesize that par will be a useful tool for predicting clinical deterioration across the institution and that it will have a higher average accuracy for predicting clinical deterioration in non-icu inpatients within 24 hours than the physiology-based tools alone. we further hypothesize that a combined metric which includes both the par and the individual physiologic components that comprise physiologic tools will not significantly improve prediction over the par alone. we further propose to use par to prospectively risk stratify patients for preemptive evaluation by the rapid response team. we hypothesize that intervening on high risk patients by preemptively activating the hospital's rapid response team (to assess and treat patients as needed) will decrease cardiac arrest rates and mortality.


Eligibility criteria:
inclusion criteria: * non-icu ward inpatients * par of 5 or above * ages 18+ years exclusion criteria: * icu or outpatients * par of 4 or lower * ages 17 years and under
multidisciplinary rehabilitation after cancer pulmonis operation

Conditions: Pulmonary Cancer

Summary: the purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. the effects of training programs on physical and mental wellbeing for cancer patients are well documented. most of the studies are though performed on patients suffering from breast, colon and prostate cancer. there are only few studies addressing patients with pulmonary cancer. they are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. these studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. there is no data referring to quality of life of patients who are radically operated for pulmonary cancer. comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. exercise training is given by a physiotherapist. both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

Eligibility criteria:
inclusion criteria: * patients who are radically operated for pulmonary cancer at aalbor hospital, aarhus university hospital exclusion criteria: * not radically operated * cannot speak and read danish * cannot cooperate in tests due to poor mental health * patients who undergo rehabilitation at other centres * cannot perform walking test due to physical impairment

Keywords: pulmonary cancer radically operated exercise training dyspnea counseling quality of life physical therapy
lipitor trial to study the effect of torcetrpib/atorvastatin to atorvastatin alone.

Conditions: Hyperlipidemia

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to look at various lipids in the blood of people with fredrickson type iia and type iib mixed dyslipidemias

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * statin eligible per ncep atp-iii guidelines * at least 18 years of age exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant * intolerance to statin therapy * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
mortality and neurologic outcomes in rapid vs. slow hyponatremia correction

Conditions: Hyponatremia; Hospitalisation; Mortality; SEVERE HYPONATREMIA

Summary: this study examines the impact of different rates of sodium correction on the outcomes of patients with severe hyponatremia (serum sodium ≤ 120 meq/l). hyponatremia is a condition where blood sodium levels are dangerously low, and its treatment must be carefully managed to avoid complications. standard guidelines recommend correcting sodium levels slowly to prevent a rare but serious neurological condition called osmotic demyelination syndrome (ods). however, recent evidence suggests that a faster rate of sodium correction may reduce hospital stay length and mortality without increasing the risk of ods. this retrospective study, conducted from 2010 to 2023 at a hospital in buenos aires, argentina. it compares the outcomes of patients who had their sodium levels corrected rapidly (≥ 8 meq/l in 24 hours) to those who had slower corrections. the primary outcomes measured are mortality and the development of ods.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * first hospitalization at hospital italiano de buenos aires with a serum sodium (natremia) level ≤ 120 meq/l at admission. exclusion criteria: * absence of serum sodium values after the first 24 hours of hospitalization. * hospitalizations shorter than 24 hours. * patients with previous hospitalizations prior to the study period where admission serum sodium levels were ≤ 120 meq/l.

Keywords: severe hyponatremia sodium correction osmotic demyelination syndrome rapid sodium correction in-hospital mortality cohort study
administration of probiotics in cirrhotic patients listed for liver transplantation

Conditions: Liver Cirrhosis

Summary: the aim of this study was to evaluate the impact of the administration of probiotics on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period.

gut microflora plays an important role in the pathogenesis of complications of liver cirrhosis, mainly due to microbial translocation. according to several studies, administration of probiotics in patients with cirrhosis has positive effect on minimal hepatic encephalopathy. the aim of this study was to evaluate the impact of probiotics administration on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period. this study will be performed on 200 patients randomized into the probiotic and placebo groups. daily administration of either probiotics or placebo will be continued from the date of inclusion in the study until the date of liver transplantation. a quantitative and qualitative analyses of faecal microflora will be performed in each patient before and after 10 week period (or shorter, depending on the time on the waiting list) of administration of either probiotic or placebo. microbiological analyses of air samples from patients' home environment will be performed in each case. both groups of patients will be compared with respect to primary and secondary outcome measures.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * active status on the waiting list for liver transplantation * confirmed etiology of liver disease exclusion criteria: * malignancy * human immunodeficiency virus infection * immunosuppressive treatment prior to liver transplantation * cystic fibrosis * creatinine clearance rate \< 50 ml/min

Keywords: liver cirrhosis liver transplantation probiotics mortality liver function infections
ce-mri&cesm in solid breast lesions

Conditions: Breast Neoplasms

Summary: our study aimed to assess the accuracy of ce-sm in comparison to contrast-enhanced breast mri in the evaluation of solid breast lesions.

breast cancer is the most common cancer in women, responsible for 23% of cancer in females worldwide (1). early detection and accurate diagnosis of breast cancer aims to reduce morbidity and mortality and have essential role in management and improved prognosis of breast cancer (2). mammography has been established as the imaging modality for screening and early detection of breast cancer; however, it is accused of having low sensitivity and specificity in women with dense breasts (3). contrast-enhanced mri considered the gold standard method for diagnosis of breast cancer; but, it has many limitations as high cost, long examination time and limited availability (4,5). contrast-enhanced spectral mammogram (cesm) is considered now a relatively new imaging modality which can provide both anatomic and functional information of the breast lesion similar to mri (6). cesm like contrast-enhanced mri (ce-mri) is used to detect angiogenesis of the lesion in the mammography suite. it includes high- and low-energy images during a single compression after contrast injection (7). the advantage of cesm over mri is that it is less expensive and easier to perform with shorter examination time. also, the higher sensitivity of mri is plagued by numerous false-positive foci of enhancement (8). also, cesm can replace mri in case of patient contraindicating for mri as patients with pacemakers, aneurysm clips or metal implants, or severe claustrophobia (7). so, our study aims to determine the value of cesm and answer the question of does cesm could replace ce-mri in diagnosing breast cancer? so,our study aimed to assess the accuracy of cesm in comparison to contrast-enhanced breast mri in the evaluation of solid breast lesions.

Eligibility criteria:
inclusion criteria: * patients who have previously undergone mammography (mg) and ultrasound and have a solid (birads iii and more) breast lesion. exclusion criteria: * cystic breast lesions * birads i and ii breast lesions(benign) * pregnancy * history of allergic reaction to iodinated contrast agent * renal insufficiency * other contraindications to mri include pacemaker, claustrophobia or metal prosthesis.

Keywords: ce-sm /ce-mri/solid breast lesions
evaluation of preoperative acceptance of proactive palliative care intervention

Conditions: Cancer; Heart Failure; Chronic Obstructive Pulmonary Disease; Postoperative Complications

Summary: advances in medicine have led to an increased life expectancy even with complex disease courses of malignant diseases. this leads to frequent critical situations for patients and high risk surgical interventions. the majority of patients and their practitioners are not prepared for the consequences of a complex and possibly fatal course. palliative medicine makes it possible to anticipate the further course of the disease. as a result, palliative medicine has become increasingly important. the beginning of palliative medical interventions has extended from accompaniment limited to the dying phase to earlier phases of the disease. an early integration of palliative medicine showed a positive effect on the quality of life, the degree of depression and survival in patients suffering from cancer, for example. furthermore, patients were more able to accept a change in therapy goal at the end of life. similar results were shown for patients with a non-malignant severe disease such as copd or heart failure. what needs further investigating is how to adequately screen and identify the patient populations who could benefit from early palliative care, so that they are prepared for potentially critical and life-threatening situations. the investigator's objective is therefore whether the anesthesiology outpatient clinic is a suitable screening location for initiating early integrated palliative care for patients with a serious, life-shortening illness and a high perioperative risk.


Eligibility criteria:
inclusion criteria: * over 18 years * one elective operation with medium or high cardiac risk and in addition at least one of the following criteria: * serious comorbidity pulmonary: emphysema and / or copd \>= 2 after gold cardiac: nyha \> = 2 * and / or a metastatic malignancy * asa physical status classification \>= 3 and pre-frail or frail exclusion criteria: * legal care * emergency operation * any reasons which contradict inclusion in studies , e.g. cognitive deficit and lack of language skills * pregnant / breastfeeding women
the prolonged effect of consumption of a partially hydrolyzed infant formula during the first 6 months of life on the development of allergic manifestations at 5 years of age

Conditions: Allergy

Summary: the present study is a 5-year follow-up of the allergy reduction trial (a.r.t.) birth cohort study of 551 infants at high-risk for allergy. the a.r.t. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (phf) or the standard formula (sf), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. in addition, differences on growth (weight, height, bmi) will be examined.

the present study is a 5-year follow-up of the allergy reduction trial (a.r.t.) birth cohort study of 551 infants at high-risk for allergy. the a.r.t. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (phf) or the standard formula (sf), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. in addition, differences on growth (weight, height, bmi) will be examined.

Eligibility criteria:
inclusion criteria: * children who were part of the intention-to-treat population of the a.r.t. study * children of the a.r.t. study itt population within the age range of 5 years up to 5 years and 3 months * children of the a.r.t. study itt population in whom at least one parent and/or legal guardian signed the written consent form exclusion criteria: * children who did not participate in the a.r.t. study or who were not assigned to any of the 3 study arms * children of the a.r.t. study who are younger than 5 years of age or older than 5 years and 3 months of age * children of the a.r.t. study in whom parents and/or guardians do not agree to provide a written consent form

Keywords: post-intervention, allergic manifestations