Kornimate/medical-research-clean huggingface dataset:
recombinant hyperimmune polyclonal antibody (giga-2050) in covid-19 patients

Conditions: COVID-19

Summary: the purpose of this study is to evaluate the safety and tolerability of single ascending iv dose administrations of giga-2050 in patients hospitalized with covid-19.

this is a phase 1, first in human (fih) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (sad) of giga-2050 in patients hospitalized with confirmed covid-19. participants will receive a single intravenous (iv) infusion dose of giga-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (day 56).

Eligibility criteria:
inclusion criteria: * participant is ≥ 18 years of age. * positive result of a sars cov-2 rna diagnostic test result ≤48 hours before enrollment, warranting hospital admission as per investigator's judgement. * covid-19 pneumonia findings on imaging (chest x-ray or ct scan). * requires oxygen supplementation with fio2 approximately 30% or greater administered by nasal cannula, mask, or niv. * participants can be on other medication on-label to treat covid-19 respiratory disease that the investigator deems clinically relevant in combination with the study drug, including corticosteroids. passage of 24 hours after administration of the eua drug will be required prior to dosing giga-2050. * men or non-lactating female participants who are surgically sterile or post-menopausal, or a woman of childbearing potential (wcbp) with a negative pregnancy test at screening willing to use highly effective contraception methods. exclusion criteria: * acute respiratory failure requiring invasive mechanical ventilation or ecmo at enrollment. * systolic blood pressure (sbp) \ 120 bpm. * pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening. * pre-existing chronic respiratory condition(s). * evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of \<0.5ml/kg/hr sustained for at least 6 hours once volume repleted. * aspartate aminotransferase (ast) ≥2.5 x uln, alanine aminotransferase (alt) ≥2.5 x uln, and/or total bilirubin \>1.5 x uln, or severe hepatic impairment. * known systemic hypersensitivity to recombinant antibody therapies. * female participant who is pregnant. * participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures. * participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.

Keywords: sars cov-2 covid-19
phase iii randomized double-blind placebo controlled study to evaluate the safety and efficacy of betaseron in aids and advanced arc patients receiving a reduced-dose azt regimen

Conditions: HIV Infections

Summary: to evaluate the safety and efficacy of interferon beta (betaseron) in aids and advanced aids related complex (arc) patients receiving a reduced-dose zidovudine (azt) regimen.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). patient must have: * uninterrupted therapy with reduced-dose azt 500 - 600 mg/day for at least 3 weeks before entry. * acceptable hepatic and renal function. * amended to delete the following sentence: * hematologic intolerance to full-dose zidovudine (azt) (1000 - 1200 mg/day). exclusion criteria co-existing condition: patients with the following are excluded: * concurrent, ineffectively controlled opportunistic infections. * extensive cutaneous and/or visceral kaposi's sarcoma requiring systemic chemotherapy. * proteinuria of 2+ or greater. * hiv encephalopathy. * hiv wasting syndrome. * new york heart classification iii or iv. * uncontrolled angina pectoris. * evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias. concurrent medication: excluded: * antiretrovirals other than zidovudine (azt) or betaseron. * chronic acyclovir therapy. * acetaminophen. patients with the following are excluded: * intolerance (hematologic or otherwise) to zidovudine (azt) at a dose of 100 mg orally every 4 hours. amended to: * intolerance at a dose of 500 to 600 mg/day. * medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study. prior medication: excluded within 30 days of study entry: * cytotoxic chemotherapy. * prior therapy with alpha, beta, or gamma interferons. active drug or alcohol abuse.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine interferon type i
a comparison of two metal surface finishes on femoral components in hip arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.

in younger patients femoral components are most often implanted without the use of cement. a direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed. the construction of a femoral implant, versys fiber metal taper®, by zimmer includes a more extensive coating than previous femoral implants. the improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use. theoretically, the greater porous surface of mid-coated implants should: * encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time * improve anchorage of the implant due to the higher friction coefficient * result in fewer postoperative complaints measured with the harris hip score and visual analog scale scores the migration of femoral components will be evaluated by rsa, performing radiostereometric analyses at the orthopaedic center, aarhus university hospital. the follow-up rsa will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. bone mineral density around the implanted femoral component will be examined by dexa scan at week 1, as well as 1 year and 2 years after surgery.

Eligibility criteria:
inclusion criteria: * patients with primary arthritis in the hip. * patients with sufficient bone density to allow uncemented implantation of a femoral component. * informed patient consent in writing. exclusion criteria: * patients with neuromuscular or vascular disease in the affected leg. * patients found upon operation to be unsuited for uncemented acetabulum component. * patients who regularly take non-steroid anti-inflammatory drugs (nsaid) and cannot interrupt intake for the postoperative phase of the study. * patients with fracture sequelae. * female patients of childbearing capacity. * hip joint dysplasia. * sequelae to previous hip joint disorder in childhood.

Keywords: rsa osteoarthritis hip arthroplasty dexa
outcomes of severe sepsis patients in surgical intensive care units

Conditions: Severe Sepsis; Septic Shock

Summary: retrospective review of the outcomes of severe sepsis patients in surgical intensive care unit of national taiwan university hospital from january 1, 2009 to december 31, 2011.

patients suffered from severe sepsis or septic shock have a mortality of 20\~54%. it is major healthcare problems, affecting millions of individuals around the world each year. an international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. lots of medical centers have joined the surviving sepsis campaign and follow the latest guideline. many reports have shown that surviving sepsis campaign guideline can reduce patient mortality. in surgical intensive care units of national taiwan university hospital (ntuh), the surviving sepsis campaign guideline was conducted since 2009. our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of ntuh by retrospective review of medical chart.

Eligibility criteria:
inclusion criteria: * patients were diagnosed as severe sepsis in surgical intensive care units of national taiwan university hospital exclusion criteria: * \< 20 years old
study of hydroxyurea to treat sickle cell disease

Conditions: Sickle Cell Disease

Summary: the aim of this single-center observational study was to evaluate quality of life, clinical effectiveness, and satisfaction in pediatric and young adult patients with sickle cell disease receiving hydroxyurea.

in this study, 34 pediatric (hbss: n= 5; hbsβ0: n= 29) and 16 (hbss: n=5; hbsβ0: n= 11) young adult adult patients with sickle cell disease receiving hydroxyurea for at least a year were participated. upon receipt of informed consent form, case report form, demographic data collection form, child health questionnaire-parent form, life quality survey short form-36, and hydroxyurea therapy satisfaction survey were used to obtain data for effectiveness of hydroxyurea therapy and parameters that may affect compliance to treatment and life quality of the participants. regarding the normal ranges, ferritin, hemoglobin a, a2, f, and s, platelet, mean corpuscular volume, erythrocyte distribution width, basophil percentage, monocyte, monocyte percentage, total bilirubin, direct bilirubin, and c-reactive protein values were higher while hemoglobin, hematocrit, and erythrocyte values were lower in these patients. our findings regarding quality of life and satisfaction with hydroxyurea therapy indicated that the patients with sickle cell disease had lower scores. demographic, clinical, and therapeutic variables as well as comorbid diseases and concomitant drug use when considered together, these findings suggest that the health quality and compliance of the pediatric and young adult patients to therapy might be low due to not sufficiently effective hydroxyurea therapy in addition to comorbidities, concomitant drug use, and side effects.

Eligibility criteria:
inclusion criteria: 1. patients willing to participate in the study 2. pediatric and young adult patients 3. patients diagnosed with hbss or hbsβ0 sickle cell disease 4. patients receiving hydroxyurea for at least a year. exclusion criteria: 1. patients not meeting the inclusion criteria 2. patients not willing to participate in the study 3. patients diagnosed with other types of anemia except hbss or hbsβ0 sickle cell disease 4. patients not receiving hydroxyurea for at least a year 5. patients having other conditions such as physical and/or mental difficulties which may affect their quality of life 6. patients having any contrindication against hydroxyurea

Keywords: sickle cell disease hydroxyurea compliance
inflammatory response to aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: a controlled un-randomized trial where the inflammatory response in 18 patients admitted for tavi procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. clinical outcomes are recorded and compared between the groups. as a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal tavi.

18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (tavi) (9 transfemoral and 9 transaortic) are included. a plasma sample is obtained at defined timepoints before, during and after surgery. at each time points the following biomarkers are analyzed:concentrations of the complement activation products c3bc and the terminal c5b-9 complement complex (tcc), the neutrophil release product myeloperoxidase (mpo), the cytokines il-6, eotaxin, mcp-1 and mip-1β (12). as marker of a myocardial cellular injury troponin t levels will be analyzed. the following clinical outcomes will also be monitored: death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction. a dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. the registry will be deleted after completion of the study.

Eligibility criteria:
inclusion criteria: * patients eligible for aortic valve replacement without need for concurrent surgery exclusion criteria: * known inflammatory disease and anti-inflammatory treatment

Keywords: cardiac surgery tavi
mri of the liver with eovist

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to determine if a new magnetic resonance (mr) protocol is better at diagnosing liver lesions.

hepatocellular carcinoma (hcc), a form of liver cancer, is the seventh most common cause of cancer mortality in the us. the incidence rate of hcc is increasing along with the incidence of hepatitis b and c which are known to promote hcc. patients have a better prognosis (survival outlook) if hcc is found and treated at an early stage. mri is the best imaging modality for diagnosing hcc. this study will compare standard mris and mris performed with a newly developed mr protocol to determine if it is possible to more confidently diagnose hcc.

Eligibility criteria:
inclusion criteria: * known hepatocellular carcinoma * undergoing mri of the liver exclusion criteria: * contraindication to mri with iv contrast

Keywords: hcc hepatocellular carcinoma eovist mr mri magnetic resonance
peripheral venous oxygen saturation and biomarkers to estimate cardiac output and filling pressures in heart failure

Conditions: Congestive Heart Failure

Summary: the relationship between peripheral venous saturation and central hemodynamics (including right and left heart filling pressures and cardiac output), mixed venous oxygen saturation, and contemporary biomarkers of heart failure is not clear. we aim to determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class iii or iv) heart failure. we will determine the relationship between cardiac output measured via thermodilution and the fick equation calculated using concurrent oxygen saturations from the distal pa, central vein, and peripheral vein. we also aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.


Eligibility criteria:
the following inclusion criteria will be utilized: 1. age\>21 2. pa-catheter insertion for therapy of congestive heart failure decided upon by the attending cardiologist the following will be considered as exclusion criteria for this study 1. known or suspected septic shock or bacteremia 2. active bleeding or hct\<24% at baseline 3. arterial oxygen saturation \<90% at baseline despite supplemental oxygen therapy. 4. previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis 5. insertion of the pa catheter through the femoral vein 6. subjects unwilling or unable to provide written consent

Keywords: congestive heart failure cardiac biomarkers hemodynamics tailored therapy
risk factors of hepatocellular carcinomas developed on non-fibrotic liver: case-control study (noflic study)

Conditions: Hepatocellular Carcinoma

Summary: the main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (nfchc).

most hepatocellular carcinoma (hcc) complicates cirrhosis, which is often caused by infection with hepatitis b or c viruses, alcohol, obesity, exposure to aflatoxin b1 (afb1) or hemochromatosis. nevertheless, 10 to 40% of hccs can develop on non-cirrhotic terrain and about 5% on nonfibrotic liver (nfhcc). in 20 to 40% of these nfhccs, no classical hcc risk factor is identified. some cases could be the result of a transformation of an adenoma. others may be associated with yet non-formally identified toxins and / or a specific genetic predisposition. while there is a lot of data on alterations of signaling pathways (ß-catenin, akt / mtor, ras / perk, etc.) in "classical" hccs, altered pathways remain unknown in most nfhccs, even in some cases, activation of β-catenin, inactivating mutations of hnf1 or activators of gp130 have been shown. a specific study of nfhccs, rather rare cancers, represents an opportunity to look for directly carcinogenic factors in the absence of cirrhosis, and to dissect the involved carcinogenesis pathways.

Eligibility criteria:
inclusion criteria: * cases: patients aged 18 years and older with a diagnosis of nfhcc with anatomopathological examination and showing a hcc according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the metavir system score or equivalent (f0 or f1) or the kleiner et al stage of ash and nash (≤stade 2); signed informed consent; affiliated or beneficiary of a social security system * controls: patients aged 18 years and older without nfhcc at baseline; patients for whom an endoscopy is programmed as part of an assessment of intestinal functional disorders, dyspeptic disorders or screening colonoscopy or hospitalized patients in orthopedic surgery / traumatology or rheumatology departments; signed informed consent; affiliated or beneficiary of a social security system exclusion criteria: * cases: hcc diagnosed without pathological examination; hepatic transplantation before the diagnosis of hcc; patients unable to answer questions; patients who do not speak french or live abroad. * controls: history of liver cancer; other cancers under treatment except cutaneous cancers; colonoscopy indicated in case of familial form of colon cancer; patient with cirrhosis; patients unable to answer questions; patients who do not speak french or live abroad; relationship or same home with the case

Keywords: hepatocellular carcinoma non-cirrhotic liver risk factors
beta-agonist efficacy and tolerability as adjuvant therapy in myasthenia gravis

Conditions: Myasthenia Gravis

Summary: this study examines the effect of adjuvant therapy with the oral beta-agonist salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms.

myasthenia gravis (mg) causes various degrees of increased muscular fatigue and ocular, bulbar, respiratory and extremity symptoms. residual symptoms often remain despite treatment with acetylcholinesterase inhibitors and immunosuppressive agents. escalation of immunosuppressive treatment may provide additional benefit but is associated with potentially severe side effects, and high economic costs. treatment with beta-agonists has been investigated in animal models of mg, and in small, randomized pilot studies of generalized mg. adjuvant therapy with oral beta-agonists in mg may be safe and cheap and may improve symptoms. the trial will examine the tolerability and efficacy of adjuvant therapy with the oral beta-agonist salbutamol in patients with generalized myasthenia gravis on stable standard of care having residual symptoms. present study is an investigator-initiated, randomized, placebo-controlled, rater and subject-blinded crossover study. study consists of screening period (4 weeks), treatment period 1 (8 weeks), washout period (4 weeks), treatment period 2 (8 weeks).

Eligibility criteria:
inclusion criteria: * generalized myasthenia gravis (mgfa iia-ivb) at screening, verified by ≥ 1 of the following: 1) achr-antibodies in medical history, 2) abnormal decrement on repetitive nerve stimulation in medical history * disease duration of ≥ 1 year * stable dose of antimyasthenic medications at screening * residual symptoms with a mg-qol15 score of ≥ 10 * age ≥ 18 years * ability to understand the requirements of the trial and provide written, informed consent exclusion criteria: * evidence of malignancy ≤ 3 years prior to screening, unless deemed completely cured * thymectomy ≤ 6 months prior to screening * impending mg crisis or respiratory insufficiency * worsening of mg symptoms due to other diseases or medications (e.g. infection, beta-blockers, aminoglycosides, etc.) * other factor(s) or medical condition(s) that may explain residual symptoms * pregnancy or breast-feeding * treatment with beta-agonists * uncontrolled diabetes * ischemic heart disease, cardiac arrhythmia or heart failure (including hypertrophic cardiomyopathy) * uncontrolled hypertension (≥ 160/110) * known hypersensitivity to any of the study drug components * treatment with tricyclic antidepressants, monoamineoxidase inhibitors, digoxine, or methylxanthines.
comparison of the femoral prothesis-rotation in conventional x-ray, in axial ct slices and 3d-reconstructed ct

Conditions: Osteoarthritis

Summary: femoral component rotation in total knee arthroplasty (tka) has been considered an important factor for outcome. however, measurement of femoral component rotation is difficult to perform. femoral tka component rotation can be assessed on special radiographs (kanekasu technique), axial ct slices and 3d reconstructed ct images. it was the hypothesis that measurements on radiographs are comparable to measurement on ct images. measurements of femoral tka rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. the absolute values of each measurement method is noted in degrees.

femoral component rotation in total knee arthroplasty (tka) has been considered an important factor for outcome. however, measurement of femoral component rotation is difficult to perform. femoral tka component rotation can be assessed on special radiographs (kanekasu technique), axial ct slices and 3d reconstructed ct images. it was the hypothesis that measurements on radiographs are comparable to measurement on ct images. in agreement with our standard diagnostic algorithm for patients with pain and problems after tka ct images as well as kanekasu radiographs are performed. if the kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead. measurements of femoral tka rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. the absolute values of each measurement method is noted in degrees. the measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others. the absolute difference of femoral tka rotation is calculated between and inter the groups investigated. intra class correlation coefficients are calculated for inter- and intraobserver reliability.

Eligibility criteria:
inclusion criteria: * total knee prosthesis (primary) * \>55 years exclusion criteria: * pregnancy * lactating women

Keywords: total knee arthroplasty total knee prothesis x-ray kanekasu radiographs femoral component rotation effects
needle-knife fistulotomy vs. standard cannulation trial

Conditions: Biliary Obstruction Due to Common Bile Duct Stone; Malignant Bile Duct Obstruction

Summary: needle-knife fistulotomy (nkf) is traditionally used to achieve biliary access when standard cannulation (sc) techniques are unsuccessful. based on technical factors and the design of prior studies, the literature suggests nkf should be reserved for expert advanced endoscopists. the aim of this study was to evaluate the efficacy and safety of nkf compared to sc for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.


Eligibility criteria:
inclusion criteria: older than 18 years of age - exclusion criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy -

Keywords: jaundice bile duct obstruction abnormal liver enzymes