Kornimate/medical-research-clean huggingface dataset:
fludarabine added to induction treatment in untreated multiple myeloma patients

Conditions: Multiple Myeloma

Summary: multiple myeloma is an incurable malignant disease which evnetuelly will relapse after primary treatment. clonal b-cells have been identified and in theory these cells might be sleeping during primary treatment and be responsible for later relapse. fluarabine has documented effect on both resting and dividing cells including b-cells. the protocol aim at evaluating safety and toxicity of adding fludarabine to induction chemotherapy with cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell support.

this is a randomised, placebo controlled, phase ii study evaluating toxicity and safety of fludarabine added to cydex (cyclophosphamide+dexamethasone) as induction therapy in younger patients with untreated and treatment demanding multiple myeloma. the treatment regimen patients will be randomised at diagnosis either to cydex + placebo (control arm a) or cydex + fludarabine (experimental arm b). objectives: * primary:to determine the toxicity and safety of fludarabine when added to induction therapy by registration of side effects and adverse events in accordance with the common toxicity criteria (ctc). * secondary:to quantitate clonal cells in bone marrow and blood by flow cytometry (mrd)and to study new potential prognostic markers identified by cytomic, genomic and proteomic analysis. * tertiary: to estimate the efficacy of fludarabine when added to induction chemotherapy(cydex) in patients with multiple myeloma by clinical end points: disease response and progression free survival.

Eligibility criteria:
inclusion criteria: * multiple myeloma, stage i-iii, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation. exclusion criteria: * severe uncontrolled clinical or microbiological evidence of infection at the time of enrolment. * other active malignancy. * severe coincident heart or lung disease including uncontrolled hypertension, unstable angina, congestive heart failure, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled cardiac arrhythmia. * other severe illness including poorly controlled diabetes. * haemolytic anaemia (coombs positive without evidence of haemolysis is accepted). * idiopathic thrombocytopenic purpura. * terminal illness. * allogenic transplantation planned within 6 months. * chemotherapy before inclusion. * pregnancy or breast-feeding, or inadequate contraceptive precautions. * psychiatric disease, abuse of alcohol or narcotics, or any other disorder that might compromise the patients ability to give informed consent.

Keywords: myeloma induction therapy high-dose melphalan autologous stem cell support fludarabine cyclophosphamide dexamethasone safety toxicity
use of artificial intelligence in a pulmonary fibrosis clinic

Conditions: Interstitial Disease

Summary: the present study aims to evaluate the usefulness of artificial intelligence (ai) in the back-office of an ild (interstitial lung disease) clinic.


Eligibility criteria:
inclusion criteria: - patients attending ild clinic of the irccs fondazione policlinico a. gemelli. exclusion criteria: * patients unable or unwilling to sign the informed consent * patients who are senders of one of the emails chosen for the questionnaire * patients with manifest inability to fill out the questionnaire

Keywords: artificial intelligence
the norwegian antirheumatic drug register

Conditions: Inflammatory Joint Diseases

Summary: nor-dmard is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (dmards) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological dmards on work participation and work productivity, to investigate different strategies for use of biological dmards, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological dmards.

this study is a modification, and an extension, of the nor-dmard study that was conducted in 5 norwegian rheumatology departments in the period 2000-2012. the study includes a structured follow-up with study visits at baseline (start of biological drug) and after 3, 6, 12 months and every 12 months thereafter. each study visit includes clinical assessment, patient-reported outcomes and measurement of acute-phase reactants. the data collection also includes blood samples for biobank at baseline and 3 months. serious adverse events data will be systematically recorded, but other adverse events can also be retrieved by linkage to other registers.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis * clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor exclusion criteria: * unwillingness or unability to give written informed consent * psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible * participation in blinded rcts or other studies incompatible with the nor-dmard study protocol

Keywords: rheumatoid arthritis psoriatic arthritis ankylosing spondylitis spondyloarthritis
operating room air filtration/sterilization

Conditions: Surgery

Summary: determine whether operating room air filtration and sterilization with the activepure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.

the investigators primary goal is thus to determine whether supplemental filtering and sterilizing operating room air reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. the primary outcome will be restricted to inpatients. however, outpatients will be simultaneously enrolled given the trial's cluster design. sample-size is based on our primary inpatient analysis, n= 66,273 inpatients. available outpatients will be included for analysis of our secondary outcome which includes both inpatients and outpatients.

Eligibility criteria:
inclusion criteria: * all patients in designated adult operating rooms * american society of anesthesiologists physical status 1-4. * surgery lasting at least 1 hour.
a focused registry on anterior cervical interbody spacer acis

Conditions: Degenerative Cervical Spine

Summary: degenerative cervical spine conditions lead to chronic neck and arm pain. surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. the anterior cervical interbody spacer (acis) is such a cage.


Eligibility criteria:
inclusion criteria: * age 21 years or older * degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels * degenerative cervical disc disease c3 through th1 or * ruptured and herniated discs c3 through th1 * ability to understand the content of the patient information / informed consent form * willingness and ability to participate in the registry according to the registry plan (rp) * signed and dated irb / ec-approved written informed consent exclusion criteria: * spinal tumor * osteoporosis * cervical trauma and instability * any not medically managed severe systemic disease (ie. infection) * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * pregnancy or women planning to conceive within the registry period * prisoner * participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry intraoperative exclusion criteria: * intraoperative decision to use implants other than the device under investigation

Keywords: cervical interbody spacer degenerative pain neck decompression fusion implant
efficacy and safety of alisporivir triple therapy in chronic hepatitis c genotype 1 treatment-naïve participants

Conditions: Hepatitis C

Summary: this study will assess the safety and efficacy of alisporivir (alv; deb025) triple therapy \[i.e., when added to peginterferon alfa-2a (peg) and ribavirin (rbv)\] to optimize treatment in treatment-naïve participants with hepatitis c virus (hcv) genotype 1 (gt1)


Eligibility criteria:
inclusion criteria: * chronic hcv infection * hcv genotype 1 * no previous treatment for hepatitis c infection * serum hcv rna level ≥ 1000 iu/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit * liver evaluation prior to baseline: liver biopsy within 3 years or fibroscan within 6 months exclusion criteria: * hcv genotype different from genotype 1 or co-infection with other hcv genotype * co-infection with hepatitis b or hiv * any other cause of relevant liver disease other than hcv * presence or history of hepatic decompensation * alanine aminotransferase (alt) ≥ 10 times upper limit of normal (uln), more than 1 episode of elevated bilirubin (\> uln) in past 6 months other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic hepatitis c cyclophilin inhibitor
study of freeze-dried black raspberry in maintenance of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this research study is about adding black raspberry powder to the treatment regimen of patients with ulcerative colitis who are currently in remission and doing well.


Eligibility criteria:
inclusion criteria: adult patients (\>18 years of age) with known diagnosis of ulcerative colitis who are currently in remission on a stable dose of 5-asa products and/or steroids (equivalent to prednisone 20 mg or less). english speaking/reading male or female patients from all ethnicities will be considered for the study. exclusion criteria: * treatment with immunomodulators and/or biologic agents, active disease flare, patients younger than 18 years old, patients who are pregnant or trying to get pregnant, breast feeding and those with reported history of allergy or hypersensitivity to berry products. patients who are using nsaids will also be excluded from the study but low dose asa (81-162 mg) is permitted if needed.
identification and characterization of novel non-coding variants that contribute to genetic disorders

Conditions: Genetic Disease; Inborn Errors of Metabolism; Glycogen Storage Disease; Lysosomal Storage Diseases; Storage Disease

Summary: the goal of this study is to identify and characterize novel non-coding and splicing variants that may contribute to genetic disorders. we will particularly focus on patients with a diagnosed genetic disorder that has inconclusive genetic findings.

to perform this study, we will use patient dna and rna that is isolated from blood samples. dna will be sequenced (targeted capture and/or whole genome dna sequencing (wgs)) to identify any non-coding single nucleotide variants (snvs), smaller insertions/deletions (indels), or larger structural variants (svs). rna will be sequenced (rna-seq) to identify genes that are expressed in a differential and/or allele-specific manner, which may indicate a functional non-coding or splicing variant. we will test the function of non-coding variants using high-throughput reporter assays and crispr based methodologies.

Eligibility criteria:
inclusion criteria: subjects will have one or more of the following: * patients (probands) diagnosed with a genetic disease * patients (probands) with inconclusive genetic results * patients (probands) that have identical coding and/or splicing variants, but display highly diverse phenotypes * unaffected family members of probands exclusion criteria: there are no exclusion criteria for this study.
a comparison of adding exenatide with switching to exenatide in patients with type 2 diabetes experiencing inadequate glycemic control with sitagliptin plus metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.


Eligibility criteria:
inclusion criteria: * present with type 2 diabetes * patients have been treated with a stable dose of the following for at least 3 months prior to screening: * 100 mg/day sitagliptin and * ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release). * have inadequate glycemic control as evidenced by an hba1c between 7.1% and 9%, inclusive. * have a body mass index (bmi) ≥20 kg/m2 and \<45 kg/m2 exclusion criteria: * are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * have previously completed or withdrawn from this study or any other study investigating exenatide. * have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin. * used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening. * are currently treated with any of the following excluded medications: * thiazolidinediones (tzd) within 3 months of screening. * sulfonylurea (su) within 3 months of screening. * dipeptidyl peptidase-4 \[dpp-4\] inhibitors, with the exception of sitagliptin, within 3 months of screening. * meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening. * alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening. * exogenous insulin within the 3 months prior to screening. * drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics. * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (iv), or intramuscular (im) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening. * any other oral antidiabetic (oad) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Keywords: diabetes exenatide byetta sitagliptin januvia amylin lilly
effect of empagliflozin and dulaglutide on mafld in patients with t2d

Conditions: Metabolic-associated Fatty Liver Disease; Type 2 Diabetes

Summary: the co-administration of sglt2 inhibitor and glp-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and mafld better than empagliflozin or dulaglutide alone. the sglt2 inhibitor and glp-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and mafld.


Eligibility criteria:
inclusion criteria: 1. age 20 or over 2. uncontrolled hba1c (7\~10%) with metformin and/or sulfonylurea 3. hepatic steatosis estimated by fibroscan (cap ≥258 db/m) 4. mafld: presence of any conditions 1. overweight or obese: bmi ≥23 kg/m2 (asian) 2. metabolic dysregulation: at least of two of following criteria * waist circumference: ≥90/80 cm in men and women (asian) * blood pressure ≥130/85 mmhg or drug treatment * plasma triglycerides ≥150 mg/dl or drug treatment * plasma hdl-cholesterol \<40/50 mg/dl for men and women or drug treatment * prediabetes (i.e. fasting glucose levels 100 to 125 mg/dl or 2-hour post-load glucose levels 140 to 199 mg/dl or hba1c 5.7% to 6.4% * homa-insulin resistance score ≥2.5 * plasma high-sensitivity crp \>2 mg/l exclusion criteria: 1. significant alcohol consumption 2. other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha1 anti-trypsin deficiency, celiac disease, overt hypothyroidism, other secondary causes 3. type 1 diabetes mellitus 4. medication usage within 3 months: vitamin e, pufa, udca, fish oil, sglt2 inhibitors, glp1-ras, tzds 5. severe organ dysfunction 1. liver damage: ast/alt \>x5 unl, albumin \<3.2, platelet \<60k, child-pugh-turcotte stage b or c 2. kidney damage: serum creatinine ≥2.0 mg/dl or egfr \<50 ml/min/1.72m2 6. hepatocellular carcinoma, active tumor, or metastasis 7. end-stage liver disease
endoarterial treatment in combination with percutaneous thermoablation for medium-sized and oligonodular hepatocellular carcinomas

Conditions: Carcinoma, Hepatocellular

Summary: background: the association of transcatheter arterial chemotherapy infusion (tac) with percutaneous ablation (pt) has been introduced as a method to increase the ablative zone. the aim of this study was to evaluate the efficacy of pt and tac performed in a single session for hccs between 30 and 50 mm or oligonodular up to 30 mm. methods: thirty patients with a histologically proven hcc, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("pt+tac group"). a "control" group consisted of 34 patients with uninodular hcc up to 30 mm without any poor prognostic criteria treated with pt alone ("pt group").


Eligibility criteria:
inclusion criteria: - hepatocellular carcinoma pouved by pathology, exclusion criteria: - metastases
effects of lutein supplementation on oxidative stress and inflammation in healthy nonsmokers

Conditions: Oxidative Stress in Healthy Subjects

Summary: lutein is one of oxygenated carotenoids. over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing immune functions. a large number of epidemiological studies support the notion that a high intake of lutein is associated with a reduced risk of coronary heart disease and certain types of cancer. the biological mechanisms for the protective effects of this carotenoid, including powerful modulation of functions and antioxidant properties, are only partially known. although several nutrients and phytochemicals have been shown to modulate immune functions in humans, few studies have investigated the role of lutein consumption. no information is available as to whether lutein supplementation could be protective against oxidative stress. therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on oxidative stress in healthy subjects.

participants with a history of smoking, alcohol consumption, body mass index (bmi)≥30kg/m2, allergies, ocular diseases and participants taking vitamins or other food supplements containing lutein were excluded from the study.

Eligibility criteria:
inclusion criteria: * healthy adult subjects aged in the range of 20 to 80 exclusion criteria: * participants with a history of smoking * alcohol consumption * body mass index (bmi)≥30kg/m2 * allergies * ocular diseases or recent infections(within the last year) and participants taking vitamins or other food supplements containing lutein the previous 2 months.
freeflow percutaneous atrial septal shunt for ipah

Conditions: Pulmonary Arterial Hypertension

Summary: the goal of this clinical trial is to explore the safety and efficacy of the freeflow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. the main questions it aims to answer are: * is the freeflow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension? * does the freeflow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of freeflow percutaneous atrial septal shunts after balloon atrial septostomy. participants will: * underwent balloon atrial septostomy and freeflow percutaneous atrial septal shunt implantation. * will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * 18≤ age ≤70 years old, female or male; * 10 mmhg≤ mean right atrial pressure (mrap) ≤20 mmhg; * the subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmhg); * who grade iii or iv; * nt-probnp≥650 ng/l; * the subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. they signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up. exclusion criteria: * local or systemic sepsis or other acute infection; * severe coagulopathy; * allergy to nickel and/or titanium and/or nickel/titanium-based materials; * patients with contraindications to antiplatelet, coagulant or thrombotic therapy; * intolerance to contrast media; * have participated in other drug or device clinical trials during the same period; * glomerular filtration rate (gfr) \< 50 ml/min; * patients with severe liver dysfunction (alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 times the upper limit of normal); * the patient had malignant arrhythmia; * the patient did not receive standardized drug therapy (triple sequential therapy) according to the chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months; * women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding; * severe restrictive or obstructive lung disease; * implanted atrial septal defect (asd)/ patent foramen ovale (pfo) closure device; * left ventricular ejection fraction (lvef) \<50%; * spo2 \< 90% without oxygen inhalation (pulse measurement); * the anatomical structure of the heart is abnormal, and the shunt cannot be implanted on the atrial septum; * other circumstances in which the patient was deemed by the investigator to be ineligible for inclusion in the trial.