Kornimate/medical-research-clean huggingface dataset:
advanced therapeutics in rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the retention rates of two advanced therapies, tumour necrosis factor (tnf) and janus kinase inhibitor (jak) in the treatment of adults with rheumatoid arthritis (ra) over a two year period. it will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (emr).

conventional therapies for rheumatoid arthritis (ra) treatment include nonsteroidal anti-inflammatory drugs (nsaids), cyclooxygenase-2 (cox-2) selective inhibitors, corticosteroids and disease modifying anti-rheumatic drugs (dmards). these therapies are often partially effective. for those patients, where conventional therapies have failed to alleviate their symptoms, tumour necrosis factor (tnfis) is often prescribed to treat the pain and inflammation associated with ra. the main problem with tnfi and other advanced therapies in ra is retention. at least ¼ of patients stop treatment within a year and another ⅕ to ¼ in the second year, mostly due to secondary loss of efficacy. another advanced therapy, the janus kinase inhibitor (jak) has demonstrated similar efficacy to tnfi treatment in ra. this trial will determine if using a different class of treatment (small molecule, oral drug, jak kinase inhibitor) will have a better retention than a tnfi (using the most commonly prescribed tnfi for ra in canada).

Eligibility criteria:
inclusion criteria: * patients with ra who meet criteria for obtaining an advanced therapeutic through usual care * active ra with 5 or more swollen joints * seropositive * presence of erosions * failure of methotrexate and hydroxychloroquine and sulfasalazine * failure of leflunomide -\> or equal to 18 years * able to provide consent * able to attend usual follow up visits exclusion criteria: * no contraindication to etanercept or tofacitinib * active serious infection * active tuberculosis * multiple sclerosis * current cancer * lymphoma ever * previous use of an advanced therapeutic (biologic or jak kinase inhibitor) * less than 18 years of age * unable to provide consent

Keywords: tumour necrosis factor janus kinase inhibitor
miltefosine to treat cutaneous leishmaniasis in bolivia

Conditions: Cutaneous Leishmaniasis

Summary: cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to l braziliensis in bolivia and cutaneous leishmaniasis due to l panamensis in colombia. this trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to l braziliensis in bolivia. patients will be randomly assigned to miltefosine or pentavalent antimony. standard dose regimens will be used for both drugs.


Eligibility criteria:
presentation: at least 1 lesion must be ulcerative. parasitology: parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion. previous rx: no specific or putatively specific therapy for leishmaniasis (sb, pentamidine, amphotericin b, imidazoles, allopurinol) other diseases: no concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (sgot) and kidney function tests (creatinine).

Keywords: cutaneous leishmaniasis drug miltefosine
a study of mabthera (rituximab) in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to anti-tnf therapies.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will evaluate the efficacy and safety of mabthera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-tnf therapies. patients will receive mabthera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of mabthera. after week 24, eligible patients may receive re-treatment. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age; * rheumatoid arthritis for \>=6 months; * receiving outpatient treatment; * an inadequate response to at least one anti-tnf therapy; * stable methotrexate for \>=12 weeks. exclusion criteria: * other rheumatic autoimmune disease or inflammatory joint disease; * previous treatment with mabthera; * concurrent treatment with any dmard (apart from methotrexate), anti-tnf alpha therapy, or other biologic agent.
study on the use of the insulin pump tandem x:2 with control iq algorithm - update

Conditions: Type 1 Diabetes; Insulin Therapy

Summary: the aim of this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the tandem t:slim x:2 pump system in patients with type 1 diabetes.

this is a non-randomized, non-blinded, prospective, observational single-center study, enrolling 2x 25 subjects in two cohorts (25 subjects in switch group and 25 subjects in start group) with diabetes mellitus for up to 12 weeks. the study will evaluate the effectiveness of the insulin therapy with the pump system tandem t:slim x:2 with the special algorithm "control iq" in comparison to each other. the test system including the control iq software will provide an hybrid-closed loop - modus, which can predict the future tissue glucose value and continuously adjust the insulin infusion according to need. the aim is to keep the glucose value permanently within the target range and to avoid hypoglycaemia or hyperglycaemia. group start starts from any other diabetes therapy (mdi, plgm (=predictive low glucose suspend), sap (=sensor augmented pump)) directly to t:slim pump with control iq; group switch switches from former use of t:slim with basal iq. the study includes two visits only (start and end). at the beginning all patients have to complete questionnaires, and the data of the glucose sensor are read out and the metric data are determined and laid down. depending on the previous form of therapy, the patients are assigned to the corresponding cohort. all participants and parents, regardless of which cohort, receive a technical briefing from the study team as well as training on how to use the new system or algorithm. subsequently, the system will be applied in everyday life in the coming weeks. after 12 weeks (end of study), the insulin pump is read out and the questionnaire on satisfaction with the device is filled out again. after the end of the study, the patients participate in standard medical care as before.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. type 1 diabetes 3. age \>6 years 4. at least 10 ie daily total insulin dose and 25 kg body weight 5. group switch: already user of t:slim x2 with basal iq 6. group start: granting of the insulin pump t:slim x2 and dexcom g6 by the health insurance exclusion criteria: 1.refusal of participation by the participant or a parent

Keywords: paediatrics type 1 diabetes closed loop csii (continuous subcutaneous insulin infusion)
artificial intelligence prediction tool in thymic epithelial tumors

Conditions: Thymic Epithelial Tumor; Thymic Carcinoma; Thymoma; Thymoma and Thymic Carcinoma

Summary: thymic epithelial tumors are rare neoplasms in the anterior mediastinum. the cornerstone of the treatment is surgical resection. administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the who histopathological classification. in this classification thymoma types a, ab, b1, b2, b3, and thymic carcinoma are distinguished. studies have shown large discordances between pathologists in subtyping these tumors. moreover, the who classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses. the investigators will develop ai models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence. in this multicentric and international project three existing databases will be used from rotterdam, maastricht and lyon. for all models one database will be used to build ai models, and the other two for external validation. the ultimate goal of this project is to develop ai models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy.


Eligibility criteria:
inclusion criteria: participants with specific diagnoses are eligible for inclusion in the study. the eligible diagnoses include various subtypes of thymoma and thymic carcinoma, specifically: * thymoma a * thymoma ab * thymoma b1 * thymoma b2 * thymoma b3 * thymic carcinoma inclusion is based on a consensus diagnosis with a level of agreement less than 70%. this criterion is applied during the training phase of the model. recurrence criteria: participants with a documented recurrence outcome within a 5-year period are considered eligible for this aspect of the study. this criterion is primarily applied during the validation phase.

Keywords: artificial intelligence digital pathology
cytokine status of covid-19 patients

Conditions: Covid19

Summary: covid-19, spreading rapidly all over the world, causes serious morbidity and mortality. in severe covid-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. it is noteworthy that it causes lymphopenia in patients. in the studies, the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and tnf-α, were evaluated. in addition, blood values of a limited number of cytokines were investigated similarly in a limited number of studies published in our country.

the causative agent of coronavirus 2019 (covid-19) disease, which started in wuhan province of china in december 2019, was severe acute respiratory failure syndrome coronavirus 2 (sars-cov-2), which quickly spread all over the world and caused a pandemic. covid-19 can cause death with symptoms such as fever, cough, muscle pain, shortness of breath, and pneumonia (1). pulmonary pathology of covid-19 is diffuse alveolar damage, focal reactive hyperplasia of pneumocytes with patchy inflammatory cells, intravascular thrombosis, monocyte, macrophage and lymphocyte infiltration into pulmonary spaces. severe infiltration of pulmonary tissue affects alveolar gas exchange. in addition, cardiovascular morbidity, tachyarrhythmia and thromboembolic events are observed in 1/5 of the hospitalized patients with troponin elevation, which is closely related to mortality. in severe covid-19 infections, after pulmonary inflammation, cardiovascular organ failure, cytokine storm, hemophagocytosis, septic shock, develops due to uncontrolled hypoxia, and isolated organ failure turns into multi-organ failure. it is noteworthy that it causes lymphopenia in patients. in the studies , the blood levels of certain inflammatory cytokines, interleukin-1β,interleukin-6 and tnf-α, were evaluated. in addition, blood values of a limited number of cytokines were investigated in a similar way in a limited number of studies published in our country. we aimed to study il-1β, ifn-α2, ifn-γ, tnf-α, mcp-1 (ccl2), il-6, il-8 (cxcl8), il-10, il-12p70, il-17a, il-18, il-23, il-33 at covid 19 and healthy volunteers.

Eligibility criteria:
inclusion criteria: * patients with covid 19 pcr (+) results exclusion criteria: * cancer patients * patients with known immunodeficiency * pregnancy

Keywords: interleukin cytokine
myocardial deformation imaging after acute alcohol excess

Conditions: Myocardial Dysfunction

Summary: background: chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. in general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. as only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap. methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. echocardiography will performed at baseline and at follow-up regarding conventional parameter \[as left ventricular ejection fraction (lvef), transmitral early (e) and late (a) doppler flow velocities, e/a ratio, deceleration time of e (dt) and isovolumic relaxation time (ivrt)\] and myocardial deformation data \[as layer specific global circumferential (endo gcs, mid gcs, epi gcs) and longitudinal (endo gls, mid gls, epi gls) strain\].


Eligibility criteria:
inclusion criteria: * healthy subjects who are not used to alcohol * subjets who had an excessive alcohol ingestion up to 12 hours before echocardiography exclusion criteria: * any heart disease * subjects under 18 years

Keywords: alcohol induced cardiomyopathy myocardial deformation imaging
efficacy and safety of vpm1002 in reducing sars-cov-2 (covid-19) infection rate and severity

Conditions: SARS-CoV-2 Infection

Summary: bacille calmette-guerin (bcg) is a live attenuated vaccine administered for prevention of tuberculosis. recently, several groups have hypothesized that bcg may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for covid-19. trials are currently being conducted in australia, netherlands, germany and the united kingdom to evaluate its effectiveness. front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. they are at high risk of infection from covid-19, with potentially high infection rate. the investigators propose an interventional trial to evaluate the effectiveness of bcg vaccination to prevent covid-19 infection and reduce its severity in front-line employees in ontario.


Eligibility criteria:
inclusion criteria: * eighteen years of age or older * employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility exclusion criteria: * prior intravesical bcg or intradermal bcg, with the exception of tuberculosis vaccination in childhood. * previous known history of latent or active tuberculosis * known kidney, liver or blood disorders which impairs organ and marrow function * chronic administration of steroids (\>10 mg prednisone) at the time of randomization * current or planned concomitant biologic therapy in the next 7 months. * known hypersensitivity or allergy to components of vpm1002 * pregnant or planning to become pregnant in the future 7 months. * breastfeeding. * current suspected viral or bacterial infection. * body temperature \> 38° c * participation in another interventional study with potentially conflicting medication within 30 days before screening. * the presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-tnf therapy, methotrexate, azathioprine, antimalarials). * active malignancy requiring treatment. * known positive hiv serology. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to bcg vaccine. * previous positive covid-19 confirmed infection. * uncontrolled intercurrent illness. * psychiatric illness/social situations that would limit compliance with study requirements.
simplification study of hiv-1 infected patients with virological suppression under the combination of lamivudine (150 mg bid) plus raltegravir (400 mg bid) switching to lamivudine (300 mg qd) plus raltegravir (1200 mg qd) : roll-over study of the ralam

Conditions: HIV Infections; HIV-1-infection; HIV Seropositivity

Summary: phase 3b, single arm, single site simplification study of hiv-1 infected patients with virological suppression under the combination of lamivudine (150 mg bid) plus raltegravir (400 mg bid) switching to lamivudine (300 mg qd) plus raltegravir (1200 mg qd): roll-over study of the ralam clinical trial (nct02284035)


Eligibility criteria:
inclusion criteria: * patients in the switch arm who have completed the 24-week follow-up of ralam (nct02284035) study and remain virologically suppressed (viral load \<50 copies/ml) on dual therapy with lamivudine plus raltegravir * patients who have signed informed consent to participate in the study. exclusion criteria: * pregnancy, lactation, or planned pregnancy during the study period * any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment * hepatitis b co-infection

Keywords: raltegravir lamivudine
a study to evaluate the efficacy and safety of 2 doses of eye103 compared with ranibizumab (0.5 mg) in participants with dme

Conditions: Diabetic Macular Edema (DME)

Summary: eye-res-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of eye103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (dme) in the first year, all 3 treatment groups will be treated every 4 weeks with either eye103 or ranibizumab. beginning at year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. approximately 960 participants will be entered in the study.

eye-res-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of eye103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (dme) approximately 960 participants will be entered in the study. participants will be randomized 1:1:1 to receive low dose eye103, high dose eye103, or 0.5 mg ranibizumab, administered via intravitreal injection. in the first year, all 3 treatment groups will be treated every 4 weeks with either eye103 or ranibizumab. beginning at year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (pti) algorithm. throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of etdrs bcva, examination by slit-lamp biomicroscopy, fundoscopy, and sd-oct. among other parameters, sd-oct will be used to measure central subfield thickness (cst) in microns.

Eligibility criteria:
inclusion criteria: * be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * be male or female ≥18 years of age. * have type 1 or type 2 diabetes mellitus and a hba1c of ≤12%. * have a decrease in vision in the study eye determined by the investigator to be primarily the result of dme. exclusion criteria: * be pregnant or breastfeeding * history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening * have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (yag) laser capsulotomy within 90 days of screening * are currently using drugs with known retinal toxicity (e.g., hydroxychloroquine, pentosan polysulfate sodium, and amiodarone) * if treatment-experienced for dme have a history of any of the following treatments within the noted time windows: * have had prior treatment with 8 mg aflibercept (eylea hd) or faricimab (vabysmo) within 120 days prior to the screening visit in the study eye * have had an ivt with other anti-vegf treatments (ranibizumab, bevacizumab, aflibercept \[2 mg\], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the screening visit

Keywords: diabetic macular edema dme
preventive effects of parecoxib on postoperative complications in hepatocellular carcinoma patients undergoing hepatic transcatheter arterial chemoembolization

Conditions: Hepatocellular Carcinoma

Summary: this study is aiming to understand the effects of parecoxib on the postoperative complications of hepatocellular carcinoma (hcc) patients undergoing hepatic transcatheter arterial embolization (tace). the investigators enrolled 242 patients who were diagnosed with hcc for the first time and who received hepatic tace at the cancer prevention and treatment center of sun yat-sen university from october 2014 to march 2015 were prospectively enrolled. the patients were divided into study and control groups according to whether parecoxib sodium was administered postoperatively. pain scores,body temperature, vomiting, and changes in liver function after surgery, as well as the length of the hospital stay, were recorded and compared.


Eligibility criteria:
inclusion criteria: 1. diagnosed with hcc according to the "primary liver cancer diagnosis and treatment practices" published by theministry of health in 2011 2. a previous history of hepatitis b or positivity for hepatitis b surface antigen (hbsag) 3. a karnofsky performance status (kps) score ≥70 points 4. age between 18 and 65 years 5. child-pugh classa or b (class b patients had scores no greater than 7 points). in addition, the baseline laboratory tests had to meet the following criteria: white blood cells (wbcs) ≥1.5 × 109/l, platelets ≥50 × 109/l, hemoglobin ≥80 g/l, serum aspartate transaminase (ast) and alanine transaminase (alt) ≤ 2 x the upper limit of normal (uln), serum creatinine ≤ 1.5 x uln, an international normalized ratio (inr)\<1.5 or prothrombin time \< the uln + 4 seconds, albumin ≥30 g/l, and total bilirubin ≤34mmol/l exclusion criteria: 1. patients who had iodine allergies, severe heart and lung diseases, significant fever or pain, or continuous use of anti-inflammatory drugs within the past three months were excluded
patient satisfaction and quality of life impact - pecfent®

Conditions: Breakthrough Cancer Pain

Summary: national multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom pecfent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions. • study objectives include assessment of early treatment satisfaction.


Eligibility criteria:
inclusion criteria: * adult (aged ≥18 years) with cancer * taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

Keywords: quality of life pecfent lazanda fentanyl intranasal breakthrough cancer pain
a phase 1b study to investigate the safety and preliminary efficacy for the combination of dasatinib plus nivolumab in patients with chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to find a dose of nivolumab that can be safely added to dasatinib in patients with chronic myeloid leukemia.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * confirmed diagnosis of chronic myeloid leukemia in chronic phase or accelerated phase : * with historically documented ph+ cells * ≥2 prior tyrosine kinase inhibitors (tki) therapies for cml * currently progressing, resistance to or with a suboptimal response to their most recent therapy * eastern cooperative oncology group (ecog) performance status (ps) score 0 - 1 exclusion criteria: * blast phase cml * known abl-kinase mutation resistant to dasatinib (e.g. t315i or t315a)