Kornimate/medical-research-clean huggingface dataset:
ciclosporin in the management of new erythema nodosum leprosum

Conditions: Leprosy

Summary: study 2a: ciclosporin in the management of new erythema nodosum leprosum objective: a pilot (double blind controlled) study randomizing patients to treatment either with ciclosporin or prednisolone to assess the safety, tolerability and efficacy of ciclosporin in the treatment of patients with new acute type 2 reactions (enl).

a pilot (double blind controlled) study randomizing patients to treatment either with ciclosporin or prednisolone to assess the safety, tolerability and efficacy of ciclosporin in the treatment of patients with new acute type 2 reactions (enl).

Eligibility criteria:
inclusion criteria: * individuals with clinical evidence of new enl * aged 18-65 * weigh more than 30kg exclusion criteria: * unwillingness to give informed consent * patients with severe active infections such as tuberculosis * pregnant or breastfeeding women (see appendix ii) * those with renal failure, abnormal renal function, hypertensive * patients taking thalidomide currently or within the last 3 months * patients not willing to return for follow-up * women of reproductive age not willing to use contraception for the duration of the study ( see appendix ii) * hiv positive patients

Keywords: leprosy enl erythema nodosum leprosum prednisolone ciclosporin
observational study of patients with chronic hepatitis c virus (hcv) infected with hcv genotype 1 low virus load (lvl 1) and effect of pegintron plus rebetol treatment (study p04793 part 2)

Conditions: Hepatitis C

Summary: the purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care pegintron plus ribavirin in part 1 of the study (nct00709228) and who then received retreatment during part 2 of the study. relapse was defined as having a positive virology result at the week 24 post-treatment follow-up, after a negative result at the week 24 end-of-treatment time point. hepatitis c virus ribonucleic acid (hcv-rna) levels were measured at day 1 and weeks 12, 24, and 48 of the extension, and at follow-up week 24.

all study activities were consistent with the eu directive 2001/20/ec section for non-interventional studies (i.e. observational studies). medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. the assignment of the participant to a particular therapeutic strategy is not decided in advance by the trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Eligibility criteria:
inclusion criteria: * willingness to participate * 18 years or older, either gender, any race * participant has relapsed at the end of the part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the week 24 end-of-treatment time point) * participant considered suitable for treatment per local label * investigator considers suitable and participant consents to be treated exclusion criteria: * pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant * participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the smpc
developing a brief intervention to communicate cardiovascular risk to patients presenting to the emergency department with chest pain: a co-production approach. phase 2.

Conditions: Cardiovascular Diseases

Summary: some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. we know this by taking a blood test (troponin) which looks at damage to their heart. these patients are often sent home from hospital with no information about their risk of heart disease. a patient survey revealed that patients in the emergency department would like to receive more information about heart disease. in this study we will provide patients who are at increased risk of cardiovascular disease with their troponin value. we will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. in a previous study we carried out some interviews with patients to find out how we should deliver their results and what information they would like to receive in a cardiovascular brief intervention. we also asked them the best way to provide patients with this information. the aim of this part of the study it to determine if the new cardiovascular brief intervention helps patients understand their risk and if it results in them making changes to their health.


Eligibility criteria:
inclusion criteria: * i) patients who present to the emergency department with symptoms suggestive of acute coronary syndrome ii) a maximum high-sensitivity cardiac troponin i between 5 ng/l and the sex-specific 99th centile. iii) resides in scotland and has a chi number iv) adults aged 18 and over v) no history of cardiovascular disease vi) at least 1 modifiable cardiovascular risk factor: current smoker, hypertension (140/90 mmhg), hypercholesterolaemia (\>6.0 mmol/l), overweight and obesity (bmi \>25), hyperglycaemia or diabetes mellitus. vii) patients who are able to provide informed consent exclusion criteria: * i) patients with a diagnosis of acute coronary syndrome during index presentation ii) patients who are not able to give informed consent iii) patients who do not speak english iv) patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention v) patients with ongoing or planned cardiovascular investigations or interventions vi) patients with chronic kidney disease and a egfr below 30 ml/min
efficacy of osteopathic manipulation on breathing mechanics in a healthy population: a randomized controlled study

Conditions: Respiratory Function Impaired

Summary: this study focused on improving breathing mechanics by using various osteopathic manipulative therapy (omt) techniques. the investigators randomly assigned participants to a control group who received sham treatment and a treatment group who received omt. the investigators measured variable pre- and post- treatment on both groups. the investigators observed an improvement in breathing mechanics in the treatment group.


Eligibility criteria:
inclusion criteria: * healthy volunteers from touro college of osteopathic medicine (tourocom), including students and staff, were recruited as subjects of this study. any participant with recent or past medical history of obstructive or restrictive lung disorders, recent trauma, or illnesses, and/or chest abnormalities were excluded from the study. exclusion criteria: * certain study results were excluded on the basis of abnormal baseline measurements, including but not limited to, heart rate, oxygen saturation, respiratory rate, improper spirometer use, technique and/or high variance among the repeated measurements obtained for each participant.

Keywords: breathing mechanics osteopathic manipulative treatment chest wall excursion pulmonary function tests
an observational study about adverse outcomes in acute pulmonary embolism patients

Conditions: Pulmonary Embolism and Thrombosis; Deterioration, Clinical

Summary: this multi-center retrospective study collected clinical, laboratory, and ct pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

this multi-center retrospective study collected clinical, laboratory, and ct pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital. eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. the discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. the consistency of the nomogram was evaluated using the validation cohort.

Eligibility criteria:
inclusion criteria: * age of ≥ 18 years and a pulmonary embolism diagnosis based on ct pulmonary angiography exclusion criteria: * pregnancy * reception of reperfusion treatment before admission * missing data regarding ct parameters, echocardiography, cardiac troponin i (c-tn i), and n-terminal-pro brain natriuretic peptide (nt-pro bnp) levels.
short duration treatment of non-severe community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: to investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe community acquired pneumonia (pac), who responded well to 3 days of beta-lactamin treatment (3gc or a/ac).


Eligibility criteria:
inclusion criteria: * subject must be 18 years old or over. * admitted three days before for community acquired pneumonia (cap) defined by at least one clinical sign of pneumonia (dyspnea, cough, mucopurulent sputum, crackling sound on lungs) associated with a temperature \>38°c on admission, and a new infiltrate consistent with pneumonia on chest x-ray, who responded favorably to 3 days of treatment with β-lactams (third generation injectable cephalosporin or amoxicillin-clavulanate) * able to take oral medication. * has given its informed consent. exclusion criteria: * creatinin \< 30ml/min * history of jaundice / hepatic impairment associated with amoxicillin / clavulanic acid * history of hypersensitivity to beta-lactam * presence of complications or severity of pneumonia (abscess , significant pleural effusion, severe chronic respiratory failure , septic shock, respiratory condition requiring the passage resuscitation). * known immunocompromised terrain ( asplenia , neutropenia, agammaglobulinemia , immunosuppressants, graft corticosteroids , myeloma , lymphoma, known hiv , sickle cell anemia , child c cirrhosis). * antibiotic treatment exceeding 24 hours prior admission. * suspected atypical bacteria requiring combined antibiotics therapy .(subjects who received a single dose of macrolides or fluoroquinolones emergency will not be excluded) . * legionella suspected on clinical, biological and radiological criteria . * subjects with clinical or epidemiological environment leading to suspect a healthcare-associated pneumonia with antibiotic resistant pathogen. * suspicion of pneumonia by aspiration. * intercurrent infection requiring antibiotic treatment. * pregnant women . * breastfeeding . * allergy to antibiotics in use. * life expectancy \<1 month . * subject without health insurance. * subjects without home adress
effect of genicular nerve block on proprioception in knee osteoarthritis

Conditions: Osteoarthritis

Summary: the study was conducted to investigate the effect of genicular nerve block on pain, quality of life, and proprioception, which are already diminished due to the impact of osteoarthritis in individuals with knee osteoarthritis. does genicular nerve block reduce pain and improve the quality of life in patients with knee osteoarthritis? does genicular nerve block affect proprioception in patients with knee osteoarthritis?

osteoarthritis (oa) is described as a degenerative joint disease characterized by cartilage erosion, osteophytes, subchondral sclerosis, and changes in the joint capsule, commonly observed in the elderly. knee osteoarthritis is identified as the most prevalent form, with an increasing prevalence attributed to aging. it is recognized as a leading cause of disability, resulting in reduced quality of life and increased healthcare costs. major risk factors include age, genetics, obesity, and muscle weakness. current treatments focus on symptom management, with options including medication, physical therapy, and surgery. genicular nerve block is a minimally invasive procedure used to manage knee osteoarthritis pain by administering local anesthetics and corticosteroids near specific genicular nerves under ultrasound guidance. temporary pain relief for up to three months has been reported, and the procedure is considered well-tolerated. proprioception is defined as the sense of joint and limb position, mediated by receptors located in muscles, tendons, and joints. assessment can be performed through simple methods, such as evaluating the ability to recognize specific joint angles or positions during passive or active movement. proprioceptive deficits are frequently observed in osteoarthritis, and a better understanding of these changes is suggested to guide treatment strategies.

Eligibility criteria:
inclusion criteria: * diagnosis of bilateral primary knee osteoarthritis according to acr (american college of rheumatology) criteria. * age between 55 and 75 years. * presence of knee osteoarthritis classified as grade 2 or grade 3 according to the kellgren-lawrence grading system on radiographs taken within the last year. * knee pain lasting longer than 6 months. * western ontario and mcmaster universities osteoarthritis index (womac) score, total score 48-96 exclusion criteria: * severe knee trauma within the last 6 months. * history of surgical operation on the knee region. * intra-articular steroid and/or hyaluronate injection into the knee joint within the last 6 months. * physical therapy targeting the knee within the last 6 months. * regular use of nsaids within the last 6 months. * presence of acute synovitis. * neurological deficits in the lower extremity. * presence of an inflammatory disease. * poor general health condition (e.g., heart failure, advanced asthma, history of malignancy). * any endocrine disorder that may cause polyneuropathy.

Keywords: genicular nerve block proprioception osteoarthritis
treatment of chronic graft-versus-host disease with mesenchymal stromal cells

Conditions: Chronic Graft-Versus-Host Disease

Summary: chronic graft-versus-host disease (cgvhd) is a potentially lethal disorder. a variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. there is therefore a need for novel treatment strategies. mesenchymal stromal cells (msc) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. in the present randomized study the efficacy and safety of msc treatment will be further studied in patients with cgvhd.


Eligibility criteria:
inclusion criteria: * newly diagnosed cgvhd * informed consent obtained from patient and donor. * any patient who has undergone allogeneic stem cell transplantation with c gvhd. * have not received additional agent for cgvhd within 3 months. * expected life is more than 90 days. * adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease. * adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process. exclusion criteria: * invasive fungal disease. * active cytomegalovirus (cmv)/epstein-barr virus(ebv)/varicella disease). * patient is with a history of hypersensitivity to bovine products. * relapsed malignancy.

Keywords: chronic graft-versus-host disease mesenchymal stromal cells
investigate the maximum tolerated dose of vandetanib and concurrent whole brain radiotherapy (wbrt) in patients with non-small cell lung cancer (nsclc) and brain metastases

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: a clinical study to investigate the maximum tolerated dose of vandetanib and concurrent wbrt in patients with nsclc and brain metastases. all patients will receive wbrt, 10 fractions of 3 gy. patients will start 7 days prior to start of radiation treatment with vandetanib. total treatment time with vandetanib is 3 weeks (21 days). patients will have the opportunity to continue vandetanib until progression at a dose of 300 mg. this multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.


Eligibility criteria:
inclusion criteria: * male and female patients aged above 18 years with histologically or cytologically confirmed nsclc and contrast-enhanced ct scan or gadolinium-enhanced mri confirmed brain metastases who have a performance status of 0 to 2 * no previous radiotherapy, surgery or chemotherapy for brain metastases * patients should not have any unstable systemic disease exclusion criteria: * serious abnormal laboratory values * evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol * clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (svc), new york heart association (nyha) classification of heart disease \>2 within 3 months before entry; or presence of cardiac disease that, in the * previous randomization of treatment in the present study and/ or current participation in another clinical study

Keywords: non-small cell lung cancer (nsclc) whole brain radiotherapy metastasis
efficacy and safety study of kn019 in rheumatoid arthritis patients with an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of kn019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.

this study is designed to provide efficacy data in support of the proposed claims of reducing signs and symptoms, improvement in physical function, and 1 year safety data for kn019 dosed at 5 and 10 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate.

Eligibility criteria:
key inclusion criteria: * the patient must meet the american college of rheumatology (acr) classification criteria for the diagnosis of rheumatoid arthritis (ra) by satisfying at least four of the seven criteria; * patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 7.5-25 mg, and a stable dose for 28 days prior to treatment (day 1) * the patient must have active disease at both screening and baseline, as defined by having both: 6 tender/painful joints on motion (out of 68 joints assessed); and; 6 swollen joints (out of 66 joints assessed); crp ≥ 7 mg/l, or esr ≥28 mm/h key exclusion criteria: * pregnant or lactating females. * history of any other autoimmune rheumatic disease. * patients who have previously received ctla4-ig therapy for any reason.
eus-guided intratumoral gemcitabine in locally advanced unresectable pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. the only effective treatment for pancreatic cancer includes surgery. however, only 20% of the patients have surgically treatable disease. also, the 5-year survival for the surgically treated patients is only 15%. about 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. for those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. systemic chemotherapy is given through peripheral vessels. the investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

in this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (eus) in the eligible patients.

Eligibility criteria:
inclusion criteria: * patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor exclusion criteria: * early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging * pancreatic cancer with distant metastasis * unwilling to sign informed consent

Keywords: pancreatic cancer pancreatic adenocarcinoma endoscopic ultrasound
pharmacokinetics of intravenous acyclovir in oncologic paediatric patients

Conditions: Herpesviridae Infections; Herpes Simplex 1; Varicella Zoster Virus Infection; Transplantation Infection; Oncology

Summary: * herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. * recipients of hematopoietic stem cell transplant (hsct) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. * although the worldwide prevalence of herpes simplex virus 1 (hsv-1) and varicella-zoster virus (vzv), antiviral prophylaxis in seropositive hsct recipients has significantly reduced the rate of infection. * acyclovir (acv) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. * since the beginning, acv has demonstrated to be characterized by a large interpatient variability, especially in children. * therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (hsct) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. that risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (hsv-1) that increases consistently with age. in particular, the majority of adult leukemia patients are hsv seropositive, while allogeneic hsct recipients had post-transplant hsv reactivation. it is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (vzv) reactivation has a rate of 13% - 55% in adult recipients. similar percentages of children receiving hsct had vzv reactivation, being also possible a disseminated infection in 10% of children. however, thanks to antiviral prophylaxis in seropositive hsct recipients, the rate of infection has significantly dropped. among the drugs most used for treatment and prophylaxis of hsv/vzv infections among children who are hsct recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. in particular, information about the optimal use of acyclovir in children with malignancies is limited.

Eligibility criteria:
inclusion criteria: * patients with hematological malignancies * hsct recipients who require acv prophylaxis or treatment for hsv-vzv infection or * children undergoing high-intensity antineoplastic chemotherapy who need acv treatment. * intravenous or oral acv dosing * active/available a therapeutic drug monitoring (tdm) protocol for acv * informed consent signed by patient's parents exclusion criteria: * lack of signed informed consent * lack of tdm for acv * unavailable patient's demographic characteristics

Keywords: hematopoietic stem cell transplantation herpes virus infections aciclovir children pharmacokinetics