Kornimate/medical-research-clean huggingface dataset:
cognitive remediation program for hospitalized in the long term patients with deficit schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. so, cognitive remediation programs were developped to focus cognitive disorders. the ipt (integrated psychological treatment) is one of the most complete program with modules on cognitive and social abilities. the aim of this study is to evaluate the efficacy of ipt+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program with ipt+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. so, cognitive remediation programs were developped to focus cognitive disorders. the ipt (integrated psychological treatment) is one of the most complete program with modules on cognitive and social abilities. the aim of this study is to evaluate the efficacy of ipt+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program the secondary objectives are to evaluate autonomy 6 months after the program, to evaluate the efficacy of the program on negative symptoms, quality of life, cognitive functions, social cognition and duration of hospitalisation. this study propose a randomised controlled study with 2 arms, with blind evaluation to compare the ipt+ versus treatment as usual (tau). the follow up will be 6 month for the with ipt+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 60 * diagnosis of schizophrenia on dsm 5 * criteria of deficit schizophrenia with the schedule for deficit syndrome * inpatient at inclusion with at least 6 month of hospitalisation during the last 2 years * clinically stable * able to understand, talk and read french * signing consent form exclusion criteria: * change in psychotropic treatment during the last month * psychotherapy in the last 8 months or planned during the study * cdss score \> 9 * drug dependency during the last year * unstable somatic disease * somatic disease with impact on cognition

Keywords: deficit schizophrenia long stay inpatients cognitive remediation negative symptoms
the effect of training on endothelial function, progression of disease,inflammation, heart rate variability and mental health after percutaneous coronary intervention

Conditions: Coronary Artery Disease

Summary: the efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.

pas er randomized to a 6 months training group or none training. at baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. further patients are asked to answer questionnaires concerning mental health (sf36, hads).

Eligibility criteria:
inclusion criteria: * successful pci with stent implantation, * able to participate in the training program, * no planned further revascularisation exclusion criteria: * cagb, * inflammatory diseases other than cad, * heart failure, * severe kidney failure, * inability to participate in the training program

Keywords: pci stent training endothelial function restenosis late luminal loss heart rate variability oxygen uptake capacity inflammatory markers
safety, tolerability, pharmacokinetics, and efficacy of jbt-101 (lenabasum) in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of jbt-101 in adult subjects with cystic fibrosis (cf).

an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of jbt-101 in 70 subjects ≥ 18 and \< 65 years of age with documented cystic fibrosis. there will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.

Eligibility criteria:
inclusion criteria: * documentation of a cf diagnosis as evidenced by 1 or more clinical features consistent with the cf phenotype and 1 or more of the following criteria: 1. sweat chloride equal to or greater than 60 meq/l by quantitative pilocarpine iontophoresis test; 2. two well-characterized mutations in the cftr gene * fev1 ≥ 40% predicted corrected * stable treatment of cf for 14 days before visit 1 exclusion criteria: * severe or unstable cf, such as: 1. intravenous antibiotic treatment within 14 days before visit 1 2. treatment with any corticosteroids \> 10 mg per day or \> 20 mg every other day oral prednisone or equivalent within 14 days before visit 1 * any one of the following values for laboratory tests at screening: 1. a positive pregnancy test (or at visit 1); 2. hemoglobin \< 10 g/dl 3. neutrophils \< 1.0 x 10\~9/l 4. platelets \< 75 x 10\~9/l 5. creatinine clearance \< 50 ml/min according to modified cockcroft-gault equation 6. serum transaminases \> 2.5 x upper normal limit 7. total bilirubin ≥ 1.5 x upper limit of normal * any other condition that, in the opinion of the principal investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Keywords: jbt-101, lenabasum, cystic fibrosis
prevention of postop atrial fibrillation through intraoperative inducibility of atrial fibrillation and amiodarone treatment

Conditions: Postoperative Atrial Fibrillation

Summary: patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for af inducibility. patients with inducible af will be randomized to prophylactic amiodarone treatment versus no treatment. patients who are not inducible to af will be treated with standard post-operative care. patients will be monitored post-operatively to explore the value of intraoperative inducibility of af to predict poaf and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of poaf

in the operating room, as part of the open heart surgery, the surgeon will stimulate the superior right atrium section of the heart with a pacemaker for 30 seconds just prior to starting the heart and lung bypass machine. the stimulation is done to see how sensitive the heart is to developing atrial fibrillation. this test result will be documented. the procedure will only take 60 seconds out of the entire operation. it does not involve taking any samples of tissue or blood. following this step, if the heart demonstrates atrial fibrillation for at least 30 seconds then the participant will then be randomized to either receive the prophylactic drug treatment using amiodarone or to no prophylactic drug administration. the participant has a 50% chance of receiving the fda approved study drug amiodarone. the study arms consist of prophylactic drug administration with amiodarone, no prophylactic drug administration, or no atrial fibrillation reaction after stimulation with the pacemaker. the remainder of the surgical procedure will not be affected, and will follow routine surgical practice.

Eligibility criteria:
inclusion criteria: * patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (cabg) revascularization, valvular repair or replacement, combined cabg with valve repair or replacement, or valve sparing aortic root repair * normal sinus rhythm * no documented history of atrial fibrillation exclusion criteria: * prior surgical procedures involving heart surgery and cardiopulmonary bypass * any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds * prior history of amiodarone treatment for the management of supraventricular tachy-arrhythmias * patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or maze procedure.
sublingual versus endovenous fentanyl for the prehospital analgesia in patients with limb trauma on the slope

Conditions: Acute Pain Due to Trauma

Summary: the purpose of this study is to determine the non-inferiority of the efficacy for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope

fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. fentanyl sublingual (abstral ®) is an excellent analgesic drug in the breakthrough cancer pain relief in oncologic patients. the immediate (less than 10 minutes) effect and the ease of administration of sublingual fentanyl is a feasible drug administration for immediate analgesia in remote areas such as mountain rescue missions eg. the slope. patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev. safety issues like control of vital signs will be warranted.

Eligibility criteria:
inclusion criteria: * trauma on the limbs with a pain score of 4 or more on the slope * asa i - ii exclusion criteria: * children (\< 18 years) * cognitive impairment: brain injury, intoxication, analgesia * weight under 50 kg and more than 100 kg * other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation; * chronic analgesic use or misuse * allergy * fear of needles * pregnancy * speech difficulties

Keywords: fentanyl transmucosal administration endovenous administration pain therapy mountain emergency medicine
evaluation of tp-e interval and tp-e/qt ratio in dermatomyositis and analysis of their relationship with inflammation

Conditions: Dermatomyositis; Myocardial Repolarization; Inflammation

Summary: the goal of this observational study is to investigate ventricular repolarization utilizing tp-e intervals and tp-e/qt ratios in patients with dm. the main questions it aims to answer are: * 1.exploring the changes in ventricular repolarization parameters (qt interval, qtc interval, qtd, tp-e interval, tp-e/qt ratio) in patients with dermatomyositis, providing quantifiable indicators for early detection of arrhythmia in dermatomyositis patients; * 2.exploring the role of inflammation in ventricular repolarization in dm patients, providing a basis for in-depth research on the diagnosis and prevention of arrhythmia in dm patients.


Eligibility criteria:
inclusion criteria: regardless of gender, registered residence and education level, voluntarily participate in this study and sign the informed consent form. clinical diagnosis of dermatomyositis. exclusion criteria: previous history of heart disease (such as myocardial infarction, cardiac pacing, congenital heart disease, ischemic heart disease, etc.), chronic kidney disease, etc; patients with other connective tissue diseases; pregnant and lactating women. taking drugs that affect electrocardiogram indicators, such as macrolides, quinolones, quinidine, amiodarone, antipsychotic drugs, etc. patients with severe lack of case data.
refractive change induced by 2.8-mm corneal incision

Conditions: Cataract; Refractive Surgery; Astigmatism

Summary: the investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral. patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. visual acuity, refraction, keratometry, pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification. outcome measures will be induced corneal refractive change (fourier power vector analysis), isv change, and visual acuity, at 6 months.


Eligibility criteria:
inclusion criteria: * visual impairment for daily tasks caused by cataract * age older than 50 years * steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20° * ability to cooperate in the protocol procedures exclusion criteria: * age below 50 * inability to cooperate with measurements

Keywords: corneal incision cataract surgery phacoemulsification surgically induced astigmatism corneal topography
ai prediction of gastric cancer response to neoadjuvant chemotherapy

Conditions: Gastric Cancer; Image; Pathology

Summary: this study seeks to develop a deep-learning-based intelligent predictive model for the efficacy of neoadjuvant chemotherapy in gastric cancer patients. by utilizing the patients' ct imaging data, biopsy pathology images, and clinical information, the intelligent model will predict the post-neoadjuvant chemotherapy efficacy and prognosis, offering assistance in personalized treatment decisions for gastric cancer patients.

this study seeks to develop a deep learning model to predict the outcomes of neoadjuvant chemotherapy in patients with gastric cancer. leveraging participants' ct scans, biopsy pathology images, and clinical profiles, this model aims to forecast the effectiveness of post-neoadjuvant chemotherapy and the subsequent prognosis, thereby aiding in individualized treatment choices for these participants. data collection: the investigators will gather data from 1,800 retrospective cases and 200 prospective cases from multiple hospitals. the retrospective data will be divided into training and testing sets to train and validate the model, respectively. the model's performance will subsequently be evaluated using the prospective dataset. clinical information: this encompasses the participant's gender, age, tumor markers, staging, type, specific treatment plans, pre and post-treatment lab results, etc. imaging data: ct imaging data taken within one month prior to the neoadjuvant chemotherapy, with at least the venous phase ct imaging included. pathology data: pathology images from a gastric tumor biopsy stained with hematoxylin and eosin (he) taken within one month prior to treatment. trg grading: based on the pathology report of the surgical samples using the ryan trg grading system. prognostic endpoints: the recorded endpoints are a 3-year progression-free survival (pfs) and a 5-year overall survival (os). all deaths due to non-disease factors are excluded from the prognosis analysis.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * pathologically diagnosed with advanced gastric cancer in accordance with the american ajcc's tnm staging standards; * have not undergone any systematic anti-cancer treatments before neoadjuvant chemotherapy and have not had surgery for local progression or distant metastasis; * received standard neoadjuvant chemotherapy as recommended by the clinical guidelines, and have documented treatment details; * ct imaging and biopsy pathology images strictly taken within one month prior to starting neoadjuvant treatment; * patients possess comprehensive preoperative clinical information and post-operative trg grading. exclusion criteria: * patients whose ct or pathology images are unclear, making lesion assessment infeasible; * patients diagnosed with other concurrent tumors.

Keywords: gastric cancer neoadjuvant chemotherapy radiomics treatment outcome prediction pathomics radiopathomics
examining the benefit of graduated compression stockings in the prevention of venous thromboembolism in low-risk surgical patients

Conditions: Venous Thromboembolism

Summary: hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. clots in the leg can cause swelling, pain and other problems. if a clot in the leg travels to the lungs, it may be life threatening. having surgery increases the risk of developing blood clots. people having short-stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. these low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot. the risks of wearing the stockings are low but they can be uncomfortable. in the uk, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. stockings cost the nhs a lot of money and it remains unknown if they work. this study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low. adults (over 18-years) who are at low risk of developing blood clots (assessed using a nationally recognised tool) will be included.


Eligibility criteria:
inclusion criteria: * adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay \<48 hours * individuals assessed as being at low-risk of developing vte as per the dhra tool (i.e. no assessed thrombosis risk factors / scoring 0) exclusion criteria: * individuals with a contraindication to gcs * individuals assessed as being at moderate or high-risk of vte as per the dhra tool * individuals requiring therapeutic anticoagulation * individuals with thrombophilia/ thrombogenic disorder * individuals with a previous history of vte * individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery * individuals requiring extended thromboprophylaxis beyond discharge * female patients of childbearing age who have a positive pregnancy test * individuals with lower limb immobilisation * inability to provide informed consent

Keywords: cluster venous thromboembolism deep vein thrombosis pulmonary embolism
a study to evaluate the efficacy of medi8968 in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the effect of medi8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (aecopd) in adult subjects with symptomatic, moderate to very severe copd (global initiative for chronic obstructive lung disease - gold stage ii-iv) receiving standard maintenance therapy for the underlying disease condition.

a phase 2 double-blind, placebo-controlled study to evaluate the efficacy of medi8968 in chronic obstructive pulmonary disease. the study will have a screening phase of 23 days, treatment phase from week 1 to 53 and follow-up phase from week 53 to 69. participants will receive either medi8968 600 milligram (mg) as intravenous (iv) infusion on day 1 followed by 300 mg injection subcutaneously (sc) every 4 weeks up to week 53 or matching placebo in the same fashion. participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (aecopd). safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * age 45 through 75 years * predicted (global initiative for chronic obstructive lung disease \[gold\] stage ii, iii, and iv) at screening * history of previous acute exacerbations of chronic obstructive pulmonary disease (aecopd) 12 months prior to screening * clinically stable and free from an aecopd for 8 weeks prior to day 1 * current smoker or ex-smoker with a tobacco history of more than or equal to (\>=) 10 pack-years. exclusion criteria: * past or present disease or disorder, * significant or unstable ischemic heart disease etc * known history of allergy or reaction to any component of the investigational manufacturing product (imp) * past or current malignancy within the past 5 years * subjects have had a chest x-ray or computed tomography (ct) scan suggestive of malignancy or tuberculosis (tb). * use of immunosuppressive medication receipt of any biologic agent.

Keywords: chronic obstructive pulmonary disease (copd) medi8968
a study of mrx-4dp0004 in asthma

Conditions: Asthma

Summary: this is a multicentre, phase i/ii, double-blind, placebo-controlled study of mrx-4dp0004 in participants taking long-term medication for asthma. participants will take two capsules of mrx-4dp0004 twice daily in addition to their existing asthma medication for 12 weeks. safety and tolerability and immune modulatory effects of mrx-4dp0004 will be assessed throughout the study.


Eligibility criteria:
inclusion criteria: * documented history and diagnosis of asthma at least 6 months prior to visit 1. * stable current asthma treatment as per gina steps 2-4 (ics with or without laba) for at least 2 months prior to visit 1. * acq-6 score \>1.5 and \<=4 * fev1 \>50% of predicted normal * following protocol specified contraception requirements. exclusion criteria: * non-compliant with prescribed asthma maintenance treatment. * at significant risk of exposure to a change in environmental sensitising substances during the study. * co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study. * hepatitis b or c or hiv. * gi fistula, feeding tubes or inflammatory bowel disease. * gi disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease. * history of life-threatening asthma. * systemic corticosteroids within 6 weeks of first dose. * allergy to all of ampicillin, clindamycin and imipenem. * probiotic supplements. * immunosuppression or immunosuppressant medication. * use of ics and laba as maintenance and reliever therapy. * smokers or nicotine users within 3 months of screening. * former smokers \>15 pack years. * systemic antibiotics within 6 weeks of first dose. * clinically significant haematology and serum biochemistry. * sensitivity to any constituent of imp. * diastolic blood pressure \ 90, systolic blood pressure \ 155mmhg, pulse rate \ 100 bpm. * clinically significant ecgs or structural cardiac abnormalities. * any other condition that may interfere with primary objective. * receipt of a positive covid-19 test result within 4 weeks of first dose of imp

Keywords: mrx-4dp0004 asthma live biotherapeutic product