Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tofacitinib in refractory blau syndrome

Conditions: Blau Syndrome

Summary: this is a prospective cohort study to observe the efficacy and safety of tofacitinib in children with blau syndrome (bs). the investigators would analyze the rate of remission or low disease activity after treatment as well as changes in inflammatory markers, patients' and physician's global assessment of disease activity to determine the efficacy and safety of tofacitinib.


Eligibility criteria:
inclusion criteria: * patients who have pathogenic mutation(s) in nod2 gene; * patients who have clinical manifestations such as granulomatous dermatitis, arthritis, uveitis, vasculitis, interstitial lung disease and so on; * clinical remission was not achieved after ≥12 weeks of treatment with at least one immunosuppressant or biologics. exclusion criteria: patients will not be included if meets any of the following criteria: * being treated with il-1 inhibitor, or other biological agents; * pregnant and lactating women; * serious organ function failure, expected life time less than 6 months.

Keywords: blau syndrome janus kinase inhibitors
supplemental oxygen in catheterized coronary emergency reperfusion

Conditions: ST Elevation Myocardial Infarction

Summary: the aim of soccer is to evaluate the effects of treatment with supplemental o2 before and during acute balloon angioplasty (pci) for patients with st-elevation myocardial infarction (stemi). one hundred stemi patients are randomized in the ambulance to either standard o2 treatment (10 l/min) or no supplemental o2, to be given until the end of the acute pci. cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to assess infarct size and myocardial performance. all patients are followed for 6 months. at 6 months, perceived health and nt-probnp are recorded for all patients, and an additional echocardiography is performed. the primary endpoint is the fraction of myocardium saved with the acute pci. the secondary endpoints include the pain difference between inclusion time and start of pci and myocardial performance on echocardiography.

almost all patients with st elevation myocardial infarction (stemi) in sweden undergo acute balloon angioplasty (pci) to open the occluded coronary artery, and thereby to reduce or abolish the myocardial infarction. standard treatment in these cases is 10-15 l of supplemental oxygen to reduce the myocardial ischemia and the infarct size. it is, however, unknown whether supplemental o2 is beneficial or detrimental to patients with stemi undergoing pci. this study aims to evaluate the effects of treatment with supplemental o2 in acute pci for stemi. the study is a multicenter single blind parallel group randomized trial. one hundred normoxic stemi ambulance patients accepted for primary pci are randomized in the ambulance to either standard o2 treatment (10 l/min) or no supplemental o2, to be given until the end of the acute pci. all patients undergo cardiac mri at day 4-6 to determine area at risk, infarct size and myocardial salvage index. fifty patients undergo an extended echocardiography during the hospital stay to assess infarct size and wall motion score index. all patients are followed for 6 months. at 6 months, perceived health (eq-5d) and nt-probnp are recorded for all patients, and an additional echocardiography is performed for the subgroup of 50 patients. the primary endpoint is myocardial salvage index. secondary endpoints include pain difference between inclusion time and start of pci and wall motion score index on echocardiography.

Eligibility criteria:
inclusion criteria: * stemi patient transported with ambulance to sus lund or malmö or helsingborg hospital, and accepted for acute pci * symptom duration less than 6 hours * normal sao2 (≥ 94 %) measured with pulse oximeter * informed consent exclusion criteria: * previous ami * inability to make decision to participate; dementia and the like * for cmr: significant claustrophobia, prostheses or other magnetic material inside the body

Keywords: oxygen myocardial infarction ambulance percutaneous coronary intervention cardiac magnetic resonance imaging
adapt - a patient registry of the real-world use of orenitram®

Conditions: Pulmonary Arterial Hypertension

Summary: this prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with orenitram for the treatment of pah for up to 78 weeks from orenitram initiation


Eligibility criteria:
inclusion criteria patients are eligible for the registry if: 1. the patient voluntarily gives informed consent to participate in the study. 2. the patient must be at least 18 years of age or older. 3. the patient is prescribed orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving orenitram for 182 or fewer days. 4. the patient agrees to dosing, prostacyclin-related ae of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study. 5. the patient has the ability to answer surveys and use the diary in english. 6. the patient must have an email address and be willing to access the pro portal. exclusion criteria patients are ineligible for the registry if: 1. the patient has previously received orenitram for more than 182 days. 2. the patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than orenitram in pah within

Keywords: pah oral treprostiinil orenitram
corneal thickness changes in patient undergoing dry eye managment

Conditions: Dry Eye Disease

Summary: the purpose of this research is to the determine effect of dry eye and to compare the effect of artificial tears on central and peripheral corneal thickness.

in this randomized controlled trial, 96 eyes of females with dry eye will be recruited through random sampling. dry eye assessments will be done including tbut, schirmer test 1, and osdi questionnaire. 96 eyes will be divided into 3 groups (32 eyes each) and will be provided intervention which is polyethylene glycol 400 0.4%-propylene glycol 0.3%. , dextran 0.1%hypromellose 0.3%, and placebo(normal saline) through randomization by an unmasked investigator. changes in central and peripheral corneal thickness will be evaluated by corneal topography. patients will be evaluated at baseline, after 15 days, after 1 month, and re-evaluated after 1 month of cessation of treatment.

Eligibility criteria:
inclusion criteria: ● females with ages ranging between 18-40 years and osdi scores greater than 13, ametropia of up to 1ds of se with astigmatism of less than 0.5dc, and emmetropes. exclusion criteria: * refractive error of more than ±1 ds of se and astigmatism of greater than ±0.5dc. * corneal surface disease other than dry eye disease. * corneal ectasia. * corneal or eyelid infections * age \ 40 years. * history of contact lens wears within the past three months. * male will be excluded because sex has a large influence on the symptomatology of ded males have significantly low symptom scores as compared to females. * corneal surgeries. * history of ocular /systemic disease within the past 6 months. * the patients already receiving any kind of treatment for ded and other ocular diseases.
ai chi method for children with asthma

Conditions: Asthma; Child; Respiratory Disease; Hydrotherapy; Respiratory Tract Diseases; Respiratory Hypersensitivity; Respiration Disorders

Summary: this study has the aim to assess the effectiveness of the ai chi method as an adjunct therapy in the treatment of children with asthma.

children from 7 to 12 years old with asthma diagnosis will be included. children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma, based on guidelines of global strategy for asthma management and prevention revised 2017.children in the intervention group will perform 12 sessions (twice a week) of treatment with the ai chi method and educational interventions similiar to the control group. the investigators will assess pulmonary function (spirometry), asthma control by the childhood asthma control test (c-act questionnaire), quality of life by the paqlq (paediatric asthma quality of life questionnaire), anxiety symptoms by the scas (spence children's anxiety scale) and disturbed sleep by the sleep disorders scale in children. in addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and beta2-agonists usage.

Eligibility criteria:
inclusion criteria: * children from 7 up to 12 years old with asthma diagnose; * regular inhaled corticosteroids with no change in dose in the preceding 4 weeks; * children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), obesity, retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations. exclusion criteria: * children that are not able to perform some of the necessary procedures; * give up participating in the research and present acute symptoms of respiratory tract during the assessments.

Keywords: asthma child respiratory exercises hydrotherapy physical therapy specialty sleep quality of life anxiety spirometry clinical trial
cannabidiol on reward- and stress-related neurocognitive processes in individuals with opioid use disorder

Conditions: Opioid-use Disorder

Summary: the purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.

individuals with opioid use disorder (oud) demonstrate reward- and stress-related neurocognitive changes compared to individuals without oud, including cravings for opioids in response to exposure to triggers, tendency to make impulsive and disadvantageous decisions, and a strong attentional bias towards drug-related cues. together, these deficits are significant contributors to relapse and discontinuation of treatment. cannabidiol (cbd) has been shown to impact some of these cognitive deficits but studies of cbd among individuals with oud are mostly lacking. therefore, this study aims to answer whether cbd has any impact on reward-related neurocognitive deficits in individuals with oud. if successful, this line of research will lay the groundwork for future studies to evaluate cbd's impact on oud treatment outcomes.

Eligibility criteria:
inclusion criteria * english speaking * dsm5 diagnosis of opioid use disorder * receiving buprenorphine or methadone for treatment of opioid use disorder * agreeable to abstaining from using any cannabis or cbd products for the duration of the trial. exclusion criteria: * any self-reported use of cannabis or cbd products in the past 30 days * baseline depression (phq9) or anxiety (gad7) scores of greater than 10 * currently pregnant * hepatic liver enzymes greater than 3x upper normal limit * hypersensitivity to cannabinoids or sesame oil (cbd solution comes in sesame oil emulsion) * currently taking any medications with known significant pharmacokinetic interactions with cbd
eluna family / sentus bp master study

Conditions: Bradycardia; Heart Failure

Summary: the eluna family / sentus bp master study is designed to confirm the safety of the new eluna pacemaker family and the sentus bp (bipolar) left ventricular lead. furthermore the new wandless rf telemetry function "safesync" and the handling of the sentus lead during implantation will be assessed.


Eligibility criteria:
inclusion criteria: * patient is willing to participate in the study and provided written informed consent * patient meets standard indication for pacemaker or crt-p or crt-d therapy * patient accepts home monitoring® concept * patient has legal capacity and ability to consent exclusion criteria: * patient with any contraindication to pacemaker and crt-p and crt-d therapy * patient under the age of 18 * pregnant or breast-feeding women * cardiac surgery planned within the next 6 months * life expectancy less than 12 months * participation in another cardiac clinical investigation with active treatment arm * group b only: currently implanted with an endocardial or epicardial lv lead or had prior attempt to place a lv lead (for crt implants only)

Keywords: heart failure eluna pacemaker family sentus otw bp l left ventricular lead bradycardia sade-free rate
prognosis and targeted therapy related molecular screening program for patients of breast cancer in china

Conditions: Breast Cancer

Summary: the anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in china (mainly her2 overexpression, triple negative and hormone receptor-positive patients) by detecting dna and rna in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and chinese population; 2) plasma samples of patients with her2 overexpression , hormone receptor-positive and triple negative (er, pr, her2 expression negative) were sequenced for ctdna and ctrna, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.


Eligibility criteria:
inclusion criteria: * patients with first treated or recurrent metastatic breast cancer, according to recist version 1.1 standard, confirmed by ct or mri, have at least one measurable lesion. * her2 positive or triple negative patients; (ihc++, fish amplification) * patients with anti-her2 treatment as first-line or not, and patients with her2 positive can be treated with adjuvant therapy containing trastuzumab. exclusion criteria: -

Keywords: targeted therapy molecular screening
type 1 diabetes virtual self-management education and support

Conditions: type1diabetes

Summary: overview: people living with type 1 diabetes (t1d) are expected to fit self-management and regular clinical consultations into busy lives. t1d self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. however, this is difficult to deliver in the context of current t1d care which involves time-consuming in-person visits during working hours. the proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. study design: a pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with t1d. planned recruitment is 580 participants from 10 specialized t1d centres in ontario. intervention: our intervention will include 1) frequent, brief virtual visits between patients with t1d and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any pc, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. this approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.


Eligibility criteria:
inclusion criteria: 1. outpatients ≥18 years of age 2. physician diagnosis of type 1 diabetes 3. currently on an insulin pump or using multiple daily insulin injections. 4. hba1c ≥ 7.5% on most recent laboratory report, within the last 4 months 5. has access to a mobile device or computer/tablet with a video camera 6. seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic or if a transitioning patient: currently enrolled in a diabetes program below and had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics 7. ohip coverage 8. currently using an active email address or be willing to obtain an email address 9. has consistent and reliable access to internet 10. willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period exclusion criteria: 1. diagnosed with non-type 1 diabetes 2. unable to use a computer/tablet or mobile phone 3. pregnant 4. on dialysis 5. unable to fluently speak or read english (self-reported)
study of two different starting doses of methotrexate when starting treatment in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). to look at the effect on efficacy ( or speed of efficacy) versus the adverse effects. hypothesis: there will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose


Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis fulfilling the acr 1987 criteria * between 18 years to 65 year of age * having active disease disease activity score (28 joints) das28-3 more than 5.1 * not on methotrexate in the last 2 months * permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day * permitted to be on other disease modifying anti-rheumatic drug (dmard) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization exclusion criteria: * pregnant/breastfeeding * ongoing/recent treatment with methotrexate (2 months) * chronic liver disease * renal failure * any leucopenia or thrombocytopenia * breast-feeding * desirous of pregnancy in the next 6 months * known hepatitis b or c positive * known clinically relevant chronic lung disease: ild * tuberculosis or other active infections * known hiv positive

Keywords: rheumatoid arthritis active
functional benefits of multisite surgery for the upper limb of children with cerebral palsy

Conditions: Cerebral Palsy, Spastic; Cerebral Palsy, Dyskinetic; Infantile Hemiplegic Cerebral Palsy

Summary: the aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with cerebral palsy on unilateral functional capacities and bimanual performance. the investigators also assessed the attainment of individualized goals and tracked any potential factors that may have an impact on final results.

cerebral palsy is responsible for the most common neurological disorders in children. although the primary lesion is non-evolutionary, the secondary consequences are evolutive, with neuro-orthopaedic degradation leading to soft tissue retraction and osteo-articular deformities. hemiplegia occurs in approximately 30% of cases of cerebral palsy, and tone disorders (spasticity, dyskinesia) affecting the upper limb generally impact function, both in unilateral capacities (range of motion, dexterity, and fluidity of movement), and in bimanual performance. the focal treatment of spasticity by botulinum toxin injections, in combination with specific occupational therapy training, has proven to be effective in improving targeted functional goals. however, there is little evidence today of the effectiveness of treatment for the management of upper limb retraction and deformity, whether by stretching, orthosis/plaster or even surgery. and apart from its effectiveness on body structure, the functional effects of upper limb surgery in cerebral palsy have been little explored. the aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with cerebral palsy on unilateral functional capacities and bimanual performance, by using such tools as the melbourne assessment (version 2) and the assisting hand assessment (version 5.0).

Eligibility criteria:
inclusion criteria: * age \<18 years at time of surgical project * unilateral upper limb injury due to cerebral palsy * having undergone neuro-orthopaedic surgery of the upper limb with prior evaluation and comparative evaluation after surgery (6 months) exclusion criteria: - refusal to process medical data concerning the child for research purposes

Keywords: upper limb contraction deformity multisite surgery treatment outcome
a multicenter prospective post-registration study of empegfilgrastim to evaluate safety and efficacy in special cancer populations

Conditions: Solid Tumor; High-Risk Cancer; Breast Cancer; Gastrointestinal Cancer; Gynecological Malignancies; Myelosuppression

Summary: this study was designed to evaluate the efficacy and safety of extimia® (inn - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with high and "gray zone" risk reccurrence breast cancer, gastointestinal cancers and gynecological malignancies


Eligibility criteria:
inclusion criteria: 1. signed informed consent form; 2. histologically verified diagnosis; 3. age between 18 and 80 years; if the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug; 4. ecog performance 0-2; 5. haematology: * anc ≥ 1,5 х 10(9) /l; * platelets ≥ 100 х 10(9) /l; * hemoglobin ≥ 90 g/l; 6. biochemistry: * creatinine ≤ 1,5 uln; * total bilirubin ≤ 1,5 uln; * ast/alt ≤ 2,5 uln; * alkaline phosphatase ≤ 5 uln; 8. life expectancy of at least 6 months from the date of the first drug administration in the study; 9. ability of the patient to comply with the protocol requirements. exclusion criteria: 1. documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs; 2. systemic use of antibiotics less than 72 hours before the first drug administration in the study; 3. concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study; 4. concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study; 5. surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study; 6. history of bone marrow or hematopoietic stem cell transplantation; 7. presence of acute or active chronic infections; 8. other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods; 9. inability to administer the drug by intravenous infusion or subcutaneous injection.