Kornimate/medical-research-clean huggingface dataset:
development of stance control orthotic knee joint for improvement of kafo users

Conditions: Ankle Osteoarthritis; Knee

Summary: i want to design stance control orthotic knee joint for improvement of kafo users which is not available in pakistan imported stance control orthotic knee joints are very expensive patients can't afford. the aim of my study to develop low cost stance control knee joint and ensure its availablity for kafo users.


Eligibility criteria:
inclusion criteria: * polio patient * proximal tibial fracture. exclusion criteria: * patients without kafo * cerebral palsy patients
single dose study to assess efficacy, safety and tolerability of las100977 in asthmatic patients.

Conditions: Asthma

Summary: the purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled las100977 qd in patients with persistent asthma.


Eligibility criteria:
inclusion criteria: 1. adult male and female patients aged 18-70 years (both included). 2. clinical diagnosis of persistent asthma (according to gina guidelines 2009 update) for at least 6 months prior to screening. 3. screening fev1 value of 60% \< fev1 ≤ 85% of the predicted normal value. 4. fev1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol. 5. pre-dose fev1 value of first treatment period within the range of ± 20% of the fev1 measured at screening prior to salbutamol inhalation. 6. patients on a stable dose and regimen exclusion criteria: 1. current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years. 2. patients diagnosed with copd. 3. recent respiratory tract infections within 6 weeks before screening visit. 4. intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit. 5. clinically significant respiratory conditions. 6. clinically significant cardiovascular conditions. 7. patients unable to properly use a dry powder or pmdi inhaler device or unable to perform acceptable spirometry. 8. clinically relevant abnormalities laboratory, ecg parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation. 9. patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.

Keywords: copd
long-term efficacy of iguratimod alone or iguratimod in combination with methotrexate in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is intended to evaluate the efficacy and safety of iguratimod alone or iguratimod in combination with methotrexate (mtx) versus methotrexate alone in patients with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of ra according to the diagnostic criteria of the american college of rheumatology (acr) (revised in 1987) * rheumatoid arthritis for 3 months to 2 years from the time of the initial diagnosis * subjects have active ra at the time of screening * subjects are naive to mtx or ra related biologics * written informed consent exclusion criteria: * preceding treatment with dmards, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or tripterygium within 4 weeks prior to study entry * chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc. * alt \>1.5×uln, ast \>1.5×uln, cr \>135umol/l * wbc\<4×109/l，hgb\<85g/l，plt\<100×109/l * subjects with serious cardiovascular, renal, hematologic or endocrine diseases * pregnant or lactating women * allergic to any of the study drugs * history of alcoholism * subjects with mental illness * subjects receiving live vaccines recently * subjects participating in other clinical study within 3 months prior to study entry

Keywords: rheumatoid arthritis iguratimod methotrexate
conjunctival autograft or limbal conjunctival autograft for recurrent pterygium using mitomycin c

Conditions: Recurrent Pterygium

Summary: the purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin c(mmc) combined with limbal conjunctival autograft(lcag) or conjunctival autograft(cag) for recurrent pterygium surgery. the investigators will also evaluate particular risk factors related to pterygium recurrence

intraoperative mitomycin c after pterygium excision is widely used to prevent recurrce of recurrent pterygium. conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect. patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin c with conjunctival autograft or limbal conjunctival autograft .the patients will be followed at least 12 months. corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

Eligibility criteria:
inclusion criteria: * recurrent pterygium * willingness to participate in research project and to attend research time * at least 6 months after last pterygium surgery exclusion criteria: * pregnant,breast-feeding women or poor general health * patients with significant ocular or lid pathology, such as sjogren's syndrome ,infection, exposure keratitis,glaucoma and trauma * patients with allergy to mitomycin c,tobramycin or local anesthetics

Keywords: recurrent pterygium pterygium limbal conjunctival autograft conjunctival autograft mitomycin c
life after sport: prior injury and sedentary behavior as mechanisms of later poor health

Conditions: Aging; Athletic Injuries; Physical Inactivity; Knee Injuries and Disorders

Summary: competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. one modifiable factor that may be associated with long-term health in athletes is physical activity patterns. the purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.

the overarching hypothesis is that former athletes, especially those with a prior injury, will have poorer function and health in midlife and that current and former athletes will engage in greater overall and longer bouts of sedentary behavior compared to non-athletes. aim 1 will compare function, strength, and cardiometabolic indicators among former athletes with and without prior knee injury and non-athlete controls in midlife (age 40-64). hypothesis 1 is that former athletes with a prior injury will have the poorest function, muscle strength, and cardiometabolic indicators. aim 2 will compare sedentary behavior and physical activity patterns in current (age 18-25) and midlife former athletes to non-athlete controls. hypothesis 2.1 is that current athletes will have greater sedentary behavior, longer sedentary behavior bouts, and higher levels of moderate-to-vigorous physical activity compared to non-athlete controls. hypothesis 2.2 is that former athletes in midlife will have greater sedentary behavior, longer sedentary behavior bouts, and lower physical activity levels compared to non-athlete controls. an exploratory aim will evaluate longitudinally the trajectory of physical activity patterns, cardiometabolic indicators, function, and strength annually in each cohort, comparing how these variables change over time in each subgroup.

Eligibility criteria:
please see cohorts for specific inclusion/exclusion criteria inclusion criteria: * age 18-25 years or age 40-64 years * current or former collegiate varsity athlete or non-athlete control exclusion criteria: * neurologic (e.g., stroke, parkinson's) and/or degenerative disease that impairs function * pregnancy * lower extremity joint replacement (e.g., hip or knee replacement)

Keywords: sports medicine injury athlete sport physical activity function health knee
non-vascular icd electrode configuration feasibility study

Conditions: Ventricular Arrythmia

Summary: this study is designed to evaluate the energy requirements of two different nonvascular icd (nv-icd) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.


Eligibility criteria:
inclusion criteria: 1. patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available tv-icd or s-icd system per local guidelines 2. patient must be at least 18 years of age 3. subject must provide written informed consent prior to any clinical investigation-related procedure. exclusion criteria: 1. pacemaker dependency 2. chronically implanted cardiac implantable electronic device or other device which delivers an electrical current 3. currently taking amiodarone or a class ic antiarrhythmic drug 4. hypertrophic cardiomyopathy 5. anticipated high risk of stroke 6. anticipated high surgical risk or risk of infection 7. severe aortic stenosis 8. severe proximal three vessel coronary disease (over 70% in each vessel) 9. greater than 50% left main stem disease 10. prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion 11. medical conditions that preclude defibrillation testing 12. chronic renal insufficiency including patients on dialysis 13. subject is currently participating in another clinical investigation. 14. pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 15. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
personalized therapy of precursor lymphoid neoplasms

Conditions: Precursor Lymphoid Neoplasms

Summary: the primary goal of this study by the polish adult leukemia group (palg) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms

between 1997-2010 the palg run three prospective studies. in the most recent plag 5-2007 protocol attempts have been made to individualize treatment. in particular, stratification to high and standard risk group was based on both conventional clinical criteria and the level of mrd after induction and consolidation. patients with unsatisfactory response were referred for allogeneic hematopoietic stem cell transplantation (allohsct). interim analysis showed significant improvement compared to previous palg 4-2002 protocol with regard to both overall survival and leukemia-free survival. the reasons of failure were relapses and non-relapse mortality (nrm) associated with allohsct. in the current protocol we intend to further adjust the therapy for individual patients needs. we assume that this way we will be able to reduce the risk of relapse and nrm and improve the cure rate. all patients will receive multiagent induction and consolidation chemotherapy. the type and intensity of the therapy, as well as indications for allogeneic and autologous hsct will depend on age, status of mrd, immunophenotype and the presence of bcr/abl fusion gene.

Eligibility criteria:
inclusion criteria: * new diagnosis of pln according to who 2008 classification * age ≥18 years * biological status allowing administration of induction therapy * informed patient consent form signed exclusion criteria: * pregnancy * psychiatric diseases * history of other malignancies * hiv infection * active hepatitis * hypersensitivity to drugs used in induction

Keywords: acute lymphoblastic leukemia induction consolidation minimal residual disease hematopoietic stem cell transplantation
study of human botulism immunoglobulin in infants with botulism

Conditions: Infant Botulism; Botulism

Summary: objectives: i. determine the safety of human botulism immune globulin (big) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis). ii. assess the efficacy of big in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.

protocol outline: this is an open label, multicenter study. patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (big) in certain circumstances after 72 hours. patients receive (big) iv. patients are monitored for side effects, disease severity, complications, and length of hospital stay. patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * clinical diagnosis of infant botulism in previously healthy infant * bulbar palsies * constipated lethargy * diminished head control * poor feeding * generalized weakness and hypotonia * weak cry * afebrile (unless secondary infection present) * subacute to acute onset * normal electrolytes * any patient eligible provided no treatment available for life-threatening condition

Keywords: bacterial infection clostridium infection immunologic disorders and infectious disorders infant botulism rare disease
mri-guided single dose preoperative radiotherapy in low-risk breast cancer

Conditions: Breast Cancer

Summary: this study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. furthermore, the aim is to collect data on response monitoring. patient-reported outcome measures and treatment-induced toxicity will be evaluated.

in this multi-center single arm interventional cohort study 70 patients will be treated with single dose preoperative partial breast irradiation (pbi). breast conserving surgery will be performed 12 months following pbi to assess pathologic response. response monitoring following pbi includes mri (3t and 7t), liquid biopsies and biopsy of the irradiated tumor. results from this trial can change the current treatment of patients with early stage breast cancer. the single dose pbi can be of benefit for all patients who are suitable for postoperative pbi according to current guidelines. if pathologic complete response can be accurately predicted by (one of) the abovementioned response monitoring modalities, the need for surgery will become disputable. moreover, in patients without expected pathologic complete response, the burden of radiotherapy can be minimized from 3-4.5 weeks of radiotherapy to a single dose of radiotherapy.

Eligibility criteria:
inclusion criteria: * who performance scale ≤2. * females at least 50 years of age with unifocal ct1n0 breast cancer or females at least 70 years of age with unifocal ct1-2(maximum 3 cm)n0 breast cancer on mammography, ultrasound and mri. * patients with an indication for chemotherapy or immunotherapy according to dutch national oncoline guidelines or own hospital protocols are not eligible. patients with an indication for endocrine therapy are eligible. * tumor size as assessed on mri. * on tumor biopsy: * bloom-richardson grade 1 or 2. * non-lobular invasive histological type carcinoma. * lcis or (non-extensive) dcis is accepted. * er positive tumor receptor. * her2 negative tumor. * tumor-negative sentinel node. * adequate communication and understanding skills of the dutch language. exclusion criteria: * legal incapacity. * brca1, brca2 or chek2 gene mutation. * previous history of breast cancer or dcis. * other type of malignancy within 5 years before breast cancer diagnosis. patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. for adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion. * collagen synthesis disease. * signs of extensive dcis component on histological biopsy or imaging. * invasive lobular carcinoma. * mri absolute contraindications as defined by the department of radiology. * nodal involvement with cytological or histological confirmation. * indication for treatment with (neo-)adjuvant chemotherapy. * non-feasible dosimetric rt plan.

Keywords: radiotherapy
real-time monitoring of heart failure across the yale new haven health system

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Heart Failure NYHA Class IV

Summary: the yale hf registry is a live ehr based registry that allows for retrospective and real-time monitoring of heart failure case across the yale new haven health system.

electronic health records based registries can be an important resource for precision medicine delivery by understanding the population burden of chronic diseases such as heart failure. these registries can allow for a deeper understanding of gaps in guideline recommended therapies among patients who are under the purview of large, integrated therefore, we have created a live registry within the integrated yale new haven health system-the yale heart failure registry-that includes all patients with a diagnosis of hf and has detailed information about demographics, comorbidities, laboratories, imaging, medications, and clinical outcomes (including hospital readmissions). the registry is updated daily and can be queried for clinically relevant questions aimed at quality improvement.

Eligibility criteria:
inclusion criteria: * seen within the yale new haven health system * diagnosis of heart failure exclusion criteria: * age\<18
prediction and secondary prevention of fractures

Conditions: Osteoporotic Fractures; Hip Fractures; Wrist Fractures; Ankle Fractures; Vertebral Compression Fractures; Humeral Fractures, Proximal

Summary: the purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.

a standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in norway from april 2015 to january 2016. this project is named nofract (norwegian capture the fracture initiative https://clinicaltrials.gov/show/nct02536898). patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. some of these patients will be asked to participate in this consent-based sub-study (nofractsub). at baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to dual x-ray apsopiometry (dxa) scan including bone mineral density(bmd), trabecular bone score(tbs) and vertebral fracture assessment (vfa). at 1-year follow-up there will be a brief questionnaire and measuring of btm. at 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of dxa including bmd, tbs and vfa. all data will be stored securly at the designated server at the university of oslo, service of sensitive data, tsd.

Eligibility criteria:
inclusion criteria: * patients participating in nofract * recent low-trauma vertebral or non-vertebral fracture * written patient consent exclusion criteria: * fractures of scull, face, toes or fingers * short life expectancy * patients not competent or willing to give consent * patients having difficulties in answering questionairies, undergoing a dxa scan, and show up on the follow-ups,
korean observational study to evaluate the efficacy and safety of anagliptin switching from other dpp4is in type2 dm

Conditions: Type 2 Diabetes Mellitus

Summary: this study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

subjects will visit the site on the 12th week (visit 2) and 24th week (visit 3) from the registration date (visit 1) to confirm the efficacy and safety. primary endpoint - hba1c change after 24 weeks treatment secondary endpoint * average rate of change in hba1c after baseline * ratio of subjects with hba1c\<7% after 24 weeks * ratio of subjects with hba1c\<6.5% after 24 weeks * subgroup analysis by gender, age, bmi, medical history, renal function, liver function, conventional dpp4 inhibitors therapy, concomitant oral antidiabetic drug, duration of disease safety endpoint : adverse event

Eligibility criteria:
inclusion criteria: * 19 years of age at the time of consenting * understands and is willing to sign an informed consent form (icf) * hba1c≥7.0% * within 7days before registration, continuing other dpp4is alone or combined therapy for than 8 weeks exclusion criteria: * prior exposure to anagliptin
stereotactic body radiotherapy vs intensity-modulated radiotherapy in prostate cancer

Conditions: Prostate Cancer

Summary: the primary goal of this phase ii study is to compare the change of epic hrqol scores (1-year minus baseline) between sbrt and imrt.


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate adenocarcinoma * low or intermediate risk prostate cancer patients (i.e. t1-t2c and psa 20 and gleason score \< 8) with the risk of pelvic node metastasis 15% as calculated by roach's formula * ecog performance score 0-1 * age ≥ 18 * history/physical examination within 2 weeks prior to registration * able to sign informed-consent exclusion criteria: * patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer. * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer * previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous hormonal therapy, such as lhrh agonists (e.g., goserelin, leuprolide) or lhrhantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.des), or surgical castration (orchiectomy) * unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration * patients who have received prior chemotherapy.