Kornimate/medical-research-clean huggingface dataset:
a study of avastin (bevacizumab) in combination with thoracic radiation and chemotherapy in patients with advanced non-squamous non-small cell lung cancer.

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this single arm study will evaluate the feasibility of treatment with 2 dose levels of avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. two cohorts of patients will receive 3 cycles of avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with avastin as a single agent for 6 additional cycles. the anticipated time on study treatment is \<3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>= 18 years of age; * non-squamous non-small cell lung cancer, locally advanced and unresectable; * ecog performance status 0 or 1; * no prior thoracic or head and neck radiation; * no prior surgical resection for current lung cancer. exclusion criteria: * malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix; * prior systemic therapy for non-small cell lung cancer; * clinically significant cardiovascular disease; * history of \>= grade 2 hemoptysis; * current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
multiple dose escalating study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of asp1941

Conditions: Healthy

Summary: this study determined the safety of asp1941 after a single and multiple once-daily doses for 10 days in healthy subjects. in addition, the pharmacokinetics (pk) and pharmacodynamics (pd) of asp1941 were assessed.


Eligibility criteria:
inclusion criteria: * body weight between 60-100kg, body mass index (bmi) between 20-30 kg/m2, inclusive exclusion criteria: * fasting plasma glucose (fpg) \> 6.4 mmol/l * hba1c \> 6.2% * abnormal pulse of blood pressure at screening, as judged by the investigator

Keywords: asp1941 diabetes mellitus multiple ascending doses healthy subjects
single pre-operative radiation therapy - with delayed surgery for low risk breast cancer

Conditions: Breast Cancer

Summary: to study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. the radiotherapy will be goven 3 months before surgery.


Eligibility criteria:
inclusion criteria: 1. female aged 65 years or older 2. world health organization (who) performance status 0-2 3. invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start 4. unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start 5. tumors less than 2cm clinically on physical exam, as well as on breast ultrasound 6. no clinical evidence of nodal disease (i.e. cn0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound 7. estrogen receptor status (er) positive on biopsy 8. her2 negative on biopsy 9. grade 1 or 2 on biopsy 10. planned surgery is a partial mastectomy with sentinel lymph node biopsy 11. localisation markers placed before treatment exclusion criteria: 1. age less than 65 years 2. a known deleterious mutation in brca 1 and/or brca 2 3. clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound 4. tumor histology limited to lobular carcinoma only 5. clinically positive axillary nodes (cn+) 6. lymphovascular invasion on biopsy 7. pure ductal or lobular carcinoma in situ on biopsy 8. extensive intraductal component on biopsy 9. neoadjuvant hormonal manipulation or chemotherapy 10. prior history of cancer (patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial) 11. more than one primary tumor in different quadrants of the same breast 12. diffuse microcalcifications on mammography 13. paget's disease of the nipple 14. previous irradiation to the ipsilateral breast 15. presence of an ipsilateral breast implant or pacemaker 16. serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (sle), scleroderma) which would preclude definitive radiation treatment 17. estrogen receptor status (er) not known 18. currently pregnant or lactating 19. psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol 20. geographic inaccessibility for follow-up 21. lack of preoperative staging with breast and axillary ultrasound 22. inability to adequately plan the patient for the experimental technique

Keywords: radiation therapy
comparing two instrumentation systems for the treatment of adolescent scoliosis

Conditions: Scoliosis

Summary: idiopathic scoliosis affects 2-5% of adolescents. this study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.


Eligibility criteria:
inclusion criteria: * age 8-18 years * diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the uss or the moss miami system * patients with scoliosis and an incidental finding of conus \< l1-2 disc level, provided they have no symptoms or signs * patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment) * patients with non-progressive spondylolysis exclusion criteria: * spinal cord abnormalities with any neurologic symptoms or signs * spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring arnold chiari decompression * primary muscle diseases, such as muscular dystrophy * neurologic diseases (e.g. charcot-marie tooth, guillain-barre syndrome, cerebral palsy, or spina bifida, etc.) * primary abnormalities of bones(e.g. osteogenesis imperfecta) * congenital scoliosis

Keywords: scoliosis spinal disease pediatrics adolescents universal spinal instrumentation system moss miami spinal instrumentation system orthopedic surgery
health-related quality of life in adults after veno-arterial extra-corporeal membrane oxygenation which is a salvage therapy used in patients with severe respiratory or cardiac failure who have not responded to maximal conventional medical therapy

Conditions: Veno-arterial Extra-Corporeal Membrane Oxygenation; Health Related Quality of Life

Summary: extracorporeal membrane oxygenation (ecmo) is a salvage therapy used in patients with refractory cardiogenic shock. this rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. the aim of this study is to evaluate the health-related quality of life in adults after veino-arterial extra-corporeal membrane oxygenation. the quality of life will be evaluated thanks to several methods : the short form 36, the eq 5d 5l and the return to work status. then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. the investigators will also evaluate current comorbidities of the patient thanks to the groll index.


Eligibility criteria:
inclusion criteria: * adults \>18 years * veno-arterial ecmo between april 2008 and december 2019 in nhc surgical intensive care of strasbourg * affiliated to the french social security system exclusion criteria: - patients under guardianship or with legal protection
tracking biologics along the silk road

Conditions: Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative

Summary: the objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, crohn's disease or ulcerative colitis as the major disease treated with remicade, simponi or stelara in clinical practice in the emerging regions of north africa, the middle east, and western asia.


Eligibility criteria:
inclusion criteria: * participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, crohn's disease, or ulcerative colitis. a participant can be included for one disease only; participants with multiple diagnoses should be included for their major disease only * initiation of treatment with remicade, simponi, or stelara should be planned at the time of enrollment into this observational study (such treatment should be started within 30 days of enrollment) * participant must be either treatment-naïve to biologics or have been treated with no more than 2 different biologic agents before enrollment * participant must sign a participation agreement/informed consent form (icf) allowing data collection and source data verification in accordance with local requirements exclusion criteria: * participant who have previously received treatment with remicade, simponi, or stelara must not be enrolled if they start the same therapy a second time * participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before baseline data collection * participant is currently enrolled in an investigational study
aries - ambrisentan in patients with moderate to severe pulmonary arterial hypertension (pah)

Conditions: Pulmonary Hypertension

Summary: the primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with pah.

aries-1 in north america and australia aries-2 in western and eastern europe, south america and israel subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. inclusion is not based on a specified who functional classification. rather, subjects with who class i-iv symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. subjects with anorexigen or hiv infection related pah are eligible but subjects with congenital heart disease and pediatric subjects are excluded. the study requires a historical cardiac catheterization and other diagnostic procedures.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pah (formally known as pph), or pah associated with collagen vascular disease, anorexigen use, or hiv infection; * historical cardiac catheterization with the following hemodynamic criteria: mean pulmonary artery pressure greater than or equal to 25 mmhg; pulmonary vascular resistance greater than 3 mmhg/l/min; pulmonary capillary wedge pressure or left ventricular end diastolic pressure less than 15 mmhg; * 6-minute walk distance of at least 150 meters, but no more than 450 meters; * total lung capacity greater than or equal to 70% and fev1 greater than or equal to 65% of predicted normal; exclusion criteria: * portopulmonary hypertension; * subjects with pah due to or associated with coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thromboembolic disease, or sleep apnea; * bosentan (tracleer®), sildenafil (viagra®), or chronic prostanoid therapy within 4 weeks of screening; * serum alt or ast lab value that is greater than 1.5 times the upper limit of normal; * contraindication to treatment with an endothelin receptor antagonist; * subject with cardiovascular, hepatic, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject; * participation in a clinical study involving another investigational drug within 4 weeks of screening.

Keywords: pulmonary arterial hypertension
firibastat or ramipril after acute myocardial infarction for prevention of left ventricular dysfunction

Conditions: Myocardial Infarction

Summary: this is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally bid (2 daily doses) versus ramipril administered orally bid over 12 weeks after acute anterior mi. subjects will be followed for 12 weeks (over 4 study visits). a total of 294 male and female subjects with a diagnosis of first acute anterior mi will be randomized. the subjects will need to have a primary percutaneous coronary intervention (pci) of the index mi related artery within 24 hours after mi.

at inclusion visit (visit 2 \[within 72 hours after acute mi\]), subjects will be randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio: * group 1: subjects will receive 50 mg firibastat bid for 2 weeks and then 100 mg bid for 10 weeks * group 2: subjects will receive 250 mg firibastat bid for 2 weeks and then 500 mg bid for 10 weeks * group 3: subjects will receive 2.5 mg ramipril bid for 2 weeks and then 5 mg bid for 10 weeks then subjects will undergo study procedures at titration visit (visit 3 \[day 14\]), treatment visit (visit 4 day 42\]) and end-of-treatment visit (visit 5 \[day 84\]).

Eligibility criteria:
inclusion criteria: * diagnosis of first acute anterior mi (st-elevation myocardial infarction) defined as chest pain \>30 minutes and st elevation ≥0.2 mv in at least 2 consecutive electrocardiogram (ecg) leads in the anterior area (di, avl, v1 v6). * primary pci of the index-mi-related artery within 24 hours after the mi. exclusion criteria: * body mass index \>45 kg/m². * subject is hemodynamically unstable or has cardiogenic shock. * subjects with clinical signs of hf (kilipp iii and iv). * systolic blood pressure \<100 mmhg at inclusion visit * early primary pci of the index-mi-related artery performed within 3 hours after mi. * subjects treated with angiotensin-converting-enzyme inhibitor (ace i), angiotensin receptor blocker (arb) or sacubitril/valsartan prior to the index magnetic resonance imaging. note: if treatment was for htn, ace i/arb should be stopped, and, if necessary, another therapeutic class can be prescribed for htn. if the ace i/arb was prescribed for congestive hf, the subject is not considered eligible; if the ace i/arb prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion. * subjects scheduled for implantable cardioverter defibrillator (icd), cardiac resynchronization therapy, or pacemaker within the next 3 months. if an icd is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the icd scheduled after study completion.
evaluation of excellence in italy's residence for execution of security measure

Conditions: Mental Disorder; Recovery; Schizophrenia and Related Disorders; Personality Disorders and Disturbances in Behavior; Personality Disorders, Antisocial; Intellectual Disability, Mild to Moderate

Summary: the model of care for forensic psychiatry in italy was changed by law (law 81/2014) so that the six legacy secure forensic hospitals (judicial psychiatric hospitals, opg) were closed and new secure community residences for the execution of security measures (rems) were opened in each of the 20 regions of italy. this transition was in place by 2015. this observational study evaluates the health gains for patients both previously in opgs and those admitted first to rems. health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.

all those detained in rems in the twelve month period 2019 to 2020 form the reference population. samples are assessed for symptom severity (bprs), global function (gaf), cognitive function (mmse), risk and protective factors for violence (hcr-20, saprof), personality factors (pcl-r), measures of need for therapeutic security (dundrum-1), treatment response relevant to violence and mental illness (dundrum-3) and forensic recovery (dundrum-4). outcome measures include violent and challenging behaviour (moas), length of stay, conditional (legal) discharge.

Eligibility criteria:
inclusion criteria: * admitted to rems * voluntarily consents to participate exclusion criteria: * mmse less than 19

Keywords: forensic social dangerousness therapeutic security
the synergy to control emergency department hyperglycemia program for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Medication Adherence; HYPERGLYCEMIA

Summary: a 4 week prospective, randomized controlled study was carried out to assess the impact of a care delivery intervention which focused on blood glucose (bg) management among adults with type 2 diabetes presenting to the emergency department (ed) with bg \> 200mg/dl (11.1 mmol/l). the intervention was designed by a multi-disciplinary team of ed physicians and nurses, endocrinologists and diabetes educators. the intervention incorporated three components: a guideline-based algorithm for diabetes medication management; survival skills diabetes self-management education (dsme); and support for health system navigation. the control group received usual care per the ed's policies and procedures for management of high blood glucose.

we evaluated a concise diabetes care delivery intervention designed to advance glycemic medications and deliver diabetes self-management education (dsme) among adults with type 2 diabetes presenting to the emergency department (ed) with uncontrolled hyperglycemia. the primary hypothesis was that there would be improvement in hba1c. a 4 week, randomized controlled trial provided algorithm-based antihyperglycemic medications management, survival skills dsme and navigation to primary care for ed patients with bg \> 200mg/dl. medications were titrated and dsme delivered by endocrinologist-supervised certified diabetes educators. controls received usual care.

Eligibility criteria:
inclusion criteria: * a new or existing diagnosis of type 2 diabetes; * bg \> 200 mg/dl in the ed; * age \>/= 18 years; * willing and able to check bg and self-inject insulin, if required and otherwise stable for discharge to the outpatient setting. exclusion criteria: * type 1 diabetes and other specific types of diabetes per the american diabetes association position statement on the classification of diabetes mellitus, * pregnancy or anticipated conception in the next 3 months; * treatment with a glucocorticoid, unless at a stable physiologic replacement dose; or * a history of diabetic ketoacidosis.

Keywords: type 2 diabetes hyperglycemia emergency department patient education as topic drug therapy
three-dimensional thyroid education model

Conditions: Satisfaction, Patient

Summary: the purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. this model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations.

background： thyroid nodular disorder is one of the most common diseases in endocrine clinics. and thyroid fine needle aspiration examination is the most important exam in evaluating the nature of thyroid nodules. in previous studies, 3d thyroid models have been introduced for patient education before thyroid surgery. nevertheless, thyroid models that can be used to practice thyroid fine needle aspiration examination were scarce. study design： this is a prospective study. methods： in our study, 3d printing technology will be used to create the thyroid high-fidelity model. we plan to choose 3d printing materials that explain thyroid fine needle aspiration for patient education efficacy evaluation. effect： through the creation of this thyroid fine needle aspiration model, we hope to enhance patients' comprehension of the thyroid and thyroid nodules. the results of our study could be applied in hospitals to improve patient education. key words： 3d printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration

Eligibility criteria:
inclusion criteria: * thyroid nodule detected * thyroid ultrasound-guided fine-needle aspiration is needed exclusion criteria: * previously underwent thyroid ultrasound-guided fine-needle aspiration * refused to participate in the study

Keywords: 3d printing medical education model high-fidelity simulation thyroid fine needle aspiration
biomarkers in chronic arthritis

Conditions: Chronic Arthritis

Summary: use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.

chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. this study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.

Eligibility criteria:
inclusion criteria: * all patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by gps questionnaires), physical therapists visits, occupational therapists, psychologists.. etc exclusion criteria: * patients treated with biological therapy for non rheumatic disease * other inflammatory diseases such as crohn's disease * refusal to participate in the collection

Keywords: biomarkers genetic chronic arthritis treatment