Kornimate/medical-research-clean huggingface dataset:
identification predictive markers of immunochemotherapy response to the primary cutaneous diffuse large b cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: the study is performed on a single-center retrospective cohort of 32 patients lbc-tj treated with r-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through rcp monthly cutaneous lymphomas managed by professor beylot-barry and inclusion of cases in the national database of rare cancer network french study group of cutaneous lymphomas in bordeaux managed by prof. beatrice vergier. fourteen patients responded to the r-pct against 18 non-responders, 14 patients for whom we have the sample to recidivism.

the objective is to identify predictive biomarkers of response to r-chemotherapy and understand what genomic markers, transcriptomic or proteomic would identify those patients ahead. this would ultimately help to identify whether dysregulated biological pathway could be targeted specifically among patients with personalized treatment. like its counterpart systemic lymphoma diffuse large b cell, the sequential analysis of the same patient at diagnosis and relapse can also identify candidate genes and biological pathways involved in recurrence and help to design new therapeutic strategies. another objective is ultimately the development of an integrative bioinformatics tool for anticipating the therapeutic response. the tumor model used is certainly a rare cancer but prototypical abc lymphomas allowing access to relapse hardware and relative homogeneity that will allow a study of a smaller number of cases for the development of correlations models genomics / proteomics. this is a pivotal project integrating proteomic data and molecular biology (mutation, expression) based on the pooling of skills of clinical teams, biological and bioinformatics to validate a predictive model for treatment response able to integrate prognostic markers known as tnm the dual expression myc / bcl2 and forward to predict the therapeutic response using this modeling by cbib. we would then validate the model established in this series of training on a range of national validation as part of an observational study with gfelc (groupe français d'etude des lymphomes cutanés).

Eligibility criteria:
* patients lbc-tj * treated with r-chemotherapy

Keywords: proteomic mutations predictive marker rituximab-polychemotherapy integrative bioinformatics tool
systemic lupus erythematosus in gullah health

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. african americans are at a disproportionately higher risk of developing sle, develop sle at an earlier age, and have increased morbidity and mortality compared with european americans. our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of sle. the african american gullah population from the sea islands of south carolina and georgia are unique in their genetic homogeneity with minimal non-african genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of sle.


Eligibility criteria:
inclusion criteria: * age 2 years and above; * self-identified as african-american "gullah" from the sea island region of south carolina; * have had at least 4 of the 11 diagnostic criteria for sle as designated by the american college of rheumatology (acr), be a relative of a known sle patient, or be an unrelated healthy gullah control; * ability to speak and understand english; * ability and willingness to give informed consent exclusion criteria: * race defined by participant as other than black or african-american; * being a prisoner, mentally ill patient, or institutionalized individual; * unwilling or unable to give informed consent

Keywords: african americans
non-invasive eye tracking for the diagnosis of delirium on icu

Conditions: Delirium

Summary: in this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of cam-icu in a small representative sample of patients in the intensive care unit (icu) at chelsea \& westminster nhs foundation trust.

delirium is an acute confusional state that affects many patients admitted to the hospital, especially intensive care. the current diagnosis of delirium is through the use of the confusional assessment method in intensive care unit (cam-icu) task based questionnaire. the core prinicipal to cam-icu is inattention; this is tested through asking the patient to remember a task and execute it on demand, e.g. squeezing the operator's hand everytime the letter a is said and then spelling casablanca. the aim of this study is to find correlates to inattention. eye-gaze data is ideally suited for this task as eyes move to pay attention to the environment. a video camera based eye-tracker has been developed that sits at the end of the bed (head-camera) and another behind the patient (scene-camera). the head-camera uses machine learning to measure the gaze of the patient's eyes while the scene-camera finds what the patient is looking at. simulations are then run from the scene camera and the patient's gaze is then compared to find whether the patient is paying attention to what is simulated. once per day, a member of the local research team will fill in a non-validated questionnaire based on work by macmurchy et al. m. macmurchy, s. stemler, m. zander, c. p. bonafide, acceptability, feasibility, and cost of using video to evaluate alarm fatigue, biomedical instrumentation \& technology 51 (2017) 25-33.

Eligibility criteria:
inclusion criteria: 1. aged \>18 2. predicted delirium as defined by the early prediction of delirium in icu patients (e-predeliric) score ≥ 20% 3. expected length of stay ≥ 2 days exclusion criteria: 1. non-concordant eyes 2. visual impairment 3. dementia 4. inability for facial recognition and eye tracking to be performed reliably 5. lack of signed consent form / nominated consultee form 6. in-ability to perform cam-icu reliably

Keywords: delirium inattention eye-gaze icu
greenlight xps laser system retrospective chart review

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the greenlight xps procedure.

this is a retrospective chart review conducted at six centers in the united states and canada. this review will evaluate the safety and efficacy of greenlight xps in subjects who received treatment on or after 01-aug-2010.

Eligibility criteria:
inclusion criteria: * men who have had a greenlight xps procedure with a moxy fiber since 01-aug-2010. exclusion criteria: * subject has had prior radiation. * subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (boo, detrusor overactivity (do), impaired detrusor contractor (idc)) * subject has a neurologic disorder that would impact bladder function (ms, parkinson, spinal cord injury) (note: stroke patients not excluded) * subject has an artificial urinary sphincter
predict the risk of axillary metastases in breast cancer patients with axillary ultrasound

Conditions: Breast Cancer Female

Summary: axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.this projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.lymph node metastasis is a multifactorial event. among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.the purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Eligibility criteria:
inclusion criteria: * female patients with primary breast cancer * receiving a successful slnb or alnd * pathological diagnosed, without distant metastasis * a clinically negative axilla exclusion criteria: * pregnancy * neoadjuvant therapy * previous ipsilateral axillary surgery * inflammatory breast cancer

Keywords: breast cancer nomogram ultrasound axillary metastases
immune interactions in severe asthma

Conditions: Asthma

Summary: this research study is being done to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma and people without asthma, at baseline and over time. individuals are being asked to join a research study to help understand the differences in the lungs and blood of participants with severe asthma compared to those with milder asthma and healthy individuals, as well as differences in overall health. investigators also want to determine whether these differences predict asthma-related and biologic outcomes over 1 year of follow up.

this study will obtain human lung samples by bronchoscopy from a range of asthmatics and healthy controls to address questions related to the mechanisms for the development of the complex immune processes observed in the lungs. samples will be evaluated for type-1, type-2 and interleukin-27 (il-27) expression (and their downstream signatures). in addition, these samples will be evaluated for the presence or absence of interleukin-10 (il-10) as a counter regulatory pathway. these pathways will be directly evaluated in epithelial brushings and bronchoalveolar lavage (bal) cells, as well as bal fluid. broad gene expression profiling (ribonucleic acid (rna)-sequencing) will also be performed to determine the range of immune-inflammatory markers present in these severe asthmatics. investigators will specifically address the signal transducers and activators of transcription (stat) signaling pathways, particularly stat-1 and stat-3 to determine the pattern of activation and downstream responses to develop new therapies. additionally, in a subset, investigators will compare targeted and untargeted gene expression as obtained from bronchoscopic samples with expression obtained from clinically performed video assisted thoracoscopic (vats) biopsies of very severe systemic corticosteroid dependent patients. the ultimate goal of this studies is to determine whether a predictive biomarker panel can be identified in the less invasive bronchoscopic samples which predict the findings seen on vats biopsy.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * non-smoker * asthmatic subjects must also demonstrate forced expiratory volume in 1 second (fev1) bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine provocative concentration causing a 20% fall in fev1 (pc20) ≤16 mg/ml (historical methacholine data from previous national institutes of health (nih) trial will be allowed) exclusion criteria: * greater than 10 pack year smoking history (none in the last year) * vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder * other lung disease, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled. healthy controls only: pre-bronchodilator fev1/forced vital capacity (fvc) \<0.70 or an improvement in fev1 of more than 12% following 4 puffs of albuterol.

Keywords: asthma severe asthma il-10 il-27 il-13 epithelial cells t lymphocytes interferon-g
ptc study to evaluate ataluren in combination with ivacaftor

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to explore the combination of ataluren and ivacaftor as a treatment for patients with nonsense mutation cystic fibrosis

cystic fibrosis (cf) is a life threatening genetic disorder resulting from mutations found in the cf gene known as the cystic fibrosis transmembrane conductance regulator or cftr. this defect prevents correct chloride absorption in and out of the cells the purpose of this study is to explore the combination of ataluren and ivacaftor as a treatment for patients with a specific cystic fibrosis mutation

Eligibility criteria:
inclusion criteria: 1. evidence of signed and dated informed consent/assent document(s) indicating that the subject (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. 2. age ≥6 years 3. body weight ≥16 kg 4. diagnosis of cystic fibrosis and documentation of the presence of a nonsense mutations of the cftr gene, as determined by historical genotyping 5. ability to perform a valid, reproducible spirometry with demonstration of a forced expiratory volume in 1second (fev1) ≥30% and ≤90% of predicted for age, gender, and height. 6. if the subject is sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration 7. willingness and ability to comply with all study procedures and assessments. 8. currently being administered ivacaftor, either alone (kalydeco) or in combination with lumacaftor (orkambi) exclusion criteria: 1. any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for cf or for cf-related conditions within 2 weeks prior to screening. 2. ongoing participation in any other therapeutic clinical trial. 3. evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 2 weeks prior to screening. 4. ongoing inhaled tobramycin therapy. 5. ongoing immunosuppressive therapy (other than corticosteroids up to 10mg/d equivalent of prednisone) 6. ongoing warfarin, phenytoin, or tolbutamide therapy. 7. history of solid organ or hematological transplantation. 8. a history of positive hepatitis b surface antigen test, hepatitis c antibody test, or human immunodeficiency 9. major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 4 weeks prior to screening. 10. pregnancy or breast-feeding. 11. current smoker or a smoking history of ≥10 pack-years (number of cigarette packs/day × number of years smoked). 12. prior or ongoing medical condition (eg, renal failure, alcoholism, drug abuse, psychiatric condition), medical history, physical findings, ecg findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results. -
early vision screening in high-risk children

Conditions: Amblyopia; Child

Summary: to evaluate the effect of early vision screening with automated photorefraction device in high risk children

pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. this project is a cross-sectional controlled study. our study includes high-risk group and normal group. high-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in femh. normal group enrolled age-matched children without those risk factors. vision screening by fda-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.

Eligibility criteria:
inclusion criteria: * high risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay * normal group: children with normal birth history and normal development exclusion criteria: * children with known ophthalmic diseases * children with congenital systemic diseases
clinical research of intravenous thrombolysis for ischemic stroke in northeast of china

Conditions: Ischemic Stroke; Thrombosis

Summary: this research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.by building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.

with the highest incidence rate,the population in northeast of china is severely tormented by stroke, especially ischemic stroke. the investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ischemic stroke causing measurable neurological deficit 2. onset of symptoms \<4.5 h before treatment begins 3. age ≥18 y exclusion criteria: 1. significant head trauma or prior stroke in the previous 3 mo 2. symptoms suggest sah 3. arterial puncture at noncompressible site in previous 7 d 4. history of previous intracranial hemorrhage 5. intracranial neoplasm, avm, or aneurysm 6. recent intracranial or intraspinal surgery 7. elevated blood pressure (systolic \>185 mm hg or diastolic \>110 mm hg) 8. active internal bleeding 9. acute bleeding diathesis, including but not limited to 10. platelet count \<100 000/mm3 11. heparin received within 48 h resulting in abnormally elevated aptt above the upper limit of normal 12. current use of anticoagulant with inr \>1.7 or pt \>15 s 13. current use of direct thrombin inhibitors or direct factor xa inhibitors with elevated sensitive laboratory tests (eg, aptt, inr, platelet count, ect, tt, or appropriate factor xa activity assays) 14. blood glucose concentration \<50 mg/dl (2.7 mmol/l) 15. ct demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere) 16. relative exclusion criteria 17. recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. consider risk to benefit of intravenous rtpa administration carefully if any of these relative contraindications is present 18. only minor or rapidly improving stroke symptoms (clearing spontaneously) 19. pregnancy 20. seizure at onset with postictal residual neurological impairments 21. major surgery or serious trauma within previous 14 d 22. recent gastrointestinal or urinary tract hemorrhage (within previous 21 d) 23. recent acute myocardial infarction (within previous 3 mo)

Keywords: ischemic stroke thrombolysis
safety and immunogenicity testing of influenza vaccine in healthy children 2 months and 6 months of age

Conditions: Influenza

Summary: primary objective: to describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. observational objective: to describe the percentage of protective hemagglutination inhibition (hai) antibody titers (following a 2-dose fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

this is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). the study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Eligibility criteria:
inclusion criteria : * aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion. * born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg. * considered to be in good health on the basis of reported medical history and history-directed physical examination. * available for the duration of the study. * parent/guardian willing and able to provide informed consent. * parent/guardian able to attend all scheduled visits and comply with all trial procedures. * willingness to permit venipuncture or heel stick for purposes of collecting a blood sample. exclusion criteria : * reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine. * previous history of influenza vaccination or documented history of influenza infection. * receipt of any vaccine in the 7 days prior to enrollment. * an acute illness with fever (rectal temperature ≥ 38.0 °c \[or ≥ 100.4 °f\]) in the 72 hours preceding enrollment in the trial (defer enrollment). * known bleeding disorder. * participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study. * known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. * personal or immediate family history of congenital immune deficiency. * developmental delay, neurologic disorder, or seizure disorder. * chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion. * known hiv-positive or hbsag-positive mother. * known hiv, hepatitis b (hbsag), or hepatitis c infection. * blood or blood-derived products received in the past 2 months. * prior history of guillain-barré syndrome. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Keywords: influenza influenza vaccine
reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section

Conditions: Hypotension

Summary: subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. animal studies suggest that in the presence of decreased blood volume, 5-ht may be an important factor inducing the bezold jarisch reflex via 5-ht3 receptors located in intracardiac vagal nerve endings. in this study, the investigators evaluated the effect of ondansetron, as a 5-ht3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.


Eligibility criteria:
inclusion criteria: * undergoing an elective lower segment caesarean section. exclusion criteria: * patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality), * history of hypersensitivity to ondansetron or local anaesthetic agents, * hypertensive disorders of pregnancy, * cardiovascular insufficiency, * receiving selective serotonin reuptake inhibitors or migraine medications.