Kornimate/medical-research-clean huggingface dataset:
asia study : french register of inflammatory eye disease

Conditions: Patients Treated for Cancer by Immunotherapy

Summary: new anticancer therapies based on lifting the inhibition of the immunological synapse are used in the therapeutic arsenal of a growing number of neoplasias (melanoma, lung cancer, hepatocellular carcinoma, etc.). these "immune check points" inhibitors "(icpi) target molecules that usually allow immunity to destroy malignant cells. at the systemic level, this results in a loss of immune homeostasis and facilitation of the inflammatory response which may be responsible for dysimmune manifestations distant from the neoplastic site. thus, since their introduction, icpis have been of interest to immunologists, rheumatologists and internists who often find themselves in the first line to deal with this type of side effect (immunotherapy-related adverse events, iraes). the frequency of these aris between 70% and 90%, depending on the immunotherapy used and the severity of these ariis (grade 1-2 vs. 3-5). the overall increase in the number of cancers, the multiplication of available molecules and the expansion of their indications should exponentially increase the number of iraes to be supported. little is known about the epidemiology, risk factors and efficacy of treatments. in these iraes, inflammatory ophthalmological manifestations have been described with an estimated prevalence of between 0.4 and 1% of the patients treated. these attacks are rare and protean (uveitis, scleritis, retinitis, inflammatory orbitopathies, vogt-koyanagi-harada -like...) and reported most often in the form of clinical cases. the main objective is to describe the inflammatory ophthalmic disorders linked to anti-cancer immunotherapy.


Eligibility criteria:
inclusion criteria: * age\> 18 * under cancer immunotherapy: anti-pd1 (nivolumab, pembrolizumab), anti-ctla4 (ipilimumab), anti-pdl1 (atezolizumab, durvalumab, avelumab) * diagnosis of uveitis / inflammatory ophthalmologic disease confirmed by at least an ophthalmologist * indicating his/her non-opposition to participating in the study exclusion criteria: * na

Keywords: immune check points" inhibitors cancer inflammatory ophthalmological manifestations
women with chest pain and normal coronary arteries study

Conditions: Chest Pain

Summary: the purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries. coronary endothelial dysfunction (ced) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). in addition, ced is associated with an increased risk for future cardiovascular events, such as heart attack and stroke. a coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. in many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. however, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.

endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease (cad) and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and blood pressure lowering medications) interventions.

Eligibility criteria:
inclusion criteria: 1. female gender 2. age 30 or greater 3. present with symptoms suggestive of angina (typical or "atypical") 4. abnormal myocardial perfusion scan 5. referred for angiography 6. normal (0% stenosis) versus nonobstructive coronary artery disease (cad) (\<50% stenosis) 7. evidence of endothelial dysfunction. exclusion criteria: 1. coronary vasospasm known or documented in cardiac catheterization 2. obstructive cad (greater than 50% stenosis) known or documented in cardiac catheterization 3. pregnancy 4. established cad, history of revascularization with percutaneous transluminal coronary angioplasty (ptca)/stent or coronary artery bypass graft (cabg) 5. contraindications to magnetic resonance imaging (mri) 6. cardiac catheterization for valvular disease 7. cardiac catheterization for heart failure assessment/biopsy 8. known congestive heart failure (chf)/hypertrophic obstructive cardiomyopathy (hocm)/dilated cardiomyopathy (dcm) 9. acute renal failure 10. chronic renal failure (estimated glomerular filtration rare (egfr) \<30 ml/min/1.73m\^2) or on hemodialysis 11. known single kidney 12. history of peptic ulcer disease, known gastrointestinal bleed, known contraindication to aspirin 13. known contraindication to statin 14. known contraindication to adenosine (asthma, high degree atrial ventricular (av) block)

Keywords: coronary artery disease (cad) chest pain myocardial ischemia endothelial function
outcome of intravenous thrombolysis for stroke patients in the 3-4.5 hour time window

Conditions: Stroke

Summary: the time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among chinese stroke patients. this exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in china.

favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the national institute of health stroke scale score at 24 hours and by the improvement of modified rankin scale score at discharge or 6-month follow-up. the safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Eligibility criteria:
inclusion criteria:stroke patients in the 3-4.5 hour time window - exclusion criteria:stroke patients in more than 4.5 hour time window -

Keywords: china stroke thrombolytic therapy
neurovision vs standard neuromonitoring

Conditions: Neurologic Deficits

Summary: the purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of ionm in patients undergoing primary, single or multilevel lateral spinal procedures. subjects will be randomized to undergo a lateral spine surgery with the use of neurovision® ionm or conventional hospital based ionm to assess incidence of new-onset neurological injury.

elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. this has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements. intraoperative neuromonitoring (ionm) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (ssep) and transcranial motor evoked potentials (tcmeps). due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. an example of a surgeon driven monitoring system is neurovision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcmep and compound muscle action potential (cmap) waveforms. this stands in comparison to hospital based methods of ionm.

Eligibility criteria:
inclusion criteria: * patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes * patients able to provide informed consent exclusion criteria: * active infection * active or history of malignancy * spinal traumatic injury within the past 2 years
endoscopic surgery or radiation therapy in treating patients with stage 0, stage i, or stage ii laryngeal cancer of the glottis

Conditions: Head and Neck Cancer

Summary: rationale: endoscopic surgery is a less invasive type of surgery for laryngeal cancer and may have fewer side effects and improve recovery. radiation therapy uses high-energy x-rays to kill tumor cells. it is not yet known whether endoscopic surgery is more effective than radiation therapy in treating laryngeal cancer of the glottis. purpose: this randomized phase ii trial is studying endoscopic surgery to see how well it works compared with radiation therapy in treating patients with stage 0, stage i, or stage ii laryngeal cancer of the glottis.

objectives: * determine the feasibility of conducting a large phase iii randomized study in the future, comparing radiotherapy vs endoscopic excision in patients with stage 0-ii laryngeal cancer of the glottis. * determine patient acceptability of the proposed trial design. * compare the effect of using dedicated head and neck research nurses vs general nurses on patient recruitment. * refine outcome measures, including voice analysis and quality of life. outline: this is a randomized, controlled, multicenter, pilot study. patients are stratified according to participating center and t stage (tis or t1 vs t2a). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo endoscopic excision via co_2 laser or cold steel. * arm ii: patients undergo radiotherapy once daily, 5 days a week, for 3-4 weeks. patients undergo vocal analysis at baseline and at 6 months and 1 and 2 years after randomization. quality of life is assessed at baseline, at 1 year, and then annually for 5 years. after completion of study treatment, patients are followed periodically for up to 5 years. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the glottic larynx, including tumors at the anterior commissure * stage 0-ii (tis, t1, or t2a) * no clinical or radiological sign of nodal involvement * no evidence of distant metastases * airway anatomy suitable for endoscopic excision patient characteristics: * fit to receive radical treatment as either radiotherapy or endoscopic excision * life expectancy ≥ 2 years * no other cancer in the past 10 years except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the uterine cervix * no vasculitic conditions adversely affecting radiotherapy * no other co-existing medical condition that would limit life expectancy * not pregnant prior concurrent therapy: * no concurrent chemotherapy * no concurrent palliative treatment

Keywords: stage i squamous cell carcinoma of the larynx stage ii squamous cell carcinoma of the larynx stage 0 laryngeal cancer
the use of micrornas dysregulation as potential biomarkers for effective diagnosis of endometriosis

Conditions: Endometriosis

Summary: objectives : 1. to investigate the expression pattern of mirnas operational in inflammation, angiogenesis, hypoxia, apoptosis and cell proliferation in eutopic and ectopic endometrium of patients with endometriosis and normal endometrium of healthy controls. 2. to understand the function of candidate predictive mirnas for endometriosis by investigating their downstream targets and associated biological pathways. 3. evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers. study design: case control study. sample size: 200

methodology : 1 investigator will take both blood and tissue samples used to study them. 2. investigator will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery. 3.small tissue samples will be taken from the tissue which is surgically excised as a part of treatment. 4. it will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.

Eligibility criteria:
inclusion criteria: * patients having more severe forms of endometriosis (stage iii and iv) * the probands were chosen randomly from the pool of available endometriosis patients and healthy controls of indian origin. exclusion criteria: * diagnosis of non-endometriotic ovarian cysts, adenomyosis, ovarian cancer, fibroids, and stage i and ii endometriosis. * exclusion criteria defined for the control group were personal history of chronic pelvic pain, secondary dysmenorrhea, abnormal uterine bleeding and family history of endometriosis.

Keywords: lining of uterus diarrhea or constipation during a menstrual period. heavy or irregular periods. spotting or bleeding between menstrual periods.
neoadjuvant camrelizumab with palbociclib for resectable esophageal squamous cell carcinomas

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(pd-1) immunotherapy, camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: * patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies. * the primary tumor should be located in the thorax and evaluated resectable( ct1b-t3n1-3m0, ct3n0m0) by ct/mri/eus * the patients should be at the range of 18-75 years old, eastern cooperative oncology group (ecog) 0-1. * the patients should have no functional disorders in major organs. blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal. * the patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent. exclusion criteria: * the stage of tumor is t4b (ajcc/international union against cancer (uicc) 8th edition) and cannot be resected. * currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy. * history of other malignancies. * have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease. * any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components. * presence of serious medical diseases, such as grade ii and above cardiac dysfunction (nyha criteria), ischemic heart diseases, etc. * the patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy etc. are excluded from the study. * female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded. * received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial. * any other factors that are not suitable for inclusion in this study judged by investigators.
dexamethasone before elective cesarean section at term in reducing neonatal respiratory distress syndrome

Conditions: C08.381.840.500.475; C08.381.840.500.737

Summary: prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births. assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and nicu admission as a result

term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications the risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks if the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect according to cochrane database of systematic reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of rds by approximately 52%. it also reduced the need for nicu admission, both due to respiratory morbidity (by approximately 58%) and for any indication. the reduction of nicu admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration

Eligibility criteria:
inclusion criteria: * gestational age (37-39wks). * singleton pregnancy. * didn't receive any steroid treatment during pregnancy. exclusion criteria: * undetermined gestational age * maternal chronic diseases (e.g: hypertension, dm-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse. * congenital fetal malformations * emergency cs * pregnant refusing to participate in the study or unable to consent
indomethacin pk-pd in extremely preterm neonates

Conditions: Patent Ductus Arteriosus After Premature Birth

Summary: this is a phase ii open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for pda treatment in preterm neonates \<27 weeks' gestational age.

neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open pda (with no other contraindications for indomethacin treatment). after enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. indomethacin levels will be measured at regular intervals. urine output and serum electrolytes will be monitored prior to each dose of indomethacin. an echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of pda.

Eligibility criteria:
inclusion criteria: * male or female infant born between 23 (0/7) and 26 (6/7) week ga * infant diagnosed with pda according to clinical protocol criteria * able to adhere to indomethacin administration protocol * the patient is born in the study center. * subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations. * in the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned. exclusion criteria: * known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system) * genetic syndromes-inborn errors of metabolism * severe renal compromise * intrauterine growth retardation with birth weight \<3rd centile * thrombocytopenia \<50,000/mm3 * moderate to severe pulmonary hypertension * clinical sepsis -meningitis- hepatitis * anticipated drug-drug-interactions (specifically cyp2c9, cyp2c19 and ugt 1-1)

Keywords: indomethacin pharmacokinetics preterm birth pharmacodynamics
rtms add on value for amelioration of negative symptoms of schizophrenia

Conditions: Negative Symptoms With Primary Psychotic Disorder; Schizophrenia

Summary: treatment of depression with repetitive transcranial magnetic stimulation (rtms) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (dlpfc) stimulation. the treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rtms. in this randomized placebo-controlled study the efficacy of high-frequency rtms and tbs are evaluated.

in this randomized placebo-controlled study the efficacy of high-frequency rtms and tbs are evaluated. the active study arms are high-frequency rtms and itbs of the left dorsolateral prefrontal cortex to treat negative symptoms in schizophrenia. the control arm will include the same number of patients as each active arm and includes both sham rtms and sham itbs in the same proportion as the active treatments. standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. each center is responsible for ethical approval and adherence to good clinical practice by itself (sponsor). interim analysis: several meta-analyses of the effect of rtms/itbs on negative symptoms in schizophrenia showing heterogeneous effect sizes have been published since begin of the trial. thefore, an interim analysis after inclusion of at least 15 patients in each arm was added to the protocol. in case of null findings and low effect sizes (no differences of either rtms or tbs vs. sham in the primary outcome), the trial will be terminated.

Eligibility criteria:
inclusion criteria: * icd-10: schizophrenia with primarily negative symptoms * age: 18-75 years * at least 35 points at the composite score of the sans * stabe medication during the last 2 weeks (at the investigator's discretion) * written informed consent (by the patient or guardian) exclusion criteria: * clinically relevant unstable concomitant somatic diseases * previous treatment by rtms * conditions in which tms may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants * history of epileptic seizures * current substance or alcohol abuse, or clinically relevant comorbidity (according to m.i.n.i. interview) * unacceptable concomitant medication (benzodiazepines in higher doses, e.g., lorazepam \> 2 mg/d, diazepam \> 10 mg/d) * insufficient knowledge of the language of the country of the treatment site * pregnancy and nursing period * current statutory hospitalisation