Kornimate/medical-research-clean huggingface dataset:
af ablation for hf with reduced ef

Conditions: Persistent Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction

Summary: this is an open label, multi-center, randomized parallel control clinical trial, to examining thethe clinical outcomes of af ablation on hfref patients with persistent atrial fibrillation.

this is an open label, multi-center, randomized parallel control clinical trial. hfref patients with persistent atrial fibrillation are 1:1 randomized into the af ablation group or the medical therapy (rate or rhythm control) group. markers of hfref severity, including composite of death from any cause or worsening of heart failure that led to an unplanned overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient symptoms. and other indicators are analyzed to demonstrate the role of af ablation in comparing the effects of af ablation vs usual medical therapy for hfref patients with persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: * symptomatic persistent atrial fibrillation failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs left ventricular ejection fraction \ = ii patient is willing and able to comply with the protocol and has written informed consent age \>= 18 years optimal therapy for hf of ≥6 weeks suitable candidate for catheter ablation or rate control for the treatment of af n-terminal pro-b-type natriuretic peptide (nt-probnp)/bnp levels above predetermined levels based on prior hospitalization and baseline rhythm exclusion criteria: * la dimension \>6.0 cm acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment untreated hypothyroidism or hyperthyroidism enrollment in another investigational drug or device study woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age mental or physical inability to take part in the study severe aortic or mitral valve disease life expectancy \<1 year
interest of pain assessment by the family of patients in limiting and stopping active treatment process admitted in er. study dofamila

Conditions: Patient's Pain in Later Life

Summary: decisions to limit and stop active therapeutics are common in the emergency unit. they are framed by the leonetti law of 22 april 2005 recommending the refusal of unreasonable obstinacy and care of the patient's pain in later life. the pain assessment is an issue for these patients whose in majority, are not communicating. moreover, no specific tool and the teams in charge, not knowing the patient make the recognition and treatment of pain symptoms very complex. this is the potential interest of directly involving the family or the person of confidence in this management , the first step being the detection and evaluation of pain.


Eligibility criteria:
inclusion criteria: * adults older than 18 * non communicating patients admitted in emergency ward * unanimous decision of stopping and limiting active treatment according to leonetti's law of april 22nd, 2005 * presence of a member of the patients family or one of his legal representative exclusion criteria: * children * no health insurance

Keywords: arrest or limitation of active treatment emergency treatment
safety and immune response to adjuvanted a(h1n1)v influenza vaccine in hiv-1 infected and immunosuppressed adult patients

Conditions: HIV-1 Infection; Cancer; Immunosuppression

Summary: the purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted a(h1n1)v influenza vaccine in hiv-infected and immunosuppressed patients after one and two injections.

the efficacy of an adjuvanted a(h1n1)v influenza vaccine in hiv-infected and immunosuppressed patients is unknown. therefore we aim to investigate the immunoresponse as assessed by a anti-hemagglutinin assay before, 21 days after the first and 21 days after the second vaccination. the safety of the vaccination will be recorded by a standardized questionaire.

Eligibility criteria:
inclusion criteria: * written informed consent * age \>18 * hiv-1 infection * cancer * immunosuppressive treatment exclusion criteria: * not willing to participate
laparoscopic versus open appendectomy

Conditions: Acute Appendicitis

Summary: appendectomy is the most common surgical procedure performed in emergency surgery. because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (oa) and laparoscopic (la) methods. in this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.


Eligibility criteria:
inclusion criteria: * acute appendicitis exclusion criteria: * pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
selective versus nonselective alpha-blockade prior to pheochromocytoma resection - systematic review and meta-analysis

Conditions: Pheochromocytoma

Summary: our aim was to systematically evaluate the current data on the efficacy of pretreatment with either selective or nonselective alpha-blockade on the hemodynamic instability and morbidity during pheochromocytoma resection.

rcts and non-randomized controlled studies comparing preoperative selective alpha-blockade (sab) with nonselective alpha-blockade (nab) in pheochromocytoma surgery in adults were eligible for inclusion. all identified articles will be screened by title and abstract. two independent reviewers will review potentially relevant articles in detail. dissent will be resolved by consensus and the recommendation of a third observer as required. data from the included studies will be extracted independently by the two researchers. the meta-analysis of observational studies in epidemiology (moose) guidelines will be used for reporting. quality of assessment the risk of bias in non-randomized studies - of interventions (robins-i) tool will be used to assess the quality of included non-randomized studies. the risk of bias of randomized studies will be assessed using the criteria described in the cochrane handbook for systematic reviews of interventions .the quality of each study will be assessed by two of the authors. in the event of uncertainties regarding the levels of the studies' quality, a third reviewer will be consulted. analysis will be performed using revman (version 5.3, freeware from the cochrane collaboration). odds ratios and their associated 95% confidence intervals will be pooled for dichotomous outcomes using the mantel-haenszel random-effects method. continuous outcomes will be pooled as weighted mean difference (wmd) with 95 per cent confidence interval using the inverse-variance random-effects method. wmd and or will be presented on the graphs as squares, and pooled wmd and or will be presented as diamond. p ≤ 0.05 will be considered a statistically significant difference for hypothesis and p \< 0.10 for heterogeneity testing, respectively. heterogeneity between the studies will be estimated by statistical tests i2 and cochran's q tests.

Eligibility criteria:
inclusion criteria: * all patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection exclusion criteria: * patients who did not receive alpha blockade * patients not undergoing surgery * no comparison for selective and non-selective pretreatment in the study * studies without primary or sufficient data (reviews, guidelines, meeting abstracts, letters), * studies reported in a language other than english

Keywords: pheochromocytoma, surgery, alpha-blockade
tacrolimus treatment for refractory prca

Conditions: Pure Red Cell Aplasia

Summary: pure red cell aplasia (prca) is a kind of anemia characterized by severe reticulocytopenia and obvious bone marrow erythroblastic cells decreased. cyclosporine and /or steroids are the first line therapy but some patients were refractory or intolerance to the treatment. the effects of the second line therapy are also not satisfactory and sometimes not available. the investigators aim to explore the efficacy and side-effect of tacrolimus for refractory prca.

pure red cell aplasia (prca) is a rare normocytic normochromic anemia with reticulocytopenia, characterized by a reduction of erythroid precursors from the bone marrow, could be divided into congenital and acquired prca according to pathogenesis. congenital prca, also known as diamond-blackfan syndrome, has been associated with pathogenic variant in gata1 and tsr2 and gene encode ribosomal proteins. acquired prca can be a primary disease which is usually mediated by immunology, or secondary to other diseases, such as lymphoproliferative diseases, autoimmune diseases, thymoma, infection, or drugs. the first line therapy of acquired prca is cyclosporine a and steroids, the second line therapy are anti-cd20, atg, immunosuppressive drugs like cyclophosphamide, bone marrow transplantation. unfortunately, some patients did not response or tolerate the above treatments. tacrolimus, also known as fk506, is an agent mainly used after allogeneic organ transplant to lower risk of organ rejection. tacrolimus could inhibit the production the production of il-2, and also used in the therapy of other t cell mediated diseases. tacrolimus primarily has been approved for prevent organ transplant rejection, especially in renal transplantation, tacrolimus also promises to treat autoimmune, degenerative and hyperproliferative disorders. recently, tacrolimus has been reported to be effective and well tolerated for many immune-mediated cytopenias, such as autoimmune lymphoproliferative syndrome, immune thrombocytopenia, evans syndrome, etc. however, due to the rare occurrence of prca and good response rate to cyclosporine, there are very few studies of tacrolimus on refractory prca so far. in this study, it is anticipate to evaluate the effect of tacrolimus on 30 patients with refractory prca, the side-effects was documented and plasma concentration of tacrolimus will be monitor.

Eligibility criteria:
inclusion criteria: refractory pure red cell aplasia. 18-80 years old. no response or intolerant to first and second line therapies. written informed consent. exclusion criteria: other diseases which might cause hematological abnormalities. response and well tolerate to first or second line therapy. patients who are under 18-year-old or over 80-year-old. pregnant or lactating. patients unwilling to or unable to comply with the protocol.

Keywords: tacrolimus refractory pure red cell aplasia prospective study
study of bms-754807 combined with letrozole or bms-754807 alone in patients with hormone receptor-positive breast cancer and resistance to non-steroidal aromatase inhibitors

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate oral doses of bms-754807 in combination with letrozole or bms-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * postmenopausal women with hormone receptor-positive and her-2 negative breast cancer * disease progression following non-steroidal aromatase inhibitor treatment exclusion criteria: * known symptomatic brain metastasis * medical condition requiring chronic steroids * history of type 1 or 2 diabetes * uncontrolled or significant cardiovascular (cv) disease * concomitant second malignancies
randomized implementation of routine patient-reported health status assessment among heart failure patients in stanford cardiology

Conditions: Heart Failure

Summary: this randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the kansas city cardiomyopathy questionnaire-12 (kccq-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. patients will be randomized 4:1 to kccq-12 assessment or usual care. participants randomized to kccq-12 assessment will complete the kccq-12 at every heart failure clinic visit. their results will be available to clinicians to assist with clinical management. heath status surveys will not be integrated into clinical care for patients in the usual care arm. the primary objective is to evaluate the impact of routine assessment of patient-reported heath status on clinical processes of care. as the primary outcome, we will evaluate clinician inertia by measuring the clinician action rating (car) - an aggregate count of medication changes, referrals, and diagnostic tests. as secondary outcomes, we will measure individual components of the composite outcome, therapy rates, resource utilization, and patient experience.


Eligibility criteria:
inclusion criteria: * seen in stanford general cardiology clinic with a diagnosis of heart failure or cardiomyopathy or in heart failure clinic exclusion criteria: * enrolled in pro-hf trial
hypofractionated vs conventional fractionated postmastectomy radiotherapy for high risk breast cancer

Conditions: Breast Cancer

Summary: the study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

the randomization is between 50 gy / 25 fractions and 42.5 gy/16 fractions, 5 fractions weekly. eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (cf) radiotherapy of 50 gy / 25 fractions and hypofractionated (hf) radiotherapy of 42.5 gy/16 fractions, 5 fractions weekly. the primary endpoint is loco-regional recurrence. other cancer related events and acute/late radiation morbidities will also be evaluated. the patients will be followed for 10 years. it is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.

Eligibility criteria:
inclusion criteria: * female * age18-75 years * pathologically confirmed invasive breast cancer * treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. immediate or delayed ipsilateral breast cancer reconstruction is accepted * negative surgical margins * pathologic t1-2n1 with at least one of the following risk factors: \<40 years, grade 3, lymphovascular invasion positive, er/pr negative or her2 overexpression, or pt3-4, or pn2-3 (four or more positive axillary lymph nodes) * no distant metastases * no supraclavicular or internal mammary nodes metastases * ecog:0-1 * adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-her2 treatment is accepted. * no neoadjuvant chemotherapy * fit for postoperative radiotherapy. no contraindications to radiotherapy * signed informed consent exclusion criteria: * concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin * previous radiotherapy to the chest wall or regional lymph node areas * patients with severe non-malignant comorbidity in cardiovascular or respiration system * patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis * pt1-2n1 with none of the following risk factors: \<40 years, grade 3, lymphovascular invasion positive, er/pr negative or her2 overexpression * patients with supraclavicular or internal mammary nodes metastases * known definitive clinical or radiologic evidence of metastatic disease * bilateral breast cancer or historically confirmed contralateral invasive breast cancer * treated with neoadjuvant chemotherapy * ecog: 3-4 * pregnant or lactating * conditions indicating that the patient cannot go through the radiation therapy or follow up * unable or unwilling to sign informed consent

Keywords: postmastectomy hypofractionated adjuvant radiotherapy
study to evaluate the bioequivalence of pfizer korea inc. "xeljanz 5mg tablet" in healthy volunteers

Conditions: Rheumatoid Arthritis

Summary: this study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of chong kun dang pharmaceutical "chong kun dang tofacitinib tablet" and pfizer korea inc. "xeljanz 5mg tablet" in healthy volunteers

to healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. reference drug: xeljanz 5mg tablet / test drug: chong kun dang tofacitinib tablet pharmacokinetic blood samples are collected up to 12hrs. the pharmacokinetic characteristics and safety are assessed.

Eligibility criteria:
inclusion criteria: 1. healthy subject older than 19 years at the screening 2. individuals who had 18 kg/m2 ≤ body mass index(bmi) ≤ 30kg/m2 \* bmi = weight(kg)/ height(m)2 3. individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, eeg, ecg, chest x-ray, endoscope or upper gastrointestinal radiography) 4. individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ecg, chest x-ray etc.) 5. women who are not pregnant at physical examination exclusion criteria: 1. individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the 1 month 2. individuals who had taken any medication within 10 days prior to the first day of dosing 3. individuals who were deemed to be inappropriate to participate in the study by the investigator 4. individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing 5. individuals who donated whole blood within the 2 months, or blood components within 2 weeks prior to the first dose of the investigational product(s) 6. individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days (only, 4 weeks for women who may be pregnant) after investigational product(s) administration (double contraception: two or more of the use of condoms, intrauterine contraception, diaphragm, cervical cap, or a sexual partner who had been medically diagnosed infertility) 7. individuals with hypersensitivity to ingredients used in the investigational product(s) 8. patients with serious infection (e.g., sepsis) or active infection including localized infection 9. patients with active tuberculosis 10. patients with severe hepatopathy 11. patients with an absolute neutrophil count (anc) less than 500 cells/mm3 12. patients with an absolute lymphocyte count (alc) less than 500 cells/mm3 13. patients who have hemoglobin levels less than 8 g/dl 14. women who are pregnant or may be pregnant or lactating 15. patients with hereditary diseases of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption etc. 16. patients with nephropathy (bun\ 20 or creatinine\>1.5)
prospective validation of clini-biological parameters including initial hemostasis, which improve the prediction of death at 1 month among patients with septic shock

Conditions: Shock, Septic

Summary: a prognostic score was proposed by the investigative team to predict death at 1 month. this score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock. the main objective of this multicenter study is to validate the performance of the score in terms of area under the roc curve and negative predictive value.

there are two secondary objectives: * validate a prognostic score for death at the end of the first week from initial data. * validate a predictive score of disseminated intravascular coagulation (dic) in patients with septic shock by comparing with the gold standard of the international society on thrombosis and haemostasis (overt-dic in the first 5 days after inclusion). as for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock. the objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the committee for the protection of persons sud mediterranée iii (mail: cpp sud-mediterranee iii, ufr medecine 186, chemin du carreau de lanes cs 83021, 30908 nimes cedex 2 france. study reference: 2008.11.04 bis) for more information: carey.suehs@chu-nimes.fr

Eligibility criteria:
inclusion criteria: * patient (or representative) received the information notice * patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with noradrenalin) and organ dysfunction, hypoperfusion or hypotension * body temperature \> 38.3°c or \< 36°c * heart rate \> 90 bpm * tachypnea \> 20 c/min or paco2 \< 32 mmhg or mechanical ventilation * leukocytes \> 12000 µl-1 ou \ 10% immature forms * oliguria \< 0.5 ml/kg/h for at least 2 hours * abrupt alteration (24 h) of conscienceness * thrombocytopenia \< 100 000 g/l or disseminated intravascular coagulation * mottled skin and / or capillary refill time\> 3 sec * pao2/fio2 \< 300 mmhg ou \< 40kpas * lactatemia \> 2mmol/l * septic shock: systolic blood pressure (sbp) \> 90 mmhg or need for vasopressors to maintain sbp\> 90 mmhg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in sbp\> 40% in the hypertensive) exclusion criteria: * patient is dying or limitation or cessation of active treatment * patient is already included in another trial * patient or family refusal * patient not affiliated with a social security system