Kornimate/medical-research-clean huggingface dataset:
stroke volume variation and plethysmography variability index as goal directed fluid therapy in major oncosurgeries

Conditions: Goal Directed Fluid Therapy

Summary: patients were allotted to two groups , svv guided fluid therapy group received intraoperative fluids to maintain svv \<11 , and pvi guided group received intraoperative fluids to maintain pvi\<11

preinduction epidural catheter will be placed and standard general anaesthesia with volume controlled ventilation (tidal volume 8ml/kilogram ) and positive end expiratory pressure 5 centimeters of water for all patients. postinduction radial artery cannulation and ultrasound guided internal jugular cannulation will be performed for all patients .maintenance fluid crystalloids 2ml/kg will be given to both the groups. in stroke volume variation svv group flotrac transducer (mhd8 model edwards lifesciences llc, irvine,ca 92614,usa) will be attached to radial artery cannula to obtain svv values and for values \> 11 colloid bolus 200ml will be given over 10 minutes and postbolus values noted. in plethysmography variability index pvi group pulse oximeter will be placed on index finger and covered to avoid ambient light will be attached to masimo radical 97 monitor to measure continuous perfusion index and plethysmography variability index for values \>11 colloid bolus 200ml will be given over 10 minutes and change in pvi value noted. intraoperative heart rate , mean arterial pressure , oxygen saturation, end tidal carbon dioxide, central venous pressure , urine output will be measured in all patients.with optimal fluids if mean arterial pressure is below 70 mmhg than titrating dosage norepinephrine infusion will be commenced.at the end of surgery reversal agents will be administered and trachea extubated , note will be made of any patient requiring postoperative ventilator support.arterial blood gas analysis will be performed at beginning and end of surgery and at postoperative 24 and 48 hours to measure serum lactate levels . patient will be monitored in postanaesthesia care unit for any cardiac , respiratory event , serum creatinine levels will be measures at 24 and 48 hours , appearance of bowel sounds will be noted , length of icu stay will be recorded for all patients.

Eligibility criteria:
inclusion criteria: patients undergoing open major oncosurgeries under general anaesthesia exclusion criteria patient refusal left ventricular ejection fraction \<40% cardiac arrythmias severe valvular heart disease peripheral vascular disease laparoscopic surgeries

Keywords: goal directed fluid therapy stroke volume variation plethysmography
illumenate eu randomized clinical trial

Conditions: Peripheral Arterial Disease; Claudication

Summary: this is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the cvi paclitaxel-coated percutaneous transluminal angioplasty (pta) balloon versus bare pta balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (sfa) and popliteal arteries.


Eligibility criteria:
inclusion criteria: * symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries * rutherford clinical category 2, 3 or 4 * male or non-pregnant female at least 18 years exclusion criteria: * co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries * significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy * known intolerance of study medications, paclitaxel or contrast agent * active participation in another investigational device or drug study

Keywords: peripheral arterial disease claudication drug-coated balloon drug-eluting balloon
evaluation of efficacy and safety of a single dose of ctx001 in participants with transfusion-dependent β-thalassemia and severe sickle cell disease

Conditions: Beta-Thalassemia; Thalassemia; Hematologic Diseases; Genetic Diseases, Inborn; Hemoglobinopathies; Sickle Cell Disease; Sickle Cell Anemia

Summary: this is a single-dose, open-label study in participants with transfusion-dependent β-thalassemia (tdt) or severe sickle cell disease (scd). the study will evaluate the safety and efficacy of autologous crispr-cas9 modified cd34+ human hematopoietic stem and progenitor cells (hhspcs) using ctx001.


Eligibility criteria:
key inclusion criteria: * participants with tdt and scd: * eligible for autologous stem cell transplant as per investigator's judgment. * participants with tdt: * diagnosis of tdt as defined by: * documented homozygous β-thalassemia or compound heterozygous β-thalassemia including β-thalassemia/hemoglobin e (hbe). participants can be enrolled based on historical data, but a confirmation of the genotype using the study central laboratory will be required before busulfan conditioning * history of at least 100 milliliter (ml)/kilograms (kg)/year or 10 units/year of packed red blood cells (rbc) transfusions in the prior 2 years before signing the consent or the last rescreening for patients going through re-screening * participants with scd: * diagnosis of severe scd as defined by: * documented scd genotypes * history of at least two severe vocs events per year for the previous two years prior to enrollment key exclusion criteria: * participants with tdt and scd: * a willing and healthy 10/10 human leukocyte antigen (hla)-matched related donor is available per investigator's judgement * prior hematopoietic stem cell transplant (hsct) * clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator * participants with tdt: * participants with associated α-thalassemia and \>1 alpha deletion, or alpha multiplications * participants with sickle cell β-thalassemia variant * participants with scd: * history of untreated moyamoya syndrome or presence of moyamoya syndrome at screening other protocol defined inclusion/exclusion criteria may apply.
trial on the safety of a new liposomal adjuvant system, caf01, when given with the tuberculosis subunit vaccine ag85b-esat-6 as two injections with two months interval to healthy adult volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the safety profile of caf01, administering 50 µg ag85b-esat-6 alone and 50 µg ag85b-esat-6 with three escalating caf01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.


Eligibility criteria:
inclusion criteria: 1. female or male adult between 18 and 55 years of age 2. healthy according to medical history and medical examinations at screening 3. signed informed consent 4. prepared to grant authorized persons access to medical records 5. likely to comply with instructions exclusion criteria: 1. history of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial 2. positive tuberculin skin test (tst) result at screening 3. positive quantiferon® -tb gold in-tube test result according to the manufacturer's specifications at screening 4. bcg vaccination any time before entering the trial 5. history of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction 6. disease affecting the lymphoid organs (hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. ana-titer, hbv, hcv, hiv sero-positive at screening 8. c-reactive protein level \> 50 mg/l at screening 9. clinically significant abnormal laboratory test results at screening as assessed by the investigator 10. severe ongoing viral or bacterial infection that might affect the cell mediated immune response 11. a condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access 12. live vaccine vaccination (mmr, yellow fever, oral typhoid) within 3 months before the first vaccination 13. immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination 14. known hypersensitivity to any of the vaccine components of the investigational vaccines 15. intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the ag85b-esat-6 antigen 16. pregnant according to a urine pregnancy test at inclusion 17. females not willing to use contraceptives or breast feeding 18. has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial

Keywords: safety vaccine tuberculosis caf01 ag85b-esat-6 prevention
cd123-targeted car-t cell therapy for relapsed/refractory acute myeloid leukemia

Conditions: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Summary: there are limited options for treatment of relapse/refractory acute myeloid leukemia (aml). cd123 car-t cells may have an attractive and permanent effect on anti-tumor. this study purpose to estimate the safety and efficiency of cd123 car-t cells to patients with relapse/refractory aml.

cd123 is expressed on most myeloid leukemia cells so it is a ideal target for car-t. some researches have revealed that cd123 is a marker of leukemia stem cells, which indicates that the eradication of cd123 cells may prevent relapse of leukemia. in this study, investigators will evaluate the safety and efficacy of car-t targeting cd123 in patients with acute myelocytic leukemia. the primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent； 2. diagnose as relapsed/refractory aml, and meet one of the following conditions： 1. with persistent disease after at least two lines of therapy； 2. relapse to the last line of therapy in 6 months，as known as early recurrence; 3. relapse to the last line of therapy after 6 months, but refractory to this last line of therapy； 4. relapse more than once. the definition of relapse: reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a cr (the most common are cns and testicular leukemia). 3. evidence for cell membrane cd123 expression; 4. kps\>60; 5. the expect time of survive is above 3 months; 6. ages: 2 to 75 years; 7. all genders; 8. the patients that diagnosis as high risks, relapse/refractory or inconformity criteria to other therapy； 9. no serious mental disorders; 10. left ventricular ejection fraction ≥40%; 11. sufficient hepatic function defined by alt/ast\<5 x uln and bilirubin≤34.2μmol/l; 12. sufficient renal function defined by creatinine clearance \<220μmol/l; 13. sufficient pulmonary function defined by indoor oxygen saturation≥92%; 14. no other illness may conflict with the protocol (e.g. autoimmune diseases, immune deficiency and organ transplantation； 15. ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: 1. previous history of other malignancy; 2. presence of uncontrolled active infection; 3. evidence of disorder that need the treatment by glucocorticoids; 4. active or chronic gvhd； 5. the patients treatment by inhibitor of t cell； 6. pregnant or breasting-feeding women; 7. any situation that investigators regard not suitable for attending in this study (e.g. hiv , hcvinfection or intravenous drug addiction) or may affect the data analysis.
effects of therapeutic hiv vaccination on control of hiv after discontinuation of anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether therapeutic hiv vaccines can help the immune system control hiv viral load after anti-hiv drugs are discontinued.

this study is a rollover study for patients who participated in a5058s: augmentation of hiv-specific helper and ctl responses through therapeutic vaccination in individuals receiving potent suppressive antiretroviral therapies. in a5058s, patients received a series of therapeutic vaccinations to elicit hiv-specific immune responses. this study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (art). upon study entry, patients will discontinue art. during the first 6 weeks of the study, viral load will be monitored weekly and cd4+ t-cell counts will be monitored every other week. viral load and cd4+ t-cell counts will be measured every other week from week 6 through week 24, then monthly until patients restart art or until week 48. patients who reinitiate art for any reason will be registered to step 2 and followed for 10 weeks.

Eligibility criteria:
inclusion criteria: * participation in a5058s and receipt of a minimum of 7 sets of injections on that study * continuation of the same stable antiretroviral treatment that was given in a5058s for the last 3 months prior to a5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure * no less than 6 weeks and no more than 18 weeks since the last injection on a5058s prior to a5172 entry * cd4+ t-cell count \> 300 cells/mm3 obtained within 30 days prior to study entry * hiv-1 rna \< 500 copies/ml obtained within 30 days prior to study entry * agreement to use approved methods of contraception exclusion criteria: * pregnancy or breast-feeding * any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (hsv) or herpes zoster, other acute medical illness, or surgery * symptomatic chronic infections other than hiv * malignancy that may require systemic therapy * history of lymph node irradiation * use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed * hydroxyurea within 30 days prior to study entry * use of gm-csf, g-csf, m-csf, ifn, il-2, or other cytokines within 30 days prior to study entry * active drug or alcohol use or dependence that would interfere with adherence to study requirements * serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry

Keywords: hiv therapeutic vaccine treatment experienced aids vaccines treatment interruption viral load t-lymphocytes, cytotoxic t-lymphocytes, helper-inducer
project health: enhancing effectiveness of an obesity prevention program

Conditions: Overweight and Obesity; Eating Disorders

Summary: this 2-site effectiveness trial will test whether a brief dissonance-based obesity prevention program delivered in single sex groups combined with food response and attention training will produce significantly larger weight gain prevention effects than an educational video control condition. an effectiveness trial is important to test whether this program reduces risk for unhealthy weight gain when delivered by real world clinicians under ecologically valid conditions, which is an important step toward broad implementation. a secondary aim focuses on eating disorder symptom prevention effects. a sample of 17-20 year olds with weight concerns (n = 120) will be randomized to single sex project health groups with food response and attention training or an educational video control condition. participants will complete assessments at baseline, posttest, and 6- and 12-month follow ups.

in the previous project health trial, the investigators found project health is most effective when implemented in single sex groups paired with food specific response and attention training. this project will evaluate the effectiveness of this version of the project health intervention compared to a video control condition and is an important step toward dissemination. a brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality. the program may also have an important secondary benefit of preventing the onset of future eating symptoms and disorders. the study has 2 aims: (1) test the hypothesis that project health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger weight gain and overweight/obesity onset prevention effects than an educational video control condition (primary outcome). (2) test the hypothesis that project health implemented in single-sex groups and paired with food response inhibition and attention training produces significantly larger eating disorder symptom prevention effects than an educational video control condition (secondary outcome).

Eligibility criteria:
inclusion criteria: * current at least moderate weight concerns (defined as a response of 4 or above on an 8 point scale ranging from none (0) to extreme (8)) * self-reported room for improvement in diet and exercise habits (response of yes to "do you believe there is room for improvement in your diet and exercise habits?" in the pre-screening questionnaire) * bmi greater than or equal to 20 and less than or equal to 30 * age between 17 and 20 years old exclusion criteria: * current diagnosis of anorexia nervosa, bulimia nervosa or binge eating disorder * previous participation in a project health study

Keywords: obesity overweight eating disorders prevention adolescent dissonance
computer-assisted diabetes self-management interventions

Conditions: Diabetes Mellitus, Type 2

Summary: this project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. it evaluates the effectiveness of personalized self-management training and community resources support, using a randomized design. this study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * diagnosed for at least one year * patient of a primary care provider exclusion criteria: * no telephone * not speaking english

Keywords: diabetes self-management randomized trial re-aim evaluation participation maintenance community resources dietary change
etoile : a feasibility study in pediatric patient education

Conditions: Leukemia, Lymphoblastic

Summary: feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of robert debré hospital ( paris, aphp). in addition to feasibility, the intermediate effectiveness of the program will be assessed.

this is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. patients' anxiety levels will also be assessed before, after and at a distance from the program. the level of health literacy will be assessed at the start of the study.

Eligibility criteria:
inclusion criteria: * criteria relating to the population studied: child between 0 and 18 years old, followed at robert debré hospital (paris), by a doctor from the hematology and immunology department * of which the 2 holders of parental authority have been informed and have signed the consent * having 1 or 2 caregivers available to accompany him during fte sessions * 1 to 2 of their adult caregivers will be eligible for the etoile program and will be included in the study after their consent. * child with acute lymphoblastic leukemia, treated at robert debré hospital (paris), in the induction or consolidation phase * child going to receive or having received an allograft of hematopoietic stem cells at the robert debré hospital (paris) * beneficiaries of a social security scheme or entitled to it, exclusion criteria: * child not mastering the french language, * child with physical or cognitive disability to participate in the program,

Keywords: therapeutic education
effect of intravenous continuous infusion heparin on rates of venous thromboembolism in high-risk, critically ill patients

Conditions: Venous Thromboembolism

Summary: the primary purpose of this study is to demonstrate that a continuous infusion of intravenous (iv) heparin (ufh) for venous thromboembolism (vte) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. antifactor xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that intravenous administration is more effective.


Eligibility criteria:
inclusion criteria: * admission to the medical icu (micu) * high-risk for venous thromboembolism (vte) ≥ 1 of the following: * body mass index (bmi) ≥ 30 kg/m2 * personal or family history of vte * receiving vasopressors exclusion criteria: * indication for therapeutic anticoagulation * evidence of deep vein thrombosis (dvt) on ultrasonography at admission * indwelling intrathecal, epidural, or other indwelling deep catheters * recent (\< 3 months) international society of thrombosis and haemostasis (isth) major bleeding13 * recent (\< 3 months) major trauma * recent (\< 3 months) neurosurgery or orthopedic surgery pregnancy * contraindication to heparin or heparin products

Keywords: heparin