Kornimate/medical-research-clean huggingface dataset:
nepa to prevent chemotherapy induced nausea and vomiting in patients with breast cancer

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: this study evaluates if the activity of one-day of nepa plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant ac-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).

patients included in the study should be treated with the following antiemetic prophylaxis, during all the ac-based chemotherapy cycles, up to a maximum of 4 cycles: * nepa will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle. * dexamethasone 12 mg will be added on day 1 only of each cycle.

Eligibility criteria:
inclusion criteria: 1. women ≥ 18 years old 2. histologically or cytologically confirmed diagnosis of breast cancer 3. naïve patients 4. be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (ac-based regimen) 5. ecog (eastern cooperative oncology group) performance status 0-2 6. body mass index (bmi) ≥ 18.5 7. written informed consent 8. if women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last nepa administration 9. acceptable hepatic function (\<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine \< 1.5 times the upper limit of normal); 10. ability and willingness of the patient to complete the diary. exclusion criteria: 1. advanced/metastatic breast cancer 2. patients already submitted to non-ac-based chemotherapy 3. treatment with investigational medications in 30 days before nepa 4. myocardial infarction within the last 6 months 5. documented or known hypersensitivity to 5ht3ra (5-hydroxytryptamine receptor 3 antagonists) or nk1ra (neurokinin-1 receptor antagonists) and excipients 6. uncontrolled diabetes mellitus 7. nausea and vomiting at baseline 8. chronic use of other antiemetic agent(s) 9. patient's inability to take oral medication 10. gastrointestinal obstruction or active peptic ulcer 11. pregnancy or breastfeeding 12. prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years 13. psychiatric or cns (central nervous system) disorders interfering with ability to comply with study protocol

Keywords: nausea vomiting breast cancer ac-based chemotherapy
safety of therapeutic step-down in neuromyelitis optica

Conditions: Neuromyelitis Optica

Summary: neuromyelitis optica (nmo) is a neuroinflammatory disease related to multiple sclerosis (ms). it affects young subjects and causes a lot of handicap without treatment. thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. a long duration of treatment exposes to iatrogenism. therapeutic de-escalation trials in ms or other autoimmune diseases show rebound phenomena. in the nmo, there are no published data on the tolerance of desescalations to guide such strategies.


Eligibility criteria:
inclusion criteria: * major patients who have received long-term treatment for nmo * patients with a prospectively diagnosed nmo using the 2015 nmo classification criteria (ipnd) * patients who retrospectively meet the classification criteria of the 2015 nmo (ipnd) * patients who have not expressed their opposition, after information, to the reuse of their data for research purposes. exclusion criteria: * patient who expressed his opposition to participating in the study * lack of data on the assay of anti-aqp4 and anti-mog antibodies * less than a year of taking a second-line treatment before the relay * end of follow-up \<1 year following the transfer, this therefore includes patients whose transfer took place less than one year before the date of data extraction

Keywords: neuromyelitis optica nmo multiple sclerosis (ms) iatrogeny. autoimmune diseases
ankle fracture treatment in the elderly

Conditions: Ankle Fracture

Summary: the purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

this study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older

Eligibility criteria:
inclusion criteria: * at least 55 years of age at time of surgery * receiving treatment for ankle fractures exclusion criteria: * none

Keywords: ankle fracture elderly at-risk population ankle fracture in at-risk elderly population
effect of protein restriction plus eaa/ka supplementation on gfr decline in ckd

Conditions: Chronic Kidney Diseases

Summary: this study aims to investigate the effect of protein restriction plus ka/eaa supplementation on gfr decline in ckd patients.

in chronic kidney disease (ckd) patients, ketoacid analogues of essential amino acids (ka/eaa) are administered to reduce the production of harmful metabolic products and enhance nutritional status. protein restriction combined with aa supplement may have beneficial effects on ckd in several ways, by reducing nitrogen waste, oxidative stress, and inflammation, and by protecting against hemodynamic changes in glomerular hyperfiltration. several clinical trials have documented that very low protein diets (vlpd) supplemented with ka/eaa preserve the rate of progression of advanced ckd. however, in long-term follow-up of the mdrd study, vlpd plus ka/eaa treatment did not delay progression to dialysis or transplantation. as a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with ka/eaa supplements in retarding ckd progression.

Eligibility criteria:
inclusion criteria: * patients with ckd stages (g2 to g4), aged ≥ 18 years old exclusion criteria: 1. active malignancy 2. protein energy wasting 3. advanced organ disease 4. pregnancy

Keywords: protein restriction essential amino acids ketoanalogues gfr ckd
effect of mantra on hypertensive patients

Conditions: High Blood Pressure

Summary: mantras are specialized energized sound or words, which are defined most important sound therapy in vedic healing. present study was undertaken to evaluate the immediate effect of specialized mantra chant on cardiovascular parameters in high blood pressure patients.


Eligibility criteria:
inclusion criteria: * diagnosed and stable hypertension * on regular medication exclusion criteria: * individuals diagnosed with another lung disease, * have psychiatric, musculoskeletal or cardiovascular diseases, * being smokers * being pregnant
a study to assess frequency of undetectable minimal residual disease (umrd) in adult participants with chronic lymphocytic leukemia (cll) receiving oral venetoclax tablets ± intravenously (iv) infused rituximab in routine clinical practice in japan

Conditions: Chronic Lymphocytic Leukemia

Summary: most cases of chronic lymphocytic leukemia (cll) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. this study will evaluate the participant's related outcomes and experience of cll in adult participants who are treated in the japan. study participants will receive oral treatments of venetoclax±rituximab for cll as prescribed by their study doctor in accordance with approved local label. adult participants prescribed various treatments venetoclax±rituximab will be enrolled. around 89 participants will be enrolled in the study in sites in japan. participants will receive oral venetoclax tablets ± intravenously (iv) infused rituximab treatments for cll according to the approved local label. the overall study duration will be 27 months. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice.


Eligibility criteria:
inclusion criteria: * diagnosed with relapsed/refractory (2 line \[2l\]+) chronic lymphocytic leukemia (cll) in japan based on international workshop on chronic lymphocytic leukemia (iwcll) criteria at the time of informed consent (ic). * treatment with venetoclax±rituximab for 24 months who are not treated with any other concurrent cll treatment. * expected to visit the hospital at + 3 months after treatment with venetoclax±rituximab for 24 months. exclusion criteria: * no data on information on the start and end dates or continuation of treatment with venetoclax. * participating in other clinical trials.

Keywords: chronic lymphocytic leukemia cll venetoclax rituximab abt-199
coagulation test changes associated with acute normovolemic hemodilution in cardiac surgery

Conditions: Coagulation Disorder; Bleeding

Summary: the researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. a unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (cpb). this unit is given back to the subject post cpb. this has been shown to reduce the need for blood transfusion in patients.

subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. if clinically indicated, the blood, about 2 units, will be withdrawn from the subject. the researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.

Eligibility criteria:
inclusion criteria: * undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass * permission to use medical records in research exclusion criteria: * unable to grant informed consent or comply with study procedure * patient refusal of anh withdrawal. * undergoing emergency open heart-surgery * cpb time is expected to be \< 30 minutes * less than 18 years of age * pregnant

Keywords: cardiac surgery bleeding transfusion acute normovolemic hemodilution
relevance of the activ'dos app for chronic low back pain patients

Conditions: Chronic Disease; Lumbago

Summary: the purpose of this study is to compare a self rehabilitation program using activ'dos app versus using a standard sheet of paper.

this study involves patients with chronic low back pain. the purpose of this study is to compare a self-rehabilitation program using activ'dos app versus a standard sheet of paper. disabilities are measured with a roland-morris questionnaire.

Eligibility criteria:
inclusion criteria: * chronic low back pain for more than 3 months * aged to 18 or more * possibility to use activ'dos application with smartphone or tablet * initial score of roland morris questionnaire \>= 4 * fit to consent * who has signed consent form exclusion criteria: * any signs of severe illness underlying to radicular and lumbar pain like red flags * guardianship or protection of vulnerable adult * pregnant or nursing * refuse to participate

Keywords: exercise self-rehabilitation chronic low back pain mobile app mhealth ehealth physiotherapy disability pain
effects of ergometer training with telemonitoring in patients with chronic obstructive pulmonary disease (copd) after exacerbation

Conditions: COPD

Summary: home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in copd patients. the primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. consequently we expect an increased quality of life related to the illness and a decreasing bode-index. a post-interventional lower bode-index correlates with a reduced risk of hospitalisation and mortality.

hypothesis: there will be an increased prevalence, morbidity and mortality of copd during the next decades. on the other hand there is a clear correlation between life expectancy and physical activity in this disease. telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of copd.

Eligibility criteria:
inclusion criteria: * copd exclusion criteria: * tumor diseases * unstable coronary heart disease * untreated cardiac valve disease * incapable of giving consent

Keywords: copd telemonitoring training ergometer telemedicine
artificial intelligence aid systems in colorectal adenoma detection

Conditions: Adenoma Detection Rate

Summary: the main purpose of the study to evaluate the usefulness of the endo-aid artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. the secondary aims were: * to evaluate the benefit of endo-aid in adenoma detection rate by comparing endoscopists with high and low adenoma detection rate. * to evaluate serrated detection rate, advanced adenoma detection rate, adenoma detection rate according to the size (\ = 10mm) and number of adenomas by colonoscopy. stratification by location and morphology.

priority guidelines have been established regarding ia applied to gastrointestinal endoscopy. regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (cade) as one of the most necessary priorities, given the importance of colorectal cancer screening (crc) and post-polypectomy surveillance. the evaluation of these systems in different clinical practices and patient groups has been recommend. in this regard, studies in the western population are limited and have been carried out by expert endoscopists. it has not been evaluated in endoscopists with different adenoma detection rates. in addition, there are no studies with the recent cade endo-aid system (olympus corp. tokyo). the main purpose of the study to evaluate the usefulness of the endo-aid artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. in addition, the benefit of the cade system will be assessed according to the endoscopist adr. a randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. patients with be randomized to one of the four groups: cade system and high adr endoscopist; cade system and low adr endoscopist; control and high adr endoscopist; control and low adr endoscopist. for the sample size calculation a 14.4 of difference in favor of the cade system was considered. taking onto account an alpha error of 0.05 in a unilateral contrast, a power of 80% and a loss of 10%, 165 patients per group would be required.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients referred for outpatient colonoscopy exclusion criteria: * colonic resection * taking anticoagulants or antiagregants that contraindicate the performance of therapy * patients with a recent colonoscopy (\<6 months) of good quality (e.g. cited for endoscopic therapy) * inflammatory bowel disease * patients with incomplete colonoscopy * patients with inadequate preparation using the boston colonic preparation scale (bbps). a cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate. * patients with polyposis syndromes * refusal to participate in the study.
comparison between medial pivot versus symmetric insert total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the functional outcome and longevity of total knee arthroplasty (tka) is still a concern. despite various developments in tka designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic. in normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. this rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism. in addition, stability throughout flexion is a crucial element to normal knee function. most tka designs removal of the acl, and the pcl in posterior-stabilized design, but the tka do not fully restore the function of those ligaments. based on this philosophy, the medial pivot tka was designed to provide better function, patient satisfaction and increased survival. the objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.

candidates for the study will be consecutive patients eligible for total knee arthroplasty (tka) at our center. all patients meeting inclusion criteria will be recruited for enrollment into the study. informed consent will be obtained from the patient prior to randomization. at that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. the two patient groups will include: 1. study group: patients treated with a medial pivot tka. 2. control group: patients treated with a conventional tka. patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee * 50 years and older * participants must be able to give informed consent exclusion criteria: * inflammatory arthritis * traumatic etiology * neurologic disease * neoplastic disease * morbid obesity * severe collateral ligament instability (\> 10° varus/valgus) * severe knee misalignment (greater than 10° of varus or valgus) * flexion contracture greater than 15º * prior surgery on the affected knee (except meniscus) * knee arthroplasty in the contralateral knee

Keywords: knee osteoarthritis total knee arthroplasty medial pivot
metformin in postmenopausal women with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged 45-60 years with metabolic syndrome according to the american heart association and the national heart, lung, and blood institute exclusion criteria: * previous cardiovascular diseases * contraindicated to metformin: serum creatinine \>1.4 mg/dl, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis * previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment * fasting blood sugar ≥ 200 mg/dl or hba1c \>8% * serum triglyceride ≥500 mg/dl * abnormal ekg

Keywords: cardiovascular risk factors
decitabine+bucy vs bucy conditioning regimen for mll+ acute leukemia undergoing allo-hsct

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Conditions; Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia

Summary: recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-hsct) could be a valuable treatment choice for mixed-lineage-leukemia (mll)-rearranged acute leukemia. unfortunately, some patients relapsed after allo-hsct. in this prospective randomized controlled study, the safety and efficacy of decitabine + bucy and bucy myeloablative conditioning regimens in mll+ acute leukemia undergoing allo-hsct are evaluated.

recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-hsct) could be a valuable treatment choice for mixed-lineage-leukemia (mll)-rearranged acute leukemia. bucy conditioning regimen is the standard myeloablative regimen for mll+ acute leukemia undergoing allo-hsct. however, it appears to have higher relapse rate and lower survival. to reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. in this prospective randomized controlled study, the safety and efficacy of decitabine + bucy and bucy myeloablative conditioning regimens in mll+ acute leukemia undergoing allo-hsct are evaluated.

Eligibility criteria:
inclusion criteria: * mll+ acute leukemia undergoing allo-hsct * 14-65 years exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)
acute stroke thrombectomy: does ct perfusion accurately predict infarct on mri after recanalization

Conditions: Stroke

Summary: the newest generation of stent---retrievers results in higher recanalization rates and faster recanalization time compared to older generation endovascular therapies for acute stroke. advanced neuroimaging can potentially improve the assessment of infarct core and inform decision---making in patients being considered for endovascular therapy. evaluation of infarct core may be performed with nect, ctasi or ct perfusion. in the past, evaluation of ctp in predicting core infarct in acute stroke has been limited because recanalization status was lacking. in addition, final infarct size may be underestimated on nect compared with mri. these two limitations can now be addressed: the new generation of stent---retrievers allows accurate determination recanalization time; evaluating the test characteristics of ctp using 24 hour dwi---mri as the reference standard can be readily performed. we aim to prospectively investigate the sensitivity and specificity of whole---brain ctp in predicting 24 hour dwi---mri infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.


Eligibility criteria:
inclusion criteria: 1. admission nect, cta neck and cow or multi-phase cta or ctp. follow---up 24 hr dwi---mri performed 2. endovascular therapy performed for acute anterior circulation stroke as per clinical practice. 3. patient with an angiographically documented ica, m1 or m2 occlusion exclusion criteria: none
the distribution of plasma drug concentrations of beta-lactam antibiotics in intensive care unit patients

Conditions: Sepsis

Summary: in this project, intensive care unit (icu) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. four regional icu-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.


Eligibility criteria:
inclusion criteria: * current treatment with beta-lactam antibiotics and admission to the icu exclusion criteria: * pregnancy, age below 18 years