Kornimate/medical-research-clean huggingface dataset:
fulvestrant in postmenopausal patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on patients who have commenced treatment with fulvestrant after january 1st of 2007. all necessary information for the purposes of the present study will be collected with the use of a paper-case record form.

to date, there are no available data on the use of fulvestrant in the treatment of postmenopausal women with metastatic breast cancer in current clinical practice in greece. in view of this significant lack of knowledge, we designed this retrospective study in order to evaluate the effectiveness of fulvestrant in real-life settings, by obtaining data regarding the use of fulvestrant in current clinical practice among treating physicians in greece. this retrospective study aims to address the following questions: * what is the clinical outcome of fulvestrant treatment in terms of ttp when used in metastatic breast cancer in a real life clinical setting? * what is the positioning of fulvestrant in the hormone therapy sequencing in metastatic breast cancer in greece? * what are the other clinical outcomes (orr, duration of response, cbr) of fulvestrant treatment in metastatic breast cancer in a real life clinical setting and what is the relation between clinical outcomes and fulvestrant's position in the treatment sequence? * what is the usual duration of fulvestrant treatment in metastatic breast cancer in the real life clinical setting and which are the reasons for treatment discontinuation? * treatment failure with fulvestrant: what is the next step in sequencing according to patients' breast cancer treatment history?

Eligibility criteria:
inclusion criteria: * postmenopausal women with er-positive and/or pgr-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease * patients who have received treatment with fulvestrant for metastatic breast cancer and have completed/discontinued the treatment regardless of outcome/reason for discontinuation (except for treatment discontinuation for non-clinical reasons) * patients who were at postmenopausal status at the time of treatment with fulvestrant exclusion criteria: * patients who are currently undergoing treatment with fulvestrant * investigators/treating physicians with no available electronical or paper-based medical records

Keywords: cancer breast metastatic hormonotherapy
the effect of gastric bypass surgery on gut hormones related to bone remodeling and intestinal growth.

Conditions: Obesity; Bone Loss

Summary: the overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). the hormones will be measured in blood samples taken before and after surgery. the results are compared with changes in body weight and body composition as measured by dexa scanning.


Eligibility criteria:
inclusion criteria: * caucasians fulfilling the criteria for laparoscopic gastric bypass. * bmi\>40kg/m2. exclusion criteria: * pregnancy * chronic obstructive pulmonary disease * diabetes mellitus * chronic inflammatory bowel disease * major psychiatric disorder * drug abuse
lower limb compression prevents hypotension after epidural in labor

Conditions: Labor Pain; Maternal Hypotension

Summary: the goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.

maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. we plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension. pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. patients will be randomized into either control or sequential compression device (scd) groups. following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.

Eligibility criteria:
inclusion criteria: * women with pregnancy at term (greater than or equal to 37 weeks 0 days gestation) * singleton gestation * in labor (spontaneous or induced) * requested epidural for pain management exclusion criteria: * any diagnosis of hypertension or cardiovascular disease * any contraindications to lower extremity compression including deep venous thrombosis in past 6 months, infected leg wound, or deformity of lower extremity * any contraindications to epidural placement including severe thrombocytopenia and spinal deformity

Keywords: epidural anesthesia lower extremity compression
tislelizumab combined with chemotherapy versus chemotherapy alone in recurrent or metastatic nasopharyngeal cancer (npc)

Conditions: Recurrent or Metastatic Nasopharyngeal Cancer

Summary: this study was designed to compare the efficacy and safety of tislelizumab (bgb-a317) combined with gemcitabine plus cisplatin versus placebo combined with gemcitabine plus cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal cancer.


Eligibility criteria:
key inclusion criteria: 1. able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments 2. aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place) 3. histologically or cytologically confirmed, recurrent or metastatic npc 4. participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[ffpe\] blocks or approximately 10 \[≥ 6\] freshly cut unstained ffpe slides) with an associated pathological report. the archival tumor tissues must be collected within 2 years before screening. in the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory 5. eastern cooperative oncology group (ecog) performance status ≤ 1 6. must have ≥ 1 measurable lesions as defined per recist v1.1 7. must be treatment-naive for recurrent or metastatic npc. key exclusion criteria: 1. participants with locally recurrence suitable for curative surgery or radiotherapy 2. received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. the following exception is allowed: * palliative radiotherapy for bone metastases or soft tissue lesions should be completed \> 7 days prior to baseline imaging. 3. has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization 4. received prior therapies targeting programmed cell death protein-1 (pd-1) or programmed cell death protein ligand-1 (pd-l1) 5. active leptomeningeal disease or uncontrolled, untreated brain metastasis 6. active autoimmune diseases or history of autoimmune diseases that may relapse 7. any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast) note: other protocol defined inclusion/exclusion criteria may apply.
impact of comorbidities after radical cystectomy using a predictive method with artificial intelligence

Conditions: Bladder Cancer; Comorbidity; Deep Learning

Summary: clinician and the multidisciplinary team meeting in oncologic urology (mmo) play a key-role in the decision making. an unexplained surgeon attributable variance, probably linked to the subjective "eyeball test" effect, was identified as a strongest factor underlying non-compliance with guide line recommendations in the management of bladder cancer. so high-quality studies that identify barriers and modulators (such as comorbidities) of provider-level adoption of guidelines and how comorbidities are associated in making therapeutic choice and their impact in bladder cancer specific survival and overall survival, are crucial. to identify patients at high risk of early death, and to improve specific guideline for treatment might be decisive. in order to assess survival, where mortality events compete, it will be more appropriate to compute a cumulative incidence function (namely cif). the investigators will compare outcomes across patient populations to obtain information to improve clinical decision-making. such learning will be done through the use of neural networks or by applying population-based approaches, such as genetic algorithms (ga), ant colony systems (acs) and particle swarm optimization (pso), using as a four-stage based approach. first, the investigators propose a "pretopology space" in order to study a dynamic phenomenon. second, the investigators recall that the k-means approach remains one of the most used approaches for classifying a set of elements (patients / persons / others) into k (disjunctive) clusters. third, the investigators propose a learning pretopology space for enhancing the clustering. such an approach can be assimilated in spirit to one applied with high success on deep learning. fourth and last, the investigators propose a reactive method that is able to include some new elements or remove some contained elements


Eligibility criteria:
inclusion criteria: * 18 years and older * patient treated by radical cystectomy for bladder cancer exclusion criteria: * computed tomography/magnetic resonance evidence of distant metastases.

Keywords: bladder cancer comorbidity deep learning pso-particle swarm optimization
a long-term extension study of e2007 in patients with refractory partial seizures uncontrolled with other anti-epileptic drugs (aeds)

Conditions: Refractory Partial Seizures

Summary: the purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed week 10 of phase ii study e2007-j081-231 study.


Eligibility criteria:
inclusion criteria: 1. patients who consent to the study entry on their free will before starting any trial-related activities. 2. patients who participated in study 231 and completed the required evaluation period (10 weeks). 3. patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator. exclusion criteria: 1. pregnant or lactating women, women of child-bearing potential, women willing to become pregnant. 2. patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period. 3. patients who operate heavy equipment or drive should not be recruited into the study. 4. patients who are ineligible for study entry judged by the investigator or sub-investigator.

Keywords: seizure epilepsy
supplementation with alpha-lipoic acid and silybum marianum(ludlev®) for the improvement of fatty liver disease

Conditions: Metabolic Associated Fatty Liver Disease

Summary: this randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.

between 80-90% of people with associated metabolic fatty liver disease present with obesity and diabetes mellitus. alpha-lipoic acid is a cofactor of mitochondrial enzymes that has been considered an antioxidant since its reduced form, dihydrolipoate, reacts with reactive oxygen species and thus protects the cell membrane. alpha-lipoic acid administration has been shown to have beneficial effects on adipokine levels and metabolic disorders such as diabetes and obesity, both of which are present in patients with mafld. it has been shown that the administration of 1200 mg of alpha-lipoic acid in patients with fatty liver decreases insulin resistance, serum leptin, increases the concentration of adiponectin. given the metabolic effects of alpha-lipoic acid, it is hypothesized that administration of this formulation may be beneficial for people with metabolic associated fatty liver disease.

Eligibility criteria:
inclusion criteria: * subjects treated at the instituto de investigaciones médico biológicas de la universidad veracruzana with a diagnosis of fatty liver disease * agree to voluntarily participate in the study and sign informed consent. * patients with evidence of hepatic steatosis who are overweight or obese * patients with evidence of hepatic steatosis with diabetes mellitus and overweight or obesity. * patients with evidence of steatosis plus metabolic risk abnormalities will be included (waist circumference \>102 in men, 88 cm in women, blood pressure \>130/85 mmhg or specific treatment, triglycerides \>150 mg/dl or specific treatment, hdl cholesterol \ 2.5, crp \>2 mg/l or prediabetes defined by fasting glucose detection 100 to 125 mg/dl, postload glucose 2 hours 140 to 199 mg/dl or hba1c between 5.7 to 6.4%) * accept not to start any diet program during the study period. * agree not to change your current exercise plan during the study period exclusion criteria: * patients meeting diagnostic criteria for fatty liver disease with normal weight * patients with terminal illness, cancer, renal disease in renal replacement therapy * pregnant women * patients with inability to understand or follow the study protocol * sensitivity to the components of the formula.

Keywords: fatty liver disease
study of absorbable biosynthetic meshes in contaminated ventral hernia repair

Conditions: Ventral Hernia Repair

Summary: the potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. however, postoperative morbidity and recurrence rate for biologic prostheses are high. the delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. the interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. current studies have been done on groups with few subjects and in clean surgery. the primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. the secondary purpose is to describe the number of recurrent ventral hernia at 12 months. the ventral hernia repair is a frequent operation of general surgery. thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.


Eligibility criteria:
inclusion criteria: * male or female adult patient ( ≥18 years) * patient who has agreed to the use of his medical data for the purposes of this research, * patient having been operated between may 2016 and september 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mvhwg grade 3 in the centers participating in the study, * patient who benefited between may 2016 and september 2018 from a biosynthetic mesh exclusion criteria: * patient who has not consented to the use of her medical data for the purposes of this research, * patients who have benefited from the placement of a phasix® st biosynthetic mesh in intraperitoneal or phasix® in retro-muscular prophylaxis, * patient under safeguard of justice, * patient under guardianship or curatorship.

Keywords: ventral hernia repair contaminated surgery biosynthetic absorbable mesh descriptive study
hepatic and cardiac metabolic flexibility in subjects with t2dm with and without nafld

Conditions: NAFLD - Non-Alcoholic Fatty Liver Disease; Type 2 Diabetes

Summary: non-alcoholic fatty liver disease (nafld) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (nash) and cirrhosis. accumulating evidence indicates that nafld is associated with development of heart failure, abnormal ventricular glucose and fatty acid (fa) utilisation and cardiac steatosis. the mechanisms behind why some subjects progress from nafld to nash and the link between cardiac involvement and nafld are poorly understood, but must include altered cardiac and intrahepatic lipid handling. investigators plan comprehensive kinetic studies of heart and liver fa uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (tg) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with type 2 diabetes with and without nafld and nash and the relationship with heart function. in addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in type 2 diabetic subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. investigators will address these questions using tracer techniques (11cpalmitate pet tracers and triglyceride (tg) tracers) to study cardiac and liver substrate trafficking, as well as mr spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. the overarching goals are to define abnormalities and differences between nafld and nash in hepatic lipid (fa and tg) metabolism.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes with and without nafld (steatosis ff% \> 5,6% on mr spectroscopy for nafld and nash groups) exclusion criteria: * active smoking * comorbidity other than hypertension and hyperlipidemia * fixed medical drug consumption (including insulin) except statins and anti-diabetic medications. however, statins and weekly based glp-1 agonist must be paused 1 week before the examination date and other antidiabetic medication 3 days before the study date. * patients with cancer or former cancer patients * blood donation within the last 3 months prior to the study * participation in experiments involving radioactive isotopes within the last 3 months * alcohol abuse (over 21 items per week for men and over 14 for women) * pregnancy
efficacy and safety of zotarolimus-eluting coronary stent system in patients with long coronary artery disease

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Summary: this study is to evaluation the efficacy and safety of zotarolimus-eluting stent in patients with long coronary artery disease of 25 mm or longer.

study objectives: from this observational prospective study, the efficacy and safety of zotarolimus-eluting stent in patients with coronary artery disease longer than 25mm is planned to be investigated. background: long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. zotarolimus-eluting stents are a new type of stent that combines the advantages of an endeavour resolute stent (drug eluting stent) and integrity stent (bare metal stent). in other words, biolinx polymer is used which is an advantage of endeavour resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of integrity stent. to date, there are only few studies to evaluate the efficacy and safety of zotarolimus-eluting stent in the treatment of coronary artery disease. therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of zotarolimus-eluting stent in patients with long coronary artery disease of 25 mm or longer.

Eligibility criteria:
inclusion criteria: * age ≥ 19 years old * evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm * at least 2.5 mm diameter coronary vessel by visual estimation * patients treated with zotarolimus-eluting stent exclusion criteria: * previous coronary stent implantation * patients perticipated in other clinical trials of drugs or device * target vessel saphenous vein graft * in-stent re-stenosis lesion * contraindicated to anti-platelet agents or hypersensitivity * past history of malignancy within 5 years * history of anaphylaxis to contrast agent * pregnancy and lactation * life expectancy \< 1-year * end stage renal disease on dialysis

Keywords: coronary artery disease zotarolimus-eluting stent long coronary artery disease target lesion failure
iron absorption from gds capsules ii

Conditions: Iron Deficiency

Summary: slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.


Eligibility criteria:
inclusion criteria: * female, * age 18-50 years, * max. body weight 65 kg, * serum ferritin \< 30 µg/l exclusion criteria: * pregnancy, * lactation, * regular intake of medication, * blood donation or significant blood losses over the past 4 months

Keywords: iron absorption slow release iron gastric delivery system iron deficiency