Kornimate/medical-research-clean huggingface dataset:
copanlisib pharmacodynamic study

Conditions: Non Hodgkin Lymphoma

Summary: this study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.


Eligibility criteria:
* histologically confirmed diagnosis of the following nhl: follicular lymphoma all grades, lymphoplasmacytic lymphoma / waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large b-cell lymphoma, burkitt lymphoma, mantle cell lymphoma, or peripheral t-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) or * advanced and / or refractory solid tumors with high prevalence (≥30%) of pik3ca or pten alteration: breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers * biopsy-accessible tumor * male or female patients equal 18 or more years of age * nhl patients must have at least 1 bi-dimensionally measurable lesion according to the modified cheson criteria. patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the response evaluation criteria in solid tumors version 1.1 (recist 1.1) criteria * eastern cooperative oncology group performance status 2 or \< * life expectancy of at least 3 months * adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug * left ventricular ejection fraction \> or equal the lower limit of normal for the institution exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from nhl or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if gleason score \< or equal to 6 and prostate-specific antigen \<10 ng/ml, and superficial bladder tumors \[ta (non-invasive tumor), tis (carcinoma in situ) and t1 (tumor invades lamina propria)\] * known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (cns) metastases if treatment completed \<3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the cns metastases * any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study * current diagnosis of type 1 or type 2 diabetes mellitus with hba1c \< or equal to 8.5% or fasting blood glucose \< or equal to 160 mg/dl

Keywords: solid tumors
phase ii cohort of spinal stereotactic radiotherapy in patients using a mr linac

Conditions: Spinal Disease

Summary: to learn whether giving spinal stereotactic radiosurgery (srss) that uses a more advanced imaging scan method called magnetic resonance imaging with a linear accelerator (mr-linac) during treatment will lead to improved responses to treatment and better quality of life. srss is radiation therapy given to the area around your spine.

primary objective: • to determine the 6-month local control (lc) of the target site of treatment. secondary objectives: * to determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable) * to determine the 1-year local control of the target site

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) 3. candidate for spine srs/sbrt as determined by treating radiation oncologist or multidisciplinary spine conference review 4. maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed 5. diagnosis of cancer documented 6. motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation 7. karnofsky performance score (kps) ≥ 40 or ecog score ≤ 3 exclusion criteria: 1. patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) 2. patients who are unable to undergo mri of the spine with contrast 3. patients who are pregnant
modified atkins diet plus ketocal for adult epilepsy

Conditions: Epilepsy; Seizure; Medically Resistant Epilepsy; Medically Resistant Seizures

Summary: the modified atkins diet (mad) has been shown to be effective in treating children and adults with medically resistant seizures. a recent study in children showed that the use of ketocal® once per day in addition to the mad appeared to be beneficial when used during the first month. the investigators hypothesize that including a daily ketocal® liquid tetrapak with one meal during the initial month of the mad will produce urinary ketosis in more adult patients than the mad alone and will lead to greater seizure reduction.


Eligibility criteria:
inclusion criteria: * adults ages \>17 years. * at least weekly seizures (or 4 per month). all seizure types allowed. * tried at least two anticonvulsants. exclusion criteria: * unwilling to restrict carbohydrates * significantly underweight (body mass index \<18.5) * prior use of the modified atkins diet for ≥ 2 days * prior use of ketocal® at any time for any duration * use of the ketogenic diet within the past year * kidney disease * history of hypercholesterolemia (total cholesterol \> 300 mg/dl) or hypertriglyceridemia (triglycerides \> 200 mg/dl) * metabolic or mitochondrial disorder * pregnancy or breastfeeding * lactose intolerance or milk allergy * aversion to liquids or inability to eat solid food

Keywords: seizures epilepsy adult intractable medically refractory atkins ketogenic diet
vibration response imaging in chronic obstructive pulmonary disease and asthma

Conditions: Chronic Obstructive Pulmonary Disease; Asthma

Summary: obstructive lung disease is usually a differential diagnostic consideration when a patient presents with breathlessness or cough. spirometry is the key diagnostic test used to confirm airflow obstruction particularly in the primary care setting. airflow obstruction that completely resolves after administration of a bronchodilator, by definition, excludes a diagnosis of copd. evaluation of obstructive lung disease must include pulmonary function testing; bronchoreversibility testing is an adjunct in differentiating between asthma and copd. bronchoreversibility cannot serve as an absolute diagnostic criterion for separating asthma from copd. vibration response imaging (vri) technology provides a simple, radiation-free method to image the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. in this study, regional quantitative and qualitative information on vibration response is compared with spirometry in assessing lungs function of copd and asthma patients.


Eligibility criteria:
inclusion criteria: * able and willing to read, understand, and provide written informed consent * male or female in the age range of 18-85 years * patients referred for evaluation of known or suspected obstructive airways disease. * subject is referred for pulmonary function testing with pre-and post- bronchodilator * bmi \> 21 * patients who are treated with bronchodilators should go through a washout period prior the vri procedure according to the pulmonary function laboratory protocol. * stable clinical condition at study baseline evaluation. exclusion criteria: * chest wall deformation * spine deformation (including severe scoliosis) * hirsutism * potentially contagious skin lesion on the back * skin lesion that would interfere with sensor placement * pregnant or lactating females.

Keywords: lung sounds, airway obstruction, asthma, auscultation
establishment and validation of a predictive model for the risk of colorectal advanced adenomas

Conditions: Colorectal Adenoma

Summary: the study aimed to analyze the risk factors of colorectal advanced adenoma and constructe a model to predict the high-risk individuals of harbouring colorectal advanced adenomas, so as to better identify screening participants and provide an important theoretical basis for the prevention of colorectal cancer.

a large cohort of eligible patients were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal advanced polyps. in the derivation cohort, the lasso regression method was applied to filter variables and multivariate logistic regression analysis was used to identify important predictors.a prediction model was established based on the results of multivariate logistic regression analysis. the predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 and ≤75 years old. patients with complete data on demography and clinicopathology. exclusion criteria: * patients with a history of inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, p-j syndrome and intestinal lymphoma. patients with a previous history of colorectal neoplasm. patients with a history of severe systemic diseases. lack of complete clinical data for analysis.
a study of a pelvic floor muscle exercise program before and after radical prostatectomy

Conditions: Prostate Cancer

Summary: the researchers are doing this study to find out if a pfme program to reduce urinary incontinence after radical prostatectomy is feasible for people with prostate cancer. the researchers will track how many participants join the study, follow the program, and stay in the study. they will also evaluate how people feel about their experience and satisfaction with participating in this program through interviews. they will also measure participants' quality of life by filling out questionnaires, and we will study whether the program shows promise in reducing urinary incontinence. radical prostatectomy sometimes causes incontinence after the surgery. the researchers think that by teaching pfme and strengthening and improving control of the pelvic floor muscles, pfme training before and after radical prostatectomy may help reduce incontinence and/or reduce how long incontinence lasts.


Eligibility criteria:
inclusion criteria: * aged ≥18 years with prostate cancer scheduled for radical prostatectomy at msk exclusion criteria: * previous radiotherapy for prostate cancer * urinary incontinence at baseline before radical prostatectomy * inability to participate in study activities (exercise program, imaging, and questionnaires) because of: * comorbidity(-ies) and/or * geographic location and/or * communication barrier(s)

Keywords: urinary incontinence pelvic floor muscle exercise
feasibility of ecg-based glucose monitoring system

Conditions: Diabetes Mellitus

Summary: this is a single-center, open-label clinical trial to assess the feasibility of using ecg information in estimating glucose level continuously in adult subjects.

about 165 subjects distributed in 3 categories according to the risk of developing events of hyperglycemia or hypoglycemia will be enrolled. subjects will wear a portable ecg recorder to monitor ecg information and use 3 blood glucose monitoring methods to monitor blood glucose level over time. all data will be pooled together to train a specific artificial intelligence (ai) algorithm to conduct a blood glucose detection model using ecg features. the trial period is about 21 days.

Eligibility criteria:
inclusion criteria: * males and females, age 18 years or older. * subjects can communicate clearly, fully understand the informed consent form, and are aware of the rights and obligations of the study. * category 1: subjects without a medical history of hyperglycemia / hypoglycemia or type 1 / type 2 diabetes. category 2: subjects having diabetes mellitus (dm) and hba1c value of. 5.5% to 10%, with egfr ≥ 60 ml/min. category 3: subjects having chronic kidney disease (ckd) and diabetes. mellitus (dm), with egfr \< 60 ml/min. • willing and able to participate in all aspects of the study. exclusion criteria: * subjects suffering from insomnia or severe digestive system disorders within 3 months prior to the screening visit. * subjects who are addicted to alcohol or caffeine. * existing severe cardiac conditions such as recent myocardial infarction or advanced heart failure within 6 months prior to the screening visit. * has experienced an episode of confirmed or suspected diabetic ketoacidosis (dka) within 6 months prior to the screening visit. * subjects who are vulnerable groups or with higher risks, such as hiv carriers, pregnant women or planning to become pregnant within the study duration, breast-feeding mothers, subjects with rare diseases, physical disabilities, incurable fatal diseases, dependents in nursing homes, incapacity, or intellectual or mental disabilities. * has a concomitant disease or condition that may compromise subject safety such as unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical conditions. * any active infection or malignancy requiring acute therapy. * having coagulation disorders. * has known allergy to medical adhesives. * subjects using any cardiac related implantable medical devices such as a pacemaker and so on. * subjects on certain drugs known to cause arrhythmias or significantly impact kidney function or blood glucose levels (except for the current daily use medication). * subjects have used defibrillators within 3 months prior to the screening visit. * currently participating in another device or drug study. * currently receiving dialysis treatment or planning to receive dialysis during the study. * any other clinical condition that, in the investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Keywords: ecg glucose singular wings
following of myeloid-derived suppressor cells (mdsc) in severe sepsis: what relationship with systemic inflammatory syndrome?

Conditions: Severe Sepsis; Inflammatory Response Syndrome, Systemic

Summary: sepsis remains a major cause of death in developed countries. a better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.


Eligibility criteria:
inclusion criteria: * patient ≥18 years old * patient with two criteria of systemic inflammatory response syndrome and one of the four following criteria within 24 hours of hospitalization in icu: * lactate \>4 mmol/l * pao2 / fio2 \<200 in the presence of lung disease as infectious source * vasopressor: adrenaline or noradrenaline ≥0.25 µg/kg/min for at least 6 hours to maintain a systolic blood pressure ≥90 mmhg or mean arterial pressure ≥65 mmhg * thrombocytopenia linked to sepsis with platelet count \<100,000 / ml or a decrease ≤50% within 48 hours exclusion criteria: * pregnancy * progressive solid cancer * hiv infection * history of blood or inflammatory disease * long-term immunosuppressive treatment * prior episode of sepsis in the previous month * chronic dialysis patient * patient under guardianship * patient not affiliated with a social security system

Keywords: myeloid-derivated suppressive cell sepsis inflammatory response syndrome, systemic
effects of unilateral wbv on muscleactivity of contralateral hip adductor

Conditions: Bone Mass; Effects of Vibration

Summary: the aim of this study is to investigate effects of femur exposed to unilateral vibration on the rest muscle electrical activity of contralateral hip adductors and contralateral soleus h-reflex in young adult men. this study hypothesize that femur exposed to unilateral vibration may affect the rest muscle electrical activity of contralateral hip adductors. vibration can effectively enhance muscle strength and power. previous studies have shown that vibration increases muscle electromyographic (emg) activity. it has been showed that bone has an effect on the increase in muscle emg activity caused by vibration in healthy young adults in a study. in this study, it was reported that vibrations-induced increases in muscle electrical activity of flexor carpi radialis (fcr) was related to ultradistal radius bone mineral content (bmc) and the fcr h-reflex was suppressed or depressed during vibration. this findings were reported to support the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate muscle activity.

a total of 20 voluntaries are planned to include in this study. vibration will be applied the right lower extremity by whole-body vibration (powerplate pro). cases will stand on vibration plate. wbv will be applied at a frequency of 40 hz and amplitude of 2 mm for 60 seconds. wbv will be applied one session only. the rest muscle electrical activity of ipsilateral and contralateral hip adductor muscles at rest will be measured by powerlab (data acquisition system, adinstruments, australia) device.the rest-emgrms will be measured at before and during vibration. we also evaluate a change in contralateral soleus h reflex during vibration. effects of bone on the rest muscle electrical activity will be assessed by hip bone mineral density, bone mineral content and serum sclerostin level. the right hip bone mineral density (bmd) and bmc will be evaluated by bone densitometer (norland). plasma sclerostin level will be measured by using human sclerostin elisa kıt before and after vibration.

Eligibility criteria:
inclusion criteria: * age: 20-40 yrs * gender: male * volunteer * healthy status: patients having hypoesthesia in his leg and healthy subjects * dominant hand:right-handed exclusion criteria: * bone diseases (osteoporosis, osteomalacia, paget's disease, neoplasm, etc), * systemic diseases (cardiovascular, endocrine, infections etc), * myopathy-tendinopathy * lower limb joint disease * vertigo * obesity (bmi \>30 kg/m2) * professional sportsman * male doing regular sports activities * skin disease in lower limb * non-cooperative subject * hemolysis of blood sample

Keywords: bone osteocyte rest muscle electrical activity whole-body vibration sclerostin
effects of contrast media on subjects with stable reduced renal function undergoing contrast-enhanced computed tomography

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the contrast-induced nephropathy (cin) rate in subjects randomized to receive either ioversol or iodixanol for contrast-enhanced computed tomography.

contrast-induced nephropathy (cin) is an acute decline in renal function after the administration of iodinated contrast agents. cin is commonly defined as an increase in post contrast serum creatinine (scr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dl from pre contrast baseline values. study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Eligibility criteria:
inclusion criteria: * males and females 18 years of age or older * subjects scheduled for a clinically indicated cect requiring 40 grams of iodine (125 ml) * subjects have an abnormal screening scr that results in a calculated egfr of \< 60 ml/min/1.73 m2 using the mdrd formula and acute causes for an elevation in scr have been excluded * subjects have stable reduced renal function which is defined as an abnormal screening scr measurement with a \< 15% difference from the oldest historical scr measurement obtained within the proceeding 1 week to 12 weeks * subjects must provide written consent and agree to abide by the site and study requirements exclusion criteria: * subjects previously entered into this study * subjects on dialysis * subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment * subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration * subjects in acute renal failure or have one or more known causes of acute renal failure * subjects have known or suspected unstable renal function * subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration * subjects taking nsaids (with the exception of asa) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast scr has been drawn * subjects taking aminoglycosides * subjects known to have an organ transplantation * subjects have severe congestive heart failure (class iii-iv)

Keywords: renal kidney contrast induced nephropathy