Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness study of autologous natural killer and natural killer t cells on cancer

Conditions: Breast Cancer; Glioma; Hepatocellular Cancer; Squamous Cell Lung Cancer; Pancreatic Cancer; Colon Cancer; Prostate Cancer

Summary: the purpose of this study is to assess the safety and effectiveness of natural killer (nk) cell and natural killer t (nkt) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.


Eligibility criteria:
inclusion criteria: * male or female not less than 18 years of age or over 80 years of age. * life expectancy of ≥ 24 weeks as measured by the eastern cooperative oncology group (ecog) performance status. * subjects must present with one of the following disease pathologies: breast cancer, glioma, hepatocellular cancer, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer * the pathology must be an assessable disease (measurable by ct scan or mri) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.) * negative for hepatitis b, hepatitis c, hiv, and cmv. * subjects must present with leukocyte counts above 3,000/μl and platelet counts above 100,000/ μl. * subjects must present with minimum hemoglobin levels of 10. * if female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses \>12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (iud) or sexual abstinence, or has a vasectomized partner. * if female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit. * able to comprehend and sign an informed consent document and comply with the requirements of the study. exclusion criteria: * no measurable malignant disease by ct scan or tumor markers. * life expectancy of ≤ 24 weeks as measured by the eastern cooperative oncology group (ecog) performance status. * age of less than 18 years or over 80 years of age. * documented/confirmed positive testing for hepatitis b, hepatitis c, hiv, or cmv. * prior or current history of autoimmune disease. * pregnant or lactating women. * leukocyte count \< 3,000 /μl prior to leukapheresis. * platelet count \< 100,000/μl prior to leukapheresis. * hemoglobin levels below 10. * ptt (prothrombin time) of \ than 15 seconds. * aptt (activated partial thromboplastin time) of \ than 39 seconds. * failure or refusal to sign informed consent for the study. * culture fails to meet specifications for study. * subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.

Keywords: metastatic malignancies tumor markers chemotherapy cancer breast cancer glioma hepatocellular cancer squamous cell lung cancer pancreatic cancer colon cancer prostate cancer
intestinal epithelial fucosylation affects the efficacy of ustekinumab in crohn's disease

Conditions: IBD

Summary: the loss of response rate of ustekinumab(ust) is high, and the specific mechanism has not yet been elucidated. molecular markers that can accurately predict the efficacy of ust are urgently needed to provide theoretical basis for guiding individualized treatment. therefore, this study intends to explore the impact of intestinal epithelial fucosylation levels on the efficacy of ust in patients with crohn's disease(cd), aiming to provide predictable molecular markers for ust to accurately treat cd.


Eligibility criteria:
inclusion criteria: 1. diagnosed with moderate to severe crohn's disease 2. receiving treatment with ustekinumab 3. received colonoscopy and collected intestinal tissue samples before and after treatment exclusion criteria: 1. pregnancy 2. hypersensitivity to any component of ustekinumab 3. cognitive or developmental disabilities prevent you from completing this study 4. combined with diseases such as ra, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors

Keywords: durg efficacy crohn's disease ustekinumab intestinal epithelial fucosylation
cardiovascular biomarkers in peripheral artery disease.

Conditions: Peripheral Artery Disease

Summary: despite the best medical management, many patients with peripheral artery disease (pad) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that may increase the risk of acute limb ischemia or amputation. there are no clear molecular associations that could explain the differences in outcomes after endovascular therapy in patients with pad. the variable outcomes following endovascular therapy may depend, at least in part, on the profile of cytokines involved in inflammatory and atherosclerotic processes. the goal of this observational study is to evaluate the potential use of circulating il-1, il-6, tnf-alpha, c reactive protein, hmgb-1, osteoprotegerin, sortilin and omentin-1 levels as biomarkers of major adverse limb events (male) and major adverse cardiovascular events (mace) in diabetic patients with pad and chronic limb-threatening ischemia (clti) requiring a procedure of endovascular revascularization. the main questions it aims to answer are: * association between serum levels of il-1, il-6, tnf-alpha, c reactive protein, hmgb-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse limb events (male) after lower extremity revascularization. * association between serum levels of il-1, il-6, tnf-alpha, c reactive protein, hmgb-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse cardiovascular events (mace) after lower extremity revascularization. diabetic patients with clti requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating il-1, il-6, tnf-alpha, c reactive protein, hmgb-1, osteoprotegerin, sortilin and omentin-1 before the endovascular procedure. incidence of male and mace will be collected in a 12-months follow-up and will be associated with il-1, il-6, tnf-alpha, c reactive protein, hmgb-1, osteoprotegerin, sortilin and omentin-1 serum levels.


Eligibility criteria:
inclusion criteria: * age of at least 18 years * diagnosis of t2dm present for a least one year * ankle/brachial index (abi) of less than 0.80 * lower limb stenosis greater than 50% documented by ultrasound color doppler (us) * category 4 or 5 of pad in accordance with the rutherford classification * presence of clti requiring endovascular treatment exclusion criteria: * pregnancy * acute infections at present or in the previous month * diabetic foot ulcers with sign of infection or osteomyelitis * previous lower-limb endovascular or surgical revascularization within the past 3 months * diabetic peripheral neuropathy * liver disease with a functional status b or c in accord to child-pugh classification * congenital or acquired thrombophilia * active autoimmune disease * active cancer * organ transplantation * life expectancy \< 12 months * contraindication to antiplatelet therapy * contraindication to endovascular revascularization

Keywords: cytokines mace male atherosclerosis diabetes mellitus peripheral artery disease
computed tomographic assessment of cardiac and extra cardiac vascular anomalies associated with tetralogy of fallot

Conditions: Fallot Tetralogy

Summary: evaluation of cardiac and extra cardiac vascular defects associated with tetralogy of fallot in pediatric patients, regarding frequency and types of anomalies with assesment of multidetector computed tomography diagnostic value.

tetralogy of fallot (tof) is the most common complex cyanotic congenital heart disease (chd), with a prevalence of 3.5-9%. almost all pediatric patients born with tof can now expect to survive to adulthood because of advances in its surgical treatment. in addition to the four diagnostic criteria of tof that include ventricular septal defect, right ventricular hypertrophy with outflow tract obstruction, and overriding aorta, other extra-cardiac vascular anomalies are frequently coexist . these may involve pulmonary, aortic, and coronary arteries with or without valve abnormalities, aorto-pulmonary vessels, and vena cava connections, is crucial for surgeons in the formulation of surgical strategies. trans-thoracic echocardiography (tte) is the initial classical procedure done for these patients, as it can demonstrate heart structure and estimate intra-cardiac pressures, gradients, and contractile functions as well as blood flow direction across any heart defect and emphasizing coronary vessels integrity. however, many extracardiac vascular defects associated with different heart diseases cannot be detected accurately by tte; consequently, heart catheterization with its invasive complications was widely used for confirming these abnormalities before surgery. recently, the evolution of multi-slice or multi-detector computed tomography (mdct) with its multi-planar information, lower doses of radiation, short scanning time, and easy availability suggested it to be a non-invasive reliable diagnostic method for detection of different malformations in pediatric patients with complex chd. thus, effective imaging modalities are required to provide a thorough preoperative anatomic description of the associated extracardiac vascular anomalies in pediatric patients with tof in order to improve surgical planning and outcomes. in recent years, multi-detector computed tomography (mdct) has become regarded as a reliable non-invasive tool for delineating various anomalies in patients with complex chd. few studies have focused on the preoperative evaluation of associated cardiac and extracardiac vascular anomalies in pediatric patients with tof using mdct, especially not large case series studies. in this study, we aim to investigate the diagnostic performance of mdct for assessing associated cardiac and extracardiac vascular abnormalities in patients with tof.

Eligibility criteria:
exclusion criteria * non-surgical patients * patients with unstable clinical conditions * renal insufficiency * hypersensitivity to iodinated contrast. age range of included patients: all pediatric patients less than 18 years were included. all patients underwent mdct and tte preoperatively. all associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.
a multi-centre survey on tramadol abuse in singapore

Conditions: Opioid Abuse

Summary: the rampant prescription of opioid has in part contributed to the ongoing worldwide opioid crisis. in the united states of america, it is estimated that death from the use of opioids outnumber death from motor vehicle accident deaths by more than 40%. consequently, many countries such as america and canada have drawn up guidelines pertaining to safe opioid prescribing. tramadol is often used by pain physicians to treat chronic pain. as it is a weak opioid and unscheduled in many countries, it is often considered to have a lower addiction potential compared to strong opioids. despite this, the literature does reveal evidence of abuse, addiction and withdrawal - although the incidence of this is unclear. in this study, the investigators aim to determine the prevalence of tramadol misuse in a pain clinic population. the investigators also aim to determine the real-life compliance of physicians to guidelines provided by international regulatory bodies (cdc) and the modifiable risk factors associated with tramadol misuse.


Eligibility criteria:
inclusion criteria: * all patients attending pain clinic in singapore general hospital, seng kang general hospital and changi general hospital exclusion criteria: -
epidural analgesia in intensive care unit (apd-rea: analgesie peridurale en reanimation)

Conditions: Critical Illness; Epidural Analgesia

Summary: epidural analgesia (ea) has been mainly investigated during the perioperative period. in the intensive care unit settings, ea should be proposed in critically ill patients, such as postoperative or trauma patients, typically. recent findings also support anti-inflammatory, vascular or respiratory effects for ea, beyond its analgesic effects. however, data on ea safety and feasibility in the intensive care unit settings are still lacking. the purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in icu patients.

background: epidural analgesia (ea) has been mainly investigated during the perioperative period. in the intensive care unit settings, ea should be proposed in critically ill patients, such as postoperative or trauma patients, typically. recent findings also support anti-inflammatory, vascular or respiratory effects for ea, beyond its analgesic effects. however, data on ea safety and feasibility in the intensive care unit settings are still lacking. design narrative: this observational multicenter prospective clinical study will report the incidence of ea-related complications, such as infectious or neurologic complications, and the mean duration of ea in the icu settings. patients admitted in three intensive care units (two from an university hospital and one from a local hospital) and receiving ea will be included in the study, whether the ea catheter is inserted in the icu or outside the icu, e.g. in the operating room. demographics, clinical and biological data will be recorded prospectively. the main goal is to evaluate the safety and feasibility of ea in critically ill patients, being assumed this technique is currently and routinely used in our intensive care units, in accordance with national and international guidelines on epidural analgesia practice.

Eligibility criteria:
inclusion criteria: * patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the icu or outside the icu, e.g. in the operating room. exclusion criteria: * none (besides classic contra-indications for epidural analgesia catheter insertion, e.g. coagulation disorder, local infection...)

Keywords: epidural catheter epidural analgesia intensive care unit safety
evaluation of renal angioplasty on atherosclerotic stenosis since 2010

Conditions: Renal Angioplasty on Atherosclerotic Stenosis

Summary: the interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by star and astral clinical trials in 2009, confirmed by the coral study in 2014. these studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. the aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.

previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, oap (acute pulmonary oedema) flash or acute renal failure of ischemic origin. there is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.

Eligibility criteria:
inclusion criteria: * oap flash: hospitalization for acute congestive heart failure without any other identified etiology than renal artery stenosis * resistant arterial hypertension under treatment including a diuretic * acute renal failure or ischemic renal failure quickly progressive * radiological criteria: renal ischemia visualized at arterial time of angio-ct or renal angio-mri exclusion criteria: * renal transplant patients * patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery * restenosis on stent, angioplasty of accessory renal artery * patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty * patients objecting to participate to the study
serum cortisol levels in patients with anxiety and depression with symptomatic oral lichen planus

Conditions: Oral Lichen Planus Related Stress

Summary: oral lichen planus (olp) is a t-cell mediated chronic immunological disease directed to a still unknown antigen. it is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors. in conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. this hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. also known as stress hormone, cortisol is a decisive index in stressful situations. this study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus. this study attempts to evaluate psychological anxiety and depression in oral lichen planus subjects using hospital anxiety and depression scale ( hads) and correlating with their serum cortisol levels. to understand and explore the etiopathogenesis for better management of oral lichen planus.

oral lichen planus (olp) is a t-cell mediated chronic immunological disease directed to a still unknown antigen. it is a mucocutaneous and a psychosomatic disorder, with unknown prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the indian population. 75% of patients with cutaneous lichen planus also experience oral lesions and may be precipitated or exacerbated by psychosocial stressors. in conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in the body, the most common effect of which is increased cortisol level in blood. this hormone is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of carbohydrates, fats, proteins and water. also known as stress hormone, cortisol is a decisive index in stressful situations. this study is intended to correlate the serum cortisol levels with anxiety and depression in patients with symptomatic oral lichen planus.

Eligibility criteria:
inclusion criteria * clinical features with burning sensation on eating spicy food. * patients with symptomatic oral lichen planus evaluated clinically and histologically. exclusion criteria: * patients not willing to be part of the study. * patients who are on corticosteroid therapy. * patients with endocrinal disorders which can alter adrenal gland function.
efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of 448 khz in the treatment of patients with organic erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of 448 khz in the treatment of patients with organic erectile dysfunction. sham comparator, parallel study including both the main and control group to demonstrate the efficiency of the device to treat erectile dysfunction.

the objectives of this study are: * to evaluate the effectiveness of the course treatment with the apparatus for continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 khz in patients with organic erectile dysfunction. * assess the safety and tolerability of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 khz in patients with organic erectile dysfunction. * to evaluate the duration of the effect of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 khz.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 79 years; 2. the diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography); 3. the diagnosis is confirmed by the assessment of the iief-5 questionnaire 4. patients with organic erectile dysfunction lasting at least 6 months. 5. patients with iief from 6 to 22 points. 6. patients with a permanent sexual partner for more than 3 months; 7. sexually active patients. non-inclusion criteria: 1. the use of other treatments for erectile dysfunction 2. age under 18 and over 79 years old; 3. anatomical deformation of the penis (angulation, cavernous fibrosis or peyronie's disease); 4. the presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia); 5. running coagulation disorders; 6. the presence of tumors in the area of electrotherapy; 7. the presence of aneurysms in the propagation of radio frequency waves; 8. angina pectoris; 9. myocardial infarction, stroke, life-threatening arrhythmias; 10. thrombosis, thromboembolic disease; 11. arterial hypertension (blood pressure ≥ 170/90 mm hg) or hypotension (blood pressure ≤ 90/50 mm hg.); 12. the patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction; 14. active tuberculosis, chronic somatic diseases in the acute stage; 15. condition after coronary artery bypass grafting (cabg); 16. patient's involvement in another clinical trial in the last 3 months; exclusion criteria: 1. serious unwanted phenomenons associated with exposure to the apparatus. 2. incorrect inclusion in the study. 3. a marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease. 4. the patient's appearance of non-inclusion criteria during the study. 5. serious deviation from the protocol. 6. the desire of the patient or his legal representative.

Keywords: high-frequency radio wave electrotherapy radio frequency 448 khz
effect of exercise timing on energy intake and appetite in adolescents with obesity: the timex 3 study

Conditions: Pediatric Obesity

Summary: the aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.

the present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. their ad libitum energy intake will be assessed during lunch as well as at dinner time. appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria:
inclusion criteria: * bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: * previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks

Keywords: appetite control obesity adolescents exercise timing