Kornimate/medical-research-clean huggingface dataset:
effect of omega 3 enriched oral nutritional supplement on nutritional status of crc and nsclc patients

Conditions: Malnutrition; Oncology

Summary: a single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of crc and nsclc patients


Eligibility criteria:
inclusion criteria: 1. histologically proven crc or histologically or cytologically proven nsclc 2. eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment 3. at risk of malnutrition or malnourished \[pg-sga-sf \> 4\] 4. performance status ecog 0 or 1 5. weight loss grade 0-3 according to martin et al1 6. \<11% weight loss in the past 6 months 7. age ≥ 18 years 8. written informed consent exclusion criteria: 1. presence of ileostoma or ileal pouch 2. gi-related or major surgery in 30 days prior to baseline 3. severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dl (3.5 mmol/l) 4. use of ons, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study 5. use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study 6. use of more than 200 iu/day of vitamin d containing supplements within 30 days prior to entry into the study or expected to use this during the study 7. life expectancy of \< 3 months 8. severe renal dysfunction (\ 30) or hepatic encephalopathy 9. allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia 10. known pregnancy or lactation 11. current alcohol or drug abuse in opinion of the investigator 12. investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements 13. participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Keywords: oral nutritional supplement oncology omega 3
smart marker annunciating response to rheumatologic treatments smart²t

Conditions: Rheumatoid Arthritis

Summary: european recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csdmard) as soon as possible to reach the remission in early ra or low disease activity in established ra. if the target is not achieved with the first csdmard and in presence of poor prognostic, addition of a biologic (b)dmard or a targeted synthetic (ts)dmard should be considered . nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsdmard according to international recommendations. this relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents: * a risk for the patient who could be usually exposed to potential side effects, * a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions * a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars. despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tdmard \[11\]. thus exploration of a new approach is totally in purpose. the aim of this project is to benefit from the declarative pro (patient reported outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsdmards


Eligibility criteria:
inclusion criteria: * social security affiliation * signed informed consent * adult patient (over 18 years old) * ra according to acr/eular 2010 criteria since less than 6 months * das28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bdmard or a tsdmard * having an internet access at home and using an email address exclusion criteria: * other arthritis than ra * to participate to a blind-randomized study to assess ra treatment * pregnancy or breastfeeding * patient unable to understand the study, unable to give consent * patient deprived of liberty or patient under guardianship * patient refusing to participate in the study * patients having difficulty using connected objects

Keywords: rheumatoid arthritis (ra) synthetic disease modifying antirheumatic drug (csdmard) biologic disease modifying antirheumatic drug (bdmard) machine learning
to compare the effect of concomitant administration of probucol and cilostazol with probucol single treatment on the atherosclerosis related markers (including the thickness of the achilles tendon) and evaluate safety (based on atorvastatin treatment) in severe hypercholesterolemia subject

Conditions: Severe Hypercholesterolemia

Summary: to evaluate the effect of concomitant administration of probucol and cilostazol (based on atorvastatin treatment) on the atherosclerosis related markers (including the thickness of the achilles tendon) in severe hypercholesterolemia subject, through the observation of the thickness of the achilles tendon, the thickness of mean carotid intima-media, anti-oxidation biomarkers and serum lipid profile.

multicenter, randomized, controlled, single-blinded, three parallel arms study. group a: atorvastatin + probucol-placebo + cilostazol-placebo group b: atorvastatin + probucol + cilostazol-placebo group c: atorvastatin + probucol + cilostazol

Eligibility criteria:
inclusion criteria: 1. the subject whose voluntary written informed consent is obtained for participation in this study; 2. 18≤age≤70； 3. the subject with low-density lipoprotein cholesterol (ldl-c) ≥ 4.66 mmol/l (180 mg/dl) (the highest level either pre-treatment or on treatment); 4. the subject with att≥9mm. exclusion criteria: 1. the subject with homozygous familial hyperlipidemia; 2. the subject who took probucol within 6 months before the screening test; 3. the subject who took cilostazol within 1 month before the screening test; 4. the subject who took ezetimibe within 1 month before the screening test; 5. the subject who hoped to treat with ezetimibe within this study period; 6. the subject being treated with cyclosporine; 7. the subject with a history of hypersensitivity to probucol and cilostazol; 8. the subject with a triglyceride (tg) level greater than 4.52 mmol/l (400 mg/dl); 9. the subject with diabetes: hba1c level greater than 8.4% (ngsp); 10. the subject with new york heart association (nyha) classification: class iii and iv; 11. the subject with a qtc interval greater than 450 msec (male) or 470 msec (female); 12. the subject with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole); 13. the subject with atrial fibrillation (including paroxysmal atrial fibrillation); 14. the subject with congestive cardiac failure or unstable angina; 15. the subject with liver and renal functions that satisfy the following criteria within 28 days prior to start of the investigational medicinal product (imp) administration. * ast ≥100 iu/l, alt≥100 iu/l * serum creatinine ≥1.5 mg/dl (133 µmol/l) 16. the subject who are participating in another clinical trial; 17. woman during pregnancy or potential pregnancy, and breastfeeding; 18. women of childbearing potential who are not agree to use an appropriate method of contraception; 19. the subject who are not considered by the investigators to be appropriate to participate in this study for any other reasons.

Keywords: the achilles tendon intima-media thickness
effects of proprioceptive focal stimulation (equistasi) on freezing of gait in parkinson's disease

Conditions: Freezing of Gait; Parkinson Disease

Summary: freezing of gait (fog) is a common disabling condition in parkinson's disease (pd), causes falls, and impairs quality of life. therapeutic options for this symptom are limited and of limited efficacy. besides, the pathophysiology has been not clarified yet. proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. however, evidence is not available. the present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (equistasi) for the treatment of fog.


Eligibility criteria:
inclusion criteria: * patient with parkinson's disease * stable drug therapy response without any change in the 3 months before the study. * written informed consent exclusion criteria: * hoehn-yahr stage ≥ 4 * cognitive decline (mini mental state examination \<26) * systemic illness involving the nervous system * diabetes * presence of cardiac pacemaker * presence of deep brain stimulation * presence of severe dysautonomia with marked hypotension * history or active neoplasia * pregnancy

Keywords: parkinson disease freezing of gait equistasi
sutures in orbital implants in retinoblastoma patients

Conditions: Surgery--Complications; Retinoblastoma Bilateral

Summary: the purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

to evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Eligibility criteria:
inclusion criteria: * diagnosed as retinoblastoma * enucleation and orbital implantation in the same surgery exclusion criteria: * death during follow-up

Keywords: retinoblastoma suture complications
granulocyte colony stimulating factor for for the prevention of febrile neutropenia in epithelial ovarian cancer

Conditions: Chemotherapy-induced Neutropenia; Febrile Neutropenia, Drug-Induced; Epithelial Ovarian Cancer; Colony Stimulating Factors Adverse Reaction; Granulocyte Colony Stimulating Factor; Cost-effectiveness Analysis; Quality of Life; Progression-free Survival; Overall Survival

Summary: this study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (g-csf) on the prevention febrile neutropenia (fn) in epithelial ovarian cancer patients. patients receive platinum-based chemotherapy of 3 to 4 weeks. patients are randomized into study group and control group. in study group, patients accept long-acting g-csf 48 hours from the chemotherapy. while the control group accept regular or prophylactic treatment of short-acting g-csf according to national comprehensive cancer network guidelines. the primary end is the incidence of fn in every course of chemotherapy. the secondary ends include: the incidences of myelosuppression, doses of g-csf and its expenses, visits to outpatient and emergency clinics, adverse events related to g-csf, quality of life, and survival outcomes (progression-free survival and overall survival).


Eligibility criteria:
inclusion criteria: * with definitive pathological results of epithelial ovarian cancer * with an eastern cooperative oncology group (ecog) performance status score of 0-2 * aged 18 or older * receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery * regularly followed up in the study centers * provided consent for participation. exclusion criteria: * failure to meet all the inclusion criteria * non-compliance with the study protocols * with a history of chemotherapy or pelvic radiotherapy for malignancies * presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome * treated with weekly chemotherapy regimens * presence of hematological disorders
breathwork app for cancer survivors

Conditions: Breast Cancer

Summary: cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer treatment protocols. non-pharmacological lifestyle and mind-body interventions have been shown to be effective and critical components of a total-health strategy for cancer survivors. pranascience institute seeks to develop and test a novel group video app for home-based delivery of a yogic breathing intervention that reduces symptoms of cancer treatment survival and supports total-health.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older, willing to provide informed consent. 2. diagnosis of stage 0-iii breast cancer. 3. completion of radiation therapy within the last 6 months. 4. ecog performance status of 0-3 during cancer treatment. 5. orally expressed visual and auditory acuity adequate for filling out all study forms and participating in telephone interviews and internet-based group video applications. 6. access to telephone and internet-connected computer or mobile phone. exclusion criteria: 1. subject is unwilling or unable to comply with any of the study procedures. 2. orally expressed dependence on alcohol or drugs.
"as required" oral sildenafil in raynaud's phenomenon

Conditions: Raynaud's Phenomenon

Summary: the purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of raynaud's phenomenon.


Eligibility criteria:
inclusion criteria: * active raynaud's phenomenon characterized by a clinical history of primary or secondary raynaud's phenomenon * at least 7 rp attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion) * patients who have dated and signed the informed consent form * contraception for women exclusion criteria: * recently diagnosed rp (less than 2 months). * uncontrolled hypertension, diabetes mellitus, angina * haemodynamic instability * nonarteritic ischemic optic neuropathy * pulmonary hypertension * subjects currently taking sildenafil, tadalafil or vardenafil * subjects currently taking nitrates * subjects currently taking strong cyp3a inhibitors * pregnancy (or considering pregnancy in the next 4 months) * breast feeding * participation in another clinical trial

Keywords: raynaud's phenomenon sildenafil systemic sclerosis local cooling microcirculation
intravoxel incoherent motion prognostic value in the initial evaluation of patients with acute ischemic strokes using 3 tesla magnetic resonance imaging

Conditions: Stroke; Magnetic Resonance Imaging

Summary: ischemic strokes are the first cause of handicap in adult people, the second cause of dementia and the third cause of death in france. brain magnetic resonance (mr) initial assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to determine the best treatment. the conventional diffusion weighted imaging sequence is used to establish the diagnosis and to estimate the volume of ischemic lesions. the perfusion weighted imaging sequences are also used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra corresponding to territories that could be saved with appropriate treatments. intravoxel incoherent motion (ivim) is a multi-b diffusion sequence which allows to extract four quantitative variables (d, d\*, f, adc) related to the true molecular diffusion and correlated to the microvascular perfusion. it's a quick sequence with no need of contrast injection and allowing a perfect coregistration with the true diffusion. it has been validated in many pathologies but not in acute strokes. the feasibility of this sequence in acute ischemic strokes has already been assessed with interesting results. the study aims to assess the correlation between the quantitative values of ivim at initial mr exam and the modified rankin scale (mrs) score 3 months after an acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * adult patients * admitted for an acute ischemic stroke * affiliated to a social security scheme exclusion criteria: * absolute contraindications to mri * pregnant or breastfeeding woman
ies-acap: influence of atrial pulse width in the behaviour of acap™ confirm algorithm.

Conditions: Sinus Bradycardia; Sinus Node Disease; Atrio-ventricular Block

Summary: the purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

the purpose of this observational study is to collect data regarding the population of patients whit a zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the algorithms acap confirm, which automatically regulates the atrial pulse width, is enabled.

Eligibility criteria:
inclusion criteria: * patient has an indication for implantation of a dual-chamber pacemaker; * patient is older than 18 years of age * patient has signed the study specific informed consent document. * primo implant. exclusion criteria: * patient is pregnant or nursing * patient is less than 18 years of age * patient is in new york heart association (nyha) class iii and iv. * patient has a pacemaker replacement; * patient is unable to attend the follow-up visits;
gene expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer

Conditions: Kidney Cancer

Summary: rationale: studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer.

objectives: primary * determine the expression levels of novel genes and proteins (hfarp, hamgr28, he9ng77) in frozen normal tissue and tumor tissue samples from patients who have undergone nephrectomy for renal cell cancer. * correlate gene and protein expression levels with disease stage, tumor size, and pathology reports (e.g., cell type, grade, and tissue architecture) in order to evaluate the rate of gene and protein expression as targets for future therapeutic interventions. secondary * compare proteomic screening of potential biomarkers using existing plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the cccwfu tumor tissue core with tissue samples from patients enrolled in this study. outline: normal and tumor tissue collected from patients who have undergone nephrectomy and diagnostic and therapeutic intervention for renal cell cancer is analyzed for histopathological expression and compared to normal kidney cells by northern blot. tissue samples are evaluated by rna and protein extraction and analyzed by gel electrophoresis, blotting, and phosphor-imaging for induction or suppression of genes and protein levels. these data are correlated with clinical stage, tumor size, and histopathological grade and architecture of the patient's disease.

Eligibility criteria:
inclusion criteria: * histologically confirmed renal cell cancer * clinical staging (if available) * underwent nephrectomy for renal cell cancer

Keywords: recurrent renal cell cancer stage i renal cell cancer stage ii renal cell cancer stage iii renal cell cancer stage iv renal cell cancer
effects of milk protein concentrate on overall health during weight loss in overweight/obese adults

Conditions: Sarcopenia; Metabolic Disease; High Blood Pressure

Summary: . the purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome

currently, over 47 million adults in the united states are known to have metabolic syndrome. metabolic syndrome is comprised of a cluster of conditions including obesity, elevated cholesterol, high blood sugar, and high blood pressure. people with metabolic syndrome have an increased risk for the development of chronic diseases such as cardiovascular disease and diabetes. recent studies have shown that a build-up of fat in the muscle of overweight and obese people may partially explain the link between metabolic syndrome and the development of chronic diseases. there is evidence to suggest that diets with a higher amount of protein can improve some aspects of metabolic syndrome, including the build-up of fat in muscle. the purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome.

Eligibility criteria:
inclusion criteria: bmi: 25-38 ,male or female; age 35-65 y; weight stable (± 3 kg) during last 3 months; no acute illness; not diabetic, pregnant or lactating; not currently (or within last 3 months) following an exercise or weight loss program; non-smoking; not taking bp medication; not lactose intolerant, exclusion criteria: subjects will be excluded if baseline protein intake is less than 0.6 or greater than 1.6 g•kg-1•d-1 subjects will also be excluded if they have any chronic or acute condition which will increase risk of illness or injury during study participation as determined by our study physician such as high bp, high fasting glucose, metabolic syndrome, etc.

Keywords: the impact of a higher dairy-based protein diet in combination with energy restriction on muscle health, metabolic health (including blood pressure) in overweight and obese, middle aged adults
cardiorespiratory exercise & chinese medicine for rehabilitation of discharged coronavirus disease (covid-19) patients

Conditions: Coronavirus Disease (COVID-19)

Summary: rehabilitation interventions can help to address the consequences of covid-19, which include medical, physical, cognitive, and psychological related problems. the specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in recovering covid-19 patients. a further aim will be to examine how chinese herbal medicines, gut microbiome, and metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.

the study will develop a new paradigm for patient rehabilitation needed now and in the future. the specific aims of this project are to investigate the effects of a 12-week program with cardiorespiratory exercise and chinese herbal medicine on recovering covid-19 patients and to collect qualitative and quantitative data to examine loneliness, anxiety, depression, quality of life, and mental health. a further aim will be to examine how chinese herbal medicines, gut microbiome, and the metabolites regulate immune function, intestinal permeability, and possibly autoimmune deficiency (aid) in the pathological recovery/rehabilitation process. in this multicenter, triple-blinded, randomized, parallel groups, controlled clinical trial, the investigator will recruit adult patients with covid-19 and have been discharged from the hospital in hong kong and the chinese mainland. a total of 172 eligible patients will be randomized 1:1:1:1 into four groups: cardiorespiratory exercise plus chinese herbal medicines group, cardiorespiratory exercise group, chinese herbal medicines group, and waiting list group for 12-week (3 months) with 12-week follow-up period. a 4-week pilot study will be conducted to test patient recruitment and maintenance, data collection, instrumentation, and observing the adaptability and practicality of the intervention. amendments will be made if necessary.

Eligibility criteria:
inclusion criteria: 1. aged 18 years and above; 2. a percentage of predicted forced vital capacity (fvc) \<90%, and/or a percentage of predicted carbon monoxide diffusing capacity \< 90% (king 2014); 3. able to communicate in cantonese. exclusion criteria: 1. having acute exacerbations in the 12-week preceding recruitment patients; 2. having any contraindications for exercise (e.g., physical disability, uncontrolled mental disorders, unstable heart disease, unable to perform muscle strength tests) 3. female - pregnant or plan to become pregnant in the next 1 year 4. unable to communicate in cantonese or mandarin 5. currently participating in other similar rehabilitation programs or research

Keywords: covid-19 cardiorespiratory exercise chinese medicine