Kornimate/medical-research-clean huggingface dataset:
effects of dietary fats on cardiovascular health and insulin sensitivity in subjects with abdominal obesity

Conditions: Inflammation; Insulin Sensitivity

Summary: rationale: it is well established that increased intake of saturated fatty acids (sfa) is associated with incidence of cardiovascular heart disease (chd). this effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. world health organisation (who) has recommended reduced intake of sfa with energy replacement from monounsaturated fatty acids (mufa) or carbohydrates (carb). however, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. the current study is designed to investigate the effects of sfa versus mufa versus carb on insulinemic response and lipid metabolism in healthy individuals with central obesity. study design: a randomized, crossover, single blind design study was carried out. the subjects consumed controlled diets for 6 weeks each. they were provided 3 meals per day during weekdays in which sfa, mufa and carb diet was assigned to them randomly. protein content was standardised at 14% energy. the sfa and mufa diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). each individual fatty acid provided approximately 7% of the total energy intake. the carb diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. the carb diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (c18:1). hypothesis: changing energy from dietary fat (sfa and mufa) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. sfa (palm olein) may be comparable with mufa (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation


Eligibility criteria:
inclusion criteria: 1. abdominally obese males and females (waist circumference \> 90 cm for male, \> 80 cm for female), 2. age 20-60 years exclusion criteria: * a medical history of cardiovascular disease, diabetes, dyslipidemia; * current use of antihypertensive or lipid lowering medication; * plasma cholesterol \> 6.5 mmol/l, tag \> 4.5 mmol/l; * alcohol intake exceeding a moderate intake (\> 28 units per week); * pregnancy, * smoker and * breastfeeding.

Keywords: inflammation insulin sensitivity interleukin-6 (il-6) c-peptide saturated fatty acid (sfa) monounsaturated fatty acid (mufa) carbohydrate (carb)
prospective evaluation of a new palatal implant for treatment of snoring and obstructive sleep apnea (osas)

Conditions: Reduction of Initial AHI; Reduction of Initial Snoaring Index

Summary: prospective evaluation of a new palatal implant for treatment of snoring and obstructive sleep apnea (osas)

the new osas implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from osa (obstructive sleep apnea). indications for use of the system include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. the system is labeled for use by physicians only. the primary endpoint is the apnea-hypopnea-index (ahi) in the 90 days follow-up. study hypothesis: reduction of initial ahi ≥20%

Eligibility criteria:
inclusion criteria: study patients must meet all of the following inclusion criteria: * socially disturbing snoring with/without obstructive sleep apnea syndrome * predominantly retropalatal obstructions established by apneagraph ≥60%, sleep nasendoscopy or successful application of the velumount palatal device * findings for predominantly retropalatal obstructions in ent-examination: * no tonsils or tonsils grade i - ii * normal finding of larynx and tongue base * no lingual tonsil hypertrophy * asa (american society of anaesthesiology, 1963) criteria i or ii * body mass index (bmi) \< 33 kg/m2 * age \> 18 yrs * fix bed partner * ability to read and understand the patient's information exclusion criteria: * previous pillar implants * previous airway surgery other than nasal, adenoid, tonsil or uppp * presence of other sleep disorders * psychiatric disorders * neurological disorders (e.g. cerebrovascular injury) * dysmorphia of the cranial skeleton * pregnancy or breastfeeding * known hypersensitivity to nitinol * participation in another clinical study
study to evaluate the efficacy and safety of an every four weeks treatment regimen of alirocumab (regn727/ sar236553) in patients with primary hypercholesterolemia (odyssey choice 1)

Conditions: Hypercholesterolemia

Summary: to determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (q4w), in comparison with placebo, as well as its potential as a starting regimen. the dose regimen of 75 mg every 2 weeks (q2w), as used in other studies, was added as a calibrator.


Eligibility criteria:
inclusion criteria: 1. men and women \> age 18 or legal age of majority with elevated ldl-c 2. patients not having adequate control of their hypercholesterolemia based on their individual level of cvd risk 3. willing and able to comply with clinic visits and study-related procedures 4. provided signed informed consent exclusion criteria: 1. recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (pci), coronary artery bypass graft surgery (cabg), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease 2. known history of positive test for human immunodeficiency virus (hiv) 3. any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy. 4. participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study. 5. certain laboratory findings obtained during the screening period the information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
inflammation, diabetes, ethnicity and obesity cohort

Conditions: Obesity; Diabetes Mellitus; Pre Diabetes

Summary: obesity affects over one third of us adults (\>72 million, with bmi ≥30 kg/m2), and the proportion of us adults with bmi ≥40 kg/m2 has doubled in the last 20 years. obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. in this proposed study, investigators will recruit participants from a wide range of body mass index (bmi), ethnicity and diabetes risk to collect data and blood, stool and adipose tissue samples in the san francisco bay area.

the inflammation, diabetes, ethnicity and obesity (ideo) cohort is recruiting 350 individuals from various ethnicities, covering a spectrum of weight and diabetes risk. the study is looking for participants between the ages of 18-75 years that are healthy with or without diabetes with a stable weight. the study will also like to include people who are slated to undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at ucsf.

Eligibility criteria:
inclusion criteria: * participants will be healthy individuals between the ages of 18-75 years. these cutoffs are designed to allow inclusion of postmenopausal women, and younger/more active patients who are increasingly undergoing bariatric surgery. * patients with either diabetes type 2 or the metabolic syndrome will be included in the cohort. exclusion criteria: * participants with chronic kidney disease (\> stage 4) * autoimmune/inflammatory disease (e.g., lupus, ulcerative colitis, etc.) * unstable angina, new york (ny) class iii or iv congestive heart failure or myocardial infarction within 3 months of entry * clinically significant liver disease (e.g. cirrhosis or liver failure) * weight \> 450 pounds (dxa scan weight limit) * history of organ transplant * treatment with chemotherapy or radiation therapy at the time of enrollment in study. * poorly controlled asthma (participants requiring inhaled glucocorticoids and/or oral glucocorticoids) * current nasal corticosteroid use (within the past month) * excessive alcohol or substance abuse * current use of anabolic steroids or testosterone for bodybuilding purposes. testosterone use is permitted if prescribed for hypogonadism and dose stable for the past 6 months. * patients actively enrolled in interventional trials involving investigational agents * pregnant or breast-feeding women * appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee. * history of abnormal clotting * previous bariatric surgery * anticoagulant use * methadone medication * glp-1 medications: * exenatide (byetta, bydureon) * liraglutide (saxenda, victoza) * semaglutide (ozempic, rybelsus, wegovy) * dulaglutide (trulicity) * tirzepatide (mounjaro)

Keywords: ethnicity inflammation obesity diabetes
anti-muc1 car t cells and pd-1 knockout engineered t cells for nsclc

Conditions: Lung Neoplasm Malignant; Non-small Cell Lung Cancer

Summary: the study is to assess the safety and efficacy of the anti-muc1 car t cells and /or pd-1 knockout engineered t cells for patients with advanced non-small cell lung cancer.

this is a combined phase 1 and 2 clinical study. the study is to assess the safety and efficacy of the anti-muc1 car t cells and /or pd-1 knockout engineered t cells for patients with advanced non-small cell lung cancer. the treatment outcomes will be compared.

Eligibility criteria:
inclusion criteria: * muc1 is expressed in malignancy tissues by immuno-histochemical (ihc). * eastern cooperative oncology group (ecog) performance status of 0-1 or karnofsky performance status (kps) score is higher than 60. * patients have a life expectancy \> 12 weeks. * adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis. * negative pregnancy test for females of child-bearing potentials. * adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: white blood cell count (wbc) ≥ 2500c/ml, platelets ≥ 50×10\^9/l, hb ≥ 9.0g/dl, lymphocyte (ly) ≥ 0.7×10\^9/l, ly% ≥ 15%, alb ≥ 2.8g/dl, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dl, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dl. these tests must be conducted within 7 days prior to registration. * signed informed consent form. exclusion criteria: * number of t cells is less than 10% or the amplification of the t cells via artificial antigen presenting cell (aapc) stimulation is less than 5 times. * patients with symptomatic central nervous system (cns) involvement. * pregnant or nursing women. * known hiv infection. * serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders. * history of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin. * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary. * previously treatment with any gene therapy products. * the existence of unstable or active ulcers or gastrointestinal bleeding. patients with portal vein vascular invasion or extrahepatic, are excluded from this study. * patients with a history of organ transplantation or are waiting for organ transplantation.

Keywords: car-t cell therapy muc+ pd-1 knockout non-small cell lung cancer
comparison between internal and external chest impedance measurement

Conditions: Heart Failure

Summary: to compare two methods of chest impedance: the medtronics optivol measurement via crt pacemakers for patients with heart failure and external non-invasive measurement


Eligibility criteria:
inclusion criteria: * crt-implanted patients with heart failure exclusion criteria: * all others
effect of the consumption of a fermented dairy drink on the immune function

Conditions: Healthy Free-living Elderly

Summary: the purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.


Eligibility criteria:
inclusion criteria: * healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion * able to comply with all the trial procedures * having given written consent to take part in the study prior to participation. * body mass index (bmi): 18,5 \< bmi \< 30 kg/m². exclusion criteria: * contra-indication to any of the products and procedures used for the study purpose * participation in another clinical trial * people currently institutionalised * immunocompromised conditions or other conditions that may impact the immune response or the product effect * subjects suffering from a not stabilized chronic disease * subjects suffering from a sever acute or chronic disease * subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion * subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * subject identified as employees of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the investigator.

Keywords: probiotic - dairy product - influenza vaccination - healthy elderly
effects of structured simplified short-term intensive insulin therapy on long-term glycemic remission

Conditions: Newly Diagnosed Type 2 Diabetes; Simplified Short-term Intensive Insulin Therapy; Glycemic Remission

Summary: short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. this study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week; * ghba1c ≥ 9% * body mass index between 20-35kg/m2 * capable to use wearable devices and mobile apps; * willling to follow the study protocol and data collection. exclusion criteria: * type 1 diabetes or specific types of diabetes; * allergic or intolercance to medicine used in the study; * acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis); * severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy; * glomerular filtration rate less than 50 ml/min * alt \>2.5 times of the upper limit of normal (uln), or bilirubin \> 1.5 times of uln； * significant macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment; * poor blood pressure control (systolic blood pressure≥180mmhg and/or sitting diastolic blood pressure ≥110mmhg) and unable to control under 160/110mmhg within 1 week; * hemoglubin level \< 100g/l or required regular blood transfusion; * chronic cardiac dysfunction with nyha grade iii or above; * use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. however, low-dose diuretics for antihypertensive purposes (hctz \< 25mg/d, indapamide \< 1.5mg/d) and physiologic replacement of thyroid hormone are allowed; * serious systemic disease or malignant tumor, chronic diarrhea, etc； * uncontrolled abnormalty in endocrine glands (cushing's syndrome, hyperthyroidism, etc.); * any factors that may affect the participation of the subject in the study or the evaluation of the results； * pregnancy or planned pregnancy, lactation subjects.
effect of colour temperature of reading lamp on refractive error development

Conditions: Refractive Errors

Summary: this is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.

myopia has reached epidemic in the world, especially in east asia. the proportion of myopic population increases drastically during schoolage. lack of light exposure has been suggested to be a risk for myopia development, in which additional reading lamp may alleviate this condition. however, the effect of colour temperature of the reading lamp is unknown on childhood refractive error development. in this study, investigators will randomly allocate school-aged children into groups, who will receive reading lamps of different colour temperatures for their daily use. the participants' refractive error and axial length will be evaluated.

Eligibility criteria:
inclusion criteria: * aged between 4 and 18 years exclusion criteria: * have received myopia control intervention

Keywords: myopia environment colour temperature lighting
anatomical location and metastasis pattern of intrapulmonary lymph nodes in nsclc (ectop-1010)

Conditions: Carcinoma; Non-small Cell Lung Cancer

Summary: this is a clinical trial from eastern cooperative thoracic oncology project (ectop), numbered as ectop-1010. anatomical location and metastasis pattern of intrapulmonary lymph nodes (group 11-13) in non-small cell lung cancer: a multi-center, prospective observational clinical trial

patients would be evaluated whether meet the criteria as clinical stage t1 non-small cell lung cancer. then, he/she would receive lobectomy. finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.

Eligibility criteria:
inclusion criteria: 1. preoperative examination showed patients with clinical t1 peripheral non-small cell lung cancer (nsclc); 2. the lesion is located in a single lung segment or between two adjacent lung segments; 3. perform radical lobectomy; 4. the preoperative examination did not reveal unresectable lymph nodes; 5. have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery; 6. no malignant tumor history; 7. no contraindications to surgery (ecog score 0-1 points); exclusion criteria: 1. pathology revealed patients with non-t1 stage non-small cell lung cancer (nsclc); 2. radical lobectomy is not performed; 3. acception of any anti-tumor treatment before surgery (excluding chinese medicine treatment); 4. refused to enter the group or asked to leave the group.

Keywords: non-small cell lung cancer intrapulmonary lymph nodes anatomical location metastasis pattern
brain mechanism and outcome of surgical intervention of conductive hearing loss.

Conditions: Conductive Hearing Loss; Tinnitus; Surgery

Summary: this study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and eeg data.

this study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and eeg data. including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (eeg, fnirs).

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years; * diagnosed with conductive hearing loss with tinnitus; * treated with surgery; * able to cooperate with all chinese version evaluation; * right-handed. exclusion criteria: * pure tone audiometry indicates that the average pure tone hearing threshold (500hz, 1khz, 2khz, 4khz) is \> 91db hl; * acoustic neuroma, nasopharyngeal carcinoma; * hearing loss caused by noise or drugs.

Keywords: conductive hearing loss tinnitus surgery outcome eeg mechanism
manipulating and optimizing brain rhythms for enhancement of sleep

Conditions: Neurological Disease; Parkinson Disease; Epilepsy

Summary: the aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.


Eligibility criteria:
inclusion criteria: * dbs in one of the defined nuclei of interest during the period of the study * be willing and able to give written and oral informed consent * ability to complete all required study procedures including travelling to mayo clinic and staying overnight * all women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. this includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (iud) or abstinence. exclusion criteria: * cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). this is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study. * patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate * pregnancy test positive.

Keywords: deep brain stimulation