Kornimate/medical-research-clean huggingface dataset:
association between gut microbiome and dietary determinants and vaccine response

Conditions: Influenza

Summary: this study evaluates the association between gut microbiome and dietary determinants and vaccine response. this study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.

primary objective: i. to evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response. secondary objective: i. to determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers. exploratory objectives: i. interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts). ii. identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response. outline: participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.

Eligibility criteria:
inclusion criteria: 1. md anderson employees and student employees with existing mrn 2. must be able to donate blood 3. participants must be age 18 or older 4. participants must receive the seasonal influenza vaccine at md anderson through employee health 5. participants must consent to gut microbiome profiling, redcap-based dietary screening questionnaire (appendix a) and survey (appendix b), and vaccine immune response testing which requires one stool sample, and two blood draws exclusion criteria: 1. participants with a contraindication to the recommended annual influenza vaccine pregnant women may be included in this study.
a study of evacetrapib in participants with abnormal cholesterol

Conditions: Dyslipidemia

Summary: the main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. information about any side effects that may occur will also be collected. this study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. the relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.


Eligibility criteria:
inclusion criteria: * generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria: * elevated low-density lipoprotein cholesterol (ldl-c) greater than 100 milligrams per deciliter (mg/dl), or * low high-density lipoprotein cholesterol (hdl-c) less than 45 mg/dl (men); less than 50 mg/dl (women), or * hypercholesterolemia on stable statin therapy for at least 3 month * have a body mass index (bmi) of 18 to 37 kilograms per square meter (kg/m\^2), inclusive, at screening exclusion criteria: * have known allergies or intolerance to evacetrapib, related compounds * have history of recurrent rashes or chronic skin conditions * have significant history of or current chronic, active inflammatory conditions * have history or current evidence of significant neurological disorder * have long-standing diabetes that is insulin requiring * have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Keywords: abnormal cholesterol
naltrexone, craving, and drinking

Conditions: Alcoholism

Summary: this 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. participants will receive naltrexone or a placebo. one week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.


Eligibility criteria:
inclusion criteria: * drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study. exclusion criteria: * current interest in treatment or a history of treatment for alcohol problems. * history of liver disease or current liver function tests greater than five times normal. * opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates. * females, who are pregnant, nursing, or not using reliable birth control method. * daily use of acetaminophen. * living with someone who participated in this study.
the role of problem solving in cognitive behavioral therapy for mothers with autistic children

Conditions: Cognitive Behavioral Therapy and Problem Solving; Autism Disorders and Maternal Stress

Summary: cognitive behavioral therapy sessions can effectively reduce distress in mothers of children with autism. here we emphasize on the role of problem solving appraisal in cbt sessions to improve problem solving skills ability and minimize psychological distress . pre- intervention assessment (t1) for all participants , then designed 8 sessions for study group will apply . post intervention assessment (t2) will conduct immediately after cbt sessions

mothers of children with autistic spectrum disorders have a lots of burdens due to child symptoms its, lack of availability of services and limited resources , thus in turn lead them to become unable to face problems/stressors and to be psychological distress. cbt is an effective therapy to minimize stress, anxiety and depression. mothers who participated in the study recruited from three governmental hospitals that has an out patients clinics specialized in autism and other developmental disorders for children at elbehairah governate , egypt . based on inclusion and exclusion criteria for mothers and their children, mothers informed about the nature of the study and their benefits for participations. assessment tools will use ; depression ,anxiety and stress scale (das) and problem solving inventory (psi). first assessment will occur , then randomly the participants divide into either study ( intervention) group or control group .cbt sessions will provide for study group to enhance their problem solving ability and psychological state. second assessment (t2) will occur after finishing program sessions for all participants

Eligibility criteria:
inclusion criteria: mothers caregivers who have: * a child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist * just one child with autistic disorder * their ages between 20-50 years old * did not expose to previous interventional / rehabilitation programs for his/her child. exclusion criteria for mothers: * have a diagnosis of any of psychiatric disorders * being absent more than three sessions in study group exclusion criteria for children: if they have: * intelligence level below 70 * have severe deterioration * receive psychiatric medication * have multiple disorders

Keywords: autism disorders, maternal stress
respiratory physiology under high flow therapy

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to gain knowledge about effects of high flow transnasal insufflation on various breathing parameters like intratracheal pressure conditions, co2 elimination, breathing frequency and tidal volume.

ten patients, who are supplied with a tracheostomy stent (placeholder) for reinsertions after long term ventilation will be treated for a short time during the day with the nasal high flow system airvo at different flow rates (15, 30, 45l/min) to estimate possible long term implications of high flow treatment. respiration is measured by impedance plethysmography with a calibrated belt system (respitrace, viasys). pressure and end tidal co2 concentration is measured inside of the placeholder. the order of the high flow rates (15, 30, 45l/min) is randomized; each flow rate is measured for 15 minutes. a wash out time of ten minutes is planned after each phase. in this time the patient breathes his individual oxygen flow rate with attention to the oxygen saturation, which should not exceed 96%. transcutaneous pco2 and spo2 is monitored with tosca during the study.

Eligibility criteria:
inclusion criteria: * patients in a stable weaning phase after long term ventilation * patients supplied with tracheostomy stent (placeholder) * patients in stable respiratory situation exclusion criteria: * incapable of giving consent * any other severe or acute physical illness which requires intensive medical care

Keywords: copd nasal high flow therapy tracheotomy stent tracheotomy
clinical trial to evaluate the efficacy and safety of d064 and d701 combination therapy

Conditions: Essential Hypertension

Summary: clinical trial to evaluate the efficacy and safety of d064 and d701 combination therapy.


Eligibility criteria:
inclusion criteria: 1. subjects who are 19 years old or older. 2. subjects who have voluntarily decided to participate in this clinical trial and signed icf. exclusion criteria: 1. subjects with a history of secondary hypertension or suspected secondary hypertension 2. subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period 3. subjects with hypersensitivity or history of clinical trial drugs and similar drugs 4. subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period 5. subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening 6. subjects who received other clinical trial drugs within 4 weeks of screening visit. 7. pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug 8. subjects who are unable to participate in this clinical trial at the discretion of the investigator.
amniotic fluid lactate in perterm premature rupture of membranes

Conditions: Rupture of Membranes; Premature

Summary: af lactate level could help in predicting the duration from rom till delivery


Eligibility criteria:
inclusion criteria: 1. women with pprom 2. ga between 24 to 34 weeks exclusion criteria: 1. chorioamnionitis 2. previous preterm labor 3. abruptio placentae 4. uti ,pyelonephritis
prevention of recurrence of diverticulitis

Conditions: Diverticulitis

Summary: the purpose of this study is to determine whether spd476 is effective in reducing recurrence of diverticulitis.


Eligibility criteria:
inclusion criteria: 1. males and females =\>18yrs of age. 2. if female of childbearing potential (focp), has demonstrated a negative beta hcg (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol 3. an episode of acute diverticulitis that resolved without colonic resection. 4. confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted exclusion criteria: 1. previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy) 2. active peptic ulcer disease 3. history of or current presence of inflammatory bowel disease (ibd) 4. subjects with active irritable bowel syndrome (ibs) requiring ongoing medication 5. allergy or hypersensitivity to aspirin or related compounds 6. allergy to radiologic contrast agents 7. use of another investigational product within 30 days of baseline 8. use of antibiotic therapy within 4 weeks of baseline 9. within 14 days of baseline, use of prebiotic, probiotic or 5-asa medications, as well as drugs active at the 5ht-receptor or anti-spasmodic agents 10. use of systemic or rectal steroids within 6 weeks of baseline. use of inhaled or nasal steroids is acceptable 11. use of anti-inflammatory drugs, (nsiads, cox-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis 12. history of alcohol or other substance abuse within the previous year 13. active or recent history of endometriosis or dysmenorrhoea within 6 months prior to baseline 14. females who are lactating
virtual patient behavioral response training for family caregivers

Conditions: Alzheimer Disease

Summary: our study is designed to help caregivers of someone with alzheimer's disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

the goal of this study is to develop and evaluate the caring response mobile app, containing a training that builds skills and stimulates practice. the investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. the research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

Eligibility criteria:
inclusion criteria: * care for an individual with alzheimer's disease or other dementia. * own a smartphone or tablet and have internet access. * minimum age of 18 years old. * spend at least 8 hours/week caring for a person with dementia. exclusion criteria: * severe psychological or physical illness. * inability to read and follow english instructions. * high level of depressive symptoms. * unwillingness to participate in all aspects of the study.
a study of prexasertib (ly2606368) in japanese participants with advanced cancers

Conditions: Neoplasm

Summary: the primary purpose of this study is to assess the tolerability of prexasertib in japanese participants with advanced solid cancers.


Eligibility criteria:
inclusion criteria: * participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed * participant must have diagnosis of cancer that is advanced or metastatic * participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy * if participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug * if the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding exclusion criteria: * participant must not have symptomatic central nervous system malignancy or metastasis * participant must not have current hematologic malignancy * participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (hiv) or hepatitis a, b, or c * participant must not have a serious cardiac condition

Keywords: neoplasm metastasis checkpoint kinase 1 chk1 chk1 inhibitor
effect of totum-854 on blood pressure in subjects with moderately elevated blood pressure

Conditions: Prehypertension; Elevated Blood Pressure; Blood Pressure; Metabolic Syndrome

Summary: this clinical study aims to assess the efficacy of totum-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. the hypothesis is that totum-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.


Eligibility criteria:
main inclusion criteria: * office systolic blood pressure between 130 and 159 mmhg and diastolic blood pressure \< 100 mmhg * body mass index (bmi) between 18.5 and 35 kg/m² * weight stable within ± 5 % in the last three months * no significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to keep them unchanged throughout the study main exclusion criteria: * known or suspected secondary hypertension * subjects with a very high cardio vascular risk score2 or score2-op according to their risk regions: (subjects \<50 years old: ≥7.5%; subjects between 50 and 69 years old: ≥10%; subjects ≥70 years old: ≥15%) * known hypertensive retinopathy and/or hypertensive encephalopathy * history of spontaneous or drug-induced angioedema * clinically significant valvular heart disease or severe aortic stenosis * history of an acute coronary syndrome (non-st elevation myocardial infarction, st-elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to inclusion * newly diagnosed or suffering from a non-treated or uncontrolled metabolic disorder such as diabetes, dyslipidemia, thyroidal dysfunction or other metabolic disorder * suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator

Keywords: diet supplement plant extracts hygiene and dietary recommendations
study comparing paclitaxel plus carboplatin versus anthracyclines followed by docetaxel as adjuvant chemotherapy for triple negative breast cancer (pattern)

Conditions: Breast Cancer

Summary: this is a prospective, multisite, randomized, open-lable phase iii clinical trial (pattern study) comparing paclitaxel plus carboplatin versus anthracyclines followed by docetaxel as adjuvant chemotherapy for triple negative breast cancer


Eligibility criteria:
inclusion criteria: 1. women aged 18-65 years old; 2. patient has localized invasive breast carcinoma, and is er-/pr-/her2- confirmed by histopathology after early breast cancer surgery（her2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an immunohistochemistry (ihc) status of 0, 1+ or 2+. if ihc is 2+, a negative in situ hybridization (fluorescence in situ hybridization (fish), chromogenic in situ hybridization (cish), or silver in situ hybridization (sish)) test is required by local laboratory testing.), positive lymph node or negative lymph node with at least one of the following conditions: (1) histological grade ii or iii; (2) tumor size \> 0.5 3. has an eastern cooperative oncology group (ecog) performance status of 0 or 1; 4. has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /l; platelet count ≥ 100 \* 109 /l; (2)adequate liver and kidney function: alanine aminotransferase (alt) ≤ 3×upper limit of normal (uln), aspartate aminotransferase (ast) ≤ 3×uln, total bilirubin (tbil)≤ 1.5×uln, serum creatinine ≤ 1×uln，and with endogenous creatinine clearance rate of \>50 ml/min (cockcroft-gault formula). 5. participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: 1. has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）; 2. has bilateral breast cancer; 3. has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. has metastic (stage 4) breast cancer; 5. has any \>t4 lesion (uicc1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); 6. is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; 7. patients participating in other clinical trials at the same time; 8. has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (lvef) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; 9. has known allergy to taxane and excipients. 10. has severe or uncontrolled infection;
epic european study: use of the fibernet® emboli protection device in carotid artery stenting

Conditions: Carotid Artery Stenosis

Summary: multicenter, prospective, study designed to demonstrate the performance and safety of the lumen biomedical, inc. fibernet embolic protection system as an adjunctive device during carotid artery percutaneous intervention. the primary endpoint is the rate of all stoke and death within 30 days of the procedure.

the purpose of this feasibility study is to demonstrate the performance and safety of the lumen biomedical, inc. fibernet® embolic protection system as an adjunctive device during carotid artery percutaneous intervention. the feasibility study will involve a maximum of 50 subjects to be enrolled using the fibernet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. subject will be enrolled in up to 5 european investigational sites. the study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.

Eligibility criteria:
inclusion criteria: * candidate for percutaneous stenting with target lesion located within common or internal carotid artery. * symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by nascet criteria. * targeted vessel diameter for fibernet placement between 1.75 mm and 7.0 mm. * the investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected. exclusion criteria: * prior stenting of ipsilateral carotid. * planned treatment of contralateral carotid within 30 days. * experienced a myocardial infarction within the last 14 days. * undergone an angioplasty or ptca/pta procedure within the past 48 hours. * undergone cardiac surgery within the past 60 days. * has a planned invasive surgical procedure within 30 days. * suffered a stroke within the past 14 days. * suffered a transient ischemic neurological attack (tia) or amaurosis fugax within the past 48 hours. * total occlusion of the target vessel. * lesions within 2 cm of the ostium of the common carotid artery. * a stenosis that is known to be unsuitable for stenting because of one or more of: tortuous or calcified anatomy proximal or distal to the stenosis, presence of visual thrombus, pseudo occlusion (string sign). * serial lesions that requires more then one stent to cover entire lesion.

Keywords: carotid artery distal protection device