Kornimate/medical-research-clean huggingface dataset:
a cancer vaccine (cg8123) given with and without cyclophosphamide for advanced stage non-small cell lung cancer (nsclc)

Conditions: Lung Cancer; Carcinoma, Non-Small-Cell Lung

Summary: the main purpose of this research study is to determine if a vaccine made from a patient's lung cancer tumor cells will be effective in making the cancer shrink or disappear. the vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. this study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath). tumors from surgical resection will be processed and made into a vaccine. prior to treatment, patients will be randomized equally to one of two treatment groups, cohort a and cohort b. patients in cohort a will be treated with cg8123 vaccine only and patients in cohort b will be treated with cg8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. the duration of this study, including active follow up, is approximately two years. after this, patients will be followed-up yearly for a total of 15 years.


Eligibility criteria:
inclusion criteria: * 18 years or older * suspicious diagnosis of or histologically- confirmed stage iiib or iv non small-cell lung cancer * accessible and adequate tumor source for vaccine production. * tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion) * measurable disease to evaluate following tumor procurement * limited metastatic tumor burden * life expectancy at least 4 months * ecog performance status 0 - 1 exclusion criteria: * active and/or untreated brain metastases * active or impending spinal cord compression * active auto-immune disease or treatment with immunosuppressants * decompensated congestive heart failure or recent significant cardiac event * coexisting malignancies * significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment * previous treatment with gene therapy (including any adenoviral-based therapy)

Keywords: cancer vaccine nsclc immunotherapy
dose effect of a plant extract on fatigue

Conditions: Mental Energy; Physical Performance

Summary: test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance


Eligibility criteria:
inclusion criteria: * 18-49 years of age * self-report of good health * physical activity requirement: recreationally active (exercise ≥3 times per week for \>30 minutes per session; both cyclists and non-cyclists may enroll) exclusion criteria: * under the care of a physician * visual impairment that cannot be corrected with glasses or contact lenses * inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the borg 6 to 20 scale. high intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.) * inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or \>50% incorrect responses) * presence of current or chronic gastrointestinal, sleep or psychiatric disorder * pregnant/lactating * current smoker * report illegal drug use * report hypersensitivity to caffeine * food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products) * current use of dietary supplements, or prescription medication except for oral contraceptives * unwillingness to abstain from over the counter medications (e.g. nsaids, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study * unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days. * participation in another clinical trial within the past 30 days or participation in another pepsico trial in the past 6 months

Keywords: cognitive phytochemicals caffeine polyphenol beverage exercise mental performance physical performance vigilance vigor energy vitality fatigue sports performance high-intensity intermittent exercise
the effect of masking on subjective results during daily disposable contact lens studies

Conditions: Myopia; Hyperopia

Summary: the purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * 17 years of age or older. * ocular exam within 2 years. * currently wearing soft contact lenses on a daily wear basis. * contact lens prescription between +6.00d and -10.00d. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular disease. * use of systemic or ocular medications that may affect ocular health. * unable to achieve an acceptable fit with the study lenses. * anisometropia \>1.00d or astigmatism \>0.75d. * other protocol-defined exclusion criteria may apply.
evaluating the efficacy of opti-speech for speech treatment

Conditions: Articulation Disorder; Dysarthria; Prelingual Deafness

Summary: the purpose of this study is to determine if feedback from a three-dimensional real-time visualization of the tongue, a program called opti-speech, can be used to improve speech.

participants will be asked to complete the goldman fristoe test of articulation along with several other assessment tests. then speech treatment, guided by opti-speech, will be provided to the participant for up to 10 treatment sessions. the participant will be asked to come back after the final treatment for a 2-month follow-up assessment.

Eligibility criteria:
inclusion criteria: * english speaking individuals with speech errors resulting from persistent speech sound disorder, individuals with dysarthria resulting from neurological disorders and individuals with pre-lingual or congenital deafness. exclusion criteria: * cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists
a study to evaluate the safety and efficacy of ym150 in patients with knee replacement surgery

Conditions: Arthroplasty, Replacement, Knee

Summary: to evaluate the safety and efficacy of twice daily dosing and once daily dosing of ym150 in subjects undergoing primary elective knee replacement surgery


Eligibility criteria:
inclusion criteria: * subject is scheduled for elective primary knee arthroplasty * written informed consent obtained exclusion criteria: * subject has documented history of previous vte * subject is considered to be at increased risk of vte * subject has active bleeding or any condition associated with increased risk of bleeding * subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Keywords: knee arthroplasty factor xa vte thrombosis anticoagulants
safety study of mocetinostat in combination with azacitidine in subjects with mds

Conditions: Myelodysplastic Syndrome

Summary: mocetinostat is an orally administered histone deacetylase (hdac) inhibitor. azacitidine is a hypomethylating agent (hma) used to treat mds. in this study, patients with intermediate- or high-risk mds will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). in addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.

the study will include multiple cohorts of patients. in the first cohort, patients may have previously received treatment with hypomethylating agents such as azacitidine. in later cohorts, prior treatment with this class of anti-cancer agents will be excluded. later cohorts will include patients that are receiving this class of agents, specifically azacitidine, for the first time.

Eligibility criteria:
inclusion criteria: diagnosis of intermediate- or high-risk (ipss criteria) myelodysplastic syndrome. cohort 1: any prior treatment, enrollment complete. cohort 2: limited or no prior treatment for mds. prior treatment should not include hypomethylating agents such as azacitidine or decitabine, or hdac inhibitors. ecog performance status 0 or 1. exclusion criteria: current or history of small, moderate or large pericardial effusion, tamponade and/or pericarditis. significant cardiac abnormalities such as recent myocardial infarction, congestive heart failure ≥ class 3, or symptomatic, uncontrolled atrial fibrillation, atrial flutter or sinus tachycardia. prolonged qt/qtc interval. other active cancer excluding basal cell carcinoma or cervical intraepithelial neoplasia.

Keywords: mocetinostat azacitidine vidaza myelodysplastic syndrome hdac hma mds
efficacy of 5-aza for post-remission therapy of acute myeloid leukemia (aml) in elderly patients

Conditions: Acute Myeloid Leukemia

Summary: the present study aims to compare the efficacy of postremission maintenance therapy with 5-aza versus best supportive care (bsc) in a cohort of aml patients aged \>60 years, who have achieved complete remission (cr) following conventional induction ('3+7') and consolidation chemotherapy.

the present study aims to compare the efficacy of postremission maintenance therapy with 5-aza versus best supportive care (bsc) in a cohort of aml patients aged \>60 years, who have achieved cr following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of overall survival and disease free survival between two arms

Eligibility criteria:
inclusion criteria: 1. age 61 years or more 2. newly diagnosed aml with \> 30% myeloid marrow blasts, either "de novo" or evolving from a mds not previously treated with chemotherapeutic agents. 3. absence of central nervous system involvement 4. no contraindications for intensive chemotherapy, defined as: 1. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; 2. a creatinine or bilirubin level more than twice the upper limit of normal, except if aml-related; 3. a performance status (ps) score of \> 2; 4. uncontrolled severe infection. 5. informed consent. exclusion criteria: 1. age ≤ 60 years 2. newly diagnosed aml with \< 30% myeloid marrow blasts 3. previously treated aml 4. central nervous system involvement 5. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; 6. a creatinine or bilirubin level more than twice the upper limit of normal, except if aml-related; 7. a ps score of \> 2; 8. uncontrolled severe infection.

Keywords: acute myeloid leukemia, post-remission therapy
cse v. epidural for postpartum depression

Conditions: Depression, Postpartum; Labor Pain

Summary: the purpose of this pilot prospective randomized control trial is to compare the initiation of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on risk for postpartum depression symptoms. investigators will randomize women to the receipt of cse or e during labor, after measuring baseline psychological, psychosocial, and psychophysical factors related to pain and depression. the immediate research goals are to understand whether the association between labor pain and ppd is modifiable through the use of tailored anesthetic techniques.


Eligibility criteria:
inclusion criteria: * nulliparous (no prior childbirth) * singleton gestation * third trimester * healthy pregnancy * english proficiency (surveys validated in english) * planned vaginal delivery * planning to use labor epidural analgesia * term delivery (\>/= 37.0 weeks) exclusion criteria: * severe maternal disease * severe fetal disease * delivery not at term (delivery prior to 37.0 weeks) * contraindications to neuraxial anesthesia known at the time of enrollment * cesarean delivery without labor * planning to list infant for adoption * did not receive epidural analgesia (either cse or e) for labor

Keywords: pregnant analgesia labor analgesia epidural combined spinal epidural
the ccus based characteristic of hemodynamic and lung pathology in early stage of shock in icu: the epidemic and prognostic value

Conditions: Shock

Summary: shock is a common condition in critical care unit (icu). it is extremely important that the patient accepts early goal-directed therapy (egdt) treatment in the early stage of shock. however, several studies failed to demonstrate that the well used variables such as cvp and others could direct to a better treatment. in recent years, critical care ultrasound (ccus) has been respected as a reliable noninvasive tool and widely used in icu practice. with ccus the investigators can accurately acquired the detailed information of the characteristic of the hemodynamics and lung pathology (the systole and diastole function, volume status, valve insufficiency, lung, edema, consolidation, and pleural effusion, etc.). to the investigators knowledge, there is no study investigating the epidemic of such ultrasonic variables and its value to predict to outcome. the aim of this study is to investigate the epidemic and the prognostic value of ccus based characteristic of hemodynamic and lung pathology in early stage of shock in patients admitted in icu.

adult patients who admitted to the intensive care unit of west china hospital of sichuan university with shock from april 2016 to april 2017 enrolled.

Eligibility criteria:
inclusion criteria: 1. sbp\ 40mmhg or need vasoactive drugs; 2. skin that is cold and clammy, capillary refill time \>4.5s, urine output of \ 2mmol/l; 3. shock presented within 6 hr. exclusion criteria: 1. \<18 years old; 2. pregnancy; 3. patient or family member refuse to be enrolled.

Keywords: shock critical care ultrasound hemodynamics lung pathology epidemic prognosis
benefits of online mahjong by older adults

Conditions: Aged

Summary: this study aims to examine the clinical efficacy of online mahjong in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, mri) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.

psychomotor function among older adult's decline was associated with reducing people interaction during pandemic has been reported. the research focused on examining the benefit and efficacy of digital based mahjong games with 6-month intervention is very limited or none. a random control design was conducted with comparing intervention group and with control group, followed the consort guidelines. six months program was intervened to ensure the impact of the intervention. primary outcome is brain imagery changes between groups, which showed changes in temporal fusiform cortex but not in resting-state fmri. the total score of moca, delayed recall was increase from baseline to after intervention in experimental group. overall cognitive function and visuospatial/executive, in experimental group improved more than control group. improving self-rating daily health status as associated with achievement rate of mahjong game. increasing level of resilience was associated with demoralization level, subtraction of cognitive function, and 5th month walking steps. in addition, affecting incased self -rate overall heath was related to demoralization. in short, online mahjong intervention has positive impact on older adults in cognitive function , resilience, demoralization and overall quality of life.

Eligibility criteria:
inclusion criteria: 1. age ≥ 55 years old. 2. more than 6 years of formal education. 3. can communicate in mandarin and taiwanese. 4. can accept mri examination without claustrophobia. 5. can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject. exclusion criteria: 1. have engaged in any mahjong games in the past three months. 2. engaged in mahjong games more than three times per year in the past three years.

Keywords: online mahjong physical activity cognitive function quality of life in older adults
chronic arterial disease, quality of life and mortality in chronic kidney injury

Conditions: Kidney Diseases; Cardiovascular Diseases

Summary: cadkid-study is a prospective follow-up study assessing arterial disease, quality of life, mortality and their predictors in patients with severe chronic kidney disease.

chronic kidney disease (ckd) is associated with increased risk of cardiovascular disease and mortality as well as impaired quality of life. participants of this study all have severe ckd, defined as estimated glomerular filtration rate \< 30 ml/min per 1.73 m\^2. stress ergometry, echocardiography, ultrasound assessment of arterial intima-media thickness, lateral lumbar radiograph, ecg, laboratory tests and quality of life assessment were performed at the baseline of the study and will be repeated during follow-up. atrial fibrillation and other cardiac arrhythmias as well as pulse wave velocity measurements will be explored. diet diaries are gathered and analysed. the aim of the study is to identify factors associated with cardiovascular disease, quality of life and mortality in this cohort.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate \< 30 ml/min per 1.73 m\^2 exclusion criteria: * age under 18 years * inability to give informed consent

Keywords: chronic kidney disease quality of life
trial to compare the efficacy of systane ultra and refresh drop in the treatment of dry eye in asian eyes

Conditions: Xerophthalmia; Blepharitis

Summary: systane ultra is at least as efficacious and safe as refresh tears in asian people with dry eyes

comparison of efficacy of systane ultra and refresh tears

Eligibility criteria:
inclusion criteria: 1. subject age is between 40 and 65 years old. 2. corneal fluorescein staining present in at least one/five sectors of at least one cornea 3. at least one question out of 6 questions on dry eye symptom present often or all the time. based on the salisbury eye study by oliver schein et al. (does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) please see appendix 1. 4. at least one of the following: tbut \<= 5 s or schirmer i less than 8 mm in at least one eye 5. yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of marx's line in line with meibomian orifice) 6. not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks. 7. use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day). 8. able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days. exclusion criteria: 1. known history of thyroid disorders (diagnosed by physician). 2. known history of sjogren syndrome or rheumatoid arthritis (diagnosed by physician). 3. no ocular surgery within 6 months and lasik within 1 year. 4. any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks. 5. ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos. 6. anticipated necessity to wear contact lens in the duration of the study. 7. not living in the same household as another participant of the study. 8. any other specified reason as determined by clinical investigator.
ketamine-assisted psychotherapy (kap) compared to ketamine alone for the treatment of depression

Conditions: Major Depressive Disorder

Summary: the proposed study is a single-site, randomized, controlled clinical trial (rct) comparing ketamine-assisted psychotherapy (kap) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (ket). eligible study participants will be adults with major depressive disorder (mdd). adults with mdd will be randomized to kap or ket in a 1:1 allocation. each treatment group will receive kap or ket over a period of four weeks. measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.


Eligibility criteria:
inclusion criteria * written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study. * age 18-90 years * participant in good physical health * participants may be on medications for depression as long as they remain on a stable dose. * a score of at least 20 on the 10 item montgomery-asberg depression scale at screening, corresponding to at least moderate current depression severity. * meets criteria for major depressive disorder (mdd) in current major depressive episode (mde) according to dsm-5 * women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion exclusion criteria * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease * clinically significant abnormalities of laboratories, physical examination, or ecg * substance drug or alcohol use disorder in the prior 12 months * history of hypersensitivity to ketamine or esketamine * lifetime history of schizophrenia, schizoaffective disorder, bipolar i or ii disorder * presence of psychotic symptoms in the current mde, or lifetime psychotic disorder * recreational ketamine or phencyclidine use in the last year * previous non-response to clinical or research ketamine or esketamine administration * concurrent treatment with ect, tms, or vns in the current mde * bmi \> 35 * significant suicidal ideation as determined by a c-ssrs score \>2 in past 30 days * history of suicide attempt or self harm in the prior 2 years * sbp \> 165 or dbp \> 95 on infusion day * moca score \< 23

Keywords: ketamine major depressive disorder ketamine assisted psychotherapy